PMID- 36644881 OWN - NLM STAT- MEDLINE DCOM- 20230403 LR - 20230403 IS - 1465-3621 (Electronic) IS - 0368-2811 (Linking) VI - 53 IP - 4 DP - 2023 Mar 30 TI - Sunitinib therapy for imatinib-resistant and/or intolerant gastrointestinal stromal tumors: comparison of safety and efficacy between standard and reduced dosage regimens. PG - 297-303 LID - 10.1093/jjco/hyac202 [doi] AB - BACKGROUND: Sunitinib therapy for patients with imatinib-resistant and/or intolerant gastrointestinal stromal tumors (GISTs) often causes severe adverse events (AEs) that lead to treatment discontinuation. METHODS: We retrospectively reviewed the clinical records of imatinib-resistant and/or intolerant GIST patients who underwent sunitinib therapy in our institutions between 2007 and 2020. Forty-one patients were enrolled and divided into two groups on the basis of the starting dosage: the standard dosage group (50 mg/day, 21 patients) and the reduced dosage group (37.5 mg/day, 20 patients). Tolerability, safety and clinical efficacy of the two groups were compared. RESULTS: Three patients (14%) in the standard dosage group and another three (15%) in the reduced dosage group (P = 1.000) discontinued sunitinib therapy because of AEs. The incidences of grade 3 or more severe treatment-related AEs were 90 and 75%, respectively (P = 0.238). Two possible treatment-related deaths were noted in the standard dosage group. Clinical efficacy was comparable between the two groups: median time to treatment failure and overall survival were 4.5 months [interquartile range (IQR), 3.6-9.0] and 13.7 months (IQR, 7.5-22.9) in the standard dosage group and 4.6 months (IQR, 2.7-17.0) and 13.4 months (IQR, 9.3-36.8) in the reduced dosage group, respectively. CONCLUSIONS: The reduced dosage of 37.5 mg sunitinib tended to decrease toxicity and the incidences of severe AEs and treatment-related deaths. This reduced dosage regimen showed equivalent clinical efficacy including patient survival. The reduced dosage of 37.5 mg sunitinib can be adopted as an alternative therapy for patients with imatinib-resistant and/or intolerant GISTs. CI - (c) The Author(s) 2023. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. FAU - Sasaki, Kenta AU - Sasaki K AD - Department of Medical Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. AD - Department of Internal Medicine, Sanjo General Hospital, Sanjo, Japan. FAU - Kanda, Tatsuo AU - Kanda T AUID- ORCID: 0000-0001-6863-1587 AD - Department of Surgery, Sanjo General Hospital, Sanjo, Japan. FAU - Matsumoto, Yoshifumi AU - Matsumoto Y AD - Department of Medical Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. FAU - Ishikawa, Takashi AU - Ishikawa T AD - Division of Digestive and General Surgery, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. FAU - Hirota, Seiichi AU - Hirota S AD - Department of Surgical Pathology, Hyogo Medical University School of Medicine, Nishinomiya, Japan. FAU - Saijo, Yasuo AU - Saijo Y AD - Department of Medical Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. LA - eng GR - Niigata University/ PT - Journal Article PL - England TA - Jpn J Clin Oncol JT - Japanese journal of clinical oncology JID - 0313225 RN - V99T50803M (Sunitinib) RN - 8A1O1M485B (Imatinib Mesylate) RN - 0 (Indoles) RN - 0 (Pyrroles) RN - 0 (Pyrimidines) RN - 0 (Antineoplastic Agents) SB - IM MH - Humans MH - Sunitinib/therapeutic use MH - Imatinib Mesylate/adverse effects MH - *Gastrointestinal Stromal Tumors/drug therapy MH - Retrospective Studies MH - Indoles/adverse effects MH - Pyrroles/adverse effects MH - Pyrimidines/therapeutic use MH - Drug Resistance, Neoplasm MH - Treatment Outcome MH - *Antineoplastic Agents/adverse effects OTO - NOTNLM OT - GIST OT - dosage OT - sunitinib EDAT- 2023/01/17 06:00 MHDA- 2023/04/03 06:41 CRDT- 2023/01/16 04:12 PHST- 2022/06/28 00:00 [received] PHST- 2022/12/11 00:00 [accepted] PHST- 2023/04/03 06:41 [medline] PHST- 2023/01/17 06:00 [pubmed] PHST- 2023/01/16 04:12 [entrez] AID - 6987660 [pii] AID - 10.1093/jjco/hyac202 [doi] PST - ppublish SO - Jpn J Clin Oncol. 2023 Mar 30;53(4):297-303. doi: 10.1093/jjco/hyac202.