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dc.contributor.authorGlynne-Jones, Rob
dc.contributor.authorMeadows, Helen
dc.contributor.authorWan, Susan
dc.contributor.authorGollins, Simon W
dc.contributor.authorLeslie, Martin
dc.contributor.authorLevine, Edward
dc.contributor.authorMcDonald, Alec C
dc.contributor.authorMyint, A Sun
dc.contributor.authorSamuel, Les
dc.contributor.authorSebag-Montefiore, David
dc.date.accessioned2009-05-12T18:01:07Z
dc.date.available2009-05-12T18:01:07Z
dc.date.issued2008-09-01
dc.identifier.citationEXTRA--a multicenter phase II study of chemoradiation using a 5 day per week oral regimen of capecitabine and intravenous mitomycin C in anal cancer. 2008, 72 (1):119-26 Int. J. Radiat. Oncol. Biol. Phys.en
dc.identifier.issn0360-3016
dc.identifier.pmid18472366
dc.identifier.doi10.1016/j.ijrobp.2007.12.012
dc.identifier.urihttp://hdl.handle.net/10541/67983
dc.description.abstractPURPOSE: 5-Fluorouracil (5-FU) + mitomycin C (MMC)-based chemoradiotherapy is standard treatment for patients with epidermoid anal carcinoma. Clinical trials in other cancers have confirmed 5-FU can successfully be replaced by the oral fluoropyrimidine capecitabine. This phase II trial aimed to determine the feasibility, toxicity, and efficacy of capecitabine, MMC and radiotherapy (RT) in anal cancer patients. METHODS AND MATERIALS: Radiotherapy comprised the schedule of the UK Anal Cancer Trial (ACT) II trial (50.4 Gy in 28 fractions of 1.8 Gy). With MMC (12 mg/m2) on Day 1 and capecitabine on each RT treatment day in two divided doses (825 mg/m2 b.i.d). The endpoints were complete response at 4 weeks, local control at 6 months and toxicity. RESULTS: Thirty-one patients entered the trial. The median age was 61 years (range 45-86) with 14 males and 17 females. Compliance with chemotherapy with no dose interruptions or delays was 68%, and with RT was 81%. Eighteen (58%) patients completed both modalities of treatment as planned. Dose-limiting Grade 3 or 4 diarrhea was seen in 1 of 31 patients. Three patients experienced Grade 3 neutropenia. There were no treatment-related deaths. Four weeks following completion of chemoradiation, 24 patients (77%) had a complete clinical response, and 4 (16%) a partial response. With a median follow-up of 14 months, three locoregional relapses occurred. CONCLUSIONS: Capecitabine with MMC and RT in with patients anal carcinoma is well tolerated, with minimal toxicity and acceptable compliance. We recommend testing this schedule in future national Phase III studies in anal cancer.
dc.language.isoenen
dc.subjectAnal Canceren
dc.subjectCancer Recurrenceen
dc.subjectCapecitabineen
dc.subjectRadical Chemoradiationen
dc.subject.meshAdministration, Oral
dc.subject.meshAged
dc.subject.meshAged, 80 and over
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.meshAnus Neoplasms
dc.subject.meshCarcinoma, Squamous Cell
dc.subject.meshCombined Modality Therapy
dc.subject.meshDeoxycytidine
dc.subject.meshDiarrhea
dc.subject.meshDrug Administration Schedule
dc.subject.meshFeasibility Studies
dc.subject.meshFemale
dc.subject.meshFluorouracil
dc.subject.meshGreat Britain
dc.subject.meshHumans
dc.subject.meshInfusions, Intravenous
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshMitomycin
dc.subject.meshNeoplasm Recurrence, Local
dc.subject.meshNeutropenia
dc.subject.meshRadiotherapy Dosage
dc.subject.meshRemission Induction
dc.titleEXTRA--a multicenter phase II study of chemoradiation using a 5 day per week oral regimen of capecitabine and intravenous mitomycin C in anal cancer.en
dc.typeArticleen
dc.contributor.departmentMount Vernon Cancer Centre, Mount Vernon Hospital, Middlesex, United Kingdom. rob.glynnejones@nhs.neten
dc.identifier.journalInternational Journal of Radiation Oncology, Biology, Physicsen
html.description.abstractPURPOSE: 5-Fluorouracil (5-FU) + mitomycin C (MMC)-based chemoradiotherapy is standard treatment for patients with epidermoid anal carcinoma. Clinical trials in other cancers have confirmed 5-FU can successfully be replaced by the oral fluoropyrimidine capecitabine. This phase II trial aimed to determine the feasibility, toxicity, and efficacy of capecitabine, MMC and radiotherapy (RT) in anal cancer patients. METHODS AND MATERIALS: Radiotherapy comprised the schedule of the UK Anal Cancer Trial (ACT) II trial (50.4 Gy in 28 fractions of 1.8 Gy). With MMC (12 mg/m2) on Day 1 and capecitabine on each RT treatment day in two divided doses (825 mg/m2 b.i.d). The endpoints were complete response at 4 weeks, local control at 6 months and toxicity. RESULTS: Thirty-one patients entered the trial. The median age was 61 years (range 45-86) with 14 males and 17 females. Compliance with chemotherapy with no dose interruptions or delays was 68%, and with RT was 81%. Eighteen (58%) patients completed both modalities of treatment as planned. Dose-limiting Grade 3 or 4 diarrhea was seen in 1 of 31 patients. Three patients experienced Grade 3 neutropenia. There were no treatment-related deaths. Four weeks following completion of chemoradiation, 24 patients (77%) had a complete clinical response, and 4 (16%) a partial response. With a median follow-up of 14 months, three locoregional relapses occurred. CONCLUSIONS: Capecitabine with MMC and RT in with patients anal carcinoma is well tolerated, with minimal toxicity and acceptable compliance. We recommend testing this schedule in future national Phase III studies in anal cancer.


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