A randomized placebo-controlled phase III study of intercalated erlotinib with gemcitabine/platinum in first-line advanced non-small cell lung cancer (NSCLC): FASTACT-II
| Autor: | Yunzhong Zhu, Kate Jin, Vichien Srimuninnimit, Jin Soo Lee, Yi-Long Wu, Chong-Jen Yu, Virote Sriuranpong, Li Zhang, Caicun Zhou, Matt Truman, Guia Ladrera, Hongming Pan, Benjamin Margono, Meilin Liao, Yan Sun, Victor C. S. Lee, Sumitra Thongprasert, Jennifer Sandoval-Tan, Yuh Min Chen, Tony Mok |
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| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Chemotherapy business.industry First line medicine.medical_treatment Phases of clinical research non-small cell lung cancer (NSCLC) chemistry.chemical_element Pharmacology medicine.disease Placebo Gemcitabine respiratory tract diseases chemistry Internal medicine Medicine Erlotinib business Platinum neoplasms medicine.drug |
| Zdroj: | ResearcherID |
| Popis: | 7519^ Background: FASTACT, a randomized, phase 2 study in advanced NSCLC, found that intercalated erlotinib with 1st-line platinum-based chemotherapy (CT) significantly prolongs progression-free survival (PFS) (HR 0.47, p=0.0002) versus CT alone (Mok et al. JCO 2009). FASTACT-II is a confirmatory, randomized, phase 3, placebo-controlled, double-blind study in a large patient population Methods: Patients with untreated stage IIIB/IV NSCLC and ECOG PS 0/1 were randomized (1:1) to receive up to 6 cycles of gemcitabine (1,250 mg/m2 on d1 and 8) plus platinum (carboplatin 5×AUC or cisplatin 75 mg/m2 on d1) q4w, with either intercalated erlotinib (150 mg/day on d15–28) or placebo. Non-progressing patients received maintenance erlotinib or placebo until progression, unacceptable toxicity or death. Stratification was by disease stage, histology, smoking status and CT regimen. Primary endpoint was PFS; secondary endpoints included overall response rate (ORR), overall survival (OS), safety, QoL and biomarker analyses. Results: From Apr 2009 to Sep 2010, 451 patients were randomized to receive erlotinib (n=226) or placebo (n=225). Baseline demographics were well balanced across the arms; overall, 49% were never smokers, 40% were female and 76% had adenocarcinoma. PFS was significantly prolonged with erlotinib vs placebo: median 7.6 vs 6.0 months, respectively; HR 0.57 (95% CI 0.46–0.70); p |
| Databáze: | OpenAIRE |
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