Vinciguerra V, Propert K J, Coleman M, Anderson J R, Stutzman L, Pajak T F, Nissen N I, Frizzera G, Gottlieb A, Holland J F
J Clin Oncol. 1986 Jun;4(6):838-46. doi: 10.1200/JCO.1986.4.6.838.
A randomized clinical trial of combination chemotherapy for patients who relapsed following primary radiation therapy for Hodgkin's disease was conducted from 1975 to 1981 by the Cancer and Leukemia Group B (CALGB). One hundred thirteen patients were prospectively randomized to receive 12 cycles of either CVPP (CCNU, vinblastine, procarbazine, and prednisone), ABOS (bleomycin, vincristine [Oncovin; Lilly, Indianapolis], doxorubicin [Adriamycin, Adria Laboratories, Columbus, Ohio], and streptozotocin), or alternating cycles of CVPP and ABOS. The median length of observation for patients in this report is 4 years. Toxicities of the three treatment programs were primarily hematologic. Frequencies of complete response were 72% for CVPP, 70% for ABOS, and 82% for CVPP/ABOS (P = .37). Females and patients who had nodular sclerosing disease at initial diagnosis had significantly higher complete response rates. The 5-year disease-free survival for the complete responders was 55%; the 5-year overall survival was 60%. There were no significant differences among the treatments on disease-free survival (P = .78) or overall survival (P = .18). Age under 40 years was the only significant positive prognostic factor for disease-free survival (P = .095) and overall survival (P = .003). This study demonstrates no statistically significant advantage for alternating cycles of combination chemotherapy in affecting complete response frequency, disease-free survival, or overall survival as compared with therapy with CVPP or ABOS alone. However, the power to detect differences in these outcome parameters is somewhat limited by the sample sizes.(ABSTRACT TRUNCATED AT 250 WORDS)
1975年至1981年期间,癌症与白血病B组(CALGB)针对霍奇金病初次放疗后复发的患者开展了一项联合化疗的随机临床试验。113名患者被前瞻性随机分组,分别接受12个周期的CVPP方案(洛莫司汀、长春花碱、丙卡巴肼和泼尼松)、ABOS方案(博来霉素、长春新碱[安可平;礼来公司,印第安纳波利斯]、阿霉素[阿霉素,阿德里亚实验室,俄亥俄州哥伦布]和链脲佐菌素),或CVPP与ABOS交替方案。本报告中患者的中位观察时长为4年。这三种治疗方案的毒性主要为血液学毒性。CVPP方案的完全缓解率为72%,ABOS方案为70%,CVPP/ABOS方案为82%(P = 0.37)。女性以及初诊时患有结节硬化型疾病的患者完全缓解率显著更高。完全缓解者的5年无病生存率为55%;5年总生存率为60%。在无病生存率(P = 0.78)或总生存率(P = 0.18)方面,各治疗组之间无显著差异。40岁以下是无病生存率(P = 0.095)和总生存率(P = 0.003)唯一显著的阳性预后因素。本研究表明,与单独使用CVPP或ABOS治疗相比,联合化疗交替方案在影响完全缓解频率、无病生存率或总生存率方面无统计学显著优势。然而,由于样本量的原因,检测这些结局参数差异的效能有所受限。(摘要截选至250词)