Aghajanian C, Fennelly D, Shapiro F, Waltzman R, Almadrones L, O'Flaherty C, O'Conner K, Venkatraman E, Barakat R, Curtin J, Brown C, Reich L, Wuest D, Norton L, Hoskins W, Spriggs D R
Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
J Clin Oncol. 1998 May;16(5):1852-60. doi: 10.1200/JCO.1998.16.5.1852.
We performed a pilot phase II study to evaluate the potential for delivery of rapidly sequenced high-dose chemotherapy treatments rescued with autologous peripheral-blood progenitor cells (PBP) in patients with previously untreated, advanced ovarian cancer.
A single cycle of mobilization was used, primed with cyclophosphamide (CPA)/paclitaxel (Txl) and filgrastim (granulocyte colony-stimulating factor [G-CSF]), followed by three cycles of high-dose carboplatin (CBDCA)/Txl and one cycle of high-dose melphalan (MEL), each rescued by PBP. We then analyzed the outcome for a total of 56 consecutive patients treated with high-dose chemotherapy as part of this program.
In the phase II pilot, 21 patients were enrolled. There were no treatment-related deaths through 98 high-dose treatments, although 34 treatments were complicated by hospitalization, primarily for neutropenic fever. Seventy-six percent of patients experienced grade 3 to 4 gastrointestinal toxicity and 62% experienced grade 2 to 3 neuropathy. Five of 15 (33%) patients who underwent second-look surgery attained a pathologic complete response. In the overall analysis, 56 patients were reviewed. Forty-four patients were assessable for response by second-look surgery or clinical progression. Fifteen of 44 patients achieved a pathologic complete response (34%). The pathologic complete response rate in optimal-disease patients was 12 of 22 (55%), while only three of 22 (13%) suboptimal stage III and IV patients achieved a pathologic complete response.
The Gynecologic Oncology Group has initiated a pilot phase II trial of this approach in patients with optimally debulked stage III ovarian cancer. There is no evidence to support the use of this or other aggressive regimens outside of a clinical trial.
我们开展了一项II期试点研究，以评估在先前未经治疗的晚期卵巢癌患者中，采用快速序贯大剂量化疗联合自体外周血祖细胞（PBP）救援治疗的可能性。
采用单周期动员方案，以环磷酰胺（CPA）/紫杉醇（Txl）和非格司亭（粒细胞集落刺激因子[G-CSF]）进行预处理，随后进行三个周期的大剂量卡铂（CBDCA）/Txl和一个周期的大剂量美法仑（MEL）治疗，每次治疗后均采用PBP救援。然后，我们分析了作为该方案一部分接受大剂量化疗的56例连续患者的治疗结果。
在II期试点研究中，纳入了21例患者。在98次大剂量治疗过程中没有与治疗相关的死亡病例，尽管有34次治疗出现了住院并发症，主要是中性粒细胞减少性发热。76%的患者出现3至4级胃肠道毒性，62%的患者出现2至3级神经病变。在接受二次探查手术的15例患者中，有5例（33%）达到了病理完全缓解。在总体分析中，对56例患者进行了评估。44例患者可通过二次探查手术或临床进展来评估反应。44例患者中有15例（34%）达到了病理完全缓解。最佳疾病状态患者的病理完全缓解率为22例中的12例（55%），而次优的III期和IV期患者中只有22例中的3例（13%）达到了病理完全缓解。
妇科肿瘤学组已针对最佳减瘤的III期卵巢癌患者启动了该方法的II期试点试验。没有证据支持在临床试验之外使用该方案或其他激进方案。
