Irinotecan+5-fluorouracil with concomitant pre-operative radiotherapy in locally advanced non-resectable rectal cancer: a phase I/II study.

2.50
Hdl Handle:
http://hdl.handle.net/10541/58722
Title:
Irinotecan+5-fluorouracil with concomitant pre-operative radiotherapy in locally advanced non-resectable rectal cancer: a phase I/II study.
Authors:
Iles, S M; Gollins, Simon W; Susnerwala, Shabbir; Haylock, B; Myint, A Sun; Biswas, A; Swindell, Ric; Levine, Edward
Abstract:
In the UK, 10% of patients diagnosed with rectal cancer have inoperable disease at presentation. This study ascertained whether the resectability rate of inoperable locally advanced rectal cancer was improved by administration of intravenous irinotecan, 5-fluorouracil (5-FU) and pelvic radiotherapy. During phase I of the trial (n=12), the dose of irinotecan was escalated in three-patient cohorts from 50 mg m(-2) to 60 mg m(-2) to 70 mg m(-2) to identify the maximum tolerated dose (60 mg m(-2)). In phase II, 31 patients with non-resectable disease received 45 Gy radiotherapy and 5-FU infusions (200 mg m(-2) per day) for 5 weeks. Irinotecan (60 mg m(-2)) was given on days 1, 8, 15 and 22. After treatment, patients were operated on if possible. Thirty patients completed the protocol, 28 underwent surgery. Before surgery, MRI restaging of 24 patients showed that 19 (79%) had a reduction in tumour stage after treatment (seven complete clinical response and 12 partial). Of 27 patients followed up after surgery, 22 (81%) had clear circumferential resection margins. Disease-free and overall survival estimates at 3 years were 65 and 90%, respectively. The regimen was well tolerated. Irinotecan, 5-FU and radiotherapy results in tumour downgrading, allowing resection of previously inoperable tumour with acceptable toxicity.
Affiliation:
Department of Clinical Oncology, The Christie Hospital NHS Trust, Manchester M20 4BX, UK.
Citation:
Irinotecan+5-fluorouracil with concomitant pre-operative radiotherapy in locally advanced non-resectable rectal cancer: a phase I/II study. 2008, 98 (7):1210-6 Br. J. Cancer
Journal:
British Journal of Cancer
Issue Date:
8-Apr-2008
URI:
http://hdl.handle.net/10541/58722
DOI:
10.1038/sj.bjc.6604292
PubMed ID:
18349840
Type:
Article
Language:
en
ISSN:
0007-0920
Appears in Collections:
All Christie Publications ; Clinical Oncology

Full metadata record

DC FieldValue Language
dc.contributor.authorIles, S M-
dc.contributor.authorGollins, Simon W-
dc.contributor.authorSusnerwala, Shabbir-
dc.contributor.authorHaylock, B-
dc.contributor.authorMyint, A Sun-
dc.contributor.authorBiswas, A-
dc.contributor.authorSwindell, Ric-
dc.contributor.authorLevine, Edward-
dc.date.accessioned2009-04-01T23:24:17Z-
dc.date.available2009-04-01T23:24:17Z-
dc.date.issued2008-04-08-
dc.identifier.citationIrinotecan+5-fluorouracil with concomitant pre-operative radiotherapy in locally advanced non-resectable rectal cancer: a phase I/II study. 2008, 98 (7):1210-6 Br. J. Canceren
dc.identifier.issn0007-0920-
dc.identifier.pmid18349840-
dc.identifier.doi10.1038/sj.bjc.6604292-
dc.identifier.urihttp://hdl.handle.net/10541/58722-
dc.description.abstractIn the UK, 10% of patients diagnosed with rectal cancer have inoperable disease at presentation. This study ascertained whether the resectability rate of inoperable locally advanced rectal cancer was improved by administration of intravenous irinotecan, 5-fluorouracil (5-FU) and pelvic radiotherapy. During phase I of the trial (n=12), the dose of irinotecan was escalated in three-patient cohorts from 50 mg m(-2) to 60 mg m(-2) to 70 mg m(-2) to identify the maximum tolerated dose (60 mg m(-2)). In phase II, 31 patients with non-resectable disease received 45 Gy radiotherapy and 5-FU infusions (200 mg m(-2) per day) for 5 weeks. Irinotecan (60 mg m(-2)) was given on days 1, 8, 15 and 22. After treatment, patients were operated on if possible. Thirty patients completed the protocol, 28 underwent surgery. Before surgery, MRI restaging of 24 patients showed that 19 (79%) had a reduction in tumour stage after treatment (seven complete clinical response and 12 partial). Of 27 patients followed up after surgery, 22 (81%) had clear circumferential resection margins. Disease-free and overall survival estimates at 3 years were 65 and 90%, respectively. The regimen was well tolerated. Irinotecan, 5-FU and radiotherapy results in tumour downgrading, allowing resection of previously inoperable tumour with acceptable toxicity.en
dc.language.isoenen
dc.subjectChemotherapyen
dc.subjectIrinotecanen
dc.subjectRectal Canceren
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols-
dc.subject.meshCamptothecin-
dc.subject.meshCombined Modality Therapy-
dc.subject.meshDisease-Free Survival-
dc.subject.meshFemale-
dc.subject.meshFluorouracil-
dc.subject.meshHumans-
dc.subject.meshMale-
dc.subject.meshMaximum Tolerated Dose-
dc.subject.meshMiddle Aged-
dc.subject.meshNeoadjuvant Therapy-
dc.subject.meshRadiotherapy Dosage-
dc.subject.meshRadiotherapy, Adjuvant-
dc.subject.meshRectal Neoplasms-
dc.subject.meshSurvival Rate-
dc.titleIrinotecan+5-fluorouracil with concomitant pre-operative radiotherapy in locally advanced non-resectable rectal cancer: a phase I/II study.en
dc.typeArticleen
dc.contributor.departmentDepartment of Clinical Oncology, The Christie Hospital NHS Trust, Manchester M20 4BX, UK.en
dc.identifier.journalBritish Journal of Canceren

Related articles on PubMed

All Items in Christie are protected by copyright, with all rights reserved, unless otherwise indicated.