Open AccessFixed‐Dose‐Rate Gemcitabine: A Viable First‐Line Treatment Option for Advanced Pancreatic and Biliary Tract Cancer
Author(s) -
Milella Michele,
Gelibter Alain J.,
Pino Maria Simona,
Bossone Giandominik,
Marolla Paolo,
Sperduti Isabella,
Cognetti Francesco
Publication year - 2010
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2008-0135
Subject(s) - medicine , gemcitabine , pancreatic cancer , neutropenia , gastroenterology , context (archaeology) , confidence interval , biliary tract cancer , population , phases of clinical research , cancer , oncology , surgery , chemotherapy , paleontology , environmental health , biology
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.