Abstract

The thrust in the management of low risk gestational trophoblastic neoplasia (GTN) has been to find the most effective agent with the least toxicity that causes the least disruption of the patient's activities. We have studied biweekly actinomycin-D 1.25 mg M^-2 (pulsed act-D, 18 evaluable patients) to determine whether it has the same primary efficacy rate as the 5-day course of actinomycin-D 12 mcg kg^-1 (5-day act-D, 43 evaluable patients) in low risk GTN. The primary cure rate was 88.4% for the 5-day act-D group and 77.8% for the pulsed act-D group. The data appear to show a therapeutic advantage for the use of the 5-day regimen. However, the difference between 22.2% failure for pulsed act-D and 11.6% failure for the 5-day act-D is not statistically significant; P=0.45(Fisher's exact test, two tails). Many studies, both of act-D and of methotrexate, may be invalid because the criteria for diagnosing GTN are not sufficiently stringent, yet all our current practice is based on the reported literature. The data from the present study illustrates the difficulties of drawing valid conclusions from the information available in the literature. Before assuming that less drug for less time is the best procedure a prospective randomized study embodying stringent diagnostic criteria and uniform patient attributes appears to be indicated.