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Neoadjuvant FOLFIRI+bevacizumab in patients with resectable liver metastases from colorectal cancer: a phase 2 trial.

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cam.issuedOnline2013-04-04
dc.contributor.authorNasti, G
dc.contributor.authorPiccirillo, MC
dc.contributor.authorIzzo, F
dc.contributor.authorOttaiano, A
dc.contributor.authorAlbino, V
dc.contributor.authorDelrio, P
dc.contributor.authorRomano, C
dc.contributor.authorGiordano, P
dc.contributor.authorLastoria, S
dc.contributor.authorCaracò, C
dc.contributor.authorde Lutio di Castelguidone, E
dc.contributor.authorPalaia, R
dc.contributor.authorDaniele, G
dc.contributor.authorAloj, L
dc.contributor.authorRomano, G
dc.contributor.authorIaffaioli, RV
dc.contributor.orcidAloj, Luigi [0000-0002-7452-4961]
dc.date.accessioned2018-12-22T00:31:40Z
dc.date.available2018-12-22T00:31:40Z
dc.date.issued2013-04-30
dc.description.abstractBACKGROUND: Preoperative treatment of resectable liver metastases from colorectal cancer (CRC) is a matter of debate. The aim of this study was to assess the feasibility and activity of bevacizumab plus FOLFIRI in this setting. METHODS: Patients aged 18-75 years, PS 0-1, with resectable liver-confined metastases from CRC were eligible. They received bevacizumab 5 mg kg(-1) followed by irinotecan 180 mg m(-)(2), leucovorin 200 mg m(-)(2), 5-fluorouracil 400 mg m(-)(2) bolus and 5-fluorouracil 2400 mg m(-)(2) 46-h infusion, biweekly, for 7 cycles. Bevacizumab was stopped at cycle 6. A single-stage, single-arm phase 2 study design was applied with 1-year progression-free rate as the primary end point, and 39 patients required. RESULTS: From October 2007 to December 2009, 39 patients were enrolled in a single institution. Objective response rate was 66.7% (95% exact CI: 49.8-80.9). Of these, 37 patients (94.9%) underwent surgery, with a R0 rate of 84.6%. Five patients had a pathological complete remission (14%). Out of 37 patients, 16 (43.2%) had at least one surgical complication (most frequently biloma). At 1 year of follow-up, 24 patients were alive and free from disease progression (61.6%, 95% CI: 44.6-76.6). Median PFS and OS were 14 (95% CI: 11-24) and 38 (95% CI: 28-NA) months, respectively. CONCLUSION: Preoperative treatment of patients with resectable liver metastases from CRC with bevacizumab plus FOLFIRI is feasible, but further studies are needed to define its clinical relevance.
dc.format.mediumPrint-Electronic
dc.identifier.doi10.17863/CAM.34716
dc.identifier.eissn1532-1827
dc.identifier.issn0007-0920
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/287412
dc.languageeng
dc.language.isoeng
dc.publisherSpringer Science and Business Media LLC
dc.publisher.urlhttp://dx.doi.org/10.1038/bjc.2013.140
dc.rightsAttribution-NonCommercial-ShareAlike 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by-nc-sa/4.0/
dc.subjectAdult
dc.subjectAged
dc.subjectAntibodies, Monoclonal, Humanized
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectBevacizumab
dc.subjectCamptothecin
dc.subjectChemotherapy, Adjuvant
dc.subjectColorectal Neoplasms
dc.subjectDisease-Free Survival
dc.subjectFemale
dc.subjectFluorouracil
dc.subjectHumans
dc.subjectKaplan-Meier Estimate
dc.subjectLeucovorin
dc.subjectLiver Neoplasms
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectNeoadjuvant Therapy
dc.subjectSurvival Rate
dc.titleNeoadjuvant FOLFIRI+bevacizumab in patients with resectable liver metastases from colorectal cancer: a phase 2 trial.
dc.typeArticle
prism.endingPage1570
prism.issueIdentifier8
prism.publicationDate2013
prism.publicationNameBr J Cancer
prism.startingPage1566
prism.volume108
rioxxterms.licenseref.startdate2013-04-04
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.typeJournal Article/Review
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1038/bjc.2013.140

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