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恶性胸膜间皮瘤的四模式疗法:一项II期研究。

Four-modality therapy in malignant pleural mesothelioma: a phase II study.

作者信息

Lucchi Marco, Chella Antonio, Melfi Franca, Dini Paolo, Tibaldi Carmelo, Fontanini Gabriella, Mussi Alfredo

机构信息

Division of Thoracic Surgery, Cardiac and Thoracic Department, University of Pisa, Italy.

出版信息

J Thorac Oncol. 2007 Mar;2(3):237-42. doi: 10.1097/JTO.0b013e318031d05c.

DOI:10.1097/JTO.0b013e318031d05c
PMID:17410047
Abstract

BACKGROUND

Treatment approaches in malignant pleural mesothelioma (MPM) patients range from mere palliation to aggressive anticancer therapy, and there is currently no consensus on the optimal therapeutic strategy. In 1999, we began a phase II study to investigate four-modality treatment of advanced stage MPM.

METHODS

From 1999 to 2004, 49 patients with International Mesothelioma Interest Group stage II-III MPM underwent four-modality treatment with intrapleural preoperative interleukin-2 (18 x 10(6) UI/day for 3 days), pleurectomy/decortication, intrapleural postoperative epidoxorubicin (25 mg/m2 for 3 days), interleukin-2 (18 x 10(6) UI/day for 3 days), adjuvant radiotherapy (30 Gy), systemic chemotherapy (cisplatin 80 mg/m2 day 1, gemcitabine 1250 mg/m2 days 1 and 8 for up to six courses) and long-term subcutaneous interleukin-2 (3 x 10(6) UI/day on 3 days per week).

RESULTS

Patients included 41 men and eight women with a median age of 61 years (range, 41-77). All patients were diagnosed with MPM by thoracoscopy before inclusion. There was no postoperative mortality. Postoperative morbidity included bleeding (n = 1) and arrhythmias (n = 3). After a median follow-up of 59 months (range, 14-81), 13 patients are still alive and the median actuarial survival is 26 months (31 and 21 months for stages II and III, respectively). The 2- and 5-year actuarial survival rates were 60.2% and 23.3%, respectively. Baseline Eastern Cooperative Oncology Group performance status significantly influenced survival time (p = 0.02).

CONCLUSION

The four-modality treatment that we adopted for advanced-stage MPM was feasible, well tolerated by most of the patients, and produced a favorable median survival. This treatment approach warrants further investigation.

摘要

背景

恶性胸膜间皮瘤(MPM)患者的治疗方法从单纯姑息治疗到积极的抗癌治疗不等,目前对于最佳治疗策略尚无共识。1999年,我们启动了一项II期研究,以探究晚期MPM的四模式治疗。

方法

1999年至2004年,49例国际间皮瘤兴趣小组II - III期MPM患者接受了四模式治疗,包括术前胸腔内注射白细胞介素-2(18×10⁶单位/天,共3天)、胸膜切除术/剥脱术、术后胸腔内注射表柔比星(25mg/m²,共3天)、白细胞介素-2(18×10⁶单位/天,共3天)、辅助放疗(30Gy)、全身化疗(顺铂80mg/m²,第1天;吉西他滨1250mg/m²,第1天和第8天,共六个疗程)以及长期皮下注射白细胞介素-2(3×10⁶单位/天,每周3天)。

结果

患者包括41名男性和8名女性,中位年龄为61岁(范围41 - 77岁)。所有患者在纳入研究前均通过胸腔镜诊断为MPM。无术后死亡病例。术后并发症包括出血(1例)和心律失常(3例)。中位随访59个月(范围14 - 81个月)后,13例患者仍存活,中位精算生存期为26个月(II期和III期分别为31个月和21个月)。2年和5年精算生存率分别为60.2%和23.3%。东部肿瘤协作组的基线体能状态对生存时间有显著影响(p = 0.02)。

结论

我们采用的晚期MPM四模式治疗可行,大多数患者耐受性良好,并产生了良好的中位生存期。这种治疗方法值得进一步研究。

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