113226-132

A phase III study of pemetrexed (Pem) plus carboplatin (Cb) plus bevacizumab (Bev) followed by maintenance pem plus bev versus paclitaxel (Pac) plus cb plus bev followed by maintenance bev in stage IIIb or IV nonsquamous non-small cell lung cancer (NS-NSCLC): Overall and age group results.

Category: 
Lung Cancer - Non-Small Cell Metastatic
Session Type and Session Title: 
Oral Abstract Session, Lung Cancer - Non-small Cell Metastatic
Abstract Number: 
8004
Citation: 
J Clin Oncol 31, 2013 (suppl; abstr 8004)
Author(s): 
Mark A. Socinski, Jyoti D. Patel, Edward B. Garon, Ramaswamy Govindan, Craig H. Reynolds, David R. Spigel, Mark R. Olsen, Jingyi Liu, Susan C. Guba, Philip Bonomi; University of Pittsburgh, Pittsburgh, PA; Northwestern University, Chicago, IL; University of California, Los Angeles, Santa Monica, CA; Washington University School of Medicine in St. Louis, St. Louis, MO; US Oncology Research, Ocala, FL; Sarah Cannon Research Institute, Nashville, TN; Cancer Care Associates, Tulsa, OK; Eli Lilly and Company, Indianapolis, IN; Rush University Medical Center, Chicago, IL

Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures

Abstract: 

Background: This study compared Pem+Cb+Bev followed by Pem+Bev maintenance (Pem arm) to Pac+Cb+Bev followed by Bev maintenance (Pac arm). The primary endpoint of improved overall survival (OS) for the Pem arm was not met. Methods: Advanced NS-NSCLC pts, ECOG PS 0/1, were randomized to 4 cycles of induction Pem+Cb+Bev with folic acid+vitamin B12 or Pac+Cb+Bev (Pem 500 mg/m2or Pac 200 mg/m2; Cb AUC 6; Bev 15 mg/kg) every 3 weeks. Eligible pts received maintenance Pem+Bev or Bev. OS, progression-free survival (PFS), overall response (ORR), and toxicity were evaluated. A hazard ratio (HR) of 0.80 required 676 OS events/900 pts with 2-sided type-I error .05 and at least 80% power for superiority of Pem over Pac arm. Exploratory Cox models estimated treatment HRs with 95% confidence intervals (CIs) for each age subgroup analyzed: ≤ or >65, 70 (prespecified) and ≤ or >75 yrs (not prespecified). Results: 939 pts (median age, 64.7) were randomized. Median (m) OS for ITT pem and pac arms was 12.6 vs 13.4 mos (HR 1.00, p=0.949); mPFS was 6.0 vs 5.6 mos (HR 0.83, p=0.012) Subgroup efficacy is shown in the Table; ≤ or >65 data were similar to ITT. Pem pts had significantly more drug-related grade 3/4 thrombocytopenia, anemia (except >75 yrs) and fatigue (except >70 and >75 yrs). Pac pts had significantly more grade 3/4 neutropenia (except >70 and >75 yrs), sensory neuropathy (except >75 yrs) and grade 1/2 alopecia. Results parallel overall safety data. Conclusions: OS was not significantly different in any of the age subgroups. PFS was significantly longer in Pem arm overall and for pts ≤70, but was similar for pts >70, >75 yrs. Toxicity profiles differed; subgroup safety data paralleled overall data. Clinical trial information: NCT00762034.

Efficacy
endpoint
≤70
Pem
n=354
75%
≤70
Pac
n=338
72%
>70
Pem
n=118
25%
>70
Pac
n=129
27.6%
>75
Pem
n=52
11.0%
>75
Pac
n=55
11.8%
OS (mos) 12.6 14.3 12.7 11.5 11.8 8.9
HR (95% CI) 1.04
(0.88-1.24)
0.90
(0.67-1.21)
0.98
(0.63-1.51)
P value 0.638 0.484 0.923
PFS (mos) 6.3 5.6 5.7 5.6 5.4 4.5
HR (95% CI) 0.77
(0.65-0.92)
0.98
(0.73-1.31)
0.82
(0.52-1.30)
P value 0.003 0.872 0.393
ORR% 36.4 35.2 27.1 27.1 19.2 23.6