ONCOLOGY Methotrexate for 2000 FIGO low-risk gestational trophoblastic neoplasia patients: efficacy and toxicity Gihad Elias Chalouhi, MD; François Golfier, MD, PhD; Pauline Soignon, MD; Jerome Massardier, MD; Jean-Paul Guastalla, MD; Veronique Trillet-Lenoir, MD; Anne-Marie Schott, MD, PhD; Daniel Raudrant, MD OBJECTIVE: We sought to review efficacy and toxicity of an 8-day methotrexate (MTX) regimen in the treatment of patients with low-risk gestational trophoblastic neoplasia (GTN) from the French Trophoblas- tic Disease Reference Center. STUDY DESIGN: Between 1999 and 2006, 142 low-risk GTNs were diagnosed according to International Federation of Gynecology and Obstetrics (FIGO) criteria for GTN and to the FIGO scoring system. We report their characteristics, remission/resistance/recurrence rates, and treatment toxicity. RESULTS: The 8-day MTX regimen achieved a 77.5% remission rate. All patients but 1 (99.9%) achieved remission and remained disease free until the time of analysis. Severe (grade 3 or 4) blood/bone mar- row toxicity and metabolic/laboratory toxicity was noted in 4.2% of cases, of which 2 (1.4%) were grade 4. CONCLUSION: For patients with GTN diagnosed according to FIGO cri- teria and considered low risk according to the FIGO scoring system, an 8-day MTX regimen is an adequate treatment associating a high rate of remission to a low rate of toxicity. Key words: efficacy, low-risk gestational trophoblastic neoplasia, methotrexate, toxicity, 2000 International Federation of Gynecology and Obstetrics scoring Cite this article as: Chalouhi GE, Golfier F, Soignon P, et al. Methotrexate for 2000 FIGO low-risk gestational trophoblastic neoplasia patients: efficacy and toxicity. Am J Obstet Gynecol 2009;200:643.e1-643.e6. T he worldwide incidence of tropho- blastic disease ranges between 0.5- 8.3/1000 live births of which 5-20% evolve toward trophoblastic tumor and require chemotherapy. 1,2 Gestational trophoblastic neoplasia (GTN) 3 re- sponds excellently to chemotherapy 4 but needs to be treated by, or at least in con- sultation with, physicians experienced in the management of this disease spec- trum. 5 The morbidity and mortality is 9 times higher when an inexperienced physician treats such patients. 6 Once di- agnosed, this disease is staged according to the International Federation of Gyne- cology and Obstetrics (FIGO) 2000 clas- sification. 7,8 In 1956, Li et al 9 first suc- cessfully treated choriocarcinoma, fatal up until then, with methotrexate (MTX). Since then, chemotherapy using MTX emerged as first-line, single-agent ther- apy for low-risk (metastatic and non- metastatic) GTN. 4,10-14 Many single- agent MTX protocols were identified regarding the association with folinic acid, the dose, and the frequency within each treatment course. However, there is as yet no consensus on a single best reg- imen as the choice often depends on lo- cal experience. 15 In a previous publica- tion, we found it difficult to compare treatment results for GTN across the world because of the heterogeneity of pa- tient groups and because of the wide va- rieties in chemotherapy regimen used. 16 One of the aims of the 2000 FIGO stag- ing/scoring system was to minimize this heterogeneity to allow comparison of treatment results between published re- ports. In our Trophoblastic Disease Ref- erence Center, we decided to use this scoring system to define patients at low risk and we chose the modified regimen of Bagshawe et al 17 as first-line treat- ment. To date, there are scarce data of results of treatment for patients with GTN classified according to the FIGO scoring system. We report our experi- ence with low-risk trophoblastic tumors treated with single-agent MTX. MATERIALS AND METHODS The medical records of all the patients registered at the French Trophoblastic Disease Reference Center between No- vember 1999 and December 2006 were reviewed. After the diagnosis of tropho- blastic disease and first suction evacua- From the Université de Lyon, F-69622 (Drs Chalouhi, Golfier, Soignon, Massardier, Trillet- Lenoir, Schott, and Raudrant); Hospices Civils de Lyon, Hôtel-Dieu, Centre de Référence des Maladies Trophoblastiques (Drs Chalouhi, Golfier, Soignon, Massardier, Trillet-Lenoir, Schott, and Raudrant); Hospices Civils de Lyon, Hôtel-Dieu, Service de Gynécologie Obstétrique (Drs Chalouhi, Golfier, Soignon, Massardier, and Raudrant); Centre Hospitalier Lyon-Sud, Service de Chirurgie Gynécologique et Cancérologie (Drs Golfier, Massardier, and Raudrant); Centre Hospitalier Lyon-Sud, Service d’Oncologie Médicale (Dr Trillet-Lenoir); Hôpital Edouard Herriot, Département d’Information Médicale en Cancérologie et Cellule d’Appui Epidémiologique (Dr Schott); Centre Léon Bérard, Service d’Oncologie Médicale (Dr Guastalla), Lyon, France. Received July 29, 2008; revised Jan. 16, 2009; accepted March 6, 2009. Reprints: François Golfier, MD, PhD, Centre de Références des Maladies Trophoblastiques, Service de Gynécologie-Obstétrique, Hôtel-Dieu de Lyon, 1 Place de l’Hôpital, 69002, Lyon, France. francois.golfier@chu-lyon.fr. 0002-9378/$36.00 • © 2009 Mosby, Inc. All rights reserved. • doi: 10.1016/j.ajog.2009.03.011 Research www. AJOG.org JUNE 2009 American Journal of Obstetrics & Gynecology 643.e1