Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2020 Jun;25(6):475-e891.
doi: 10.1634/theoncologist.2019-0746. Epub 2019 Oct 24.

Updated Survival Data for a Phase I/II Study of Carboplatin plus Nab-Paclitaxel and Concurrent Radiotherapy in Patients with Locally Advanced Non-Small Cell Lung Cancer

Yuko Tsuchiya-Kawano  1 , Tomonari Sasaki  2 , Hiroyuki Yamaguchi  3 , Katsuya Hirano  4 , Atsushi Horiike  5 , Miyako Satouchi  6 , Shinobu Hosokawa  7 , Ryotaro Morinaga  8 , Kazutoshi Komiya  9 , Koji Inoue  1 , Yuka Fujita  10 , Ryo Toyozawa  11 , Tomoki Kimura  12 , Kosuke Takahashi  13 , Kazuo Nishikawa  14 , Junji Kishimoto  15 , Yoichi Nakanishi  16 , Isamu Okamoto  17
Affiliations
Clinical Trial

Updated Survival Data for a Phase I/II Study of Carboplatin plus Nab-Paclitaxel and Concurrent Radiotherapy in Patients with Locally Advanced Non-Small Cell Lung Cancer

Yuko Tsuchiya-Kawano et al. Oncologist. 2020 Jun.

Abstract

Lessons learned: Updated survival data for a phase I/II study of carboplatin plus nab-paclitaxel and concurrent radiotherapy were collected. In the group of 58 patients who were enrolled at 14 institutions in Japan, the median overall survival was not reached and the 2-year overall survival rate was 66.1% (95% confidence interval, 52.1%-76.8%). Results reveal encouraging feasibility and activity for this regimen.

Background: We report the updated survival data for a phase I/II study of carboplatin plus nab-paclitaxel (nab-P/C) and concurrent radiotherapy (CRT) in patients with locally advanced non-small cell lung cancer (NSCLC).

Methods: Individuals 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. Patients received weekly nab-paclitaxel at 50 mg/m2 for 6 weeks together with weekly carboplatin at an area under the curve (AUC) of 2 mg/ml/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 (100 mg/m2 on days 1, 8, and 15) plus carboplatin (AUC of 6 on day 1). After the treatment, patients were observed off therapy. The primary endpoint 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, 4.0-49.6 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%-76.8%). The median PFS was 11.8 months (95% CI, 8.2-21.0 months), and the 2-year PFS rate was 35.9% (95% CI, 23.1%-48.9%). Subgroup analysis according to tumor histology or patient age revealed no differences in median PFS or OS. Long-term follow-up of toxicities did not identify new safety signals, and no treatment-related deaths occurred during the study period.

Conclusion: Concurrent chemoradiation with nab-P/C was safe and provided a long-term survival benefit for patients with locally advanced NSCLC.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Kaplan‐Meier curves for overall survival (A) and progression‐free survival (B) in the study patients.
Figure 2
Figure 2
Kaplan‐Meier curves for overall survival and progression‐free survival according to tumor histology or patient age.
See this image and copyright information in PMC

References

    1. Antonia SJ, Villegas A, Daniel D et al. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. N Engl J Med 2018;379:2342–2350. - PubMed
    1. Antonia SJ, Villegas A, Daniel D et al. Durvalumab after chemoradiotherapy in stage III non‐small‐cell lung cancer. N Engl J Med 2017;377:1919–1929. - PubMed
    1. Yamamoto N, Nakagawa K, Nishimura Y et al. Phase III study comparing second‐ and third‐generation regimens with concurrent thoracic radiotherapy in patients with unresectable stage III non‐small‐cell lung cancer: West Japan Thoracic Oncology Group WJTOG0105. J Clin Oncol 2010;28:3739–3745. - PubMed
    1. Belani CP, Choy H, Bonomi P et al. Combined chemoradiotherapy regimens of paclitaxel and carboplatin for locally advanced non‐small‐cell lung cancer: A randomized phase II locally advanced multi‐modality protocol. J Clin Oncol 2005;23:5883–5891. - PubMed
    1. Vokes EE, Herndon JE 2nd, Kelley MJ et al. Induction chemotherapy followed by chemoradiotherapy compared with chemoradiotherapy alone for regionally advanced unresectable stage III non‐small‐cell lung cancer: Cancer and Leukemia Group B. J Clin Oncol 2007;25:1698–1704. - PubMed

Publication types

MeSH terms