Sites of failure and times to failure in carcinoma of the vulva treated conservatively: A Gynecologic Oncology Group study,☆☆,

Presented by invitation at the Fourteenth Annual Meeting of the American Gynecological and Obstetrical Society, Napa, California, September 7-9, 1995.
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Abstract

OBJECTIVE: The objective of this review was to examine the patterns of failure after conservative therapy for vulvar carcinoma to establish a basis for the design of prospective cooperative trials in this disease. STUDY DESIGN: The records and characteristics of all patients in whom cancer recurred after conservative therapy in two prospective clinical trials were analyzed. RESULTS: Of 143 patients who received one or more modifications of therapy, 37 patients had recurrence of cancer and 20 died of the disease. The median intervals to recurrence were 35.9 months for vulvar cancer and 7.0 months for groin cancer (p = 0.0002). There were 12 groin recurrences; 11 (91.7%) of these patients have died of the disease. The median survival time after recurrence was 52.4 months for patients with vulvar cancer and 9.4 months for those with groin cancer (p = 0.0025). CONCLUSIONS: Groin cancer recurs earlier than vulvar cancer among patients treated conservatively. Future trials that evaluate modified therapy to the groin need to include early interim analyses. Follow-up for >36 months after study entry may not be necessary to evaluate the impact of new treatments. (AM J OBSTET GYNECOL 1996;174:1128-33.)

Section snippets

Eligibility

Between 1983 and 1990, the GOG conducted two prospective trials evaluating the efficacy of conservative therapy for patients with carcinoma of the vulva.3, 4 One hundred forty-three patients in these studies received one or more modifications of traditional therapy. All patients had primary, previously untreated invasive squamous cell carcinoma of the vulva, clinical stages I to III (International Federation of Gynecology and Obstetrics, 1971). On clinical examination the vulvar lesion must

RESULTS

There were 143 patients entered in the two conservative study arms (120 in protocol No. 74 and 23 on protocol No. 88). Patient characteristics are shown in Table II. The median patient age was 61 years. The majority of patients (121, 84.6%) had clinical stage I disease and were considered candidates for conservative therapy.

There were 20 deaths (14.0%) caused by recurrent vulvar cancer. No deaths resulted from treatment or treatment-related complications; 17 patients died of intercurrent

COMMENT

For patients with stage I vulvar cancer, recurrence on the vulva is found in 6% to 11% of patients; recurrence in the groin is seen in 4% to 6% of patients.1, 2, 3, 15, 16 For patients with more advanced disease the risk of vulvar recurrence increased to as high as 17%.1, 2, 7 The risk of groin recurrence is low except for the subset of patients with metastatic disease in the inguinal nodes.8

Other authors have noted a trend for vulvar recurrence to develop earlier than groin recurrence. In a

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    From the Department of Obstetrics and Gynecology, Indiana University School of Medicinea; the Gynecologic Oncology Group and the Roswell Park Cancer Instituteb; the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, New England Medical Center and Tufts University School of Medicinec; and the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke University School of Medicine.d

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