nscl

Question 1

PROFILE 1007 Trial

Answer 1

PROFILE 1007 Trial - 2013 NEJM Shaw – Crizotinib versus Chemotherapy in Advanced ALK-Positive Lung Cancer.pdf - PH - PMID:23724913 - phase 3; open-label; 347 pts previously treated; Median PFS Crizotinib 7.7 m VS chemotherapy 3.0 m, HR 0.49; RR 65% VS 20%;

Question 2

IPASS Trial

Answer 2

IPASS Trial (Iressa Pan Asian Study) – 2009 NEJM Mok -- Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma.pdf – PH - PMID:19692680 - Schema IPASS - phase 3; open-label; first-line; 1-PFS; 1217 pts randomized 609 Geftinib VS 608 Carboplatin + Paclitaxel; 1-year PFS 24.9% VS 6.7%; For 261 EGFR mutant pts RR 71.2% VS 47.3% and PFS 9.5 VS 6.3 m, HR 0.48; For 176 EGFR wild-type pts Improved PFS wth chemotherapy (HR with gefitinib 2.85)
Critique – The First trial to demonstrate efficiacy of Geftinib in first-line setting

Question 3

OPTIMAL Trial

Answer 3

OPTIMAL Trial (Erlotinib Versus Gemcitabine/Carboplatin in Chemo-naïve State IIIB/IV Non-Small Cell Lung Cancer Patients with EGFR mutations) – 2011 Lancet Oncol Zhou – Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer - PMID:21783417 - Asian study, 83 pts Erlotinib, 82 pts Chemotherapy; PFS 13.1 m vs 4.6 m;

Question 4

***SATURN Trial

Answer 4

***SATURN Trial (Sequential Tarceva in Unresectable NSCLC) - 2010 Lancet Oncol Cappuzzo – Erlotinib as maintenance treatment in advanced non-small-cell lung cancer - PMID:20493771 - 884 patients, Improved PFS with Erlotinib maintenance for patients without disease progression;

Question 5

***EURTAC Trial

Answer 5

***EURTAC Trial (European Erlotinib Versus Chemotherapy) – 2012 Lancet Oncol Rosell – Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer - PMID:22285168 - Non-Asian Study, open label, 174 pts, Median PFS Erlotinib 9.7 m VS Chemotherapy 5.2 m;

Question 6

EGFR MUTATIONS IN NSCL

Answer 6

deletion mutation in exon 19 (LREA frame deletion) in 45% patients
point mutation in exon 21 (L858R in 40%, L861)
point mutation in exon 18 (G719X, G719)