Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 24, No 18S (June 20 Supplement), 2006: 13559
© 2006 American Society of Clinical Oncology

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Abstract

Tolerability assessment of urasil-tegafur (UFT)/folinic acid (FA) as concurrent chemoradiation (CRT) in adjuvant rectal cancer treatment

Marmara University School of Medicine, Istanbul, Turkey; Lutfi Kirdar Kartal State Hospital, Istanbul, Turkey

13559

Background: The objective of the present phase II study was to evaluate the feasibility of UFT and FA as a concomittant CRT administration for rectal cancer in the adjuvant setting. Methods: Between October 2003 and December 2005 thirty-one (10 female; 21 male) patients were treated. All the patients were locally advanced (T2N1–2M0 (2), T3N0M0 (12), T3–4N1M0 (9), T3–4N2M0 (7)) and median age was 62 (range, 21–85). Inclusion criteria were WHO 0–1, age 18, complete tumor resection, stage T3/4 or N+, adequate CBC, liver function tests and signed informed consent form. RT was performed in 8 weeks following the surgery and the dose was 50.4 Gy given at 1.8 Gy daily. Chemotherapy consisted of UFT (300 mg/m²/day) and FA (30 mg/day) during week-days of radiotherapy and continued 4 cycles with same dose (D1–28/35days) after CRT. Acute toxicity was assessed according to CTC 2.0 criteria. Results: Median follow-up for all patients was 12 months (between 3–27 months). No toxic death occurred. CRT related side effects were diarrhea Gr 2 (25%) and Gr 3 (25%); emesis Gr 2 (29%) and Gr 3 (10%); dysuria Gr 2 (10%) and Gr 3 (10%). All patients completed radiotherapy but 21 out of 31 (67%) continued with UFT/LV until the end of concurrent treatment. The full compliance to the adjuvant CT part was 63%. During the adjuvant CT period there were diarrhea Gr 3–4 (10%), emesis Gr 3 (10%) and no Gr 3–4 hematological toxicity observed during the whole treatment. During the study period none of the patients failed locally, 3 patients developed distant metastases (2 liver, 1 bone), and 3 patients died (1 with disease, 2 without). Two-year disease-free and overall survival rates were 84% and 71%, respectively. Conclusion: The acute and subacute toxicity of CRT with UFT/LV is acceptable and seems comparable to infusional 5-FU based combined modality treatments.

No significant financial relationships to disclose.