Abstract
BACKGROUND. Gemcitabine infusion at the fixed dose rate of 10 mg/m 2 per minute (FDR-gemcitabine) has pharmacokinetic advantages and may result in improved therapeutic efficacy. METHODS. Between April 2002 and September 2003, 40 patients with advanced-stage pancreatic adenocarcinoma (PDAC; n = 27) or biliary tree carcinoma (BTC; n = 13) were treated with weekly FDR-gemcitabine (1000 mg/m2). The primary end point was the response rate. The secondary end points were progression-free and overall survival (PFS and OS), tumor marker response, and clinical benefit response (CBR). RESULTS. The overall response rate (ORR) on an intent-to-treat basis was 15% (95% confidence interval [95% CI], 4-26%). A positive CBR was obtained in 14 of 29 (48%) patients. Seventeen of 25 (68%) patients had a reduction in carbohydrate antigen 19-9 (CA 19-9) of > 25%. The median time to treatment failure and the median PFS were 17 weeks (95% CI, 13-22 weeks) and 19 weeks (95% CI, 15-23 weeks), respectively. The median OS was 40 weeks (95% CI, 36-45 weeks) and the 1-year actuarial survival rate was 25.8%. Multivariate analysis showed that a performance status score of 0-1 at study entry and locally advanced disease were the only independent predictors of longer PFS and OS, whereas a reduction in CA 19-9 serum levels > 75% was an independent predictor of longer PFS, but had no impact on OS. Toxicity was mild with Grade 3-4 neutropenia (according to the National Cancer Institute-Common Toxicity Criteria [version 2.0]) in 18 of 427 treatment weeks (4.2%), and Grade 3 anemia and thrombocytopenia in 6 of 427 treatment weeks (1.4%) and 9 of 427 treatment weeks (2.1%), respectively, and asymptomatic Grade 3-4 transaminase elevation in 21 of 427 treatment weeks (4.9%). CONCLUSIONS. FDR-gemcitabine at the weekly dose of 1000 mg/m2 demonstrated promising activity, despite negligible toxicity, in patients with advanced-stage PDAC and BTC.
| Original language | English |
|---|---|
| Pages (from-to) | 1237-1245 |
| Number of pages | 9 |
| Journal | Cancer |
| Volume | 104 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - Sep 15 2005 |
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Keywords
- Biliary tree carcinoma
- Carbohydrate antigen 19-9
- Fixed dose rate
- Gemcitabine
- Pancreatic carcinoma
ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Fixed dose-rate gemcitabine infusion as first-line treatment for advanced-stage carcinoma of the pancreas and biliary tree. / Gelibter, Alain; Malaguti, Paola; Di Cosimo, Serena; Bria, Emilio; Ruggeri, Enzo Maria; Carlini, Paolo; Carboni, Fabio; Ettorre, Giuseppe Maria; Pellicciotta, Mario; Giannarelli, Diana; Terzoli, Edmondo; Cognetti, Francesco; Milella, Michele.
In: Cancer, Vol. 104, No. 6, 15.09.2005, p. 1237-1245.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Fixed dose-rate gemcitabine infusion as first-line treatment for advanced-stage carcinoma of the pancreas and biliary tree
AU - Gelibter, Alain
AU - Malaguti, Paola
AU - Di Cosimo, Serena
AU - Bria, Emilio
AU - Ruggeri, Enzo Maria
AU - Carlini, Paolo
AU - Carboni, Fabio
AU - Ettorre, Giuseppe Maria
AU - Pellicciotta, Mario
AU - Giannarelli, Diana
AU - Terzoli, Edmondo
AU - Cognetti, Francesco
AU - Milella, Michele
PY - 2005/9/15
Y1 - 2005/9/15
N2 - BACKGROUND. Gemcitabine infusion at the fixed dose rate of 10 mg/m 2 per minute (FDR-gemcitabine) has pharmacokinetic advantages and may result in improved therapeutic efficacy. METHODS. Between April 2002 and September 2003, 40 patients with advanced-stage pancreatic adenocarcinoma (PDAC; n = 27) or biliary tree carcinoma (BTC; n = 13) were treated with weekly FDR-gemcitabine (1000 mg/m2). The primary end point was the response rate. The secondary end points were progression-free and overall survival (PFS and OS), tumor marker response, and clinical benefit response (CBR). RESULTS. The overall response rate (ORR) on an intent-to-treat basis was 15% (95% confidence interval [95% CI], 4-26%). A positive CBR was obtained in 14 of 29 (48%) patients. Seventeen of 25 (68%) patients had a reduction in carbohydrate antigen 19-9 (CA 19-9) of > 25%. The median time to treatment failure and the median PFS were 17 weeks (95% CI, 13-22 weeks) and 19 weeks (95% CI, 15-23 weeks), respectively. The median OS was 40 weeks (95% CI, 36-45 weeks) and the 1-year actuarial survival rate was 25.8%. Multivariate analysis showed that a performance status score of 0-1 at study entry and locally advanced disease were the only independent predictors of longer PFS and OS, whereas a reduction in CA 19-9 serum levels > 75% was an independent predictor of longer PFS, but had no impact on OS. Toxicity was mild with Grade 3-4 neutropenia (according to the National Cancer Institute-Common Toxicity Criteria [version 2.0]) in 18 of 427 treatment weeks (4.2%), and Grade 3 anemia and thrombocytopenia in 6 of 427 treatment weeks (1.4%) and 9 of 427 treatment weeks (2.1%), respectively, and asymptomatic Grade 3-4 transaminase elevation in 21 of 427 treatment weeks (4.9%). CONCLUSIONS. FDR-gemcitabine at the weekly dose of 1000 mg/m2 demonstrated promising activity, despite negligible toxicity, in patients with advanced-stage PDAC and BTC.
AB - BACKGROUND. Gemcitabine infusion at the fixed dose rate of 10 mg/m 2 per minute (FDR-gemcitabine) has pharmacokinetic advantages and may result in improved therapeutic efficacy. METHODS. Between April 2002 and September 2003, 40 patients with advanced-stage pancreatic adenocarcinoma (PDAC; n = 27) or biliary tree carcinoma (BTC; n = 13) were treated with weekly FDR-gemcitabine (1000 mg/m2). The primary end point was the response rate. The secondary end points were progression-free and overall survival (PFS and OS), tumor marker response, and clinical benefit response (CBR). RESULTS. The overall response rate (ORR) on an intent-to-treat basis was 15% (95% confidence interval [95% CI], 4-26%). A positive CBR was obtained in 14 of 29 (48%) patients. Seventeen of 25 (68%) patients had a reduction in carbohydrate antigen 19-9 (CA 19-9) of > 25%. The median time to treatment failure and the median PFS were 17 weeks (95% CI, 13-22 weeks) and 19 weeks (95% CI, 15-23 weeks), respectively. The median OS was 40 weeks (95% CI, 36-45 weeks) and the 1-year actuarial survival rate was 25.8%. Multivariate analysis showed that a performance status score of 0-1 at study entry and locally advanced disease were the only independent predictors of longer PFS and OS, whereas a reduction in CA 19-9 serum levels > 75% was an independent predictor of longer PFS, but had no impact on OS. Toxicity was mild with Grade 3-4 neutropenia (according to the National Cancer Institute-Common Toxicity Criteria [version 2.0]) in 18 of 427 treatment weeks (4.2%), and Grade 3 anemia and thrombocytopenia in 6 of 427 treatment weeks (1.4%) and 9 of 427 treatment weeks (2.1%), respectively, and asymptomatic Grade 3-4 transaminase elevation in 21 of 427 treatment weeks (4.9%). CONCLUSIONS. FDR-gemcitabine at the weekly dose of 1000 mg/m2 demonstrated promising activity, despite negligible toxicity, in patients with advanced-stage PDAC and BTC.
KW - Biliary tree carcinoma
KW - Carbohydrate antigen 19-9
KW - Fixed dose rate
KW - Gemcitabine
KW - Pancreatic carcinoma
UR - http://www.scopus.com/inward/record.url?scp=24644484046&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=24644484046&partnerID=8YFLogxK
U2 - 10.1002/cncr.21286
DO - 10.1002/cncr.21286
M3 - Article
C2 - 16078261
AN - SCOPUS:24644484046
VL - 104
SP - 1237
EP - 1245
JO - Cancer
JF - Cancer
SN - 0008-543X
IS - 6
ER -