美国《临床肿瘤学杂志》2018年1月2日在线先发
针对局部晚期非小细胞肺癌被动散射质子治疗和调强光子放疗的贝叶斯自适应随机化试验
目的
这项随机试验比较了被动散射质子治疗（PSPT）同步化疗对比调强（光子）放疗（IMRT）同步化疗治疗不能手术的非小细胞肺癌（NSCLC）的结果。我们假设被动散射质子治疗（PSPT）对肺组织的辐射暴露比调强放疗（IMRT）少，从而在不影响肿瘤控制的情况下可减轻毒副反应。主要研究终点是≥3级放射性肺炎（RP）和局部失败（LF）。
病例和方法
符合条件的患者为适合同步放化疗的IIB-IIIB期（或IV期非小细胞肺癌伴有单个脑转移灶、或伴术后肺复发或纵隔肿瘤）患者。为每位患者配对建立了调强放疗（IMRT）和被动散射质子治疗（PSPT）的治疗计划。只有当两个计划都满足相同的肿瘤剂量下对高危器官有相同的预设剂量-体积限定，患者才符合随机分组条件。
结果
与调强放疗（IMRT）（n=92）相比，被动散射质子治疗（n=57）使较少的肺组织暴露于5-10Gy（RBE）的辐射剂量，5-10Gy（RBE）的辐射剂量是所吸收的Gy剂量乘以质子的相对生物效应（RBE）因子；被动散射质子治疗使更多的肺组织暴露于≥20Gy（RBE）的辐射剂量、更少的心脏组织暴露于5-80Gy（RBE）之间的所有辐射剂量水平。所有患者≥3级放射性肺炎（RP）的发生率为8.1%（IMRT组6.5%，PSPT组10.5%）；相应的局部失败（LF）发生率为10.7%（所有患者）、10.9%（IMRT组）和10.5%（PSPT组）。IMRT优于PSPT的后验概率为0.54。探索性分析显示，对于试验中点前对比试验中点后纳入分析的患者，12个月时放射性肺炎（RP）和局部失败（LF）发生率，IMRT组为21.1%（前）和18.2%（后）（P=0.047），PSPT组为31.0%（前）和13.1%（后）（P=0.027）。
结论
被动散射质子治疗（PSPT）并没有改善肺的剂量-体积指数，但改善了心脏的剂量-体积指数。被动散射质子治疗（PSPT）后放射性肺炎（RP）或局部失败（LF）没有获益。在试验过程中，观察到两组研究终点均有改善。
《壹篇》孙莉
Zhongxing Liao, M.D.
Department of Radiation Oncology, Division of Radiation Oncology
Professor, Department of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX
放射肿瘤科教授
湖南医科大学毕业。医学博士。美国德克萨斯州大学MD安德森癌症中心放射肿瘤科教授。ASTRO成员。美国德克萨斯州大学MD安德森癌症中心校外计划亚洲工作小组成员、校外计划中国监督委员会会员、医疗人员执行委员会会员、放射肿瘤科临床执行委员会主席。
Bayesian Adaptive Randomization Trial of Passive Scattering Proton Therapy and Intensity-Modulated Photon Radiotherapy for Locally Advanced Non–Small-Cell Lung Cancer
Zhongxing Liao, J. Jack Lee, Ritsuko Komaki, Daniel R. Gomez, Michael S. O’Reilly, Frank V. Fossella
Purpose
This randomized trial compared outcomes of passive scattering proton therapy (PSPT) versus intensity-modulated (photon) radiotherapy (IMRT), both with concurrent chemotherapy, for inoperable non–small-cell lung cancer (NSCLC). We hypothesized that PSPT exposes less lung tissue to radiation than IMRT and thereby reduces toxicity without compromising tumor control. The primary end points were grade ≥ 3 radiation pneumonitis (RP) and local failure (LF).
Patients and Methods
Eligible patients had stage IIB to IIIB NSCLC (or stage IV NSCLC with a single brain metastasis or recurrent lung or mediastinal disease after surgery) who were candidates for concurrent chemoradiation therapy. Pairs of treatment plans for IMRT and PSPT were created for each patient. Patients were eligible for random assignment only if both plans satisfied the same prespecified dose-volume constraints for at-risk organs at the same tumor dose.
Results
Compared with IMRT (n = 92), PSPT (n = 57) exposed less lung tissue to doses of 5 to 10 Gy(RBE), which is the absorbed Gy dose multiplied by the relative biologic effectiveness (RBE) factor for protons; exposed more lung tissue was exposed to $ 20 Gy(RBE), but exposed less heart tissue at all dose levels between 5 and 80 Gy(RBE). The grade $ 3 RP rate for all patients was 8.1% (IMRT, 6.5%; PSPT, 10.5%); corresponding LF rates were 10.7% (all), 10.9% (IMRT), and 10.5% (PSPT). The posterior probability of IMRT being better than PSPT was 0.54. Exploratory analysis showed that the RP and LF rates at 12 months for patients enrolled before versus after the trial midpoint were 21.1% (before) versus 18.2% (after) for the IMRT group (P = .047) and 31.0% (before) versus 13.1% (after) for the PSPT group (P = .027).
Conclusion
PSPT did not improve dose-volume indices for lung but did for heart. No benefit was noted in RP or LF after PSPT. Improvements in both end points were observed over the course of the trial.
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