A prospective phase II trial of induction chemotherapy with docetaxel/cisplatin for Masaoka stage III/IV thymic epithelial tumors.

BACKGROUND

Initial complete resection is a powerful prognostic indicator of survival in thymic epithelial tumors (TETs), but is obviously related to tumor stage. Here, we report the results of a prospective study of neoadjuvant docetaxel/cisplatin in locally advanced TETs.

METHODS

Patients with histologically proven, Masaoka stage III/IV TETs at presentation were enrolled in this open-label, phase II, nonrandomized study. Patients received docetaxel 75 mg/m² I.V, followed by cisplatin 75 mg/m² I.V on day 1 of every 3-week cycle. After three cycles, surgical resection was performed if the tumor was considered resectable.

RESULTS

From March 2007 to July 2011, 27 patients were enrolled in the trial. Masaoka stage at presentation was III (n = 8; 29.6%), IVA (n = 17; 63.0%), and IVB (n = 2; 7.4%). Histologic types were nine thymomas (33.3%) and 18 thymic carcinomas (66.7%). After completion of neoadjuvant chemotherapy, 17 patients (63.0%) achieved partial response and 10 (37.0%) had stable disease. Nineteen patients (70.4%) underwent surgery and eight did not because of surgeons' decision (n = 5), patient refusal (n = 2), or decision to undergo radiation therapy instead (n = 1). Fifteen among the 19 patients achieved complete resection (78.9%), which yields 55.6% of complete resection rate with intent-to-treat analysis. The most common side effects of severity greater than grade 3 were neutropenia and diarrhea. With a median follow-up of 42.6 months, 4-year overall survival, and progression-free survival in all patients was 79.4 and 40.6%, respectively.

CONCLUSION

Neoadjuvant docetaxel/cisplatin is both feasible and well tolerated, and potentially improves surgical resectability in patients with advanced TETs.