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Randomized phase II...
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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- Barlesi, Fabrice (author)
- Hop Marseille, AP HP, Marseille, France
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- Scherpereel, Arnaud (author)
- Univ Lille, Ctr Hosp Reg, Hop A Calmette, Lille, France
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- Rittmeyer, Achim (author)
- Lungenfachklin Immenhausen, Immenhausen, Germany
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- Pazzola, Antonio (author)
- Osped Civile Santissima, Sassari, Italy
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- Ferrer Tur, Neus (author)
- Hosp Son Llatzer, Palma De Mallorca, Spain
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- Kim, Joo-Hang (author)
- Yonsei Univ, Coll Med, Seoul 120749, South Korea
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- Ahn, Myung-Ju (author)
- Sungkyunkwan Univ, Sch Med, Seoul, South Korea
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- Aerts, Joachim G J V (author)
- Amphia Hosp, Breda, Netherlands
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- Gorbunova, Vera (author)
- NN Blokhin Canc Res Ctr Russia, Moscow, Russia
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- Vikström, Anders (author)
- Östergötlands Läns Landsting,Linköpings universitet,Institutionen för klinisk och experimentell medicin,Hälsouniversitetet,Lungmedicinska kliniken US
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- Wong, Elaine K (author)
- F Hoffmann Roche, Basel, Switzerland
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- Perez-Moreno, Pablo (author)
- F Hoffmann Roche, Basel, Switzerland
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- Mitchell, Lada (author)
- F Hoffmann Roche, Basel, Switzerland
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- Groen, Harry J M (author)
- Univ Med Ctr Groningen, Groningen, Netherlands
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(creator_code:org_t)
- Alexandria, VA, USA : American Society of Clinical Oncology, 2013
- 2013
- English.
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In: Journal of Clinical Oncology. - Alexandria, VA, USA : American Society of Clinical Oncology. - 0732-183X .- 1527-7755. ; 31:24, s. 3004-3011
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- MEDICINE
- MEDICIN
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Barlesi, Fabrice
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Scherpereel, Arn ...
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Rittmeyer, Achim
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Pazzola, Antonio
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Ferrer Tur, Neus
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Kim, Joo-Hang
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show more...
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Ahn, Myung-Ju
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Aerts, Joachim G ...
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Gorbunova, Vera
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Vikström, Anders
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Wong, Elaine K
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Perez-Moreno, Pa ...
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Mitchell, Lada
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Groen, Harry J M
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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Journal of Clini ...
- By the university
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Linköping University