Pass H W, Temeck B K, Kranda K, Steinberg S M, Pass H I
Thoracic Oncology Section, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA.
Ann Surg Oncol. 1995 May;2(3):214-20. doi: 10.1007/BF02307026.
The treatment of malignant pleural mesothelioma (MPM) continues to be inadequate with the use of standard techniques, including surgery, radiotherapy and chemotherapy. We initiated a phase II trial of immunochemotherapy with cisplatinum (25 mg/m2 four times weekly), interferon-alpha (5 mU/m2 s.c. three times weekly, and tamoxifen (20 mg orally twice a day for 35 days) (CIT) based on in vitro and in vivo data suggesting interrelating efficacy of this combination.
Since July 1991, 36 patients have been evaluable for response after receiving one to five cycles of CIT. Ten additional patients had debulking surgery followed by two cycles of postoperative adjuvant CIT commencing a mean of 6 weeks after surgery.
Toxicity was acceptable (4% grade III/IV). One treatment-related death (2%) occurred, from myocardial infarction. A 19% partial response rate, objectively quantified using three-dimensional computerized tomographic (CT) measurement of solid disease volume, was recorded. The median survival for the seven responders was 14.7 months, whereas that of the nonresponders was 8 months (p2 = 0.2). Median survival for the entire group was 8.7 months. Preoperative size, platelet count > 360,000/ml, and nonepithelial histology were associated with shortened survival.
The CIT regimen has some activity in MPM and can be delivered after debulking resection. In good-risk patients, as defined by favorable prognostic factors, a randomized trial using this combination may be warranted.
包括手术、放疗和化疗在内的标准技术对恶性胸膜间皮瘤（MPM）的治疗效果仍然欠佳。基于体外和体内数据显示该联合方案具有协同疗效，我们开展了一项使用顺铂（25mg/m²，每周4次）、α-干扰素（5mU/m²，皮下注射，每周3次）和他莫昔芬（20mg，口服，每日2次，共35天）（CIT）的免疫化疗II期试验。
自1991年7月起，36例患者在接受1至5个周期的CIT治疗后可评估疗效。另外10例患者接受了减瘤手术，术后平均6周开始接受2个周期的辅助CIT治疗。
毒性反应可接受（4%为III/IV级）。发生1例与治疗相关的死亡（2%），死于心肌梗死。采用三维计算机断层扫描（CT）测量实体瘤体积进行客观量化，记录到19%的部分缓解率。7例缓解者的中位生存期为14.7个月，而未缓解者为8个月（p2 = 0.2）。整个组的中位生存期为8.7个月。术前肿瘤大小、血小板计数>360,000/ml以及非上皮组织学类型与生存期缩短相关。
CIT方案对MPM有一定活性，可在减瘤切除术后应用。对于由有利预后因素定义的低风险患者，使用该联合方案进行随机试验可能是必要的。
