Adjuvant therapy in stage I and stage II epithelial ovarian cancer. Results of two prospective randomized trials

Journal Article · Thu Apr 12 04:00:00 EDT 1990 · New England Journal of Medicine; (USA)

DOI:https://doi.org/10.1056/NEJM199004123221501· OSTI ID:6809181

Young, R C; Walton, L A; Ellenberg, S S; Homesley, H D; Wilbanks, G D; Decker, D G; Miller, A; Park, R; Major, F Jr ^[1]

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1. Gynecologic Oncology Group, Philadelphia, PA (USA)

About a third of patients with ovarian cancer present with localized disease; despite surgical resection, up to half the tumors recur. Since it has not been established whether adjuvant treatment can benefit such patients, we conducted two prospective, randomized national cooperative trials of adjuvant therapy in patients with localized ovarian carcinoma. All patients underwent surgical resection plus comprehensive staging and, 18 months later, surgical re-exploration. In the first trial, 81 patients with well-differentiated or moderately well differentiated cancers confined to the ovaries (Stages Iai and Ibi) were assigned to receive either no chemotherapy or melphalan (0.2 mg per kilogram of body weight per day for five days, repeated every four to six weeks for up to 12 cycles). After a median follow-up of more than six years, there were no significant differences between the patients given no chemotherapy and those treated with melphalan with respect to either five-year disease-free survival or overall survival. In the second trial, 141 patients with poorly differentiated Stage I tumors or with cancer outside the ovaries but limited to the pelvis (Stage II) were randomly assigned to treatment with either melphalan (in the same regimen as above) or a single intraperitoneal dose of 32P (15 mCi) at the time of surgery. In this trial (median follow-up, greater than 6 years) the outcomes for the two treatment groups were similar with respect to five-year disease-free survival (80 percent in both groups) and overall survival (81 percent with melphalan vs. 78 percent with 32P; P = 0.48). We conclude that in patients with localized ovarian cancer, comprehensive staging at the time of surgical resection can serve to identify those patients (as defined by the first trial) who can be followed without adjuvant chemotherapy.

• OSTI ID: 6809181
• Journal Information: New England Journal of Medicine; (USA), Journal Name: New England Journal of Medicine; (USA) Vol. 322:15; ISSN NEJMA; ISSN 0028-4793
• Country of Publication: United States
• Language: English

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62 RADIOLOGY AND NUCLEAR MEDICINE
BETA DECAY RADIOISOTOPES
BETA-MINUS DECAY RADIOISOTOPES
BODY
CARCINOMAS
COMBINED THERAPY
DAYS LIVING RADIOISOTOPES
DISEASES
FEMALE GENITALS
GONADS
ISOTOPES
LIGHT NUCLEI
MEDICINE
NEOPLASMS
NUCLEI
ODD-ODD NUCLEI
ORGANS
OVARIES
PATIENTS
PHOSPHORUS 32
PHOSPHORUS ISOTOPES
RADIOISOTOPES
SURGERY
SURVIVAL CURVES
THERAPY