van den Heuvel Michel M, Uyterlinde Wilma, Vincent Andrew D, de Jong Jeroen, Aerts Joachim, Koppe Frederike, Knegjens Joost, Codrington Henk, Kunst Peter W E, Dieleman Edith, Verheij Marcel, Belderbos José
Department of Thoracic Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Biometrics Department, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Radiother Oncol. 2014 Jan;110(1):126-31. doi: 10.1016/j.radonc.2013.10.009. Epub 2013 Nov 11.
Modest benefits from concurrent chemoradiotherapy in patients with locally advanced NSCLC warrant further clinical investigations to identify more effective treatment regimens. Cetuximab, a monoclonal antibody against the epidermal growth factor receptor has shown activity in NSCLC. We report on the safety and efficacy of the combination of daily dose Cisplatin and concurrent radiotherapy with or without weekly Cetuximab.
Patients received high dose accelerated radiotherapy (66 Gy in 24 fractions) and concurrent daily Cisplatin (6 mg/m(2)) without (Arm A) or with (Arm B) weekly Cetuximab (400 mg/m(2) loading dose one week prior to radiotherapy followed by weekly 250 mg/m(2)). The primary endpoint of the trial was objective local control rate (OLCR) determined at 6-8 weeks after treatment. Toxicity was reported as well.
Between February 2009 and May 2011, 102 patients were randomized. Median follow up was 29 months. The OLCR was 84% in Arm A and 92% in Arm B (p=0.36). The one-year local progression free interval (LPFI) and overall survival (OS) were 69% and 82% for Arm A and 73% and 71% for Arm B, respectively (LPFI p=0.39; OS p=0.99). Toxicity compared equally between both groups.
The addition of Cetuximab to radiotherapy and concurrent Cisplatin did not improve disease control in patients with locally advanced NSCLC but increased treatment related toxicity.
局部晚期非小细胞肺癌患者接受同步放化疗的获益有限，需要进一步开展临床研究以确定更有效的治疗方案。西妥昔单抗是一种抗表皮生长因子受体的单克隆抗体，已显示出对非小细胞肺癌有活性。我们报告了每日剂量顺铂联合放疗加或不加每周一次西妥昔单抗的安全性和疗效。
患者接受高剂量加速放疗（24次分割，共66 Gy）并同时每日给予顺铂（6 mg/m²），其中一组（A组）不加西妥昔单抗，另一组（B组）每周给予西妥昔单抗（放疗前一周给予400 mg/m²的负荷剂量，随后每周给予250 mg/m²）。该试验的主要终点是治疗后6 - 8周确定的客观局部控制率（OLCR）。同时也报告了毒性反应。
2009年2月至2011年5月，102例患者被随机分组。中位随访时间为29个月。A组的客观局部控制率为84%，B组为92%（p = 0.36）。A组的一年局部无进展间期（LPFI）和总生存率（OS）分别为69%和82%，B组分别为73%和71%（LPFI p = 0.39；OS p = 0.99）。两组的毒性反应相当。
在放疗和顺铂同步治疗中加入西妥昔单抗并未改善局部晚期非小细胞肺癌患者的疾病控制情况，但增加了治疗相关毒性。
