Rimner Andreas, Zauderer Marjorie G, Gomez Daniel R, Adusumilli Prasad S, Parhar Preeti K, Wu Abraham J, Woo Kaitlin M, Shen Ronglai, Ginsberg Michelle S, Yorke Ellen D, Rice David C, Tsao Anne S, Rosenzweig Kenneth E, Rusch Valerie W, Krug Lee M
Andreas Rimner, Marjorie G. Zauderer, Prasad S. Adusumilli, Preeti K. Parhar, Abraham J. Wu, Kaitlin M. Woo, Ronglai Shen, Michelle S. Ginsberg, Ellen D. Yorke, Kenneth E. Rosenzweig, Valerie W. Rusch, and Lee M. Krug, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical Center, New York, NY; and Daniel R. Gomez, David C. Rice, and Anne S. Tsao, MD Anderson Cancer Center, Houston, TX
Andreas Rimner, Marjorie G. Zauderer, Prasad S. Adusumilli, Preeti K. Parhar, Abraham J. Wu, Kaitlin M. Woo, Ronglai Shen, Michelle S. Ginsberg, Ellen D. Yorke, Kenneth E. Rosenzweig, Valerie W. Rusch, and Lee M. Krug, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical Center, New York, NY; and Daniel R. Gomez, David C. Rice, and Anne S. Tsao, MD Anderson Cancer Center, Houston, TX.
J Clin Oncol. 2016 Aug 10;34(23):2761-8. doi: 10.1200/JCO.2016.67.2675. Epub 2016 Jun 20.
We conducted a two-center phase II study to determine the safety of hemithoracic intensity-modulated pleural radiation therapy (IMPRINT) after chemotherapy and pleurectomy-decortication (P/D) as part of a multimodality lung-sparing treatment.
Patients received up to four cycles of pemetrexed plus platinum. If feasible, P/D was performed. Hemithoracic IMPRINT was administered to a planned dose of 50.4 Gy in 28 fractions. The primary end point was the incidence of grade 3 or greater radiation pneumonitis (RP).
A total of 45 patients were enrolled; 18 were not evaluable (because of disease progression before radiation therapy [RT], n = 9; refusal of surgery or RT, n = 5; extrapleural pneumonectomy at time of surgery, n = 2; or chemotherapy complications, n = 2). A total of 26 patients received pemetrexed plus cisplatin, 18 received pemetrexed plus carboplatin, and four received a combination. Thirteen patients (28.9%) had a partial response, 15 patients (33.3%) experienced disease progression, one patient died during chemotherapy, and all others had stable disease. Eight patients underwent P/D or an extended P/D, and 13 underwent a partial P/D. A total of 27 patients started IMPRINT (median dose, 46.8 Gy; range, 28.8 to 50.4 Gy) and were evaluable for the primary end point (median follow-up, 21.6 months). Six patients experienced grade 2 RP, and two patients experienced grade 3 RP; all recovered after corticosteroid initiation. No grade 4 or 5 radiation-related toxicities were observed. The median progression-free survival and overall survival (OS) were 12.4 and 23.7 months, respectively; the 2-year OS was 59% in patients with resectable tumors and was 25% in patients with unresectable tumors.
Hemithoracic IMPRINT for malignant pleural mesothelioma (MPM) is safe and has an acceptable rate of RP. Its incorporation with chemotherapy and P/D forms a new lung-sparing treatment paradigm for patients with locally advanced MPM.
我们开展了一项双中心II期研究，以确定在化疗及胸膜剥脱术（P/D）后进行半胸强度调制胸膜放射治疗（IMPRINT）作为多模式肺保留治疗一部分的安全性。
患者接受至多4个周期的培美曲塞加铂类化疗。若可行，则进行P/D。半胸IMPRINT的计划剂量为50.4 Gy，分28次给予。主要终点为3级或更高级别放射性肺炎（RP）的发生率。
共入组45例患者；18例不可评估（因放疗前疾病进展，n = 9；拒绝手术或放疗，n = 5；手术时行胸膜外肺切除术，n = 2；或化疗并发症，n = 2）。共26例患者接受培美曲塞加顺铂，18例接受培美曲塞加卡铂，4例接受联合用药。13例患者（28.9%）部分缓解，15例患者（33.3%）疾病进展，1例患者在化疗期间死亡，其他所有患者疾病稳定。8例患者接受P/D或扩大的P/D，13例接受部分P/D。共27例患者开始IMPRINT（中位剂量，46.8 Gy；范围，28.8至50.4 Gy）并可评估主要终点（中位随访时间，21.6个月）。6例患者发生2级RP，2例患者发生3级RP；所有患者在开始使用皮质类固醇后均康复。未观察到4级或5级放射性相关毒性。中位无进展生存期和总生存期（OS）分别为12.4个月和23.7个月；可切除肿瘤患者的2年OS为59%，不可切除肿瘤患者为25%。
用于恶性胸膜间皮瘤（MPM）的半胸IMPRINT是安全的，RP发生率可接受。其与化疗及P/D相结合，为局部晚期MPM患者形成了一种新的肺保留治疗模式。
