Actinomycin d versus methotrexate-folinic acid as the treatment of stage I, low-risk gestational trophoblastic neoplasia: a randomized controlled trial.

This study is to compare the remission and complication rates of actinomycin D (Act-D) and methotrexate-folinic acid (MTX-FA) as single-agent treatments of stage I, low-risk gestational trophoblastic neoplasia (GTN). From 1994 to 2005, all women with International Federation of Gynecology and Obstetrics stage I, low-risk GTN were randomly assigned to received either intravenous Act-D 10 microg/kg per day for 5 days every 2 weeks or intramuscular methotrexate 1 mg/kg per day on days 1, 3, 5, and 7 with intramuscular folinic acid 0.1 mg/kg per day on days 2, 4, 6, and 8 every 2 weeks. Forty-nine women met the eligibility criteria. Age, human chorionic gonadotropin level, and International Federation of Gynecology and Obstetrics score were similar in both treatment groups. Of the 22 women who received Act-D, 2 were lost to follow-up. Among the 27 women who received MTX-FA, 2 were lost to follow-up, and 6 had to switch to Act-D because of the rising levels of liver enzymes. All 20 women (100%) in the Act-D arm achieved remission compared with 14 (73.6%) in 19 women in the MTX-FA arm (P = 0.02). Mucositis and alopecia were reported more frequently in the Act-D group, whereas elevations of liver enzyme levels were more frequent in the MTX-FA group. Actinomycin D seems to be more effective than MTX-FA in the treatment of stage I, low-risk GTN. Larger multicenter randomized controlled trials should be conducted to establish the most appropriate regimen for these patients.

Detection of residual disease by cytology in patients with cervical intraepithelial neoplasia III post-large loop excision of the transformation zone.

OBJECTIVE: To evaluate the diagnostic accuracy of cytology in detecting residual disease in patients with cervical intraepithelial neoplasia (CIN) III post-large loop excision of the transformation zone (LLETZ). METHODS: This prospective study was performed between February 1994 and August 1999 at the Department of Obstetrics and Gynecology, Ramathibodi Hospital, and involved 90 patients who underwent LLETZ and had histologic confirmation of CIN III. Simple hysterectomy was performed in all patients 2-3 months after LLETZ. Two Papanicolaou smears were taken using Ayre spatula on each patient 6 weeks after LLETZ and 1 day before hysterectomy. Histologic findings of hysterectomy specimens were used as the 'gold standard'. RESULTS: Forty-six cases (51.1%) were found to have residual diseases: seven cases with CIN I, 11 cases with CIN II, 27 cases with CIN III and one case with invasive squamous cell carcinoma. Using the most severe diagnosis of two Papanicolaou smears performed on each patient as the cytologic diagnosis, the sensitivity, specificity, positive predictive value and negative predictive value were 28.3, 93.2, 81.3 and 55.4%, respectively. The accuracy rate was 60.0%. Residual diseases were found in 62.5 and 39.0% of cases with the presence and absence of CIN at the margin of the LLETZ specimen, respectively. CONCLUSION: Cytology using the Ayre spatula has low accuracy in detecting residual disease in the cervix post-LLETZ.