| 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)
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