E1505: Adjuvant chemotherapy ± bevacizumab for early stage NSCLC—outcomes based on chemotherapy subsets

Conference Correspondent - ASCO 2016

Adjuvant chemotherapy (chemo) for resected early-stage non–small-cell lung cancer (NSCLC) provides modest survival benefit. The E1505 trial offered the first opportunity to study 4 modern cisplatin-based regimens in the adjuvant setting in the context of a single trial. As previously reported from this trial,1 the addition of bevacizumab to adjuvant chemo failed to improve the primary end point of overall survival (OS; hazard ratio [HR], 0.99; 95% confidence interval [CI], 0.82-1.19; P = 0.91) or disease-free survival (DFS; HR, 0.99; 95% CI, 0.85-1.15; P = 0.89). In the current report, Wakelee and colleagues explored outcomes by chemo regimen utilized.2 Patients with resected early-stage NSCLC, stratified by stage, histology, sex, and chemo option, were randomized 1:1 to chemo alone or chemo with bevacizumab (15 mg/kg every 3 weeks for up to 1 year). Chemo consisted of a planned 4 cycles of every-3-week cisplatin (75 mg/m2 on day 1) with the investigator’s choice of vinorelbine (30 mg/m2 on days 1, 8), docetaxel (75 mg/m2 on day 1), gemcitabine (1200 mg/m2 on days 1, 8), or pemetrexed (500 mg/m2 on day 1). A total of 1501 patients were enrolled: vinorelbine, 25%; docetaxel, 23%; gemcitabine, 19%; and P, 33%. Arms were well-balanced for known prognostic factors; 28% had squamous (Sq) histology. The median follow-up per chemo group was vinorelbine in 54.3 months, docetaxel in 60.3 months, gemcitabine in 57.0 months, and pemetrexed in 40.6 months. When patients were pooled across arms with or without bevacizumab, and divided into nonsquamous (NSq) and Sq cohorts, there was no significant difference in OS or DFS by chemo regimen: OS NSq, P = 0.19; DFS NSq, P = 0.67; OS Sq, P = 0.96; DFS Sq, P = 0.85. Toxicities were consistent with known profiles of the drugs. Vinorelbine was associated with more neutropenia and gemcitabine with more thrombocytopenia. Sq patients demonstrated no differences in total grade 3-5 toxicity by chemo groups, but NSq patients who received pemetrexed had significantly less total grade 3-5 toxicity (P <0.001) than NSq patients receiving other regimens. The authors concluded that there are no differences in OS or DFS among 4 different adjuvant cisplatin-based chemotherapy regimens for surgically resected early-stage NSCLC patients.
  1. No authors listed. Clin Adv Hematol Oncol. 2007;5:206-208.
  2. Wakelee HA, et al. ASCO 2016. Abstract 8507.