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.
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.