Clinical utility of pegfilgrastim on day 3 of preoperative docetaxel, cisplatin and 5-fluorouracil chemotherapy in elderly patients with resectable esophageal cancer

Background: Preoperative docetaxel, cisplatin, and 5-fluorouracil (DCF) has become the standard treatment for resectable esophageal squamous cell carcinoma (ESCC) based on the results of the JCOG1109 trial. However, preoperative DCF is associated with a high frequency of febrile neutropenia (FN), especially in elderly patients with risk factors for FN. The utility of primary prophylactic pegfilgrastim on day 3 of preoperative DCF for preventing FN was demonstrated in a Phase II study, but it did not report comparison data in elderly ESCC patients. We aimed to evaluate the utility of primary prophylactic pegfilgrastim in these patients. Methods: We retrospectively evaluated the clinical utility of primary prophylactic pegfilgrastim on day 3 of preoperative DCF in elderly patients with resectable ESCC. The patients were divided into a day 3 pegfilgrastim group (D3PG) and a no pegfilgrastim group (NPG). The incidence of FN and grade ≥3 neutropenia, histopathological effects, and relapse-free survival (RFS) were compared between the groups. Results: Thirty patients were enrolled in each group. FN was observed in 3.3% of patients in the D3PG and 26.6% of those in the NPG (P=0.02), and grade ≥3 neutropenia was observed in 10% and 70%, respectively (P<0.001). The pathological complete response rate was 24.1% in the D3PG and 33.3% in the NPG (P=0.44); the respective 3-year RFS rates were 73.6% and 59.8% (P=0.33). The relative dose intensity was 0.914 in the D3PG and 0.850 in the NPG for docetaxel (P=0.01), 0.858 and 0.844, respectively, for cisplatin (P=0.45), and 0.916 and 0.846 for 5-fluorouracil (P=0.01). Conclusions: Primary prophylactic pegfilgrastim on day 3 of preoperative DCF significantly reduced the risks of FN and grade ≥3 neutropenia in elderly patients with ESCC. There was no significant difference between the groups in histological effects or RFS.