BALTIMOREGiving paclitaxel(Drug information on paclitaxel) (Taxol) and cisplatin(Drug information on cisplatin) (Platinol) in an intensive intraperitoneal (IP) regimen increased progression-free survival by 5 months over standard intravenous (IV) treatment for stage III epithelial ovarian carcinoma and primary peritoneal carcinoma in a phase III clinical trial (ASCO abstract 803).
Deborah K. Armstrong, MD, of the Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins University School of Medicine presented the preliminary results from Gynecologic Oncology Group (GOG) trial 172. "This is the third randomized clinical trial to show a clinical benefit for the use of IP therapy in patients with optimally debulked ovarian cancer," she said. "Survival outcomes from this study will be key in determining the role of intensive IP therapy in future clinical trials and as part of standard treatment for optimally debulked ovarian cancer."
Median overall progression-free survival was 24.3 months for 205 women who were in the IP arm compared to 19.3 months for 211 women who received standard IV therapy. In the IP arm, more women were progression free (112) than had failed treatment (93). Conversely, in the IV arm, more women failed therapy (115) than were progression free (96).
For patients with gross residual disease, Dr. Armstrong reported the median progression-free survival was 20.7 months with IP therapy, compared to 15.7 months on the IV arm. Previous studies have also shown a 5-month gain from the intensive treatment, she said.
Not enough events have occurred to reach a median in overall survival, according to Dr. Armstrong. At the time of her presentation, she reported that 61 IV patients and 46 IP patients had died. The study identified the following factors as being associated with a worse prognosis for patients in the study:
- gross residual disease;
- mucinous and clear cell histologies; and
- increasing age, starting at 45 years.
Each woman in the trial had a newly diagnosed tumor that was reduced surgically to 1 cm in diameter or less no more than 6 weeks before starting chemotherapy. Nearly two-thirds of the women in both arms had gross residual disease that was visible at the end of initial surgery.