The key evidence for this regimen comes from several studies:
In the study by Newlands et al,r the efficacy, toxicity and survival in patients with high risk gestational trophoblastic tumours treated with EMA/CO was assessed. Between 1979 and 1989, a total of 148 patients were enrolled to this open non-randomised study. 76 patients had received no prior chemotherapy and 72 patients had received prior chemotherapy.
In the study by Turan et al,r the efficacy and toxicity of EMA/CO for the treatment of high-risk gestational trophoblastic neoplasia (GTN) was evaluated. Between 1994 and 2004, a total of 33 patients with high-risk GTN, scored according to the WHO classification of risk groups were treated with EMA/CO. 23 patients were treated primarily with EMA/CO and 10 patients were treated secondarily after failure of prior chemotherapy.
In the study by Lurain et al, the efficacy of EMA/CO in the primary treatment of metastatic high-risk gestational trophoblastic neoplasia was evaluated. Between 1986 and 2005, a total of 30 women were treated primarily with EMA/CO.
In the study by Quinn et al,r a total of 65 patients were treated with EMA/CO between 1981 and 1990. Patients with evidence of CNS metastases were given further treatment with intrathecal methotrexate and an increased dose of intravenous methotrexate. The mean age of the women was 27 years and 94% of these women were disease free after a period of 10 years follow-up.
In the study by Newlands et al,r the overall survival rate was 85% for the 148 patients. Of the 76 patients who had received no prior chemotherapy, 82% were in remission and of the 72 patients who had received prior chemotherapy, 89% were in remission.
In the study by Turan et al,r the overall survival rate was 91% with survival rates of 90% for primary and secondary treatment respectively. Drug resistance was found to be 18.2% and recurrence was observed in 3.6% of patients.
In the study by Lurain et al, the overall survival rate was 93.3% with 66.7% having a lasting clinical response and 26.7% developing drug resistance.
None of the chemotherapy schedules was cancelled or changed because toxicity. Treatment was deferred in 12% of cases. Febrile neutropenia developed in 1 patient (3%) and 3 patients required G-CSF for grade 4 leukopenia and 2 patients for grade 3 leukopenia and concurrent infection.r
Secondary tumour development is known to increase slightly with EMA/CO but this is uncertain. Newlands et al did not find any secondary tumours in the 12 year follow up.r
|Adverse event r
||Grade 1 to 2 (%)
||Grade 3 to 4 (%)
|Nausea and vomiting
© International Journal of Gynaecological Cancer 2006