Abstract
Initiating chemotherapy usually requires a delay of more than 4 weeks after surgically resecting colorectal cancer. However, there is little evidence regarding the required delay interval. We have previously reported a pilot study to determine the safety and feasibility of early initiation of chemotherapy after resecting primary colorectal cancer with distant metastases. We aimed to determine the safety and efficacy of early initiation of chemotherapy after resecting colorectal cancer with distant metastases.This phase II study (trial number UMIN000006310) was a prospective, single‐arm trial. A total of 20 patients (men, 15 and women, 5) were enrolled. They underwent XELOX therapy (130 mg/m2 oxaliplatin on day 1+1000 mg/m2 capecitabine twice daily on days 1‐4) on postoperative day 7 and XELOX+bevacizumab (7.5 mg/kg bevacizumab on day 1) after the second chemotherapy cycle.Baseline characteristics included a median age of 64 (range, 43‐72) years. Surgical procedures included right hemicolectomy in six patients, sigmoidectomy in three, anterior resection in five, and Hartmann procedure in six. All patients started chemotherapy on postoperative day 7. Median progression‐free survival was 14.9 months; overall response rate was 80%. Disease control rate was 100%. Grade 3 or higher hemotoxicity and grade 3 or higher non‐hematological toxicity was noted in 5.0% and 25.0% of patients, respectively. Postoperative complications were observed in two patients (superficial incisional surgical site infection and ileus).Early initiation of chemotherapy after surgery is feasible. These findings suggest future changes of the start time of chemotherapy after surgery.
Highlights
The National Comprehensive Cancer Network recommends that patients with metastatic colorectal cancer (CRC) undergo primary tumor resection if they have impending obstruction, bowel obstruction, or potentially resectable metastases
Adjuvant therapy initiation is most often defined as starting therapy within 8 weeks after surgery, and it reportedly reduces the risks of recurrence and increases overall survival (OS) and disease-free survival.[8,9]
Because we previously reported that early initiation of chemotherapy after surgery is feasible,[12] we evaluated its efficacy in patients subjected to colorectal surgery for symptomatic CRC with synchronous multiple distant metastases
Summary
The National Comprehensive Cancer Network recommends that patients with metastatic colorectal cancer (CRC) undergo primary tumor resection if they have impending obstruction, bowel obstruction, or potentially resectable metastases. In stage III disease, the time to start adjuvant therapy is an important prognostic factor for both colon and rectal cancers.[8,9,10,11] Early adjuvant therapy initiation is most often defined as starting therapy within 8 weeks after surgery, and it reportedly reduces the risks of recurrence and increases overall survival (OS) and disease-free survival.[8,9] Metastatic tumors may rapidly enlarge before starting chemotherapy and may lead to patient death. Because we previously reported that early initiation of chemotherapy after surgery is feasible,[12] we evaluated its efficacy in patients subjected to colorectal surgery for symptomatic (narrowing of the stool, constipation, rectal bleeding, abdominal pain etc.) CRC with synchronous multiple distant metastases
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