Phase II Trial of Adjuvant Chemotherapy with S-1 for Colorectal Liver Metastasis

• Published in: Annals of surgical oncology 2013-02, Vol.20 (2), p.475-481
• Main Authors: Uehara, Keisuke, Maeda, Atsuyuki, Sakamoto, Eiji, Hiramatsu, Kazuhiro, Takeuchi, Eiji, Sakaguchi, Kenji, Tojima, Yuichiro, Takahashi, Yu, Ebata, Tomoki, Nagino, Masato
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adult; Aged; Aged, 80 and over; Antimetabolites, Antineoplastic - therapeutic use; Chemotherapy, Adjuvant; Colorectal Cancer; Colorectal Neoplasms - drug therapy; Colorectal Neoplasms - pathology; Drug Combinations; Feasibility Studies; Female; Follow-Up Studies; Humans; Liver Neoplasms - drug therapy; Liver Neoplasms - secondary; Lymphatic Metastasis; Male; Medicine; Medicine & Public Health; Middle Aged; Neoplasm Recurrence, Local - diagnosis; Neoplasm Recurrence, Local - drug therapy; Neoplasm Staging; Oncology; Oxonic Acid - therapeutic use; Prognosis; Salvage Therapy; Surgery; Surgical Oncology; Tegafur - therapeutic use; Young Adult
• ISSN: 1068-9265; 1534-4681
• DOI: 10.1245/s10434-012-2665-z

Background This phase II trial was designed to evaluate the safety and efficacy of adjuvant chemotherapy with S-1 in patients with curatively resected liver metastasis from colorectal cancer. Results of an interim analysis of safety and short-term outcomes are reported. Methods Patients who underwent curative resection of liver metastasis from colorectal cancer received S-1 monotherapy (on days 1–28, followed by 14 days’ rest, 8 cycles) as adjuvant chemotherapy. Results Among 62 patients enrolled between October 2008 and August 2010, a total of 60 patients were eligible for analysis. The most frequent grade 3 or higher hematologic toxicity involved neutropenia in three patients (5.0 %). Nonhematologic toxicities of grade 3 or higher were fatigue in 6.7 % of patients. Grade 4 enteritis occurred in one patient, but resolved promptly after withdrawal of S-1 therapy. The completion rate of the eight scheduled cycles of chemotherapy was 58.3 %. The most common reasons for withdrawal of treatment was the detection of early relapse in 16 patients (64 %). When the 16 patients who had recurrence during adjuvant treatment were excluded from analysis, 79.5 % of the remaining 44 patients completed the scheduled treatment. Early recurrence within 1 year after curative liver resection occurred in 21 patients (35 %). The most common site was the remnant liver in 14 patients. Conclusions Orally administered S-1 after curative liver resection has an acceptable toxicity profile and a high rate of completion of the therapy. S-1 can be safely used and might be a viable treatment option in an adjuvant setting.