A PHASE-II TRIAL INVESTIGATING PRIMARY IMMUNOCHEMOTHERAPY FOR MALIGNANT PLEURAL MESOTHELIOMA AND THE FEASIBILITY OF ADJUVANT IMMUNOCHEMOTHERAPY AFTER MAXIMAL CYTOREDUCTION
A PHASE-II TRIAL INVESTIGATING PRIMARY IMMUNOCHEMOTHERAPY FOR MALIGNANT PLEURAL MESOTHELIOMA AND THE FEASIBILITY OF ADJUVANT IMMUNOCHEMOTHERAPY AFTER MAXIMAL CYTOREDUCTION
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DOI：
10.1007/bf02307026
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发表时间：
1995-05-01
影响因子：
3.7
通讯作者：
PASS, HI
中科院分区：
文献类型：
--
作者：
PASS, HW;TEMECK, BK;PASS, HI
背景资料：恶性胸膜间皮瘤（MPM）的治疗仍然是不充分的标准技术，包括手术，放疗和化疗的使用。我们启动了一项免疫化疗的II期试验，顺铂（25 mg/m2，每周4次），干扰素-α（5 mU/m2，皮下注射），每周三次，和他莫昔芬（20毫克口服，每天两次，持续35天）（CIT）的基础上，在体外和体内的数据表明相互关联的疗效，这种combination.Methods：自1991年7月，36例患者已被评价后，接受1至5个周期的CIT的反应。另外10例患者进行了减瘤手术，术后两个周期的辅助CIT开始平均6周后surgical.Results：毒性是可以接受的（4%的III/IV级）。发生1例治疗相关死亡（2%），死于心肌梗死。记录了19%的部分缓解率，使用三维计算机断层扫描（CT）测量实体疾病体积进行客观量化。7例应答者的中位生存期为14.7个月，而无应答者为8个月（p2 = 0.2），整个组的中位生存期为8.7个月。术前大小、血小板计数> 360，000/ml和非上皮组织学与生存期缩短相关。结论：CIT方案对MPM有一定的疗效，可在肿瘤减积切除术后应用。在有良好预后因素的高危患者中，可能需要进行一项使用该组合的随机试验。
Background: 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/m(2) four times weekly), interferon-alpha (5 mU/m(2) 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.Methods: 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.Results: 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.Conclusions: 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.