March 30, 2012 — A combination of 2 chemotherapy agents is as effective as and less toxic than a combination of 3 agents that has been a standard of care for advanced endometrial cancer, according to new results from a phase 3 trial.
The results were presented this week at the Society of Gynecologic Oncologist's Annual Meeting on Women's Cancer in Austin, Texas.
The study enrolled 1381 women (although 69 were ineligible), who were assigned to receive the standard triple combination of doxorubicin, cisplatin, and paclitaxel or the doublet of cisplatin and paclitaxel.
The 3-drug combination is the evidence-based standard, explained principal investigator David Scott Miller, MD, from the University of Texas Southwestern Medical Center, Dallas. The 2-drug combination is already widely used in the oncologic community, but there has been little evidence to support its equivalence to the standard 3-drug combination, he told Medscape Medical News.
The results show that the doublet is not inferior to and is less toxic than the triplet of chemotherapy, Dr. Miller said.
"Patients can now be reassured that they are getting equivalent therapy with the 2-drug regimen," he toldMedscape Medical News.
"Also, importantly, we anticipate the 2-drug regimen will be easier to combine with biologic or 'targeted' agents," he said.
More Than 4 Years' Follow-up
The aim of the trial was for all women to have 7 cycles of chemotherapy, and this was achieved in 62% of those receiving the triple combination and 69% receiving the doublet.
When all the women had completed therapy, the data monitoring committee approved early release of the data from a second planned interim analysis, based on 551 deaths.
These were the results that Dr. Miller presented at the meeting, and they come from a follow-up of more than 4 years, he said.
They show that the 2 different chemotherapy regimens were similar in efficacy. Median progression-free survival was 14 months in both treatment groups, and the median overall survival was 32 months with the doublet and 38 months with the triplet (hazard ratio, 1.01). The results for the doublet were not inferior to those of the triplet, Dr. Miller told the meeting attendees.
Overall, the toxicity profile favored the doublet, he continued. Neurologic toxicity was more frequently reported with the triplet: 26% of patients receiving the 3-drug combination reported sensory neuropathy (grade 1) compared with 16% of those receiving the doublet (P < .01).
Several other adverse events were also more frequent in the triplet therapy group, including thrombocytopenia (23% with triplet vs 12% with doublet), other hematologic events (30% vs 22%), vomiting (7% vs 4%), diarrhea (6% vs 2%), and electrolyte abnormalities (14% vs 85%).
In contrast, neutropenia was more common among the patients in the doublet group (79% vs 52% in the triplet group). The incidence of neutropenic fever was similar in the 2 treatment groups (7% with triplet and 6% with doublet).
Society of Gynecologic Oncologist's Annual Meeting on Women's Cancer. Late-breaking abstract #1. Presented March 25, 2012.
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