OBJECTIVE(S): The Gynecologic Oncology Group (GOG) examined the association between ERBB2 amplification and clinical covariates, tumor response, disease status post-chemotherapy, progression-free survival (PFS), and overall survival (OS) in epithelial ovarian cancer (EOC). METHODS:Women with suboptimally-resected, advanced stage EOC who participated in GOG-111, a multi-center randomized phase III trial of cyclophosphamide+cisplatin versus paclitaxel+cisplatin, and provided a tumor block through the companion protocol GOG-9404 were eligible. ERBB2 amplification was examined using fluorescence in situ hybridization (FISH) with probes for ERBB2 and the centromere of chromosome 17 (CEP17). RESULTS:ERBB2 amplification, defined as >2 copies of ERBB2/CEP17, was a rare event in EOC with 7% (9/133) of women exhibiting between 2.2 and 33.7 copies of ERBB2/CEP17, and was not associated with patient age, race, GOG performance status, stage, cell type, grade, measurable disease status, volume of ascites, tumor response or disease status post-chemotherapy. Women with >2 verses < or =2 copies of ERBB2/CEP17 did not have a reduced risk of disease progression (hazard ratio [HR]=0.56; 95% confidence interval [CI]=0.27-1.16; p=0.120) or death (HR=0.57; 95% CI=0.26-1.23; p=0.152), and ERBB2 amplification was not an independent prognostic factor for PFS or OS. ERBB2 amplification, defined as >4 copies of ERBB2/nuclei, was observed in 9% (12/133) of women with levels ranging from 4.2 to 49.2 copies of ERBB2/nuclei, and was associated with older age and volume of ascites, but not with the other clinical covariates or outcome. CONCLUSION(S): ERBB2 amplification is a rare event and has no predictive or prognostic value in suboptimally-resected, advanced stage EOC treated with platinum-based combination chemotherapy.
RCT Entities:
OBJECTIVE(S): The Gynecologic Oncology Group (GOG) examined the association between ERBB2 amplification and clinical covariates, tumor response, disease status post-chemotherapy, progression-free survival (PFS), and overall survival (OS) in epithelial ovarian cancer (EOC). METHODS:Women with suboptimally-resected, advanced stage EOC who participated in GOG-111, a multi-center randomized phase III trial of cyclophosphamide+cisplatin versus paclitaxel+cisplatin, and provided a tumor block through the companion protocol GOG-9404 were eligible. ERBB2 amplification was examined using fluorescence in situ hybridization (FISH) with probes for ERBB2 and the centromere of chromosome 17 (CEP17). RESULTS:ERBB2 amplification, defined as >2 copies of ERBB2/CEP17, was a rare event in EOC with 7% (9/133) of women exhibiting between 2.2 and 33.7 copies of ERBB2/CEP17, and was not associated with patient age, race, GOG performance status, stage, cell type, grade, measurable disease status, volume of ascites, tumor response or disease status post-chemotherapy. Women with >2 verses < or =2 copies of ERBB2/CEP17 did not have a reduced risk of disease progression (hazard ratio [HR]=0.56; 95% confidence interval [CI]=0.27-1.16; p=0.120) or death (HR=0.57; 95% CI=0.26-1.23; p=0.152), and ERBB2 amplification was not an independent prognostic factor for PFS or OS. ERBB2 amplification, defined as >4 copies of ERBB2/nuclei, was observed in 9% (12/133) of women with levels ranging from 4.2 to 49.2 copies of ERBB2/nuclei, and was associated with older age and volume of ascites, but not with the other clinical covariates or outcome. CONCLUSION(S): ERBB2 amplification is a rare event and has no predictive or prognostic value in suboptimally-resected, advanced stage EOC treated with platinum-based combination chemotherapy.
Authors: Kathleen M Darcy; William E Brady; John W McBroom; Jeffrey G Bell; Robert C Young; William P McGuire; R Ilona Linnoila; Denver Hendricks; Tomas Bonome; John H Farley Journal: Gynecol Oncol Date: 2008-10-02 Impact factor: 5.482
Authors: A Berchuck; A Kamel; R Whitaker; B Kerns; G Olt; R Kinney; J T Soper; R Dodge; D L Clarke-Pearson; P Marks Journal: Cancer Res Date: 1990-07-01 Impact factor: 12.701
Authors: Michael A Bookman; Kathleen M Darcy; Daniel Clarke-Pearson; Richard A Boothby; Ira R Horowitz Journal: J Clin Oncol Date: 2003-01-15 Impact factor: 44.544
Authors: Fan Zhang; Ying Yang; Terry Smith; Shu-Wan Kau; Judy M McConathy; Francisco J Esteva; Henry M Kuerer; W Fraser Symmans; Aman U Buzdar; Gabriel N Hortobagyi; Lajos Pusztai Journal: Cancer Date: 2003-04-01 Impact factor: 6.860
Authors: W P McGuire; W J Hoskins; M F Brady; P R Kucera; E E Partridge; K Y Look; D L Clarke-Pearson; M Davidson Journal: N Engl J Med Date: 1996-01-04 Impact factor: 91.245