Desmoid with biweekly methotrexate and vinblastine shows similar effects to weekly administration: A phase II clinical trial.

Abstract

Low-dose methotrexate (MTX) plus vinblastine (VBL) chemotherapy is an effective treatment for desmoid-type fibromatosis (DF). However, previous reports have described a weekly regimen, with no reports available on a biweekly one. The aim of this study was to determine the clinical outcomes of a biweekly regimen in a cohort prospectively treated in our single institution. Since 2010, we have prospectively treated refractory DF patients with biweekly MTX (30 mg/m2 ) + VBL (6 mg/m2 ). Efficacy, progression-free survival (PFS), and correlating factors were analyzed. Adverse events (AEs) were recorded. In total, 38 patients received low-dose MTX + VBL therapy, and its efficacy was assessed in 37 of them. Nineteen (51%) patients showed partial response (PR). Clinical benefit rate was 95%. PFS at 5 y was 80.8%. In PR cases, median time to response was 10 mo. Longer duration of therapy was significantly associated with the response of PR (P = .007) by univariate analysis. There was no clear association between various clinicopathological factors, including tumor size, location, catenin beta-1 (CTNNB1) mutation status with effect. Only 3 AEs of grade 3/4 were observed. Tumor regrowth after MTX + VBL discontinuation was observed in 5 (20%) of 25 patients. Biweekly administration of MTX + VBL chemotherapy was well tolerated compared with weekly administration, and its efficacy was anticipated in DF patents, although the time needed to achieve a response may be relatively long. The treatment interval should be determined taking into account both the condition of the tumor and the patient's preference.

• Authors: Yoshihiro Nishida, Shunsuke Hamada, Hiroshi Urakawa, Kunihiro Ikuta, Tomohisa Sakai, Hiroshi Koike, Kan Ito, Ryo Emoto, Yuichi Ando, Shigeyuki Matsui
• Journal: Cancer science (Cancer Sci) Vol. 111 Issue 11 Pg. 4187-4194 (Nov 2020) ISSN: 1349-7006 [Electronic] England
• PMID: 32816351 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
• Copyright: © 2020 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

Chemical References

• Vinblastine
• Methotrexate

Topics

• Adolescent
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Child
• Child, Preschool
• Drug Administration Schedule
• Female
• Fibromatosis, Aggressive (diagnosis, drug therapy, mortality)
• Follow-Up Studies
• Humans
• Kaplan-Meier Estimate
• Male
• Methotrexate (administration & dosage)
• Middle Aged
• Neoplasm Staging
• Prognosis
• Proportional Hazards Models
• Treatment Outcome
• Vinblastine (administration & dosage)
• Young Adult