Safety and efficacy profile of ramucirumab alone or combined with paclitaxel in metastatic gastric cancer (MGC): A real-life overview of compassionate-use named patients (pts) (RAMoss study)

Background

Ramucirumab, an anti-VEGFR2 monoclonal antibody, improved the outcome of MGC pts both as a single agent and in combination with paclitaxel, achieving recent approval in second-line therapy. However, few ”real life” data are available. The objective of the RAMoss study is to evaluate the safety and efficacy of ramucirumab in the Italian compassionate-use program, prior to marketing authorization.

Methods

The primary endpoint was safety and secondary were overall response rate (ORR), progression free-survival (PFS) and overall survival (OS). Pts received ramucirumab 8 mg/kg/iv every 2 weeks or in combination with paclitaxel 80 mg/m2/iv on days 1, 8, and 15 of a 28-days cycle until progression, death or unacceptable toxicity. Complete blood test were performed before each drug administration and disease was assessed every 2 cycles.

Results

109 pts were enrolled with the following characteristics: median age: 61 yrs; gastric site: 69,7%, cardias: 23,8%, distal oesophagus: 6,4%; PS ECOG: 0(56,8%) 1(34,8%) ≥2(8.2%); monotherapy : 12,9%, combination therapy: 87,1%; peritoneal metastasis: 41,2%. Median treatment duration was 3 mos(1-12 mos). The most frequent grade ≥ 3 AEs were: neutropenia (5.5%), asthenia (2.7%), hypertension (1.8%). Febrile neutropenia occurred in 0.9% of the pts. No bleeding of grade ≥ 2 was reported. There were no treatment-related deaths. ORR was 17,4%, 7.1% (monotherapy) and 18,9% (combination), respectively. Stable disease was observed in 30.2%; disease control rate (DCR) was 47,6%. With a median follow-up of 8.0 mos (95% CI: 6.5-9.5), median PFS was 3.0 mos (95% CI: 2.32-3.67), median OS was 7.0 mos (95% CI: 5.76-8.23). On a multivariate analysis, age 61 (HR 3.18, 95% CI: 1.8-5.6, p= 0.0001) and PS ECOG

Conclusions

Ramucirumab treatment, in a "real-life" setting, is proven to be well tolerated in an Italian cohort of pretreated MGC pts with no new safety signals.

Clinical trial identification

Legal entity responsible for the study

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Funding

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Disclosure

All authors have declared no conflicts of interest.