Stage I and II Ovarian Epithelial Cancer
Note: Some citations in the text of this section are followed by a level of
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therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more
- If the tumor is well- or moderately well-differentiated, total abdominal
hysterectomy and bilateral salpingo-oophorectomy with omentectomy is adequate
for patients with stage IA and stage IB disease. The undersurface of the diaphragm
should be visualized and biopsied; pelvic and abdominal peritoneal biopsies and
pelvic and para-aortic lymph node biopsies are required and peritoneal washings
should be obtained routinely. In selected patients who desire childbearing
and have grade I tumors, unilateral salpingo-oophorectomy may be
associated with a low risk of recurrence.
- If the tumor is grade III, densely adherent, or stage IC, the chance of
relapse and death from ovarian cancer is as much as 30%.[3,4,5,6] Clinical trials evaluating the following treatment approaches have been performed:
- Intraperitoneal P-32 or radiation therapy.[1,7,8]
- Systemic chemotherapy based on platinums alone or in combination with alkylating agents.[1,7,9,10,11]
- Systemic chemotherapy based on platinums with paclitaxel.
In 2 large European trials, European Organisation for Research and Treatment of Cancer–Adjuvant ChemoTherapy in Ovarian Neoplasm (EORTC–ACTION) and International Collaborative Ovarian Neoplasm (ICON1), patients with stage IA and stage IB (grades II and III), all stage IC and stage II, and all stage I and stage IIA clear-cell carcinoma were randomized to adjuvant chemotherapy or observation. Data were reported individually and in pooled form.[12,13,14]
The EORTC–ACTION trial required =4 cycles of carboplatin or cisplatin-based chemotherapy as treatment. Although surgical staging criteria were monitored, inadequate staging was not an exclusion criterion. Recurrence-free survival (RFS) was improved in the adjuvant chemotherapy arm (hazard ratio [HR] = 0.63; P = .02), but overall survival (OS) was not affected (HR = 0.69; 95% confidence interval [CI], 0.44-1.08; P = .10). OS was improved by chemotherapy in the subset of patients with inadequate surgical staging.
The ICON1 trial randomized patients to 6 cycles of single-agent carboplatin or cisplatin or platinum-based chemotherapy (usually cyclophosphamide, doxorubicin, and cisplatin) versus observation and had similar entry criteria to the EORTC–ACTION trial, but the ICON1 trial did not monitor whether adequate surgical staging was performed. Both RFS and OS were significantly improved: 5-year survival figures were 79% with adjuvant chemotherapy versus 70% without adjuvant chemotherapy.
The pooled data from both studies, which were completed in January 2000, indicate significant improvement in RFS (HR = 0.64; 95% CI, 0.50-0.82; P = .001) and OS (HR = 0.67; 95% CI, 0.50-0.90; P = .008). These pooled data provide for an OS at 5 years of 82% with chemotherapy and 74% with observation, with a 95% CI in the difference of 2% to 12%. An accompanying editorial emphasizes that the focus of subsequent trials must be to identify patients who do not require additional therapy among the early ovarian cancer subset.[Level of evidence: 1iA]. Optimal staging is one way to better identify these patients. Except for the most favorable subset (patients with stage IA well-differentiated disease), Gynecologic Oncology Group (GOG) trials and the evidence above, which is based on double-blinded, randomized controlled trials with total mortality endpoints, support treatment with cisplatin, carboplatin, and paclitaxel (in the United States).