Secondary Surgical Cytoreduction for Advanced Ovarian Carcinoma

Rose, Peter G.
Nerenstone, Stacy
Brady, Mark F.
Clarke-Pearson, Daniel
Olt, George
Rubin, Stephen C.
Moore, David H.
Small, James M.

For the Gynecologic Oncology Group
From Case Western Reserve University and the Division of Gynecologic Oncology, MetroHealth Medical Center - both in Cleveland (P.G.R.); the Department of Medicine, University of Connecticut, and Hartford Hospital - both in Hartford (S.N.); the Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, N.Y. (M.F.B.); the Division of Gynecologic Oncology, Duke University Medical Center, Durham, N.C. (D.C.-P.); the Division of Gynecologic Oncology, Pennsylvania State University, Hershey Medical Center, Hershey (G.O.); the Division of Gynecologic Oncology, University of Pennsylvania Cancer Center, Philadelphia (S.C.R.); the Division of Gynecologic Oncology, Indiana University School of Medicine, Indianapolis (D.H.M.); and UniPath and Colorado Gynecologic Oncology - both in Denver (J.M.S.). Address reprint requests to Ms. Denise Mackey at the Gynecologic Oncology Group Administrative Office, 4 Penn Center, 1600 JFK Blvd., Suite 1020, Philadelphia, PA 19103.

New England Journal of Medicine 351(24):p 2489-2497, December 9, 2004. | DOI: 10.1056/NEJMoa041125

Background

We evaluated the effect of adding secondary cytoreductive surgery to postoperative chemotherapy on progression-free survival and overall survival among patients who had advanced ovarian cancer and residual tumor exceeding 1 cm in diameter after primary surgery.

Methods

Women were enrolled within six weeks after primary surgery. If, after three cycles of postoperative paclitaxel plus cisplatin, a patient had no evidence of progressive disease, she was randomly assigned to undergo secondary cytoreductive surgery followed by three more cycles of chemotherapy or three more cycles of chemotherapy alone.

Results

We enrolled 550 women. After completing three cycles of postoperative chemotherapy, 216 eligible patients were randomly assigned to receive secondary surgical cytoreduction followed by chemotherapy and 208 to receive chemotherapy alone. Surgery was declined by or medically contraindicated in 15 patients who were assigned to secondary surgery (7 percent). As of March 2003, 296 patients had died and 82 had progressive disease. The likelihood of progression-free survival in the group assigned to secondary surgery plus chemotherapy, as compared with the chemotherapy-alone group, was 1.07 (95 percent confidence interval, 0.87 to 1.31; P=0.54), and the relative risk of death was 0.99 (95 percent confidence interval, 0.79 to 1.24; P=0.92).

Conclusions

For patients with advanced ovarian carcinoma in whom primary cytoreductive surgery was considered to be maximal, the addition of secondary cytoreductive surgery to postoperative chemotherapy with paclitaxel plus cisplatin does not improve progression-free survival or overall survival.

N Engl J Med 2004;351

2489-97.