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顺二氯二氨铂与长春花碱联合化疗用于晚期非小细胞肺癌

Combination chemotherapy with cis-diamminedichloroplatinum and vinblastine in advanced non-small cell lung cancer.

作者信息

Woodcock T M, Blumenreich M S, Richman S P, Kubota T T, Gentile P S, Allegra J C

出版信息

J Clin Oncol. 1983 Apr;1(4):247-50. doi: 10.1200/JCO.1983.1.4.247.

Abstract

Twenty-seven patients (25 males and 2 females) with histologically confirmed, unresectable, or metastatic non-small cell lung cancer were entered on a combination chemotherapy protocol including cisplatinum and vinblastine sulfate (DDP)(VLB). Patients had to have measurable disease as defined by the presence of two clearly measurable perpendicular diameters, be untreated with either chemotherapy or radiation therapy, and give informed consent to be eligible for study entry. The median age was 57 yr and the median performance status was 70 (Karnofsky scale); 10 patients had epidermoid carcinoma, 9 adenocarcinoma, 4 large cell carcinoma, and 4 undifferentiated carcinoma. All patients had intrathoracic disease, 12 also had extrathoracic lymph node involvement, 8 bone involvement, 2 liver metastasis, and 2 central nervous system metastasis prior to beginning chemotherapy; 9 patients had involvement of one site, 12 of two sites, 5 of three sites, and 1 of four sites. Cisplatinum was given as a short intravenous infusion of 120 mg/m2 on days 1 and 28, and then every 6 wk. Vinblastine was administered as an intravenous injection of 8 mg/m2 on days 1, 14, and 28, and then every 3 wk. Patients were evaluated prior to each course of cisplatinum. If progression occurred, therapy was discontinued. If stabilization or response was noted, then therapy was continued until intolerable toxicity or progression supervened. Every patient entered is considered evaluable for toxicity and response. There were no complete remissions; 14 patients achieved a partial response, 3 had a minimal response, 5 had stabilization of their disease, 1 had disease progression, and 4 are considered to have had drug deaths. Responses were seen after the first cisplatinum course in 13 patients and after the second in 1. Toxicities seen were universal nausea and vomiting; elevation of creatinine occurred in 6 patients, ranging from 2.1 to 14.6 mg/dl, and was clinically significant in 2 patients. Myelosuppression, with a leukocyte nadir of less than 3.0 X 10(9)l in 10 cases and platelet nadir of less than 100.0 X 10(9)l was seen in 5 cases and partial hearing deficit occurred in 2 patients. Median survival was 22 wk for the whole group (24 wk for the whole group if the 4 early drug deaths are excluded). Median survival was 26 wk for responding patients and 13 wk for nonresponding patients (remains the same if the early deaths are excluded from the latter group).(ABSTRACT TRUNCATED AT 400 WORDS)

摘要

27例经组织学确诊为不可切除或转移性非小细胞肺癌的患者(25例男性,2例女性)进入了一项联合化疗方案,该方案包括顺铂和硫酸长春碱(DDP)(VLB)。患者必须有可测量的疾病,即存在两个清晰可测量的垂直直径,未接受过化疗或放疗,并签署知情同意书才有资格进入研究。中位年龄为57岁,中位体能状态为70(卡诺夫斯基量表);10例为鳞状细胞癌,9例为腺癌,4例为大细胞癌,4例为未分化癌。所有患者在开始化疗前均有胸内疾病,12例还有胸外淋巴结受累,8例有骨受累,2例有肝转移,2例有中枢神经系统转移;9例患者累及一个部位,12例累及两个部位,5例累及三个部位,1例累及四个部位。顺铂在第1天和第28天以120mg/m²的剂量短时间静脉输注,然后每6周一次。长春碱在第1、14和28天以8mg/m²的剂量静脉注射,然后每3周一次。在每个顺铂疗程前对患者进行评估。如果病情进展,则停止治疗。如果观察到病情稳定或有反应,则继续治疗,直到出现无法耐受的毒性或病情进展。每例入组患者均被视为可评估毒性和反应。无完全缓解;14例患者达到部分缓解,3例有微小反应,5例病情稳定,1例病情进展,4例被认为死于药物相关原因。13例患者在第一个顺铂疗程后出现反应,1例在第二个疗程后出现反应。观察到的毒性包括普遍的恶心和呕吐;6例患者肌酐升高,范围为2.1至14.6mg/dl,2例患者具有临床意义。10例患者出现骨髓抑制,白细胞最低点低于3.0×10⁹/L,5例患者血小板最低点低于100.0×10⁹/L,2例患者出现部分听力减退。全组中位生存期为22周(如果排除4例早期药物死亡病例,则全组中位生存期为24周)。有反应患者的中位生存期为26周,无反应患者的中位生存期为13周(如果从后一组中排除早期死亡病例,结果不变)。(摘要截短至400字)

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