Weight-based chemotherapy dosing does not increase chemotherapy-related toxicity in obese gynecologic cancer patients

Weight-based chemotherapy dosing does not increase chemotherapy-related toxicity in obese gynecologic cancer patients

Abstracts / Gynecologic Oncology 133 (2014) 2–207 1) weight fluctuation struggles; 2) psychosocial barriers, including motivation and gaps between kno...

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Abstracts / Gynecologic Oncology 133 (2014) 2–207

1) weight fluctuation struggles; 2) psychosocial barriers, including motivation and gaps between knowledge and action; and 3) economic and resource limitations for food choice and exercise. External and internal barriers to lifestyle change included: 1) perceived cost of healthy food, exercise resources, or participation in formal weight loss programs; 2) lack of dietary knowledge; 3) poor food choices available at social events; 4) physical limitations (pain or mobility); 5) prior developed habits; 6) depression/other stressors; and 7) poor eating habits due to social isolation and boredom. Participants identified factors to facilitate change, including 1) having friends/family with similar goals, 2) receiving information from their physicians about diet and exercise, 3) linkage to community resources, and 4) reinforcement of goals by peers or medical staff. Participants demonstrated limited awareness of the association of endometrial cancer risk and obesity. Conclusions: Endometrial cancer patients face poor health outcomes related to obesity. A cancer diagnosis can be a teachable moment to influence health behaviors in patients and their extended social network. This study identifies concrete economic, educational, and psychosocial barriers that can be addressed in a multidisciplinary approach to lifestyle change as a critical part of survivorship for this high-risk group.

doi:10.1016/j.ygyno.2014.03.434

415 — Poster Session B Body mass index (BMI) associations, including mismatch repair protein expression, in 1051 endometrial carcinomas A.S. Joehlin-Price1, C.M. Perrino2, J. Stephens1, F.J. Backes1, P.J. Goodfellow1, D.E. Cohn1, A. Suarez1. 1The Ohio State University, Columbus, OH, USA, 2Washington University, St. Louis, MO, USA. Objectives: Links between obesity, with its attendant estrogen abnormalities, and the endometrial carcinoma (EC) DNA Mismatch Repair Protein (MMR) system have recently been proposed. We investigated relationships between BMI and clinicopathological correlates, including MMR expression in a large single-institution EC cohort. Methods: Clinical and pathological databases from 2007 to 2012 were used to identify consecutive hysterectomy specimens with EC. Univariate and multivariate analyses were used to explore relationships among BMI; age; stage; tumor type; and immunohistochemical results for MLH1, PMS2, MSH2, and MSH6. Results: A total of 1051 EC cases were identified. Overall, BMI was higher among women with normal MMR (P = 0.002), and the lowest rate of protein loss (20.3%) was seen in the obese group (n = 750) (P = 0.003). However, when stratified by age and specific MMR, statistically significant differences localized exclusively to women b50 years old with loss of MSH2 and/or MSH6 (P = 0.003 and P = 0.005, respectively). Higher BMI correlated with endometrioid FIGO 1 and 2 tumors (P b 0.001) and with stage IA (P b 0.001). Conversely, MMR abnormalities did not show significant associations with stage (P = 0.359) or histologic grade (P = 0.107). Conclusions: BMI showed statistically significant associations with MMR expression, tumor grade, and stage among 1051 consecutive EC cases. Obesity correlated with lower-grade and -stage EC. A link between BMI and maintenance of the MMR system is not supported by our data because the only statistically significant association occurred in women b50 years old with MSH2 and/or MSH6 abnormalities, where Lynch syndrome-related cases are expected to cluster.

doi:10.1016/j.ygyno.2014.03.435

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416 — Poster Session B Increasing minority participation in gynecologic oncology clinical trials through patient navigation B.K. Erickson, R.D. Alvarez, C.A. Leath III, M. Fouad, A. Forero-Torez, S. Bae, E.E. Partridge. University of Alabama at Birmingham, Birmingham, AL, USA. Objectives: African American patients are less likely to enroll in clinical trials than other racial groups. The project “Increasing Minority Participation in Clinical Trials” (IMPaCT) aims to enhance the recruitment and retention of African Americans in therapeutic cancer clinical trials through patient navigation. The objective of this study was to assess the effect of the IMPaCT program on enrollment into gynecologic oncology clinical trials in a racially and socioeconomically diverse National Comprehensive Cancer Network cancer center. Methods: Community health advisors were trained to serve as patient navigators (PNs) to help African American cancer patients overcome barriers to participation in clinical trials. The PNs educated patients about therapeutic trials, assisted with their recruitment into trials, and helped retain them by linking them to institutional services and community resources. Data were collected regarding number of patients referred to IMPaCT as well as the number of patients who declined, were ineligible, or were ultimately enrolled. Results: Since 2006, 54 African American patients with gynecologic malignancies were referred to the IMPaCT program, and 28 (51.9%) were enrolled into clinical trials. Between 2006 and 2010, an average of 4.8 gynecologic oncology patients per year was referred and 1.8 patients per year were enrolled. Since 2011, an average of 10.0 patients per year was referred and an average of 6.3 patients per year was enrolled. This translated to an improvement in the proportion of enrolled to referred from 0.38 to 0.63 in this time period. Conclusions: Through an intensive institutional effort, the IMPaCT program has successfully recruited and enrolled African American women into gynecologic oncology clinical trials. As barriers to enrollment have been better identified, rates of referral and subsequent enrollment have improved. doi:10.1016/j.ygyno.2014.03.436

417 — Poster Session B Weight-based chemotherapy dosing does not increase chemotherapy-related toxicity in obese gynecologic cancer patients J. Hansen, J.M. Stephan, M. Freesmeier, D.P. Bender, A. Button, M.J. Goodheart. University of Iowa Hospitals and Clinics, Iowa City, IA, USA. Objectives: American Society of Clinical Oncology recommends the use of full weight-based (WB) doses of chemotherapy to treat obese patients with cancer. Many clinicians cap chemotherapy doses at a body surface area (BSA) of 2 m2. The objective of this study was to determine how chemotherapy-related toxicities compare between groups of patients that varied with respect to BSA and dosing regimen. We hypothesized that obese patients receiving WB dosing would not have significantly higher chemotherapy-related toxicities than controls. Methods: We performed a retrospective review of patients with BSA ≥2 m2 who received WB chemotherapy for a gynecologic cancer between January and August 2013. Subjects were matched with two controls: patients with BSA b2 m2 who received WB dosing and patients with BSA ≥2 m2 who received capped dosing at BSA = 2 m2. The groups were matched for medical comorbidities and prior cancer treatment. Agents included paclitaxel, gemcitabine, and liposomal doxorubicin. A subanalysis was performed for patients receiving carboplatin and paclitaxel (CT) for primary therapy. Demographic and clinical information were extracted and analyzed via ANOVA and Fisher's exact test.

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Abstracts / Gynecologic Oncology 133 (2014) 2–207

Results: A total of 75 patients were included. The three groups were similar in their medical comorbidities and prior cancer treatment. When comparing the pre- and posttreatment laboratory values for each cycle between the groups, there were no differences in white blood cell count (WBC), absolute neutrophil count (ANC) or platelet count. There was no difference between groups with regard to treatment delays, unplanned admissions, transfusions, or dose reductions for toxicity (all P values NS). This same association was consistent within the subanalysis of patients (n = 50) receiving CT. Additionally, patients in each group who had received prior radiation therapy for gynecologic cancer experienced no added toxicity. Conclusions: At our institution, gynecologic cancer patients with BSA ≥2 m2 treated with WB chemotherapy had no increase in chemotherapy-related toxicities or dose reductions as compared to controls. A subanalysis of obese patients receiving WB doses of paclitaxel demonstrated similar results. Based on these data, consideration should be given to using WB dosing in obese patients. Further investigation is required to determine the effect of WB dosing on progression-free and overall survival. doi:10.1016/j.ygyno.2014.03.437

418 — Poster Session B Minority participation in Gynecologic Oncology Group (GOG) studies J.M. Scalici1, M.A. Finan1, J. Black1, H. Lankes2, W.E. Brady2, R.P. Rocconi1. 1University of South Alabama, Mobile, AL, USA, 2Gynecologic Oncology Group Statistical and Data Center, Buffalo, NY, USA. Objectives: National Cancer Institute Strategic Plan for Leading the Nation, Objective #8 calls for overcoming cancer health disparities. As such, participation of minority populations in clinical trials is paramount to understanding and overcoming cancer racial disparities. The goal of this project was to evaluate minority participation in GOG clinical trials. Methods: GOG publications from years 1985 to 2013 were reviewed. Data abstracted included racial breakdown, tumor type, study type, and year published. Minority enrollment was stratified by tumor site (ovarian, endometrial, cervical, and sarcoma), type of study (phases I, II, and III, translational, and observational/quality-of-life studies) and year published. Based on Centers for Disease Control and Prevention (CDC) age-adjusted incidence for race, expected and observed ratios of racial participation were calculated. Results: A total of 311 GOG publications involving 57,016 patients were reviewed. Racial breakdown was provided in 169 studies (54%) for a total of 44,820 patients: 83% white (n = 37,321), 8% African American (AA) (n = 3574), and 9% other (n = 3925). The majority of studies were ovarian (n = 150) and phase II (n = 187). When evaluating the proportion of AA patients that were enrolled by quartile of publication year, a steady decline in the proportion of AA patients was seen. Compared to years 1985–1999, a 3.2-fold lower proportion of AA was noted in years 2010–2013 (21% and 6.7%, respectively, P b 0.01). Additionally, “other” races exceeded AA enrollment in 67 of 169 trials that listed race (40%). Using a CDC age-adjusted incidence, observed enrollment of AA patients onto GOG clinical trials was significantly less than expected if accrual rates were equal across all races. Observed AA enrollment was 15-fold lower than expected for ovarian trials, 10-fold lower for endometrial, 4.5-fold lower for cervical, and 5.2-fold lower for sarcoma (each P b 0.001). Additionally, observed AA enrollment was significantly lower for each study type (P b 0.001). Individually, none of the GOG studies met the expected enrollment for AA patients by these methods. Conclusions: Enrollment of minority populations is vital for adequately describing the true racial disparity in gynecologic malignancies. Based on

this study, significant attention should be directed toward strategies to enhance minority enrollment onto clinical trials.

doi:10.1016/j.ygyno.2014.03.438

419 — Poster Session B Positive margins on cervical excision in a high-risk population: Are our best practices good enough? T.R. Buchanan Jr., J.N. Rasner, M.L. Podolsky, R.K. Brannon, G.D. Alleyne, S.D. Richard. Drexel University College of Medicine, Philadelphia, PA, USA. Objectives: Multiple studies show racial disparities for the survival of cervical cancer, which is predominant in women of African American (AA) descent. These at-risk populations may be spared from this survival disadvantage with proper screening and treatment. Our aim was to look at margin status for patients treated with cervical excisional procedures at an inner city, university-based academic teaching center. Methods: All patients treated at a referral colposcopy clinic at a single inner city academic teaching facility from March of 2011 to June of 2012 were retrospectively reviewed. All demographic, pathologic, and surgical data were collected. Patients with a diagnosis of cervical intraepithelial neoplasia (CIN) 2 or greater were recommended for excisional biopsy. Generalists within the department of obstetrics/gynecology who were members of the faculty teaching practice performed or supervised all aspects of patient care. Statistical analysis was performed with Chisquare analysis with a 95% CI. Results: During this study period, 416 patients were referred to the colposcopy clinic, with 95 patients having CIN 2 (22.8%) or greater on biopsy. All patients received recommended procedures, with 73 having a loop electrosurgical excision procedure (39 operating room and 34 office-based) and 22 undergoing cold knife cone (CKC). There were six providers in this study, and the median procedures performed was 16 (range, 12–21). Patients were predominately AA (93%). Of the 95 patients, six (6.3%) had a diagnosis of adenocarcinoma in situ or invasive cervical cancer. In the remaining 89 patients, 34 (38.2%) had positive margins of at least CIN 1, and 26 of the 34 (76.5%) positive margins were CIN 2 or greater. No difference in margin status was noted for patients b30 years of age compared to those ≥30 years (38.9% vs 37.7%, P = 0.913) or for parity of G0 or G1 when compared to G2 or greater (43.8% vs 35.1%, P = 0.562). No one provider was noted to have a statistically significant higher positive margin status. Unfortunately, 22 positive margin patients (64.7%) were lost to follow-up. Conclusions: Successful excision of high-grade lesions is necessary to prevent at-risk patients from developing cervical cancer. Because an experienced high-volume provider would better treat these patients and may prevent high rates of positive margins, consideration should be given to referral of affected patients to a gynecologic oncologist. doi:10.1016/j.ygyno.2014.03.439

420 — Poster Session B Geographic disparities in cancer care: Is optimizing the distribution of the gynecologic oncology workforce the answer? A Gynecologic Oncology Fellows Research Network study S. Ricci1, A.I. Tergas2,3, M. Gerardi Fairbairn4, K.N. Slaughter5, A.S. Bruegl6, E. Pelkofski7, R. Spencer8, R.E. Bristow9, A. Nickles Fader1. 1 Johns Hopkins Medical Institutions, Baltimore, MD, USA, 2Columbia University, Physicians and Surgeons, New York, NY, USA, 3Columbia University, New York, NY, USA, 4Johns Hopkins Medical Institutions,