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Intraperitoneal Regimen Boosts Survival in Phase III Ovarian Cancer Clinical Trial

Intraperitoneal Regimen Boosts Survival in Phase III Ovarian Cancer Clinical Trial

BALTIMORE—Giving paclitaxel (Taxol) and 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

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.

Prognostic Factors

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:

  1. gross residual disease;
  2. mucinous and clear cell histologies; and
  3. 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.


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