A phase II trial of erlotinib as maintenance treatment after concurrent chemoradiotherapy in stage III non-small-cell lung cancer (NSCLC): a Galician Lung Cancer Group (GGCP) study

被引:11
作者
Casal Rubio, J. [1 ,2 ]
Firvida-Perez, J. L. [3 ]
Lazaro-Quintela, M. [1 ]
Baron-Duarte, F. J. [4 ]
Alonso-Jaudenes, G. [5 ]
Santome, L. [6 ]
Afonso-Afonso, F. J. [7 ]
Amenedo, M. [8 ]
Huidobro, G. [1 ]
Campos-Balea, B. [9 ]
Lopez-Vazquez, M. D. [10 ]
Vazquez, S. [9 ]
机构
[1] Complexo Hosp Univ Vigo CHUVI, Dept Med Oncol, Vigo, Spain
[2] Complexo Hosp Univ Vigo, Med Oncol Serv, Vigo 36211, Spain
[3] Complexo Hosp Ourense CHOU, Dept Med Oncol, Orense, Spain
[4] CHUS, Dept Med Oncol, Santiago De Compostela, Spain
[5] CHUAC, Dept Med Oncol, La Coruna, Spain
[6] Hosp Povisa, Dept Med Oncol, Vigo, Spain
[7] Complexo Hosp Arquitecto Marcide Novoa Santos, Dept Med Oncol, Ferrol, Spain
[8] Ctr Reg Oncol Galicia, La Coruna, Spain
[9] HULA, Dept Med Oncol, Lugo, Spain
[10] Complexo Hosp Ourense CHOU, Dept Radiat Oncol, Orense, Spain
关键词
Non-small-cell lung cancer; Erlotinib; Maintenance chemotherapy; Stage III disease; INDUCTION CHEMOTHERAPY; TARGETED THERAPIES; RADIATION-THERAPY; RADIOTHERAPY; CISPLATIN; PLACEBO; CHEMORADIATION; CONSOLIDATION; GEMCITABINE; PACLITAXEL;
D O I
10.1007/s00280-013-2370-z
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
This single arm, phase II study aims to evaluate the role of epidermal growth factor receptor-tyrosine-kinase inhibitor erlotinib as maintenance therapy following concurrent chemoradiotherapy (cCRT) in unresectable locally advanced non-small-cell lung cancer (NSCLC). Patients with unresectable stage IIIA o dry IIIB NSCLC with no evidence of tumor progression after receiving a standard cCRT regimen with curative intent were included. Oral erlotinib 150 mg/day was administered within 4-6 weeks after the end of the cCRT for a maximum of 6 months if no disease progression or intolerable toxicity occurred. Primary end point was the progression-free rate (PFR) at 6 months. Secondary end points included time to progression (TTP) and overall survival (OS). Sixty-six patients were enrolled and received maintenance treatment with erlotinib [average: 4.5 months (95 % CI 4.0-5.0)]. PFR at 6 months was 63.5 % (41/66). With a median follow-up of 22.7 months (95 % CI 13.5-37.1), the median TTP was 9.9 months (95 % CI 6.2-12.1), and the median OS was 24.0 months (95 % CI 17.3-48.6). Most common adverse events (AEs) related to erlotinib were rash (78.8 %; 16.7 % grade 3), diarrhea (28.8 %; 1.5 % grade 3), fatigue (15.2 %; 1.5 % grade 3), anorexia (7.6 %; 1.5 % grade 3) and vomiting (4.6 %; none grade 3). Five patients (7.6 %) were withdrawn due to AEs. Erlotinib as maintenance therapy is an active treatment after cCRT in unselected patients with stage III NSCLC, reaching a 6-month PFR of 63.5 % and a median OS of 24 months. The safety profile of maintenance erlotinib was as expected and manageable.
引用
收藏
页码:451 / 457
页数:7
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