Garcia-del-Muro Xavier, Maroto Pablo, Gumà Josep, Sastre Javier, López Brea Marta, Arranz José A, Lainez Nuria, Soto de Prado Diego, Aparicio Jorge, Piulats José M, Pérez Xavier, Germá-Lluch Josep R
Genitourinary Tumors and Sarcoma Unit, Department of Medical Oncology, Institut Català d'Oncologia L'Hospitalet, Barcelona, Spain.
J Clin Oncol. 2008 Nov 20;26(33):5416-21. doi: 10.1200/JCO.2007.15.9103. Epub 2008 Oct 20.
To assess the long-term efficacy and toxicity of front-line cisplatin-based chemotherapy in patients with stage IIA or IIB testicular seminoma.
Untreated patients with pure seminoma of the testis after orchiectomy, with clinical stage IIA or IIB, were considered eligible for this prospective observational study. Chemotherapy consisted of either four cycles of cisplatin and etoposide or three cycles of cisplatin, etoposide, and bleomycin.
Between April 1994 and March 2003, 72 patients were entered onto the study at 26 participating centers. Eighteen patients had stage IIA disease, and 54 patients had stage IIB disease. Eighty-three percent of patients achieved complete response, and 17% achieved partial response with residual mass. After a median follow-up time of 71.5 months, six patients with stage IIB disease experienced relapse, and one of these patients died as a result of seminoma. Three patients experienced non-seminoma-related deaths (two died from a further esophageal carcinoma, and one died from an upper digestive hemorrhage). The estimated 5-year progression-free survival rates for patients with stage IIA or IIB disease were 100% and 87% (95% CI, 77.5% to 97%), respectively. Five-year progression-free and overall survival rates for the whole group were 90% (95% CI, 82% to 98%) and 95% (95% CI, 89% to 100%), respectively. Severe granulocytopenia and thrombocytopenia were observed in eight and two patients, respectively. Mild to moderate emesis, stomatitis, and diarrhea were the most common nonhematologic effects.
Chemotherapy is a highly effective and well-tolerated treatment for patients with stage IIA or IIB seminoma and represents an available alternative that could avoid some of the serious late effects associated with radiotherapy. Further studies focusing on long-term toxicities of different treatment modalities are needed.
评估一线顺铂为基础的化疗方案对IIA期或IIB期睾丸精原细胞瘤患者的长期疗效和毒性。
睾丸切除术后未经治疗的纯睾丸精原细胞瘤患者，临床分期为IIA期或IIB期，被认为符合这项前瞻性观察性研究的条件。化疗方案包括四个周期的顺铂和依托泊苷，或三个周期的顺铂、依托泊苷和博来霉素。
1994年4月至2003年3月期间，26个参与中心的72例患者进入该研究。18例患者为IIA期疾病，54例患者为IIB期疾病。83%的患者达到完全缓解，17%的患者有残留肿块达到部分缓解。中位随访时间71.5个月后，6例IIB期疾病患者出现复发，其中1例患者因精原细胞瘤死亡。3例患者发生非精原细胞瘤相关死亡（2例死于另发的食管癌，1例死于上消化道出血）。IIA期或IIB期疾病患者的估计5年无进展生存率分别为100%和87%（95%CI，77.5%至97%）。全组的5年无进展生存率和总生存率分别为90%（95%CI，82%至98%）和95%（95%CI，89%至100%）。分别有8例和2例患者观察到严重粒细胞减少和血小板减少。轻至中度呕吐、口腔炎和腹泻是最常见的非血液学不良反应。
化疗对IIA期或IIB期精原细胞瘤患者是一种高效且耐受性良好的治疗方法，是一种可避免一些与放疗相关严重晚期效应的可用替代方案。需要进一步研究不同治疗方式的长期毒性。
