Biweekly oxaliplatin, raltitrexed, 5-fluorouracil and folinic acid combination chemotherapy during preoperative radiation therapy for locally advanced rectal cancer: A phase I-II study

A. Avallone, P. Delrio, C. Guida, F. Tatangelo, A. Petrillo, P. Marone, L. G. Cascini, B. Morrica, S. Lastoria, V. Parisi, A. Budillon, P. Comella

Research output: Contribution to journalArticlepeer-review

Abstract

Oxaliplatin (OXA), raltitrexed (RTX), 5-fluorouracil (FU) and folinic acid (FA) have shown activity in metastatic colorectal cancer, radioenhancing effect and synergism when combined. We evaluated a chemotherapy (CT) combination of OXA, RTX and FU/FA during preoperative radiotherapy (RT) in locally advanced rectal cancer (LARC) patients. Fifty-one patients with LARC at high risk of recurrence (T4, N+ or T3N0 ≤5 cm from anal verge and/or circumferential resection margin ≤5 mm) received three biweekly courses of CT during pelvic RT (45 Gy). Surgery was planned 8 weeks after CT-RT. Recommended doses (RDs) determined during phase I were utilised in the subsequent phase II trial, where the rate of tumour regression grade (TRG) 1 or 2 was the main end point. No toxic deaths occurred, and severe toxicity was easily managed. In phase II, RDs delivered in 31 patients were OXA 100 mg m-2 and RTX 2.5 mg m -2 on day 1, and FU 900 mg m-2 and LFA 250 mg m -2 on day 2. Main severe toxicities by patients were grade 4 neutropenia (23%) and grade 3 diarrhoea (19%). In 71% (95% confidence limits, 52-86%) of patients, TRG1 (13) or TRG2 (9) was obtained. All patients are alive and recurrence-free after a median follow-up of 29 months. Combination of OXA, RTX and FU/FA with pelvic RT has an acceptable toxicity and a high clinical activity in LARC and should be studied further in patients at high risk of recurrence.

Original languageEnglish
Pages (from-to)1809-1815
Number of pages7
JournalBritish Journal of Cancer
Volume94
Issue number12
DOIs
Publication statusPublished - Jun 19 2006

Keywords

  • 5-fluorouracil
  • Oxaliplatin
  • Preoperative radiotherapy
  • Raltitrexed
  • Rectal cancer
  • Tumour regression grade (TRG)

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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