38.10 Saving Your Tail: How Do We Improve Overall Survival in Anal Cancer?

Posted on December 22, 2014

C. P. Probst1, C. T. Aquina1, A. Z. Becerra1, B. J. Hensley1, K. Noyes1, M. G. Gonzalez1, A. W. Katz2, J. R. Monson1, F. J. Fleming1  1University Of Rochester Medical Center,Surgical Health Outcomes & Research Enterprise,Rochester, NY, USA 2University Of Rochester Medical Center,Department Of Radiation Oncology,Rochester, NY, USA

Introduction:
Since the 1980s, combined modality treatment with radiotherapy (RT) and multi-agent chemotherapy has replaced abdominoperineal resection as the preferred definitive treatment for anal cancer. However, there is little data regarding factors affecting long-term overall survival (OS). This study examined the effect of patient, treatment, and hospital factors as well as year of diagnosis on overall survival.

Methods:
Patients with clinical stage I-III squamous cell carcinoma of the anus with complete information about RT treatment were selected from the 1998-2006 National Cancer Data Base. Bivariate analyses were used to examine differences in 5-year overall survival across patient, treatment, and facility characteristics. Kaplan-Meier curves compared survival differences between patients diagnosed from 1998-2002 and those diagnosed from 2003-2006. Subsequently, factors with a p-value <0.2 were entered into a Cox Proportional Hazards model to examine factors associated with 5-year OS. Factors that did not contribute to model fit were manually removed to produce an optimized final model.

Results:
Of the 11,027 patients that met inclusion criteria, 25% were clinical stage I, 49% clinical stage II and 26% clinical stage III. On Kaplan Meier analysis, minimal improvements in mean overall survival were noted for those diagnosed in later years compared to earlier years. Only 40% of patients were treated with guideline-indicated multi-agent chemotherapy and 45 Gray (Gy) RT dose. Additionally, suboptimal chemotherapy and radiation treatments resulted in reduced survival (Figure 1, p<0.001 for all comparisons). Within the multivariable analysis, numerous factors had a negative impact on OS. Compared to those receiving multi-agent chemotherapy and 45 Gy RT dose, increased hazard of death was observed in those treated with single-agent, no chemotherapy or RT dose less than 45 Gy (HR=1.10 95% CI=1.05-1.16) as well as those with both suboptimal chemotherapy regimen and RT dose (HR=1.35, 95% CI=1.26-1.45). Compared to patients with private insurance, decreased survival was observed among those with no insurance (HR=1.12, 95% CI=1.01-1.24), Medicaid (HR=1.20, 95% CI=1.10-1.30), and Medicare (HR=1.20, 95% CI=1.13-1.26). Compared to white patients, black patients had increased risk of death (HR=1.10 95% CI=1.02-1.19). Male sex was also an independent predictor of poor survival (HR=1.17, 95% CI=1.12-1.23).

Conclusion:
There has been minimal improvement in anal cancer survival over time. Sixty percent of patients are still undertreated, with widespread disparity in survival across patient groups. Utilization of a multi-disciplinary tumor board for anal cancer may help improve the delivery of appropriate treatment to all patients.
 

39.06 Influence of Body-Mass Index on Outcomes Following Major Resection for Cancer

Posted on December 22, 2014

C. K. Zogg1, B. Mungo2, A. O. Lidor3, M. Stem3, K. S. Yemul1, A. H. Haider1, D. Molena2  1Johns Hopkins University School Of Medicine,Center For Surgical Trials And Outcomes Research, Department Of Surgery,Baltimore, MD, USA 2Johns Hopkins University School Of Medicine,Division Of Thoracic Surgery, Department Of Surgery,Baltimore, MD, USA 3Johns Hopkins University School Of Medicine,Department Of Surgery,Baltimore, MD, USA

Introduction:  More than 1 in 3 adults in the United States, accounting for >106 million people, is obese. From a surgical perspective, the high prevalence of obesity means that operations on this population are common in everyday practice. Despite the assumption that obesity is associated with increased surgical risks, current evidence to suggest that obese patients fair worse is inconclusive. This study sought to examine associations between body-mass index (BMI) and outcomes following major resection for cancer using a nationally-validated outcomes-based database.

Methods:  Data from the 2006-2012 American College of Surgeons NSQIP were queried for patients ≥18 years of age with a primary ICD-9 cancer diagnosis and corresponding CPT code for lung surgery, esophagectomy, hepatectomy, gastrectomy, colectomy or pancreatectomy. BMI calculated for included patients were categorized according to World Health Organization classification (Table). Patients were compared first via single logistic regression for differences in 30-day mortality, extended length of stay (LOS), serious morbidity, overall morbidity and isolated morbid conditions among three cohorts: normal vs. (1) underweight, (2) overweight-obese I and (3) obese II-III. Similar methodology was employed using multivariate logistic regression adjusted for clinical/demographic factors and type of resection preformed. Risk-adjusted, stratified analyses for each resection were also considered in addition to an overall propensity score-adjusted logistic analysis (Table).

Results: Consistent with the distribution of BMI in the United States, we identified 529,955 patients of whom 32.06% (169,880) were normal weight, 3.45% (18,284) underweight, 32.52% (172,355) overweight and 17.76% (93,669), 7.51% (39,820) and 4.94% (26,177) obese I-III. Unadjusted, multivariate and propensity-score adjusted logistic regression found that 30-day mortality, extended LOS and serious and overall morbidity were significantly increased in cohort 1. Overall, we did not observe worse surgical outcomes in cohort 2; although, these patients had increased risk for isolated complications such as wound infection, venous thromboembolism, prolonged mechanical ventilation and renal complications. In cohort 3, obese patients experienced a 3-9% increased odds of overall and serious morbidity. Analyses stratified by cancer-resection type reported similar trends.

Conclusion: Evidence-based assessment of outcomes following major resection for cancer suggests that obese patients should be treated according to optimal oncologic standards Surgeons should not be hindered by unproven perceptions of prohibitively increased perioperative risk in this population.

37.10 Indirect Costs Incurred by Patients Obtaining Free Breast Cancer Care in Haiti

Posted on December 22, 2014

K. M. O’Neill1, M. Mandigo5, R. Damuse6,7, Y. Nazaire6,7, J. Pyda4, R. Gillies7, J. G. Meara2,3,7  1University Of Pennsylvania,Perelman School Of Medicine,Philadelphia, PA, USA 2Harvard School Of Medicine,Brookline, MA, USA 3Children’s Hospital Boston,Plastic Surgery,Boston, MA, USA 4Beth Israel Deaconess Medical Center,Surgery,Boston, MA, USA 5University Of Miami,School Of Medicine,Miami, FL, USA 6Hopital Universitaire Mirebalais,Mirebalais, CENTRE, Haiti 7Partners In Health,Boston, MA, USA

Introduction: In low- and middle-income countries (LMIC), it has been reported that 90% of patients with breast cancer have stage III or IV upon presentation.[i] Although many factors contribute to this phenomenon, the financial burden of seeking care incurred through indirect costs such as user fees, food, travel and lost wages is an important consideration that is often overlooked.

Methods:  In this study, we delineated the costs that Haitian patients pay out-of-pocket to seek comprehensive oncology care at Hôpital Universitaire de Mirebalais (HUM), where oncologic care is offered free of charge. In total, 61 patients were directly interviewed about associated costs during different points along the treatment cycle: (1) Diagnostic visits; (2) Chemotherapy visits (pre- and post-surgery) and (3) Surgical visit.

Results: On average, patient indirect expenses were: $619.04 for diagnostic costs, $635.68 for chemotherapy and $94.33 for the surgical visit. When costs at outside facilities were included, we found that patients paid $1,698.84 out-of-pocket on average during the course of their treatment. When comparing these expenses to the income of the patients, we found that patients were spending 193% (95% CI: 99%-287%) of their income on average for out of pocket expenses, with 68% of patients spending >40% of their potential income on medical expenses. When we included lost wages into the indirect costs, the average indirect costs came to $6,465 (95% CI: $1,833 – $11,096). The indirect costs to the patient were on average 3.36 times higher than the direct costs to the hospital (calculated in a separate study as $1,922 per patient).

Conclusion: Health expenditures are financially catastrophic for families throughout the world. In Haiti, 74% of people live on less than $2 per day and 65% live in extreme poverty (less than $1 per day).[ii] Given the findings in this study, it is likely that the financial burden of seeking care for breast cancer—even when that care is offered “free of charge”—may be insurmountable for the majority of patients.

[i] Fregene A & Newman LA. Breast cancer in sub-Saharan Africa: How does it relate to breast cancer in African American women? Cancer 2005;103(8):154050.

[iI] "Objectifs du Millenaire pour le developpement etat, tendances et perspectives. Ministere de L’Economie et des Finances. Institut Haitien De Statistique et D’informatique. December 2009 http://www.ihsi.ht/pdf/odm/OMD_Novembre_2010.pdf Accessed June 20, 2014 

 

38.01 Joints Under Study Trial (JUST)

Posted on December 22, 2014

R. Martin1, A. Chan1  1Mount Hospital Breast Cancer Research Centre

Overview:
The JUST trial is a Phase II, randomised, double blind, placebo-controlled study to evaluate the efficacy of topical pure Emu oil for arthralgic pain, related to aromatase inhibitor use in postmenopausal women with early breast cancer.

Background:
20% of patients using aromatase inhibitors for treatment of breast cancer cease them due to arthralgias and joint pains.
Emu oil has been shown to have topical anti-inflammatory effect in animal studies. A phase 1 trial has demonstrated 45% reduction in pain scores in 13 women applying Emu oil to affected joints after 8 weeks treatment.

Aim:
Using Visual Analogue Scores (VAS) we aim to demonstrate an improvement in joint pain as assessed from baseline to end of 8 weeks of treatment.

Secondary end points are to demonstrate an improvement in joint stiffness as assessed by a 4 point categorical scale from baseline to end of 8 weeks of treatment. We will also look at: Adverse effects related to the use of emu oil, compliance with application of Emu oil, and assess overall pain at the end of 8 weeks using the Brief Pain Inventory score

Methods:
~75 patients with joint pain subjectively worsening whilst on an aromatase inhibitor, randomized to receive either 250ml Emu Oil or 250ml placebo oil on a 1:1 basis. 1.25 ml oil applied over 30mins to up to 3 affected joints nominated at baseline. Baseline 5 point visual analogue scores completed with Brief pain inventory (BPI). Daily diary entry will be checked to ensure compliance, with final VAS and BPI scores completed at 8 weeks. At 8 weeks participants will be offered a further 8 weeks of treatment with open label Emu oil with VAS and BPI to be completed at the end of 16 weeks.

Accrual expected to be complete end February 2015. 72 patients will give 80% power to detect a 40% difference allowing for 25% placebo effect.
 

38.02 Staging Studies are of Limited Utility for Newly Diagnosed Clinical Stage I-II Breast Cancer

Posted on December 22, 2014

A. Linkugel1, J. Margenthaler1, A. Cyr1  1Washington University,General Surgery/College Of Medicine,St. Louis, MO, USA

Introduction:   For patients diagnosed with clinical Stage I-II breast cancer, treatment guidelines recommend against the routine use of radiologic staging studies in the absence of signs or symptoms suggestive of distant metastasis. However, these tests continue to be used for many early-stage breast cancer patients. This study aims to determine the utilization and yield of these studies at a National Comprehensive Cancer Network (NCCN) member institution.

Methods:   Female patients presenting with AJCC 7th Edition clinical stage I-II invasive breast cancer between 1998 and 2012 at Siteman Cancer Center, an NCCN member institution, were identified in a prospectively maintained institutional surgical database. Patients treated with neoadjuvant chemotherapy were excluded. Charts were reviewed to verify clinical stage and to document staging studies performed within six months of diagnosis.  Staging studies of interest included computed tomography (CT) of the chest, abdomen, and/or pelvis, bone scan, and positron emission tomography (PET).  Results of staging studies and additional diagnostic studies or procedures were recorded.  Descriptive statistics were used for the analysis.

Results:  A total of 3291 patients were included in the analysis (2044 were stage I and 1247 were stage II). Of these, 882 (27%) received CT of the chest, abdomen, and/or pelvis; bone scan; or PET within 6 months of diagnosis. A total of 691/882 (78%) received chest CT, 705/882 (80%) abdominal/pelvic CT, 704/882 (80%) bone scan, and 70/882 (8%) PET. Of these 882 patients, 312 were stage I (15% of the stage I cohort) and 570 were stage II (46% of the stage II cohort). Of the 882 patients imaged, 194 (22%) required additional imaging (x-ray, CT, bone scan, sonogram, or PET) and/or biopsies to follow-up abnormalities seen on the staging studies. However, only 11 of those 194 (6%) were confirmed to have metastatic disease (1.2% of the 882 imaged patients, 0.33% of the total study cohort). Of these 11 patients, one was clinically stage I at presentation, and 10 were stage II. Metastatic sites identified included lung (n=3), bone (n=4), liver (n=1), and a combination of sites (n=3). Numbers of patients determined to have metastatic disease were too small for comparative analysis.

Conclusions:  The identification of distant metastasis among clinical Stage I-II patients in this study was rare (0.33% of the total cohort). Even among patients judged appropriate for staging studies (CT, bone scan, and/or PET), only 1.2% were diagnosed with metastatic disease. These findings suggest that even at an NCCN member institution, staging studies are overused and lead to additional procedures in over 20% of patients.

38.03 Cancer-Directed Surgery and Conditional Survival in Advanced Stage Colorectal Cancer

Posted on December 22, 2014

L. M. Wancata1, M. Banerjee4, D. G. Muenz4, M. R. Haymart5, S. L. Wong3  1University Of Michigan,Department Of General Surgery,Ann Arbor, MI, USA 3University Of Michigan,Division Of Surgical Oncology,Ann Arbor, MI, USA 4University Of Michigan,Department Of Biostatistics,Ann Arbor, MI, USA 5University Of Michigan,Division Of Metabolism, Endocrinology, & Diabetes & Hematology/Oncology,Ann Arbor, MI, USA

Introduction: Though historically associated with poor survival rates, recent data demonstrate that some patients with advanced (stage IV) colorectal cancer (CRC) are surviving longer in the modern era.  Treatments have included improvements in systemic therapies and increased use of metastasectomy.  Traditional survival estimates are less useful for longer-term cancer survivors and conditional survival, or survival prognosis based on time already survived, is becoming more accepted as a means of estimating prognosis for certain subsets of patients who live beyond predicted survival times.  What is unknown is how specific treatment modalities affect survival.  We evaluated the use of cancer-directed surgery in patients with advanced CRC to determine its impact on long term survival in this patient population.

Methods: We used data from the Surveillance, Epidemiology, and End Results (SEER) registry to identify 323,415 patients with CRC diagnosed from 2000-2009.  The SEER program collects data on patient demographics, tumor characteristics, treatment, and survival data from cancer registries across the country. This cohort represents approximately 26% of the incident cases and its demographics are comparable to that of the general US population. Conditional survival estimates by SEER stage, age and cancer-directed surgery were obtained based on Cox proportional hazards regression model of disease-specific survival.

Results: Of the 323,415 patients studied 64,956 (20.1%) had distant disease at the time of diagnosis.  Median disease-specific survival for this cohort was just slightly over 1 year. The proportion of patients with distant disease who underwent cancer-directed surgery was 65.1% (n=42,176).  Cancer-directed surgery in patients with distant disease appeared to have a significant effect on survival compared to patients who did not undergo surgery [hazard ratio 2.22 (95% CI 2.17-2.27)].  These patients had an approximately 25% improvement in conditional 5 year disease specific survival across all age groups as compared to their counterparts who did not receive cancer-directed surgery, demonstrating sustained survival benefits for selected patients with advanced CRC who undergo resection.  A significant improvement in conditional survival was observed over time, with the greatest gains in patients with distant disease compared to those with localized or regional disease (Figure).

Conclusion: Five-year disease-specific conditional survival improves dramatically over time for selected patients with advanced stage CRC who undergo cancer-directed surgery.  This information is important in determining long term prognosis associated with operative intervention and will help inform treatment planning for patients with metastatic disease.

38.04 Temporal Trends in Receipt of Immediate Breast Reconstruction

Posted on December 22, 2014

L. L. Frasier1, S. E. Holden1, T. R. Holden2, J. R. Schumacher1, G. Leverson1, B. M. Anderson3, C. C. Greenberg1, H. B. Neuman1,4  1University Of Wisconsin,Wisconsin Surgical Outcomes Research Program, Department Of Surgery,Madison, WI, USA 2University Of Wisconsin,Department Of Medicine,Madison, WI, USA 3University Of Wisconsin,Department Of Human Oncology,Madison, WI, USA 4University Of Wisconsin,Carbone Cancer Center,Madison, WI, USA

Introduction:  : Research suggests an inverse relationship between post-mastectomy radiation (PMRT) and immediate breast reconstruction (IR). Recent data on the effectiveness of PMRT has led to increasing use in patients at intermediate risk (tumor ≤ 5cm with 1-3 positive nodes) of recurrence. At the same time, significant increases in the use of IR over the last decade have been observed. We sought to determine whether the increased use of PMRT in intermediate risk patients has led to a slower increase in rates of IR when compared to groups in whom the guidelines for PMRT have not changed.  

Methods:  The SEER Database was used to identify female patients with stages I‑III breast cancer undergoing mastectomy over the decade from 2002‑2011 (n=40,889). Patients ≥ 65 were excluded due to low rates of IR (5.1%). Three patient cohorts defined by likelihood of PMRT were formed based on tumor characteristics: High Likelihood (four or more positive lymph nodes or tumors >5 cm with 1‑3 positive lymph nodes), Intermediate Likelihood (tumors ≤5 cm with 1‑3 positive lymph nodes), and Low Likelihood (tumors ≤5 cm with 0 positive nodes). Changes in IR for each of these groups over time were assessed using joinpoint regression and summarized using annual percentage change (APC), which represents the slope of the line.

Results: The overall use of reconstruction increased from 22% in 2002 to 41% in 2011.  This statistically significant increase was observed across all 3 cohorts defined by the likelihood of receiving PMRT and across all ages. Receipt of IR was lower among groups with a higher likelihood of a recommendation for PMRT at the start of the study period: 14.1%, 19.4%, and 27.8% in the High, Intermediate, and Low Likelihood cohorts, respectively, in 2002. The highest risk group demonstrated the most increase in receipt of IR, as evidenced by its annual percentage change of 9.8%, with intermediate and low risk exhibiting APCs of 6.2% and 5.9%, respectively.  No group showed a significant change in APC from 2002-2011, meaning the rate of change was constant over the study period.

Conclusion: Rates of reconstruction have increased over the study period across tumor characteristics and are highest in patients that are least likely to receive a recommendation for PMRT. At no point did any group exhibit any evidence of a decreased rate of change, despite increased indications for PMRT over this time period. In fact, rates of IR for patients at intermediate and high likelihood of receiving PMRT are increasing faster than rates for the lowest-likelihood patients.  This may indicate that surgeons and radiation oncologists are becoming increasingly more comfortable with the prospect of immediate reconstruction in the setting of anticipated PMRT.
 

38.05 Factors impacting patient compliance with breast cancer screening guidelines in the US.

Posted on December 22, 2014

S. C. Pawar1, R. S. Chamberlain1  1Saint Barnabas Medical Center,Surgery,Livingston, NJ, USA

Introduction: Breast cancer screening guidelines for women between age 40 and 49, 50 and 74, and over 75 years of age are variable.  Controversies exist as to the effectiveness and potential risk associated with screening among different age groups and important predictors of mammography remains unclear. The study sought to determine breast cancer screening rates among US women of various ages, identify factors predictive of adherence to mammographic screening guidelines, and determination of the impact of physician recommendation.  

Methods: The National Health Interview survey database was queried to identify female patients who underwent a screening mammography between 2008 and 2010. Univariate and multivariate logistic regression models were used to identify predictors of mammography. 

Results:The median age of the study cohort was 53 yr. Among 11,312 women surveyed, and 8,155 (72%) had undergone a mammogram. Women undergoing mammographic screening were significantly older than women did not undergo a mammogram (53 Vs 39; P < 0.001). The high to low possibility of women undergoing mammographic screening were age 50-74 years followed by ≥ 75 years (85%), and 40-49 years (77%) and  < 40 years (27%). 74% of this cohort were Caucasians, 18% African Americans, 0.8% Asians and 2% other races.  86% of women had insurance coverage for mammographic screening while 14% lacked any insurance coverage. Overall 53% of the uninsured received a mammogram.  Northeastern region had the highest percentage of women screened; however there were no significant geographic differences.  Mammographic screening was completed by 59% of women in whom it was recommended by physicians and by 75% in whom it was recommended by their designated primary care provider (p < 0.01). The percentage of women undergoing mammographic screening dropped from 78% (2008) to 76% (2010) over the study period and this was significant across women of all age groups except those < 40 years. The strongest predictors of completing mammography were physician recommendation, a designated primary care provider recommendation, adherence with annual breast examination, race/ethnicity, insurance type, and income status. The strongest association between physician recommendation and undergoing mammography was in the youngest age group women (OR: 20; 95% CI 15-27). Among women < 40 years for whom a mammogram was recommended by the physician, 23% had a history of BRCA1/BRCA2 gene mutation, while 34% reported of a family history of breast cancer.

Conclusion:A decrease in mammography screening among women of all age groups was observed during the study period and was most conspicuous in younger women. Explanations are likely multifactorial, but may be related to implementation of the USPSTF (United States prevention services task force). Barriers to mammography identified included the absence of physician recommendation, lack of a designated primary care provider, lack of adherence to annual breast examination, racial minorities, lower socioeconomic status, decreased education level and deprived insurance status. Physician recommendation is the strongest predictor of mammographic screening among patients compliant in all age groups, although there may be over recommendation of mammography among those > 70 years and < 40 years. 

 

38.06 Utilization of PET in Patients with Lung and Esophageal Cancers

Posted on December 22, 2014

M. A. Healy1, H. Yin1, R. M. Reddy1, S. L. Wong1  1University Of Michigan,Department Of Surgery And Center For Health Outcomes & Policy,Ann Arbor, MI, USA

Introduction: Positron Emission Tomography (PET) scans are commonly used for cancer patients as part of the staging process. PET scans are often used for surveillance without evidence that they are superior to lower cost screening scans, and there are concerns about potential overuse. We evaluated PET utilization patterns for patients with lung (LC) and esophageal (EC) cancers.

Methods: Using national Surveillance Epidemiology and End Results (SEER) and Medicare linked data from 2005-2009, we examined the use of PET in a cohort of patients with primary lung (n=105,697) and esophageal (n=6,961) cancers who were diagnosed during this period. Cancer diagnoses were identified with ICD-9 diagnoses codes: lung 162.xx and esophagus 150.xx. Diagnostic services such as PET are captured as charges, which are covered under Medicare. We examined a fee-for-service cohort of patients, excluding patients in risk-bearing Medicare managed care plans and patients who are not continuously enrolled in parts A and B. We examined the frequency and timing of PET usage, including with regard to diagnosis, treatment and cancer stage.

Results: There was similar overall utilization of PET in these groups, with 47,795 (45.2%) and 3,734 (53.6%) of lung and esophageal cancer patients, respectively, receiving at least one scan. Most patients received a first scan within 3 months of diagnosis (78.3% LC, 87.3% EC), indicating likely use for staging. Use of 2 or more scans occurred in 20,216 (19.1%) and 1,867 (26.7%) of LC and EC patients, respectively.  Additionally, 11,117 (10.5%) LC and 1,052 (15.1%) EC patients underwent 3 or more scans. Among patients with stage IV disease, 2 or more scans were performed in 4,987 (11.8%) and 382 (21%) of LC and EC patients, respectively. In this stage IV group, 2,710 (6.4%) LC and 222 (12.2%) EC underwent 3 or more scans.

For patients who underwent PET prior to chemotherapy, 10,085 (28.5%) and 781 (26.8%) of LC and EC patients received a single additional scan, 11,467 (32.3%) and 1,345 (46.2%) had 2 or more scans, and 6,774 (19.1%) and 793 (27.2%) had 3 or more scans. Total PET usage for LC was 96,475 scans and for EC was 8,223 scans.

Conclusion: Our results show that PET usage is common, though only half of patients with LC and EC received staging scans. However, many patients undergo multiple scans. A large number of patients with stage IV disease underwent as many as 3 or more scans, and it is in these patients that the likelihood of any benefit is the least. Our data supports the need for continued education to avoid using PET for surveillance in these cancers, especially in patients with advanced disease. Medicare’s current policy limiting routine reimbursement to 3 scans probably does not effectively curb wasteful PET usage.

33.10 Risk Stratification of Sentinel Lymph Node Positivity in Intermediate Thickness Melanoma

Posted on December 22, 2014

M. G. Peters1, E. K. Bartlett1, R. E. Roses1, B. J. Czerniecki1, D. L. Fraker1, R. R. Kelz1, G. C. Karakousis1  1Hospital Of The University Of Pennsylvania,General Surgery,Philadelphia, PA, USA

Introduction:  Patients with intermediate thickness cutaneous melanoma are routinely recommended for sentinel lymph node biopsy (SLNB) as standard of practice.  Conversely, those with thin melanoma are selectively offered the procedure given the low risk of SLN positivity in this group overall.  We sought to identify a low-risk subset of patients with intermediate thickness melanoma who, like many patients with thin melanoma, may be spared the additional LN procedure.

Methods: Demographics and histo-pathological characteristics of the primary tumor were reviewed for 952 patients undergoing SLNB for primary intermediate thickness cutaneous melanoma (1.01-4.00mm) treated at our institution from 1995-2011. Univariate analysis using chi-square and Wilcoxon rank-sum as appropriate was used to determine associations with SLN positivity. Factors approaching statistical significance (p<0.20) were included in a forward step-wise multivariate logistic regression.  All significant factors (p<0.05) were then included in a risk scoring system. 

Results:  The rate of positive SLNB in the study cohort was 16.5% (n=157).   In univariate analyses, significant factors associated with SLN positivity were increasing thickness (p<.001), absence of tumor infiltrating lymphocytes (p=.043), ulceration (p=.014), lymphovascular invasion (p<.001), and the presence of microsatellites (p<.001).   With regards to age <60 (p=.18) and presence of mitoses (p=.071), there was a trend toward significant association with SLN positivity.  When all of these factors were included in a multivariate model, five factors were identified as significantly associated with SLN positivity; younger age (<60 years, OR=1.52, p=.032), absence of tumor infiltrating lymphocytes (OR=1.64, p=.02), thicker primary tumors (OR=2.6 for 1.51-2, OR=3.5 for 2.01-4, p<.001), the presence of satellites (OR=2.2, p=.015), and lymphovascular invasion (OR=2.1, p=.014).  These factors were used to develop a risk stratification scoring system (see Table).  The rate of positive SLN ranged from 4.6% (when no factors were present, score=0) to 44.0% (when all factors were present, score= 5). 

Conclusion:Patients with intermediate thickness melanoma can be risk stratified for SLN positivity using clinical and pathologic factors. While SLNB appears justified for the majority of patients with intermediate thickness melanomas, for appreciable minority (nearly 10%) the risk of LN positivity is more similar to that of low risk T1 (<1.0mm) melanomas.  For this subgroup of patients, SLNB can be offered selectively.

34.04 Long-term Health-Related Quality of Life After Cancer Surgery: A Prospective Study

Posted on December 22, 2014

M. C. Mason1,2, G. M. Barden1,2, N. Massarweh1,2,3, S. Sansgiry1, A. Walder1, D. L. White1, D. L. Castillo1, A. Naik1, D. H. Berger1,2,3, D. A. Anaya1,2,3  1Michael E. DeBakey Veterans Affairs Medical Center,Houston VA Center For Innovations In Quality, Effectiveness, And Safety (IQUEST),Houston, TX, USA 2Baylor College Of Medicine,Michael E. DeBakey Department Of Surgery,Houston, TX, USA 3Michael E. DeBakey Veterans Affairs Medical Center,Operative Care Line,Houston, TX, USA

Introduction: The Institute of Medicine recently emphasized the importance of patient-reported outcomes following cancer care, and their relevance for the growing geriatric population. There are limited data on the impact of cancer surgery on health-related quality of life (HRQoL) in elderly patients. The goal of our study was to examine trends over time and changes in HRQoL measures following cancer surgery, and to evaluate the effect of age and receipt of adjuvant therapy on these outcomes.

Methods:  A prospective cohort study of patients undergoing elective cancer surgery at a tertiary referral center was performed (2012-2014). Demographic, clinical, cancer, and treatment variables were recorded. Cancer-specific HRQoL was prospectively measured using the EORTC C-30 questionnaire (6 domains) at the preoperative visit and at 1-month and 6-months postoperatively. The primary outcome of interest was a clinically significant drop in HRQoL, defined using the validated cutoff of a ≥10 point drop in Global Health Score (GHS) preoperatively to 6-month postoperatively. Patients were categorized based on their age into Young (<65y) and Elderly (≥65y), and trends over time as well as changes in GHS scores were compared between both groups. Univariate and multivariate logistic regression analyses were used to examine the association between age ≥ 65 and the primary outcome (Model 1) adjusting for receipt of adjuvant therapy (Model 2) and other important cofounders (Model 3).

Results: A total of 236 patients were included; 177 (75%) had major surgery, 105 (44.5%) were elderly, and 73 (31%) received adjuvant therapy. Baseline mean GHS score (67.2 [± 24.6]) dropped at 1-month (61.0 [± 25.0]) and increased close to baseline at 6-months (64.2 [± 23.4]) for the whole cohort, with no differences in trends over time between age groups. In all, 74 patients (31.4%) experienced a clinically significant drop in GHS score. Age ≥65 years was not associated with a clinically significant drop in HRQoL after univariate (Model 1: OR 1.62 [95% CI 0.93-2.82], P=0.09), and multivariate analyses (Model 2: OR 1.62 [0.93-2.83], P=0.09; and Model 3: OR 1.67 [0.93-2.99]; P=0.08).

Conclusions: Cancer patients overall experience a drop in HRQoL shortly after surgery (1-month), with a return close to baseline by 6 months. However, a high proportion of patients do not regain their baseline HRQoL, with almost one-third having a clinically significant drop that persists at 6 months postoperatively. Clinically significant drops in HRQoL were not associated with age ≥65 years, even among patients who received adjuvant therapy. Surgical and multimodality treatment should not be withheld from elderly patients based on concerns regarding long-term HRQoL.

34.05 Efficacy of Post-Mastectomy Radiation Therapy in the Setting of T3 Node-Negative Breast Cancer

Posted on December 22, 2014

L. Elmore1, A. D. Deshpande1, J. A. Margenthaler1  1Washington University,Surgery,St. Louis, MO, USA

Introduction: In the absence of lymph node involvement, tumor size is arguably the most important prognostic factor for women with breast cancer.  Development of an optimal adjuvant treatment regimen for women with locally-advanced node-negative breast cancer is critical due to the risk of locoregional failure.  Radiation therapy has been shown to improve locoregional control in selected populations of women with breast cancer but its efficacy in T3 node-negative breast cancer is controversial.  We investigated patterns of post-mastectomy radiation therapy (PMRT) use and the survival impact of this treatment modality in women with T3 node-negative breast cancer.

Methods: A retrospective cohort study was conducted by identifying women with T3 node-negative breast cancer from the 1988-2009 Surveillance, Epidemiology and End Results (SEER) database.  Our primary outcome variable was breast cancer-specific mortality.  Several sociodemographic variables and tumor characteristics were obtained to evaluate patterns of use of adjuvant therapy.  Survival curves were generated using the Kaplan-Meier method.  Hazard ratios were computed using Cox proportional hazard analysis.  Propensity score analysis was used to evaluate the effect of radiation on overall and breast cancer-specific mortality.

Results:We identified 2874 patients with T3 node-negative breast cancer.  Within this cohort of women, 961 (33%) received PMRT and 1913 (67%) did not.  Statistically significant differences were seen in adjuvant radiation therapy use based upon patient age, marital status, tumor grade, tumor size and receptor status (p<0.05 for all).  Younger age at diagnosis, marriage, and grade 3 tumor pathology were associated with adjuvant therapy use. Tumor size >9cm was associated with decreased use of adjuvant radiation therapy.  Analysis of overall mortality demonstrated lower mortality in the PMRT group in unadjusted analysis (cHR 0.718; 95% CI 0.614,0.840); however, adjusted hazard ratios demonstrated no difference in overall mortality (aHR 0.898; 95% CI 0.765, 1.054).  Unadjusted analysis of breast-cancer specific mortality demonstrated no difference in those who received PMRT and those who did not (cHR 0.834; 95% CI 0.682,1.021).  After adjusting for potential confounders using a propensity score analysis, again no significant difference in breast-cancer specific mortality was observed based on PMRT use (aHR 0.939; 95% CI 0.762, 1.157).

Conclusion:Analysis of the SEER database demonstrated that several patient and tumor characteristics are associated with use of adjuvant radiation therapy.  Results of the current study indicate that receipt of PMRT does not affect breast-cancer specific or overall survival in women with T3 node-negative breast cancer.

 

34.06 The Effect of Surgical Approach on Oncologic Outcomes in Rectal Cancer Surgery

Posted on December 22, 2014

E. F. Midura2, D. J. Hanseman2, R. S. Hoehn2, B. R. Davis2, D. E. Abbott2, S. A. Shah2, I. M. Paquette2  2University Of Cincinnati,General Surgery,Cincinnati, OH, USA

Introduction:  The oncologic safety of minimally invasive surgery for colon cancer has been well established, however the role for a minimally invasive approach to rectal cancer has yet to be fully defined. Though current evidence to support the use of laparoscopic and robotic approaches is limited, these approaches are being adopted broadly into clinical practice. We sought to describe national practice patterns in different surgical approaches and operative outcomes for rectal cancer in the US. 

Methods:  The 2010 National Cancer Database (NCDB) was queried for surgical cases of rectal cancer. Surgical approach was classified as open, laparoscopic, or robotic. Patient, tumor, and hospital characteristics were examined for variation in approach. Oncologic efficacy was studied by examining whether harvest of ≥ 12 lymph nodes (controlling for radiation use) and negative surgical margins were achieved. We used propensity-score matching to compare laparoscopic or robotic surgery to open surgery, while controlling for case-mix differences. 

Results: We identified 9,253 patients, of which 68.6% had open, 26.4% laparoscopic, and 5.0% robotic surgery. Patients who underwent a minimally invasive approach were more likely to have private insurance, higher income, and be operated on in higher volume, urban hospitals. Patients who underwent open operations were more likely to have elevated CEA levels, higher histologic grade and more advanced pathologic stage. Patients who had robotic surgery were more likely to receive preoperative radiation compared to other approaches (p = 0.01). In unadjusted analysis, patients who had a minimally invasive approach had a lower incidence of positive resection margin, a shorter length of stay and a lower readmission rate compared to open surgery, however there were no differences in lymph nodes harvested or 30-day mortality (Table 1). After propensity score matching on age, gender, radiation use, tumor grade, and pathologic T and N stage, the laparoscopic approach was associated with a 2.6% decrease in the incidence of positive margin when compared to open surgery (p = 0.02), whereas the robotic approach was not associated with a difference in margin status when compared to open surgery. 

Conclusion: Minimally invasive approaches for rectal cancer resections are more commonly performed in high volume, urban, academic centers on privately insured patients. Patients with more advanced tumors are being resected by an open approach. Examination of a matched cohort of patients indicates that the laparoscopic approach may lead to improvements in resection margin status, though longer follow-up will be needed to determine whether this translates into better long-term survival.

 

34.07 Multimodality Therapy Improves Survival in Resected Early Stage (IB-II) Gastric Cancer

Posted on December 22, 2014

J. Datta1, M. T. McMillan1, L. Ruffolo1, R. Mamtani2, J. A. Drebin1, D. L. Fraker1, G. C. Karakousis1, R. Roses1  2University Of Pennsylvania,Medicine (Oncology),Philadelphia, PA, USA 1University Of Pennsylvania,Surgery,Philadelphia, PA, USA

Introduction:  Multimodality therapy (MT) is a recommended component of treatment for early stage gastric adenocarcinoma (ESGA). Compliance with these guidelines, and the impact of MT on survival in ESGA has not been extensively explored. We examined (1) temporal trends in sequencing of MT, (2) factors associated with MT use, and (3) effect of MT receipt on overall survival (OS) in resected ESGA.

Methods:  The National Cancer Data Base was queried for stage IB-II GA patients undergoing gastrectomy (1998-2011). Multivariate models were developed to identify factors associated with adjuvant chemoradiotherapy (ACRT) or perioperative chemotherapy (PC) receipt and to compare risk-adjusted OS by treatment group.

Results: Of 7,357 resected ESGA patients (median age 68 years, 69.1% male), 50.6%, 25.5%, and 23.9% received surgery only (SO), PC, and ACRT, respectively. Utilization of MT rose consistently between 1998 and 2011, increasing by 42.4% (p<0.001). While ACRT use increased only modestly (12.0%–23.5%, p=0.02), receipt of PC increased dramatically (8.0%–38.8%, p<0.001). Predictors of ACRT receipt were multifactorial, but most strongly associated with age<56 years (OR 3.31, 95% CI 2.62-4.17) and non-proximal tumor location (OR 2.78, 95% CI 2.42-3.19). Proximal tumor location (OR 3.79, 95% CI 3.26-4.41) and AJCC clinical stage IIB (OR 2.42, 95% CI 1.99-2.92) were the strongest predictors of PC use. Younger, white, higher-income, and less comorbid patients were also significantly more likely to receive PC (all p<0.01). Hospital-based selection of MT varied significantly by geographic region and academic affiliation (all p≤0.01). Survival analyses included 1,275 patients with a minimum follow-up of 5 years. Median, 1-yr, and 5-yr survival was 44.8 months, 75.0%, and 46.0% respectively. In this cohort, median survival was significantly longer for patients selected to receive MT (i.e. ACRT or PC) compared with those undergoing SO (47.1 vs. 43.3 months; p<0.001). R1 resection (HR 2.08, 95% CI 1.56-2.76), pathologic lymph node positivity (HR 1.91, 95% CI 1.65-2.22), and tumor T-classification 3/4 (HR 1.75, 95% CI 1.50-2.04) were strongly predictive of worse risk-adjusted OS. On stage-stratified Cox regression analysis, utilization of MT was independently associated with improved OS in both stage IB and II GA (IB: HR 0.65; p=0.002; II: HR 0.73; p=0.003).

Conclusion: Adoption of MT in ESGA is steadily increasing nationally, but remains incomplete. Patient-, tumor-, and hospital-related factors influence selection of MT sequence. In ESGA, MT receipt is independently associated with improved survival compared with undergoing SO.

 

34.08 Routine Somatostatin Analogue Use Decreases Pancreatic Fistulas After Whipple: A Meta-Analysis

Posted on December 22, 2014

K. Mahendraraj1, R. S. Chamberlain1,2,3  1Saint Barnabas Medical Center,Department Of Surgery,Livingston, NJ, USA 2New Jersey Medical School,Department Of Surgery,Newark, NJ, USA 3Saint George’s University,Department Of Surgery,Grenada, Grenada, Grenada

Introduction:
Pancreatic fistulas remain one of the most common and detrimental complications following the Whipple operation (pancreaticoduodenectomy). The prophylactic use of somatostatin analogues (SA) for the prevention of pancreatic fistulas is controversial. This meta-analysis aimed to assess the effectiveness of SA in preventing pancreatic fistulas among the conflicting data from published randomized controlled trials.

Methods:
A comprehensive search of  PUBMED, Embase and both the Cochrane and NIH Clinical Trial Registries was completed using the keywords ‘somatostatin’, ‘octreotide’, ‘fistula’, and ‘randomized controlled trial (RCT)’. Citations of relevant review articles were examined. Data on patient recruitment, intervention and outcome were extracted from the included trials and analyzed. 42 full-text articles were identified in this manner, and 22 of these were excluded for lack of randomization, inadequate blinding and incomplete outcome data. Only RCTs which were completed and had an endpoint of ‘pancreatic fistula’ were included. The risk ratio (RR) was calculated with 95% confidence intervals.

Results:
20 RCTs involving 2,596 patients who underwent pancreaticoduodenectomy were identified. 1,312 patients (50.5%) were randomized to receive SA while 1,284 patients (49.5%) received either a placebo or no intervention. The incidence of pancreatic fistula was 32% lower in the SA group (RR 0.68, 95% CI 0.54-0.86;p=0.001). The proportion of these fistulas that were clinically significant is not clear. On subgroup analysis, there was no significant difference in perioperative mortality between the two groups (RR 0.80, 95% CI 0.56-1.16; p=0.24), but there was a 30% lower incidence of overall complications in the SA group (RR 0.70, 95% CI 0.60-0.82; p=0.03). Significant heterogeneity was found among the identified trials with regard to the definition of fistula, dosage of octreotide, starting time and duration of treatment.

Conclusion:
The use of SA following pancreaticoduodenectomy significantly reduces both pancreatic fistula and overall complication rates, with no effect on perioperative mortality. Available data suggests a role for routine prophylactic SA use to improve patient outcomes following major pancreatic resection. Further clarification of the effects of these drugs is required through additional large, adequately powered randomized controlled trials with low risk of bias.

34.09 The Role of Intraoperative Pathologic Assessment in the Surgical Management of DCIS

Posted on December 22, 2014

M. R. Decker1, H. B. Neuman1, A. Trentham-Dietz3, N. K. LoConte4, M. A. Smith3, R. S. Punglia2, C. C. Greeberg1, L. G. Wilke1  1University Of Wisconsin Hospital & Clinics,Department Of Surgery,Madison, WI, USA 2Dana Farber Cancer Institute,Radiation Oncology,Boston, MA, USA 3University Of Wisconsin School Of Medicine & Public Health,Population Health Sciences,Madison, WI, USA 4University Of Wisconsin Hospital & Clinics,Carbone Cancer Center,Madison, WI, USA

Introduction: The elevated number of repeat operations for the treatment of ductal carcinoma in situ (DCIS) is costly for patients and the medical community, financially and psychologically.  Intraoperative pathologic assessment of DCIS may lead to reduction in these additional surgeries. This study examines the relationship between intraoperative pathologic assessment and subsequent operations after a diagnosis of DCIS.

Methods: SEER-Medicare patients diagnosed with DCIS from 1999 to 2007 who underwent lumpectomy without axillary surgery, as their initial surgical procedure, were eligible.  All subsequent breast surgical procedures were identified.  Use of intraoperative pathology (frozen section or touch preparation) during the initial surgery was assessed.  Multivariable logistic regression was used to describe the relationship between the use of intraoperative pathologic assessment and any subsequent mastectomy or lumpectomy within 90 days of the initial operation. 

Results: Of 8,259 DCIS patients who underwent lumpectomy without axillary surgery, 3,510(43%) underwent a subsequent mastectomy or lumpectomy. Claims for intraoperative pathologic assessment were present for 2,172 (26%) patients.  On univariate analysis, patients with intraoperative pathology during their initial surgery were more likely to have additional breast surgery than patients without intraoperative pathology (28% vs 25%, p=0.009). However, multivariable analysis demonstrated that intraoperative pathologic assessment had no statistically significant relationship with ocurrance of subsequent breast surgery (Adjusted OR 1.06 (95%CI: 0.93-1.19), p = 0.387). Only tumor size >2cm (AOR 2.28 (95%CI: 1.99 ­-2.60), p<0.001), poorly differentiated tumor grade (AOR 1.36 (95%CI: 1.13 -1.63), p<0.001 ), and patient residence in a rural area (AOR 1.20 (95%CI: 1.01 to 1.43), p=0.034) were associated with greater likelihood of subsequent surgery. 

Conclusion: The use of intraoperative pathologic assessment during lumpectomy from 1999-2007 was not associated with a reduction in subsequent breast operations in women with DCIS. Surgery in 2014 for DCIS has not changed from 2000, as there are no novel intraoperative tools that have been developed or standardization of margin assessment implemented.  These results highlight a need to identify cost-effective tools and strategies to facilitate surgical decision making and reduce the number of subsequent operations for women with intraductal disease.

34.10 Small Cell Gastric Carcinoma is a Lethal Diagnosis: A Clinical Outcomes Study from the SEER Database

Posted on December 22, 2014

B. L. Siracuse1,4, K. Mahendraraj1, R. S. Chamberlain1,2,3  1Saint Barnabas Medical Center,Department Of Surgery,Livingston, NJ, USA 2New Jersey Medical School,Department Of Surgery,Newark, NJ, USA 3St. George’s University School Of Medicine,St. George’s, St. George’s, Grenada 4Duke University,Durham, NC, USA

Introduction:  Small cell gastric carcinoma (SCGC) is an aggressive neuroendocrine malignancy that comprises less than 0.1% of all gastric carcinomas. No large patient series exist and clinical information regarding SCGC is derived from limited case studies. This study sought to examine the demographic and clinical factors in a large cohort of SCGC patients in order to compare clinical outcomes of SCGC to the more common gastric adenocarcinoma (GA).

Methods:  Demographic and clinical data on 71,607 patients with gastric cancer was abstracted from the SEER database (1973-2010). 207 SCGC and 71,400 GA patients formed the study populations. Abstracted data was analyzed using Chi square tests, t-tests, and multivariate analysis. Kaplan-Meier analysis was used to compare long-term survival between the groups.

Results: SCGC comprised 0.3% of all gastric cancers identified. The mean age of SCGC and GA patients was similar (68±12 vs.70±13 years, p=0.03) and both cancers were more common in males (64.7% and 66.0%, p<0.001) and Caucasians (70.4% and 65.6%, p<0.001). SCGC was more often undifferentiated (66.9%vs.2.9%, p<0.001) and had more lymph node positivity (59.6% vs. 55.9%, p=0.01) and metastatic disease than GA (64.5% vs. 46.1%, p<0.001). SCGC had lower mean survival times than GA (1.00±1.78 vs. 2.02±3.91 years, p=0.03). Mean survival time for SCGC patients treated with radiation was inferior to GA, but SCGC patients benefited more from surgery than GA patients (2.20±0.61 vs. 1.23±0.04 years, p<0.001). Multivariate analysis identified tumor size greater than 2 cm (OR=2.1, CI=1.9-2.4), regional (OR=2.8, CI=2.6-3.0) or distant disease (OR=2.1, CI=1.9-2.4), lymph node positivity (OR=1.6, CI=1.4-1.8), undifferentiated grade (OR=1.3, CI=1.1-1.4), Caucasian race (OR=2.0, CI=1.8-2.2), and male gender (OR=1.2, CI=1.1-1.3) as independently associated with increased mortality for SCGC, p<0.001. A survival advantage for SCGC was seen in patients treated with surgery alone (OR=0.5, CI=0.4-0.6) or in combination with radiation (OR=0.23, CI=0.2-0.3), p<0.001.

Conclusion: SCGC is a rare and often lethal gastric malignancy that presents most often in Caucasian males in their seventh decade of life, with larger tumor size, more undifferentiated histology, greater lymph node positivity, and higher rates of metastatic disease than GA. The majority of SCGC was untreated presumably due to advanced disease, but when treatment was employed, surgical resection resulted in a greater survival advantage than similarly treated GA. The combination of surgery and radiation was associated with the longest survival compared to other treatment modalities for SCGC, and should therefore be considered in patients with operable disease.

32.04 Prognostic Relevance of Lymph Node Ratio and Total Lymph Node Count for Small Bowel Adenocarcinoma

Posted on December 22, 2014

T. Tran1, M. Dua1, G. Poultsides1, J. Norton1, B. Visser1  1Stanford University School Of Medicine,Surgery,Stanford, CA, USA

Introduction:  Nodal metastasis is a known prognostic factor for small bowel adenocarcinoma (SBA). Like many gastrointestinal malignancies, inadequate lymph node evaluation may adversely influence survival and lead to understaging. The objective of this study is to evaluate the number of lymph node (LN) that should be retrieved and the impact of lymph node ratio (LNR) on survival.   

Methods:  The Surveillance, Epidemiology, and End Results database was queried to identify patients diagnosed with SBA and treated with curative surgical resection from 1988 to 2010. Patients who did not undergo lymphadenectomy (Nx) or had distant metastases (M1) were excluded from our analysis. The greatest survival difference for duodenal and jejunoileal tumors was determined using cut-point analysis and maximum log-rank test χ2 statistic. Survival was estimated using Kaplan-Meier method and compared using log-rank test. Multivariate cox proportional hazard model was utilized to identify independent predictors of survival. 

Results: A total of 2773 patients underwent surgical resection with lymphadenectomy for SBA from 1988 to 2010. Duodenal and jejunoileal adenocarcinomas each consisted of 50% of all small intestine tumors (n=1387 and n=1386, respectively). There were 1371 patients (49.4%) with negative nodal metastases (N0), whereas 928 (33.5%) and 474 patients (17.1%) had N1 and N2 metastases, respectively. Median LN examined for duodenal and jejunoileal adenocarcinomas were 9 and 8, respectively. Cut-point analysis demonstrated that harvesting at least 9 for jejunoileal and 5 for duodenal tumors resulted in the greatest survival difference. However, there was a significant survival difference for each additional LN examined up to 11 for duodenal and 20 for jejunoileal tumors. Increasing LNR was associated with decreased overall median survival (LNR=0, 71 months; LNR 0-0.2, 35 months; LNR 0.21-0.4, 25 months, and LNR > 0.4, 16 months; p<0.001).  This inverse pattern of survival in relation to LNR was observed in the entire cohort (see figure, p<0.001) and each subsite. Multivariate analysis revealed extent of lymph node retrieval, T-stage, and lymph node positivity were independent predictors of survival.  

Conclusion: LNR has a profound impact on survival in SBA. In order to achieve adequate staging, we recommend retrieving a minimum of 5 and 9 LN for duodenal and jejunoileal tumors.   

 

32.05 Wider Sentinel Lymph Node Diameter Is A Predictor Of Positivity For Cutaneous Melanoma

Posted on December 22, 2014

J. S. Merkow1, A. Paniccia1, E. Jones1, T. Jones1, M. Hodges1, J. Byers1, K. Lewis1, R. Gonzales1, W. Robinson1, N. Kounalakis1, R. Stovall1, C. Gajdos1, N. Pearlman1, M. McCarter1  1University Of Colorado Denver,Aurora, CO, USA

Introduction: The prognostic implication of a positive SLN is powerful. There are multiple studies that have identified factors such as Breslow thickness, presence of ulceration, regression, and age as predictors of a positive SLN.  However, there are no studies to date that have specifically looked at the size of a SLN and its relationship to positivity.  THE PURPOSE of this study was to determine if lymph node size was indeed associated with a positive SLN.

Methods: Retrospective review of an institutional prospectively maintained database of patients undergoing SLNB for cutaneous melanoma between February 1995 to January 2013. The diameters of the largest sentinel lymph nodes were measured at the time of histopathologic analysis and the widest of the three diameters (length, width, or height) was used for the analysis. A nodal diameter of 1.5 cm, included in two interquartile ranges of maximal nodal size in both positive and negative SLN, was used as the cut off value for a multivariate logistic regression model.

Results: A thousand and seventeen patients underwent SLN biopsy. Of these, 826 (81%) had complete information on SLN measurements and were included in the final analysis. Negative SLN biopsy was obtained in 677 patients (82%) vs. 149 (18%) with positive SLN biopsy. Patients with positive SLN biopsy were younger with median age of 50 years (38-59) vs. 53 years (43-61, p=0.032) and had a deeper primary lesion of 2 mm (1.3-3.2) vs. 1.4 mm (1-2.2, p<0.001). Gender and other tumor characteristics including ulceration, mitosis, regression, lymphovascular invasion, type of melanoma, and location were not statistically different between the two groups. The largest SLN diameter was 1.9 cm (1.5-2.2) in the positive SLN group and 1.6 cm (1.2-2.2) in the negative SLN group (1.2-2.2, p=0.030). A SLN with a diameter wider than 1.5 cm was found to have an 87% increased odds of being positive for nodal metastasis after adjusting for age, sex, and depth of primary lesion (p=0.005).

Conclusion: A sentinel lymph node biopsy is considered the standard of care for melanoma. Here we demonstrated that a wider sentinel lymph node size is associated with significant increased odds for a positive biopsy result that is independent from the depth of primary lesion. Sentinel lymph nodes wider than 1.5 cm are more likely to be positive than not.

 

33.05 IORT with CT-Guided HDR Brachytherapy for the Treatment of Early-Stage Breast Cancer

Posted on December 22, 2014

S. L. Showalter1, D. R. Brenin1, A. Schroen1, M. Morris2, B. Libby2, G. Petroni3, T. N. Showalter2  1University Of Virginia,Surgical Oncology/Surgery,Charlottesville, VA, USA 2University Of Virginia,Radiation Oncology,Charlottesville, VA, USA 3University Of Virginia,Public Health Sciences,Charlottesville, VA, USA

Introduction:  Intraoperative radiation therapy (IORT) is an increasingly popular choice as an alternative to whole breast irradiation in patients with early-stage breast cancer. Currently available breast IORT systems have been criticized for their inability to directly image the lumpectomy cavity, “one size fits most” radiation dose planning, and the poor dosimetry provided by superficial photons.  At the University of Virginia, an integrated high dose-rate (HDR) brachytherapy suite with CT-on-rails imaging permits IORT with superior target volume coverage compared to other methods of IORT, while maintaining doses within tolerance limits for normal tissues, including the heart and ribs.

Methods:  We designed a single-arm, pilot study to demonstrate the safety and feasibility of IORT with CT-guided HDR brachytherapy for the adjuvant treatment of breast cancer, with a planned total sample of 28 evaluable patients.  Eligibility criteria include biopsy proven invasive ductal (IDC) or lobular carcinoma (ILC), ductal carcinoma in situ (DCIS), age > 50 years, tumor < 3cm, and N0 disease.  Patients may be eligible prior to receiving BCS or within 30 days of receiving breast surgery.  Exclusion criteria include multicentric disease, history of ipsilateral breast cancer, skin invasion or nodal involvement.  Surgery is performed in the brachytherapy suite.  After removal of the cancer, a multi-lumen balloon catheter is placed in the lumpectomy cavity.  CT imaging is obtained, radiation planning is performed, HDR brachytherapy is delivered and then the catheter is removed and the skin closure is completed.   A dose of 12.5 Gy is prescribed to cover the target volume.  Primary endpoints are IORT treatment interval (time from acquisition of CT until IORT is complete) and safety.  Secondary endpoints include dosimetry, cosmesis, patient-reported quality of life, toxicity and safety.  

Results:  In the first 8 months of the study, 9 patients with early-stage breast cancer were accrued, including: 4 with IDC, 4 with DCIS and 1 with ILC.  Median time required for IORT treatment planning and delivery is 68 minutes.  Median follow-up time is 4 months [Interquartile Range (IQR): 2.4, 6.7]. Target volume coverage met protocol objectives: median D90% (dose covering 90% of volume) is 99.3% (IQR: 98.78, 101.1); V100% (volume covered by the prescription dose) is 89.2% (IQR 88.23, 91.54).  Normal tissue structure planning objectives were met: median heart dose is 2.9% of the prescription dose (IQR 0, 7.15), and median maximum rib dose is 100.5% of the prescription dose (IQR 63.3, 138.44).  There have been no adverse events attributable to study treatment.  

Conclusion:  Preliminary data suggest IORT with CT-guided HDR brachytherapy is safe and feasible.  This IORT approach provides excellent target volume coverage and normal tissue sparing, and is deliverable within a reasonable amount of operative time.

 

« Previous Page
Next Page »