Published in:
01-10-2019 | Bevacizumab | Original Article
Phase II study of S-1 on alternate days plus bevacizumab in patients aged ≥ 75 years with metastatic colorectal cancer (J-SAVER)
Authors:
Toshikazu Moriwaki, Yoshinori Sakai, Hiroyasu Ishida, Yoshiyuki Yamamoto, Shinji Endo, Hideaki Kuramochi, Mikio Sato, Yukimasa Hatachi, Yoshiaki Bando, Takashi Maeba, Kazuto Ikezawa, Mitsuo Shimada, Kenji Amagai, Masamitsu Morimoto, Kazuma Kobayashi, Akihito Tsuji, Tomohiro Nishina, Ichinosuke Hyodo
Published in:
International Journal of Clinical Oncology
|
Issue 10/2019
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Abstract
Background
Alternate-day administration of S-1 is thought to reduce toxicities. This phase II study evaluated S-1 on alternate days combined with bevacizumab as first-line treatment for elderly patients with metastatic colorectal cancer.
Patients and methods
Eligible patients had histologically proven colorectal adenocarcinoma, measurable metastatic lesions, age ≥ 75 years, Eastern Cooperative Oncology Group performance status ≤ 1, no previous chemotherapy, and refused oxaliplatin- or irinotecan-containing regimens. Patients received 40 mg, 50 mg, or 60 mg (body surface area ≤ 1.25 m2, > 1.25 to ≤ 1.50 m2, or > 1.50 m2, respectively) of S-1 twice orally on Sunday, Monday, Wednesday, and Friday every week. Bevacizumab (7.5 mg/kg) was administered every 3 weeks. The primary endpoint was progression-free survival.
Results
Of 54 enrolled patients, 50 patients were evaluated for efficacy and 53 for safety. The median age was 79 years (range 75–88 years). The median progression-free survival was 8.1 months (95% confidence interval (CI) 6.7–9.5 months). The median overall survival was 23.1 months (95% CI 17.4–28.8 months). The response rate was 44% (95% CI 30.2–57.8%), and the disease control rate was 88% (95% CI 79.0–97.0%). Grade 3 or higher hematologic, non-hematologic, and bevacizumab-related adverse events occurred in 9%, 11%, and 25% of patients, respectively. The most common grade 3 and 4 treatment-related adverse events were hypertension (11%), nausea (6%), fatigue (6%), anemia (6%), and proteinuria (6%). Only 6 patients discontinued treatment due to adverse events.
Conclusion
S-1 on alternate days combined with bevacizumab showed better tolerability and comparable survival compared with the results of similar studies.