12-cycle Chemo Offers DF Advantage-Not OS

It has long been recognized that despite the high objective response rate (60% to 80%) of ovarian cancer to current front-line chemotherapy, the majority of patients ultimately progress and die of complications of the malignancy.[1-5]

In an effort to improve upon the results of initial treatment, the Southwest Oncology Group (SWOG) and the GOG conducted a novel trial in women with advanced ovarian cancer who had attained a clinically defined complete response to a platinum/paclitaxel combination chemotherapy program.[8]

Patients agreeing to enter this trial were randomized to receive either 3 monthly cycles of single-agent paclitaxel (175 mg/m2 over 3 hours) or 12 monthly cycles (175 mg/m2 over 3 hours).

This study, which was to enter 450 eligible patients, was stopped early by the SWOG Data Safety and Monitoring Committee due to the finding of "extreme positive results" in favor of the 12-month maintenance regimen.

The median progression-free survival in the 3-month treatment program was 21 months compared with 28 months in the 12-month consolidation regimen (P = .0023). At the time of study closure, there was no difference in overall survival between the 2 study arms.

It remains uncertain if this trial will reveal an ultimate survival advantage associated with the additional 12 months of treatment.

For the present, it is important that at all women with advanced ovarian cancer who achieve a clinically defined complete response to initial chemotherapy are made aware of the results of this study.

In consultation with their physicians, patients will need to determine how these trial results should influence their subsequent management.

Excerpted from:

Challenging Ovarian Cancer: How Can We Improve Quantity and Quality of Life?

Maurie Markman, MD Medscape General Medicine 4(4), 2002

Posted 11/01/2002

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