Docetaxel Plus Ramucirumab With Primary Prophylactic Pegylated Granulocyte-Colony Stimulating Factor Support for Elderly Patients With Advanced NSCLC: A Multicenter Prospective Single Arm Phase 2 Trial: DRAGON Study (WJOG9416L)

Motoko Tachihara, MD, PhD; Akito Hata, MD; Takaaki Tokito, MD, PhD; Satoshi Hara, MD, PhD; Hideaki Okada, MD; Satoru Miura, MD, PhD; Yuki Sato, MD; Eriko Tabata, MD, PhD; Hiroshi Watanabe, MD, PhD; Yusuke Takayama, MD, PhD; Ryo Toyozawa, MD, PhD; Keiichi Ota, MD, PhD; Kazushige Wakuda, MD, PhD; Atsushi Nakamura, MD, PhD; Mototsugu Shimokawa, PhD; Nobuyuki Yamamoto, MD, PhD; Kazuhiko Nakagawa, MD, PhD

JTO Clinical and Research Reports (Oct 2023)

Docetaxel Plus Ramucirumab With Primary Prophylactic Pegylated Granulocyte-Colony Stimulating Factor Support for Elderly Patients With Advanced NSCLC: A Multicenter Prospective Single Arm Phase 2 Trial: DRAGON Study (WJOG9416L)

Motoko Tachihara, MD, PhD,
Akito Hata, MD,
Takaaki Tokito, MD, PhD,
Satoshi Hara, MD, PhD,
Hideaki Okada, MD,
Satoru Miura, MD, PhD,
Yuki Sato, MD,
Eriko Tabata, MD, PhD,
Hiroshi Watanabe, MD, PhD,
Yusuke Takayama, MD, PhD,
Ryo Toyozawa, MD, PhD,
Keiichi Ota, MD, PhD,
Kazushige Wakuda, MD, PhD,
Atsushi Nakamura, MD, PhD,
Mototsugu Shimokawa, PhD,
Nobuyuki Yamamoto, MD, PhD,
Kazuhiko Nakagawa, MD, PhD

Affiliations

Motoko Tachihara, MD, PhD: Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
Akito Hata, MD: Division of Thoracic Oncology, Kobe Minimally Invasive Cancer Center, Kobe, Japan; Corresponding author. Address for correspondence: Akito Hata, MD, Division of Thoracic Oncology, Kobe Minimally Invasive Cancer Center, 8-5-1, Minatojima-nakamachi, Chuo-ku, Kobe, 650-0047, Japan.
Takaaki Tokito, MD, PhD: Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University, Kurume, Japan
Satoshi Hara, MD, PhD: Department of Respiratory Medicine, Itami City Hospital, Itami, Japan
Hideaki Okada, MD: Division of Thoracic Oncology, Kobe Minimally Invasive Cancer Center, Kobe, Japan
Satoru Miura, MD, PhD: Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan
Yuki Sato, MD: Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan
Eriko Tabata, MD, PhD: Department of Respiratory Medicine, Ikeda City Hospital, Ikeda, Japan
Hiroshi Watanabe, MD, PhD: Department of Respiratory Medicine, Saka General Hospital, Shiogama, Japan
Yusuke Takayama, MD, PhD: Department of Respiratory Medicine, Hiroshima Citizens Hospital, Hiroshima, Japan
Ryo Toyozawa, MD, PhD: Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan
Keiichi Ota, MD, PhD: Research Institute for Diseases of the Chest, Kyushu University Hospital, Fukuoka, Japan
Kazushige Wakuda, MD, PhD: Division of Thoracic Oncology, Shizuoka Cancer Center, Mishima, Japan
Atsushi Nakamura, MD, PhD: Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan
Mototsugu Shimokawa, PhD: Department of Biostatistics, Yamaguchi University Graduate School of Medicine Yamaguchi, Ube, Japan
Nobuyuki Yamamoto, MD, PhD: Internal Medicine III, Wakayama Medical University, Wakayama, Japan
Kazuhiko Nakagawa, MD, PhD: Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan

Journal volume & issue: Vol. 4, no. 10
p. 100569

Abstract

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Introduction: Docetaxel plus ramucirumab could be a promising treatment for chemo-naive elderly patients with NSCLC, but high incidence of febrile neutropenia (FN) is a critical concern. We thus adopted a routine primary prophylactic pegylated-granulocyte-colony stimulating factor (PEG-G-CSF) to reduce FN and maximize the efficacy of docetaxel plus ramucirumab in elderly patients. Methods: This is a single arm phase 2 trial for chemo-naive elderly patients (aged ≥75 y) with advanced NSCLC. Docetaxel (60 mg/m2, d 1) plus ramucirumab (10 mg/kg, d 1) with PEG-G-CSF (3.6 mg, d 2) was administered every 3 weeks until progression. The primary end point was overall response rate (ORR) (expected ORR: 35%). Results: Between February 2018 and January 2021, 54 patients were enrolled. Median age was 78 (range: 75–86). A total of 21 (38.9%) partial response, 22 (40.7%) stable disease, nine (16.7%) progressive disease, and two (3.7%) not assessable were confirmed, resulting in ORR of 38.9% (90% confidence interval [CI]: 27.7%–51.0%) and disease control rate of 79.6%. Median progression-free survival and overall survival were 5.2 (95% CI: 4.2–6.9) and 12.7 (95% CI: 10.2–18.9) months, respectively. There were one (1.9%) FN, two (3.7%) bleeding grade greater than or equal to 3, and one (1.9%) treatment-related death (pneumonitis). Pneumonitis occurred in five patients (9.3%). Main adverse events grade greater than or equal to 3 were observed: four (7%) thrombocytopenia; three (5.6%) neutropenia; six (11.1%) hyposodium; five (9.3%) infection; five (9.3%) hypertension; four (7.4%) anorexia; and three (5.6%) oral mucositis. Conclusions: Docetaxel plus ramucirumab with PEG-G-CSF revealed efficacy and safety for chemo-naive elderly patients with NSCLC. Primary prophylactic PEG-G-CSF highly prevented FN.

Published in JTO Clinical and Research Reports

ISSN: 2666-3643 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.journals.elsevier.com/jto-clinical-and-research-reports/

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