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/m2infused at 10 mg/m2per 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.

Fixed-dose-rate gemcitabine. A viable first-line treatment option for advanced pancreatic and biliary tract cancer / Milella, M.; Gelibter, A. J.; Pino, MARIA SIMONA; Bossone, G.; Marolla, P.; Sperduti, I.; Cognetti, F.. - In: THE ONCOLOGIST. - ISSN 1083-7159. - 15:2(2010), pp. 1-4. [10.1634/theoncologist.2008-0135]

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

Milella M.;Gelibter A. J.
;
PINO, MARIA SIMONA;Sperduti I.;Cognetti F.
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/m2infused at 10 mg/m2per 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.
2010
first-line treatment; fixed dose-rate; gemcitabine; pancreatic cancer; adult; aged; aged, 80 and over; antimetabolites, antineoplastic; biliary tract neoplasms; carcinoma, pancreatic ductal; deoxycytidine; disease-free survival; drug administration schedule; female; humans; male; middle aged; treatment outcome
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Fixed-dose-rate gemcitabine. A viable first-line treatment option for advanced pancreatic and biliary tract cancer / Milella, M.; Gelibter, A. J.; Pino, MARIA SIMONA; Bossone, G.; Marolla, P.; Sperduti, I.; Cognetti, F.. - In: THE ONCOLOGIST. - ISSN 1083-7159. - 15:2(2010), pp. 1-4. [10.1634/theoncologist.2008-0135]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1310610
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