دورية أكاديمية
أعرض في EDS

Metformin plus lrinotecan in patients with refractory colorectal cancer: a phase 2 clinical trial.

التفاصيل البيبلوغرافية
العنوان: Metformin plus lrinotecan in patients with refractory colorectal cancer: a phase 2 clinical trial.
المؤلفون: Bragagnoli AC; Hospital de Câncer de Barretos, Barretos, SP, Brazil. aryscampos@yahoo.com.br., Araujo RLC; Hospital de Câncer de Barretos, Barretos, SP, Brazil.; Universidade Federal de São Paulo, São Paulo, SP, Brazil.; Hospital Israelita Albert Einstein, São Paulo, SP, Brazil., Ferraz MW; Hospital de Câncer de Barretos, Barretos, SP, Brazil., Dos Santos LV; Beneficência Portuguesa de São Paulo, São Paulo, SP, Brazil., Abdalla KC; Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto, SP, Brazil., Comar F; Aliança Instituto de Oncologia, Brasília, DF, Brazil., Santos FA; Hospital de Câncer de Barretos, Barretos, SP, Brazil., Oliveira MA; Hospital de Câncer de Barretos, Barretos, SP, Brazil., Carvalheira JBC; Universidade Estadual de Campinas, Campinas, SP, Brazil., Cárcano FM; Hospital de Câncer de Barretos, Barretos, SP, Brazil., da Silveira Nogueira Lima JP; AC Camargo Cancer Center, São Paulo, SP, Brazil.
المصدر: British journal of cancer [Br J Cancer] 2021 Mar; Vol. 124 (6), pp. 1072-1078. Date of Electronic Publication: 2021 Jan 04.
نوع المنشور: Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Nature Publishing Group on behalf of Cancer Research UK Country of Publication: England NLM ID: 0370635 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-1827 (Electronic) Linking ISSN: 00070920 NLM ISO Abbreviation: Br J Cancer Subsets: MEDLINE
أسماء مطبوعة: Publication: 2002- : London : Nature Publishing Group on behalf of Cancer Research UK
Original Publication: London, Lewis.
مواضيع طبية MeSH: Antineoplastic Combined Chemotherapy Protocols/*therapeutic use , Colorectal Neoplasms/*drug therapy , Neoplasm Recurrence, Local/*drug therapy, Adult ; Aged ; Colorectal Neoplasms/pathology ; Female ; Follow-Up Studies ; Humans ; Irinotecan/administration & dosage ; Male ; Metformin/administration & dosage ; Middle Aged ; Neoplasm Recurrence, Local/pathology ; Prognosis ; Survival Rate ; Young Adult
مستخلص: Background: Patients with refractory colorectal (CRC) cancer have few treatment options. This trial tests the combination of metformin and irinotecan in this setting.
Methods: A phase 2 single-arm trial was conducted, patients received metformin 2500 mg orally a day plus irinotecan 125 mg/m 2 intravenously weekly D1 and D8 every 21 days. The primary endpoint was the disease control rate according to the Response Evaluation Criteria in Solid Tumors version 1.1 at 12 weeks.
Results: Between December 2015 and January 2018, 41 patients were enrolled. Seventeen patients (41%) met the primary endpoint of disease control in 12 weeks; hence, the study was deemed positive. The median progression-free survival was 3.3 months (CI 95%, 2.0-4.5 months), and the median overall survival was 8.4 months (CI 95%, 5.9-10.8 months). Both mutation RAS status and disease control at 12 weeks impacted overall survival in the multivariate model (HR 2.28, CI 95%, 1.12-4.7, p = 0.02; and HR 0.21, CI 95%, 0.08-0.5, p = 0.001, respectively). The most common adverse event was diarrhoea (29.2% grade 3).
Conclusions: In this trial, metformin plus irinotecan demonstrated disease control in patients with refractory CRC. Further trials with optimised diarrhoea control are needed to confirm these results.
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المشرفين على المادة: 7673326042 (Irinotecan)
9100L32L2N (Metformin)
تواريخ الأحداث: Date Created: 20210105 Date Completed: 20210927 Latest Revision: 20230127
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC7961008
DOI: 10.1038/s41416-020-01208-6
PMID: 33398062
قاعدة البيانات: MEDLINE
الوصف
تدمد:1532-1827
DOI:10.1038/s41416-020-01208-6