Efficacy and Safety of Bevacizumab Combined With First-Line Chemotherapy in Elderly (≥75 Years) Patients With Metastatic Colorectal Cancer: A Real-World Study
| Autor: | Stefano Kim, Denis Smith, Alexandre Tanang, Eric Francois, Florence Rollot, Yoann Lelarge, Kalaivani Veerabudun, P. Laplaige, Gael Deplanque, Miruna Ionescu-Goga, Sophie Gourgou, Laurent Mineur |
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| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Bevacizumab Colorectal cancer Population 03 medical and health sciences 0302 clinical medicine Internal medicine Antineoplastic Combined Chemotherapy Protocols Medicine Humans Prospective Studies education Adverse effect Stroke Geriatric Assessment Aged Aged 80 and over education.field_of_study business.industry Gastroenterology Age Factors medicine.disease Primary tumor Confidence interval Progression-Free Survival Clinical trial Hemorrhagic Stroke Oncology 030220 oncology & carcinogenesis Mesenteric Ischemia 030211 gastroenterology & hepatology Female France business Colorectal Neoplasms medicine.drug |
| Zdroj: | Clinical colorectal cancer. 19(3) |
| ISSN: | 1938-0674 |
| Popis: | Although elderly patients are the first concerned by colorectal cancer (CRC), they are underrepresented in clinical trials. The real-world CASSIOPEE study was thus conducted in elderly patients treated for metastatic CRC (mCRC).This French prospective, multicenter, noninterventional study aimed to estimate 1-year progression-free survival (PFS) and overall survival (OS), and describe treatments, patient autonomy (Instrumental Activities of Daily Living; Balducci scale), and safety over 24 months, in patients older than 75 with mCRC, starting first-line bevacizumab plus chemotherapy (NCT01555762).From 2012 to 2014, 402 patients were included (safety population: n = 383, efficacy population: n = 358). Patient characteristics were as follows: mean age, 81 ± 4 years (80 years, 46%; 80-85 years, 44%;85 years, 10%); men, 52%; colon primary tumor, 80%; main metastatic site, liver 66%; Eastern Cooperative Oncology Group performance 0-1, 81%. Median PFS was 9.1 months (95% confidence interval [CI]: 8.3-10.2). It was superior for patients ≤85 years (80 years: 9.3 months; 80-85 years: 9.5 months) compared with patients85 years (8.3 months). Median OS was 19.0 months (95% CI, 16.5-21.5) and decreased in the 2 oldest groups (20.6, 17.8, and 13.0 months). Autonomy assessments decreased over time leading to nonconclusive results. Twenty-six percent of patients experienced serious adverse events (SAEs): 7% bevacizumab-related SAEs, and 6% bevacizumab-targeted SAEs. Two fatal bevacizumab-related adverse events were reported (hemorrhagic stroke and intestinal ischemia).This large French real-world study showed that medically fit older patients with mCRC could have a benefit/risk balance similar to that of younger patients when treated with first-line bevacizumab plus chemotherapy. Improvements in geriatric assessments are needed to better define this population. |
| Databáze: | OpenAIRE |
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