Lashkari Ashkan, Chow Warren A, Valdes Frances, Leong Lucille, Phan Vu, Twardowski Przemyslaw, Kapoor Neena, Molina Arturo, Al-Kadhimi Zaid, Frankel Paul, Somlo George
City of Hope Comprehensive Cancer Center, Division of Medical Oncology, 1500 E. Duarte Road, Duarte, CA 91010, USA.
Anticancer Res. 2009 Aug;29(8):3281-8.
Patients with locally advanced or metastatic/recurrent soft tissue and Ewing's sarcoma (EWS) have few treatment options. The purpose of our phase II study was to assess the feasibility, safety and efficacy of tandem high-dose chemotherapy (HDCT) followed by autologous stem cell transplantation (ASCT) in such patients.
Thirteen patients were enrolled onto this study. The first cycle of HDCT consisted of doxorubicin (150 mg/m(2)) and ifosfamide (14 g/m(2)) mixed with mesna (14 g/m(2)), while the second cycle consisted of melphalan (150 mg/m(2)) and cisplatin (200 mg/m(2)).
Eleven out of 13 patients were able to complete both cycles of HDCT. No treatment-related mortality occurred and grade 3 or 4 toxicity was clinically tolerable. The 5-year progression-free survival (PFS) and overall survival (OS) for all patients was 23% (confidence interval, CI: 0-46%) and 31% (CI: 14-70%), respectively. Out of the four patients still alive, two had EWS and measurable disease at the time of ASCT and achieved a complete remission, remaining progression free 126 and 155 months after ASCT.
Our study demonstrates the feasibility and safety of tandem HDCT in patients with high-risk or metastatic/recurrent sarcoma, with some patients achieving long-term PFS and OS.
局部晚期或转移性/复发性软组织和尤因肉瘤(EWS)患者的治疗选择有限。我们这项II期研究的目的是评估串联大剂量化疗(HDCT)继以自体干细胞移植(ASCT)在此类患者中的可行性、安全性和疗效。
13例患者入组本研究。HDCT的第一个周期由阿霉素(150mg/m²)和异环磷酰胺(14g/m²)与美司钠(14g/m²)混合组成,而第二个周期由美法仑(150mg/m²)和顺铂(200mg/m²)组成。
13例患者中有11例能够完成两个周期的HDCT。未发生与治疗相关的死亡,3级或4级毒性在临床上可耐受。所有患者的5年无进展生存期(PFS)和总生存期(OS)分别为23%(置信区间,CI:0 - 46%)和31%(CI:14 - 70%)。在仍存活的4例患者中,2例在ASCT时患有EWS且疾病可测量,并实现了完全缓解,在ASCT后分别无进展存活126个月和155个月。
我们的研究证明了串联HDCT在高危或转移性/复发性肉瘤患者中的可行性和安全性,一些患者实现了长期的PFS和OS。