Phase II study of 5-fluorouracil–leucovorin plus bevacizumab for chemotherapy-naïve older or frail patients with metastatic colorectal cancer (OGSG 0802)
| Autor: | Hisato Kawakami, Naotoshi Sugimoto, Takeshi Kato, Taroh Satoh, Masaki Tsujie, Shu Okamura, Yukihiko Tokunaga, Shigeyoshi Iwamoto, Takashi Ohta, Masato Nakamura, Masahito Kotaka, Taishi Hata, Toshio Shimokawa, Hideyuki Mishima, Yukinori Kurokawa, Yasuhiro Miyake, Toshio Otsuji, Masahiro Goto |
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| Rok vydání: | 2020 |
| Předmět: |
Male
0301 basic medicine medicine.medical_specialty Bevacizumab Frail Elderly Leucovorin Phases of clinical research Neutropenia Irinotecan Gastroenterology 03 medical and health sciences 0302 clinical medicine Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Mucositis Humans Aged Aged 80 and over Performance status business.industry Hematology General Medicine Middle Aged medicine.disease Progression-Free Survival Oxaliplatin Treatment Outcome 030104 developmental biology Oncology Fluorouracil 030220 oncology & carcinogenesis Female Surgery Colorectal Neoplasms business medicine.drug |
| Zdroj: | International Journal of Clinical Oncology. 25:1291-1298 |
| ISSN: | 1437-7772 1341-9625 |
| Popis: | Older or frail patients are often underrepresented in clinical trials for metastatic colorectal cancer (mCRC). We here assessed the efficacy and safety of 5-fluorouracil (5-FU)–leucovorin plus bevacizumab in such patients. The study (OGSG 0802) was designed as a single-arm, open-label, multicenter phase II trial. Eligible patients had mCRC and at least one of the following: an age of ≥ 65 years, an Eastern Cooperative Oncology Group performance status of 1 or 2, a serum albumin level of ≤ 3.5 g/dL, incompatibility with oxaliplatin or irinotecan, and a history of abdominal or pelvic radiotherapy. Patients received 5-FU (600 mg/m2) and l-leucovorin (200 mg/m2) on days 1, 8, and 15 together with bevacizumab (5 mg/kg) on days 1 and 15 every 4 weeks. The primary end point was objective response rate (ORR), and secondary end points were progression-free survival (PFS), overall survival (OS), and safety. Forty-one patients were enrolled and eligible. Median age was 76 years (range 56–90 years), and 51% of patients had a performance status of 0. The ORR was 36.6% [95% confidence interval (CI) 22.1–53.1%], median PFS was 9.4 months (95% CI 7.4–17.7 months), and median OS was 24.0 months (95% CI 19.9 months—not reached). The most common treatment-related adverse events of grade ≥ 3 were neutropenia (24%), anorexia (10%), leukopenia (7%), and mucositis/stomatitis (7%). There were no treatment-related deaths. Weekly 5-FU–leucovorin with biweekly bevacizumab may be a tolerable and effective treatment option for older or frail patients with mCRC. |
| Databáze: | OpenAIRE |
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