Annals of Cancer Research and Therapy
Online ISSN : 1880-5469
Print ISSN : 1344-6835
ISSN-L : 1344-6835
TWO SEQUENTIAL RANDOMIZED PHASE II TRIALS OF COMBINATION CHEMOTHERAPY WITH METHOTREXATE/5-FLUOROURACIL AND CISPLATIN/5-FLUOROURACIL FOR ADVANCED PANCREATIC CANCER
Hitoshi InagakiHiroshi KojimaJunji KatoTsuyoshi KurokawaMitsunori YasueJunichi Sakamoto
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2002 Volume 10 Issue 1-2 Pages 107-119

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Abstract

Aim:
Two sequential studies were performed to examine the effect of combination chemotherapy for patients with preoperative TNM stage III/IV advanced pancreatic cancer.
Methods:
In the first study, a randomized Phase II trial, comparing intraoperative radiation therapy (IORT) to IORT plus combination chemotherapy of methotrexate (MTX) and 5-fuluorouracil (5-FU) was performed. Based on the results of the first trial, a second randomized trial combination therapy comparing MTX plus 5-FU to that of cisplatin (CDDP) plus 5-FU was performed.
Results:
Thirty-three patients were entered into the first study. The second study was conducted sequentially and enrolled 27 patients. In the first study, overall survival and hospital-free survival were significantly better in the IORT plus MTX/5-FU group compared to the IORT alone group. In the second study, comparison of the overall survival and HFS between MTX/5FU group and CDDP/5FU group did not show any significant difference between the two groups. However, MTX/5-FU group showed better treatment compliance and less toxicity compared to the CDDP/5-FU group.
Conclusions:
The results of these two sequential studies of combination chemotherapies for advanced pancreatic cancer suggested that the treatment with IORT plus MTX/5FU was superior to the treatment without chemotherapy in the first study. In the second study, IORT plus MTX/5-FU was also shown to have less toxicity and better compliance compared to the IORT plus CDDP/5-FU.

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© by The Japanese Society of Strategies for Cancer Research and Therapy
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