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Prospective multicenter phase II study of gemcitabine plus cisplatin in patients with unresectable gallbladder cancer.
- Source :
-
Cancer Chemotherapy & Pharmacology . Jul2017, Vol. 80 Issue 1, p119-125. 7p. - Publication Year :
- 2017
-
Abstract
- <bold>Purpose: </bold>To evaluate the efficacy and safety of gemcitabine plus cisplatin in Japanese patients with unresectable gallbladder cancer (GBC).<bold>Methods: </bold>Chemo-naïve patients with histologically proven unresectable GBC were enrolled in this study. The patients received gemcitabine (1000 mg/m2) and cisplatin (25 mg/m2) on days 1 and 8, every 21 days. A response assessment was done by CT scan every 4 weeks. The primary end points were to determine the response rates [RR; complete response (CR) + partial response (PR)] and the disease control rate [DCR; CR + PR + stable disease (SD)]. The secondary end points were to evaluate toxicity, progression-free survival (PFS), and overall survival (OS).<bold>Results: </bold>From March 2012 to February 2015, 14 patients from seven different institutions were enrolled in the study, and 13 cases were evaluable for assessment. Eleven cases (84.6%) had distant metastases, and 8 cases (61.5%) had obstructive jaundice. There was no CR, 1 PR (7.7%), 11 SD (84.6%), and 1 progressive disease (PD) (7.7%). The RR was 7.7%, whereas the DCR was 92.3%. The median PFS was 3.1 months, the median OS was 6.2 months, and the one-year survival rate was 0%. Grade 3 hematologic toxicity was observed in three cases (23%), but all of them recovered upon drug withdrawal, and there was no treatment-related death.<bold>Conclusion: </bold>Although gemcitabine plus cisplatin has a high DCR (92.3%) and relatively low toxicity, the RR is less than 10%, and development of new therapies is desired for the treatment of unresectable GBC. [ABSTRACT FROM AUTHOR]
- Subjects :
- *CISPLATIN
*GALLBLADDER cancer
*STOMACH cancer treatment
*PROGRESSION-free survival
*SURVIVAL analysis (Biometry)
*ANTINEOPLASTIC agents
*CLINICAL trials
*COMPARATIVE studies
*GALLBLADDER tumors
*LONGITUDINAL method
*RESEARCH methodology
*MEDICAL cooperation
*PROGNOSIS
*RESEARCH
*SURVIVAL
*EVALUATION research
*TREATMENT effectiveness
*DEOXYCYTIDINE
Subjects
Details
- Language :
- English
- ISSN :
- 03445704
- Volume :
- 80
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- Cancer Chemotherapy & Pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 123716897
- Full Text :
- https://doi.org/10.1007/s00280-017-3341-6