Secondary Cytoreduction for Ovarian Cancer May Not Improve Survival

Laurie Barclay, MD

December 09, 2004

Dec. 9, 2004 — Secondary cytoreduction for advanced ovarian cancer does not improve survival, according to the results of a randomized study published in the Dec. 9 issue of the New England Journal of Medicine.

"Efforts to improve survival among women with advanced ovarian cancer have had only limited success," write Peter G. Rose, MD, from Case Western Reserve University in Cleveland, Ohio, and colleagues. "Standard treatment of such cases is a combination of maximal resection of primary and metastatic carcinoma and postoperative chemotherapy.... Secondary surgical cytoreduction after chemotherapy is a strategy for reducing tumor burden."

Within six weeks after primary surgery, 550 women with advanced ovarian cancer and residual tumor exceeding 1 cm in diameter after primary surgery were enrolled. If a patient had no evidence of progressive disease after three cycles of postoperative paclitaxel plus cisplatin, she was randomized to undergo secondary cytoreductive surgery followed by three more cycles of chemotherapy or three more cycles of chemotherapy alone.

Of 424 eligible patients, 216 patients were randomized to receive secondary surgical cytoreduction followed by chemotherapy and 208 patients were randomized to receive chemotherapy alone. Of the patients randomized to secondary surgery, 15 patients (7%) did not undergo surgery because they declined it or because it was medically contraindicated.

As of March 2003, 296 patients had died and 82 had progressive disease. Compared with the chemotherapy-alone group, the secondary surgery group had a likelihood of progression-free survival of 1.07 (95% confidence interval [CI], 0.87 - 1.31; P = .54) and a relative risk of death of 0.99 (95% CI, 0.79 - 1.24; P = .92).

Study limitations include possible differences in surgical aggressiveness that are difficult to quantify and interobserver variability in tumor measurements,

"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," the authors write. "Although surgery is currently considered the initial standard treatment for patients with a good performance status who have apparent, advanced disease, the value of neoadjuvant (preoperative) chemotherapy is being investigated.... A randomized European trial comparing primary surgery plus postoperative chemotherapy with neoadjuvant chemotherapy plus surgery is ongoing."

The National Cancer Institute supported this study. One of the authors reports having received consulting fees from Eli Lilly and Aventis.

In an accompanying editorial, Tate Thigpen, MD, from the University of Mississippi School of Medicine in Jackson, discusses the history of treatment options for ovarian cancer. Important predictors of outcome include the volume of residual disease, biology of the tumor, and extent of surgical debulking.

"The five points cited as the rationale for surgical debulking support the contention that such surgery should be performed before the initiation of chemotherapy," Dr. Thigpen writes. "This approach is consistent with the current standard of care for advanced ovarian carcinoma in the United States: initial surgical cytoreduction is followed by chemotherapy with paclitaxel plus carboplatin. Secondary surgical cytoreduction should be reserved for patients in whom the initial surgical effort at cytoreduction was not considered to be maximal."

N Engl J Med. 2004;351:2489-2497, 2544-2546

Reviewed by Gary D. Vogin, MD

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