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Ramucirumab: Use in Third or Later Line for Gastric Cancer
The use of ramucirumab in third- or later-line for the treatment of gastric cancer has been evaluated in retrospective analyses.
A multicenter, retrospective, observational study was conducted to evaluate the safety and efficacy of ramucirumab monotherapy in the salvage line treatment of Japanese patients with advanced gastric cancer.1
Patients were eligible for inclusion in the analysis if they
were ≥18 years of age
had histologically proven gastric or GEJ adenocarcinoma
had an ECOG PS ≤2
initiated ramucirumab monotherapy as third- or later-line treatment between June 2015 and April 2017, and
had disease refractory to, or intolerant of, fluoropyrimidine and taxane.1
Analysis of Patients Who Received Treatment in Third- or Later-Line
All patients in this analysis received ramucirumab monotherapy at a dose of 8 mg/kg every 2 weeks. Treatment was continued until PD, unacceptable toxicity, or patient decision.The median number of cycles administered was 4 (range, 1-31) and a total of 281 cycles were administered for all 51 patients.1
Efficacy results are summarized in Efficacy Results.A univariate analysis found that NLR <2.5 and previous gastrectomy were associated with a statistically significant longer PFS (p=.002 and p=.019, respectively). No background factors were found to be significant prognostic factors for OS.1
Abbreviations: IQR = interquartile range; SD = standard deviation.
aEvaluable patients; patients may have received ramucirumab in multiple lines of therapy.
The majority of patients in this study received ramucirumab in combination with cytotoxic agents (77.2%). Line of therapy was a predictive factor associated with the use of monotherapy versus combination therapy. Compared with patients who received ramucirumab in first-line treatment, patients receiving ramucirumab as
third line of therapy were 4.39 times more likely to receive monotherapy (p=.0244), and
fourth line of therapy were 9.82 times more likely to receive monotherapy (p<.0047).2
Ongoing Clinical Study
A randomized, phase 3 study comparing irinotecan with or without ramucirumab for the treatment of Japanese patients with advanced gastric cancer is ongoing and recruiting patients for participation (RINDBeRG; UMIN000023065).3,4 Eligible patients must have
histologically proven gastric or esophagogastric adenocarcinoma
unresectable or recurrent disease
ECOG PS <2
≥2 lines of chemotherapy with platinum, fluoropyrimidines, taxanes, and ramucirumab
no prior use of irinotecan, and
disease progression during prior chemotherapy containing ramucirumab.3
Patients will be randomized (1:1) ratio to receive irinotecan 150 mg/m2 alone or in combination with ramucirumab 8 mg/kg. The primary endpoint is OS. Secondary endpoints include
1Kawai S, Fukuda N, Yamamoto S, et al. Retrospective observational study of salvage line ramucirumab monotherapy for patients with advanced gastric cancer. BMC Cancer. 2020;20(1):338. https://doi.org/10.1186/s12885-020-06865-7
2Paulson AS, Hess LM, Liepa AM, et al. Ramucirumab for the treatment of patients with gastric or gastroesophageal junction cancer in community oncology practices. Gastric Cancer. 2018;21(5):831-844. http://dx.doi.org/10.1007/s10120-018-0796-z
3Sakai D, Boku N, Kodera Y, et al. An intergroup phase III trial of ramucirumab plus irinotecan in third or more line beyond progression after ramucirumab for advanced gastric cancer (RINDBeRG trial). Poster presented at: 54th Annual Meeting of the American Society of Clinical Oncology (ASCO); June 1-5, 2018; Chicago, IL. Accessed June 1, 2020. https://meetinglibrary.asco.org/record/165419/poster