Ciardiello F, Troiani T, Caputo F, De Laurentiis M, Tortora G, Palmieri G, De Vita F, Diadema M R, Orditura M, Colantuoni G, Gridelli C, Catalano G, De Placido S, Bianco A R
Cattedra di Oncologia Medica, Dipartimento Medico-Chirurgico di Internistica Clinica e Sperimentale 'F Magrassi e A Lanzara', Seconda Università degli Studi di Napoli, Via S Pansini 5, 80131 Naples, Italy.
Br J Cancer. 2006 Jun 5;94(11):1604-9. doi: 10.1038/sj.bjc.6603141.
We have evaluated the activity and safety of gefitinib, a small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in combination with docetaxel as first-line treatment of women with metastatic breast cancer (MBC). In total, 41 patients with MBC were enrolled in a first-line combination therapy study with oral gefitinib (250 mg day(-1)) and intravenous docetaxel (75 mg m(-2), the first 14 patients; or 100 mg m(-2), the following 27 patients, on day 1 of a 3-week cycle). Out of 41 patients, 38 received at least one cycle of therapy. There were no differences in activity or tolerability between the two docetaxel doses. G3/4 toxicities were neutropenia (49%), diarrhoea (10%), acne-like rash (5%), and anaemia (2%). Complete plus partial responses (CR+PR) were observed in 22 out of 41 patients with a 54% response rate (95% confidence interval (CI) 45-75%). The 22 patients that achieved a response following six cycles of docetaxel plus gefitinib continued gefitinib monotherapy (median duration, 24 weeks; range, 2-108+ weeks). Two patients with PR following combination therapy achieved a CR during gefitinib monotherapy. Complete plus partial responses correlated with oestrogen receptor (ER) status, since they occurred in 19 out of 27 (70%) patients with ER-positive tumours as compared to three out of 14 (21%) patients with ER-negative tumours (P=0.01).
我们评估了小分子表皮生长因子受体（EGFR）酪氨酸激酶抑制剂吉非替尼联合多西他赛作为转移性乳腺癌（MBC）女性患者一线治疗的活性和安全性。共有41例MBC患者参加了一项一线联合治疗研究，口服吉非替尼（250 mg/天）和静脉注射多西他赛（75 mg/m²，前14例患者；或100 mg/m²，随后27例患者，每3周周期的第1天）。41例患者中，38例接受了至少一个周期的治疗。两种多西他赛剂量在活性或耐受性方面无差异。3/4级毒性为中性粒细胞减少（49%）、腹泻（10%）、痤疮样皮疹（5%）和贫血（2%）。41例患者中有22例观察到完全缓解加部分缓解（CR+PR），缓解率为54%（95%置信区间（CI）45-75%）。在接受多西他赛加吉非替尼六个周期治疗后达到缓解的22例患者继续接受吉非替尼单药治疗（中位持续时间，24周；范围，2-108+周）。联合治疗后有部分缓解的两名患者在吉非替尼单药治疗期间达到完全缓解。完全缓解加部分缓解与雌激素受体（ER）状态相关，因为在27例ER阳性肿瘤患者中有19例（70%）出现，而在14例ER阴性肿瘤患者中有3例（21%）出现（P=0.01）。
