Kumar R, Dubashi B, Kayal S, Lazzar S C, Barathi D, Kumar V
Department of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
Department of Radio-diagnosis and Imaging, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
Indian J Cancer. 2017 Jan-Mar;54(1):188-192. doi: 10.4103/ijc.IJC_46_17.
Maintenance treatment of patients with advanced nonsmall cell lung cancer (NSCLC) without disease progression after first-line chemotherapy is a subject of ongoing research. The aim of this study was to investigate the efficacy, safety, and tolerability of the epidermal growth factor receptor (EGFR)-tyrosine-kinase inhibitor, i.e., gefitinib in the maintenance setting irrespective of EGFR status.
Patients aged 18 years or older of Indian origin, who had a life expectancy of >12 weeks with histologically or cytologically confirmed Stage IV NSCLC, the WHO performance status of 0-2, and who had completed four to six cycles of first-line platinum-based doublet chemotherapy without disease progression or unacceptable toxic effects were included in the study. The primary endpoint of the study was progression-free survival in the intention-to-treat population.
Twenty-five patients with a median age of 55 years (40-68) were included in the study. The median progression-free survival (PFS) for the entire group was 8 months (95% confidence interval [CI] =1.45-14.54) had not reached for EGFR-positive patient, but in the EGFR negative cohort, the PFS was 4.98 months (hazard ratio = 0.092, 95% CI = 3.4-6.5, P = 0.01). The median overall survival (OS) of the study group was 15 months (95% CI = 3.7-26.4), all patients with EGFR positive were alive (100% survival). The median OS for EGFR negative group was about 6.3 months. The major toxicity observed was rash/acne in 15 patients, pruritus in 7 patients, and one patient had Grade 4 pneumonitis.
Gefitinib maintenance is safe, well-tolerated therapy, produces significant PFS and OS benefit in EGFR mutation-positive patient. It is definitely not a choice for EGFR negative group. In EGFR unknown group, the role of maintenance still needs to be explored.
对于一线化疗后无疾病进展的晚期非小细胞肺癌（NSCLC）患者的维持治疗是一项正在进行研究的课题。本研究的目的是探讨表皮生长因子受体（EGFR）-酪氨酸激酶抑制剂吉非替尼在维持治疗中的疗效、安全性和耐受性，无论EGFR状态如何。
纳入年龄≥18岁的印度裔患者，其预期寿命>12周，经组织学或细胞学确诊为IV期NSCLC，世界卫生组织体能状态为0 - 2，且已完成四至六个周期的一线铂类双联化疗且无疾病进展或不可接受的毒性反应。本研究的主要终点是意向性治疗人群的无进展生存期。
25例患者纳入研究，中位年龄55岁（40 - 68岁）。整个组的中位无进展生存期（PFS）为8个月（95%置信区间[CI]=1.45 - 14.54），EGFR阳性患者未达到，但在EGFR阴性队列中，PFS为4.98个月（风险比=0.092，95%CI = 3.4 - 6.5，P = 0.01）。研究组的中位总生存期（OS）为15个月（95%CI = 3.7 - 26.4），所有EGFR阳性患者均存活（生存率100%）。EGFR阴性组的中位OS约为6.3个月。观察到的主要毒性反应为15例患者出现皮疹/痤疮，7例患者出现瘙痒，1例患者发生4级肺炎。
吉非替尼维持治疗是一种安全、耐受性良好的治疗方法，对EGFR突变阳性患者的无进展生存期和总生存期有显著益处。对于EGFR阴性组绝对不是一个选择。在EGFR未知组中，维持治疗的作用仍需探索。
