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Clinical Trial
. 2010;15(2):e1-4.
doi: 10.1634/theoncologist.2008-0135.

Fixed-dose-rate gemcitabine: a viable first-line treatment option for advanced pancreatic and biliary tract cancer

Michele Milella  1 , Alain J Gelibter, Maria Simona Pino, Giandominik Bossone, Paolo Marolla, Isabella Sperduti, Francesco Cognetti
Affiliations
Clinical Trial

Fixed-dose-rate gemcitabine: a viable first-line treatment option for advanced pancreatic and biliary tract cancer

Michele Milella et al. Oncologist. 2010.

Abstract

Background: We have already reported on fixed-dose-rate gemcitabine (FDR-Gem) in advanced, inoperable pancreatic ductal adenocarcinoma (PDAC) and biliary tract cancer (BTC) in the context of a formal phase II study; building on that experience, we have now expanded the study to reach a cumulative accrual of 106 patients.

Methods: One hundred six patients (PDAC/BTC, 75/31) were treated with weekly FDR-Gem (1,000 mg/m(2) infused at 10 mg/m(2) per minute). Patient characteristics included: male-to-female ratio, 0.83; median age, 63 years (range, 28-82); metastatic disease in 66% of patients; and an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1 in 81% of patients.

Results: The median and total number of treatment weeks delivered were 8 (range, 2-22) and 1,154, respectively. Thirteen percent of patients achieved an objective response, 42% experienced a positive clinical benefit response, and 54% achieved a >50% reduction in serum cancer antigen (CA)19.9 levels. The median progression-free survival (PFS) and overall survival (OS) times for the entire population were 4.4 months (95% confidence interval [CI], 3.5-5.1 months) and 7.7 months (95% CI, 6.3-8.8 months), respectively, with 20% of patients alive at 1 year. On multivariate analysis, a CA19.9 reduction >50% and baseline ECOG PS score of 0 were the only independent predictors of PFS and OS, respectively. Treatment was well tolerated, with grade 3-4 neutropenia in 47 of 1,154 treatment weeks (4.1%), and grade 3 anemia and thrombocytopenia in 8 of 1,154 (0.7%) and 16 of 1,154 (1.4%) treatment weeks, respectively.

Conclusions: Currently available evidence, including this updated analysis, supports the use of FDR-Gem as a first-line option in advanced PDAC, and possibly in BTC, patients and prompts the continued evaluation of this approach in combination regimens.

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Conflict of interest statement

Disclosures: Michele Milella: None; Alain J. Gelibter: None; Maria Simona Pino: None; Giandominik Bossone: None; Paolo Marolla: None; Isabella Sperduti: None; Francesco Cognetti: None.

The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias. No financial relationships relevant to the content of this article have been disclosed by the authors or independent peer reviewers.

Figures

Figure 1.
Figure 1.
Kaplan–Meier estimates of progression-free survival (A) and overall survival (B) for the intent-to-treat population (n = 106).
See this image and copyright information in PMC

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