Abstract
Fluoropyrimidine combined with bevacizumab is commonly used in elderly patients with metastatic colorectal cancer worldwide. However, the proportion of elderly patients who discontinued treatment due to toxicities was higher than that of younger patients. The aim of this study is to develop a less toxic schedule of S-1, while maintaining the anti-tumor effect. This phase II study is aimed to evaluate an alternate-day administration of S-1 combined with bevacizumab in untreated elderly patients (aged ≥75 years) with metastatic colorectal cancer. The primary endpoint is progression-free survival, and the secondary endpoints are safety, response rate, and overall survival. The expected median progression-free survival is 8.5 months, and the minimum efficacy threshold is 5.0 months. The total required sample size is calculated as 50 patients, with a 2-sided type I error of 0.10 and a power of more than 80%. This study is ongoing, and fifty-four patients were enrolled until October 2016. We hope that S-1 on alternate days combined with bevacizumab for elderly patients with colorectal cancer is well tolerated and can maintain effectiveness. Trial registration: UMIN clinical trials UMIN000010402.
Highlights
Colorectal cancer (CRC) is one of the most common causes of cancer-related deaths worldwide [1], and the mortality from CRC among all cancers in Japan is the third highest for men and the highest for women [2]
This phase II study is aimed to evaluate an alternate-day administration of S-1 combined with bevacizumab in untreated elderly patients with metastatic colorectal cancer
Doublet [fluoropyrimidine (FP) plus oxaliplatin or irinotecan] chemotherapy combined with a targeted agent is recognized as the standard treatment for patients with metastatic CRC (mCRC) [3] [4] [5]
Summary
Colorectal cancer (CRC) is one of the most common causes of cancer-related deaths worldwide [1], and the mortality from CRC among all cancers in Japan is the third highest for men and the highest for women [2]. Among patients with CRC, those aged 75 years and older account for more than 70% of the total mortality in men and women combined. Doublet [fluoropyrimidine (FP) plus oxaliplatin or irinotecan] chemotherapy combined with a targeted agent (e.g., bevacizumab, cetuximab, or panitumumab) is recognized as the standard treatment for patients with mCRC [3] [4] [5]. Younger patients can tolerate the doublet regimen combined with a targeted agent, whereas elderly patients often cannot tolerate this combination because many of them develop comorbidity and/or functional disorders. A combination of FP and bevacizumab is selected when physicians determine that a patient is unable to tolerate doublet therapy with/without a targeted agent or if the patient refuses those regimens. FP plus bevacizumab has been recognized as one of the standard chemotherapies in elderly patients with mCRC
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