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顺铂、长春碱和博来霉素用于晚期及复发性卵巢生殖细胞肿瘤。妇科肿瘤学组的一项试验。

Cisplatin, vinblastine, and bleomycin in advanced and recurrent ovarian germ-cell tumors. A trial of the Gynecologic Oncology Group.

作者信息

Williams S D, Blessing J A, Moore D H, Homesley H D, Adcock L

机构信息

Gynecologic Oncology Group, Philadelphia, Pennsylvania.

出版信息

Ann Intern Med. 1989 Jul 1;111(1):22-7. doi: 10.7326/0003-4819-111-1-22.

DOI:10.7326/0003-4819-111-1-22
PMID:2472080
Abstract

STUDY OBJECTIVE

To evaluate the efficacy of cisplatin-based combination chemotherapy in patients with advanced ovarian germ-cell tumors.

DESIGN

Nonrandom prospective trial with endpoints of tumor response, results of repeat surgical exploration, progression-free interval, and survival.

SETTING

Cooperative university-based cancer study comprising 27 participating institutions.

PATIENTS

Ninety-seven patients were treated and all were evaluable. Of these, 8 had dysgerminoma and 89 had other cell types.

INTERVENTIONS

Patients received 3 to 4 courses of cisplatin. vinblastine, and bleomycin (PVB). After chemotherapy, suitable patients had re-staging laparotomy. Maintenance vinblastine therapy was originally given but was discontinued for all patients in 1981. Patients with persistent or recurrent disease were treated with vincristine, dactinomycin, and cyclophosphamide (VAC) or etoposide plus cisplatin (EP).

RESULTS

Of 35 patients with tumors other than dysgerminoma who had clinically measurable disease, 15 (43%; CI, 26% to 61%) had complete responses. Forty of fifty-six second-look laparotomies (71%; CI, 58% to 83%) revealed no tumor or mature teratoma. Forty-seven patients are still disease-free and 59 are alive. The survival rate is 71% (CI, 62% to 89%) and the disease-free rate is 51% (CI, 41% to 62%) at 2 years. Eight patients had durable remissions with second- or third-line therapy. Seven of eight patients with dysgerminoma are also disease-free.

CONCLUSIONS

Cisplatin-based chemotherapy is effective for patients with ovarian germ-cell tumors, is superior to previous regimens, and will cure a substantial number of patients.

摘要

研究目的

评估以顺铂为基础的联合化疗对晚期卵巢生殖细胞肿瘤患者的疗效。

设计

非随机前瞻性试验,以肿瘤反应、再次手术探查结果、无进展生存期和生存率为终点指标。

研究地点

由27个参与机构组成的合作性大学癌症研究。

患者

97例患者接受治疗且均具有可评估性。其中,8例为无性细胞瘤,89例为其他细胞类型。

干预措施

患者接受3至4个疗程的顺铂、长春花碱和博来霉素(PVB)治疗。化疗后,合适的患者接受分期剖腹手术。最初给予维持性长春花碱治疗,但在1981年所有患者均停止使用。持续性或复发性疾病患者接受长春新碱、放线菌素D和环磷酰胺(VAC)或依托泊苷加顺铂(EP)治疗。

结果

35例非无性细胞瘤且具有临床可测量疾病的患者中,15例(43%;可信区间,26%至61%)完全缓解。56例二次探查剖腹手术中的40例(71%;可信区间,58%至83%)未发现肿瘤或成熟畸胎瘤。47例患者仍无疾病,59例存活。2年时生存率为71%(可信区间,62%至89%),无病率为51%(可信区间,41%至62%)。8例患者通过二线或三线治疗获得持久缓解。8例无性细胞瘤患者中的7例也无疾病。

结论

以顺铂为基础的化疗对卵巢生殖细胞肿瘤患者有效,优于先前的治疗方案,且能治愈大量患者。

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