Safety and Feasibility of Biweekly Divided-dose of DCF as Neoadjuvant Chemotherapy for Esophageal Squamous Cell Carcinoma.
Docetaxel, cisplatin, and 5-fluorouracil (DCF) have been established as a standard neoadjuvant chemotherapy regimen for resectable esophageal squamous cell carcinoma (ESCC); however, the substantial toxicity of this regimen may limit its use in clinical practice. Therefore, a biweekly divided-dose DCF regimen (Bi-DCF) has been developed to improve tolerability while maintaining dose intensity. This study aimed to evaluate the safety and feasibility of preoperative Bi-DCF in a real-world clinical setting.
This retrospective single-institution study included 63 patients with ESCC who had received preoperative Bi-DCF between January 2016 and December 2020. Patients were stratified by age (≤75 years and ≥76 years), and age-based comparisons were performed as exploratory analyses. The primary endpoint was the incidence of grade ≥3 adverse events. Secondary endpoints included treatment feasibility, as assessed by the average relative dose intensity (ARDI), surgical outcomes, pathological responses, and recurrence-free survival (RFS).
Grade ≥3 adverse events occurred in 44.4% of patients. Non-hematological toxicities were generally infrequent, and severe renal dysfunction occurred in only two patients. No treatment-related mortality occurred. In exploratory analyses, no apparent differences in the incidence of grade ≥3 adverse events were observed between age groups. The median ARDI was 100% (range=33.3-100%) in the overall cohort and was maintained across age groups. Exploratory analyses did not demonstrate clear differences in RFS between age groups; however, these findings should be interpreted with caution because of the limited number of elderly patients.
Biweekly divided-dose DCF appears to be a feasible and tolerable neoadjuvant regimen for ESCC, with preserved dose intensity and acceptable perioperative outcomes in a real-world clinical setting. This regimen may represent a practical alternative for selected patients who are not suitable candidates for standard-dose DCF, although prospective validation in larger cohorts is warranted.
This retrospective single-institution study included 63 patients with ESCC who had received preoperative Bi-DCF between January 2016 and December 2020. Patients were stratified by age (≤75 years and ≥76 years), and age-based comparisons were performed as exploratory analyses. The primary endpoint was the incidence of grade ≥3 adverse events. Secondary endpoints included treatment feasibility, as assessed by the average relative dose intensity (ARDI), surgical outcomes, pathological responses, and recurrence-free survival (RFS).
Grade ≥3 adverse events occurred in 44.4% of patients. Non-hematological toxicities were generally infrequent, and severe renal dysfunction occurred in only two patients. No treatment-related mortality occurred. In exploratory analyses, no apparent differences in the incidence of grade ≥3 adverse events were observed between age groups. The median ARDI was 100% (range=33.3-100%) in the overall cohort and was maintained across age groups. Exploratory analyses did not demonstrate clear differences in RFS between age groups; however, these findings should be interpreted with caution because of the limited number of elderly patients.
Biweekly divided-dose DCF appears to be a feasible and tolerable neoadjuvant regimen for ESCC, with preserved dose intensity and acceptable perioperative outcomes in a real-world clinical setting. This regimen may represent a practical alternative for selected patients who are not suitable candidates for standard-dose DCF, although prospective validation in larger cohorts is warranted.
Authors
Tamura Tamura, Toyokawa Toyokawa, Lee Lee, Ishidate Ishidate, Sakurai Sakurai, Kubo Kubo, Deguchi Deguchi, Seki Seki, Kuroda Kuroda, Kasashima Kasashima, Miki Miki, Yoshii Yoshii, Shibutani Shibutani, Ohira Ohira, Maeda Maeda
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