Phase I/II study of biweekly nab‐paclitaxel in patients with platinum‐pretreated non‐small cell lung cancer: NJLCG1402
Abstract Background NJLCG1402 was a phase I/II trial investigating biweekly nanoparticle albumin‐bound paclitaxel (nab‐PTX) in patients with advanced non‐small cell lung cancer (NSCLC). Methods The study included patients aged ≥20 years with previously treated NSCLC. Nab‐PTX (100–150 mg/m2) was admi...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2021-11-01
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| Series: | Thoracic Cancer |
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| Online Access: | https://doi.org/10.1111/1759-7714.14149 |
| _version_ | 1819009379502915584 |
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| author | Eisaku Miyauchi Hisashi Tanaka Atsushi Nakamura Toshiyuki Harada Taku Nakagawa Mami Morita Daisuke Jingu Tomoya Kuda Shunichi Gamou Ryota Saito Akira Inoue |
| author_facet | Eisaku Miyauchi Hisashi Tanaka Atsushi Nakamura Toshiyuki Harada Taku Nakagawa Mami Morita Daisuke Jingu Tomoya Kuda Shunichi Gamou Ryota Saito Akira Inoue |
| author_sort | Eisaku Miyauchi |
| collection | DOAJ |
| description | Abstract Background NJLCG1402 was a phase I/II trial investigating biweekly nanoparticle albumin‐bound paclitaxel (nab‐PTX) in patients with advanced non‐small cell lung cancer (NSCLC). Methods The study included patients aged ≥20 years with previously treated NSCLC. Nab‐PTX (100–150 mg/m2) was administered biweekly in a 28‐day cycle. The phase I portion was performed to determine the recommended phase II dose of nab‐PTX. In the phase II portion, the primary endpoint was the objective response rate. Secondary endpoints were disease control rate, progression‐free survival, overall survival, and safety. Results A total of 15 patients received biweekly nab‐PTX (100–150 mg/m2) and 12 patients in phase II were treated with 150 mg/m2. In the phase I portion, 150 mg/m2 was determined as the recommended dose. Among those treated with 150 mg/m2, the objective response rate was 22%, and the median progression‐free and overall survival was 3.6 and 11.2 months, respectively. Adverse events grade ≥3 were observed in 39% of patients. Conclusions Biweekly nab‐PTX monotherapy was well tolerated and exhibited favorable antitumor activity in patients with previously treated NSCLC. |
| first_indexed | 2024-12-21T00:55:26Z |
| format | Article |
| id | doaj.art-1d2e818515ca48b8833458e79cf91807 |
| institution | Directory Open Access Journal |
| issn | 1759-7706 1759-7714 |
| language | English |
| last_indexed | 2024-12-21T00:55:26Z |
| publishDate | 2021-11-01 |
| publisher | Wiley |
| record_format | Article |
| series | Thoracic Cancer |
| spelling | doaj.art-1d2e818515ca48b8833458e79cf918072022-12-21T19:21:17ZengWileyThoracic Cancer1759-77061759-77142021-11-0112212886289310.1111/1759-7714.14149Phase I/II study of biweekly nab‐paclitaxel in patients with platinum‐pretreated non‐small cell lung cancer: NJLCG1402Eisaku Miyauchi0Hisashi Tanaka1Atsushi Nakamura2Toshiyuki Harada3Taku Nakagawa4Mami Morita5Daisuke Jingu6Tomoya Kuda7Shunichi Gamou8Ryota Saito9Akira Inoue10Department of Respiratory Medicine Tohoku University Hospital Sendai JapanDepartment of Respiratory Medicine Hirosaki University Hospital Hirosaki JapanDepartment of Respiratory Medicine Sendai Kosei Hospital Sendai JapanDepartment of Respiratory Medicine JCHO Hokkaido Hospital Sapporo JapanDepartment of Thoracic Surgery Omagari Kosei Medical Center Omagari JapanDepartment of Respiratory Medicine Miyagi Cancer Center Natori JapanDepartment of Respiratory Medicine Saka General Hospital Shiogama JapanDepartment of Respiratory Medicine Naha City Hospital Naha JapanDepartment of Respiratory Medicine Kesennuma City Hospital Kesennuma JapanDepartment of Respiratory Medicine Tohoku University Hospital Sendai JapanDepartment of Palliative Medicine Tohoku University School of Medicine Sendai JapanAbstract Background NJLCG1402 was a phase I/II trial investigating biweekly nanoparticle albumin‐bound paclitaxel (nab‐PTX) in patients with advanced non‐small cell lung cancer (NSCLC). Methods The study included patients aged ≥20 years with previously treated NSCLC. Nab‐PTX (100–150 mg/m2) was administered biweekly in a 28‐day cycle. The phase I portion was performed to determine the recommended phase II dose of nab‐PTX. In the phase II portion, the primary endpoint was the objective response rate. Secondary endpoints were disease control rate, progression‐free survival, overall survival, and safety. Results A total of 15 patients received biweekly nab‐PTX (100–150 mg/m2) and 12 patients in phase II were treated with 150 mg/m2. In the phase I portion, 150 mg/m2 was determined as the recommended dose. Among those treated with 150 mg/m2, the objective response rate was 22%, and the median progression‐free and overall survival was 3.6 and 11.2 months, respectively. Adverse events grade ≥3 were observed in 39% of patients. Conclusions Biweekly nab‐PTX monotherapy was well tolerated and exhibited favorable antitumor activity in patients with previously treated NSCLC.https://doi.org/10.1111/1759-7714.14149nab‐PTX monotherapynon‐small cell lung cancerphase I/II trial |
| spellingShingle | Eisaku Miyauchi Hisashi Tanaka Atsushi Nakamura Toshiyuki Harada Taku Nakagawa Mami Morita Daisuke Jingu Tomoya Kuda Shunichi Gamou Ryota Saito Akira Inoue Phase I/II study of biweekly nab‐paclitaxel in patients with platinum‐pretreated non‐small cell lung cancer: NJLCG1402 Thoracic Cancer nab‐PTX monotherapy non‐small cell lung cancer phase I/II trial |
| title | Phase I/II study of biweekly nab‐paclitaxel in patients with platinum‐pretreated non‐small cell lung cancer: NJLCG1402 |
| title_full | Phase I/II study of biweekly nab‐paclitaxel in patients with platinum‐pretreated non‐small cell lung cancer: NJLCG1402 |
| title_fullStr | Phase I/II study of biweekly nab‐paclitaxel in patients with platinum‐pretreated non‐small cell lung cancer: NJLCG1402 |
| title_full_unstemmed | Phase I/II study of biweekly nab‐paclitaxel in patients with platinum‐pretreated non‐small cell lung cancer: NJLCG1402 |
| title_short | Phase I/II study of biweekly nab‐paclitaxel in patients with platinum‐pretreated non‐small cell lung cancer: NJLCG1402 |
| title_sort | phase i ii study of biweekly nab paclitaxel in patients with platinum pretreated non small cell lung cancer njlcg1402 |
| topic | nab‐PTX monotherapy non‐small cell lung cancer phase I/II trial |
| url | https://doi.org/10.1111/1759-7714.14149 |
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