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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