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- Title
Administration of docetaxel plus ramucirumab with primary prophylactic pegylated-granulocyte colony-stimulating factor for pretreated non-small cell lung cancer: a phase II study.
- Authors
Kasahara, Norimitsu; Sunaga, Noriaki; Kuwako, Tomohito; Naruse, Ichiro; Imai, Hisao; Jingu, Asuka; Tsukagoshi, Yusuke; Masuda, Tomomi; Kitahara, Shinsuke; Tsurumaki, Hiroaki; Yatomi, Masakiyo; Hara, Kenichiro; Koga, Yasuhiko; Sakurai, Reiko; Mori, Keita; Kaira, Kyoichi; Maeno, Toshitaka; Asao, Takayuki; Hisada, Takeshi
- Abstract
<bold>Purpose: </bold>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.<bold>Methods: </bold>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 colony-stimulating 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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
NON-small-cell lung carcinoma; OLDER patients; TREATMENT effectiveness; FEBRILE neutropenia; THERAPEUTIC use of antineoplastic agents; LUNG cancer; DISEASE progression; RESEARCH; CLINICAL trials; RESEARCH methodology; LUNG tumors; MONOCLONAL antibodies; ANTINEOPLASTIC agents; EVALUATION research; MEDICAL cooperation; COMPARATIVE studies; POLYETHYLENE glycol
- Publication
Supportive Care in Cancer, 2020, Vol 28, Issue 10, p4825
- ISSN
0941-4355
- Publication type
journal article
- DOI
10.1007/s00520-020-05317-z