Athanassiou A E, Potamianou A, Bountouroglou N, Ziras N, Frangoulidis A, Varthalitis J, Karvounis N, Chrysanthou C, Pectasidis D
Department of Medical Oncology A, Metaxa Cancer Hospital, Piraeus, Greece.
J BUON. 2002 Jan-Mar;7(1):35-41.
To evaluate the antitumor activity and toxicity of methotrexate (M), etoposide (V), ifosfamide (I) and cisplatin (P) combination chemotherapy (MVIP) administered to chemotherapy-naive patients with intermediate / poor prognosis germ-cell tumors (GCT) according to the International Germ Cell Cancer Collaborative Group (IGCCCG) consensus classification system (IGCCC).
From 1992 to 2001 24 consecutive intermediate (n=14)/poor prognosis (n=10) GCT male patients entered prospectively this phase II trial. Patients received methotrexate 250 mg/m(2), day 1, with folinic acid rescue; cisplatin 100 mg/m(2) with appropriate hydration, day 3; ifosfamide 5 g/m(2) with mesna uroprotection, day 3; and etoposide 100 mg/m(2)/day, days 3-5. MVIP was repeated every 3 weeks.
After 120 cycles of MVIP (median 5, range 2- 7) 18 (75%) patients achieved complete remission (CR). CR was attained by 12 out of 14 (86%) intermediate prognosis and 6 out of 10 (60%) poor prognosis patients. Three CR patients (2 intermediate, 1 poor prognosis) of out 18 (16.7%) relapsed after a median of 6 months and 1 of them (poor prognosis) achieved a durable CR with second-line chemotherapy. After a median follow-up of 37 months (range 5-115 months) 16 patients (10, 71% intermediate and 6, 60% poor prognosis) are long-term survivors with no evidence of disease (NED), and 2 (one of each group) are alive with disease. Actuarial overall survival at 3 and more years is 75% and NED survival is 67%. Hematologic toxicity was most common and easily manageable (grade 3-4 neutropenia 46% of the cycles and thrombocytopenia 25% of the cycles). There were no deaths, withdrawals or delays in chemotherapy administration because of toxicity.
MVIP conventional chemotherapy proved very effective in terms of CR rate, overall survival and longterm NED survival in these unfavorable groups of GCT patients. The results obtained are encouraging and compare favorably with those taken by more intensive regimens including high-dose chemotherapy. We believe that MVIP justifies further studies.
根据国际生殖细胞癌协作组(IGCCCG)共识分类系统(IGCCC),评估甲氨蝶呤(M)、依托泊苷(V)、异环磷酰胺(I)和顺铂(P)联合化疗(MVIP)用于初治的预后中等/较差的生殖细胞肿瘤(GCT)患者的抗肿瘤活性和毒性。
1992年至2001年,24例连续的预后中等(n = 14)/较差(n = 10)的GCT男性患者前瞻性地进入了该II期试验。患者在第1天接受甲氨蝶呤250 mg/m²,同时给予亚叶酸解救;第3天给予顺铂100 mg/m²并进行适当水化;第3天给予异环磷酰胺5 g/m²并使用美司钠进行尿路保护;第3至5天给予依托泊苷100 mg/m²/天。MVIP每3周重复一次。
在120个周期的MVIP治疗后(中位周期数为5,范围2 - 7),18例(75%)患者达到完全缓解(CR)。14例预后中等的患者中有12例(86%)达到CR,10例预后较差的患者中有6例(60%)达到CR。18例CR患者中有3例(2例预后中等,1例预后较差)在中位6个月后复发,其中1例(预后较差)通过二线化疗获得了持久的CR。中位随访37个月(范围5 - 115个月)后,16例患者(10例预后中等的患者中的71%和6例预后较差的患者中的60%)为无疾病证据(NED)的长期幸存者,2例(每组各1例)仍患有疾病存活。3年及以上的精算总生存率为75%,NED生存率为67%。血液学毒性最为常见且易于处理(3 - 4级中性粒细胞减少占周期数的46%,血小板减少占周期数的25%)。没有因毒性导致的死亡、退出或化疗延迟。
在这些预后不良的GCT患者组中,MVIP传统化疗在CR率、总生存率和长期NED生存率方面证明非常有效。所获得的结果令人鼓舞,与包括高剂量化疗在内的更强化方案的结果相比具有优势。我们认为MVIP值得进一步研究。