Su ShengFa, Li Tao, Lu Bing, Wang XiaoHu, Li JianCheng, Chen Ming, Lu You, Bai YuJu, Hu YinXiang, Ouyang WeiWei, Ma Zhu, Li QingSong, Li HuiQin, Wang Yu
Department of Thoracic Oncology, Affiliated Hospital of Guizhou Medical University, and Guizhou Cancer Hospital, Guiyang, PR China; Teaching and Research Section of Oncology, Guizhou Medical University, Guiyang, PR China.
Department of Radiation Oncology, Sichuan Cancer Hospital, Chengdu, PR China.
Int J Radiat Oncol Biol Phys. 2015 Nov 15;93(4):769-77. doi: 10.1016/j.ijrobp.2015.08.012. Epub 2015 Aug 7.
The aim of this prospective multi-institutional phase 2 study was to investigate disease control, survival outcomes, and toxicity after thoracic three-dimensional radiation therapy (3D-RT) with concurrent chemotherapy for newly diagnosed stage IV non-small cell lung cancer (NSCLC).
Eligible patients were 18 to 80 years of age, had a Karnofsky performance status (KPS) score ≥70%, and newly diagnosed stage IV NSCLC with limited metastatic disease (defined as involving ≤3 organs). Patients received platinum-doublet chemotherapy with concurrent irradiation to the primary tumor. Primary endpoints were overall survival (OS) and acute toxicity.
From May 2008 to May 2012, 198 eligible patients were enrolled from 7 cancer centers. Most patients died with distant metastasis; only 10% died with isolated primary recurrence. Median OS time was 13.0 months (95% confidence interval [CI]: 11.7-14.3); OS rates were 53.5% at 1 year, 15.8% at 2 years, and 9.2% at 3 years. Median progression-free survival (PFS) time was 9.0 months (95% CI: 7.7-10.3); corresponding PFS rates were 30.8%, 8.2%, and 6.1%. The 1-year, 2-year, and 3-year local (primary tumor) control rates were 78.8%, 57.7%, and 55.4%. Multivariate analysis showed that delivery of ≥63 Gy to the primary tumor (P=.014), having a primary tumor volume <134 cm(3) (P=.008), and having a stable or higher KPS score after treatment (P=.01) were independent predictors of better OS. The most common severe (grades 3-4) acute toxicities were hematologic: leukopenia (37.9%), thrombocytopenia (10.1%), and anemia (6.9%). No patients experienced grade 4 or 5 radiation-related toxicity; 2.5% had acute grade 3 pneumonitis, and 6.6% had acute grade 3 radiation esophagitis.
Thoracic 3D-RT to the primary tumor with concurrent chemotherapy led to satisfactory survival outcomes with acceptable toxicity. Radiation dose, primary tumor volume, and PFS after treatment all predicted survival in these patients with limited-metastasis NSCLC.
这项前瞻性多机构2期研究的目的是调查新诊断的IV期非小细胞肺癌（NSCLC）患者在接受胸部三维放疗（3D-RT）联合化疗后的疾病控制情况、生存结局和毒性反应。
符合条件的患者年龄在18至80岁之间，卡氏功能状态（KPS）评分≥70%，且为新诊断的IV期NSCLC，转移病灶有限（定义为累及器官≤3个）。患者接受铂类双联化疗并同时对原发肿瘤进行放疗。主要终点为总生存期（OS）和急性毒性反应。
2008年5月至2012年5月，从7个癌症中心招募了198例符合条件的患者。大多数患者死于远处转移；仅10%死于孤立的原发灶复发。中位OS时间为13.0个月（95%置信区间[CI]：11.7 - 14.3）；1年、2年和3年的OS率分别为53.5%、15.8%和9.2%。中位无进展生存期（PFS）时间为9.0个月（95%CI：7.7 - 10.3）；相应的PFS率分别为30.8%、8.2%和6.1%。1年、2年和3年的局部（原发肿瘤）控制率分别为78.8%、57.7%和55.4%。多因素分析显示，对原发肿瘤给予≥63 Gy的放疗剂量（P = 0.014）、原发肿瘤体积<134 cm³（P = 0.008）以及治疗后KPS评分稳定或更高（P = 0.01）是OS较好的独立预测因素。最常见的严重（3 - 4级）急性毒性反应为血液学毒性：白细胞减少（37.9%）、血小板减少（10.1%）和贫血（6.9%）。没有患者出现4级或5级放射性毒性反应；2.5%的患者发生急性3级肺炎，6.6%的患者发生急性3级放射性食管炎。
对原发肿瘤进行胸部3D-RT联合化疗可带来令人满意的生存结局，且毒性反应可接受。放疗剂量、原发肿瘤体积以及治疗后的PFS均能预测这些转移病灶有限的NSCLC患者的生存情况。
