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.

Abstract

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/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.

• Authors: Rob Glynne-Jones, Helen Meadows, Susan Wan, Simon Gollins, Martin Leslie, Ed Levine, Alec C McDonald, Sun Myint, Les Samuel, David Sebag-Montefiore, National Cancer Research Institute Anal Sub Group and Colorectal Clinical Oncology Group
• Journal: International journal of radiation oncology, biology, physics (Int J Radiat Oncol Biol Phys) Vol. 72 Issue 1 Pg. 119-26 (Sep 01 2008) ISSN: 0360-3016 [Print] United States
• PMID: 18472366 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Deoxycytidine
• Mitomycin
• Capecitabine
• Fluorouracil

Topics

• Administration, Oral
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Anus Neoplasms (drug therapy, radiotherapy)
• Capecitabine
• Carcinoma, Squamous Cell (drug therapy, radiotherapy)
• Combined Modality Therapy (adverse effects, methods)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Diarrhea (etiology)
• Drug Administration Schedule
• Feasibility Studies
• Female
• Fluorouracil (administration & dosage, adverse effects, analogs & derivatives)
• Humans
• Infusions, Intravenous
• Male
• Middle Aged
• Mitomycin (administration & dosage, adverse effects)
• Neoplasm Recurrence, Local
• Neutropenia (etiology)
• Radiotherapy Dosage
• Remission Induction
• United Kingdom