Randomized phase III trial of treatment duration for oral uracil and tegafur plus leucovorin as adjuvant chemotherapy for patients with stage IIB/III colon cancer: final results of JFMC33-0502
| Autor: | Susumu Kodaira, Kazuaki Sasaki, Yoshiyuki Yamaguchi, Takayuki Morita, Genichi Nishimura, Sotaro Sadahiro, T. Tsuchiya, Seiji Sato, Hisashi Usuki, Junji Matsuoka, Keiji Koda, Chikuma Hamada, Kenji Katsumata, Ken Kondo, Yoshihiro Kakeji, Hideo Baba |
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| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Colorectal cancer Adjuvant chemotherapy Treatment duration medicine.medical_treatment Leucovorin Tegafur/uracil Administration Oral Gastroenterology Tegafur Drug Administration Schedule chemistry.chemical_compound Internal medicine Gastrointestinal Tumors medicine Humans UFT/LV Uracil Aged Neoplasm Staging Aged 80 and over Chemotherapy treatment duration business.industry Hematology Original Articles Middle Aged medicine.disease digestive system diseases Surgery adjuvant chemotherapy Oncology chemistry colon cancer Chemotherapy Adjuvant Colonic Neoplasms Female business Adjuvant medicine.drug |
| Zdroj: | Annals of Oncology |
| ISSN: | 1569-8041 0923-7534 |
| Popis: | While adjuvant chemotherapy is preferable for colon cancer, treatment duration is controversial. This phase III trial is investigated optimal duration of adjuvant chemotherapy for Stage IIB/III colon cancer. Eighteen-month treatment with UFT/LV did not improve DFS compared with 6-month UFT/LV treatment. This study suggests that 6 months treatment duration is enough for Stage IIB/III colon cancer. Background While adjuvant chemotherapy is preferable for high-risk colon cancer, treatment duration is controversial. Oral uracil and tegafur (UFT)/leucovorin (LV) is widely used as a standard adjuvant chemotherapy for colon cancer in Japan. We conducted a phase III trial to investigate the optimal duration of adjuvant chemotherapy for stage IIB/III colon cancer. Patients and methods Patients with curatively resected stage IIB/III colon cancer were eligible for enrollment in this trial. Patients were registered within 6 weeks after surgery and were randomly assigned to receive UFT/LV for 28 of 35 days for 6 months in the control group or for 5 consecutive days per week for 18 months in the study group. The primary end point was the disease-free survival (DFS), and the secondary end points were overall survival (OS) and safety. Result A total of 1071 patients were registered from 233 centers. A statistically significant difference in DFS was not observed between the study group and the control group; the 5-year DFS was 69% in the study group and 69% in the control group. The 5-year OS was 85% in the study group and 85% in the control group. Conclusion Eighteen-month treatment with UFT/LV did not improve DFS or OS compared with 6-month UFT/LV treatment in patients with stage IIB/III colon cancer. The important finding from this study is that not 18 months but 6 months of treatment is enough for postoperative UFT/LV for stage IIB/III colon cancer. Clinical trial number UMIN-CTR C000000245. |
| Databáze: | OpenAIRE |
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