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Report on NRG Oncology and the GOG Partners Program
Gynecologic Oncology 134 (2014) 445–446
Contents lists available at ScienceDirect
Gynecologic Oncology journal homepage: www.elsevier.com/locate/ygyno
Conference Report
Report on NRG Oncology and the GOG Partners Program
This report will provide an update on the NRG Oncology and the GOG Partners Program and review the educational and scientific activities noted during the NRG Oncology Summer Semi-Annual Meeting in Chicago, IL. NRG Oncology The Gynecologic Cancer Committee, now one of seven disease specific committees for NRG Oncology, is working hard to expand the number of CTEP sponsored trials in ovarian, endometrial and cervical cancer. Disease site committees are being reorganized to incorporate expertise in experimental medicine, developmental therapeutics and rare tumors to foster the development of innovative randomized phase II/III target driven trials that incorporate integral or integrated tissue or imaging biomarkers. For example, OVM1403 and OVM1405 are trial concepts recently reviewed by the NCI's Gynecologic Cancer Steering Committee (GCSC), which will evaluate the PARP inhibitor olaparib and the antiangiogenic agent cediranib in platinum sensitive and resistant ovarian cancer patients, respectively. Several other new concepts were presented to the NRG Oncology Research Strategy Committee and will soon be forwarded to the GCSC. The Cancer Prevention and Control Committee, now a separate committee from the Gynecologic Committee, also submitted a concept to the Research Strategy Committee evaluating salpingectomy as a means of reducing high grade serous ovarian cancer in premenopausal BRCA 1/2 carriers. GOG Partners Program The GOG Partners Program is also expanding its portfolio of clinical trials. Protocol 3004 is an active randomized trial evaluating the PARP inhibitor olaparib as a maintenance strategy in BRCA1/2 mutation carriers who have newly diagnosed advanced high grade serous or high grade endometrioid ovarian cancer and who have achieved a clinical complete or partial response to platinum based chemotherapy. GOG3005 is a key trial under development that will evaluate the PARP inhibitor veliparib in combination with chemotherapy in newly diagnosed ovarian cancer patients. This trial is anticipated to open to accrual in the first quarter of 2015. Highlights from NRG Oncology's Summer Semi-Annual Meeting Symposium and Scientific Session The Summer Symposium, organized by Drs. Joan Walker and Mark Sherman, was entitled, “New Paradigms in the Pathogenesis of Highgrade Serous Carcinoma: Translating Biological Advances into Prevention.” Lecturers reviewed the molecular pathogenesis of high grade
http://dx.doi.org/10.1016/j.ygyno.2014.08.002
serous ovarian carcinoma, the identification of women who harbor genetic risks for ovarian cancer, the medical consequences of oophorectomy, and the experience from GOG-0199 and ongoing efforts to perform risk reducing salpingectomy in Vancouver. The Symposium provided great background information for the aforementioned trial that will evaluate salpingectomy in premenopausal BRCA1/2 carriers. A separate NRG Oncology Scientific Session included a lecture on gastrointestinal adverse events noted in GOG-0218, which evaluated the role of bevacizumab in patients with newly diagnosed ovarian cancer. Another lecture reviewed the results of GOG-0219, which evaluated tirapazimine in combination with chemoradiation in patients with cervical cancer. Recently activated clinical trial NRG GY002 will soon be activated within NRG Oncology. This trial, funded by the NCI's Division of Cancer Prevention, is entitled “Preoperative Assessment in Elderly Women with Gynecologic Cancers.” ASCO abstract presentations The following GOG abstracts were presented at the 2014 ASCO Annual Meeting. Tew et al. A randomized phase II trial of bevacizumab (BV) plus oral everolimus (EV) versus bevacizumab alone for recurrent or persistent epithelial ovarian (EOC), fallopian tube (FTC) or primary peritoneal cancer (PPC) Makker et al. Phase II evaluation of dalantercept, a soluble recombinant activin receptor-like kinase 1 (ALK1) receptor-fusion protein, for treatment of recurrent/persistent endometrial cancer: GOG 0229N Huh et al. A phase 2 study of live-attenuated Listeria monocytogenes immunotherapy (ADXS11-001) in the treatment of persistent or recurrent cancer of the cervix (GOG-0265) GOG publications Select recent GOG publications of potential interest are listed as follows. Sherman et al. Pathologic findings in risk-reducing salpingooophorectomy (RRSO): primary results from Gynecologic Oncology Group trial GOG-199. JCO, 2014. Miller et al. GOG#76-GG: a limited access phase II trial of pemetrexed (Alimta, LY231514) in combination with cisplatin in the treatment of advanced, persistent, or recurrent carcinoma of the cervix. JCO, 2014.
446
Conference Report
Powell et al. A phase II evaluation of brivanib, in recurrent or persistent endometrial carcinoma: a Gynecologic Oncology Group study. JCO, 2014. Martin et al. A phase II evaluation of AMG 102 (rilotumomab) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol, 2014. Alvarez et al. A phase II evaluation of intraperitoneal EGEN-001 (IL12 plasmid formulated with PEG–PEI–cholesterol lipopolymer) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer: a GOG study. Gynecol Oncol, 2014. Tewari et al. Chemotherapy-induced neutropenia as a biomarker of survival in advanced ovarian carcinoma: an exploratory study of the GOG. Gynecol Oncol, 2014.
GOG Young Investigator Award Program The Young Investigator Award Program was designed to afford the opportunity for young investigators to become more familiar with the GOG and develop into future leaders of the organization. Postdoctoral fellows and junior faculty within five years of completion of fellowship are invited to submit a clinical research proposal that will utilize published ancillary data that has been collected from prior GOG studies in which the primary objectives have been achieved and reported. For more information log onto http://www.gog.org/YIbrochure2015.pdf. The deadline for 2015 applications is October 1, 2014.
What's next? The 2015 Winter NRG Oncology Semi-Annual Meeting will be held on February 5–8, 2015 in San Diego, CA. The Symposium will be held on February 5, 2015 and will be entitled, “Neoadjuvant Chemotherapy for Ovarian Cancer — Clinical Considerations and Research Opportunities.” This Symposium will include sessions that will discuss novel strategies to assess functional status and resectability in patients with newly diagnosed advanced stage ovarian cancer and how that may impact the decision to perform primary debulking or administer neoadjuvant chemotherapy in advance of an interval debulking. Additional lectures will review the NCI's MATCH (Molecular Analysis for Therapy Choice) Trial and ongoing efforts within NRG Oncology to develop a neoadjuvant chemotherapy in ovarian cancer that will allow assessment of the biologic and clinical effects of unique targeted agents for this disease. For more information on NRG Oncology, log onto www.nrgoncology. org, and for more information on the GOG, log onto gog.org. Conflict of interest statement The author declares that there are no conflicts of interest.
Ronald D. Alvarez University of Alabama at Birmingham, USA
Contents lists available at ScienceDirect
Gynecologic Oncology journal homepage: www.elsevier.com/locate/ygyno
Conference Report
Report on NRG Oncology and the GOG Partners Program
This report will provide an update on the NRG Oncology and the GOG Partners Program and review the educational and scientific activities noted during the NRG Oncology Summer Semi-Annual Meeting in Chicago, IL. NRG Oncology The Gynecologic Cancer Committee, now one of seven disease specific committees for NRG Oncology, is working hard to expand the number of CTEP sponsored trials in ovarian, endometrial and cervical cancer. Disease site committees are being reorganized to incorporate expertise in experimental medicine, developmental therapeutics and rare tumors to foster the development of innovative randomized phase II/III target driven trials that incorporate integral or integrated tissue or imaging biomarkers. For example, OVM1403 and OVM1405 are trial concepts recently reviewed by the NCI's Gynecologic Cancer Steering Committee (GCSC), which will evaluate the PARP inhibitor olaparib and the antiangiogenic agent cediranib in platinum sensitive and resistant ovarian cancer patients, respectively. Several other new concepts were presented to the NRG Oncology Research Strategy Committee and will soon be forwarded to the GCSC. The Cancer Prevention and Control Committee, now a separate committee from the Gynecologic Committee, also submitted a concept to the Research Strategy Committee evaluating salpingectomy as a means of reducing high grade serous ovarian cancer in premenopausal BRCA 1/2 carriers. GOG Partners Program The GOG Partners Program is also expanding its portfolio of clinical trials. Protocol 3004 is an active randomized trial evaluating the PARP inhibitor olaparib as a maintenance strategy in BRCA1/2 mutation carriers who have newly diagnosed advanced high grade serous or high grade endometrioid ovarian cancer and who have achieved a clinical complete or partial response to platinum based chemotherapy. GOG3005 is a key trial under development that will evaluate the PARP inhibitor veliparib in combination with chemotherapy in newly diagnosed ovarian cancer patients. This trial is anticipated to open to accrual in the first quarter of 2015. Highlights from NRG Oncology's Summer Semi-Annual Meeting Symposium and Scientific Session The Summer Symposium, organized by Drs. Joan Walker and Mark Sherman, was entitled, “New Paradigms in the Pathogenesis of Highgrade Serous Carcinoma: Translating Biological Advances into Prevention.” Lecturers reviewed the molecular pathogenesis of high grade
http://dx.doi.org/10.1016/j.ygyno.2014.08.002
serous ovarian carcinoma, the identification of women who harbor genetic risks for ovarian cancer, the medical consequences of oophorectomy, and the experience from GOG-0199 and ongoing efforts to perform risk reducing salpingectomy in Vancouver. The Symposium provided great background information for the aforementioned trial that will evaluate salpingectomy in premenopausal BRCA1/2 carriers. A separate NRG Oncology Scientific Session included a lecture on gastrointestinal adverse events noted in GOG-0218, which evaluated the role of bevacizumab in patients with newly diagnosed ovarian cancer. Another lecture reviewed the results of GOG-0219, which evaluated tirapazimine in combination with chemoradiation in patients with cervical cancer. Recently activated clinical trial NRG GY002 will soon be activated within NRG Oncology. This trial, funded by the NCI's Division of Cancer Prevention, is entitled “Preoperative Assessment in Elderly Women with Gynecologic Cancers.” ASCO abstract presentations The following GOG abstracts were presented at the 2014 ASCO Annual Meeting. Tew et al. A randomized phase II trial of bevacizumab (BV) plus oral everolimus (EV) versus bevacizumab alone for recurrent or persistent epithelial ovarian (EOC), fallopian tube (FTC) or primary peritoneal cancer (PPC) Makker et al. Phase II evaluation of dalantercept, a soluble recombinant activin receptor-like kinase 1 (ALK1) receptor-fusion protein, for treatment of recurrent/persistent endometrial cancer: GOG 0229N Huh et al. A phase 2 study of live-attenuated Listeria monocytogenes immunotherapy (ADXS11-001) in the treatment of persistent or recurrent cancer of the cervix (GOG-0265) GOG publications Select recent GOG publications of potential interest are listed as follows. Sherman et al. Pathologic findings in risk-reducing salpingooophorectomy (RRSO): primary results from Gynecologic Oncology Group trial GOG-199. JCO, 2014. Miller et al. GOG#76-GG: a limited access phase II trial of pemetrexed (Alimta, LY231514) in combination with cisplatin in the treatment of advanced, persistent, or recurrent carcinoma of the cervix. JCO, 2014.
446
Conference Report
Powell et al. A phase II evaluation of brivanib, in recurrent or persistent endometrial carcinoma: a Gynecologic Oncology Group study. JCO, 2014. Martin et al. A phase II evaluation of AMG 102 (rilotumomab) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol, 2014. Alvarez et al. A phase II evaluation of intraperitoneal EGEN-001 (IL12 plasmid formulated with PEG–PEI–cholesterol lipopolymer) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer: a GOG study. Gynecol Oncol, 2014. Tewari et al. Chemotherapy-induced neutropenia as a biomarker of survival in advanced ovarian carcinoma: an exploratory study of the GOG. Gynecol Oncol, 2014.
GOG Young Investigator Award Program The Young Investigator Award Program was designed to afford the opportunity for young investigators to become more familiar with the GOG and develop into future leaders of the organization. Postdoctoral fellows and junior faculty within five years of completion of fellowship are invited to submit a clinical research proposal that will utilize published ancillary data that has been collected from prior GOG studies in which the primary objectives have been achieved and reported. For more information log onto http://www.gog.org/YIbrochure2015.pdf. The deadline for 2015 applications is October 1, 2014.
What's next? The 2015 Winter NRG Oncology Semi-Annual Meeting will be held on February 5–8, 2015 in San Diego, CA. The Symposium will be held on February 5, 2015 and will be entitled, “Neoadjuvant Chemotherapy for Ovarian Cancer — Clinical Considerations and Research Opportunities.” This Symposium will include sessions that will discuss novel strategies to assess functional status and resectability in patients with newly diagnosed advanced stage ovarian cancer and how that may impact the decision to perform primary debulking or administer neoadjuvant chemotherapy in advance of an interval debulking. Additional lectures will review the NCI's MATCH (Molecular Analysis for Therapy Choice) Trial and ongoing efforts within NRG Oncology to develop a neoadjuvant chemotherapy in ovarian cancer that will allow assessment of the biologic and clinical effects of unique targeted agents for this disease. For more information on NRG Oncology, log onto www.nrgoncology. org, and for more information on the GOG, log onto gog.org. Conflict of interest statement The author declares that there are no conflicts of interest.
Ronald D. Alvarez University of Alabama at Birmingham, USA