Sleijfer S, Willemse P H, de Vries E G, van der Graaf W T, Schraffordt Koops H, Mulder N H
Department of Internal Medicine, University Hospital, Groningen, The Netherlands.
Br J Cancer. 1996 Sep;74(6):947-50. doi: 10.1038/bjc.1996.462.
This study describes the efficacy and toxicity of a combination regimen consisting of cyclophosphamide, vincristine (oncovin) and carboplatin (COC) for advanced seminoma on an outpatient basis. Twenty-seven patients (mean age 43 years, range 28-63 years) were classified as stage IIC (n = 5), stage IID (n = 12), stage III (n = 9) or stage IV (n = 1). Six had been treated with prior radiotherapy; elevated beta-HCG and elevated LDH serum levels were observed in 15 and 25 patients respectively. Patients were treated with four cycles of 750 mg m-2 cyclophosphamide intravenously (i.v.), 1.4 mg m-2 vincristine i.v. (maximum 2 mg) and carboplatin adjusted to creatinine clearance. Cycles were given at 3 week intervals. The median dose of carboplatin administered was 400 mg m-2 (range 300-450 mg m-2). Six patients [22%; 95% confidence interval (CI), 6-38%] achieved a complete response (CR), 19 (70%; 95% CI, 51-88%) a partial response and two (8%; 95% CI, 0 18%) showed only a response in tumour markers but not a reduction of retroperitoneal mass (NR). Post-chemotherapeutic masses were not removed surgically or irradiated. After a median follow-up of 26 months (range 5-69 months), two patients have died, one from cardiac arrest 2 years after achieving CR, the other with relapsed seminoma 5 months after therapy. None of the other patients relapsed. Main toxicity was haematological, with 22 patients (81%) experiencing thrombocytopenia WHO grade III/IV and 27 (100%) leucocytopenia WHO grade III/IV, requiring dose reduction in five patients. Seven patients experienced granulocytopenic fever. Non-haematological toxicity was rare. Peripheral neuropathy grade I was observed in four patients and grade III in one. Haemorrhagic cystitis occurred once. In conclusion, despite considerable haematological toxicity, COC is feasible on an outpatient basis, even after prior radiotherapy, and is an effective regimen for advanced seminoma with only 1/27 treatment failures after a median follow-up of 26 months.
本研究描述了环磷酰胺、长春新碱（癌可平）和卡铂（COC）联合方案对晚期精原细胞瘤门诊治疗的疗效和毒性。27例患者（平均年龄43岁，范围28 - 63岁）分为II C期（n = 5）、II D期（n = 12）、III期（n = 9）或IV期（n = 1）。6例曾接受过放疗；15例和25例患者分别观察到β-HCG升高和乳酸脱氢酶血清水平升高。患者接受4个周期的治疗，静脉注射750 mg/m²环磷酰胺、1.4 mg/m²长春新碱（最大2 mg），卡铂根据肌酐清除率调整剂量。周期每3周进行一次。卡铂的中位给药剂量为400 mg/m²（范围300 - 450 mg/m²）。6例患者[22%；95%置信区间（CI），6 - 38%]达到完全缓解（CR），19例（70%；95% CI，51 - 88%）部分缓解，2例（8%；95% CI，0 - 18%）仅肿瘤标志物有反应但腹膜后肿块未缩小（NR）。化疗后的肿块未进行手术切除或放疗。中位随访26个月（范围5 - 69个月）后，2例患者死亡，1例在达到CR后2年因心脏骤停死亡，另1例在治疗后5个月精原细胞瘤复发。其他患者均未复发。主要毒性为血液学毒性，22例患者（81%）出现WHO III/IV级血小板减少，27例（100%）出现WHO III/IV级白细胞减少，5例患者需要减量。7例患者出现粒细胞缺乏性发热。非血液学毒性罕见。4例患者观察到I级周围神经病变，1例为III级。出血性膀胱炎发生1次。总之，尽管有相当大的血液学毒性，但COC方案在门诊治疗是可行的，即使在先前接受过放疗的情况下，也是晚期精原细胞瘤的有效方案，中位随访26个月后仅27例中有1例治疗失败。
