Randomized phase II trial of three intrapleural therapy regimens for the management of malignant pleural effusion in previously untreated non-small cell lung cancer: JCOG 9515
Randomized phase II trial of three intrapleural therapy regimens for the management of malignant pleural effusion in previously untreated non-small cell lung cancer: JCOG 9515
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DOI：
10.1016/j.lungcan.2007.07.009
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发表时间：
2007-12-01
期刊：
影响因子：
5.3
通讯作者：
Saijo, Nagahiro
中科院分区：
文献类型：
--
作者：
Yoshida, Kimihide;Sugiura, Takahiko;Saijo, Nagahiro
评估由博来霉素（BLM）、OK-432（热灭活化脓性链球菌的粉状产物）或顺铂加依托泊苷（PE）组成的三种胸腔内治疗方案治疗恶性胸腔积液（MPE）的疗效和毒性。未经治疗的非小细胞肺癌。符合条件的患者被随机分配至BLM组：BLM 1 mg/kg（最大60 mg/人），OK-432组：OK-432 0.2 Klinische Einheit单位（KE）/kg（最大10 KE/人），或PE组：顺铂（80 mg/m2）和依托泊苷（80 mg/m2）。根据研究特定标准，每4周评价一次胸膜缓解。所有.应答者接受全身化疗，包括PE，每3-4周一次，持续两个或更多个疗程。胸膜无进展生存期（PPFS）定义为从随机化至首次观察到胸膜进展或任何原因导致的死亡的时间。主要终点是4周PPFS率。在入组的105例患者中，对102例患者进行了缓解评估。BLM组、OK-432组和PE组的4周PPFS率分别为68.6%、75.8%和70.6%。BLM组、OK-432组和PE组的中位生存时间（MST）分别为32.1周、48.1周和45.7周。然而，两组的结局无显著差异。除1例因BLM诱导的间质性肺炎导致的治疗相关死亡外，所有组的毒性均可耐受。我们将选择使用OK-432进行胸膜内治疗以管理NSCLC中的MPE进行进一步研究，因为它具有最高的4周PPFS率。(c)2007爱思唯尔爱尔兰有限公司保留所有权利。
To evaluate the efficacy and toxicity of three intrapleural therapy regimens consisting of bleomycin (BLM), OK-432 (a pulverized product of heat-killed Streptococcus pyogenes) or cisplatin plus etoposide (PE) for the management of malignant pleura( effusion (MPE) in previously untreated non-small cell lung cancer. Eligible patients were randomized to the BLM arm: BLM 1 mg/kg (maximum 60 mg/ body), the OK-432 arm: OK-432 0.2 Klinische Einheit units (KE)/kg (maximum 10 KE/body), or the PE arm: cisplatin (80 mg/m(2)) and etoposide (80 mg/m(2)). Pleural, response was evaluated every 4 weeks according to the study-specific criteria. All. responders received systemic chemotherapy consisting of PE every 3-4 weeks for two or more courses. Pleural progression-free survival (PPFS) was defined as the time from randomization to the first observation of pleural progression or death due to any cause. The primary endpoint was the 4-week PPFS rate. Of 105 patients enrolled, 102 were assessed for response. The 4-week PPFS rate for the BLM arm was 68.6%, 75.8% for the OK-432 arm, and 70.6% for PE arm. Median survival time (MST) for the BLM arm was 32.1 weeks, 48.1 weeks for the OK-432 arm, and 45.7 weeks for the PE arm. However, the outcomes did not differ significantly between groups. Toxicity was tolerable in all arms except for one treatment-related death due to interstitial pneumonia induced by BLM. We will select intrapleural treatment using OK-432 in the management of MPE in NSCLC for further investigation because it had the highest 4-week PPFS rate. (c) 2007 Elsevier Ireland Ltd. All rights reserved.