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Richard Li, Wei-Hsien Hou, Joseph Chao, Yanghee Woo, Scott Glaser, Arya Amini, Rebecca A. Nelson, and Yi-Jen Chen

Background: Limited data are available to guide management of patients with stage I–III gastric cancer not undergoing potentially curative surgical resection. We compared survival outcomes associated with chemotherapy alone versus chemoradiation (CRT) in the treatment of nonmetastatic gastric cancer. Methods: Patients with gastric adenocarcinoma from 2004 to 2015 were identified using the National Cancer Database. Patients were excluded if they had surgery, metastatic disease, or T0, Tis, or T1a disease. Logistic regression was used to evaluate predictors of CRT use. Cox proportional hazards modeling was performed to compare overall survival (OS) between chemotherapy alone and CRT in overall and propensity score–matched cohorts. Results: We identified 4,795 patients with stage I–III gastric adenocarcinoma who did not undergo surgery, at a median follow-up of 11.8 months. A total of 3,316 patients (69.2%) received chemotherapy alone and 1,479 patients (30.8%) received CRT. Predictors of increased CRT use were age ≥65 years (odds ratio [OR] 1.68; 95% CI, 1.43–1.99; P<.001), Charlson-Deyo comorbidity score ≥2 (OR, 1.46; 95% CI, 1.18–1.81), and treatment at a community facility (OR, 1.27; 95% CI, 1.07–1.51; P=.006). Patients receiving CRT had a 2-year OS rate of 28.3% compared with 21.5% among those receiving chemotherapy. Multivariate analysis showed that CRT was associated with improved OS (hazard ratio [HR], 0.82; 95% CI, 0.77–0.89; P<.001). After propensity score matching, a persistent survival benefit was observed (HR, 0.80; 95% CI, 0.74–0.88; P<.001). Conclusions: In patients with stage I–III gastric cancer not undergoing surgical resection, CRT was associated with improved survival compared with chemotherapy alone. However, only 30.8% of patients received CRT in this setting.

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Neelima Denduluri, Debra A. Patt, Yunfei Wang, Menaka Bhor, Xiaoyan Li, Anne M. Favret, Phuong Khanh Morrow, Richard L. Barron, Lina Asmar, Shanmugapriya Saravanan, Yanli Li, Jacob Garcia, and Gary H. Lyman

Background: A wide variety of myelosuppressive chemotherapy regimens are used for the treatment of cancer in clinical practice. Neutropenic complications, such as febrile neutropenia, are among the most common side effects of chemotherapy, and they often necessitate delays or reductions in doses of myelosuppressive agents. Reduced relative dose intensity (RDI) may lead to poorer disease-free and overall survival. Methods: Using the McKesson Specialty Health/US Oncology iKnowMed electronic health record database, we retrospectively identified the first course of adjuvant or neoadjuvant chemotherapy received by patients without metastases who initiated treatment between January 1, 2007, and March 31, 2011. For each regimen, we estimated the incidences of dose delays (≥7 days in any cycle of the course), dose reductions (≥ 15% in any cycle of the course), and reduced RDI (<85% over the course) relative to the corresponding standard tumor regimens described in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Results: This study included 16,233 patients with 6 different tumor types who received 1 of 20 chemotherapy regimens. Chemotherapy dose delays, dose reductions, and reduced RDI were common among patients treated in community oncology practices in the United States, but RDI was highly variable across patients, regimens, and tumor types (0.486–0.935 for standard tumor regimen cohorts). Reduced RDI was more common in older patients, obese patients, and patients whose daily activities were restricted. Conclusions: In this large evaluation of RDI in US clinical practice, physicians frequently administered myelosuppressive agents at dose intensities lower than those of standard regimens.

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Jeffrey M. Martin, Tianyu Li, Matthew E. Johnson, Colin T. Murphy, Alan G. Howald, Marc C. Smaldone, Alexander Kutikov, David Y.T. Chen, Rosalia Viterbo, Richard E. Greenberg, Robert G. Uzzo, and Eric M. Horwitz

Purpose: Characterize use of postprostatectomy radiation (PPRT) for patients with prostate cancer at an NCI-designated comprehensive cancer center. Methods: We queried our prospective prostate cancer database for patients treated with 60 to 68 Gy of radiation therapy (RT) to the prostate bed after prostatectomy from 2003 to 2011. Prostatectomy cases were obtained from billing records. Patients with an intact prostate treated with definitive RT served as a control for the change in volume of patients with prostate cancer treated in the department. Chi-square analysis assessed differences between adjuvant and salvage RT cohorts. Spearman correlation assessed yearly trends in prostate-specific antigen (PSA) level at the time of referral for RT. Linear regression models tested trends for number of PPRT cases, prostatectomies, and patients with intact prostate receiving radiation across years. Results: PPRT was used to treat 475 men at Fox Chase Cancer Center from 2003 to 2011 (83 adjuvant and 392 salvage). Over time, an increased proportion of patients receiving RT to the prostate were treated with PPRT. No increase was seen in the proportion of patients treated with adjuvant RT compared with salvage RT (P=.5). Patients receiving adjuvant RT were younger, had higher pathologic Gleason score, pathologic T stage, and rates of positive margins than those receiving salvage RT. Pre-RT PSA values were inversely correlated with year (P=.005). The number of patients referred for salvage RT with a PSA of 0.5 ng/mL or less increased significantly from 7.9% in 2003 to 26.6% in 2011 (P=.002). Conclusions: A larger proportion of patients treated with RT for localized prostate cancer are now receiving PPRT. No increase was seen in the proportion of patients treated with adjuvant RT. Over time, patients with lower PSAs were referred for salvage RT.

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Richard Li, Ashwin Shinde, Marwan Fakih, Stephen Sentovich, Kurt Melstrom, Rebecca Nelson, Scott Glaser, Yi-Jen Chen, Karyn Goodman, and Arya Amini

Background: Anal adenocarcinoma is a rare malignancy with a poor prognosis, and no randomized data are available to guide management. Prior retrospective analyses offer differing conclusions on the benefit of surgical resection after chemoradiotherapy (CRT) in these patients. We used the National Cancer Database (NCDB) to analyze survival outcomes in patients undergoing CRT with and without subsequent surgical resection. Methods: Patients with adenocarcinoma of the anus diagnosed in 2004 through 2015 were identified using the NCDB. Patients with metastatic disease and survival <90 days were excluded. We analyzed patients receiving CRT and stratified by receipt of surgical resection. Logistic regression was used to evaluate predictors of use of surgery and to form a propensity score–matched cohort. Overall survival (OS) was compared between treatment strategies using Cox proportional hazards regression. Results: We identified 1,747 patients with anal adenocarcinoma receiving CRT, of whom 1,005 (58%) received surgery. Predictors of increased receipt of surgery included age <65 years, private insurance, overlapping involvement of the anus and rectum, N0 disease, and external-beam radiation dose ≥4,000 cGy. With a median follow-up of 3.5 years, 5-year OS was 61.1% in patients receiving CRT plus surgery compared with 39.8% in patients receiving CRT alone (log-rank P<.001). In multivariate analysis, surgery was associated with significantly improved OS (hazard ratio, −0.59; 95% CI, 0.50–0.68; P<.001). This survival benefit persisted in a propensity score–matched cohort (log-rank P<.001). Conclusions: In the largest series of anal adenocarcinoma cases to date, treatment with CRT followed by surgery was associated with a significant survival benefit compared with CRT alone in propensity score–matching analysis. Our findings support national guideline recommendations of neoadjuvant CRT followed by resection for patients with anal adenocarcinoma.

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Ashwin Shinde, Richard Li, Arya Amini, Yi-Jen Chen, Mihaela Cristea, Wenge Wang, Mark Wakabyashi, Ernest Han, Catheryn Yashar, Kevin Albuquerque, Sushil Beriwal, and Scott Glaser

Background: Vulvar cancer with pelvic nodal involvement is considered metastatic (M1) disease per AJCC staging. The role of definitive therapy and its resulting impact on survival have not been defined. Patients and Methods: Patients with pelvic lymph node–positive vulvar cancer diagnosed in 2009 through 2015 were evaluated from the National Cancer Database. Patients with known distant metastatic disease were excluded. Logistic regression was used to evaluate use of surgery and radiation therapy (RT). Overall survival (OS) was evaluated with log-rank test and Cox proportional hazards modeling (multivariate analysis [MVA]). A 2-month conditional landmark analysis was performed. Results: A total of 1,304 women met the inclusion criteria. Median follow-up was 38 months for survivors. Chemotherapy, RT, and surgery were used in 54%, 74%, and 62% of patients, respectively. Surgery was associated with prolonged OS (hazard ratio [HR], 0.58; P<.001) but had multiple significant differences in baseline characteristics compared with nonsurgical patients. In patients managed nonsurgically, RT was associated with prolonged OS (HR, 0.66; P=.019) in MVA. In patients undergoing surgery, RT was associated with better OS (3-year OS, 55% vs 48%; P=.033). Factors predicting use of RT were identified. MVA revealed that RT was associated with prolonged OS (HR, 0.75; P=.004). Conclusions: In this cohort of women with vulvar cancer and positive pelvic lymph nodes, use of RT was associated with prolonged survival in those who did not undergo surgery. Surgery followed by adjuvant RT was associated with prolonged survival compared with surgery alone.

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Gabrielle B. Rocque, Richard A. Taylor, Aras Acemgil, Xuelin Li, Maria Pisu, Kelly Kenzik, Bradford E. Jackson, Karina I. Halilova, Wendy Demark-Wahnefried, Karen Meneses, Yufeng Li, Michelle Y. Martin, Carol Chambless, Nedra Lisovicz, Mona Fouad, Edward E. Partridge, Elizabeth A. Kvale, and the Patient Care Connect Group

Background: There is growing interest in psychosocial care and evaluating distress in patients with cancer. As of 2015, the Commission on Cancer requires cancer centers to screen patients for distress, but the optimal approach to implementation remains unclear. Methods: We assessed the feasibility and impact of using distress assessments to frame lay navigator interactions with geriatric patients with cancer who were enrolled in navigation between January 1, 2014, and December 31, 2014. Results: Of the 5,121 patients enrolled in our lay patient navigation program, 4,520 (88%) completed at least one assessment using a standardized distress tool (DT). Navigators used the tool to structure both formal and informal distress assessments. Of all patients, 24% reported distress scores of 4 or greater and 5.5% reported distress scores of 8 or greater. The most common sources of distress at initial assessment were pain, balance/mobility difficulties, and fatigue. Minority patients reported similar sources of distress as the overall program population, with increased relative distress related to logistical issues, such as transportation and financial/insurance questions. Patients were more likely to ask for help with questions about insurance/financial needs (79%), transportation (76%), and knowledge deficits about diet/nutrition (76%) and diagnosis (66%) when these items contributed to distress. Conclusions: Lay navigators were able to routinely screen for patient distress at a high degree of penetration using a structured distress assessment.

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Andrew D. Zelenetz, Islah Ahmed, Edward Louis Braud, James D. Cross, Nancy Davenport-Ennis, Barry D. Dickinson, Steven E. Goldberg, Scott Gottlieb, Philip E. Johnson, Gary H. Lyman, Richard Markus, Ursula A. Matulonis, Denise Reinke, Edward C. Li, Jessica DeMartino, Jonathan K. Larsen, and James M. Hoffman

Biologics are essential to oncology care. As patents for older biologics begin to expire, the United States is developing an abbreviated regulatory process for the approval of similar biologics (biosimilars), which raises important considerations for the safe and appropriate incorporation of biosimilars into clinical practice for patients with cancer. The potential for biosimilars to reduce the cost of biologics, which are often high-cost components of oncology care, was the impetus behind the Biologics Price Competition and Innovation Act of 2009, a part of the 2010 Affordable Care Act. In March 2011, NCCN assembled a work group consisting of thought leaders from NCCN Member Institutions and other organizations, to provide guidance regarding the challenges health care providers and other key stakeholders face in incorporating biosimilars in health care practice. The work group identified challenges surrounding biosimilars, including health care provider knowledge, substitution practices, pharmacovigilance, naming and product tracking, coverage and reimbursement, use in off-label settings, and data requirements for approval.