A Japanese randomized phase II trial comparing docetaxel plus ramucirumab with docetaxel monotherapy (JVCG) showed that effectiveness of additional ramucirumab was comparable to that of a randomized phase III trial (REVEL). However, in the JVCG study, febrile neutropenia (FN) was confirmed in 34% of the patients in the combination arm. It was assumed that the high frequency of FN was related to the fact that preventive prophylactic pegylated (PEG)-granulocyte-colony stimulating factor (G-CSF) was administered to only 6% of the patients. The aim of our study was to evaluate the efficacy and safety of docetaxel plus ramucirumab with primary prophylactic PEG-G-CSF for Japanese pretreated non-small cell lung cancer (NSCLC).
We retrospectively reviewed medical records of pretreated NSCLC cases who had received docetaxel plus ramucirumab in our departments.
Sixty-one pretreated NSCLC patients underwent docetaxel plus ramucirumab. Primary prophylactic PEG-G-CSF was performed in 52 (85%) patients (prophylactic group). No FN (0%) was confirmed in 52 prophylactic group patients, whereas FN was observed in 3 (33%) of 9 non-prophylactic group patients. Among prophylactic group, median lines of prior therapy was 2 (range, 1-9). Median cycles of docetaxel plus ramucirumab was 3 (range, 1-25) (9 and 3 cases moved to ramucirumab and docetaxel monotherapies, respectively). Response rate and disease control rate were 30.8% and 73.1%, respectively. Median progression-free survival was 4.5 (95% confidence interval [CI], 3.0-6.6) months. Median overall survival was 11.4 (95% CI, 8.0-13.9) months. Six (11.5%) patients had grade 3/4 neutropenia. Observed grade 3 (incidence ≥10%) adverse event (AE) was oral mucositis (13.5%). There were no grade 4/5 non-hematological AEs.
Our study demonstrated the efficacy and safety of docetaxel plus ramucirumab with PEG-G-CSF. Primary prophylactic PEG-G-CSF could markedly reduce incidence of FN in Japanese clinical practice.
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Has not received any funding.
We thank Ayami Asakawa, Mizuho Awaki, Suemi Minamihara, Hiroko Ishikawa and Mamiya Atagi for their assistance, and Mr. David Martin for writing support.
D. Harada: Lecture fees: Ono, Bristol-Myers Squibb, Yakult Honsha, Kyowa Hakko Kirin, AstraZeneca, Nippon Boehringer Ingelheim, Eli Lilly Japan. A. Hata: Lecture fees: Chugai, AstraZeneca, Boeringer Ingelheim, Eli Lilly. T. Kozuki: Honoraria: Chugai, AstraZeneca, Eli Lilly Japan, Boehringer Ingelheim, Ono, Bristol-Myers Squibb, Taiho, MSD, Pfizer, Kyowa Hakko Kirin; Research funding: Chugai, AstraZeneca, MSD, Eli Lilly Japan. N. Nogami: Honoraria: Astellas, AstraZeneca, Ono, Taiho, Chugai, Eli Lilly, Boehringer Ingelheim, Pfizer. N. Katakami: Grants: AstraZeneca, Eisai, Ono, Kyowa Kirin, Shionogi, Daiichi-Sankyo, Taiho, Chugai, Eli Lilly, Boeringer Ingelheim, Merck Serono; Payment for lectures: Dainippon Sumitomo, Chugai, Boeringer Ingelheim, AstraZeneca, Eli Lilly, Taiho, Janssen, Novartis, Pfizer, Ono, Daiichi-Sankyo. All other authors have declared no conflicts of interest.