• Oncology Clinical Trials
• Cancer
• Respiratory Cancers

• Oncology Clinical Trials
• Cancer
• Oncology
• Respiratory Cancers

In patients with advanced nonsquamous non-small cell lung cancer (NSCLC), first-line treatment with pemetrexed plus carboplatin (PemC) followed by maintenance Pem is not associated with superior progression-free survival without Grade 4 toxicities (G4PFS) compared with treatment with paclitaxel/carboplatin/bevacizumab (PCB) followed by maintenance bevacizumab (BEV).

Ralph Zinner, MD, University of Texas MD Anderson Cancer Center, Houston, Texas, USA, presented the results of the Study of Patients With Advanced Non-Small Cell Lung Cancer [PRONOUNCE; NCT0948675; Zinner R et al. J Clin Oncol 2013 (suppl; abstr LBA8003)], a randomized, open-label, Phase 3 study that assessed the superiority of 2-drug regimen PemC compared with 3-drug regimen PCB in patients with advanced NSCLC.

A total of 361 patients were enrolled in the study, all of who met the eligibility criteria: age ≥18 years, stage IV NSCLC, an ECOG PS of 0 to 1, chemotherapy-naïve status, and stable treated central nervous system metastases. Patients with uncontrolled effusions were excluded from the study.

Of the 361 patients, 182 were randomized to PemC and 179 to PCB. Patients in both arms received 4 cycles of induction therapy followed by maintenance therapy in the absence of progressive disease or discontinuation of therapy. The PemC group received 4 cycles of induction Pem (500 mg/m²) and CBP (area under the curve [AUC]=6) followed by Pem maintenance therapy, and the PCB group received induction paclitaxel (200 mg/m²), CBP (AUC=6), and BEV (15 mg/kg) followed by BEV maintenance therapy.

Baseline characteristics were similar between the two treatment groups, with a median age of 66 years, 42% female, the majority Caucasian, 47% ECOG PS 0, and 70% disease stage M1b.

The primary endpoint of the study was a composite endpoint of G4PFS. Secondary endpoints included PFS, overall survival (OS), response rates (RR), disease-control rates (DCR), and safety/tolerability.

Based on an intention-to-treat analysis, the study found no difference in G4PFS between PemC and PCB (median 3.9 vs 2.9 months; HR, 0.85; 90% CI, 0.70 to 1.04; log-rank p=0.176).

In addition, the study found no differences between PemC and PCB in PFS (median 4.4 vs 5.5 months; HR, 1.06; 95% CI, 0.84 to 1.35; log-rank p=0.610), OS (median 10.5 vs 11.7 months; HR, 1.07; 95% CI, 0.83 to 1.36; log-rank p=0.616), RR (23.6% vs 27.4%; p=0.414), or DCR (59.9% vs 57.0%; p=0.575).

Based on the actual study regimen of 171 patients treated with PemC and 166 treated with PCB, the study found that the PemC group had significantly more drug-related Grade 3/4 anemia (18.7% vs 5.4%; p<0.001) and thrombocytopenia (24.0% vs 9.6%; p<0.001). Patients treated with PCB had significantly more drug-related Grade 3/4 neutropenia than the PemC group (48.8% vs 24.6%; p<0.001) and Grade 1 and Grade 2 alopecia (16.3% vs 5.8%;p=0.003; and 12.0% vs 2.3%; p<0.001, respectively).

According to the investigators, there were no unexpected toxicities and both treatments demonstrated tolerability.

• © 2013 MD Conference Express®