دورية أكاديمية
Real-World Activity and Safety of Trifluridine-Tipiracil Plus Bevacizumab Therapy in Patients with Refractory Metastatic Colorectal Cancer.
| العنوان: | Real-World Activity and Safety of Trifluridine-Tipiracil Plus Bevacizumab Therapy in Patients with Refractory Metastatic Colorectal Cancer. |
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| المؤلفون: | Arrichiello G; Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Via Pansini 5, 80131, Naples, Italy., Perrone A; Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Via Pansini 5, 80131, Naples, Italy., Napolitano S; Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Via Pansini 5, 80131, Naples, Italy., Martini G; Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Via Pansini 5, 80131, Naples, Italy., De Falco V; Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Via Pansini 5, 80131, Naples, Italy.; Oncology Unit, Ospedale del Buon Consiglio 'Fatebenefratelli', Via Alessandro Manzoni, 220, 80123, Naples, Italy., Incoronato P; ASL Napoli 2 Nord, Via Lupoli 27, Frattamaggiore, 80027, Naples, Italy., Laterza MM; ASL Napoli 2 Nord, Via Lupoli 27, Frattamaggiore, 80027, Naples, Italy., Facchini G; ASL Napoli 2 Nord, Via Lupoli 27, Frattamaggiore, 80027, Naples, Italy., Famiglietti V; Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Via Pansini 5, 80131, Naples, Italy., Nacca V; Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Via Pansini 5, 80131, Naples, Italy., Paragliola F; Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Via Pansini 5, 80131, Naples, Italy., Napolitano R; Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Via Pansini 5, 80131, Naples, Italy., Suarato G; Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Via Pansini 5, 80131, Naples, Italy., Nicastro A; Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Via Pansini 5, 80131, Naples, Italy., Martinelli E; Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Via Pansini 5, 80131, Naples, Italy., Ciardiello D; Oncology Unit, Casa Sollievo della Sofferenza Hospital, 71013, San Giovanni Rotondo , Foggia, Italy., Ciardiello F; Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Via Pansini 5, 80131, Naples, Italy., Troiani T; Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, Via Pansini 5, 80131, Naples, Italy. teresa.troiani@unicampania.it. |
| المصدر: | Targeted oncology [Target Oncol] 2022 Nov; Vol. 17 (6), pp. 635-642. Date of Electronic Publication: 2022 Oct 14. |
| نوع المنشور: | Observational Study; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Springer-Verlag France Country of Publication: France NLM ID: 101270595 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1776-260X (Electronic) Linking ISSN: 17762596 NLM ISO Abbreviation: Target Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Paris : Springer-Verlag France, c2006- |
| مواضيع طبية MeSH: | Colorectal Neoplasms*/pathology , Colonic Neoplasms*/drug therapy, Humans ; Male ; Adult ; Middle Aged ; Aged ; Aged, 80 and over ; Female ; Trifluridine/pharmacology ; Trifluridine/therapeutic use ; Bevacizumab/pharmacology ; Bevacizumab/therapeutic use ; Retrospective Studies ; Uracil/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/pharmacology ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use |
| مستخلص: | Background: The combination of trifluridine-tipiracil and bevacizumab was compared with trifluridine-tipiracil monotherapy in a randomized, open-label, phase II trial, resulting in a statistically significant and clinically relevant improvement in progression-free survival (PFS), with tolerable toxicity in patients with refractory metastatic colorectal cancer (mCRC); however, evidence supporting the role of this combination in a real-world setting is limited. Objective: The aim of our work was to provide further evidence on the activity and safety of this combination in a real-world series of Western mCRC patients refractory or intolerant to previous therapies. Patient and Methods: We conducted a retrospective, observational study of patients with mCRC refractory or intolerant to standard therapies. Patients were treated with trifluridine-tipiracil and bevacizumab. Previous therapy with fluoropyrimidines, irinotecan, oxaliplatin, bevacizumab, aflibercept, regorafenib, and cetuximab or panitumumab (only RAS wild-type) was allowed, as was previous participation in clinical trials. Clinicopathological characteristics, overall response rate (ORR), disease control rate (DCR), overall survival (OS), PFS, and safety data were retrospectively collected and analyzed. Results: We recorded 31 patients treated between 1 December 2017 and 30 June 2022. Median age was 69 years (range 38-82 years), 39% were male, 100% had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1, tumor location was left-sided in 77% of cases, 54% had synchronous presentation, 35% were RAS mutant, 3% were BRAF mutant, and 71% underwent primary tumor resection; 64% of patients had liver metastases, 55% had lung metastases, and 23% had peritoneal carcinomatosis. The median number of previous treatment lines was 2 (range 0-5), and 84% of patients received at least one previous anti-angiogenic agent. The ORR and DCR were 3% and 71%, respectively. With a median follow-up of 8 months (range 2-39), median PFS was 6 months (95% confidence interval [CI] 3.1-8.9 months) and median OS was 14 months (95% CI 10.1-17.8 months). Adverse events of any grade were reported in 58% of patients. The most common grade 3-4 toxicities were neutropenia (19%) and anemia (6%); 35% of patients required either dose delays or dose reductions due to toxicity. Granulocyte colony-stimulating factor (G-CSF) prophylaxis was administered either on first or subsequent cycles of treatment in 35% of patients. No treatment-related deaths occurred. Sixty percent of the patients who discontinued treatment eventually received one or more lines of subsequent therapy. Conclusions: Our series provides further evidence on the activity and safety of the combination of trifluridine-tipiracil and bevacizumab in a real-world series of Western refractory mCRC patients. (© 2022. The Author(s).) |
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| المشرفين على المادة: | RMW9V5RW38 (Trifluridine) NGO10K751P (tipiracil) 2S9ZZM9Q9V (Bevacizumab) 56HH86ZVCT (Uracil) |
| تواريخ الأحداث: | Date Created: 20221014 Date Completed: 20221125 Latest Revision: 20221214 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC9684226 |
| DOI: | 10.1007/s11523-022-00916-8 |
| PMID: | 36239883 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 1776-260X |
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| DOI: | 10.1007/s11523-022-00916-8 |