Unknown

Dataset Information

0

Phase III trial of weekly methotrexate or pulsed dactinomycin for low-risk gestational trophoblastic neoplasia: a gynecologic oncology group study.


ABSTRACT:

Purpose

There is no consensus on the best regimen for the primary treatment of low-risk gestational trophoblastic neoplasia (GTN).

Patients and methods

Two commonly used single-drug regimens were compared with respect to the proportion of patients 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 patients with a WHO risk score of 0 to 6 and patients with metastatic disease (limited to lung lesions < 2 cm, adnexa, or vagina) or choriocarcinoma.

Results

Two hundred forty women were enrolled, and 216 were deemed eligible. Biweekly intravenous dactinomycin 1.25 mg/m² was statistically superior to weekly intramuscular (IM) methotrexate 30 mg/m² (CR: 70% v 53%; P = .01). Similarly, in patients with low-risk GTN as defined before the 2002 WHO risk score revisions (risk score of 0 to 4 and excluding choriocarcinoma), response was 58% and 73% in the methotrexate and dactinomycin arms, respectively (P = .03). Both regimens were less effective if the WHO risk score was 5 or 6 or if the diagnosis was choriocarcinoma (CR: 9% and 42%, respectively). There were two potential recurrences; one at 4 months (dactinomycin) and one at 22 months (methotrexate). Not all patients completed follow-up. Both regimens were well tolerated.

Conclusion

The biweekly dactinomycin regimen has a higher CR rate than the weekly IM methotrexate regimen in low-risk GTN, a generally curable disease.

SUBMITTER: Osborne RJ 

PROVIDER: S-EPMC3068058 | biostudies-literature |

REPOSITORIES: biostudies-literature

Similar Datasets

2017-03-03 | GSE88873 | GEO
| S-EPMC3304432 | biostudies-literature
| S-EPMC5273590 | biostudies-other
| S-EPMC5537086 | biostudies-other
| S-EPMC6768657 | biostudies-literature
2017-10-17 | E-MTAB-5185 | biostudies-arrayexpress
| S-EPMC7432963 | biostudies-literature
| S-EPMC4993663 | biostudies-literature
| S-EPMC4164471 | biostudies-other
| S-EPMC6483742 | biostudies-literature