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Randomized phase III study of erlotinib versus observation in patients with no evidence of disease progression after first-line platin-based chemotherapy for ovarian carcinoma: a European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group, and Gynecologic Cancer Intergroup study.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2014 Feb 01; Vol. 32 (4), pp. 320-6. Date of Electronic Publication: 2013 Dec 23. - Publication Year :
- 2014
-
Abstract
- Purpose: This trial evaluated the efficacy of maintenance erlotinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, after first-line chemotherapy.<br />Patients and Methods: Eligible patients had high-risk International Federation of Gynecology and Obstetrics stage I or stage II to IV epithelial ovarian, primary peritoneal, or fallopian tube cancer and were not selected for EGFR expression. All patients underwent first-line platinum-based chemotherapy (CT) and showed no signs of progression at the end of CT. Patients were randomly assigned to maintenance erlotinib 150 mg orally daily for 2 years or to observation. EGFR immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), and mutation analyses were performed in 318 patients.<br />Results: Between October 2005 and February 2008, 835 patients were randomly assigned (median follow-up, 51 months). Twenty-six percent of the patients stopped erlotinib as a result of adverse effects (of these, 67% were due to rash). For erlotinib and observation, respectively, the median progression-free survival was 12.7 and 12.4 months (hazard ratio [HR], 1.05; 95% CI, 0.90 to 1.23), and the median overall survival was 50.8 and 59.1 months (HR, 0.99; 95% CI, 0.81 to 1.20 months), respectively. No subgroup could be identified with improved effect of erlotinib, based on IHC or FISH for EGFR, or mutations in genes related to the EGFR pathway, or on rash during erlotinib therapy. However, patients with a positive FISH EGFR score had a worse overall survival (46.1 months) than those with a negative score (67.0 months; HR, 1.56; 95% CI, 1.01 to 2.40; P = .044). Global health/quality-of-life scores showed a significant difference during the first year (P = .0102) in favor of the observation arm.<br />Conclusion: Maintenance erlotinib after first-line treatment in ovarian cancer did not improve progression-free or overall survival.
- Subjects :
- Adult
Aged
Aged, 80 and over
Carcinoma, Ovarian Epithelial
Disease-Free Survival
Drug Administration Schedule
Drug Eruptions etiology
ErbB Receptors genetics
Erlotinib Hydrochloride
Europe
Fallopian Tube Neoplasms pathology
Female
Follow-Up Studies
Humans
Immunohistochemistry
In Situ Hybridization, Fluorescence
Kaplan-Meier Estimate
Maintenance Chemotherapy
Middle Aged
Mutation
Neoplasm Staging
Neoplasms, Glandular and Epithelial pathology
Ovarian Neoplasms pathology
Peritoneal Neoplasms pathology
Platinum Compounds administration & dosage
Protein Kinase Inhibitors adverse effects
Quality of Life
Quinazolines adverse effects
Signal Transduction genetics
Watchful Waiting
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Fallopian Tube Neoplasms drug therapy
Neoplasms, Glandular and Epithelial drug therapy
Ovarian Neoplasms drug therapy
Peritoneal Neoplasms drug therapy
Protein Kinase Inhibitors administration & dosage
Quinazolines administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 32
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 24366937
- Full Text :
- https://doi.org/10.1200/JCO.2013.50.5669