Literature DB >> 25937430

A phase II study of bevacizumab with modified OPTIMOX1 as first-line therapy for metastatic colorectal cancer: the TCOG-GI 0802 study.

Norisuke Nakayama1, Atsushi Sato, Soichi Tanaka, Ken Shimada, Kazuo Konishi, Eisaku Sasaki, Kenji Hibi, Hiroko Ichikawa, Yoshinori Kikuchi, Toshikazu Sakuyama, Takashi Sekikawa, Kazuhiko Hayashi, Haruhiro Nishina.   

Abstract

BACKGROUND: Although bevacizumab plus FOLFOX is a standard treatment for metastatic colorectal cancer, oxaliplatin must be withdrawn in many patients because of cumulative neurotoxicity. We postulated that a reduced dose of oxaliplatin and modified treatment schedule would prolong the time to treatment failure and evaluated bevacizumab combined with a modified OPTIMOX1 regimen (mOPTIMOX1, oxaliplatin dose: 85 mg/m(2)).
METHODS: Eligible patients had a histologically confirmed diagnosis of metastatic colorectal cancer and a performance status of 0-1. Patients were excluded if they had grade 1 or higher peripheral sensory neuropathy or had previously received chemotherapy for metastatic colorectal cancer. Patients received bevacizumab plus mFOLFOX6 every 2 weeks for 6 cycles, followed by 12 cycles of a simplified biweekly regimen of leucovorin and fluorouracil (sLV5FU2) plus bevacizumab. Oxaliplatin was then reintroduced, and bevacizumab plus mFOLFOX6 was continued until progressive disease.
RESULTS: The median duration of disease control was 11.7 months (95 % confidence interval [CI], 9.7-13.5 months). The median overall survival was 23.1 months (95 % CI, 18.8-27.9 months). The overall response rate according to both the RECIST and WHO criteria was 51.3 %. The most common grade 3 or 4 toxicities were neutropaenia (32.5 %), hypertension (17.5 %), leukocytopaenia, sensory neuropathy, and diarrhoea (10.0 %). There were no treatment-related deaths.
CONCLUSIONS: Bevacizumab plus mFOLFOX6 was well tolerated, and patients could continue chemotherapy for longer than with conventional FOLFOX regimens. This regimen might be an effective treatment option for patients with metastatic colorectal cancer.

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Year:  2015        PMID: 25937430     DOI: 10.1007/s10637-015-0239-1

Source DB:  PubMed          Journal:  Invest New Drugs        ISSN: 0167-6997            Impact factor:   3.850


  13 in total

1.  Phase III trial of cetuximab, bevacizumab, and 5-fluorouracil/leucovorin vs. FOLFOX-bevacizumab in colorectal cancer.

Authors:  Leonard Saltz; Suprith Badarinath; Shaker Dakhil; Bryan Bienvenu; W Graydon Harker; George Birchfield; Laurence K Tokaz; David Barrera; Paul R Conkling; Mark A O'Rourke; Donald A Richards; Diane Reidy; David Solit; Efsevia Vakiani; Marinella Capanu; Amy Scales; Feng Zhan; Kristi A Boehm; Lina Asmar; Allen Cohn
Journal:  Clin Colorectal Cancer       Date:  2011-11-04       Impact factor: 4.481

2.  Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study.

Authors:  A de Gramont; J F Bosset; C Milan; P Rougier; O Bouché; P L Etienne; F Morvan; C Louvet; T Guillot; E François; L Bedenne
Journal:  J Clin Oncol       Date:  1997-02       Impact factor: 44.544

3.  OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study.

Authors:  Christophe Tournigand; Andres Cervantes; Arie Figer; Gérard Lledo; Michel Flesch; Marc Buyse; Laurent Mineur; Elisabeth Carola; Pierre-Luc Etienne; Fernando Rivera; Isabel Chirivella; Nathalie Perez-Staub; Christophe Louvet; Thierry André; Isabelle Tabah-Fisch; Aimery de Gramont
Journal:  J Clin Oncol       Date:  2006-01-20       Impact factor: 44.544

4.  FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study.

Authors:  Christophe Tournigand; Thierry André; Emmanuel Achille; Gérard Lledo; Michel Flesh; Dominique Mery-Mignard; Emmanuel Quinaux; Corinne Couteau; Marc Buyse; Gérard Ganem; Bruno Landi; Philippe Colin; Christophe Louvet; Aimery de Gramont
Journal:  J Clin Oncol       Date:  2003-12-02       Impact factor: 44.544

5.  Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study.

Authors:  Benoist Chibaudel; Frédérique Maindrault-Goebel; Gérard Lledo; Laurent Mineur; Thierry André; Mostepha Bennamoun; May Mabro; Pascal Artru; Elisabeth Carola; Michel Flesch; Olivier Dupuis; Philippe Colin; Annette K Larsen; Pauline Afchain; Christophe Tournigand; Christophe Louvet; Aimery de Gramont
Journal:  J Clin Oncol       Date:  2009-09-28       Impact factor: 44.544

6.  A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer.

Authors:  Richard M Goldberg; Daniel J Sargent; Roscoe F Morton; Charles S Fuchs; Ramesh K Ramanathan; Stephen K Williamson; Brian P Findlay; Henry C Pitot; Steven R Alberts
Journal:  J Clin Oncol       Date:  2003-12-09       Impact factor: 44.544

7.  Cediranib with mFOLFOX6 versus bevacizumab with mFOLFOX6 as first-line treatment for patients with advanced colorectal cancer: a double-blind, randomized phase III study (HORIZON III).

Authors:  Hans-Joachim Schmoll; David Cunningham; Alberto Sobrero; Christos S Karapetis; Philippe Rougier; Sheryl L Koski; Ilona Kocakova; Igor Bondarenko; György Bodoky; Paul Mainwaring; Ramon Salazar; Peter Barker; Bijoyesh Mookerjee; Jane Robertson; Eric Van Cutsem
Journal:  J Clin Oncol       Date:  2012-09-10       Impact factor: 44.544

8.  Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer.

Authors:  Jim Cassidy; Stephen Clarke; Eduardo Díaz-Rubio; Werner Scheithauer; Arie Figer; Ralph Wong; Sheryl Koski; Mikhail Lichinitser; Tsai-Shen Yang; Fernando Rivera; Felix Couture; Florin Sirzén; Leonard Saltz
Journal:  J Clin Oncol       Date:  2008-04-20       Impact factor: 44.544

9.  Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study.

Authors:  Leonard B Saltz; Stephen Clarke; Eduardo Díaz-Rubio; Werner Scheithauer; Arie Figer; Ralph Wong; Sheryl Koski; Mikhail Lichinitser; Tsai-Shen Yang; Fernando Rivera; Felix Couture; Florin Sirzén; Jim Cassidy
Journal:  J Clin Oncol       Date:  2008-04-20       Impact factor: 44.544

10.  Safety and efficacy of oxaliplatin and fluoropyrimidine regimens with or without bevacizumab as first-line treatment of metastatic colorectal cancer: results of the TREE Study.

Authors:  Howard S Hochster; Lowell L Hart; Ramesh K Ramanathan; Barrett H Childs; John D Hainsworth; Allen L Cohn; Lucas Wong; Louis Fehrenbacher; Yousif Abubakr; M Wasif Saif; Lee Schwartzberg; Eric Hedrick
Journal:  J Clin Oncol       Date:  2008-07-20       Impact factor: 44.544

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  2 in total

1.  Optimal Maintenance Strategy for First-Line Oxaliplatin-Containing Therapy with or without Bevacizumab in Patients with Metastatic Colorectal Cancer: A Meta-Analysis.

Authors:  Toshikazu Moriwaki; Masahiko Gosho; Akinori Sugaya; Takeshi Yamada; Yoshiyuki Yamamoto; Ichinosuke Hyodo
Journal:  Cancer Res Treat       Date:  2020-12-01       Impact factor: 4.679

2.  Is there an efficacy-effectiveness gap between randomized controlled trials and real-world studies in colorectal cancer: a systematic review and meta-analysis.

Authors:  Xiao Zhang; Shihui Fu; Rui Meng; Yu Ren; Ye Shang; Lei Tian
Journal:  Transl Cancer Res       Date:  2020-11       Impact factor: 1.241

  2 in total

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