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Poster Display session (Friday) (ID 65)
- Event: ELCC 2018
- Type: Poster Display session
- Presentations: 1
- Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
171P - A phase I/II study of weekly nab-paclitaxel plus cisplatin in chemotherapy-naïve patients with advanced non-small cell lung cancer (ID 300)
12:30 - 13:00 | Author(s): F. Imamura
In the treatment of non-small-cell lung cancer (NSCLC), solvent-based paclitaxel (sb-paclitaxel) plus cisplatin can be expected to have high response rate, but strong neurotoxicity is observed. Currently, nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus carboplatin is considered as one of the standard regimen, and a higher response rate and lower neurotoxicity are expected as compared with sb-paclitaxel plus carboplatin. Therefore, we planned this study to evaluate the efficacy and safety of nab-paclitaxel plus cisplatin in chemotherapy-naïve patients with advanced NSCLC.
Chemotherapy-naïve patients with advanced NSCLC were eligible. In phase 1 dose escalation cohort (3 + 3 design), patients received nab-paclitaxel (80 or 100 mg/m iv on days 1, 8 and 15) plus cisplatin (60 or 75 mg/m iv on day 1) every 4 weeks. The maximum tolerated dose was not reached. Nab-paclitaxel (100 mg/m iv on days 1, 8 and 15) plus cisplatin (75 mg/m iv on day1) every 4 weeks was selected for phase 2 cohort. The primary endpoint was objective response rate (ORR).
23 patients (phase 1, n = 6; phase 2, n = 17) were enrolled from October 2013 to September 2017, and 22 patients were eligible. The median age was 67.5 years (range 37–75 years), 90.9% were males, 100% had smoked, 45.5% had adenocarcinoma and 81.8% had Stage IV. The ORR was 59.1% (95% confidence interval (CI); 38.7–76.7%) 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 months) and the median overall survival was 24.2 months (95% CI; 8.4- not estimable (NE) months). The common grade ≥ 3 adverse events was neutropenia (31.8%), leukopenia (27.3%), lung infection (18.2%) and hyponatremia (18.2%). There was one grade 2 interstitial pneumonia and no treatment related death.
Nab-paclitaxel plus cisplatin was well tolerated and associate with encouraging response outcomes in chemotherapy-naïve patients with advanced NSCLC. Further investigation is warranted.
Clinical trial identification:
UMIN000011776 (17 Sep 2013)
Legal entity responsible for the study:
Y. Hattori: Honoraria: Astra Zeneca, Boehringer Ingelheim, Chugai Pharmaceutical, Eli Lilly, MSD, Novartis, Ono Pharmaceutical, Taiho Pharmaceutical Research funding: Bristol-Myers Squibb, MSD. S. Morita: Honoraria: Taiho Pharmaceutical. F. Imamura: Honoraria: Taiho Pharmaceutical Research funding: Taiho Pharmaceutical. M. Satouchi: Honoraria: Astra Zeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly, MSD, Novartis, Ono Pharmaceutical, Pfizer, Taiho Pharmaceutical Research funding: Astellas, Astra Zeneca, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly, MSD, Ono Pharmaceutical, Novartis, Pfizer. All other authors have declared no conflicts of interest.