Phase I/II study of biweekly nab-paclitaxel in patients with platinum-pretreated non-small cell lung cancer: NJLCG1402.
Phase I/II study of biweekly nab-paclitaxel in patients with platinum-pretreated non-small cell lung cancer: NJLCG1402.
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DOI：
10.1111/1759-7714.14149
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发表时间：
2021-11
期刊：
影响因子：
2.9
通讯作者：
Inoue A
中科院分区：
文献类型：
--
作者：
Miyauchi E;Tanaka H;Nakamura A;Harada T;Nakagawa T;Morita M;Jingu D;Kuda T;Gamou S;Saito R;Inoue A
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). 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. 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. Biweekly nab‐PTX monotherapy was well tolerated and exhibited favorable antitumor activity in patients with previously treated NSCLC. We conducted the first prospective multicenter phase I/II trial to evaluate the efficacy and safety of biweekly nab‐PTX treatment in patients with previously treated advanced NSCLC. In 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%; median progression‐free and overall survival was 3.6 and 11.2 months, respectively.
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影响因子：
1.6
作者：
Anzai M;Morikawa M;Okuno T;Umeda Y;Demura Y;Sonoda T;Yamaguchi M;Kanno K;Shiozaki K;Ameshima S;Akai M;Ishizuka T
通讯作者：
Ishizuka T
影响因子：
3.6
作者：
Asahina, Hajime;Sekine, Ikuo;Tamura, Tomohide
通讯作者：
Tamura, Tomohide
DOI：
10.1016/s0140-6736(16)32517-x
发表时间：
2017-01-21
期刊：
Lancet (London, England)
影响因子：
--
作者：
Rittmeyer A;Barlesi F;Waterkamp D;Park K;Ciardiello F;von Pawel J;Gadgeel SM;Hida T;Kowalski DM;Dols MC;Cortinovis DL;Leach J;Polikoff J;Barrios C;Kabbinavar F;Frontera OA;De Marinis F;Turna H;Lee JS;Ballinger M;Kowanetz M;He P;Chen DS;Sandler A;Gandara DR;OAK Study Group
通讯作者：
OAK Study Group
影响因子：
45.3
作者：
Shepherd, FA;Dancey, J;Berille, J
通讯作者：
Berille, J
影响因子：
3.4
作者：
Nakao, Akira;Uchino, Junji;Fujita, Masaki
通讯作者：
Fujita, Masaki