Management of intermediate‐prognosis germ‐cell cancer: Results of a phase I/II study of Taxol‐BEP
Management of intermediate‐prognosis germ‐cell cancer: Results of a phase I/II study of Taxol‐BEP
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中期预后生殖细胞癌的治疗：紫杉醇-BEP I/II 期研究结果
DOI：
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发表时间：
1999
影响因子：
6.4
通讯作者：
J. Schornagel
中科院分区：
文献类型：
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作者：
R. de Wit;M. Louwerens;P. D. De Mulder;J. Verweij;S. Rodenhuis;J. Schornagel
转移性生殖细胞癌的标准化疗方案是博莱霉素、依托泊苷和顺铂 (BEP)。测试顺铂剂量和异环磷酰胺替代博莱霉素的化疗研究并未表明其优于 BEP。紫杉醇（Taxol）已被证明作为复发性或顺铂难治性生殖细胞癌患者的二线治疗具有良好的活性。因此，应研究将紫杉醇纳入一线化疗的潜力。我们在一项 I/II 期研究中评估了在 BEP (T-BEP) 中添加紫杉醇的可行性，该研究针对的是中等或不良预后的生殖细胞癌或原发灶不明的癌 (CUP) 患者。在 BEP 开始前的第 1 天，对紫杉醇进行了研究，剂量水平为 75、125、175 和 200 mg/m2，输注时间为 3 小时。 BEP 包含依托泊苷，剂量为第 1、3 和 5 天 120 mg/m2 或第 1-5 天 100 mg/m2。为了将尽可能高剂量的紫杉醇输送到 BEP 中，所有患者均接受非格司亭 (G-CSF) 治疗。研究共纳入 30 名患者，其中 14 名患有中等（n = 7）或不良（n = 7）预后生殖细胞癌。高达 200 mg/m2 的紫杉醇和 360 mg/m2 的 BEP 耐受性良好。使用 4 个 T-BEP 周期时，神经感觉毒性最小，没有神经运动毒性。较高剂量的依托泊苷产生更明显的骨髓毒性和腹泻，因此紫杉醇 175 mg/m2 和 BEP 500 mg/m2 的多中心 II/III 期试验的推荐剂量水平。在 13 名可评估的中等或不良预后生殖细胞癌患者中，全部实现了完全缓解。中位随访 18 个月后，这些患者均未复发。我们的结论是，T-BEP 是一种耐受性良好的诱导方案，应进一步测试其治疗潜力。 T-BEP 与 BEP 的随机 II/III 期研究已经开始，作为针对中期预后疾病患者的 EORTC 试验。国际。 J. Cancer 83:831–833, 1999。© 1999 Wiley-Liss, Inc.
The standard chemotherapy regimen in metastatic germ‐cell cancer is bleomycin, etoposide and cisplatin (BEP). Chemotherapy studies testing cisplatin dosage and the substitution of ifosfamide for bleomycin have not shown this to be superior to BEP. Paclitaxel (Taxol) has demonstrated promising activity as a second‐line treatment in patients with relapsing or cisplatin‐refractory germ‐cell cancer. Hence, the potential of incorporating paclitaxel in first‐line chemotherapy should be investigated. We assessed the feasibility of the addition of paclitaxel to BEP (T‐BEP) in a phase I/II study in patients with intermediate‐ or poor‐prognosis germ‐cell cancer or with carcinoma of unknown primary (CUP). Paclitaxel was investigated at dose levels of 75, 125, 175 and 200 mg/m2 given as a 3 hr infusion on day 1, before the start of BEP. BEP comprised etoposide at a dose of either 120 mg/m2 on days 1, 3 and 5 or 100 mg/m2 on days 1–5. To deliver the highest possible dose of paclitaxel into BEP, all patients received filgrastim (G‐CSF). Thirty patients were entered, 14 of whom had intermediate‐ (n =7) or poor‐ (n = 7) prognosis germ‐cell cancer. Paclitaxel up to 200 mg/m2 and BEP at 360 mg/m2 was well tolerated. There was minimal neurosensory and no neuromotor toxicity with the use of 4 T‐BEP cycles. More pronounced myelotoxicity and diarrhea at the higher dose level of etoposide resulted in a recommended dose level for multicenter phase II/III testing of paclitaxel 175 mg/m2 and BEP 500 mg/m2. Of the 13 evaluable patients with intermediate‐ or poor‐prognosis germ‐cell cancer, all achieved complete response. With a median follow‐up of 18 months, none of these patients has relapsed. We conclude that T‐BEP is a well‐tolerated induction regimen that should be further tested for its therapeutic potential. A randomized phase II/III study of T‐BEP vs. BEP has been started as an EORTC trial in patients with intermediate‐prognosis disease. Int. J. Cancer 83:831–833, 1999. © 1999 Wiley‐Liss, Inc.
紫杉醇的 II 期试验显示出对先前接受过治疗的生殖细胞肿瘤患者的抗肿瘤活性。
DOI：
10.1200/jco.1994.12.11.2277
发表时间：
1994
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
Motzer,RJ;Bajorin,DF;Schwartz,LH;Hutter,HS;Bosl,GJ;Scher,HI;Lyn,P;Fischer,P
通讯作者：
Fischer,P
影响因子：
45.3
作者：
Nichols, CR;Catalano, PJ;Loehrer, PJ
通讯作者：
Loehrer, PJ