The researchers conducted a Phase III trial to compare gemcitabine alone or with cisplatin for the treatment of patients with locally advanced and/or metastatic pancreatic carcinoma.
They published their results in the 15 February issue of Cancer.
Time to disease progression and the clinical benefit rate were determined.
The objective response rate, overall survival rate, and toxicity patterns of patients in the two treatment arms were evaluated as secondary end points
A total of 107 patients were randomized to receive gemcitabine (Arm A, n = 54) or a combination of gemcitabine and cisplatin (Arm B, n = 53).
In Arm A, a dose of 1000 mg/m2 gemcitabine per week was administered for 7 consecutive weeks. After a 2-week rest, treatment was resumed on Days 1, 8, and 15, of a 28-day cycle for 2 cycles.
In Arm B, cisplatin was given at a dose of 25 mg/m2 per week, 1 hour before gemcitabine, at the same dose that was used in Arm A. On Day 22, only gemcitabine was administered.
Patients were restaged after the first 7 weeks of therapy, and then again after the other 2 cycles.
The median time to disease progression was found to be 8 weeks in Arm A, and 20 weeks in Arm B.
In Arm A, 1 complete response and 4 partial responses were recorded on the basis of an intent-to-treat analysis, with an overall response rate of 9%.
Gemcitabine alone: 9%
Gemcitabine plus cisplatin: 26%
In Arm B, there were no complete responses, whereas 14 partial responses were achieved, with an overall response rate of 26%.
This difference in the overall response rates was statistically significant.
The researchers found that the tumor growth control rate (total number of patients who achieved complete responses, partial responses, and stable disease) was 43% in Arm A and 57% in Arm B.
A clinical benefit was observed in 21 of 43 patients (49%) in Arm A and in 20 of 38 patients (53%) in Arm B, without any significant difference.
The median overall survival was 20 weeks for patients in Arm A, and 30 weeks for patients in Arm B.
Toxicity was mild in both treatment arms, with no significant differences between the two groups. However, there was a statistically higher incidence of Grade 1-2 asthenia in Arm B.
Dr Giuseppe Colucci, of the Oncology Institute in Bari, said on behalf of the group, "The addition of cisplatin to gemcitabine significantly improved the median time to disease progression and the overall response rate, compared with gemcitabine alone.
"The clinical benefit rate was similar in both arms. However, the median overall survival rate was more favorable for Arm B, although the difference did not attain statistical significance."
"The combination of cisplatin and gemcitabine currently may be considered as an optimal treatment for patients with locally advanced and/or metastatic adenocarcinoma of the pancreas," it was concluded.