Authors' recommendations: The European HTA network, EUnetHTA, published an assessment on ramuciurmab for the treatment of gastric cancer or gastro-oesophageal junction (GEJ) adenocarcinoma in March 2015. This assessment investigated ramucirumab in combination with paclitaxel for the treatment of adult patients with advanced gastric cancer or GEJ adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy. Ramucirumab, a monoclonal antibody, was approved for this indication by the EMA in December 2014 based on the findings of the RAINBOW study. This phase 3 study compared ramucirumab plus paclitaxel with placebo plus paclitaxel in overall 665 patients. Patients had metastatic gastric cancer or GEJ adenocarcinoma and disease progression while on or within 4 months after the last dose of standard first-line platinum- and fluoropyrimidine-based combination chemotherapy. Overall survival was significantly longer in the ramucirumab plus paclitaxel group than in the placebo plus paclitaxel group (median 9.6 months vs.7.4 months, hazard ratio (HR) 0.807; p=0.017). Treatment with ramucirumab plus paclitaxel significantly reduced the risk of disease progression or death (HR=0.64; p<0.0001); the median PFS was 1.5 months longer in the ramucirumab plus paclitaxel group compared with the placebo plus paclitaxel group (4.4 months vs. 2.9). Treatment with ramucirumab plus paclitaxel was associated with a delay in the time to worsening of functional status, as measured with the Eastern Cooperative Oncology Status Performance Status compared with placebo plus paclitaxel. Most patients experienced adverse events (AEs), but there was no indication for a different frequency of AEs in patients treated with ramucirumab plus paclitaxel compared with placebo plus paclitaxel treatment (relative risk (RR) 1.01 (95% CI 0.99 to 1.03). Concerning AEs of grade 3 or higher, the RR was 1.30 (95% CI 1.18 to 1.44), favouring the control group. Serious AEs and deaths due to an AE were similar in patients treated with ramucirumab plus paclitaxel and those treated with placebo plus paclitaxel. With the exception of paclitaxel alone, there is no direct head-to-head evidence to position ramucirumab plus paclitaxel compared with the other treatment alternatives used for the second-line therapy of advanced gastric cancer. Direct comparisons and large observational studies are needed to facilitate more robust conclusions and upcoming evidence from registries will provide results that should help to clarify these issues.

Project Status: Completed

URL for project: http://hta.lbg.ac.at/page/horizon-scanning-in-der-onkologie

Year Published: 2015

URL for published report: http://eprints.hta.lbg.ac.at/1069

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Austria

Organisation Name: Ludwig Boltzmann Institute for Health Technology Assessment

Contact Address: Ludwig Boltzmann Institute for fuer Health Technology Assessment (LBI-HTA), Garnisongasse 7/rechte Stiege Mezzanin (Top 20), 1090 Vienna, Austria. Tel: +43 1 236 8119 - 0 Fax: +43 1 236 8119 - 99

Contact Name: tarquin.mittermayr@aihta.at

Contact Email: office@aihta.at

Copyright: Ludwig Boltzmann Institut fuer Health Technology Assessment (LBI-HTA)