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Attend this session at the
2019 ASCO Annual Meeting!


Session: Lung Cancer—Non-Small Cell Metastatic

Type: Oral Abstract Session

Time: Monday June 3, 8:00 AM to 11:00 AM

Location: Hall B1

ECOG-ACRIN 5508: Pemetrexed, bevacizumab or the combination as maintenance therapy for advanced non-squamous NSCLC.

Sub-category:
Metastatic Non-Small Cell Lung Cancer

Category:
Lung Cancer—Non-Small Cell Metastatic

Meeting:
2019 ASCO Annual Meeting

Abstract No:
9002

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 9002)

Author(s): Suresh S. Ramalingam, Suzanne Eleanor Dahlberg, Chandra Prakash Belani, Joel N. Saltzman, Gopakumar S. Nambudiri, John McCann, Jerome D. Winegarden, Mohammed Azher Kassem, Mohamed K. Mohamed, Jan M. Rothman, Alan P. Lyss, Leora Horn, Tom Stinchcombe, Joan H. Schiller, ECOG-ACRIN Cancer Research Group; Winship Cancer Institute, Emory University, Atlanta, GA; Dana-Farber Cancer Institute, Boston, MA; Penn State Hershey Cancer Institute, Hershey, PA; University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH; Health East Cancer Care, Woodbury, MN; Baystate Medcl Ctr, Springfield, MA; Ann Arbor Hem Onc Assocs, Ypsilanti, MI; Mt.Sinai Hosp, Chicago, IL; Cone Health Center at Wesley Long, Greensboro, NC; The Regional Cancer Center, Erie, PA; Missouri Baptist Cancer Ctr, St Louis, MO; Vanderbilt University Medical Center, Nashville, TN; Duke Cancer Institute, Durham, NC; The University of Texas Southwestern Medical Center, Dallas, TX

Abstract Disclosures

Abstract:

Background: Maintenance therapy is a standard approach for advanced non-squamous NSCLC. Pemetrexed or bevacizumab are considered evidence-based options. The combination of bevacizumab and pemetrexed has been documented to improve progression-free survival (PFS). We conducted a phase 3 study to determine the optimal maintenance therapy for advanced NSCLC. Methods: Patients (pts) with advanced non-squamous NSCLC, no prior systemic therapy, and ECOG performance status 0/1 were treated with carboplatin (AUC = 6), paclitaxel (200 mg/m2) and bevacizumab (15 mg/Kg) every 3 weeks for up to 4 cycles (step 1). Patients with CR/PR/SD after 4 cycles were then randomized 1:1:1 to maintenance therapy with bevacizumab (15 mg/Kg), pemetrexed (500 mg/m2) or the combination of the two agents every 3 weeks until disease progression (step 2). The primary endpoint was overall survival (OS), defined as the time from randomization to death from any cause and censoring defined at the last date of followup. 1495 pts provided 81% power to detect a hazard ratio of 0.75 while controlling the 2-sided type I error at 0.025 for each comparison, assuming approximately 60% of those patients would be randomized. Results: We enrolled 1516 pts to step 1 (male 52%; ECOG PS 1 62%; adenocarcinoma 90%); After induction therapy, 874 (57%) pts were randomized to step 2 (median age 64 yrs; male 49%; ECOG PS 1 55%). Baseline characteristics were balanced across all three groups. The median follow-up in maintenance is 50.6 months. Conclusions: Single agent bevacizumab or pemetrexed is the optimal maintenance therapy for advanced non-squamous NSCLC. The combination of bevacizumab and pemetrexed cannot be recommended due to the lack of survival benefit in this definitive study. (Drs. Ramalingam, Dahlberg and Belani contributed equally to this work). Supported by the NCI: CA180820, CA180794,CA180799, CA180821, CA180838, CA180844, CA180847, CA180853, CA180857, CA180864, CA180867, CA180868, CA180870, CA180882, CA189830, CA189859, CA189863, CA189971. Clinical trial information: NCT01107626

BevacizumabPemetrexedBevacizumab + Pemetrexed
Number of patients287294293
Efficacy (Medians, 97.5% CIs)
PFS4.2 m5.1 m7.5 m
HR 0.85,(0.69, 1.03)HR 0.67,(0.55, 0.82) p < 0.001
p = 0.06
OS14.4 m15.9 m16.4 m
HR 0.86,(0.70, 1.07)p = 0.12HR 0.90,(0.73, 1.12)p = 0.28
Grade 3/4/5 Toxicity
Worst Degree30%37%50%
Anemia2%7%6%
Neutropenia1%7%11%
Thrombocytopenia-3%4%
Fatigue2%7%8%
Hypertension16%5%19%

 
Other Abstracts in this Sub-Category:

 

1. Association of STK11/LKB1 genomic alterations with lack of benefit from the addition of pembrolizumab to platinum doublet chemotherapy in non-squamous non-small cell lung cancer.

Meeting: 2019 ASCO Annual Meeting Abstract No: 102 First Author: Ferdinandos Skoulidis
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer

 

2. Real-world outcomes of patients with advanced non-small cell lung cancer (aNSCLC) and autoimmune disease (AD) receiving immune checkpoint inhibitors (ICIs).

Meeting: 2019 ASCO Annual Meeting Abstract No: 110 First Author: Sean Khozin
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer

 

3. RELAY: A multinational, double-blind, randomized Phase 3 study of erlotinib (ERL) in combination with ramucirumab (RAM) or placebo (PL) in previously untreated patients with epidermal growth factor receptor mutation-positive (EGFRm) metastatic non-small cell lung cancer (NSCLC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 9000 First Author: Kazuhiko Nakagawa
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer

 

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