Phase 3 trial of pemetrexed plus cisplatin versus cisplatin alone in malignant pleural mesothelioma
Adding pemetrexed to cisplatin lengthened survival by almost three months in pleural mesothelioma, making platinum-pemetrexed the first, and for many years the only, standard chemotherapy for the disease.
Overview
Phase 3 trial of 456 chemotherapy-naive patients with malignant pleural mesothelioma randomised to pemetrexed plus cisplatin or cisplatin alone, with folic acid and vitamin B12 supplementation introduced part-way through to reduce toxicity.
Median overall survival was 12.1 versus 9.3 months, response rate 41.3 versus 16.7 percent, and lung function and symptoms were better with the combination; vitamin supplementation markedly reduced severe toxicity.
- Median overall survival 12.1 vs 9.3 months.
- Objective response 41.3 percent vs 16.7 percent.
Platinum-pemetrexed remains the chemotherapy backbone in mesothelioma, now combined with pembrolizumab or bevacizumab, or replaced by dual immunotherapy in non-epithelioid disease.
- Single-agent cisplatin comparator.
- Vitamin supplementation changed mid-trial.
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