Randomized Phase II Trial Evaluating Treatment with EGFR-TKI Associated with Antiestrogen in Women with Nonsquamous Advanced-Stage NSCLC: IFCT-1003 LADIE Trial.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
Julien MazieresPierre-Jean Souquet

Abstract

The incidence of lung cancer has dramatically increased in women. Preclinical data have suggested that combining EGFR-tyrosine kinase inhibitor (TKI) with an antiestrogen may overcome resistance to EGFR-TKI. The IFCT-1003 LADIE trial was a 2 × 2 arms parallel open-label randomized phase II trial. EGFR-TKI-naïve postmenopausal women with advanced lung cancer were treated with gefitinib (G) versus gefitinib + fulvestrant (G+F) in the EGFR-mutated group (EGFR+) or with erlotinib (E) versus erlotinib + fulvestrant (E+F) in the EGFR wild-type group (EGFR-WT). The primary objective was progression-free survival (PFS) at 3 and 9 months for EGFR-WT and EGFR+ patients. Overall, 204 patients (gefitinib 104 and G+F 100) and 175 patients (erlotinib 87 and E+F 88) were enrolled in the EGFR+ and EGFR-WT cohorts. In the EGFR+ cohort, the primary endpoint was reached, with 58% of the G+F group patients being nonprogressive at 9 months. Adding fulvestrant to gefitinib was not associated with improved PFS (9.9 vs 9.4 months) or overall survival (OS; 22.1 vs 28.6 months). In the EGFR-WT cohort, the primary endpoint was also achieved (33.7% of the patients were nonprogressive at 3 months). Adding fulvestrant to erlotinib was not associated with im...Continue Reading

References

Oct 16, 1999·Genetic Epidemiology·A G SchwartzL Weiss
Jul 26, 2002·Lung Cancer : Journal of the International Association for the Study of Lung Cancer·Steen MollerupAage Haugen
Jun 26, 2004·Clinical Lung Cancer·James Gasperino, William N Rom
Jul 22, 2005·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Hideki KawaiJunichi Ogawa
Oct 11, 2005·The Journal of Thoracic and Cardiovascular Surgery·Chen-Tu WuYung-Chie Lee
Oct 26, 2005·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Ann G SchwartzSam Brooks
Nov 30, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Apar Kishor GantiAnil Potti
Oct 2, 2007·Lung Cancer : Journal of the International Association for the Study of Lung Cancer·Birgit Guldhammer SkovHelle Pappot
Jun 27, 2008·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Hiromichi NiikawaHironobu Sasano
Aug 15, 2008·Lung Cancer : Journal of the International Association for the Study of Lung Cancer·Anne M TraynorJill M Siegfried
Dec 10, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Naohiro NoseKosei Yasumoto
Feb 18, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Christopher G SlatoreEmily White
Dec 27, 2011·Lung Cancer : Journal of the International Association for the Study of Lung Cancer·Isabelle RouquetteJulien Mazières
Jun 9, 2016·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Duane H HamiltonClaudia Palena
Jan 10, 2018·CA: a Cancer Journal for Clinicians·Rebecca L SiegelAhmedin Jemal
Aug 10, 2018·Lung Cancer : Journal of the International Association for the Study of Lung Cancer·Edward B GaronRichard J Pietras

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