EXTRA-A Multicenter Phase II Study of Chemoradiation Using a 5 Day per Week Oral Regimen of Capecitabine and Intravenous Mitomycin C in Anal Cancer

Journal Article · Mon Sep 01 04:00:00 EDT 2008 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2007.12.012· OSTI ID:21124432

Glynne-Jones, Rob ^[1]; Meadows, Helen ^[2]; Wan, Susan ^[3]; Gollins, Simon ^[4]; Leslie, Martin ^[5]; Levine, Ed ^[6]; McDonald, Alec C ^[7]; Myint, Sun ^[8]; Samuel, Les ^[9]; Sebag-Montefiore, David ^[10]

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1. Mount Vernon Cancer Centre, Mount Vernon Hospital, Middlesex (United Kingdom)
2. Cancer Research UK, London (United Kingdom)
3. UCL Cancer Trials Centre, London (United Kingdom)
4. North Wales Cancer Treatment Centre, Denbighshire (United Kingdom)
5. St. Thomas Hospital, London (United Kingdom)
6. Christie Hospital, Manchester (United Kingdom)
7. Beatson West of Scotland Cancer Centre, Glasgow (United Kingdom)
8. Clatterbridge Centre for Oncology, Wirral (United Kingdom)
9. Aberdeen Royal Infirmary, Aberdeen (United Kingdom)
10. Cookridge Hospital, Leeds (United Kingdom)

Purpose: 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/m{sup 2}) on Day 1 and capecitabine on each RT treatment day in two divided doses (825 mg/m{sup 2} 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.

• OSTI ID: 21124432
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 1 Vol. 72; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
CARCINOMAS
CHEMOTHERAPY
CLINICAL TRIALS
COMBINED THERAPY
DIARRHEA
MITOMYCIN
PATIENTS
RADIOTHERAPY
TOXICITY
URACILS