1. Docetaxel and intermittent erlotinib in patients with metastatic Non-Small Cell Lung Cancer; a phase II study from the Hellenic Cooperative Oncology Group
- Author
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Vasilios, Karavasilis, Paris, Kosmidis, Konstantinos N, Syrigos, Polyxeni, Mavropoulou, Meletios A, Dimopoulos, Vassiliki, Kotoula, Dimitrios, Pectasides, Ioannis, Boukovinas, George, Klouvas, Anna, Kalogera-Fountzila, Christos N, Papandreou, George, Fountzilas, and Evangelos, Briasoulis
- Subjects
Adult ,Male ,Lung Neoplasms ,Docetaxel ,Middle Aged ,Erlotinib Hydrochloride ,Treatment Outcome ,Risk Factors ,Carcinoma, Non-Small-Cell Lung ,Antineoplastic Combined Chemotherapy Protocols ,Quinazolines ,Humans ,Female ,Taxoids ,Neoplasm Grading ,Neoplasm Metastasis ,Aged - Abstract
To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating chemotherapy-naive patients with advanced Non-Small Cell Lung Cancer (NSCLC).Patients were randomized to receive daily erlotinib for 12 consecutive days prior to docetaxel (Arm A) or after docetaxel (Arm B). Progression-free survival (PFS) was the primary end-point; secondary end-points were overall survival (OS) and objective response rate (ORR).Fifty eligible patients received a total of 226 treatment cycles (median: 3). Median PFS and OS were 3.6 months and 10.5 months, respectively (differences were not statistically significant between the two arms). Neutropenia grade 3 and 4 occurred in 15 patients, while two patients developed grade 3 diarrhea. There were two treatment-related deaths (pulmonary embolism and non-neutropenic sepsis).Intermittent administration of erlotinib does not appear to improve the clinical outcome of single-agent docetaxel chemotherapy in unselected patients with NSCLC in the first-line setting.
- Published
- 2014