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. 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.

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]
   
   

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