Bevacizumab Combined with S-1 and Raltitrexed for Patients with Metastatic Colorectal Cancer Refractory to Standard Therapies: A Phase II Study
Autor: | Xin Wang, Feng Bi, Hongfeng Gou, Qiu Li, Ye Chen, Ji-Yan Liu, Zhiping Li, Ke Cheng, Yali Shen, Yu Yang, Dan Cao, Deyun Luo, Meng Qiu, Yuwen Zhou |
---|---|
Rok vydání: | 2021 |
Předmět: |
Oncology
Cancer Research medicine.medical_specialty Bevacizumab Colorectal cancer medicine.medical_treatment Leucovorin Phases of clinical research Thiophenes 03 medical and health sciences 0302 clinical medicine Internal medicine Antineoplastic Combined Chemotherapy Protocols Clinical endpoint medicine Humans 030212 general & internal medicine Chemotherapy business.industry Clinical Trial Results medicine.disease Oxaliplatin Irinotecan 030220 oncology & carcinogenesis Quinazolines Fluorouracil Colorectal Neoplasms business Raltitrexed medicine.drug |
Zdroj: | Oncologist |
ISSN: | 1549-490X 1083-7159 |
Popis: | Lessons Learned Background In patients with metastatic colorectal cancer (mCRC) refractory to standard therapies, S-1 plus raltitrexed showed a good objective response rate (ORR) and significant survival benefit in our previous study. In the present study, we assessed the activity and safety of bevacizumab combined with S-1 and raltitrexed. Methods This investigator-initiated, open-label, single-arm, phase II trial was performed at West China Hospital in China. Patients with mCRC who had disease progression after fluoropyrimidine, irinotecan, and oxaliplatin and had at least one measurable lesion were eligible for this trial. Anti–epidermal growth factor receptor (EGFR) (for tumors with wild-type RAS) and anti–vascular endothelial growth factor (VEGF) therapy in the first or second line was allowed, but patients who had been treated with bevacizumab across two consecutive chemotherapy regimens were excluded. Patients received bevacizumab (7.5 mg/kg on day 1), oral S-1 (80–120 mg per day for 14 days), and raltitrexed (3 mg/m2 on day 1) every 3 weeks. The primary endpoint was ORR. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity. Results From September 2015 to November 2019, 44 patients were enrolled. Tumor response evaluation was available in 44 patients at the time of the analysis. There were no complete responses; the ORR was 15.9%, and the disease control rate was 54.5%. Median PFS and OS were 110 days (95% confidence interval [CI], 65.0–155.0) and 367 days (95% CI, 310.4–423.6), respectively. The combination was well tolerated. Conclusion Bevacizumab combined with S-1 and raltitrexed showed promising antitumor activity and safety in refractory mCRC. |
Databáze: | OpenAIRE |
Externí odkaz: |