A phase I/II study of weekly nab-paclitaxel plus cisplatin in chemotherapy-naïve patients with advanced non-small-cell lung cancer.
In: BMC Cancer, Jg. 20 (2020-02-11), Heft 1, S. 1-8
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Zugriff:
Background: The aim of this study was to evaluate the efficacy and safety of nab-paclitaxel plus cisplatin in chemotherapy-naïve patients with advanced non-small-cell lung cancer (NSCLC). Methods: Chemotherapy-naïve patients with advanced NSCLC were eligible. In the phase I dose-escalation cohort (3 + 3 design), patients received nab-paclitaxel (80 or 100 mg/m2 given intravenously on days 1, 8 and 15) plus cisplatin (60 or 75 mg/m2 given intravenously on day 1) every 4 weeks. The maximum tolerated dose was not reached. Nab-paclitaxel (100 mg/m2 given intravenously on days 1, 8 and 15) plus cisplatin (75 mg/m2 given intravenously on day 1) every 4 weeks was selected for the phase II cohort. The primary endpoint was the objective response rate (ORR). Results: Twenty-three patients (phase I, n = 6; phase II, n = 17) were enrolled, and 22 patients were eligible. The median age was 67.5 years (range 37-75), 90.9% were males, 45.5% had adenocarcinoma and 81.8% had stage IV disease. The ORR was 59.1% (90% confidence interval (CI); 41.8-74.4), and the disease control rate was 86.4% (95% CI; 66.7-95.3). The median progression-free survival was 5.1 months (95% CI; 4.0-6.7), and the median overall survival was 24.2 months (95% CI; 8.4 months to not estimable). The common grade ≥ 3 adverse events were neutropenia (31.8%), leukopenia (27.3%), lung infection (18.2%) and hyponatremia (18.2%). There was one instance of grade 2 interstitial pneumonia and no treatment-related death. Conclusions: Nab-paclitaxel plus cisplatin was well tolerated and associated with encouraging response outcomes in chemotherapy-naïve patients with advanced NSCLC. Further investigation is warranted. Trial Registration: UMIN Clinical Trials Registry: UMIN000011776; Date of registration: 17 September 2013; Date of enrolment of the first participant to the trial: 23 January 2014. [ABSTRACT FROM AUTHOR]
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A phase I/II study of weekly nab-paclitaxel plus cisplatin in chemotherapy-naïve patients with advanced non-small-cell lung cancer.
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Autor/in / Beteiligte Person: | Hattori, Yoshihiro ; Kono, Yuko ; Itoh, Shoichi ; Inoue, Takako ; Urata, Yoshiko ; Kawa, Yoshitaka ; Tohnai, Rie ; Kumagai, Toru ; Nishino, Kazumi ; Uozumi, Ryuji ; Morita, Satoshi ; Negoro, Shunichi ; Imamura, Fumio ; Satouchi, Miyako |
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Zeitschrift: | BMC Cancer, Jg. 20 (2020-02-11), Heft 1, S. 1-8 |
Veröffentlichung: | 2020 |
Medientyp: | academicJournal |
ISSN: | 1471-2407 (print) |
DOI: | 10.1186/s12885-020-6588-y |
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