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Phase I/II study of nab-paclitaxel plus gemcitabine for chemotherapy-naive Japanese patients with metastatic pancreatic cancer.
- Source :
-
Cancer Chemotherapy & Pharmacology . Mar2016, Vol. 77 Issue 3, p595-603. 9p. - Publication Year :
- 2016
-
Abstract
- <bold>Purpose: </bold>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.<bold>Methods: </bold>The patients were administered 125 mg/m(2) nab-paclitaxel followed by 1000 mg/m(2) 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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.<bold>Clinical Trial Number: </bold>JapicCTI-121987. [ABSTRACT FROM AUTHOR]
- Subjects :
- *PANCREATIC cancer treatment
*PACLITAXEL
*CANCER chemotherapy
*DEOXYCYTIDINE
*JAPANESE people
*METASTASIS
*DISEASES
*ANTINEOPLASTIC agents
*ASIANS
*CLINICAL trials
*COMPARATIVE studies
*LONGITUDINAL method
*RESEARCH methodology
*MEDICAL cooperation
*PANCREATIC tumors
*PROGNOSIS
*RESEARCH
*SURVIVAL
*EVALUATION research
*ALBUMINS
*TREATMENT effectiveness
Subjects
Details
- Language :
- English
- ISSN :
- 03445704
- Volume :
- 77
- Issue :
- 3
- Database :
- Academic Search Index
- Journal :
- Cancer Chemotherapy & Pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 113305389
- Full Text :
- https://doi.org/10.1007/s00280-016-2972-3