Combined use of ramucirumab and gemcitabine significantly improved overall survival following first-line standard chemotherapy, thus making it a novel treatment option in patients with pretreated malignant pleural mesothelioma.
This inference was deduced from a multicentre, randomised phase 2 study which assessed the effectiveness of combination of anti-VEGFR-2 antibody ramucirumab and gemcitabine in case of malignant pleural mesothelioma.
One hundred and sixty-five patients (aged 18 years or above) suffering from histologically proven malignant pleural mesothelioma progressing during or following the first-line therapy with pemetrexed and platinum were included. They were administered with gemcitabine intravenous (IV) 1000 mg/m2 on days 1 and 8 every 3 weeks along with either placebo IV (gemcitabine and placebo) or ramucirumab 10 mg/kg (gemcitabine and ramucirumab) on day 1 every 3 weeks, up until tumour progression or toxicity.
Central randomisation was done as per minimisation algorithm technique, linked with a random element via the stratification factors i.e. age, ECOG performance status, histology, and first-line time-to-progression. The primary endpoint comprised of overall survival, assessed from the date of randomisation till the date of death. Efficacy analyses included patients who had been accurately randomised and received their assigned therapy. Safety analyses included patients with a minimum of 1 dose of their allocated therapy.
Out of a total lot of patients, 161 were precisely assigned and received either gemcitabine and placebo (81 patients) or gemcitabine and ramucirumab (80 patients). The overall survival was longer in the ramucirumab group after a median follow-up of 21·9 months. Median overall survival was 13·8 months and 7·5 months in the gemcitabine plus ramucirumab group and in the gemcitabine plus placebo group, respectively.
About 44% of patients in the gemcitabine plus ramucirumab group and 30% of patients in the gemcitabine plus placebo group had therapy-linked adverse events (Grade 3 to 4). Neutropenia and hypertension or high blood pressure were commonly observed. Serious adverse events were noted in only 6% of patients in the gemcitabine + ramucirumab group and 5% of patients in the gemcitabine + placebo group. No therapy-linked deaths were reported.
In conclusion, ramucirumab and gemcitabine combination was safe for use in treating pleural mesothelioma.
|Source:||THE LANCET – Oncology|
|Original title of the article:||Gemcitabine with or without ramucirumab as second-line treatment for malignant pleural mesothelioma (RAMES): a randomised, double-blind, placebo-controlled, phase 2 trial|