Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
J Thorac Oncol. 2013 Jul;8(7):959-66. doi: 10.1097/JTO.0b013e318292c41e.
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.
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.
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.
Neoadjuvant docetaxel/cisplatin is both feasible and well tolerated, and potentially improves surgical resectability in patients with advanced TETs.
在胸腺瘤（TET）中，完全初始切除是生存的有力预后指标，但显然与肿瘤分期有关。在这里，我们报告了新辅助多西紫杉醇/顺铂在局部晚期 TET 中的前瞻性研究结果。
在本开放性、二期、非随机研究中，纳入了组织学证实的 Masaoka 分期 III/IV 期 TET 患者。患者每 3 周周期的第 1 天接受静脉注射多西紫杉醇 75mg/m²，随后静脉注射顺铂 75mg/m²。如果肿瘤被认为可切除，则在三个周期后进行手术切除。
从 2007 年 3 月至 2011 年 7 月，共有 27 例患者参加了试验。就诊时的 Masaoka 分期为 III 期（n=8；29.6%）、IVA 期（n=17；63.0%）和 IVB 期（n=2；7.4%）。组织学类型为 9 例胸腺瘤（33.3%）和 18 例胸腺癌（66.7%）。新辅助化疗完成后，17 例患者（63.0%）部分缓解，10 例患者（37.0%）疾病稳定。19 例患者（70.4%）接受了手术，8 例患者因外科医生决定（n=5）、患者拒绝（n=2）或决定接受放射治疗而未手术（n=1）。19 例患者中有 15 例达到完全切除（78.9%），意向治疗分析的完全切除率为 55.6%。最常见的 3 级以上严重程度的不良反应是中性粒细胞减少和腹泻。中位随访 42.6 个月后，所有患者的 4 年总生存率和无进展生存率分别为 79.4%和 40.6%。
新辅助多西紫杉醇/顺铂既可行又耐受良好，可潜在提高晚期 TET 患者的手术可切除性。
