NEW YORK (Reuters Health) – Pegylated liposomal doxorubicin may be an alternative to paclitaxel in combination with carboplatin for advanced ovarian cancer, based on the results of an Italian randomized comparison trial reported in the Journal of Clinical Oncology online August 15.
The authors note that the toxicity of the standard treatment of ovarian cancer with carboplatin and paclitaxel reduces quality of life significantly. For relapsed ovarian cancer, pegylated liposomal doxorubicin (PLD) is considered the second-line treatment of choice because of favorable tolerability.
Dr. Sandro Pignata, at the Istituto Nazionale Tumori in Naples, and colleagues therefore investigated the effect of carboplatin/PLD compared with standard carboplatin/paclitaxel as first-line therapy in 820 patients with advanced ovarian cancer.
The primary endpoint of median progression-free survival was not significantly different in the two groups, the team found: 19.0 months with carboplatin/PLD and 16.8 months with carboplatin/paclitaxel (hazard ratio 0.95; p=0.58).
Median overall survival times were also similar at 61.6 months and 53.2 months in the two groups, respectively (HR 0.89; p=0.32), the investigators report.
Regarding safety, there were four deaths in the standard arm and two in the experimental arm that were possibly related to treatment, according to the report.
There were more hematologic adverse effects with the carboplatin/PLD combination, and non-hematologic side effects were significantly different between the two groups: alopecia, diarrhea, and neuropathy were significantly worse in the standard treatment group while skin toxicity and stomatitis were significantly worse in the experimental arm.
“The dramatic reduction of hair loss and neurotoxicity seen with the experimental treatment is extremely important,” the authors comment. “Approximately three fourths of patients experience some degree of peripheral neuropathy while on carboplatin/paclitaxel.”
Nonetheless, there were no meaningful differences in global quality-of-life scores during treatment, Dr. Pignata and colleagues report.
Summing up, they conclude, “The combination of carboplatin/PLD does not prolong progression-free survival compared with standard carboplatin/paclitaxel. However, given the observed difference in toxicity, it can be considered as a reasonable alternative for first-line treatment of advanced ovarian cancer, particularly in patients at high risk of neurotoxicity or wishing to avoid alopecia.”
Carboplatin Plus Paclitaxel Versus Carboplatin Plus Pegylated Liposomal Doxorubicin As First-Line Treatment for Patients With Ovarian Cancer: The MITO-2 Randomized Phase III Trial
SOURCE: http://dx.doi.org/10.1200/JCO.2010.33.8566J Clin Oncol 2011.