PMID- 36947210 OWN - NLM STAT- MEDLINE DCOM- 20230406 LR - 20230524 IS - 1432-0843 (Electronic) IS - 0344-5704 (Linking) VI - 91 IP - 4 DP - 2023 Apr TI - A prospective feasibility study of uracil-tegafur and leucovorin as adjuvant chemotherapy for patients aged >/= 80 years after curative resection of colorectal cancer, the HiSCO-03 study. PG - 317-324 LID - 10.1007/s00280-023-04526-7 [doi] AB - PURPOSE: There is no consensus on the safety and effectiveness of adjuvant chemotherapy for patients with stage III colorectal cancer (CRC) aged >/= 80 years. We conducted a prospective multi-institutional phase II study of uracil-tegafur and leucovorin (UFT/LV) as adjuvant chemotherapy in this population. PATIENTS AND METHODS: Patients with stage III CRC aged >/= 80 years who underwent curative resection were enrolled. Eligible patients received UFT/LV therapy (UFT, 300 mg/m(2) per day as tegafur; LV, 75 mg/day on days 1-28, every 35 days for five courses). Primary endpoint was feasibility, and secondary endpoints were safety and relative dose intensity. RESULTS: Sixty-nine patients were enrolled between 2013 and 2021. Of the 69 patients, 65 were included in the analysis. There were 32 males and 33 females with a median age of 82 years (range 80-88 years). In the primary endpoint, administration completion rate was 67.3% (95% confidence interval 54.9-77.6%), and the lower limit of the 95% confidence interval was below the threshold of 60%. 21 patients discontinued treatment because of adverse events (AEs) and refused treatment. The median relative dose intensities were 84% (range 4-100%) for UFT, and 100% (range 4-100%) for LV. Incidence of grade three or higher AEs were neutropenia (1.5%), aspartate transaminase elevation (3%), alanine transaminase elevation (1.5%), oral mucositis (3%), anemia (1.5%), and diarrhea (4.6%). CONCLUSIONS: The indications for adjuvant UFT/LV therapy for elderly CRC aged >/= 80 years were considered limited. It is necessary to clarify the background of patients in whom drug administration is discontinued and investigate their impact on long-term prognosis. CI - (c) 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. FAU - Okuda, Hiroshi AU - Okuda H AD - Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan. AD - Department of Surgery, Onomichi General Hospital, Onomichi, Japan. FAU - Shimomura, Manabu AU - Shimomura M AD - Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan. AD - Department of Surgery, Hiroshima City Asa Citizens Hospital, Hiroshima, Japan. FAU - Ikeda, Satoshi AU - Ikeda S AUID- ORCID: 0000-0002-6285-6643 AD - Department of Surgery, Hiroshima Prefectural Hospital, 1-5-54, Ujina-Kanda, Minami-ku, Hiroshima, Japan. sikeda1965@gmail.com. FAU - Nakahara, Masahiro AU - Nakahara M AD - Department of Surgery, Onomichi General Hospital, Onomichi, Japan. FAU - Miguchi, Masashi AU - Miguchi M AD - Department of Surgery, Hiroshima Prefectural Hospital, 1-5-54, Ujina-Kanda, Minami-ku, Hiroshima, Japan. FAU - Ishizaki, Yasuyo AU - Ishizaki Y AD - Department of Surgery, National Hospital Organization Hiroshima-Nishi Medical Center, Hiroshima, Japan. FAU - Saitoh, Yasuhumi AU - Saitoh Y AD - Department of Surgery, Chugoku Rosai Hospital, Hiroshima, Japan. FAU - Toyota, Kazuhiro AU - Toyota K AD - Department of Surgery, National Hospital Organization Higashihiroshima Medical Center, Hiroshima, Japan. FAU - Sumitani, Daisuke AU - Sumitani D AD - Department of Surgery, JR Hiroshima Hospital, Hiroshima, Japan. FAU - Shimizu, Yosuke AU - Shimizu Y AD - Department of Surgery, National Hospital Organization Kure Medical Center, Hiroshima, Japan. FAU - Takakura, Yuji AU - Takakura Y AD - Department of Surgery, Chuden Hospital, Hiroshima, Japan. FAU - Shimizu, Wataru AU - Shimizu W AD - Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan. FAU - Yoshimitsu, Masanori AU - Yoshimitsu M AD - Department of Surgery, Hiroshima City Hospital, Hiroshima, Japan. FAU - Kodama, Shinya AU - Kodama S AD - Department of Surgery, Yoshida General Hospital, Hiroshima, Japan. FAU - Fujimori, Masahiko AU - Fujimori M AD - Department of Surgery, Kure City Medical Association Hospital, Hiroshima, Japan. FAU - Oheda, Mamoru AU - Oheda M AD - Department of Surgery, Cera Central Hospital, Hiroshima, Japan. FAU - Kobayashi, Hironori AU - Kobayashi H AD - Department of Surgery, Hiroshima Memorial Hospital, Hiroshima, Japan. FAU - Ohdan, Hideki AU - Ohdan H AD - Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan. CN - Hiroshima Surgical Study Group of Clinical Oncology (HiSCO) LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study DEP - 20230322 PL - Germany TA - Cancer Chemother Pharmacol JT - Cancer chemotherapy and pharmacology JID - 7806519 RN - Q573I9DVLP (Leucovorin) RN - 1548R74NSZ (Tegafur) RN - 56HH86ZVCT (Uracil) SB - IM MH - Aged MH - Aged, 80 and over MH - Female MH - Humans MH - Male MH - Administration, Oral MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - Chemotherapy, Adjuvant MH - *Colorectal Neoplasms/drug therapy/surgery MH - Disease-Free Survival MH - Feasibility Studies MH - Leucovorin MH - Prospective Studies MH - *Tegafur MH - Uracil OTO - NOTNLM OT - Adjuvant chemotherapy OT - Colorectal cancer OT - Elderly OT - Uracil-tegafur and leucovorin EDAT- 2023/03/23 06:00 MHDA- 2023/04/04 06:42 CRDT- 2023/03/22 12:14 PHST- 2022/12/12 00:00 [received] PHST- 2023/03/16 00:00 [accepted] PHST- 2023/04/04 06:42 [medline] PHST- 2023/03/23 06:00 [pubmed] PHST- 2023/03/22 12:14 [entrez] AID - 10.1007/s00280-023-04526-7 [pii] AID - 10.1007/s00280-023-04526-7 [doi] PST - ppublish SO - Cancer Chemother Pharmacol. 2023 Apr;91(4):317-324. doi: 10.1007/s00280-023-04526-7. Epub 2023 Mar 22.