A PROSPECTIVE, PHASE II TRIAL OF INDUCTION CHEMOTHERAPY WITH DOCETAXEL/CISPLATIN FOR MASAOKA STAGE III/IV THYMIC EPITHELIAL TUMORS

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Abstract

Background

Thymic epithelial tumors (TETs), thymoma and thymic carcinoma, are the most common tumor of the anterior mediastinum. Initial complete resection is the most powerful prognostic indicator of survival. However, it is obviously related to stage. Here, we report the result of a prospective phase II study of neoadjuvant docetaxel/cisplatin in patients with locally advanced TETs.

Methods

In this open-label, phase II, non-randomized study, patients with histologically proven, masaoka stage III/IV TETs at presentation were enrolled. Patients received docetaxel 75 mg/m2 I.V for 1 h, followed by I.V cisplatin 75 mg/m2 over 1.5 h on day 1 of every 3 week. After 3 cycles of chemotherapy, subsequent surgical resection was carried out, if resectable.

Results

From March 2007 to July 2011, a total of 27 TETs patients were entered into the trial. The median age was 54 (range, 15–68), and Masaoka stage at presentation was III (n = 8, 29.6%), IVA (n = 17, 63.0%), and IVB (n = 2, 7.4%). Histologic type by the WHO includes type B1 (n = 2, 7.4%), B2 (n = 3, 11.1%), B3 (n = 5, 18.5%), and thymic carcinoma designated as type C (n = 16, 59.3%). After completion of neoadjuvant chemotherapy, 17 (63.0%) achieved PR and 10 (37.0%) had SD. Nineteen patients (70.4%) underwent surgical resection, and 8 patients did not (surgeons' decision, n = 5; patients' refusal, n = 2; radiation therapy, n = 1). Of the 19 patients undergoing surgical resection, 17 (89.5%) had complete resections and 2 (10.5%) did not. Major side-effects of chemotherapy include grade 3 anorexia (n = 1), nausea (n = 2), diarrhea (n = 3), alopecia (n = 1). After completion of surgical resection, adjuvant therapy was carried out as follows: radiotherapy (RT, n = 8), chemotherapy (CTx, n = 6), radiotherapy with chemotherapy (RT + CTx, n = 2) and observation (n = 3). Overall, 4-year OS and PFS was 79.4 and 40.6%. Patients with complete resection showed 93.8% of 4-year OS and 50.2% of 4-year PFS whereas patients without complete resection showed 47.6% of 4-year OS and 26.7% of 4-year PFS, respectively (OS, P = 0.06; PFS, P = 0.27).

Conclusions

Neoadjuvant docetaxel/cisplatin was well tolerated and feasible and improved the surgical respectability in patients with advanced TETs.

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