Phase II trial of biweekly carboplatin and nab-paclitaxel with concurrent radiotherapy for patients with locally advanced unresectable stage III non-small cell lung cancer.

Authors

null

Hisashi Tanaka

Department of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Japan

Hisashi Tanaka , Fumihiko Okumura , Chiori Tabe , Yoshiko Ishioka , Masamichi Itoga , Kageaki Taima , Yukihiro Hasegawa , Junichi Yokouchi , Shingo Takanashi , Masahiko Aoki , Sadatomo Tasaka

Organizations

Department of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Japan, Hirosaki University Graduate School of Medicine, Hirosaki, Japan, Aomori Prefectual Central Hospital, Aomori, Japan, Aomori Prefectural Central Hospital, Aomori, Japan, Hirosaki University, Health Administration Center, Hirosaki, Japan

Research Funding

No funding received
None

Background: Concurrent chemoradiotherapy (CCRT) is the standard treatment for patients with locally advanced non-small cell lung cell cancer (LA-NSCLC). We previously reported the phase I study of biweekly carboplatin and nab-paclitaxel (nab-PTX) with RT. Recommended dose for phase II study was carboplatin (AUC 4) and nab-PTX (100 mg/m2) (J Clin Oncol 2015 suppl; abstr 7529). Here we report the phase II part designed to assess the efficacy of biweekly carboplatin and nab-PTX with concurrent RT (UMIN000023802). Methods: Patients with inoperable stage Ⅲ NSCLC were treated with carboplatin (AUC 4) and nab-PTX 100 mg/m2 on days 1, 15, and 29. Thoracic radiotherapy was administered from day 1 to a total dose of 60 Gy in 30 fractions. Consolidation chemotherapy after CCRT was 2 cycles of carboplatin (AUC 6) on day 1 and nab-PTX 100 mg/m2 on days 1, 8, and 15. The primary endpoint for the phase II part is 2-year overall survival (OS) rate. Assuming an expected survival rate was 60% and a lower limit was 35% (alfa 0.05, beta 0.2). Secondary endpoints were the objective response rate (ORR), progression-free survival (PFS), OS, and safety profile. Results: A total of 28 patients (median age 66 years, male 94%) were enrolled. Of the evaluable patients (n = 28), the rate of 2-year OS was 67.8% (95% CI: 49.3–82.1). The ORR was 96%, a median follow-up time was 33.2 months. Median PFS was 18.2 months (95% CI 13.1–not reached), and median OS was not reached (95% CI, 25.6–not reached). The most common toxicities of grade 3 or higher were neutropenia (60.5%), anemia (14.2%), thrombocytopenia (7.6%) and pneumonitis (3.6%). Conclusions: This study achieved the primary endpoint. Biweekly carboplatin and nab-PTX with concurrent RT therapy was well tolerated and promising systemic antitumor activity for patients with LA-NSCLC. Clinical trial information: 000023802.

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Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Publication Only

Session Title

Publication Only: 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

000023802

Citation

J Clin Oncol 38: 2020 (suppl; abstr e21078)

DOI

10.1200/JCO.2020.38.15_suppl.e21078

Abstract #

e21078

Abstract Disclosures