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A prospective phase II study of carboplatin and nab-paclitaxel in patients with advanced non-small cell lung cancer and concomitant interstitial lung disease (HOT1302)

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Title: A prospective phase II study of carboplatin and nab-paclitaxel in patients with advanced non-small cell lung cancer and concomitant interstitial lung disease (HOT1302)
Authors: Asahina, Hajime Browse this author →KAKEN DB
Oizumi, Satoshi Browse this author →KAKEN DB
Takamura, Kei Browse this author
Harada, Toshiyuki Browse this author
Harada, Masao Browse this author
Yokouchi, Hiroshi Browse this author →KAKEN DB
Kanazawa, Kenya Browse this author
Fujita, Yuka Browse this author
Kojima, Tetsuya Browse this author
Sugaya, Fumiko Browse this author
Tanaka, Hisashi Browse this author
Honda, Ryoichi Browse this author
Kikuchi, Eiki Browse this author →KAKEN DB
Ikari, Tomoo Browse this author
Ogi, Takahiro Browse this author
Shimizu, Kaoruko Browse this author →KAKEN DB
Suzuki, Masaru Browse this author →KAKEN DB
Konno, Satoshi Browse this author →KAKEN DB
Dosaka-Akita, Hirotoshi Browse this author →KAKEN DB
Isobe, Hiroshi Browse this author →KAKEN DB
Nishimura, Masaharu Browse this author →KAKEN DB
Keywords: Non-small cell lung cancer
Interstitial lung disease
Carboplatin
Nab-paclitaxel
Clinical trial
Issue Date: Dec-2019
Publisher: Elsevier
Journal Title: Lung cancer
Volume: 138
Start Page: 65
End Page: 71
Publisher DOI: 10.1016/j.lungcan.2019.09.020
Abstract: Objectives: Patients with concomitant advanced non-small cell lung cancer (NSCLC) and interstitial lung disease (ILD) are excluded from most clinical chemotherapy trials because of the high risk of exacerbating the latter condition. This study prospectively investigated the efficacy and safety of albumin-bound paclitaxel (nab-paclitaxel) in combination with carboplatin in patients with both advanced NSCLC and ILD. Patients and methods: The enrolled patients had treatment-naive, advanced NSCLC with ILD. Patients received 100 mg/m(2) nab-paclitaxel weekly and carboplatin at an area under the concentration-time curve of 6 once every 3 weeks for 4-6 cycles. The primary endpoint was the overall response rate (ORR); secondary endpoints included toxicity, progression-free survival (PFS), and overall survival (OS). Results: Thirty-six patients were enrolled between April 2014 and September 2017. Sixteen patients (44.4%) had adenocarcinoma, 15 (41.7%) had squamous cell carcinoma (Sq), and 5 (13.9%) had non-small cell carcinoma. The median number of cycles administered were 4 (range: 1-6). The ORR was 55.6% (95% confidence interval [CI]: 39.6-70.5). The median PFS and OS were 5.3 months (95% CI: 3.9-8.2) and 15.4 months (95% CI: 9.4-18.7), respectively. A greater proportion of patients with Sq experienced improvements than did those with non-Sq: ORRs, 66.7% (95% CI: 41.7-84.8) vs. 47.6% (95% CI: 28.3-67.6) (P = 0.254); median PFS, 8.2 months (95% CI: 4.0-10.2) vs. 4.1 months (95% CI: 3.3-5.4) (HR, 0.60 [95% CI, 0.30-1.20]; P = 0.15); and median OS, 16.8 months (95% CI: 9.8 not reached) vs. 11.9 months (95% CI: 7.3-17.4) (HR, 0.56 [95% CI, 0.24-1.28]; P = 0.17). Two patients (5.6%) experienced grade >= 2 pneumonitis and 1 patient (2.8%) died. Conclusion: Weekly nab-paclitaxel combined with carboplatin showed favorable efficacy with acceptable toxicity in patients with both advanced NSCLC and ILD.
Rights: © 2019. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/
http://creativecommons.org/licenses/by-nc-nd/4.0/
Type: article (author version)
URI: http://hdl.handle.net/2115/79852
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 朝比奈 肇

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