A Phase III Trial comparing Gemcitabine plus Cisplatin vs. Gemcitabine alone in advanced pancreatic cancer
Reviewer: Tracy d'Entremont, MD
Last Modified: June 2, 2003
Presenter: V. Heinemann Presenter's Affiliation: University of Munich; Munich, Germany Type of Session: Scientific
Pancreatic cancer has a very poor prognosis.
Most patients are diagnosed in the metastatic stage.
Median survival is 3-4 months with best supportive care.
Single agent gemcitabine (Gem) has increased this MS to 5-6 months
Phase II data have projected MS to increase to 8.2 months with Gem + Cis
This study was designed to compare Gem + cis to Gem alone
Materials and Methods
195 patients were required to have 80% power to detect a 60% increase in survival from 5-8 months.
The regimens were as follows:
- Gem + Cis: Gem 1000mg/m2 d1,15, Cis 50mg/m2 d1, 15 q 28d
- Gem: Gem 1000mg/m2 d1, 8, 15 q 28d
The two groups were well balanced with average age of 65, PS of 80%, 80% had metastases while 20% had locally advanced disease.
The primary endpoint was O
Median F/U was 7.4 months for the gem/cis arm and 6 months for the gem arm
PFS was improved in the combination arm 5.4 vs. 2.8 months
TTP was also in favor of the combination with 4.6 vs. 2.5 months
However, there was no difference in overall survival, the primary endpoint of the trial.
Treatment was reported as relatively well tolerated with rare dose reductions or delays. However, 22% of the patients receiving cisplatin suffered from gr 3/4 nausea and vomiting.
The combination of gem + cis for metastatic or locally advanced pancreatic cancer is active with improved TTP and higher clinical benefit rate.
With the exception of nausea and vomiting, the toxicity of the combined regimen was comparable.
The combination should be considered an option for patients with symptoms or in whom the disease is rapidly progressing.
This trial is a negative study.
Despite the prolonged TTP, there is no difference in OS.
With the known added toxicities of cisplatin chemotherapy, it is hard to justify using it in this patient population without a documented improvement in OS.
Although the authors suggest using the regimen in patients with aggressive disease in whom you may want a rapid response, those are not the type of patient that were enrolled in this trial so it is hard to generalize this data to them. We don't have any data on how they would respond to this sort of regimen. They may in fact have more toxicity.
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Apr 9, 2010 - In patients with advanced biliary tract cancer, cisplatin plus gemcitabine is linked to a survival advantage compared to gemcitabine alone, with no additional substantial toxicity, according to research published in the April 8 issue of the New England Journal of Medicine.