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Annals of Oncology 13:730-736, 2002
© 2002 European Society for Medical Oncology

Original Paper

Neoadjuvant therapy of rectal carcinoma with UFT–leucovorin plus radiotherapy

J. Feliu1,+, J. Calvillo2, A. Escribano3, J. de Castro1, M. E. Sánchez3, A. Mata2, E. Espinosa1, A. García Grande3, A. Mateo2 and M. González Barón1

1Department of Medical Oncology, 2Department of General Surgery and 3Department of Radiotherapy, Hospital La Paz, Madrid, Spain

Received 5 July 2001; revised 30 October 2001; accepted 15 November 2001.

Background

The object of this phase II study was to assess the impact of preoperative external radiation therapy combined with UFT and leucovorin on tumor response, sphincter preservation and tumor control in patients with rectal carcinoma.

Patients and methods

Forty-one patients with resectable extraperitoneal rectal adenocarcinoma received radiation therapy and two courses of chemotherapy. Chemotherapy consisted of a 2-h infusion of 6S-steroisomer of leucovorin (6SLV) 250 mg/m2 on day 1, oral 6SLV 7.5 mg every 12 h on days 2–14, and UFT either 350 or 300 mg/m2 on days 1 to 14 every 28 days. Six additional courses of chemotherapy were given after surgery.

Results

Seven of 16 patients (43%) who received 350 mg/m2/day of UFT had grade 3–4 diarrhea and two other patients (12%) had grade 3–4 dermatitis. The next 25 patients received 300 mg/m2/day of UFT and only 14% of them had grade 3–4 diarrhea. Surgery consisted of low-anterior resection in 26 patients (63%) and abdominal-perineal amputation in 15 (37%). There were six histological complete responses (15%). Downstaging occurred in 25 patients (63%). The overall survival at 3 years was 90% and the pelvic disease-free survival 92%.

Conclusions

Preoperative therapy with radiotherapy and UFT–6SLV downstaged 63% of tumors and allowed a sphincter-preserving procedure in some patients. Toxicity was moderate. This scheme is convenient because of the oral administration of chemotherapy.

Key words: leucovorin, neoadjuvant, preoperative, radiotherapy, rectal carcinoma, UFT


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