Abstract
Combination therapy with gefitinib and fulvestrant (G/F) for women with non-small cell lung cancer (NSCLC)
Journal of clinical oncology, Vol.23(16_suppl), pp.7224-7224
06/2005
DOI: 10.1200/jco.2005.23.16_suppl.7224
Abstract
Abstract only
Background: Estrogen receptors (ERs) have been detected in NSCLC specimens. Fulvestrant has blocked estradiol-stimulated tumor growth in NSCLC cell lines. Preclinical data show an inverse cross-talk between the EGFR and ER pathways. Objectives: Determine safety and efficacy of G/F and correlate with markers of ER and EGFR pathways. Methods: Post-menopausal women with advanced NSCLC received gefitinib 250 po mg daily and fulvestrant 250 mg IM monthly, every 28 days. Results: Accrual goal is 22 pts; 15 have enrolled to date. Median age is 72 yrs. 8 pts had adenocarcinoma, 3 squamous cell, 3 NSCLC-NOS, and 1 bronchoalveolar carcinoma. 5 pts never smoked; 9 were former smokers. Prior lines of chemotherapy received: ≥2 (6 pts), 1 (5 pts), 0 (4 pts). PS: 0 (7 pts), 1 (6 pts), 2 (2 pts). Gr 3/4 treatment-related toxicities: Gr 4 dyspnea (1 pt). No unexpected toxicities have been seen. 11 pts are evaluable for response: 2 confirmed PRs (1 adenocarcinoma and 1 NSCLC-NOS), both in never smokers. Median number of cycles of treatment, PFS, and OS are 5.29 cycles, 21 wks, and 28+ wks (not yet reached; range 7–38+). 6 pts have stable disease [SD] (1 current smoker, 4 former smokers, 1 never smoker); the median duration of SD is 21 wks. There was no correlation between total ER or amount of nuclear ER staining and response to treatment or histology in 8 tumors examined. 1 patient receiving 2nd-line treatment had a heterozygous point mutation (G2591A) in EGFR exon 21 and SD for 21 wks; neither pt with PR had sufficient tumor for mutation analysis. None of the 6 tumors analyzed displayed EGFR gene amplification. Genotyping for MDR-1 and CYP3A4*1B was performed in 11 tumors; variants did not correlate with toxicity or response. Conclusions: G/F in post-menopausal women with NSCLC is well-tolerated and demonstrates disease activity. Correlative studies indicate there is no relation between amount of ERα, ERβ or EGFR expression in the tumor and response to treatment. 5 of the 6 pts with SD were active or former smokers. 1 pt with an EGFR mutation had prolonged SD, but no PR.
Details
- Title: Subtitle
- Combination therapy with gefitinib and fulvestrant (G/F) for women with non-small cell lung cancer (NSCLC)
- Creators
- A. M. Traynor - UPMC Hillman Cancer CenterJ. H. Schiller - UPMC Hillman Cancer CenterL. P. Stabile - UPMC Hillman Cancer CenterJ. M. Kolesar - UPMC Hillman Cancer CenterC. P. Belani - UPMC Hillman Cancer CenterT. Hoang - UPMC Hillman Cancer CenterS. Dubey - UPMC Hillman Cancer CenterJ. Eickhoff - UPMC Hillman Cancer CenterS. M. Marcotte - UPMC Hillman Cancer CenterJ. M. Siegfried - UPMC Hillman Cancer Center
- Resource Type
- Abstract
- Publication Details
- Journal of clinical oncology, Vol.23(16_suppl), pp.7224-7224
- DOI
- 10.1200/jco.2005.23.16_suppl.7224
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Language
- English
- Date published
- 06/2005
- Academic Unit
- Pharmacy; Pharmaceutical Sciences and Experimental Therapeutics
- Record Identifier
- 9984695791402771
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