Efficacy and Safety of Regorafenib With 2/1 Schedule for Patients ≥ 75 Years With Metastatic Colorectal Cancer (mCRC) After Failure of 2 Lines of Chemotherapy
| Autor: | Luciana Messuti, Roberto Petrioli, Anna Ida Fiaschi, Edoardo Francini, Martina Chirra, Vinno Savelli, Ignazio Martellucci |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Oncology
Male medicine.medical_specialty Lung Neoplasms Colorectal cancer Pyridines Placebo Drug Administration Schedule 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Elderly Internal medicine Regorafenib medicine Clinical endpoint Humans Geriatric assessment Metastatic cancer Gastroenterology 030212 general & internal medicine Prospective Studies Adverse effect Peritoneal Neoplasms Aged Aged 80 and over Salvage Therapy business.industry Phenylurea Compounds Liver Neoplasms medicine.disease Prognosis Oxaliplatin Irinotecan Survival Rate Tolerability chemistry 030220 oncology & carcinogenesis Lymphatic Metastasis Female Safety business Colorectal Neoplasms medicine.drug Follow-Up Studies |
| Popis: | Background In the CORRECT (patients with metastatic COloRectal Cancer treated with REgorafenib or plaCebo after failure of standard Therapy) trial, regorafenib was proven to extend survival of patients with metastatic colorectal cancer (mCRC) that progressed after all available therapies. Grade 3 to 4 toxicity occurred in 54% of patients, and data on the activity and tolerability of regorafenib in elderly patients were scarce. The aim of this study was to evaluate the efficacy and safety of an alternative schedule, 2-week-on treatment and 1 week-off (2/1 schedule), of regorafenib for elderly patients with mCRC. Patients and Methods Patients ≥ 75 years with mCRC who progressed after oxaliplatin- and irinotecan-based chemotherapy received regorafenib on a 2/1 schedule. Potentially frail subjects were identified by G8 screening tool and excluded. The 2-month disease-control rate was the primary endpoint, and the secondary endpoints included safety, progression-free survival (PFS), overall survival (OS), and objective response rate. Results Between February 2014 and May 2017, 23 patients with mCRC were recruited at our institution. No partial or complete responses were observed, and the stable disease and disease-control rate were 52.2%. The median PFS was 4.8 months (95% confidence interval, 3.8-6.3 months), and the median OS was 8.9 months (95% confidence interval, 6.9-10.6 months). Adverse events were uncommon, and the most frequent grade 3 toxicity adverse events were hand-foot skin reaction (9%) and fatigue (9%). Toxicity-related dose reductions and discontinuations occurred in 5 and 2 patients, respectively. Conclusion Regorafenib administered with a modified 2/1 schedule to patients who were aged ≥ 75 years and non-frail with treatment-refractory mCRC seems to be tolerable and achieve encouraging results in terms of PFS and OS. |
| Databáze: | OpenAIRE |
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