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Previous Volume 332:629-634 March 9, 1995 Number 10 Next

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ABSTRACT

Background Although the value of primary cytoreductive surgery for epithelial ovarian cancer is beyond doubt, the value of debulking surgery after induction chemotherapy has not yet been defined. In this randomized study we investigated the effect on survival of debulking surgery.

Methods Eligible patients had residual lesions measuring more than 1 cm in diameter after primary surgery. After three cycles of cyclophosphamide and cisplatin, these patients were randomly assigned to undergo either debulking surgery or no surgery, followed by further cycles of cyclophosphamide and cisplatin. The study end points were progression-free survival and overall survival. At surgery 65 percent of the patients had lesions measuring more than 1 cm. In 45 percent of this group, the lesions were reduced surgically to less than 1 cm.

Results Of the 319 patients who underwent randomization, 278 could be evaluated (140 patients who underwent surgery and 138 patients who did not). Progression-free and overall survival were both significantly longer in the group that underwent surgery (P = 0.01). The difference in median survival was six months. The survival rate at two years was 56 percent for the group that underwent surgery and 46 percent for the group that did not. In the multivariate analysis, debulking surgery was an independent prognostic factor (P = 0.012). Overall, after adjustment for all other prognostic factors, surgery reduced the risk of death by 33 percent (95 percent confidence interval, 10 to 50 percent; P = 0.008). Surgery was not associated with death or severe morbidity.

Conclusions Debulking surgery significantly lengthened progression-free and overall survival. The risk of death was reduced by one third, after adjustment for a variety of prognostic factors.

Source Information

From the Rotterdam Cancer Institute, Daniel den Hoed Kliniek, Rotterdam, the Netherlands (M.E.L.B., M.L.); the International Institute for Drug Development, Brussels, Belgium (M.B.); the Medical Academy, Gdansk, Poland (A.K.); Ospedale San Gerardo, Monza, Italy (N.C.); the University of Brescia, Brescia, Italy (G.F., S.P.); the Central Hospital of Asturias, Oviedo, Spain (A.J.L.); the Regina Elena Cancer Institute, Rome (M.N.); and the European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium (J.R.).

Address reprint requests to Dr. van der Burg at the Rotterdam Cancer Institute, Daniel den Hoed Kliniek, P.O. Box 5201, 3008 AE Rotterdam, the Netherlands.

Full Text of this Article

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Interval Cytoreduction in Ovarian Cancer
Kehoe S., Shafi M., Luesley D., Neijt J.P., Cannistra S. A., van der Burg M. E.L., Buyse M., Pecorelli S.
Extract | Full Text  
N Engl J Med 1995; 333:254-255, Jul 27, 1995. Correspondence

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