Phase II study of 5-fluorouracil-leucovorin plus bevacizumab for chemotherapy-naïve older or frail patients with metastatic colorectal cancer (OGSG 0802).

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSION:

Weekly 5-FU-leucovorin with biweekly bevacizumab may be a tolerable and effective treatment option for older or frail patients with mCRC.

• Authors: Takashi Ohta, Takeshi Kato, Hisato Kawakami, Yasuhiro Miyake, Masahiro Goto, Shigeyoshi Iwamoto, Toshio Otsuji, Masato Nakamura, Naotoshi Sugimoto, Shu Okamura, Masahito Kotaka, Masaki Tsujie, Yukihiko Tokunaga, Hideyuki Mishima, Taishi Hata, Toshio Shimokawa, Yukinori Kurokawa, Taroh Satoh
• Journal: International journal of clinical oncology (Int J Clin Oncol) Vol. 25 Issue 7 Pg. 1291-1298 (Jul 2020) ISSN: 1437-7772 [Electronic] Japan
• PMID: 32219630 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Oxaliplatin
• Bevacizumab
• Irinotecan
• Leucovorin
• Fluorouracil

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Bevacizumab (administration & dosage, adverse effects)
• Colorectal Neoplasms (drug therapy, mortality, pathology)
• Female
• Fluorouracil (administration & dosage, adverse effects)
• Frail Elderly
• Humans
• Irinotecan (adverse effects)
• Leucovorin (administration & dosage, adverse effects)
• Male
• Middle Aged
• Oxaliplatin (adverse effects)
• Progression-Free Survival
• Treatment Outcome