Safety analysis of two different regimens of uracil–tegafur plus leucovorin as adjuvant chemotherapy for high-risk stage II and III colon cancer in a phase III trial comparing 6 with 18 months of treatment: JFMC33-0502 trial

PURPOSE: The JFMC33-0502 trial is a phase III clinical study designed to determine the most appropriate duration of postoperative adjuvant chemotherapy with uracil–tegafur (UFT) plus leucovorin in patients with stage IIB or III colon cancer. We report the interim results of preplanned safety analyses. METHODS: Patients with stage IIB or III colon cancer who had undergone curative resection were randomly assigned to receive UFT (300 mg/m(2)) plus leucovorin (75 mg/day) for 6 months (control group, 4 weeks of treatment followed by a 1-week rest, five courses) or for 18 months (study group, 5 days of treatment followed by a 2-day rest, 15 courses). Treatment status and safety were evaluated. RESULTS: A total of 1,071 patients were enrolled, and 1,063 were included in safety analyses. Treatment completion rate at 6 months was 74.0 % in the control group and 76.7 % in the study group. Treatment completion rate in the study group at 18 months was 56.0 %. The overall incidence of adverse events (AEs) was 75.3 % in the control group and 77.6 % in the study group. The incidences of grade 3 or higher AEs were low in both groups. During the first 6 months, the incidences of the subjective AEs were significantly lower in the study group. CONCLUSIONS: Oral UFT plus leucovorin given by either dosage schedule is a very safe regimen for adjuvant chemotherapy. In particular, 5 days of treatment followed by a 2-day rest was a useful treatment option from the viewpoint of toxicity even when given for longer than 6 months. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s00280-014-2461-5) contains supplementary material, which is available to authorized users

トクシマシ イシカイ ガ ウンエイ スル トクシマシ チイキ ホウカツ シエン センター ノ トリクミ

The Tokushima City Integrated Community Care Support Center, a public institution responsible for the Long-Term Care Insurance and welfare administration of Tokushima City, has high business operations fair and neutrality. The only support center in Tokushima City has been entrusted to the Tokushima City Medical Association and is a large center unusual in Japan. We are working to cooperation with relevant organizations to support the medical and health, welfare and care of the community. We try to establish an Integrated Community Care system, as elderly can continue to live so long and dignified. We divided a daily living area of Tokushima City into four, and have placed the staff for each area. The current number of staff is ５４ people in total, including public health nurses, social workers, chief care managers, and so on. Number of consultations reaches ３６，０００ per year. Occasionally, we received over １６０ consultations a day. There are a wide variety of consultation contents such as Dementia and long-term care services, elder abuse and consumer damage. Because of Medical Association’s operation, we are able to easily construct cooperation with the healthcare and the long-time care system. Therefore, the all citizens of Tokushima City can receive standard services equally, fair, and neutrally. There is no regional disparity, there is no user of the enclosure. Because we have１４branches of the support center in the city, they can bring a high level convenience to the citizens. It seems necessary to focus on the development of four promotions for the future citizens, ① Enhancement of the center output ② Cooperation of the healthcare and the long-term care ③ Improvement of the area community care conference ④ Increase of measures against Dementia