恶性胸膜间皮瘤手术联合或不联合术中光动力治疗及术后免疫化疗的III期随机试验。

Phase III randomized trial of surgery with or without intraoperative photodynamic therapy and postoperative immunochemotherapy for malignant pleural mesothelioma.

作者信息

Pass H I, Temeck B K, Kranda K, Thomas G, Russo A, Smith P, Friauf W, Steinberg S M

机构信息

Thoracic Oncology Section, National Institutes of Health, Bethesda, Maryland, USA.

出版信息

Ann Surg Oncol. 1997 Dec;4(8):628-33. doi: 10.1007/BF02303746.

DOI:10.1007/BF02303746

PMID:9416409

Abstract

BACKGROUND

Patients with malignant pleural mesothelioma (MPM) usually die of progressive local disease. This report describes the results of a Phase III trial comparing maximum debulking surgery and postoperative cisplatin, interferon alpha-2b, and tamoxifen (CIT) immunochemotherapy with and without intraoperative photodynamic therapy (PDT) to determine (1) whether such a multimodal approach can be performed with minimum morbidity and mortality in malignant pleural mesothelioma (MPM), and (2) whether first-generation (i.e., 630-nm laser light, Photofrin II) intrapleural PDT impacts on local recurrence of survival.

METHODS

From July 1993 to June 1996, 63 patients with localized MPM were randomized to either PDT or no PDT. The tumors of 15 patients could not be debulked to 5 mm. Patients assigned to PDT (n = 25) and no PDT (n = 23) were similar with respect to age, sex, tumor volume, and histology.

RESULTS

The type of resection (11 pleurectomies and 14 pneumonectomies vs. 12 pleurectomies and 11 pneumonectomies), length postoperative stay, and ICU time were comparable (PDT vs. no PDT). There was one operative death (hemorrhage), and each group had two bronchopleural fistulas. Postoperative staging divided patients into the following categories: stage I: PDT, 2, no PDT, 2; stage II: PDT, 2, no PDT, 2; stage III, PDT, 21; no PDT, 17; stage IV, PDT, 0; no PDT, 2. Comparable numbers of CIT cycles were delivered. Median survival for the 15 non-debulked patients was 7.2 months, compared to 14 months for the 48 patients on protocol. There were no differences in median survival (14.4 vs. 14.1 months) or median progression-free time (8.5 vs. 7.7 months), and sites of first recurrence were similar.

CONCLUSIONS

Aggressive multimodal therapy can be delivered for patients with higher stage MPM. First-generation PDT does not prolong survival or increase local control for MPM.

摘要

背景

恶性胸膜间皮瘤（MPM）患者通常死于局部疾病进展。本报告描述了一项III期试验的结果，该试验比较了最大程度减瘤手术及术后顺铂、α-2b干扰素和他莫昔芬（CIT）免疫化疗联合或不联合术中光动力疗法（PDT）的疗效，以确定（1）这种多模式方法在恶性胸膜间皮瘤（MPM）中能否以最低的发病率和死亡率实施，以及（2）第一代（即630纳米激光、卟吩姆钠）胸膜内PDT是否会影响局部复发或生存。

方法

1993年7月至1996年6月，63例局限性MPM患者被随机分为接受PDT组或不接受PDT组。15例患者的肿瘤无法减瘤至5毫米。在年龄、性别、肿瘤体积和组织学方面，分配至PDT组（n = 25）和未分配至PDT组（n = 23）的患者相似。

结果

切除类型（11例胸膜切除术和14例肺切除术与12例胸膜切除术和11例肺切除术）、术后住院时间和重症监护病房时间相当（PDT组与未接受PDT组）。有1例手术死亡（出血），每组有2例支气管胸膜瘘。术后分期将患者分为以下类别：I期：PDT组2例，未接受PDT组2例；II期：PDT组2例，未接受PDT组2例；III期，PDT组21例；未接受PDT组17例；IV期，PDT组0例；未接受PDT组2例。给予的CIT周期数相当。15例未减瘤患者的中位生存期为7.2个月，而方案中的48例患者为14个月。中位生存期（14.4个月对14.1个月）或中位无进展时间（8.5个月对7.7个月）无差异，首次复发部位相似。