NRG Oncology/GOG Studies
The addition of paclitaxel to doxorubicin and cisplatin and volume-directed radiation does not improve overall survival (OS) or long-term recurrence-free survival (RFS) in advanced endometrial cancer (EC): A randomized phase III NRG/Gynecologic Oncology Group (GOG) study
To determine if the addition of paclitaxel (P) to cisplatin and doxorubicin (CD) following surgical debulking and volume-directed radiation therapy improved long-term, recurrence-free survival (RFS) and overall survival (OS) in patients with advanced-stage endometrial cancer (EC).Shaping the standard of care in ovarian cancer management: A review of Gynecologic Oncology Group (GOG)/NRG oncology clinical trials of the past twenty years
The Gynecologic Oncology Group (GOG), now part of the NRG Oncology network since the re-alignment of the National Clinical Trials Network in 2014, has played a fundamental role in creating the standard of care for women with ovarian cancer. GOG/NRG Oncology has had a series of achievements that have contributed to how we treat this disease; the approval of bevacizumab in frontline therapy, defining the role of intraperitoneal chemotherapy, optimal chemotherapy for early stage disease and the role of surgery in primary and recurrent disease management.GOG 8020/210: Risk stratification of lymph node metastasis, disease progression and survival using single nucleotide polymorphisms in endometrial cancer: An NRG oncology/gynecologic oncology group study
The ability to stratify a patient's risk of metastasis and survival permits more refined care. A proof of principle study was undertaken to investigate the relationship between single nucleotide polymorphisms (SNPs) in literature based candidate cancer genes and the risk of nodal metastasis and clinical outcome in endometrioid endometrial cancer (EEC) patients.A randomized phase II study of cabozantinib versus weekly paclitaxel in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer: An NRG Oncology/Gynecologic Oncology Group study
Cabozantinib is a receptor tyrosine kinases inhibitor that targets MET (c-MET), VEGF receptor 2 (VEGFR2), RET, AXL, KIT, FLT-3, and TIE-2 and previously showed promising single agent activity in recurrent ovarian cancer.Corrigendum to “Does adjuvant chemotherapy dose modification have an impact on the outcome of patients diagnosed with advanced stage ovarian cancer? An NRG Oncology/Gynecologic Oncology Group study” [Gynecol. Oncol. 151 (2018) 18–23]
The authors regret that there was some conflict of interest information missing from their original article. The conflict of interest statement for Dr. Robert Wenham has now been updated in the online version and can be found below:A phase II evaluation of elesclomol sodium and weekly paclitaxel in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube or primary peritoneal cancer: An NRG oncology/gynecologic oncology group study
Preclinical data suggest elesclomol increases oxidative stress and enhances sensitivity to cytotoxic agents. The objective of this prospective multicenter phase 2 trial was to estimate the activity of IV elesclomol plus weekly paclitaxel in patients with platinum-resistant recurrent ovarian, tubal or peritoneal cancer through the frequency of objective tumor responses (ORR).A Phase I Evaluation of Extended Field Radiation Therapy With Concomitant Cisplatin Chemotherapy Followed by Paclitaxel and Carboplatin Chemotherapy in Women With Cervical Carcinoma Metastatic to the Para-aortic Lymph Nodes: An NRG Oncology/Gynecologic Oncology Group Study
Chemo-radiation (chemoRT) has improved the overall survival for locally advanced cervical cancer (LACC) though women whose disease involves the para-aortic nodes (PAN) experience recurrence rates and worse survival outcomes compared to those without PAN involvement. This Phase I study determined if additional cycles of systemic chemotherapy could be safely added to extended field chemoRT in this population of patients.Randomized phase II trial of bevacizumab plus everolimus versus bevacizumab alone for recurrent or persistent ovarian, fallopian tube or peritoneal carcinoma: An NRG oncology/gynecologic oncology group study
Bevacizumab (BV) monotherapy leads to compensatory upregulation of multiple signaling pathways, resulting in mTOR activation. We evaluated combining BV and everolimus (EV), an mTOR kinase inhibitor, to circumvent BV-resistance in women with recurrent or persistent ovarian, fallopian tube or primary peritoneal cancer (OC).Does adjuvant chemotherapy dose modification have an impact on the outcome of patients diagnosed with advanced stage ovarian cancer? An NRG Oncology/Gynecologic Oncology Group study
To determine the relationship between chemotherapy dose modification (dose adjustment or treatment delay), overall survival (OS) and progression-free survival (PFS) for women with advanced-stage epithelial ovarian carcinoma (EOC) and primary peritoneal carcinoma (PPC) who receive carboplatin and paclitaxel.Phase II evaluation of dalantercept in the treatment of persistent or recurrent epithelial ovarian cancer: An NRG Oncology/Gynecologic Oncology Group study
To determine the efficacy of dalantercept, a soluble ALK1 inhibitor receptor fusion protein, in patients with persistent or recurrent ovarian carcinoma and related malignancies.Twenty-first century cervical cancer management: A historical perspective of the gynecologic oncology group/NRG oncology over the past twenty years
Since 1970, the Gynecologic Oncology Group (GOG) has been at the forefront of evaluating and helping to implement ground breaking and paradigm changing research in the management of cervical cancer. While the most dramatic example of this impact was a series of clinical trials published in 1999 that evaluated chemoradiation therapy versus radiation therapy alone for patients with various clinical scenarios, including both locally advanced as well as post radical hysterectomy patients, investigation has continued to further refine and improve therapy.A phase II evaluation of sunitinib in the treatment of persistent or recurrent clear cell ovarian carcinoma: An NRG Oncology/Gynecologic Oncology Group Study (GOG-254)
Accounting for 3–12% of all epithelial ovarian cancers, patients with clear cell carcinomas have a poorer prognosis compared to those with serous cancers [1–6]. Clinical and translational studies have shown that the biology and clinical behavior of clear cell carcinoma is distinct compared to other epithelial cell types [2,7–9].Pre-operative assessment and post-operative outcomes of elderly women with gynecologic cancers, primary analysis of NRG CC-002: An NRG oncology group/gynecologic oncology group study
CC-002 is a prospective cooperative group study conducted by NRG Oncology to evaluate whether a pre-operative GA-GYN score derived from a predictive model utilizing components of an abbreviated geriatric assessment (GA) is associated with major post-operative complications in elderly women with suspected ovarian, fallopian tube, primary peritoneal or advanced stage papillary serous uterine (GYN) carcinoma undergoing primary open cytoreductive surgery.Quality of life, symptoms and care needs in patients with persistent or recurrent platinum-resistant ovarian cancer: An NRG Oncology/Gynecologic Oncology Group study
The goals of treating recurrent platinum-resistant ovarian cancer are palliative, aimed at reducing symptoms and improving progression free survival. A prospective trial was conducted to determine the prevalence and severity of symptoms, and associated care needs.Phase II study of single-agent cabozantinib in patients with recurrent clear cell ovarian, primary peritoneal or fallopian tube cancer (NRG-GY001)
To evaluate the efficacy and tolerability of cabozantinib in recurrent clear cell ovarian, primary peritoneal or fallopian tube cancer.Correlation between Surgeon's assessment and radiographic evaluation of residual disease in women with advanced stage ovarian cancer reported to have undergone optimal surgical cytoreduction: An NRG Oncology/Gynecologic Oncology Group study
We sought to determine the level of concordance among surgeons' assessment of residual disease (RD) and pre-treatment computed tomography (CT) findings among women who underwent optimal surgical cytoreduction for advanced stage ovarian cancer.Clinicopathologic characteristics associated with long-term survival in advanced epithelial ovarian cancer: an NRG Oncology/Gynecologic Oncology Group ancillary data study
Studies by the Gynecologic Oncology Group (GOG) and others describe multiple clinical and pathologic characteristics that are associated with recurrence and survival in advanced epithelial ovarian cancer (EOC) patients [1–8]. In a retrospective analysis of a large group of EOC patients treated with primary cytoreduction and intravenous platinum and paclitaxel chemotherapy on one of six GOG trials, Winter and colleagues confirmed that increasing age, impaired performance status, mucinous or clear-cell histology, and gross residual disease were independent predictors of decreased progression free (PFS) and overall survival (OS).Predictive modeling for determination of microscopic residual disease at primary cytoreduction: An NRG Oncology/Gynecologic Oncology Group 182 Study
Microscopic residual disease following complete cytoreduction (R0) is associated with a significant survival benefit for patients with advanced epithelial ovarian cancer (EOC). Our objective was to develop a prediction model for R0 to support surgeons in their clinical care decisions.An NRG Oncology/GOG study of molecular classification for risk prediction in endometrioid endometrial cancer
The purpose of this study was to assess the prognostic significance of a simplified, clinically accessible classification system for endometrioid endometrial cancers combining Lynch syndrome screening and molecular risk stratification.Dysregulation of miR-181c expression influences recurrence of endometrial endometrioid adenocarcinoma by modulating NOTCH2 expression: An NRG Oncology/Gynecologic Oncology Group study
Endometrial carcinoma is the fourth most common malignancy among women world-wide and is the most common gynecologic cancer [1]. Endometrial cancer is broadly categorized into three histologic types: endometrioid adenocarcinoma (EEA), accounting for up to 75% of cases, serous adenocarcinoma (ESA), accounting for an additional 20% of cases and carcinosarcoma (UCS), which makes up most of the remaining cases [2]. In general, EEA has a better prognosis and a low recurrence risk, while ESA and UCS are more aggressive with accordingly worse prognosis and increased recurrence risk.Genome-wide association study evaluating single-nucleotide polymorphisms and outcomes in patients with advanced stage serous ovarian or primary peritoneal cancer: An NRG Oncology/Gynecologic Oncology Group study
This study evaluated single nucleotide polymorphisms (SNPs) associated with progression free (PFS) and overall survival (OS) in patients with advanced stage serous EOC.An evaluation of progression free survival and overall survival of ovarian cancer patients with clear cell carcinoma versus serous carcinoma treated with platinum therapy: An NRG Oncology/Gynecologic Oncology Group experience
Ovarian tumors are classified into three categories based on progenitor cell type: surface-epithelial, sex cord-stromal and germ cell neoplasms [1]. Of these, epithelial ovarian cancers (EOCs which may, in fact, often originate from the fallopian tube) comprise the majority of cases, and these are usually diagnosed at an advanced stage with an associated poor prognosis. Serous epithelial ovarian carcinoma (SOC) is the most commonly observed subtype of EOC both in the United States [2] and worldwide [3,4].A phase I trial of intraperitoneal GEN-1, an IL-12 plasmid formulated with PEG-PEI-cholesterol lipopolymer, administered with pegylated liposomal doxorubicin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancers: An NRG Oncology/Gynecologic Oncology Group study
Advanced epithelial ovarian cancer (EOC) remains the most lethal gynecologic malignancy. Despite advances in surgical cytoreduction and chemotherapy, the five-year survival remains approximately 45.6% [1]. Due to EOC being an immunogenic tumor, there has been significant interest in developing immunotherapy strategies using cytokines, monoclonal antibodies, checkpoint inhibitors, immune modulators, therapeutic vaccines, adoptive T cell transfer and oncolytic viruses.Randomized phase IIB evaluation of weekly paclitaxel versus weekly paclitaxel with oncolytic reovirus (Reolysin®) in recurrent ovarian, tubal, or peritoneal cancer: An NRG Oncology/Gynecologic Oncology Group study
Few FDA approved options exist for the treatment of recurrent ovarian cancer. In patients with recurrent disease, re-treatment with paclitaxel using a weekly schedule has demonstrated activity, possibly through anti-angiogenic as well as direct cytotoxic mechanisms [1]. Gynecologic Oncology Group (GOG)-0126N demonstrated a 21% objective response rate (and a 46% rate of stable disease) in this population [2].Quality of life is significantly associated with survival in women with advanced epithelial ovarian cancer: An ancillary data analysis of the NRG Oncology/Gynecologic Oncology Group (GOG-0218) study
For the approximately 22,000 patients projected to be diagnosed with ovarian cancer in 2015, the vast majority will have epithelial ovarian cancer (EOC) [1]. Maximal cytoreductive surgery and administration of adjuvant or neoadjuvant primary chemotherapy with a platinum and taxane combination regimen have proven to be the two most important factors influencing survival [2–6]. Apart from modifying the dose schedule [7] and route of administration of the platinum and taxane combination [8], there have been no new drugs alone or in combination with the platinum and taxane backbone that have resulted in improved overall survival (OS) [9].
