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Abstract
Ramucirumab plus docetaxel (RD) can cause febrile neutropenia (FN), which frequently requires the prophylactic administration of pegfilgrastim. However, the effects of prophylactic pegfilgrastim on FN prevention, therapeutic efficacy, and prognosis after RD have not been fully evaluated in patients with advanced non-small-cell lung cancer (NSCLC). Two hundred and eighty-eight patients with advanced NSCLC who received RD as second-line therapy after platinum-based chemotherapy plus PD-1 blockade were included. Patients were divided into groups with and without prophylactic pegfilgrastim, and adverse events, efficacy, and prognosis were compared between both groups. Of the 288 patients, 247 received prophylactic pegfilgrastim and 41 did not. The frequency of grade 3/4 neutropenia was 62 patients (25.1%) in the pegfilgrastim group and 28 (68.3%) in the control group (p < 0.001). The frequency of FN was 25 patients (10.1%) in the pegfilgrastim group and 10 (24.4%) in the control group (p = 0.018). The objective response rate was 31.2% and 14.6% in the pegfilgrastim and control groups (p = 0.039), respectively. The disease control rate was 72.9% in the pegfilgrastim group and 51.2% in the control group (p = 0.009). Median progression free survival was 4.3 months in the pegfilgrastim group and 2.5 months in the control group (p = 0.002). The median overall survival was 12.8 and 8.1 months in the pegfilgrastim and control groups (p = 0.004), respectively. Prophylactic pegfilgrastim for RD reduced the frequency of grade 3/4 neutropenia and febrile neutropenia and did not appear to be detrimental to patient outcome RD.
Clinical Trial Registration Number: UMIN000042333.
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1 Juntendo University Graduate School of Medicine, Department of Respiratory Medicine, Tokyo, Japan (GRID:grid.258269.2) (ISNI:0000 0004 1762 2738)
2 Saitama Medical University International Medical Center, Department of Respiratory Medicine, Comprehensive Cancer Center, Hidaka, Japan (GRID:grid.410802.f) (ISNI:0000 0001 2216 2631)
3 Shizuoka Cancer Center, Clinical Research Center, Nagaizumi, Japan (GRID:grid.415797.9) (ISNI:0000 0004 1774 9501)
4 Sendai Kousei Hospital, Department of Pulmonary Medicine, Sendai, Japan (GRID:grid.415501.4)
5 Osaka International Cancer Institute, Department of Thoracic Oncology, Osaka, Japan (GRID:grid.489169.b)
6 Saitama Red Cross Hospital, Department of Respiratory Medicine, Saitama, Japan (GRID:grid.416704.0) (ISNI:0000 0000 8733 7415)
7 The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Department of Thoracic Medical Oncology, Tokyo, Japan (GRID:grid.410807.a) (ISNI:0000 0001 0037 4131)
8 Saitama Cancer Center, Department of Thoracic Oncology, Saitama, Japan (GRID:grid.416695.9) (ISNI:0000 0000 8855 274X)
9 National Hospital Organization Shikoku Cancer Center, Department of Thoracic Oncology and Medicine, Matsuyama, Japan (GRID:grid.415740.3) (ISNI:0000 0004 0618 8403)
10 Niigata Cancer Center Hospital, Department of Internal Medicine, Niigata, Japan (GRID:grid.416203.2) (ISNI:0000 0004 0377 8969)
11 Matsusaka Municipal Hospital, Respiratory Center, Matsusaka, Japan (GRID:grid.513264.7)
12 Nippon Medical School, Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Tokyo, Japan (GRID:grid.410821.e) (ISNI:0000 0001 2173 8328)
13 Saiseikai Utsunomiya Hospital, Department of Internal Medicine, Utsunomiya, Japan (GRID:grid.416684.9) (ISNI:0000 0004 0378 7419)
14 Shizuoka Cancer Center, Division of Thoracic Oncology, Shizuoka, Japan (GRID:grid.415797.9) (ISNI:0000 0004 1774 9501)