Nov 21, 2005 - 3:34 pm
Single Agent Carboplatin For First-Line Ovarian Cancer
Single-agent carboplatin is acceptable as first-line chemotherapy for ovarian cancer, with its superior toxicity profile and equivalent survival benefit compared with other regimens, according to the results of a randomized trial reported in the August 17, 2002 issue of The Lancet.
The International Collaborative Ovarian Neoplasm (ICON) group reports the results of the ICON3 trial in which 2074 women with ovarian cancer were randomly assigned to treatment with paclitaxel plus carboplatin or to a control group.
Women in the control group received a combination of three drugs or single-agent carboplatin. The drug combination consisted of cyclophosphamide, doxorubicin and cisplatin (CAP). During a follow-up period with a median of 51 months, the researchers looked for overall survival, progression-free survival and toxicity.
Over the follow-up period, 1265 women died. According to an analysis of survival curves, there was no difference in overall survival between women receiving paclitaxel plus carboplatin and CAP or single-agent carboplatin (hazard ratio 0.98, p = 0.74 and hazard ratio 0.99, p = 0.94, respectively).
The median survival time for women receiving paclitaxel and carboplatin was 36.1 months, compared with 35.4 months for women in the control group.
For the 1538 women whose diseased progressed or who died, Kaplan-Meier curves showed no significant difference between the treatment groups (hazard ratio 0.93, p = 0.16), the researchers report.
Among women in the paclitaxel plus carboplatin group, median progression-free survival was 17.3 months, compared with 16.1 months among women in the control group, they add.
Patients receiving paclitaxel and carboplatin had more occurrences of alopecia, fever, and sensory neuropathy than patients receiving carboplatin alone and more sensory neuropathy than women receiving CAP. Women receiving CAP had more fever than women receiving paclitaxel and carboplatin, the ICON team found.
"The results of ICON3 suggest that, up to 5 years from treatment, single-agent carboplatin, CAP, and paclitaxel plus carboplatin are all safe and show similar effectiveness as first-line treatments for women requiring chemotherapy for ovarian cancer," Dr. Peter Harper, leader of the ICON group, from Guy's Hospital, London, said in a statement. "Of these three treatments, carboplatin might be regarded as the preferred treatment because of its better toxicity profile."
Another study has shown that "patients value survival more highly than the quality of life during chemotherapy," Dr. Martin H. N. Tattersall from the University of Sydney, Australia, notes in a related editorial. Yet "the proportion of women with advanced ovarian cancer who have a normal life expectancy remains low despite claims of major progress in treatment in the past few years," he adds.
SOURCE: Lancet 2002;360:500-501, 505-515.