Activity of gefitinib in advanced non-small-cell lung cancer with very poor performance status
Activity of gefitinib in advanced non-small-cell lung cancer with very poor performance status
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DOI：
10.1023/b:drug.0000047108.39129.7c
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发表时间：
2005-01-01
影响因子：
3.4
通讯作者：
Hsu, JY
中科院分区：
文献类型：
--
作者：
Chang, GC;Chen, KC;Hsu, JY
体能状态（PS）较差的晚期非小细胞肺癌（NSCLC）患者不太可能对化疗有反应，或生存期有所改善，但更可能出现毒性。我们回顾性评估吉非替尼在台湾晚期非小细胞肺癌和极差PS患者中的疗效和耐受性。东部肿瘤协作组（ECOG）PS为3-4的IIIB、IV期NSCLC患者接受吉非替尼250 mg口服，每日一次。共纳入52例患者（25例男性，27例女性）。43例患者（82.7%）的PS为3。肿瘤缓解率为25.0%（13/52）。吉非替尼的肿瘤缓解率在化疗未治患者中最高，为38.1%（8/21），1个化疗方案失败患者为13.3%（2/15），2个或2个以上化疗方案失败患者为18.8%（3/16），p = 0.015。中位总生存期为2.5个月（缓解组9.1个月，稳定组3.1个月，进展组0.8个月，p < 0.001）。除甲沟炎和痤疮外，不良事件（主要是皮肤反应和腹泻）通常为轻度（1级或2级）。因此，吉非替尼在台湾晚期NSCLC患者中具有临床抗肿瘤活性和良好的耐受性，且体能状态非常差，缓解率高于欧洲或欧洲血统的美国人。化疗患者的反应优于既往化疗患者。正式的临床试验是必要的，以评估吉非替尼在这种情况下的作用。
Advanced non-small-cell lung cancer (NSCLC) patients with poor performance status (PS) are less likely to respond to chemotherapy, or to have an improvement in survival, but more likely to experience toxicity. We retrospectively evaluated the efficacy and tolerability of gefitinib in patients with advanced NSCLC and very poor PS in Taiwan. Patients with stage IIIB, IV NSCLC with an Eastern Cooperative Oncology Group (ECOG) PS of 3-4 received oral gefitinib 250 mg once daily. Totally, 52 patients were included (25 men, 27 women). Forty-three patients (82.7%) were in a PS of 3. Tumor response rate was 25.0% (13/52). Tumor response rate to gefitinib was highest in chemonaive patients 38.1% (8/21) vs. failed 1 chemotherapy regimen 13.3% (2/15) vs. failed 2 or more chemotherapy regimens 18.8% (3/16), p = 0.015. The median overall survival was 2.5 months (response group 9.1 months, stable disease 3.1 months, and progressive group 0.8 month, p < 0.001). Adverse events, mainly skin reactions and diarrhea, were generally mild (grade 1 or 2) except paronychia and acne. Thus, gefitinib has clinically antitumor activity and good tolerability in Taiwan patients with advanced NSCLC and very poor performance status, with a higher response rate than that seen Europe or in European heritage Americans. Chemonaive patients responded better than patients with prior chemotherapy. Formal clinical trials are warranted to evaluate the role of gefitinib in this situation.