Safety and Efficacy of a Modified FLOX Adjuvant Regimen for Patients With Stage III Colorectal Cancer Treated in the Community

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorPROTASIO, Bruno Mendonca
dc.contributor.authorMATUTINO, Adriana
dc.contributor.authorLAGE, Liana Valente
dc.contributor.authorSANTANA, Iuri
dc.contributor.authorRAMOS, Ricardo
dc.contributor.authorSABBAGA, Jorge
dc.contributor.authorCAPARELI, Fernanda
dc.contributor.authorSARAGIOTTO, Daniel
dc.contributor.authorRIECHELMANN, Rachel
dc.contributor.authorHOFF, Paulo M.
dc.date.accessioned2017-06-09T15:32:33Z
dc.date.available2017-06-09T15:32:33Z
dc.date.issued2017
dc.description.abstractThe efficacy and safety of adjuvant modified FLOX (combination of oxaliplatin with a bolus regimen of fluorouracil) for patients with stage III colorectal cancer were analyzed retrospectively. A total of 267 patients were included, with a 74.9% rate of a 2-year disease-free survival and a Grade >= 3 toxicity rate of 36.7%. Age 70 years or older was associated with a higher risk of Grade >= 3 adverse events, suggesting that adjuvant oxaliplatin should be restricted to patients younger than 70 years. Background: The efficacy and safety of the combination of a fluoropyrimidine with oxaliplatin for patients with stage III colorectal cancer (CRC) have been evaluated in selected patients who took part in clinical trials. We evaluated the outcomes of FLOX (bolus fluorouracil [5-FU] combined with oxaliplatin) in patients with resected stage III CRC treated in the community in a large cancer center. Patients and Methods: We performed a retrospective unicenter cohort study of all consecutive stage III CRC patients who received adjuvant chemotherapy with an mFLOX (modified FLOX) regimen. The schedule consisted of 5-FU bolus 500 mg/m(2) and bolus of leucovorin 20 mg/m(2) per week for 6 consecutive weeks and oxaliplatin 85 mg/m(2) in a 2-hour infusion at weeks 1, 3, and 5, every 8 weeks. Logistic regression multivariate analyses were used to evaluate prognostic factors for relapse at 2 years, and to investigate potential predictors of Grade >= 3 toxicity. Results: A total of 267 consecutive patients were eligible and included. The median age was 59 years and pathological stage was mostly IIIB (68.2%). With a median follow-up of 24 months, n = 67 patients (25.1%) relapsed, representing a 74.9% rate of disease-free survival at 2 years. In multivariable analyses, urgent surgery (odds ratio [OR], 1.89; 95% confidence interval [CI], 1.02-3.48; P =.042), angiolymphatic invasion (OR, 1.92; 95% CI, 1.05-3.52; P =.034), and any interruption or dose reduction of chemotherapy (OR, 2.37; 95% CI, 1.31-4.27; P =.004) were predictors of recurrence or death at 2 years. Nine patients (3.4%) died from any cause within 60 days of starting mFLOX. Grade >= 3 toxicity occurred in 98 (36.7%) patients, with diarrhea (n = 43; 16.1%) and neutropenia (n = 38; 15.3%) being the most frequent ones. Peripheral neurotoxicity Grade >= 3 occurred in 5 patients (1.8%). Age 70 years or older (OR, 5.85; 95% CI, 2.5-13.66; P <=.001) was independently associated with a higher risk of a Grade >= 3 adverse events. Conclusion: Results suggest that the effectiveness of combining oxaliplatin with bolus 5-FU in patients in the community is reasonably similar to that obtained in clinical trials. However, community patients presented a higher risk of death, especially for those who were older than 70 years. Adjuvant oxaliplatin should be used carefully and probably restricted to fit patients younger than 70 years in this setting.
dc.description.indexMEDLINE
dc.identifier.citationCLINICAL COLORECTAL CANCER, v.16, n.1, p.65-72, 2017
dc.identifier.doi10.1016/j.clcc.2016.07.001
dc.identifier.eissn1938-0674
dc.identifier.issn1533-0028
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/20018
dc.language.isoeng
dc.publisherCIG MEDIA GROUP, LP
dc.relation.ispartofClinical Colorectal Cancer
dc.rightsrestrictedAccess
dc.rights.holderCopyright CIG MEDIA GROUP, LP
dc.subjectAdjuvant chemotherapy
dc.subjectElderly patients
dc.subjectOxaliplatin
dc.subjectToxicities
dc.subject.othercolon-cancer
dc.subject.othernsabp c-07
dc.subject.otherfluorouracil
dc.subject.otheroxaliplatin
dc.subject.otherleucovorin
dc.subject.otherresection
dc.subject.othersurvival
dc.subject.othertrial
dc.subject.otherchemotherapy
dc.subject.othercarcinoma
dc.subject.wosOncology
dc.titleSafety and Efficacy of a Modified FLOX Adjuvant Regimen for Patients With Stage III Colorectal Cancer Treated in the Community
dc.typearticle
dc.type.categoryoriginal article
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.author.externalSANTANA, Iuri:Univ Sao Paulo, Fac Med, Inst Canc Estado Sao Paulo, Sao Paulo, SP, Brazil
hcfmusp.citation.scopus5
hcfmusp.contributor.author-fmusphcBRUNO MENDONCA PROTASIO DA SILVA
hcfmusp.contributor.author-fmusphcADRIANA REIS BRANDAO MATUTINO
hcfmusp.contributor.author-fmusphcLIANA VALENTE LAGE
hcfmusp.contributor.author-fmusphcRICARDO EMANUEL DE OLIVEIRA RAMOS
hcfmusp.contributor.author-fmusphcJORGE SABBAGA
hcfmusp.contributor.author-fmusphcFERNANDA CUNHA CAPARELI
hcfmusp.contributor.author-fmusphcDANIEL FERNANDES SARAGIOTTO
hcfmusp.contributor.author-fmusphcRACHEL SIMOES PIMENTA RIECHELMANN
hcfmusp.contributor.author-fmusphcPAULO MARCELO GEHM HOFF
hcfmusp.description.beginpage65
hcfmusp.description.endpage72
hcfmusp.description.issue1
hcfmusp.description.volume16
hcfmusp.origemWOS
hcfmusp.origem.pubmed27515842
hcfmusp.origem.scopus2-s2.0-84995608732
hcfmusp.origem.wosWOS:000397944500010
hcfmusp.publisher.cityDALLAS
hcfmusp.publisher.countryUSA
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hcfmusp.scopus.lastupdate2024-05-17
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