Saeki Sho, Hotta Katsuyuki, Sakata Shinya, Oda Naohiro, Inoue Koji, Tamura Tomoki, Toyozawa Ryo, Harada Daijiro, Tanaka Kentaro, Inoue Koji, Shioyama Yoshiyuki, Gemba Kenichi, Sasaki Tomonari, Bessho Akihiro, Kishimoto Junji, Katsui Kuniaki, Kiura Katsuyuki, Sugio Kenji
Department of Respiratory Medicine, Kumamoto University Hospital, Kumamoto, JPN.
Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, JPN.
Cureus. 2025 Jun 23;17(6):e86575. doi: 10.7759/cureus.86575. eCollection 2025 Jun.
Background and objective We had previously conducted a phase II study (LOGIK0902/OLCSG0905 study) involving the eight-week administration of gefitinib, followed by cisplatin-based chemoradiotherapy, to treat locally advanced, epidermal growth factor receptor (EGFR)-mutated, non-small cell lung cancer (NSCLC). Despite favorable overall survival outcomes, more than half of the patients relapsed after the protocol therapy, highlighting the need to clarify the clinical significance of retreatment with EGFR-tyrosine kinase inhibitors (TKIs). We investigated the efficacy and safety of EGFR-TKI retreatment after disease progression. Materials and methods We included 14 patients who relapsed after the protocol treatment and received any type of EGFR-TKI as post-progression treatment in this sub-analysis. We evaluated the efficacy and safety of retreatment with EGFR-TKI in these patients. Results Among the 14 patients, 11 (78.6%) responded to the induction of gefitinib in the treatment protocol. After relapse, 9/14 patients (64.3%) received gefitinib, 3/14 (21.4%) received afatinib, and 2/14 (14.3%) received erlotinib monotherapy, respectively. The median duration of post-progression EGFR-TKI treatment was 17.9 (0.7-45.5) months. The overall response rate (ORR) and disease control rate were 64.3% [9/14 patients; 95% confidence interval (CI): 35.1%-87.2%] and 85.7% (12/14 patients; 95% CI: 57.2%-98.2%), respectively. The median progression-free survival (PFS) and median survival durations after the initiation of EGFR-TKI retreatment were 11.8 months (95% CI: 5.7-20.7 months) and 47.4 months (95% CI: 31.8 months to not estimable), respectively. Adverse events were comparable to those previously reported. Conclusions Patients with disease progression after protocol therapy demonstrated sensitivity to retreatment with an EGFR-TKI, with acceptable safety.
我们之前开展了一项II期研究（LOGIK0902/OLCSG0905研究），对局部晚期、表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）患者进行为期8周的吉非替尼治疗，随后进行基于顺铂的放化疗。尽管总体生存结果良好，但超过一半的患者在方案治疗后复发，这凸显了明确表皮生长因子受体酪氨酸激酶抑制剂（TKI）再治疗临床意义的必要性。我们研究了疾病进展后EGFR-TKI再治疗的疗效和安全性。
本亚组分析纳入了14例在方案治疗后复发并接受任何类型EGFR-TKI作为进展后治疗的患者。我们评估了这些患者EGFR-TKI再治疗的疗效和安全性。
14例患者中，11例（78.6%）在治疗方案中对吉非替尼诱导治疗有反应。复发后，9/14例患者（64.3%）接受吉非替尼治疗，3/14例（21.4%）接受阿法替尼治疗，2/14例（14.3%）接受厄洛替尼单药治疗。进展后EGFR-TKI治疗的中位持续时间为17.9（0.7 - 45.5）个月。总缓解率（ORR）和疾病控制率分别为64.3% [9/14例患者；95%置信区间（CI）：35.1% - 87.2%]和85.7%（12/14例患者；95% CI：57.2% - 98.2%）。EGFR-TKI再治疗开始后的中位无进展生存期（PFS）和中位生存期分别为11.8个月（95% CI：5.7 - 20.7个月）和47.4个月（CI：31.8个月至无法估计）。不良事件与之前报道的相当。
方案治疗后疾病进展的患者对EGFR-TKI再治疗表现出敏感性，且安全性可接受。
