Yamaguchi Masafumi, Ichinose Yukito, Shimamatsu Shinichiro, Yoshida Tsukihisa, Toyokawa Gouji, Nosaki Kaname, Hirai Fumihiko, Seto Takashi, Takenoyama Mitsuhiro
Department of Thoracic Oncology, National Kyushu Cancer Center, 3-1-1, Notame, Minami-ku, Fukuoka City 811-1395, Japan.
Department of Thoracic Oncology, National Kyushu Cancer Center, 3-1-1, Notame, Minami-ku, Fukuoka City 811-1395, Japan.
Surg Oncol. 2015 Jun;24(2):78-83. doi: 10.1016/j.suronc.2015.02.004. Epub 2015 Mar 26.
Malignant pleural effusion and/or pleural nodules are a final stage of disease extension of non-small cell lung cancer (NSCLC), which is currently classified as M1a-Stage IV disease. The role of surgery, especially extrapleural pneumonectomy (EPP) for local disease control and its impact on the survival of patients remains uncertain.
This single institute phase II trial was performed from March 1997 to March July 2004 to assess the effects of induction concurrent chemoradiotherapy (CRT) using a pro-drug of 5-FU, uracil-tegafur (UFT(®), Taiho Pharmaceutical Co., Ltd, Tokyo, Japan), plus cisplatin concurrently with 40 Gy hemithorax radiation followed by EPP. Intraoperative hypotonic cisplatin treatment in the pleural cavity before resection of the pericardium and diaphragm was performed. The primary endpoint of this study was the overall survival (OS), and the secondary endpoint was the disease-free survival (DFS), safety, response to the induction CRT, local disease control period in the affected thorax and the type of disease recurrence.
This trial was prematurely terminated because of the slow registration pace. During the study period, 11 patients were enrolled. There were five males and six females, with a median age of 55 (36-64) years. All patients had adenocarcinoma. All patients received the planned induction CRT. Five patients achieved a partial response and five achieved stable disease, and one patient could not be evaluated. One patient underwent exploratory thoracotomy due to unresectable chest wall invasion, and nine patients (81.8%) underwent EPP. No perioperative deaths were encountered. The median follow-up time was matured at 32.1 (range 15.0-100) months. The one-, three- and five-year DFS rates were 77.8% (95%CI: 50.6-100%), 11.1% and 11.1% (95%CI: 95%CI: 0-31.7%), respectively. The one-, three- and five-year OS rates were 100.0%, 33.3% (95%CI: 2.5-64.1%) and 22.2% (95%CI: 0.0-49.4%), respectively. Recurrence developed in eight of nine patients who underwent EPP (88.9%). All first recurrent sites were distant regions, and no ipsilateral local recurrence was identified.
The trimodality treatment used in this trial appears to be a choice of treatment for highly selected patients. However, the impact on the survival of NSCLC patients with malignant pleural effusion and/or pleural nodules still remains uncertain given the small number of patients enrolled in the study.
恶性胸腔积液和/或胸膜结节是非小细胞肺癌（NSCLC）疾病扩散的终末期，目前被归类为M1a期IV期疾病。手术的作用，尤其是胸膜外全肺切除术（EPP）对局部疾病控制的作用及其对患者生存的影响仍不确定。
这项单中心II期试验于1997年3月至2004年7月进行，以评估使用5-氟尿嘧啶的前体药物替加氟尿嘧啶（UFT®，日本东京大鹏药品工业株式会社）加顺铂同时进行40 Gy半胸放疗，随后行EPP的诱导同步放化疗（CRT）的效果。在切除心包和膈肌之前，术中在胸腔内进行低渗顺铂治疗。本研究的主要终点是总生存期（OS），次要终点是无病生存期（DFS）、安全性、对诱导CRT的反应、患侧胸腔的局部疾病控制期以及疾病复发类型。
由于入组速度缓慢，该试验提前终止。在研究期间，共纳入11例患者。其中男性5例，女性6例，中位年龄55（36 - 64）岁。所有患者均为腺癌。所有患者均接受了计划的诱导CRT。5例患者达到部分缓解，5例患者病情稳定，1例患者无法评估。1例患者因胸壁侵犯无法切除而接受了 exploratory thoracotomy（此处英文有误，推测应为exploratory thoracotomy，即开胸探查术），9例患者（81.8%）接受了EPP。未发生围手术期死亡。中位随访时间为32.1（范围15.0 - 100）个月。1年、3年和5年的DFS率分别为77.8%（95%CI：50.6 - 100%）、11.1%和11.1%（95%CI：95%CI：0 - 31.7%）。1年、3年和5年的OS率分别为100.0%、33.3%（95%CI：2.5 - 64.1%）和22.2%（95%CI：0.0 - 49.4%）。接受EPP的9例患者中有8例（88.9%）复发。所有首次复发部位均为远处，未发现同侧局部复发。
本试验中使用的三联疗法似乎是高度选择患者的一种治疗选择。然而，鉴于本研究纳入的患者数量较少，对伴有恶性胸腔积液和/或胸膜结节的NSCLC患者生存的影响仍不确定。
