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Phase III trial comparing 4-day chronomodulated therapy delivery of fluorouracil, leucovorin, and oxaliplatin as first-line chemotherapy of metastatic colorectal cancer: the European Organisation for Research and Treatment of Cancer Chronotherapy Group

2006Journal article Open access
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dc.contributor.authorGiacchetti, S
dc.contributor.authorBjarnason, G
dc.contributor.authorGarufi, C
dc.contributor.authorGenet, D
dc.contributor.authorIacobelli, S
dc.contributor.authorTampellini, M
dc.contributor.authorSmaaland, R
dc.contributor.authorFocan, C
dc.contributor.authorCoudert, B
dc.contributor.authorHumblet, Y
dc.contributor.authorCanon, J
dc.contributor.authorAdenis, A
dc.contributor.authorLo Re, G
dc.contributor.authorCarvalho, C
dc.contributor.authorSchueller, J
dc.contributor.authorAnciaux, N
dc.contributor.authorLentz, MA
dc.contributor.authorBaron, B
dc.contributor.authorGorlia, T
dc.contributor.authorLévi, F
dc.date.accessioned2011-08-30T15:43:11Z
dc.date.available2011-08-30T15:43:11Z
dc.date.issued2006
dc.description.abstractPurpose: In two previous randomized trials, the adjustment of chemotherapy delivery to circadian rhythms improved tolerability and anticancer activity compared with constant-rate infusion during 5 days in patients with metastatic colorectal cancer. Patients and Methods: For this multicenter randomized trial, it was hypothesized that a chronomodulated infusion of fluorouracil, leucovorin, and oxaliplatin for 4 days (chronoFLO4) would improve survival by 10% compared with conventional 2-day delivery of the same drugs (FOLFOX2). Patients were treated every 2 weeks with intrapatient dose escalation. Results: Baseline characteristics were similar in both arms for the 564 patients (36 institutions, 10 countries). Median survival was 19.6 months (95% confidence limit [CL] 18.2, 21.2) with chronoFLO4 and 18.7 months with FOLFOX2 (95% CL 17.7, 21.0; P .55). The main dose-limiting toxicities were diarrhea for chronoFLO4 and neutropenia for FOLFOX2. The analysis of survival predictors showed that sex was the single most important factor (P .001). In women, the risk of an earlier death with chronoFLO4 was increased by 38% compared with FOLFOX2, with median survival times of 16.3 and 19.1 months (P .03), respectively. In men, the risk of death was decreased by 25% with chronoFLO4 compared with FOLFOX2, with median survival times of 21.4 and 18.3 months (P=.02), respectively. Conclusion: Both regimens achieved similar median survival times more than 18 months with an acceptable toxicity. The chronomodulated schedule produced a survival advantage over FOLFOX in men. The strong sex dependency of optimal scheduling of fluorouracil, leucovorin, and oxaliplatin calls for translational investigations of determinants related to the patient’s molecular clock.por
dc.identifier.citationJ Clin Oncol. 2006 Aug 1;24(22):3562-9por
dc.identifier.issn0732-183X
dc.identifier.urihttp://hdl.handle.net/10400.10/417
dc.language.isoengpor
dc.peerreviewedyespor
dc.publisherAmerican Society of Clinical Oncologypor
dc.subjectNeoplasias colorrectaispor
dc.subjectEstadiamento de neoplasiapor
dc.subjectProtocolos de quimioterapia combinada antineoplásicapor
dc.subjectMarcadores tumorais biológicospor
dc.subjectEuropapor
dc.subjectColorectal neoplasmspor
dc.subjectChronotherapypor
dc.titlePhase III trial comparing 4-day chronomodulated therapy delivery of fluorouracil, leucovorin, and oxaliplatin as first-line chemotherapy of metastatic colorectal cancer: the European Organisation for Research and Treatment of Cancer Chronotherapy Grouppor
dc.typejournal article
dspace.entity.typePublication
oaire.citation.conferencePlaceAlexandria, VApor
oaire.citation.endPage3569por
oaire.citation.startPage3562por
oaire.citation.titleJournal of Clinical Oncologypor
rcaap.rightsopenAccesspor
rcaap.typearticlepor

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