Department of Hematology/Oncology, Winship Cancer Institute of Emory University School of Medicine, Atlanta, USA.
Department of Medical Oncology, University Hospital of Heraklion, Crete, Greece.
Lung Cancer. 2013 Sep;81(3):416-421. doi: 10.1016/j.lungcan.2013.06.002. Epub 2013 Jul 10.
Cetuximab has demonstrated improved efficacy in combination with chemotherapy and radiotherapy. We evaluated the integration of cetuximab in the combined modality treatment of stage III non-small cell lung cancer (NSCLC).
Patients with surgically unresectable stage IIIA or IIIB NSCLC were treated with chest radiotherapy, 73.5 Gy (with lung and tissue heterogeneity corrections) in 35 fractions/7 weeks, once daily (63 Gy without heterogeneity corrections). Cetuximab was given weekly during radiotherapy and continued during consolidation therapy with carboplatin and paclitaxel up to a maximum of 26 weekly doses. The primary endpoint was overall survival. Baseline tumor tissue was analyzed for EGFR by fluorescence in situ hybridization (FISH).
Forty patients were enrolled in this phase II study. The median overall survival was 19.4 months and the median progression-free survival 9.3 months. The best overall response rate in 31 evaluable patients was 67%. No grade 3 or 4 esophagitis was observed. Three patients experienced grade 3 rash; 16 patients (69%) developed grade 3/4 neutropenia during consolidation therapy. One patient died of pneumonitis, possibly related to cetuximab. EGFR gene copy number on baseline tumor tissues, analyzed by FISH, was not predictive of efficacy outcomes.
The addition of cetuximab to chest radiotherapy and consolidation chemotherapy was tolerated well and had modest efficacy in stage III NSCLC. Taken together with the lower incidence of esophagitis, our results support evaluation of targeted agents instead of chemotherapy with concurrent radiotherapy in this setting.
西妥昔单抗联合化疗和放疗显示出更好的疗效。我们评估了西妥昔单抗在 III 期非小细胞肺癌（NSCLC）综合治疗中的整合。
手术不可切除的 IIIA 或 IIIB 期 NSCLC 患者接受胸部放射治疗，73.5 Gy（肺和组织异质性校正）35 次/7 周，每日一次（无异质性校正时为 63 Gy）。西妥昔单抗在放射治疗期间每周给予，并在卡铂和紫杉醇巩固治疗期间继续使用，最多 26 个周剂量。主要终点是总生存期。基线肿瘤组织通过荧光原位杂交（FISH）分析 EGFR。
这项 II 期研究共纳入 40 例患者。中位总生存期为 19.4 个月，中位无进展生存期为 9.3 个月。31 例可评估患者的最佳总缓解率为 67%。未观察到 3 或 4 级食管炎。3 例患者出现 3 级皮疹；16 例（69%）患者在巩固治疗期间出现 3/4 级中性粒细胞减少症。1 例患者死于肺炎，可能与西妥昔单抗有关。FISH 分析的基线肿瘤组织 EGFR 基因拷贝数与疗效结果无关。
西妥昔单抗联合胸部放疗和巩固化疗的耐受性良好，在 III 期 NSCLC 中疗效适度。结合较低的食管炎发生率，我们的结果支持在这种情况下评估靶向药物而不是化疗联合放疗。
