TY - JOUR
T1 - Post hoc analyses of GOG 9923
T2 - Does BRCA status affect toxicities?: An NRG oncology study
AU - Gillen, Jessica
AU - Miller, Austin
AU - Bell-McGuinn, Katherine M.
AU - Schilder, Russell J.
AU - Walker, Joan L.
AU - Mathews, Cara A.
AU - Duska, Linda R.
AU - Guntupalli, Saketh R.
AU - O'Cearbhaill, Roisin
AU - Hays, John
AU - Hagemann, Andrea R.
AU - Gray, Heidi J.
AU - Gordon, Sarah W.
AU - Armstrong, Deborah K.
AU - Chen, Alice
AU - Fracasso, Paula M.
AU - Aghajanian, Carol
AU - Moore, Kathleen N.
N1 - Funding Information:
This study was supported by National Institute of Health grants to NRG Oncology (1 U10 CA180822) and NRG Operations (U10CA180868). The following Gynecologic Oncology Group member institutions participated in the primary treatment studies: University of Oklahoma Health Sciences Center, Women and Infants Hospital, University of Virginia, University of Colorado Cancer Center ? Anschutz Cancer Pavilion, Memorial Sloan-Kettering Cancer Center, Washington University School of Medicine, Fred Hutchinson Cancer Research Center, Virginia Commonwealth University, Georgia Center for Oncology Research and Education (CORE), Georgia Cares Minority Underserved NCORP, University of Iowa Hospitals and Clinics, University of Chicago, Johns Hopkins University/Sidney Kimmel Cancer Center, Roswell Park Comprehensive Cancer Center, Cleveland Clinic Foundation, Case Western Reserve University and University of Wisconsin Hospital and Clinics.
Funding Information:
This study was supported by National Institute of Health grants to NRG Oncology (1 U10 CA180822) and NRG Operations (U10CA180868).
Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2021/5
Y1 - 2021/5
N2 - Objective: To evaluate how women with epithelial ovarian cancer (EOC), dichotomized by BRCA status, tolerate intravenous (IV) or intraperitoneal (IP) chemotherapy given with veliparib and bevacizumab (bev) on a GOG phase I study (GOG 9923, NCT00989651). Methods: This is an unplanned, post hoc analysis of an IRB approved, multi-institutional, prospective study (GOG 9923). Clinical characteristics and toxicity data based on BRCA status were evaluated and descriptive statistics were used to summarize baseline patient characteristics and toxicities. The Kaplan Meier method was used to generate survival estimates. Results: Four hundred twenty-four patients were evaluable. Patients were treated with IV carboplatin, paclitaxel, and bev every 21 days (regimen 1), weekly IV paclitaxel with carboplatin and bev (regimen 2) or IV paclitaxel and bev with IP cisplatin (regimen 3). Bev was continued as maintenance in all arms. Within each of these regimens, veliparib was given either twice daily for the entirety of each cycle (continuous) or on days −2 to 5 (intermittent). Ten percent of patients treated on regimen 1, 12% on regimen 2, and 19.8% on regimen 3 had BRCA-associated tumors. Patients with BRCA-associated tumors, when compared to wild type, experienced similar rates of anemia, febrile neutropenia (, abdominal pain, colonic perforation, nausea, vomiting, and peripheral sensory neuropathy. Median progression free survival (PFS) was not significantly different between BRCA-associated and wild type cancers (HR 0.96, CI 0.65–1.42), though this study's primary aim was not to evaluate outcomes. Conclusions: Germline BRCA mutations positively affect chemosensitivity in EOC, but whether differences in toxicities among BRCA-associated and BRCA wild type tumors existed was previously not reported. In this population with newly diagnosed ovarian cancer no differences in reported toxicity between the two groups was observed.
AB - Objective: To evaluate how women with epithelial ovarian cancer (EOC), dichotomized by BRCA status, tolerate intravenous (IV) or intraperitoneal (IP) chemotherapy given with veliparib and bevacizumab (bev) on a GOG phase I study (GOG 9923, NCT00989651). Methods: This is an unplanned, post hoc analysis of an IRB approved, multi-institutional, prospective study (GOG 9923). Clinical characteristics and toxicity data based on BRCA status were evaluated and descriptive statistics were used to summarize baseline patient characteristics and toxicities. The Kaplan Meier method was used to generate survival estimates. Results: Four hundred twenty-four patients were evaluable. Patients were treated with IV carboplatin, paclitaxel, and bev every 21 days (regimen 1), weekly IV paclitaxel with carboplatin and bev (regimen 2) or IV paclitaxel and bev with IP cisplatin (regimen 3). Bev was continued as maintenance in all arms. Within each of these regimens, veliparib was given either twice daily for the entirety of each cycle (continuous) or on days −2 to 5 (intermittent). Ten percent of patients treated on regimen 1, 12% on regimen 2, and 19.8% on regimen 3 had BRCA-associated tumors. Patients with BRCA-associated tumors, when compared to wild type, experienced similar rates of anemia, febrile neutropenia (, abdominal pain, colonic perforation, nausea, vomiting, and peripheral sensory neuropathy. Median progression free survival (PFS) was not significantly different between BRCA-associated and wild type cancers (HR 0.96, CI 0.65–1.42), though this study's primary aim was not to evaluate outcomes. Conclusions: Germline BRCA mutations positively affect chemosensitivity in EOC, but whether differences in toxicities among BRCA-associated and BRCA wild type tumors existed was previously not reported. In this population with newly diagnosed ovarian cancer no differences in reported toxicity between the two groups was observed.
KW - BRCA
KW - Epithelial ovarian cancer
KW - Post hoc analyses
KW - Toxicities
UR - http://www.scopus.com/inward/record.url?scp=85101154430&partnerID=8YFLogxK
U2 - 10.1016/j.ygyno.2021.01.037
DO - 10.1016/j.ygyno.2021.01.037
M3 - Article
C2 - 33610319
AN - SCOPUS:85101154430
VL - 161
SP - 512
EP - 515
JO - Gynecologic Oncology
JF - Gynecologic Oncology
SN - 0090-8258
IS - 2
ER -