Administration of docetaxel plus ramucirumab with primary prophylactic pegylated-granulocyte colony-stimulating factor f
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ORIGINAL ARTICLE
Administration of docetaxel plus ramucirumab with primary prophylactic pegylated-granulocyte colony-stimulating factor for pretreated non-small cell lung cancer: a phase II study Norimitsu Kasahara 1 & Noriaki Sunaga 2 & Tomohito Kuwako 3 & Ichiro Naruse 4 & Hisao Imai 5 & Asuka Jingu 3 & Yusuke Tsukagoshi 2 & Tomomi Masuda 2 & Shinsuke Kitahara 2 & Hiroaki Tsurumaki 2 & Masakiyo Yatomi 2 & Kenichiro Hara 2 & Yasuhiko Koga 2 & Reiko Sakurai 6 & Keita Mori 7 & Kyoichi Kaira 8 & Toshitaka Maeno 2 & Takayuki Asao 1 & Takeshi Hisada 9 Received: 7 October 2019 / Accepted: 17 January 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Purpose Although docetaxel plus ramucirumab has shown superior treatment efficacy over docetaxel monotherapy for patients with non-small cell lung cancer (NSCLC), the high rate of febrile neutropenia (FN) presents a clinical problem. This study aimed to validate the primary prophylactic use of pegfilgrastim with docetaxel and ramucirumab treatment in Japanese patients with NSCLC. Methods Patients with NSCLC with progression after at least one round of chemotherapy were enrolled and administered docetaxel (60 mg/m2) plus ramucirumab (10 mg/kg) intravenously on day 1, followed by pegylated-granulocyte colonystimulating factor (3.6 mg) on day 2 of a 21-day treatment cycle. The primary study endpoint was the percentage of patients who developed FN. Secondary endpoints included overall survival, progression-free survival, overall response rate, and safety. Results Overall, 20 patients (15 men and 5 women) were enrolled, of whom one developed FN, resulting in an overall FN rate of 5%. The response and disease control rates were 40% and 85%, respectively. The median progression-free survival was 6.6 (95% confidence interval [CI], 0.5-NR) months. The median overall survival was 18.4 (95% CI, 2.2–11.0) months. Six patients aged over 75 years were included in this study, and although most adverse events were durable, ramucirumab-associated adverse events occurred more frequently in these patients. Conclusions We observed a 5% FN rate using primary prophylactic pegylated-granulocyte colony-stimulating factor with docetaxel plus ramucirumab in Japanese patients with NSCLC. While most adverse events were durable, elderly patients should be closely monitored. Keywords Febrile neutropenia . Pegylated-granulocyte colony-stimulating factor . Docetaxel . Ramucirumab . Non-small cell lung cancer
* Norimitsu Kasahara [email protected] 1
2
5
Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota, Gunma, Japan
6
Innovative Medical Research Center, Gunma University Hospital, Maebashi, Gunma 371-8511, Japan
Oncology Center, Gunma University Hospital, Maebashi, Gunma, Japan
7
Department of Respiratory Medicine, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan
Clinical Research Center, Shizuoka Cancer Center, Nagaizumi, Shizuoka, Japan
8
Department of Respiratory Medicine, Comprehensive Cancer Center, International Medica
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