Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 3775
© 2004 American Society of Clinical Oncology

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Abstract

Phase II study of capecitabine and radiotherapy (RT) plus concomitant boost in patients (pts) with locally advanced rectal cancer (LARC)

MD Anderson Cancer Center, Houston, TX

3775

Rationale: Preoperative RT with continuous infusional 5-fluorouracil (CI-5FU) improves sphincter preservation and produces pathological complete remissions (pCR) in 10–30% of pts with LARC. Capecitabine (Xeloda) mimics CI-5-FU via daily oral administration and is preferentially converted to 5-FU by high intra-tumor thymidine phosphorylase, which is further activated by RT. Design: Based on the promising phase I data (Dunst et al JCO 20:3983:2002), we initiated a phase II study of capecitabine 825 mg/m² orally twice-daily plus RT (52.5 Gy/30 fractions to the primary and perirectal nodes) in 54 pts with T3 or greater LARC. All eligible pts will receive 4 cycles of adjuvant capecitabine (1250 mg/m² orally twice daily for 2 wks every 3 wks). Results: Of the 31 pts enrolled (median age: 56, performance status: 0–1, 24 males, 7 females, 14 T3N0, 15 T3N1, 1 TXN1, 1 T4N1), all had completed chemoradiation and 12 pts also had completed adjuvant capecitabine with additional 5 pts still on adjuvant therapy to date. Toxicities during chemoradiation and adjuvant therapy were summarized below. There were no grade 4 events except in 1 pt with ileus possibly related to treatment. The grade 3 events consisted of diarrhea (13%), and radiation dermatitis (6%) and mostly clustered in pts who are > 65 yr of age. Grade 2 events were: diarrhea (26%), fatigue (19%), HFS (16%), anemia (16%), radiation dermatitis (13%), rectal pain (6%) and neutropenia (3%). Transient non-complicating lymphocytopenia were also noted in 58% of pts. Of 28 pts evaluable for tumor response, 20 pts (71.4%) achieved pathological down-staging (5 pathological complete remissions, 15 partial remissions, 7 stable disease). Conclusions: RT with capecitabine and adjuvant capecitabine for LARC appeared to be very well tolerated and produced comparable results to that with RT plus CI-5FU and could replace inconvenient CI-5FU. Updated results will be presented at the meeting. *Study supported by Roche

Author Disclosure

Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Roche Roche; Pfizer; Novartis