دورية أكاديمية
أعرض في EDS

A randomized phase II study of SM-88 plus methoxsalen, phenytoin, and sirolimus in patients with metastatic pancreatic cancer treated in the second line and beyond.

التفاصيل البيبلوغرافية
العنوان: A randomized phase II study of SM-88 plus methoxsalen, phenytoin, and sirolimus in patients with metastatic pancreatic cancer treated in the second line and beyond.
المؤلفون: Noel MS; Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, USA., Kim S; TYME Technologies Inc., Bedminster, New Jersey, USA., Hartley ML; The Ruesch Center for the Cure of Gastrointestinal Cancers, Washington, District of Columbia, USA., Wong S; Sarcoma Oncology Research Center, Santa Monica, California, USA., Picozzi VJ; Virginia Mason Hospital and Medical Center, Seattle, Washington, USA., Staszewski H; Mather Hospital, Port Jefferson, New York, USA., Kim DW; The University of Texas MD Anderson Cancer Center, Houston, Texas, USA., Van Tornout JM; TYME Technologies Inc., Bedminster, New Jersey, USA., Philip PA; Karmanos Cancer Center, Wayne State University, Michigan, Detroit, USA.; SWOG, Farmington Hills, Michigan, USA., Chung V; City of Hope, Duarte, California, USA., Ocean AJ; Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York, USA., Wang-Gillam A; Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.
المصدر: Cancer medicine [Cancer Med] 2022 Nov; Vol. 11 (22), pp. 4169-4181. Date of Electronic Publication: 2022 May 02.
نوع المنشور: Randomized Controlled Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: John Wiley & Sons Ltd Country of Publication: United States NLM ID: 101595310 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2045-7634 (Electronic) Linking ISSN: 20457634 NLM ISO Abbreviation: Cancer Med Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [Malden, MA] : John Wiley & Sons Ltd., c2012-
مواضيع طبية MeSH: Pancreatic Neoplasms*/pathology , Adenocarcinoma*/pathology, Humans ; Methoxsalen/therapeutic use ; Phenytoin/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Sirolimus/adverse effects ; Quality of Life ; Pancreatic Neoplasms
مستخلص: Background: This trial explores SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in pretreated metastatic pancreatic ductal adenocarcinoma (mPDAC) METHODS: Forty-nine patients were randomized to daily 460 or 920 mg oral SM-88 with MPS (SM-88 Regimen). The primary endpoint was objective response rate (RECIST 1.1).
Results: Thirty-seven patients completed ≥ one cycle of SM-88 Regimen (response evaluable population). Disease control rate (DCR), overall survival (OS), and progression-free survival (PFS) did not differ significantly between dose levels. Stable disease was achieved in 9/37 patients (DCR, 24.3%); there were no complete or partial responses. Quality-of-life (QOL) was maintained and trended in favor of 920 mg. SM-88 Regimen was well tolerated; a single patient (1/49) had related grade 3 and 4 adverse events, which later resolved. In the intention-to-treat population of 49 patients, the median overall survival (mOS) was 3.4 months (95% CI: 2.7-4.9 months). Those treated in the second line had an mOS of 8.1 months and a median PFS of 3.8 months. Survival was higher for patients with stable versus progressive disease (any line; mOS: 10.6 months vs. 3.9 months; p = 0.01).
Conclusions: SM-88 Regimen has a favorable safety profile with encouraging QOL effects, disease control, and survival trends. This regimen should be explored in the second-line treatment of patients with mPDAC.
Clinicaltrials: gov Identifier: NCT03512756.
(© 2022 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)
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سلسلة جزيئية: ClinicalTrials.gov NCT03512756
المشرفين على المادة: U4VJ29L7BQ (Methoxsalen)
6158TKW0C5 (Phenytoin)
W36ZG6FT64 (Sirolimus)
تواريخ الأحداث: Date Created: 20220502 Date Completed: 20221123 Latest Revision: 20231213
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC9678093
DOI: 10.1002/cam4.4768
PMID: 35499204
قاعدة البيانات: MEDLINE
الوصف
تدمد:2045-7634
DOI:10.1002/cam4.4768