Phase III trial of weekly @entity1499 or pulsed XXXX for low-risk @entity1469 : a gynecologic oncology group study.

@entity1 @entity1466 @entity1469 @entity4316 @entity3 @entity1499
PURPOSE: There is no consensus on the best regimen for the primary treatment of low-risk @entity1469 ( @entity1469 ). @entity1 AND METHODS: Two commonly used single-drug regimens were compared with respect to the proportion of @entity1 meeting the criteria for a complete response (CR) in a randomized phase III trial conducted by the Gynecologic Oncology Group. Eligibility was purposefully broad to maximize the generalizability of the results and included @entity1 with a WHO risk score of 0 to 6 and @entity1 with @entity3 (limited to lung lesions < 2 cm, adnexa, or vagina) or @entity1466 . RESULTS: Two hundred forty @entity1 were enrolled, and 216 were deemed eligible. Biweekly intravenous @entity4316 1.25 mg/m   was statistically superior to weekly intramuscular (IM) @entity1499 30 mg/m   (CR: 70% v 53%; P = .01). Similarly, in @entity1 with low-risk @entity1469 as defined before the 2002 WHO risk score revisions (risk score of 0 to 4 and excluding @entity1466 ), response was 58% and 73% in the @entity1499 and @entity4316 arms, respectively (P = .03). Both regimens were less effective if the WHO risk score was 5 or 6 or if the diagnosis was @entity1466 (CR: 9% and 42%, respectively). There were two potential recurrences; one at 4 months ( @entity4316 ) and one at 22 months ( @entity1499 ). Not all @entity1 completed follow-up. Both regimens were well tolerated. CONCLUSION: The biweekly @entity4316 regimen has a higher CR rate than the weekly IM @entity1499 regimen in low-risk @entity1469 , a generally curable disease.
