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既往未经治疗的 III 期和 IV 期次优疾病卵巢癌患者化疗免疫疗法的随机 III 期试验:一项西南肿瘤学组研究

Randomized phase III trial of chemoimmunotherapy in patients with previously untreated stages III and IV suboptimal disease ovarian cancer: a Southwest Oncology Group Study.

作者信息

Alberts D S, Mason-Liddil N, O'Toole R V, Abbott T M, Kronmal R, Hilgers R D, Surwit E A, Eyre H J, Baker L H

机构信息

Arizona Cancer Center, Tucson 85724.

出版信息

Gynecol Oncol. 1989 Jan;32(1):8-15. doi: 10.1016/0090-8258(89)90841-x.

DOI:10.1016/0090-8258(89)90841-x
PMID:2642455
Abstract

Between 1979 and 1984, 185 fully evaluable patients with stage III or IV epithelial type ovarian cancer and suboptimal surgical resections were randomly assigned to treatment with doxorubicin + cyclophosphamide + BCG (DC + BCG) vs doxorubicin + cyclophosphamide + cisplatin (DCP) vs. doxorubicin + cyclophosphamide + cisplatin + BCG (DCP + BCG). Patients with measurable disease (119) were analyzed separately from those with nonmeasurable disease (66). In measurable disease patients the overall clinical complete plus partial response rates for DC + BCG, DCP, and DCP + BCG-treated patients were 36, 57, and 59%, respectively. Although there were no significant patient characteristic differences between the DCP and DCP + BCG treatment groups, the addition of cisplatin to the DC + BCG regimen resulted in significantly prolonged response (P less than 0.03) and survival (P less than 0.002) durations. To the contrary, the addition of BCG to the DCP regimen did not improve objective response rates or response or survival durations. For patients with nonmeasurable, suboptimal disease there were no significant differences between the three treatments with respect to response or survival parameters; however, patients in this disease category fared generally better than those with clinically measurable disease. We conclude that cisplatin adds significantly to the efficacy of DC + BCG, but BCG does not add to the efficacy of DCP in patients with measurable, stage III or IV disease.

摘要

1979年至1984年间,185例患有III期或IV期上皮型卵巢癌且手术切除不彻底的完全可评估患者被随机分配接受阿霉素+环磷酰胺+卡介苗(DC + BCG)、阿霉素+环磷酰胺+顺铂(DCP)或阿霉素+环磷酰胺+顺铂+卡介苗(DCP + BCG)治疗。可测量疾病患者(119例)与不可测量疾病患者(66例)分开分析。在可测量疾病患者中,接受DC + BCG、DCP和DCP + BCG治疗的患者总体临床完全缓解加部分缓解率分别为36%、57%和59%。虽然DCP和DCP + BCG治疗组之间患者特征无显著差异,但在DC + BCG方案中加入顺铂可显著延长缓解期(P小于0.03)和生存期(P小于0.002)。相反,在DCP方案中加入卡介苗并未提高客观缓解率、缓解期或生存期。对于不可测量、手术切除不彻底的疾病患者,三种治疗方法在缓解或生存参数方面无显著差异;然而,这类疾病患者总体上比有临床可测量疾病的患者预后更好。我们得出结论,对于可测量的III期或IV期疾病患者,顺铂可显著提高DC + BCG的疗效,但卡介苗不能提高DCP的疗效。

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