Randomized Phase III Trial of Maintenance Bevacizumab With or Without Pemetrexed After First-Line Induction With Bevacizumab, Cisplatin, and Pemetrexed in Advanced Nonsquamous Non–Small-Cell Lung Cancer: AVAPERL (MO22089)

Barlesi, Fabrice; Scherpereel, Arnaud; Rittmeyer, Achim; Pazzola, Antonio; Ferrer Tur, Neus; Kim, Joo-Hang; Ahn, Myung-Ju; Aerts, Joachim G.J.V.; Gorbunova, Vera; Vikström, Anders; Wong, Elaine K.; Perez-Moreno, Pablo; Mitchell, Lada; Groen, Harry J.M.

doi:10.1200/jco.2012.42.3749

Cited by 323Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentLung Cancer Research Studies

Randomized Phase III Trial of Maintenance Bevacizumab With or Without Pemetrexed After First-Line Induction With Bevacizumab, Cisplatin, and Pemetrexed in Advanced Nonsquamous Non–Small-Cell Lung Cancer: AVAPERL (MO22089)

Barlesi, Fabrice, Scherpereel, Arnaud, Rittmeyer, Achim, Pazzola, Antonio, Ferrer Tur, Neus, Kim, Joo-Hang, Ahn, Myung-Ju, Aerts, Joachim G.J.V. +6 more·2013·Journal of Clinical Oncology

DOI 10.1200/jco.2012.42.3749

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Abstract

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/m 2, and pemetrexed 500 mg/m 2 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/m 2 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.

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At the time of study publication, OS had not yet been reached in the trial comparing maintenance pemetrexed plus bevacizumab with bevacizumab alone.
“At the time of study publication, OS had not yet been reached.”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [33]
In a second trial comparing maintenance pemetrexed plus bevacizumab with bevacizumab alone after first-line induction with bevacizumab, cisplatin, and pemetrexed, the study met its primary end point of statistically significantly longer PFS with bevacizumab plus pemetrexed (7.4 v 3.7 months; HR, 0.48; 95% CI, 0.35 to 0.66; P < .001).
“A second trial33 compared maintenance pemetrexed plus bevacizumab with bevacizumab alone (after first-line induction with bevacizumab, cisplatin, and pemetrexed). The study met its primary end point of statistically significantly longer PFS with bevacizumab plus pemetrexed (7.4 v 3.7 months; hazard ratio [HR], 0.48; 95% CI, 0.35 to 0.66; P < .001).”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [33]

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Authors: Barlesi, F., Scherpereel, A., Rittmeyer, A., Pazzola, A., Ferrer Tur, N., Kim, J.-H., Ahn, M.-J., Aerts, J. G. J. V., Gorbunova, V., Vikström, A., Wong, E. K., Perez-Moreno, P., Mitchell, L., & Groen, H. J. M.
Affiliations: Fabrice 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,...
Aix-Marseille Université (FR)
F. Hoffmann-La Roche AG (CH)
University of Groningen (NL)
ORCID: Scherpereel, Arnaud
Rittmeyer, Achim
Pazzola, Antonio
Kim, Joo-Hang
Ahn, Myung-Ju
Aerts, Joachim G.J.V.
Vikström, Anders
Groen, Harry J.M.
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2013-08-20
Volume: 31
Issue: 24
Pages: 3004-3011
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2012.42.3749
OpenAlex: W2122798232
Cited by: 323
References: 29
Citations by year: 2026: 3 · 2025: 7 · 2024: 15 · 2023: 7 · 2022: 14 · 2021: 16 · 2020: 22 · 2019: 33 · 2018: 25 · 2017: 29 · 2016: 39 · 2015: 44 · 2014: 44 · 2013: 22 · 2012: 3
FWCI: 40.37
Type: journal article
Language: en
Open access: closed
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
Keywords: bevacizumab, pemetrexed, maintenance therapy, non-squamous non-small cell lung cancer, cisplatin, progression-free survival, anti-angiogenic therapy, adverse events, subgroup analysis, smoking history, performance status, age, stable disease, partial response
MeSH terms: Bevacizumab, Pemetrexed, Adult, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Cisplatin, Drug Administration Schedule, Female, Glutamates, Guanine, Humans, Lung Neoplasms, Male, Middle Aged, Young Adult, Induction Chemotherapy, Antibodies, Monoclonal, Humanized

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Randomized Phase III Trial of Maintenance Bevacizumab With or Without Pemetrexed After First-Line Induction With Bevacizumab, Cisplatin, and Pemetrexed in Advanced Nonsquamous Non–Small-Cell Lung Cancer: AVAPERL (MO22089)

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