Phase II open-label study of erlotinib in combination with gemcitabine in unresectable and/or metastatic adenocarcinoma of the pancreas: relationship between skin rash and survival (Pantar study)

被引:39
作者
Aranda, E. [1 ]
Manzano, J. L. [2 ]
Rivera, F. [3 ]
Galan, M. [4 ]
Valladares-Ayerbes, M. [5 ]
Pericay, C. [6 ]
Safont, M. J. [7 ]
Mendez, M. J. [1 ]
Irigoyen, A. [8 ]
Arrivi, A. [9 ]
Sastre, J. [10 ]
Diaz-Rubio, E. [10 ]
机构
[1] Hosp Univ Reina Sofia, Dept Oncol, Cordoba 14004, Spain
[2] Hosp Badalona Germans Trias & Pujol, Dept Oncol, Badalona, Spain
[3] Hosp Univ Marques de Valdecilla, Dept Oncol, Santander, Spain
[4] Hosp Duran & Reynals, Dept Oncol, Inst Catala Oncol, Lhospitalet De Llobregat, Spain
[5] Complejo Hosp Univ A Coruna, Dept Oncol, La Coruna, Spain
[6] Corp Sanitaria Parc Tauli, Dept Oncol, Sabadell, Spain
[7] Hosp Gen Univ Valencia, Dept Oncol, Valencia, Spain
[8] Hosp Univ Virgen de las Nieves, Dept Oncol, Granada, Spain
[9] Hosp Son Llatzer, Dept Oncol, Palma De Mallorca, Spain
[10] Spanish Minist Sci & Innovat, Dept Oncol, Hosp Clin San Carlos,Inst Carlos 3, Ctr Affiliated Red Temat Invest Cooperat RD06 002, Madrid, Spain
关键词
epidermal growth factor receptor inhibitors; erlotinib; gemcitabine; pancreatic cancer; rash; tyrosine kinase inhibitors; GROWTH-FACTOR RECEPTOR; TYROSINE KINASE INHIBITOR; CANCER; TRIAL; DETERMINANTS; MANAGEMENT; EFFICACY; THERAPY;
D O I
10.1093/annonc/mdr560
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Skin rash is an adverse event which might be associated with longer survival in patients treated with epidermal growth factor receptor tyrosine kinase inhibitors. The aim of this nonrandomised phase II clinical trial is to prospectively evaluate the relationship between skin rash and overall survival (OS) in advanced/metastatic pancreatic cancer treated with erlotinib plus gemcitabine. Patients were given gemcitabine (1000 mg/m(2)/week, 3 weeks every 4 weeks) plus erlotinib (100 mg/day orally continuously) until disease progression/unacceptable toxicity. The primary end point was OS. A total of 153 eligible patients were enrolled (grade >= 2 rash, 25%; grade < 2 rash, 75%). OS was longer in patients with grade >= 2 rash versus grade < 2 (11 versus 5 months; P < 0.001). Progression-free survival was longer in patients with grade >= 2 rash versus grade < 2 (6 versus 3 months; P < 0.001) and shorter in those without rash versus grade 1 (2 versus 4 months; P = 0.005) or grade >= 2 (2 versus 6 months; P < 0.001). Patients with grade >= 2 rash showed higher rates of overall response (21% versus 7%; P < 0.05) and disease control (84% versus 43%; P < 0.05) versus grade < 2. This study prospectively confirms the relationship between rash and longer OS in unresectable locally advanced/metastatic pancreatic cancer treated with erlotinib plus gemcitabine.
引用
收藏
页码:1919 / 1925
页数:7
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