Pemetrexed-cisplatin and thoracic radiation therapy followed by consolidated pemetrexed was not superior to standard chemotherapy for treatment of stage 3 unresectable nonsquamous cell non-small cell lung cancer, according to a study published in the Journal of Clinical Oncology.1
A total of 598 patients with stage 3a/b unresectable nonsquamous non-small cell lung cancer were randomized to receive either arm A: pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 intravenously every 3 weeks for 3 cycles plus concurrent thoracic radiation therapy (60 to 66 Gy) followed by pemetrexed consolidation every 3 weeks for 4 cycles (n = 301) or arm B: etoposide 50 mg/m2 and cisplatin 50 mg/m2 every 4 weeks for 2 cycles plus concurrent thoracic radiation treatment (60 to 66 Gy) followed by 2 cycles of consolidation platinum-based doublet chemotherapy (n = 297).
The study’s primary endpoint was overall survival and it was designed as a superiority trial with 80% power to detect an overall survival hazard ratio of 0.74 with a type 1 error of .05.
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Enrollment was discontinued early because of futility. Patients in arm A had a median overall survival rate of 26.8 months vs 25.0 months in arm B (HR, 0.98; 95% CI, 0.79 – 1.20; P = .831). There were significantly fewer grade 3/4 drug-related adverse in arm A (64.0% vs 76.8%; P = .001).
- Senan S, Brade A, Wang L, 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.