Panitumumab-based maintenance after oxaliplatin discontinuation in metastatic colorectal cancer: A retrospective analysis of two randomised trials.


Journal

International journal of cancer
ISSN: 1097-0215
Titre abrégé: Int J Cancer
Pays: United States
ID NLM: 0042124

Informations de publication

Date de publication:
15 07 2019
Historique:
received: 25 07 2018
revised: 20 11 2018
accepted: 11 12 2018
pubmed: 8 1 2019
medline: 2 11 2019
entrez: 8 1 2019
Statut: ppublish

Résumé

Panitumumab is approved for RAS wild-type metastatic colorectal cancer and was evaluated in Phase III (PRIME, NCT00364013) and Phase II (PEAK, NCT00819780) first-line randomised studies. This retrospective analysis of these trials investigated efficacy and toxicity of panitumumab-based maintenance after oxaliplatin discontinuation in RAS wild-type patients. First-line regimens were FOLFOX4 ± panitumumab in PRIME and mFOLFOX6 plus panitumumab or mFOLFOX6 plus bevacizumab in PEAK. Outcomes included median progression-free survival (PFS) and overall survival (OS), from randomisation and oxaliplatin discontinuation, and toxicity. Overall, median duration of panitumumab plus 5-fluorouracil/leucovorin (5-FU/LV) maintenance was 21 (interquartile range: 11-41) weeks; that of 5-FU/LV ± bevacizumab maintenance was 16 (6-31) weeks. Median OS from randomisation was 40.2 (95% confidence interval: 30.3-50.4) and 39.1 (34.2-63.0) months for panitumumab plus 5-FU/LV maintenance and 24.1 (17.7-33.0) and 28.9 (21.0-32.0) months for 5-FU/LV ± bevacizumab maintenance in PRIME and PEAK, respectively. Median PFS from randomisation was 16.6 (11.3-23.6) and 15.4 (11.6-18.4) months for panitumumab plus 5-FU/LV maintenance and 12.6 (9.4-16.2) and 13.1 (9.5-16.6) months for 5-FU/LV ± bevacizumab maintenance in PRIME and PEAK, respectively. From oxaliplatin discontinuation, median OS was 33.9 (24.7-42.8) and 33.5 (24.5-54.9) months for panitumumab plus 5-FU/LV maintenance and 16.4 (12.4-24.1) and 23.3 (15.7-26.3) months for 5-FU/LV ± bevacizumab maintenance in PRIME and PEAK, respectively; PFS was 11.7 (7.8-19.2) and 9.7 (5.8-14.8) months and 7.1 (5.6-10.2) and 7.0 (3.9-10.6) months, respectively. The most frequently reported adverse events were rash, fatigue and diarrhoea. Maintenance of panitumumab plus 5-FU/LV after oxaliplatin discontinuation was well tolerated and may be an acceptable treatment paradigm for patients demonstrating a good response to first-line treatment. Prospective studies are warranted.

Identifiants

pubmed: 30614531
doi: 10.1002/ijc.32110
pmc: PMC6590196
doi:

Substances chimiques

Organoplatinum Compounds 0
Oxaliplatin 04ZR38536J
Bevacizumab 2S9ZZM9Q9V
Panitumumab 6A901E312A
Leucovorin Q573I9DVLP
Fluorouracil U3P01618RT

Banques de données

ClinicalTrials.gov
['NCT00364013', 'NCT00819780']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

576-585

Informations de copyright

© 2019 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.

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Auteurs

Dominik Paul Modest (DP)

Department of Medicine III & Comprehensive Cancer Center, Hospital of the University (LMU) Grosshadern, Ludwig-Maximilians-University, Munich, Germany.

Fernando Rivera (F)

Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, Santander, Spain.

Jean-Baptiste Bachet (JB)

Department of Gastroenterology, La Pitié-Salpetrière Hospital, Assistance Publique des Hôpitaux de Paris (APHP), Paris, France.

Filippo de Braud (F)

Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Department of Oncology and Hemato-Oncology, Università degli Studi di Milano, Milan, Italy.

Filippo Pietrantonio (F)

Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Department of Oncology and Hemato-Oncology, Università degli Studi di Milano, Milan, Italy.

Reija Koukakis (R)

Department of Biostatistics, Amgen Ltd, Uxbridge, United Kingdom.

Gaston Demonty (G)

Medical Development, Amgen (Europe) GmbH, Rotkreuz, Switzerland.

Jean-Yves Douillard (JY)

Department of Medical Oncology, Institut de Cancérologie de l'Ouest (ICO) René Gauducheau, Nantes, France.

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