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Title: 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/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 completemore » 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.« less

Authors:
 [1];  [2];  [3];  [4];  [5];  [6];  [7];  [8];  [9];  [10]
  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)
Publication Date:
OSTI Identifier:
21124432
Resource Type:
Journal Article
Journal Name:
International Journal of Radiation Oncology, Biology and Physics
Additional Journal Information:
Journal Volume: 72; Journal Issue: 1; Other Information: DOI: 10.1016/j.ijrobp.2007.12.012; PII: S0360-3016(07)04703-7; Copyright (c) 2008 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); Journal ID: ISSN 0360-3016
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CARCINOMAS; CHEMOTHERAPY; CLINICAL TRIALS; COMBINED THERAPY; DIARRHEA; MITOMYCIN; PATIENTS; RADIOTHERAPY; TOXICITY; URACILS

Citation Formats

Glynne-Jones, Rob, Meadows, Helen, UCL Cancer Trials Centre, London, Wan, Susan, Cancer Research UK, London, Gollins, Simon, Leslie, Martin, Levine, Ed, McDonald, Alec C, Myint, Sun, Samuel, Les, and Sebag-Montefiore, David. 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. United States: N. p., 2008. Web. doi:10.1016/j.ijrobp.2007.12.012.
Glynne-Jones, Rob, Meadows, Helen, UCL Cancer Trials Centre, London, Wan, Susan, Cancer Research UK, London, Gollins, Simon, Leslie, Martin, Levine, Ed, McDonald, Alec C, Myint, Sun, Samuel, Les, & Sebag-Montefiore, David. 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. United States. https://doi.org/10.1016/j.ijrobp.2007.12.012
Glynne-Jones, Rob, Meadows, Helen, UCL Cancer Trials Centre, London, Wan, Susan, Cancer Research UK, London, Gollins, Simon, Leslie, Martin, Levine, Ed, McDonald, Alec C, Myint, Sun, Samuel, Les, and Sebag-Montefiore, David. 2008. "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". United States. https://doi.org/10.1016/j.ijrobp.2007.12.012.
@article{osti_21124432,
title = {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},
author = {Glynne-Jones, Rob and Meadows, Helen and UCL Cancer Trials Centre, London and Wan, Susan and Cancer Research UK, London and Gollins, Simon and Leslie, Martin and Levine, Ed and McDonald, Alec C and Myint, Sun and Samuel, Les and Sebag-Montefiore, David},
abstractNote = {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.},
doi = {10.1016/j.ijrobp.2007.12.012},
url = {https://www.osti.gov/biblio/21124432}, journal = {International Journal of Radiation Oncology, Biology and Physics},
issn = {0360-3016},
number = 1,
volume = 72,
place = {United States},
year = {Mon Sep 01 00:00:00 EDT 2008},
month = {Mon Sep 01 00:00:00 EDT 2008}
}