The effect of diameter of largest residual disease on survival after primary cytoreductive surgery in patients with suboptimal residual epithelial ovarian carcinoma*,**,

Presented by invitation at the Twelfth Annual Meeting of the American Gynecological and Obstetrical Society, Carlsbad, California, September 9-11,1993..
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Abstract

OBJECTIVE: The Gynecologic Oncology Group has divided patients with advanced epithelial ovarian cancer into those with optimal residual cancer, in which the maximum diameter of residual is ≤1 cm, and suboptimal residual cancer, in which the residual disease is >1 cm. Within the optimal group of patients there is a survival difference between patients with microscopic residual disease and those with any macroscopic disease ≤1 cm. No analysis of the effect of various residual disease diameters in patients with residual disease ≥1 cm has been performed. This study evaluates the effect of residual disease diameter in patients with suboptimal disease entered on a randomized trial of intense versus standard chemotherapy. STUDY DESIGN: Gynecologic Oncology Group protocol 97 compared cisplatin 50 mg/m2 and cyclophosphamide 500 mg/m2 for eight courses with the same drugs at 100 mg/m2 and 1000 mg/m2 for four courses, respectively. There was no difference in progression-free interval or survival between the two arms. Of the 458 stage III (with residual disease >1 cm) and stage IV patients entered in this study, 294 stage III patients comprise the current analysis. Surgical reporting forms, operation reports, and pathology reports were reviewed to determine initial greatest tumor diameter and residual tumor diameter. Patients were grouped by residual diameter. Multivariate analysis considered residual diameter of disease, age, histologic characteristics, performance status, and ascites. An adjusted relative hazard of dying of ovarian cancer was calculated for each residual disease group. RESULTS: Patients ranged in age from 20 to 80 years, with a median of 60 years. All patients were Gynecologic Oncology Group performance status 0 to 2. Fifty-two percent had grade 3 tumors, and 39% and 9%, respectively, had grade 2 or 1 tumors. All patients had stage III disease. Ninety percent had serous, endometrioid, or mixed epithelial cell type tumors. Multivariate analysis revealed a relative risk of dying as follows: residual disease ≥2 cm, relative risk 1.00; 2 to 2.9 cm, relative risk 1.90; 3 to 3.9 cm, relative risk 1.91; 4 to 5.9 cm, relative risk 1.74; 6 to 7.9 cm, relative risk 1.85; 8 to 9.9 cm, relative risk 2.16; ≥10 cm, relative risk 1.82. The difference in survival between those with <2 cm residual disease and those with ≥2 cm residual disease was significant (p < 0.01). There is no significant difference in the risk of dying between groups with residual disease ≥2 cm. CONCLUSIONS: Among patients with suboptimal (>1 cm residual disease) epithelial ovarian cancer, those who have small diameter residual disease (<2 cm) tend to survive longer than those who have larger residual disease. Among those with larger residual disease, size does not affect prognosis appreciably. (AM J OBSTET GYNECOL 1994; 170:974-80.)

Section snippets

MATERIAL AND METHODS

Protocol 97 was a prospective, randomized trial to assess dose intensity in relation to progression-free interval and survival in patients with suboptimal residual disease after primary cytoreductive surgery. In this study suboptimal disease was defined as any residual disease with a diameter >1 cm. No attempt was made to judge actual volume of disease or to measure the number of residual lesions. Location of residual disease was not a factor in allowing entry to the study, except that any

RESULTS

Between December 1986 and April 1990, 458 evaluable patients were entered on protocol 97. Patients with stage IV disease (153, 33%) were excluded from this analysis, because the amount of residual disease in the abdomen did not affect entry into the protocol. For example, a patient who had complete resection of intraabdominal disease could still be entered into this protocol on the basis of metastasis outside the abdomen. Thus residual abdominal disease may not be an accurate representation of

COMMENT

The focus of this study was to investigate the potential prognostic value of the maximum diameter of disease after primary cytoreductive surgery in a group of patients with stage III epithelial ovarian cancer, all of whom had residual diameters >1 cm after initial operation. In this analysis, we found no relationship between survival and the size of the tumor at exploration. However, the diameter of largest residual disease before chemotherapy is related to survival. Thus this study, similar to

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*

From the Gynecology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, and Cornell University Medical College,a Johns Hopkins Oncology Center,b Gynecologic Oncology Group, Roswell Park Cancer Institute,c the Department of Obstetrics and Gynecology and the Section on Gynecologic Oncology, Comprehensive Cancer Center of Wake Forest University,d the Department of Obstetrics and Gynecology, Medical University of South Carolina,e the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of California, Irvine,f the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, New England Medical Center and Tufts University School of Medicine,g and the Gynecologic Oncology Service, Department of Obstetrics and Gynecology, University of California, Los Angeles, School of Medicine, Jonsson Comprehensive Cancer Center.h

**

Reprint requests: Ms. Denise Mackey, Administrative Assistant, GOG Administrative Office, 1234 Market St., Suite 1945, Philadelphia, PA 19107.

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