Updated survival date of phase I/II study of carboplatin plus nab-paclitaxel and concurrent radiotherapy for patients with locally advanced non-small cell lung cancer.

Authors

null

Atsushi Horiike

Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan

Atsushi Horiike , Yuko Kawano , Tomonari Sasaki , Hiroyuki Yamaguchi , Katsuya Hirano , Miyako Satouchi , Shinobu Hosokawa , Ryotaro Morinaga , Kazutoshi Komiya , Koji Inonue , Yuka Fujita , Ryo Toyozawa , Tomoki Kimura , Kosuke Takahashi , Kazuo Nishikawa , Junji Kishimoto , Yoichi Nakanishi , Isamu Okamoto

Organizations

Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan, Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan, Department of Clinical Radiology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan, Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan, Hyogo Cancer Center, Akashi, Japan, Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan, Department of Thoracic Medical Oncology, Oita Prefectural Hospital, Oita, Japan, Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan, Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan, Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan, Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan, Tosei General Hospital, Seto, Japan, Aichi Cancer Center Aichi Hospital, Okazaki, Japan, Oita University Hospital, Oita-Shi, Japan, Department of Research and Development of Next Generation Medicine, Kyushu University, Fukuoka, Japan, Kyushu University Hospital, Fukuoka, Japan

Research Funding

Pharmaceutical/Biotech Company

Background: Chemoradiation regimens of greater efficacy are needed for patients with locally advanced non–small cell lung cancer (NSCLC). Methods: Patients between 20 and 74 years of age with unresectable NSCLC of stage IIIA or IIIB and a performance status of 0 or 1 were eligible for the study. In the phase II part of the study, patients received weekly nab-paclitaxel at 50 mg/m2 together with weekly carboplatin at an area under the curve (AUC) of 2 mg mL–1 min and concurrent radiotherapy with 60 Gy in 30 fractions. This concurrent phase was followed by a consolidation phase consisting of two 3-week cycles of nab-paclitaxel plus carboplatin. The primary end point of the phase II part of the study was progression-free survival (PFS). Results: Between October 2014 and November 2016, 58 patients were enrolled at 14 institutions in Japan, with 56 of these individuals being evaluable for treatment efficacy and safety. At the median follow-up time of 26.0 months (range, 4.0 to 49.6 months), the median overall survival (OS) was not reached (95% confidence interval [CI], 25.3 months to not reached) and the 2-year OS rate was 66.1% (95% CI, 52.1% to 76.8 %). The median PFS was 11.8 months (60% CI, 10.6 to 16.8 months; 95% CI, 8.2 to 21.0 months). The overall response rate was 76.8% (95% CI, 64.2% to 85.9%), and the disease control rate was 94.6% (95% CI, 85.4% to 98.2%). Subgroup analysis according to histology or age revealed no significant differences in median PFS or OS. Common toxicities of grade 3 or 4 in the concurrent phase included leukopenia (60.7%) and neutropenia (28.6%). Pneumonitis of grade 3 was observed in two patients during the study period. No treatment-related deaths occurred. Conclusions: Our results reveal encouraging feasibility and activity for concurrent chemoradiation with nab-paclitaxel at 50 mg/m2 and carboplatin at an AUC of 2 mg mL–1 min in patients with locally advanced NSCLC. Clinical trial information: UMIN000012719.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Track

Lung Cancer

Sub Track

Local-Regional Non–Small Cell Lung Cancer

Clinical Trial Registration Number

UMIN000012719

Citation

J Clin Oncol 37, 2019 (suppl; abstr 8529)

DOI

10.1200/JCO.2019.37.15_suppl.8529

Abstract #

8529

Poster Bd #

285

Abstract Disclosures