113046-132

Effect of maintenance bevacizumab (Bev) plus pemetrexed (Pem) after first-line cisplatin/Pem/Bev in advanced nonsquamous non-small cell lung cancer (nsNSCLC) on overall survival (OS) of patients (pts) on the AVAPERL (MO22089) phase III randomized trial.

Category: 
Lung Cancer - Non-Small Cell Metastatic
Session Type and Session Title: 
Poster Discussion Session, Lung Cancer - Non-small Cell Metastatic
Abstract Number: 
8014
Citation: 
J Clin Oncol 31, 2013 (suppl; abstr 8014)
Author(s): 
Achim Rittmeyer, Arnaud Scherpereel, Vera A. Gorbunova, Radj Gervais, Anders Vikström, Christos Chouaid, Antonio Chella, Joo-Hang Kim, Myung-Ju Ahn, Martin Reck, Antonio Pazzola, Heung Tae Kim, Joachim Aerts, Harry J.M. Groen, Claire Morando, Anderson Loundou, Fabrice Barlesi; Lungenfachklinik Immenhausen, Immenhausen, Germany; Centre Hospitalier Universitaire Lille, Lille, France; N. N. Blokhin Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Centre François Baclesse, Caen, France; Universitetssjukhuset, Linköping, Sweden; Hôpital Saint-Antoine, Paris, France; University Hospita, Pisa, Italy; Department of Internal Medicine (Medical Oncology), Yonsei Cancer Research Institute, Yonsei Cancer Center, Seoul, South Korea; Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea; Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Grosshansdorf, Germany; Medical Oncology - Ospedale Civile SS. Annunziata, Sassari, Italy; Center for Lung Cancer, National Cancer Center, Goyang, South Korea; Amphia Hospital, Breda, Netherlands; University Medical Center Groningen, Groningen, Netherlands; Aix Marseille University, Marseille, France; Aix Marseille University, Assistance Publique Hôpitaux de Marseille, Marseille, France

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: Maintenance monotherapy has been associated with improved survival for NSCLC pts. AVAPERL was designed to evaluate the safety and efficacy of bevacizumab with or without pemetrexed as continuation maintenance treatment and demonstrated improved progression-free survival (PFS) (Barlesi, JCO in press). Methods: Pts with advanced nsNSCLC received first-line Bev (7.5 mg/kg), cisplatin (75 mg/m2), and Pem (500 mg/m2) every 3 weeks (q3w) for 4 cycles. Those non progressing were randomized to maintenance Bev (7.5 mg/kg) +/-Pem (500 mg/m2) q3w until progressive disease or unacceptable toxicity. The primary end point (PFS) was met. An independent update analysis has been conducted to assess OS. Results: A total of 376 pts receive induction treatment; 125 and 128 were randomized to the Bev-alone and Bev+Pem arms, respectively. Induction therapy resulted in confirmed disease control in 71.9% of pts. After a median follow-up of 14.8 months, PFS for the Bev+Pem arm was significantly improved both from induction (10.2 v 6.6 m, HR 0.58 [0.45-0.76], p<.0001) and randomization (7.4 v 3.7 m, HR 0.57 [0.44-0.75], p<.0001). With 58% of events, OS for the Bev+Pem arm was also improved both from induction (19.8 v 15.9 m, HR 0.88 [0.64-1.22], p=.32) and randomization (17.1 v 13.2 m, HR 0.87 [0.63-1.21], p=.29). The PFS and OS improvements were comparable across age, PS, smoking status, and response to induction (SD vPR/CR) subgroups. No new safety signal was observed during this updated analysis. Conclusions: Continuation maintenance with Bev+Pem in an unselected population of nsNSCLC pts who had achieved disease control after induction was associated with an increase by almost 4 months in OS benefit over standard Bev alone. Clinical trial information: NCT00961415.