Ramucirumab for the treatment of patients with gastric or gastroesophageal junction cancer in community oncology practices
- 279 Downloads
Limited real-world research has investigated ramucirumab for the treatment of patients with gastric or gastroesophageal junction (GEJ) cancer. This study was designed to describe ramucirumab monotherapy or combination therapy use in a community oncology practice setting.
This was a retrospective observational cohort study to describe the treatment of adult patients with gastric or GEJ cancer who initiated ramucirumab treatment between 4/21/14 and 6/30/16 within the US Oncology Network. Kaplan–Meier method and Cox proportional hazards regression analyses were used to assess clinical outcomes. Multivariable logistic regression models were used to assess patient-level predictors of ramucirumab monotherapy or combination therapy.
A total of 505 patients (mean age 64.4 years; 75.1% male) were included in the analysis; subgroups included: monotherapy (22.8%; n = 115), combination therapy (77.2%; n = 390). Monotherapy patients were significantly older (67.7 vs. 63.4 years; P = 0.0006), received ramucirumab approximately 3 months later after diagnosis (16.9 vs. 14.1 months; P = 0.0318) and more frequently initiated ramucirumab in the third or later lines of treatment (38.3 vs. 8.2%; P<0.0001) than patients receiving combination therapy. Median overall survival (OS) for monotherapy and combination therapy from the start of second-line therapy was 5.5 months (confidence interval [CI] 4.3, 7.8) and 7.4 months (CI 6.6, 8.8), respectively.
The results showed that patients who received ramucirumab monotherapy started ramucirumab therapy later after diagnosis and were older than those who received ramucirumab in combination. Additionally, survival data suggest that outcomes observed in community oncology practices are similar to data from phase 3 clinical trials.
KeywordsGastric cancer Gastroesophageal junction cancer Ramucirumab Outcomes research Overall survival
Compliance with ethical standards
This study was funded Eli Lilly and Company.
Conflict of Interest
Dr. Paulson has advisory board roles at Taiho, Merrimack, Bristol Myers Squibb, and Advanced Accelerator Application, as well as owns stock in Juno and Immunomedics. Dr. Hess is employed by Eli Lilly and Company. Dr. Liepa is employed by and owns stock in Eli Lilly and Company. Dr. Cui is employed by and owns stock in Eli Lilly and Company. Ms. Aguilar is employed by McKesson Specialty Health and provided research consulting services to Eli Lilly and Company. Ms. Clark is employed by McKesson Specialty Health, owns stock in McKesson and provided research consulting services to Eli Lilly and Company. Dr. Schelman is employed by and owns stock in Eli Lilly and Company.
Institutional Review Board and Compliance/Privacy approval was gained prior to initiation of the retrospective research. Since this project involved the analysis of existing data and records, study information was analyzed in such a manner that research participants could not be directly identified. Patient informed consent was not required due to the nature of the study design. Thus, exemption status and a waiver of informed consent were approved by The US Oncology, Inc. Institutional Review. Data was handled in compliance with HIPAA and Health Information Technology for Economic and Clinical Health (HITECH).
- 3.National Cancer Institute. Cancer stat facts: stomach cancer. December 20, 2016. https://seer.cancer.gov/statfacts/html/stomach.html.
- 4.National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: gastric cancer, 2.20172017 8/1/17. https://www.nccn.org/professionals/physician_gls/pdf/gastric.pdf.
- 6.Eli Lilly and Company. Cyramza—package insert. 2015.Google Scholar
- 8.Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014;383(9911):31–9. https://doi.org/10.1016/S0140-6736(13)61719-5.CrossRefPubMedGoogle Scholar
- 9.Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014;15(11):1224–35. https://doi.org/10.1016/S1470-2045(14)70420-6.CrossRefPubMedGoogle Scholar
- 11.Fuchs CS, Muro K, Tomasek J, Van Cutsem E, Cho JY, Oh SC, et al. Prognostic factor analysis of overall survival in gastric cancer from two phase III studies of second-line ramucirumab (REGARD and RAINBOW) using pooled patient data. J Gastric Cancer. 2017;17(2):132–44. https://doi.org/10.5230/jgc.2017.17.e16.CrossRefPubMedPubMedCentralGoogle Scholar
- 12.Chau I, Norman AR, Cunningham D, Waters JS, Oates J, Ross PJ. Multivariate prognostic factor analysis in locally advanced and metastatic esophago-gastric cancer–pooled analysis from three multicenter, randomized, controlled trials using individual patient data. J Clin Oncol. 2004;22(12):2395–403. https://doi.org/10.1200/JCO.2004.08.154.CrossRefPubMedGoogle Scholar