A Phase II Trial of Neoadjuvant Preoperative Chemoradiotherapy With S-1 Plus Irinotecan and Radiation in Patients With Locally Advanced Rectal Cancer: Clinical Feasibility and Response Rate

Journal Article · Tue Mar 01 04:00:00 EST 2011 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2009.11.007· OSTI ID:21491614

Sato, Takeo; Ozawa, Heita; Hatate, Kazuhiko; Onosato, Wataru; Naito, Masanori; Nakamura, Takatoshi; Ihara, Atsushi ^[1]; Koizumi, Wasaburo ^[2]; Hayakawa, Kazushige ^[3]; Okayasu, Isao ^[4]; Yamashita, Keishi ^[1]; Watanabe, Masahiko ^[1]

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1. Department of Surgery, Kitasato University School of Medicine, Kanagawa (Japan)
2. Department of Internal Medicine, Kitasato University School of Medicine, Kanagawa (Japan)
3. Department of Radiology, Kitasato University School of Medicine, Kanagawa (Japan)
4. Department of Pathology, Kitasato University School of Medicine, Kanagawa (Japan)

Purpose: We aimed to validate our hypothesis that a preoperative chemoradiotherapy regimen with S-1 plus irinotecan is feasible, safe, and active for the management of locally advanced rectal cancer in a single-arm Phase II setting. Methods and Materials: Eligible patients had previously untreated, locally advanced rectal adenocarcinoma. Radiotherapy was administered in fractions of 1.8Gy/d for 25 days. S-1 was administered orally in a fixed daily dose of 80mg/m{sup 2} on Days 1 to 5, 8 to 12, 22 to 26, and 29 to 33. Irinotecan (80mg/m{sup 2}) was infused on Days 1, 8, 22, and 29. Four or more weeks after the completion of the treatment, total mesorectal excision with lateral lymph node dissection was performed. The primary endpoint was the rate of completing treatment in terms of feasibility. The secondary endpoints were the response rate and safety. Results: We enrolled 43 men and 24 women in the study. The number of patients who completed treatment was 58 (86.6%). Overall, 46 patients (68.7%) responded to treatment and 24 (34.7%) had a complete histopathologic response. Three patients had Grade 3 leukopenia, and another three patients had Grade 3 neutropenia. Diarrhea was the most common type of nonhematologic toxicity: 3 patients had Grade 3 diarrhea. Conclusions: A preoperative regimen of S-1, irinotecan, and radiotherapy to the rectum was feasible, and it appeared safe and effective in this nonrandomized Phase II setting. It exhibited a low incidence of adverse events, a high rate of completion of treatment, and an extremely high rate of pathologic complete response.

• OSTI ID: 21491614
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 3 Vol. 79; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

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62 RADIOLOGY AND NUCLEAR MEDICINE
ANTINEOPLASTIC DRUGS
BODY
CARCINOMAS
COMBINED THERAPY
DIARRHEA
DIGESTIVE SYSTEM
DISEASES
DRUGS
GASTROINTESTINAL TRACT
HEMIC DISEASES
IMMUNE SYSTEM DISEASES
INTESTINES
LARGE INTESTINE
LEUKOPENIA
MEDICINE
NEOPLASMS
NUCLEAR MEDICINE
ORGANS
RADIOLOGY
RADIOTHERAPY
RECTUM
SYMPTOMS
THERAPY
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