Current Clinical Trials

Patients with any of the high-risk factors fall into this category. Patients with a WHO score greater than eight are considered to be especially (“ultra”) high-risk. Therapy needs to be instituted quickly and should consist of multiple-agent chemotherapy. Additional therapy (including radiation to central nervous system metastases and adjuvant surgery) is often necessary. These patients should be treated at a regional Trophoblastic Disease Center or by a physician with prior experience in treating poor-risk patients. Radiation to liver metastasis is contraindicated since it has no clear value and leads to myelosuppression that may make administration of cytotoxic chemotherapy more difficult.

Standard treatment options:

For patients with a WHO prognostic score less than eight:

• EMA-CO: etoposide plus methotrexate plus dactinomycin and vincristine plus cyclophosphamide.[1-3] A dose-intensive regimen, EMA-CE, in which etoposide and cisplatin are substituted for vincristine and cyclophosphamide of the EMA-CO regimen, may offer additional benefits.[4]

For patients with a WHO prognostic score greater than eight:

• EMA-CO.[1] A dose-intensive regimen, EMA-CE, may offer additional benefits.[4]

Other regimens that may produce similar outcome but have been studied less extensively or are in less common use include:

• APE: dactinomycin plus cisplatin plus etoposide. [5]
• PVB: cisplatin plus vinblastine plus bleomycin. [6]
• PEBA: cisplatin plus etoposide plus bleomycin plus adriamycin. [7]
• Ifosfamide plus carboplatin plus etoposide with autologous bone marrow transplant. [8]

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with poor prognosis metastatic gestational trophoblastic tumor ¹. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site ².

References

1. Soper JT, Evans AC, Clarke-Pearson DL, et al.: Alternating weekly chemotherapy with etoposide-methotrexate-dactinomycin/cyclophosphamide-vincristine for high-risk gestational trophoblastic disease. Obstet Gynecol 83 (1): 113-7, 1994.  [PUBMED Abstract]
   
   
2. Newlands ES, Bagshawe KD, Begent RH, et al.: Results with the EMA/CO (etoposide, methotrexate, actinomycin D, cyclophosphamide, vincristine) regimen in high risk gestational trophoblastic tumours, 1979 to 1989. Br J Obstet Gynaecol 98 (6): 550-7, 1991.  [PUBMED Abstract]
   
   
3. Bower M, Newlands ES, Holden L, et al.: EMA/CO for high-risk gestational trophoblastic tumors: results from a cohort of 272 patients. J Clin Oncol 15 (7): 2636-43, 1997.  [PUBMED Abstract]
   
   
4. Surwit EA, Childers JM: High-risk metastatic gestational trophoblastic disease. A new dose-intensive, multiagent chemotherapeutic regimen. J Reprod Med 36 (1): 45-8, 1991.  [PUBMED Abstract]
   
   
5. Theodore C, Azab M, Droz JP, et al.: Treatment of high-risk gestational trophoblastic disease with chemotherapy combinations containing cisplatin and etoposide. Cancer 64 (9): 1824-8, 1989.  [PUBMED Abstract]
   
   
6. Azab M, Droz JP, Theodore C, et al.: Cisplatin, vinblastine, and bleomycin combination in the treatment of resistant high-risk gestational trophoblastic tumors. Cancer 64 (9): 1829-32, 1989.  [PUBMED Abstract]
   
   
7. Chen LP, Cai SM, Fan JX, et al.: PEBA regimen (cisplatin, etoposide, bleomycin, and adriamycin) in the treatment of drug-resistant choriocarcinoma. Gynecol Oncol 56 (2): 231-4, 1995.  [PUBMED Abstract]
   
   
8. Lotz JP, André T, Donsimoni R, et al.: High dose chemotherapy with ifosfamide, carboplatin, and etoposide combined with autologous bone marrow transplantation for the treatment of poor-prognosis germ cell tumors and metastatic trophoblastic disease in adults. Cancer 75 (3): 874-85, 1995.  [PUBMED Abstract]