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01.03.2016 | Original Article

Phase I/II study of nab-paclitaxel plus gemcitabine for chemotherapy-naive Japanese patients with metastatic pancreatic cancer

verfasst von: Hideki Ueno, Masafumi Ikeda, Makoto Ueno, Nobumasa Mizuno, Tatsuya Ioka, Yasushi Omuro, Takako Eguchi Nakajima, Junji Furuse

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 3/2016

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Abstract

Purpose

Efficacy and safety of nab-paclitaxel plus gemcitabine have not been clarified in Japanese patients with metastatic pancreatic cancer. No pharmacokinetic profile of co-administration of nab-paclitaxel and gemcitabine has been reported. We conducted a phase I/II study of the efficacy, safety, and pharmacokinetics in Japanese patients with metastatic pancreatic cancer.

Methods

The patients were administered 125 mg/m² nab-paclitaxel followed by 1000 mg/m² gemcitabine on day 1, 8, and 15 every 4 weeks. Treatment was continued until disease progression, unacceptable adverse events, or withdrawal of consent, whichever occurred first. The primary endpoints were tolerability in phase I and overall response rate according to RECIST in phase II.

Results

A total of 34 patients were enrolled. At the time of 1-year follow-up analysis since the last patient enrollment, the objective response rate by independent review committee was 58.8 % (20 of 34 patients; 95 % confidence interval [CI], 40.7–75.4 %). The median progression-free survival and median overall survival were 6.5 months (95 % CI, 5.1–8.3) and 13.5 months (95 % CI, 10.6—not reached), respectively. Main adverse drug reactions of grade 3 or higher were neutropenia (70.6 %), leukopenia (55.9 %), anemia (14.7 %), lymphocytopenia (14.7 %), thrombocytopenia (14.7 %), and peripheral sensory neuropathy (11.8 %). There were no treatment-related deaths and no marked differences in pharmacokinetics of combined paclitaxel and gemcitabine in historical comparison between co-administration and monotherapies.

Conclusions

Nab-paclitaxel plus gemcitabine regimen showed highly promising efficacy with manageable safety profile under careful observation and with appropriate supportive care in Japanese patients with metastatic pancreatic cancer.

Clinical trial number

JapicCTI-121987.

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Titel: Phase I/II study of nab-paclitaxel plus gemcitabine for chemotherapy-naive Japanese patients with metastatic pancreatic cancer
verfasst von: Hideki Ueno
Masafumi Ikeda
Makoto Ueno
Nobumasa Mizuno
Tatsuya Ioka
Yasushi Omuro
Takako Eguchi Nakajima
Junji Furuse
Publikationsdatum: 01.03.2016
Verlag: Springer Berlin Heidelberg
Erschienen in: Cancer Chemotherapy and Pharmacology / Ausgabe 3/2016
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-016-2972-3

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Phase I/II study of nab-paclitaxel plus gemcitabine for chemotherapy-naive Japanese patients with metastatic pancreatic cancer