Current Clinical Trials

Note: Some citations in the text of this section are followed by a level of evidence. The PDQ editorial boards use a formal ranking system to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more information.)

Standard treatment options (in order of decreasing effectiveness):

1. Repeat surgical resection, particularly for local recurrences and, in some cases, pleural and pericardial implants. Postoperative radiation therapy has been used for patients with incomplete resections and has been employed in selected patients following complete resection of recurrent thymoma.[1]
2. Radiation therapy (when possible, based on previous treatment).
3. Corticosteroids in unresectable tumors that have not responded to radiation therapy.

Treatment options under clinical evaluation:

1. Chemotherapy: Only a few phase II clinical studies have evaluated the role of chemotherapy. Because of the rarity of these cancers, all series of patients have been relatively small and reflect weak evidence. Combination chemotherapy, however, has been reported to produce complete and partial remissions; some of the complete remissions have been pathologically confirmed at subsequent surgery. In a series of 30 patients with stage IV or locally progressive recurrent tumor following radiation therapy, the PAC regimen (cisplatin, doxorubicin, cyclophosphamide) achieved a 50% response rate, including three complete responses. The median duration of response was 12 months, and 5-year survival was 32%.[2][Level of evidence: 3iiiDiv] In another study, the ADOC regimen (doxorubicin, cisplatin, vincristine, cyclophosphamide) produced a 92% response rate (34 of 37 patients), including complete responses in 43% of patients.[3] One study of combined chemotherapy with cisplatin and etoposide produced responses in 9 of 16 patients treated, with a median response duration of 3.4 years and a median survival of 4.3 years.[4] Nine of 28 patients with invasive thymoma or thymic carcinoma who received four cycles of etoposide, ifosfamide, and cisplatin at 3-week intervals had partial responses.[5] The median duration of response was 11.9 months (range, <1 to 26 months), and the median overall survival was 31.6 months. The 1-year and 2-year survival rates were 89% and 70%, respectively.[5][Level of evidence: 3iiiDiv]

   Of uncertainty is whether combination chemotherapy regimens are more effective than single agents; no randomized comparisons have been conducted. A partial response rate of only 10% (2 of 20 patients) was observed in a phase II study (EST-2582) of cisplatin alone (50 mg/m² every 21 days).[6] A retrospective analysis of 17 patients treated with cisplatin with or without prednisone over a 10-year period, however, revealed an overall response rate of 64%.[7] Five complete responses and one partial response were observed in 13 patients with advanced thymoma in a prospective study of single-agent ifosfamide.[8] Transient partial responses to corticosteroids have also been noted. Corticosteroids and many chemotherapeutic agents are lympholytic; shrinkage of thymic tumors with substantial lymphoid cell infiltration may reflect shrinkage of the nonmalignant components of the tumors rather than the malignant epithelial components.

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with thymoma and thymic carcinoma. 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. Urgesi A, Monetti U, Rossi G, et al.: Aggressive treatment of intrathoracic recurrences of thymoma. Radiother Oncol 24 (4): 221-5, 1992.  [PUBMED Abstract]
   
   
2. Loehrer PJ Sr, Kim K, Aisner SC, et al.: Cisplatin plus doxorubicin plus cyclophosphamide in metastatic or recurrent thymoma: final results of an intergroup trial. The Eastern Cooperative Oncology Group, Southwest Oncology Group, and Southeastern Cancer Study Group. J Clin Oncol 12 (6): 1164-8, 1994.  [PUBMED Abstract]
   
   
3. Fornasiero A, Daniele O, Ghiotto C, et al.: Chemotherapy for invasive thymoma. A 13-year experience. Cancer 68 (1): 30-3, 1991.  [PUBMED Abstract]
   
   
4. Giaccone G, Ardizzoni A, Kirkpatrick A, et al.: Cisplatin and etoposide combination chemotherapy for locally advanced or metastatic thymoma. A phase II study of the European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group. J Clin Oncol 14 (3): 814-20, 1996.  [PUBMED Abstract]
   
   
5. Loehrer PJ Sr, Jiroutek M, Aisner S, et al.: Combined etoposide, ifosfamide, and cisplatin in the treatment of patients with advanced thymoma and thymic carcinoma: an intergroup trial. Cancer 91 (11): 2010-5, 2001.  [PUBMED Abstract]
   
   
6. Bonomi PD, Finkelstein D, Aisner S, et al.: EST 2582 phase II trial of cisplatin in metastatic or recurrent thymoma. Am J Clin Oncol 16 (4): 342-5, 1993.  [PUBMED Abstract]
   
   
7. Park HS, Shin DM, Lee JS, et al.: Thymoma. A retrospective study of 87 cases. Cancer 73 (10): 2491-8, 1994.  [PUBMED Abstract]
   
   
8. Harper PG, Highly M, Rankin E, et al.: Ifosfamide monotherapy demonstrates high activity in malignant thymoma. [Abstract] Proceedings of the American Society of Clinical Oncology 10: A-1049, 300, 1991. 
   
   

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