Fabrice Barlési1,2, Arnaud Scherpereel2, Achim Rittmeyer2, Antonio Pazzola2, Neus Ferrer Tur2, Joo-Hang Kim2, Myung‐Ju Ahn2, Joachim G.J.V. Aerts2, В. А. Горбунова2,3, Anders Vikström2,4, Elaine K. Wong5,2, Pablo Ernesto Pérez5,2, Lada Mitchell5,2, Harry J.M. Groen2,6
1Ctr Invest Clin CIC Inserm
2Fabrice Barlesi, Aix Marseille University–Assistance Publique Hôpitaux de Marseille and Centre d'Investigation Clinique, Marseille; Arnaud Scherpereel, Hôpital Calmette, Centre Hospitalier Régional Universitaire de Lille, Lille, France; Achim Rittmeyer, Lungenfachklinik Immenhausen, Immenhausen, Germany; Antonio Pazzola, Ospedale Civile Santissima, Annunziata, Sassari, Italy; Neus Ferrer Tur, Hospital Son Llàtzer, Palma de Majorca, Spain; Joo-Hang Kim, Yonsei University College of Medicine; Myung-Ju Ahn,...
3Russian Academy of Medical Sciences - N.N. Blokhin Russian Cancer Research Center
4Lungkliniken, Pulm Clin
5F Hoffmann La Roche, Roche Holding
6University of Groningen
Tóm tắt
Purpose Maintenance therapy is associated with improved survival in patients with non–small-cell lung cancer (NSCLC), but few studies have compared active agents in this setting. AVAPERL evaluated the safety and efficacy of bevacizumab with or without pemetrexed as continuation maintenance treatment. Patients and Methods Patients with advanced nonsquamous NSCLC received first-line bevacizumab 7.5 mg/kg, cisplatin 75 mg/m2, and pemetrexed 500 mg/m2 once every 3 weeks for four cycles. Those achieving response or stable disease were randomly assigned at a ratio of 1:1 to maintenance bevacizumab 7.5 mg/kg or bevacizumab 7.5 mg/kg plus pemetrexed 500 mg/m2 once every 3 weeks until disease progression or unacceptable toxicity. The primary end point was progression-free survival (PFS) after random assignment. Results In total, 376 patients received induction treatment, 71.9% achieved disease control, and 67.3% were randomly assigned to maintenance therapy, with 125 and 128 receiving single-agent bevacizumab and bevacizumab plus pemetrexed treatment, respectively. At a median follow-up of 8.1 months, PFS from random assignment was significantly improved in the bevacizumab plus pemetrexed arm (median, 3.7 v 7.4 months; hazard ratio, 0.48; 95% CI, 0.35 to 0.66; P < .001) per a stratified model. The PFS benefit extended across age, performance status, smoking history, and induction response (stable disease v partial response) subgroups. Any grade, grade ≥ 3, and serious adverse events occurred more often with bevacizumab plus pemetrexed maintenance. No new safety signals were observed. Conclusion In an unselected population of patients with nonsquamous NSCLC who had achieved disease control with platinum-based chemotherapy plus bevacizumab, bevacizumab plus pemetrexed maintenance was associated with a significant PFS benefit compared with bevacizumab alone. The combination was well tolerated.
