Final Overall Survival Results of the Phase 3 PROCLAIM Trial
In the phase 3 PROCLAIM trial, the efficacy and safety of concurrent pemetrexed plus cisplatin (Pem+Cis) and thoracic radiation therapy (TRT) followed by consolidation Pem vs other cytotoxic chemotherapy regimens were evaluated.1 A total of 598 patients with stage III unresectable nonsquamous (ns) NSCLC were randomized 1:1 to Pem+Cis plus concurrent TRT (66.0 Gy) every 21 days x 3 cycles followed by Pem consolidation x 4 cycles vs. the control arm etoposide plus cisplatin (Eto+Cis) plus concurrent TRT (66.0 Gy) x 2 cycles followed by 2 cycles of a consolidation chemotherapy regimen of choice: either Cis+Eto, Cis+vinorelbine, or paclitaxel+carboplatin. The primary objective was overall survival (OS). Progression-free survival (PFS), objective response rate (ORR), and safety were key secondary objectives. Pem+Cis vs Eto+Cis median OS was 26.8 vs 25.0 months (HR 0.98; 95% CI: 0.79, 1.20; P = 0.831) and median PFS was 11.4 vs 9.8 months (HR 0.86; 95% CI: 0.71, 1.04; P = 0.130). Pem+Cis/Eto+Cis ORR was 35.9%/33.0% (P = 0.458) and disease control rate was 80.7%/70.7% (P = 0.004). Possibly related Grade 3/4 toxicities (Pem+Cis vs Eto+Cis) occurred in 64.0% vs 76.8% of pts (P = 0.001). The Pem+Cis arm had a lower incidence of Grade 3/4 neutropenia/granulocytopenia vs the Eto+Cis arm: 24.4% vs 44.5% of pts (P < 0.001). Pem+Cis vs Eto+Cis rates of Grade 3/4 pneumonitis/pulmonary infiltrates and esophagitis were 1.8% vs 2.6% and 15.5% vs 20.6%, respectively. The authors concluded that while Pem+Cis did not improve OS vs the control arm, Pem+Cis had a better safety profile than the Eto+Cis.
- Senan S, et al. ASCO 2015. Abstract 7506.