Pemetrexed plus cisplatin in combination with concurrent thoracic radiation therapy (TRT) followed by consolidation pemetrexed was not superior to standard chemotherapy with etoposide plus cisplatin for the treatment of patients with unresectable stage 3 nonsquamous non-small cell lung cancer (NSCLC), a study published online ahead of print in the Journal of Clinical Oncology has shown.1
The phase 3 PROCLAIM trial was designed to evaluate overall survival of concurrent pemetrexed plus cisplatin and TRT followed by consolidation pemetrexed compared with etoposide plus cisplatin with TRT followed by doublet consolidation therapy without pemetrexed.
For the study, researchers enrolled 598 patients with stage 3A/B unresectable nonsquamous NSCLC. Participants were randomly assigned 1:1 to receive pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 intravenously every 3 weeks for 3 cycles with concurrent TRT 60 to 66 Gy followed by pemetrexed every 3 weeks for 4 cycles; or etoposide 50 mg/m2 and cisplatin 50 mg/m2 intravenously every 4 weeks for 2 cycles plus concurrent TRT followed by 2 cycles of platinum-based doublet chemotherapy.
Results showed that median overall survival was 26.8 months in the pemetrexed arm compared with 25.0 months in the standard chemotherapy arm (HR, 0.98; 95% CI: 0.79-1.20; P=.831), suggesting that the pemetrexed arm was not superior to the standard treatment arm.
In regard to safety, the pemetrexed regimen was associated with a significantly lower incidence of any drug-related grade 3-4 adverse events than the standard chemotherapy regimen (P=.001), including neutropenia (P<.001).
1. Senan S, Brade A, Wang L-H, et al. PROCLAIM: Randomized phase III trial of pemetrexed-cisplatin or etoposide-cisplatin plus thoracic radiation therapy followed by consolidation chemotherapy in locally advanced nonsquamous non–small-cell lung cancer [published online ahead of print January 25, 2016]. J Clin Oncol. doi:10.1200/JCO.2015.64.8824.