Combination chemotherapy with docetaxel and gemcitabine in patients with metastatic or locally advanced pancreatic carcinoma: results of a multicenter phase II study

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 4101-4101
Author(s):  
J. Fahlke ◽  
K. Ridwelski ◽  
C. Schmidt ◽  
P. Stübs ◽  
M. Weber ◽  
...  
2005 ◽  
Vol 76 (1) ◽  
pp. 48-53 ◽  
Author(s):  
Morten Hoyer ◽  
Henrik Roed ◽  
Lisa Sengelov ◽  
Anders Traberg ◽  
Lars Ohlhuis ◽  
...  

2000 ◽  
Vol 23 (5) ◽  
pp. 436-442 ◽  
Author(s):  
T.B. Brunner ◽  
G.G. Grabenbauer ◽  
S. Kastl ◽  
O. Herrmann ◽  
U. Baum ◽  
...  

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 124-124
Author(s):  
Kazumasa Fujitani ◽  
Yutaka Kimura ◽  
Hiroshi Imamura ◽  
Masahiro Gotoh ◽  
Shohei Iijima ◽  
...  

124 Background: Docetaxel combined with cisplatin and 5-fluorouracil is active in advanced gastric cancer, but not generally accepted because of its substantial toxicities. We conducted a multicenter phase II study of triplet combination using paclitaxel, cisplatin and S-1 (PCS) as first-line treatment for advanced gastric cancer. Methods: Patients with previously untreated, locally advanced or metastatic measurable gastric cancer, a performance status < 2, age of 20-75 years, and adequate organ functions were given intravenous paclitaxel at 70 mg/m2 and cisplatin at 30 mg/m2 on days 1 and 15, plus oral S-1 at 40 mg/m2 b.i.d. on days 1 to 21, followed by 2-week rest, repeated every 5 weeks. Treatment was continued until disease progression or unacceptable toxicity occurred, or the patient refused the therapy. Study endpoints included overall response rate (ORR) as primary, progression free survival (PFS), overall survival (OS), and toxicity. Sample size of 40 patients was determined to reject the ORR of 55% under the expectation of 75% with a power of 80% and a one-sided α of 5%. Results: A total of 52 patients were enrolled in this study, among whom 49 were assessable for efficacy and 51 assessable for toxicity. ORR was 46.9% (95% CI: 32.5-61.7%). The median PFS and median OS were 5.4 months (95% CI: 4.1-7.0) and 11.5 months (95% CI: 7.3-16.1), respectively. Frequent grade 3/4 toxicities were neutropenia (51%), leucopenia (25%), anemia (20%), hyponatremia (16%), anorexia (14%), diarrhea (8%) and fatigue (8%). There was no treatment-related death. Conclusions: Triplet combination chemotherapy with PCS demonstrated superior feasibility with promising antitumor activity, though which did not meet the statistical hypothesis, for advanced gastric cancer.


2014 ◽  
Vol 46 (10) ◽  
pp. 950-955 ◽  
Author(s):  
Michel Ducreux ◽  
Marc Giovannini ◽  
Charlotte Baey ◽  
Carmen Llacer ◽  
Jaafar Bennouna ◽  
...  

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4625-4625
Author(s):  
F. Viret ◽  
M. Ychou ◽  
C. Baey ◽  
J. Bennouna ◽  
A. Adenis ◽  
...  

4625 Background: Locally advanced pancreatic carcinoma remains a challenging tumor with no clear standard of care in terms of radio-chemotherapy. The purpose of this phase II trial was to determine the efficacy and the toxicity of radiotherapy and docetaxel and cisplatin in histologically proven adenocarcinoma of the pancreas. Methods: Patients (pts) received external beam radiotherapy (54 Gy in 1.8 Gy fractions, six weeks) and weekly chemotherapy regimen of association docetaxel and cisplatine (20 mg/m2/weeks each) for six weeks. Results: 51 pts (20 women and 31 men, with median age of 62 years) with disease considered to be unresectable but confined to pancreas area and celiac nodes were included between 06/10/2003 and 15/02/2008. Location of the tumor: head (33 pts), body (13 pts), and tail (5 pts). The median dose of radiotherapy received by the patients was 54 Gy. The median dose of docetaxel and cisplatin administered was 19.8 mg/m2/w (relative dose intensity 97%). Radiotherapy has to be interrupted in 7 pts. 30 pts experienced at least one episode of grade 3 or 4 toxicity (asthenia 12 pts, anorexia 11 pts, vomiting 10 pts, nausea 9 pts, abdominal pain 5 pts). No toxic death was observed. 6 pts underwent secondary pancreatic resection (4 compete resection and 1 pt with histological complete remission). The objective response rate (CR 5 pts, PR 3 pts), was 16% with a median duration of 7.6 months. At 6 months, 30 pts had progressed. Median progression free survival was 5.8 months. With a 21 months median follow up, median overall survival was 9.6 months and 18 months survival rate of 31%. Conclusions: The association docetaxel+cisplatin+radiotherapy has limited effect in patients with locally advanced pancreatic carcinoma but major objective responses have been observed allowing secondary resections. Grant by sanofi-aventis, Amgen, and Ligue Nationale Contre Le Cancer. No significant financial relationships to disclose.


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