4 CYCLES OF BEP VERSUS AN ALTERNATING REGIME OF PVB AND BEP IN PATIENTS WITH POOR-PROGNOSIS METASTATIC TESTICULAR NONSEMINOMA - A RANDOMIZED STUDY OF THE EORTC GENITOURINARY TRACT CANCER COOPERATIVE GROUP
4 CYCLES OF BEP VERSUS AN ALTERNATING REGIME OF PVB AND BEP IN PATIENTS WITH POOR-PROGNOSIS METASTATIC TESTICULAR NONSEMINOMA - A RANDOMIZED STUDY OF THE EORTC GENITOURINARY TRACT CANCER COOPERATIVE GROUP
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DOI：
10.1038/bjc.1995.254
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发表时间：
1995-06-01
影响因子：
8.8
通讯作者：
SYLVESTER, R
中科院分区：
文献类型：
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作者：
DEWIT, R;STOTER, G;SYLVESTER, R
我们研究了PVB/BEP交替诱导化疗方案在预后不良的睾丸非肿瘤患者中是否优于BEP上级方案。共有234名合格患者随机接受PVB/BEP交替方案治疗，共治疗4个周期或4个周期的BEP。预后不良的定义是：淋巴结转移大于5 cm，肺转移大于4个或大于2 cm，血细胞扩散到肺外，如肝和骨，人绒毛膜促性腺激素> 10000 IU 1（-1）或甲胎蛋白> 1000 IU 1（-1）。PVB/BEP和BEP的完全缓解（CR）率相似，分别为76%和72%（P = 0.58）。此外，在平均6年随访时，复发率、无病生存率和总生存率无显著差异。两个治疗组的5年无进展率和生存率均接近80%。PVB/BEP方案对骨髓功能的毒性更大，在4个周期中，白细胞低于1000 μ l（-1）、白细胞减少性发热和血小板低于25000 μ l（-1）的频率分别为28% vs 5%（P < 0.001）、16% vs 5%（P = 0.006）和10% vs 1%（P = 0.001）。PVB/BEP组神经病变的发生率也更高：47% vs 25%（P = 0.001）。这项研究表明，PVB/BEP交替方案并不上级于BEP，并且它具有更强的骨髓和神经毒性。
We have investigated whether an alternating induction chemotherapy regimen of PVB/BEP is superior to BEP in patients with poor-prognosis testicular non-seminoma. A total of 234 eligible patients were randomised to receive an alternating schedule of PVB/BEP for a total of foul cycles or four cycles of BEP. Poor prognosis Was defined as any of the following: lymph node metastases larger than 5 cm, lung metastases more than four in number or larger than 2 cm, haematogenic spread outside the lungs, such as in liver and bone, human chorionic gonadotrophin > 10000 IU 1(-1) or alphafetoprotein > 1000 IU 1(-1). The complete response (CR) rates to PVB/BEP and BEP were similar, 76% and 72% respectively (P = 0.58). In addition, there was no significant difference in relapse rate, disease-free and overall survival at an average follow-up of 6 years. The 5-year progression-free and survival rates in both treatment groups were approximatley 80%. The PVB/BEP regime was more toxic with regard to bone marrow function; the frequencies of leucocytes below 1000 mu l(-1), leucocytopenic fever and platelets below 25000 mu l(-1), throughout four cycles were 28% vs 5% (P < 0.001), 16% vs 5% (P = 0.006), and 10% vs 1% (P = 0.001) respectively. Neuropathy also occurred more often in the PVB/BEP arm: 47% vs 25% (P = 0.001). This study shows that an alternating regimen of PVB/BEP is not superior to BEP and that it is more myelo- and neurotoxic.