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2. Effects of the WRITE Symptoms Interventions on Symptoms and Quality of Life Among Patients With Recurrent Ovarian Cancers: An NRG Oncology/GOG Study (GOG-0259)

Author

Donovan, Heidi S, Sereika, Susan M, Wenzel, Lari B, Edwards, Robert P, Knapp, Judith E, Hughes, Susan H, Roberge, Mary C, Thomas, Teresa H, Klein, Sara Jo, Spring, Michael B, Nolte, Susan, Landrum, Lisa M, Casey, A Catherine, Mutch, David G, DeBernardo, Robert L, Muller, Carolyn Y, Sullivan, Stephanie A, and Ward, Sandra E

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Behavioral and Social Science, Ovarian Cancer, Cancer, Women's Health, Rare Diseases, Clinical Trials and Supportive Activities, Clinical Research, Aged, Carcinoma, Ovarian Epithelial, Fatigue, Female, Humans, Middle Aged, Ovarian Neoplasms, Palliative Care, Quality of Life, Symptom Assessment, Clinical Sciences, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

PurposeGOG-259 was a 3-arm randomized controlled trial of two web-based symptom management interventions for patients with recurrent ovarian cancer. Primary aims were to compare the efficacy of the nurse-guided (Nurse-WRITE) and self-directed (SD-WRITE) interventions to Enhanced Usual Care (EUC) in improving symptoms (burden and controllability) and quality of life (QOL).MethodsPatients with recurrent or persistent ovarian, fallopian, or primary peritoneal cancer with 3+ symptoms were eligible for the study. Participants completed baseline (BL) surveys (symptom burden and controllability and QOL) before random assignment. WRITE interventions lasted 8 weeks to develop symptom management plans for three target symptoms. All women received EUC: monthly online symptom assessment with provider reports; online resources; and every 2-week e-mails. Outcomes were evaluated at 8 and 12 weeks after BL. Repeated-measures modeling with linear contrasts evaluated group by time effects on symptom burden, controllability, and QOL, controlling for key covariates.ResultsParticipants (N = 497) reported mean age of 59.3 ± 9.2 years. At BL, 84% were receiving chemotherapy and reported a mean of 14.2 ± 4.9 concurrent symptoms, most commonly fatigue, constipation, and peripheral neuropathy. Symptom burden and QOL improved significantly over time (P < .001) for all three groups. A group by time interaction (P < .001) for symptom controllability was noted whereby both WRITE intervention groups had similar improvements from BL to 8 and 12 weeks, whereas EUC did not improve over time.ConclusionBoth WRITE Intervention groups showed significantly greater improvements in symptom controllability from BL to 8 and BL to 12 weeks compared with EUC. There were no significant differences between Nurse-WRITE and SD-WRITE. SD-WRITE has potential as a scalable intervention for a future implementation study.

Published
2022

3. Randomized Controlled Phase II Evaluation of Two Dose Levels of Bupropion Versus Placebo for Sexual Desire in Female Cancer Survivors: NRG-CC004

Author

Barton, Debra L, Pugh, Stephanie L, Ganz, Patricia A, Plaxe, Steven C, Koontz, Bridget F, Carter, Jeanne, Greyz-Yusupov, Natalya, Page, Seth J, Rowland, Kendrith M, Balcueva, Ernie P, Nabeel, Sobia, Basil, Jack B, Hill, Matthew L, Muller, Carolyn Y, Bell, Maria C, Deshmukh, Snehal, and Kachnic, Lisa A

Subjects
Behavioral and Social Science, Clinical Trials and Supportive Activities, Aging, Breast Cancer, Clinical Research, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Reproductive health and childbirth, Adult, Aged, Breast Neoplasms, Bupropion, Cancer Survivors, Delayed-Action Preparations, Dopamine Uptake Inhibitors, Double-Blind Method, Female, Genital Neoplasms, Female, Humans, Middle Aged, Patient Reported Outcome Measures, Patient Satisfaction, Postmenopause, Sexual Behavior, Sexual Dysfunctions, Psychological, Time Factors, Treatment Outcome, United States, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeBecause of the negative impact of cancer treatment on female sexual function, effective treatments are warranted. The purpose of this multisite study was to evaluate the ability of two dose levels of extended-release bupropion, a dopaminergic agent, to improve sexual desire more than placebo at 9 weeks, measured by the desire subscale of the Female Sexual Function Index (FSFI), and to evaluate associated toxicities.MethodsPostmenopausal women diagnosed with breast or gynecologic cancer and low baseline FSFI desire scores (< 3.3), who had completed definitive cancer therapy, were eligible. Women were randomly assigned to receive 150 mg or 300 mg once daily of extended-release bupropion or a matching placebo. t-tests were performed on the FSFI desire subscale to evaluate whether there was a significantly greater change from baseline to 9 weeks between placebo and each bupropion arm as the primary end point. Sixty-two patients per arm provided 80% power using a one-sided t-test.ResultsTwo hundred thirty women were randomly assigned from 72 institutions through the NRG Oncology NCORP network. At 9 weeks, there were no statistically significant differences in change of the desire subscale scores between groups; participants in all three arms reported improvement. The mean changes for each arm were placebo 0.62 (standard deviation [SD] = 1.18), 150-mg once daily bupropion 0.64 (SD = 0.95), and 300-mg once daily bupropion 0.60 (SD = 0.89). Total and subscale scores on the FSFI were low throughout the study, indicating dysfunction in all groups.ConclusionBupropion was not more effective than placebo in improving the desire subscale of the FSFI. Subscale and total scores of the FSFI demonstrated dysfunction throughout the 9 weeks of the study. More research is needed to support sexual function in female cancer survivors.

Published
2022

4. A phase II randomized, double-blind trial of a polyvalent Vaccine-KLH conjugate (NSC 748933 IND# 14384) + OPT-821 versus OPT-821 in patients with epithelial ovarian, fallopian tube, or peritoneal cancer who are in second or third complete remission: An NRG Oncology/GOG study.

Author

Lucci, Joseph, Behbakht, Kian, Spirtos, Nick, Muller, Carolyn, Benigno, Benedict, Powell, Matthew, Berry, Emily, OCearbhaill, Roisin, Hanjani, Parviz, Lankes, Heather, Aghajanian, Carol, Sabbatini, Paul, Tewari, Krishnansu, Chen, Lee-may, and Deng, Wenbin

Subjects
OPT-821, Ovarian, Randomized, Remission, Vaccine, Adjuvants, Immunologic, Adult, Aged, Aged, 80 and over, Cancer Vaccines, Carcinoma, Ovarian Epithelial, Double-Blind Method, Fallopian Tube Neoplasms, Female, Hemocyanins, Humans, Middle Aged, Neoplasm Staging, Ovarian Neoplasms, Peritoneal Neoplasms, Vaccines, Conjugate
Abstract

OBJECTIVE: Early-phase data have demonstrated induction of antibody responses to a polyvalent vaccine conjugate (Globo-H, GM2, MUC1-TN, TF) with adjuvant OPT-821. We sought to determine if this combination decreases the hazard of progression or death compared to OPT-821 alone in patients with ovarian cancer in second/third clinical complete remission following chemotherapy. Secondary and translational objectives were overall survival (OS), safety, and immunogenicity. METHODS: From 2010-2013, patients were randomized (1:1) to receive OPT-821±vaccine-KLH conjugate subcutaneously at weeks 1, 2, 3, 7, 11, and then every 12 weeks (total 11). Dose delay or reduction was not permitted. Patients were removed for pre-defined dose-limiting toxicity. RESULTS: Of 171 patients randomized, 170 were treated. Most had disease of serous histology (85%), stage 3 disease at diagnosis (77%), and had received 2 prior regimens (68%). 32% received >6 treatment cycles [median 6, each arm (p = 0.33)]. 77% discontinued due to progression, 4% due to toxicity, and 1 due to myeloid dysplastic syndrome (MDS). Maximum toxicities included grade 4 MDS and depression/personality change (1 each, unlikely related), as well as grade 3 gastrointestinal disorders and others (n = 21, 4 related). Lesser adverse events were injection site reactions (82%) and fever (11%). Estimated HR for progression-free survival (PFS) of the vaccine + OPT-821 to OPT-821 arm was 0.98 (95% CI: 0.71-1.36). At a median follow-up of 60 months, median OS was 47 and 46 months, respectively. CONCLUSIONS: Vaccine + OPT-821 compared to OPT-821 alone was modestly immunogenic and did not prolong PFS or OS. Multi-remission patients are a viable, well-defined population for exploring innovative consolidation and maintenance approaches. TRIAL REGISTRATION: NCT00857545.

Published
2019

5. A phase II randomized, double-blind trial of a polyvalent Vaccine-KLH conjugate (NSC 748933 IND# 14384) + OPT-821 versus OPT-821 in patients with epithelial ovarian, fallopian tube, or peritoneal cancer who are in second or third complete remission: An NRG Oncology/GOG study

Author

O'Cearbhaill, Roisin E, Deng, Wei, Chen, Lee-May, Lucci, Joseph A, Behbakht, Kian, Spirtos, Nick M, Muller, Carolyn Y, Benigno, Benedict B, Powell, Matthew A, Berry, Emily, Tewari, Krishnansu S, Hanjani, Parviz, Lankes, Heather A, Aghajanian, Carol, and Sabbatini, Paul J

Subjects
Clinical Trials and Supportive Activities, Immunization, Cancer, Vaccine Related, Rare Diseases, Clinical Research, Prevention, Pediatric Research Initiative, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adjuvants, Immunologic, Adult, Aged, Aged, 80 and over, Cancer Vaccines, Carcinoma, Ovarian Epithelial, Double-Blind Method, Fallopian Tube Neoplasms, Female, Hemocyanins, Humans, Middle Aged, Neoplasm Staging, Ovarian Neoplasms, Peritoneal Neoplasms, Vaccines, Conjugate, Randomized, Vaccine, Ovarian, Remission, OPT-821, Oncology and Carcinogenesis, Paediatrics and Reproductive Medicine, Oncology & Carcinogenesis
Abstract

ObjectiveEarly-phase data have demonstrated induction of antibody responses to a polyvalent vaccine conjugate (Globo-H, GM2, MUC1-TN, TF) with adjuvant OPT-821. We sought to determine if this combination decreases the hazard of progression or death compared to OPT-821 alone in patients with ovarian cancer in second/third clinical complete remission following chemotherapy. Secondary and translational objectives were overall survival (OS), safety, and immunogenicity.MethodsFrom 2010-2013, patients were randomized (1:1) to receive OPT-821±vaccine-KLH conjugate subcutaneously at weeks 1, 2, 3, 7, 11, and then every 12 weeks (total 11). Dose delay or reduction was not permitted. Patients were removed for pre-defined dose-limiting toxicity.ResultsOf 171 patients randomized, 170 were treated. Most had disease of serous histology (85%), stage 3 disease at diagnosis (77%), and had received 2 prior regimens (68%). 32% received >6 treatment cycles [median 6, each arm (p = 0.33)]. 77% discontinued due to progression, 4% due to toxicity, and 1 due to myeloid dysplastic syndrome (MDS). Maximum toxicities included grade 4 MDS and depression/personality change (1 each, unlikely related), as well as grade 3 gastrointestinal disorders and others (n = 21, 4 related). Lesser adverse events were injection site reactions (82%) and fever (11%). Estimated HR for progression-free survival (PFS) of the vaccine + OPT-821 to OPT-821 arm was 0.98 (95% CI: 0.71-1.36). At a median follow-up of 60 months, median OS was 47 and 46 months, respectively.ConclusionsVaccine + OPT-821 compared to OPT-821 alone was modestly immunogenic and did not prolong PFS or OS. Multi-remission patients are a viable, well-defined population for exploring innovative consolidation and maintenance approaches.Trial registrationNCT00857545.

Published
2019

6. Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study

Author

Raspagliesi, Francesco, Melichar, Bohuslav, Gaba Garcia, Lydia, Jackson, Amanda, Henry, Stephanie, Kral, Zdenek, Harter, Philipp, De Giorgi, Ugo, Bjurberg, Maria, Gold, Michael, O'Malley, David, Honhon, Brigitte, Vulsteke, Christof, De Cuypere, Eveline, Denys, Hannelore, Baurain, Jean-Francois, Zamagni, Claudio, Tenney, Meaghan, Gordinier, Mary, Bradley, William, Schlumbrecht, Matthew, Spirtos, Nicola, Concin, Nicole, Mahner, Sven, Scambia, Giovanni, Leath, Charles, Farias-Eisner, Robin, Cohen, Joshua, Muller, Carolyn, Bhatia, Sumeet, Coleman, Robert L, Lorusso, Domenica, Gennigens, Christine, González-Martín, Antonio, Randall, Leslie, Cibula, David, Lund, Bente, Woelber, Linn, Pignata, Sandro, Forget, Frederic, Redondo, Andrés, Vindeløv, Signe Diness, Chen, Menghui, Harris, Jeffrey R, Smith, Margaret, Nicacio, Leonardo Viana, Teng, Melinda S L, Laenen, Annouschka, Rangwala, Reshma, Manso, Luis, Mirza, Mansoor, Monk, Bradley J, and Vergote, Ignace

Published
2021
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7. A phase II randomized, double-blind trial of a polyvalent Vaccine-KLH conjugate (NSC 748933 IND# 14384) + OPT-821 versus OPT-821 in patients with epithelial ovarian, fallopian tube, or peritoneal cancer who are in second or third complete remission: An NRG Oncology/GOG study

Author

O’Cearbhaill, Roisin E., Deng, Wei, Chen, Lee-may, Lucci, Joseph A., III, Behbakht, Kian, Spirtos, Nick M., Muller, Carolyn Y., Benigno, Benedict B., Powell, Matthew A., Berry, Emily, Tewari, Krishnansu S., Hanjani, Parviz, Lankes, Heather A., Aghajanian, Carol, and Sabbatini, Paul J.

Published
2019
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8. Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001): a randomised, double-blind, phase 3 trial

Author

Vergote, Ignace, Scambia, Giovanni, Park, Sang Yoon, Song, Yong Sang, Makarova, Yulia, Trinidad, Joshua, Ngan, Hextan Yuen Sheung, Bamias, Aristotelis, Aravantinos, Gerasimos, Nam, Joo-Hyun, Gorbunova, Vera, Krikunova, Ludmila, Bae, Duk-Soo, Arija, Jose Angel Arranz, Mirza, Mansoor Raza, Zamagni, Claudio, Papandreou, Christos, Raspagliesi, Francesco, Lisyanskaya, Alla, Benzaquen, Ana Oaknin, Tognon, Germana, Ortega, Eugenia, Herraez, Antonio Casado, Buscema, Joseph, Green, Andrew, Burger, Robert, Sakaeva, Dina, Sanchez, Andres Redondo, Ghamande, Sharad, King, Laurel, Petru, Edgar, Peen, Ulla, Takeuchi, Satoshi, Ushijima, Kimio, Martin, Antonio Gonzalez, Kamelle, Scott, Carney, Michael, Marth, Christian, Forget, Frédéric, Bentley, James, Sehouli, Jalid, Colombo, Nicoletta, Zola, Paolo, Kato, Hidenori, Fadeeva, Natalya, Gotovkin, Evgeny, Vladimirov, Vladimir, Marin, Margarita Romeo, Alia, Eva Guerra, Shahin, Mark, Bhoola, Snehalkumar, Tewari, Krishnansu, Anderson, Daniel, Honhon, Brigitte, Pelgrims, Joseph (Gino), Oza, Amit, Jimenez, Jesus Garcia-Donas, Hansen, Vincent, O'Malley, David, Benjamin, Ivor, Renard, Vincent, Van den Bulck, Heidi, Meier, Werner, Haenle, Claudia, Koumakis, Georgios, Yokota, Harushige, Popov, Vadim, Bradley, William, Wenham, Robert, Reid, Robert, McNamara, Donna, Friedman, Richard, Barlin, Joyce, Spirtos, Nicola, Chapman, Julia, Sevelda, Paul, Huizing, Manon, Lamot, Caroline, Goffin, Frédéric, Hondt, Lionel D, Covens, Allan, Spadafora, Silvana, Rautenberg, Beate, Reimer, Toralf, Möbus, Volker, Hilpert, Felix, Gropp-Meier, Martina, Savarese, Antonella, Pignata, Sandro, Verderame, Francesco, Mizuno, Mika, Takano, Hirokuni, Ottevanger, Petronella, Velasco, Andres Poveda, Palacio-Vazquez, Isabel, Law, Amy, McIntyre, Kristi, Teneriello, Michael, Fields, Abbie, Lentz, Samuel, Street, Daron, Schwartz, Benjamin, Mannel, Robert, Lim, Peter, Pulaski, Heather, Janni, Wolfgang, Zorr, Andreas, Karck, Ulrich, Cheng, Ashley Chi Kin, Sorio, Roberto, Gridelli, Cesare, Aoki, Daisuke, Oishi, Tetsuro, Hirashima, Yasuyuki, Boere, Ingrid, Ferrer, Esther Falco, Braly, Patricia, Wilks, Sharon, Lee, Christine, Schilder, Jeanne, Veljovich, Dan, Secord, Angeles, Davis, Kevin, Rojas-Espaillat, Luis, Lele, Shashikant, DePasquale, Stephen, Squatrito, Robert, Schauer, Christian, Dirix, Luc, Vuylsteke, Peter, Joosens, Eric, Provencher, Diane, Lueck, Hans-Joachim, Hein, Alexander, Burges, Alexander, Canzler, Ulrich, Park-Simon, Tjoung-Won, Griesinger, Frank, Gadducci, Angiolo, Alabiso, Oscar, Okamoto, Aikou, Sawasaki, Takashi, Saito, Toshiaki, Ibañez, Ana Herrero, Calomeni, Coralia, Spillman, Monique, Choksi, Janak, Taylor, Nicholas, Muller, Carolyn, Moore, David, DiSilvestro, Paul, Cunningham, Mary, Rose, Peter, Oppelt, Peter, Verhoeven, Didier, Graas, Marie-Pascale, Ghatage, Prafull, Tonkin, Katia, Kurzeder, Christian, Schnappauf, Benjamin, Müller, Volkmar, Schmalzrie, Hannah, Kalofonos, Haralambos, Bruzzone, Milena, Kroep, Judith, Diaz, Cristina Caballero, Garcia, Jeronimo Martinez, Polo, Susana Hernando, Garrison, Mitchell, Rocconi, Rodney, Andrews, Stephen, Bristow, Robert, McHale, Michael, Basil, Jack, Houck III, William, Bell, Maria, Cosin, Jonathan, Modesitt, Susan, Kendrick, James, Wade III, James, Wong, Cheung, Evans, Anthony, Buekers, Thomas, Vanderkwaak, Timothy, Ferriss, James, Darus, Christopher, DAndre, Stacy, Higgins, Robert, Monk, Bradley, Bakkum-Gamez, Jamie, DeMars, Leslie, Van Le, Linda, Puls, Larry, Trehan, Shruti, LaPolla, James, Michelson, Elizabeth Dickson, Merchant, Joseph, Peterson, Christopher, Reid, Gary, Seago, Donald, Zweizig, Susan, Gajewski, Walter, Panwalkar, Amit, Leikermoser, Rudolf, Bogner, Gerhard, Debruyne, Philip, D'hondt, Randal, Berteloot, Patrick, Kerger, Joseph, Biagi, James, Castonguay, Vincent, Welch, Stephen, Muhic, Aida, Heubner, Martin, Grischke, Eva-Maria, Rack, Brigitte, Fleisch, Markus, Lordick, Florian, Pectasides, Dimitrios, Ho, Wing Ming, Selvaggi, Luigi, Vasquez, Flavia Morales, Villanueva, William Orlando Brito, Alavez, Alejandro Molina, Kessels, Lonneke, Bertran, Ana Santaballa, Fernandez, Cesar Mendiola, Fabregat, Miguel Beltran, Del Prete, Salvatore, Elkas, John, Cecchi, Gary, Kumar, Pallavi, Huh, Warner, Messing, Mark, Karimi, Misagh, Kelley, Ann, Edraki, Babak, Mutch, David, Leiserowitz, Gary, Anderson, Jeanne, Lentz, Scott, Chambers, Setsuko, Morris, Robert, Waggoner, Steven, Gordon, Alan, Method, Michael, Johnson, Peter, Lord, Raymond, Drake, Janet, Sivarajan, Kulumani, Midathada, Madhu, Rice, Kristen, Wadsworth, Troy, Pavelka, James, Edwards, Robert, Miller, David Scott, Ford, Patricia Locantore, Hurteau, Jean, Bender, David, Schimp, Veronica, Creasman, William, Lerner, Rachel, Chamberlain, Donald, Kueck, Angela, McDonald, John, Malad, Salman, Robinson-Bennett, Bernice, Davidson, Susan, Krivak, Thomas, Lestingi, Timothy, Arango, Hector, Berard, Paul, Finkelstein, Karen, Gaur, Rakesh, Krasner, Carolyn, Ueland, Frederick, Talmage, Lance, Yamada, Seiko, Sutton, Gregory, Potkul, Ronald, Prasad-Hayes, Monica, Osborne, Janet, Celano, Paul, Thigpen, James, Sharma, Sudarshan, Schilder, Russell, Tammela, Jonathan, Kemeny, Mary, Brown, Amy, Eisenhauer, Eric, Williams, James, Rowland, Kendrith, Nahum, Kenneth, Burke, James, Dar, Zahid, Fleming, Nicole, Gibb, Randall, Guirguis, Alfred, Herzog, Thomas, John, Veena, Kumar, Santhosh, Kamat, Aparna, Kassar, Mohamad, Leitao, Mario, Levine, Lyuba, Mendez, Luis, Patel, Dhimant, Berry, Emily, Warshal, David, Wolf, Judith, Zarwan, Corrine, Collins, Yvonne, Spitzer, Gary, Miller, Brigitte, Einstein, Mark, O'Malley, David M, Van Calster, Ben, Park, Sang-Yoon, del Campo, Josep M, Wenham, Robert M, Covens, Al, Raza Mirza, Mansoor, Kroep, Judith R, Ma, Haijun, Pickett, Cheryl A, and Monk, Bradley J

Published
2019
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9. Phase III randomized trial of weekly cisplatin and irradiation versus cisplatin and tirapazamine and irradiation in stages IB2, IIA, IIB, IIIB, and IVA cervical carcinoma limited to the pelvis: a Gynecologic Oncology Group study.

Author

DiSilvestro, Paul, Ali, Shamshad, Craighead, Peter, Lucci, Joseph, Lee, Yi-Chun, Cohn, David, Spirtos, Nicola, Muller, Carolyn, Gajewski, Walter, Steinhoff, Margaret, Monk, Bradley, and Tewari, Krishnansu

Subjects
Adenocarcinoma, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Canada, Carcinoma, Adenosquamous, Carcinoma, Squamous Cell, Chemoradiotherapy, Chi-Square Distribution, Cisplatin, Disease Progression, Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Middle Aged, Neoplasm Staging, Proportional Hazards Models, Prospective Studies, Time Factors, Tirapazamine, Treatment Outcome, Triazines, United States, Uterine Cervical Neoplasms
Abstract

PURPOSE: This prospective, randomized phase III intergroup trial of the Gynecologic Oncology Group and National Cancer Institute of Canada Clinical Trials Group was designed to test the effectiveness and safety of adding the hypoxic cell sensitizer tirapazamine (TPZ) to standard cisplatin (CIS) chemoradiotherapy in locally advanced cervix cancer. PATIENTS AND METHODS: Patients with locally advanced cervix cancer were randomly assigned to CIS chemoradiotherapy versus CIS/TPZ chemoradiotherapy. Primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS) and tolerability. RESULTS: PFS was evaluable in 387 of 402 patients randomly assigned over 36 months, with enrollment ending in September 2009. Because of the lack of TPZ supply, the study did not reach its original target accrual goal. At median follow-up of 28.3 months, PFS and OS were similar in both arms. Three-year PFS for the TPZ/CIS/RT and CIS/RT arms were 63.0% and 64.4%, respectively (log-rank P = .7869). Three-year OS for the TPZ/CIS/RT and CIS/RT arms were 70.5% and 70.6%, respectively (log-rank P = .8333). A scheduled interim safety analysis led to a reduction in the starting dose for the TPZ/CIS arm, with resulting tolerance in both treatment arms. CONCLUSION: TPZ/CIS chemoradiotherapy was not superior to CIS chemoradiotherapy in either PFS or OS, although definitive commentary was limited by an inadequate number of events (progression or death). TPZ/CIS chemoradiotherapy was tolerable at a modified starting dose.

Published
2014

10. Investigation of Mammographic Breast Density as a Risk Factor for Ovarian Cancer

Author

Wernli, Karen J, O’Meara, Ellen S, Kerlikowske, Karla, Miglioretti, Diana L, Muller, Carolyn Y, Onega, Tracy, Sprague, Brian L, Henderson, Louise M, and Buist, Diana SM

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Prevention, Breast Cancer, Cancer, Aging, Women's Health, Ovarian Cancer, Clinical Research, Biomedical Imaging, Rare Diseases, Adult, Age Factors, Aged, Breast, Carcinoma, Ovarian Epithelial, Cohort Studies, Female, Humans, Incidence, Mammography, Middle Aged, Neoplasms, Glandular and Epithelial, Odds Ratio, Ovarian Neoplasms, Risk Assessment, Risk Factors, Self Report, Surveys and Questionnaires, United States, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundEndogenous hormones and growth factors that increase mammographic breast density could increase ovarian cancer risk. We examined whether high breast density is associated with ovarian cancer risk.MethodsWe conducted a cohort study of 724,603 women aged 40 to 79 years with 2,506,732 mammograms participating in the Breast Cancer Surveillance Consortium from 1995 to 2009. Incident epithelial ovarian cancer was diagnosed in 1373 women. We used partly conditional Cox regression to estimate the association between breast density and 5-year risk of incident epithelial ovarian cancer overall and stratified by 10-year age group. All statistical tests were two-sided.ResultsCompared with women with scattered fibroglandular densities, women with heterogeneously dense and extremely dense breast tissue had 20% and 18% increased 5-year risk of incident epithelial ovarian cancer (hazard ratio [HR] = 1.20, 95% confidence interval [CI] = 1.06 to 1.36; HR = 1.18, 95% CI = 0.93 to 1.50, respectively; P(trend) = .01). Among women aged 50 to 59 years, we observed a trend in elevated risk associated with increased breast density (P(trend) = .02); women with heterogeneously and extremely dense breast tissue had 30% (HR = 1.30; 95% CI = 1.03 to 1.64) and 65% (HR = 1.65; 95% CI = 1.12 to 2.44) increased risk, respectively, compared with women with scattered fibroglandular densities. The pattern was similar but not statistically significant at age 40 to 49 years. There were no consistent patterns of breast density and ovarian cancer risk at age 60 to 79 years.ConclusionsDense breast tissue was associated with a modest increase in 5-year ovarian cancer risk in women aged 50 to 59 years but was not associated with ovarian cancer at ages 40 to 49 or 60 to 79 years.

Published
2014

11. 627 The effect of LNS8801 in combination with pembrolizumab in patients with treatment-refractory cutaneous melanoma

Author

Rodon, Jordi, primary, Chaney, Marya, additional, Cohen, Justine, additional, Garyantes, Tina, additional, Lin, Jessica, additional, Ishizuka, Jeffrey, additional, Mita, Alain, additional, Mita, Monica, additional, Muller, Carolyn, additional, Natale, Christopher, additional, Orloff, Marlana, additional, Papadopoulos, Kyriakos P, additional, Patel, Sapna, additional, and Shoushtari, Alexander, additional

Published
2023
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13. 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

Author

Thaker, Premal H., Brady, William E., Lankes, Heather A., Odunsi, Kunle, Bradley, William H., Moore, Kathleen N., Muller, Carolyn Y., Anwer, Khursheed, Schilder, Russell J., Alvarez, Ronald D., and Fracasso, Paula M.

Published
2017
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14. Ofranergene Obadenovec (Ofra-Vec, VB-111) With Weekly Paclitaxel for Platinum-Resistant Ovarian Cancer: Randomized Controlled Phase III Trial (OVAL Study/GOG 3018).

Author

Arend, Rebecca C., Monk, Bradley J., Shapira-Frommer, Ronnie, Haggerty, Ashley F., Alvarez, Edwin A., Amit, Amnon, Alvarez Secord, Angeles, Muller, Carolyn, Casado Herraez, Antonio, Herzog, Thomas J., Tewari, Krishnansu S., Cohen, Joshua G., Huang, Marilyn, Yachnin, Adelya, Holeman, Laura L., Ledermann, Jonathan A., Rachmilewitz Minei, Tamar, Buyse, Marc, Fain Shmueli, Shifra, and Lavi, Michal

Published
2024
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21. Supplemental Figure S1 from A Novel Pharmacologic Activity of Ketorolac for Therapeutic Benefit in Ovarian Cancer Patients

Author

Guo, Yuna, primary, Kenney, S. Ray, primary, Cook, Linda, primary, Adams, Sarah F., primary, Rutledge, Teresa, primary, Romero, Elsa, primary, Oprea, Tudor I., primary, Sklar, Larry A., primary, Bedrick, Edward, primary, Wiggins, Charles L., primary, Kang, Huining, primary, Lomo, Lesley, primary, Muller, Carolyn Y., primary, Wandinger-Ness, Angela, primary, and Hudson, Laurie G., primary

Published
2023
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24. Supplemental Figures S4-S7 from A Novel Pharmacologic Activity of Ketorolac for Therapeutic Benefit in Ovarian Cancer Patients

Author

Guo, Yuna, primary, Kenney, S. Ray, primary, Cook, Linda, primary, Adams, Sarah F., primary, Rutledge, Teresa, primary, Romero, Elsa, primary, Oprea, Tudor I., primary, Sklar, Larry A., primary, Bedrick, Edward, primary, Wiggins, Charles L., primary, Kang, Huining, primary, Lomo, Lesley, primary, Muller, Carolyn Y., primary, Wandinger-Ness, Angela, primary, and Hudson, Laurie G., primary

Published
2023
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26. BXQ-350: Modulating ceramide and sphingosine-1-phosphate for antitumor activity in patients with advanced CRC.

Author

Rixe, Olivier, primary, Curry, Richard Charles, additional, Morris, John Charles, additional, Muller, Carolyn, additional, Noonan, Anne M., additional, Puduvalli, Vinay K., additional, Villano, John L., additional, Wise-Draper, Trisha Michel, additional, Wesolowski, Robert, additional, Yilmaz, Emrullah, additional, Tapolsky, Gilles, additional, and Takigiku, Ray, additional

Published
2023
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27. BXQ-350 may alleviate symptoms of chemotherapy- induced peripheral neuropathy via modulation of S1P.

Author

Wesolowski, Robert, primary, Noonan, Anne M., additional, Curry, Richard Charles, additional, Morris, John Charles, additional, Muller, Carolyn, additional, Puduvalli, Vinay K., additional, Rixe, Olivier, additional, Villano, John L., additional, Wise-Draper, Trisha Michel, additional, Yilmaz, Emrullah, additional, Tapolsky, Gilles, additional, and Takigiku, Ray, additional

Published
2023
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28. O014/#415 Phase II trial of pembrolizumab and epacadostat in recurrent clear cell carcinoma of the ovary: an NRG oncology study

Author

Gien, Lilian, primary, Enserro, Danielle, additional, Block, Matthew, additional, Waggoner, Steven, additional, Duska, Linda, additional, Hendrickson, Andrea Wahner, additional, Thaker, Premal, additional, Backes, Floor, additional, Bottsford-Miller, Justin, additional, Muller, Carolyn, additional, Disilvestro, Paul, additional, Covens, Allan, additional, Gershenson, David, additional, Moore, Kathleen, additional, Aghajanian, Carol, additional, and Coleman, Robert L, additional

Published
2022
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29. 759 Phase 1b study of LNS8801 in combination with pembrolizumab in patients with secondary resistance to immune checkpoint inhibitors

Author

Rodon, Jordi, primary, Chaney, Marya, additional, Cohen, Justine, additional, Garyantes, Tina, additional, Lin, Jessica, additional, Lorusso, Patricia, additional, Mita, Alain, additional, Mita, Monica, additional, Muller, Carolyn, additional, Natale, Christopher, additional, Orloff, Marlana, additional, Papadopoulos, Kyriakos, additional, and Patel, Sapna, additional

Published
2022
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32. RNAseq correlative biomarkers IFIT1B and VSTM5 predict progression free survival and clinical benefit in a multi-site Phase I/II trial of Olaparib and Tremelimumab for gBRCAm recurrent ovarian cancer (LBA 11)

Author

Adams, Sarah, primary, Muller, Carolyn, additional, O’Malley, David, additional, Ring, Kari, additional, Wenham, Robert, additional, Finkelstein, Karen, additional, Rutledge, Teresa, additional, Lokich, Elizabeth, additional, Paliard, Xavier, additional, Rixe, Olivier, additional, Kinjyo, Ichiko, additional, Eberhardt, Steven, additional, Lee, Ji-Hyun, additional, and Gimotty, Phyllis, additional

Published
2022
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33. Olaparib With or Without Cediranib Versus Platinum-Based Chemotherapy in Recurrent Platinum-Sensitive Ovarian Cancer (NRG-GY004): A Randomized, Open-Label, Phase III Trial

Author

Liu, Joyce F., primary, Brady, Mark F., additional, Matulonis, Ursula A., additional, Miller, Austin, additional, Kohn, Elise C., additional, Swisher, Elizabeth M., additional, Cella, David, additional, Tew, William P., additional, Cloven, Noelle G., additional, Muller, Carolyn Y., additional, Bender, David P., additional, Moore, Richard G., additional, Michelin, David P., additional, Waggoner, Steven E., additional, Geller, Melissa A., additional, Fujiwara, Keiichi, additional, D'Andre, Stacy D., additional, Carney, Michael, additional, Alvarez Secord, Angeles, additional, Moxley, Katherine M., additional, and Bookman, Michael A., additional

Published
2022
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34. Bedside to benchtop translational development: Targeting the S1P/ceramide axis may alleviate symptoms of chemical induced peripheral neuropathy.

Author

Takigiku, Ray, primary, Wesolowski, Robert, additional, Rixe, Olivier, additional, Morris, John Charles, additional, Yilmaz, Emrullah, additional, Villano, John L., additional, Muller, Carolyn, additional, Curry, Richard Charles, additional, Puduvalli, Vinay K., additional, Wise-Draper, Trisha Michel, additional, Wolfe, Darren, additional, and Tapolsky, Gilles, additional

Published
2022
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35. EPEN-14. A Phase 1, Safety and Dose Escalation Study of BXQ-350 in Patients with Advanced Solid Malignancies Demonstrates that BXQ-350 is Well Tolerated and Shows Signs of Potential Clinical Activity in Ependymoma Patients

Author

Rixe, Olivier, primary, Morris, John, additional, Wesolowski, Robert, additional, Yilmaz, Emrullah, additional, Villano, John, additional, Muller, Carolyn, additional, Wise-Draper, Trisha, additional, Puduvalli, Vinay, additional, Curry III, Richard, additional, Takigiku, Ray, additional, and Tapolsky, Gilles, additional

Published
2022
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36. S1P/ceramides and cytokines as potential biomarkers of response following administration of bxq-350.

Author

Tapolsky, Gilles, primary, Rixe, Olivier, additional, Morris, John Charles, additional, Wesolowski, Robert, additional, Yilmaz, Emrullah, additional, Noonan, Anne M., additional, Villano, John L., additional, Curry, Richard Charles, additional, Muller, Carolyn, additional, Wise-Draper, Trisha Michel, additional, Puduvalli, Vinay K., additional, and Takigiku, Ray, additional

Published
2022
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37. A phase 1, safety and dose escalation study of BXQ-350, a nanovesicle formulation of saposin c, a modulator of sphingolipid metabolism, in patients with advanced solid malignancies.

Author

Curry, Richard Charles, primary, Rixe, Olivier, additional, Morris, John Charles, additional, Wesolowski, Robert, additional, Yilmaz, Emrullah, additional, Villano, John L., additional, Muller, Carolyn, additional, Wise-Draper, Trisha Michel, additional, Noonan, Anne M., additional, Puduvalli, Vinay K., additional, Tapolsky, Gilles, additional, and Takigiku, Ray, additional

Published
2022
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38. NRG-CC008: A nonrandomized prospective clinical trial comparing the non-inferiority of salpingectomy to salpingo-oophorectomy to reduce the risk of ovarian cancer among BRCA1 carriers [SOROCk].

Author

Huh, Warner King, primary, Pugh, Stephanie L., additional, Walker, Joan L., additional, Pennington, Kathryn, additional, Jewell, Elizabeth Lin, additional, Havrilesky, Laura J, additional, Carter, Jeanne, additional, Muller, Carolyn, additional, Drapkin, Ronny, additional, Lankes, Heather A., additional, Demora, Lyudmila, additional, and Kachnic, Lisa A., additional

Published
2022
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39. Phase 1b study of the novel first-in-class G protein-coupled estrogen receptor (GPER) agonist, LNS8801, in combination with pembrolizumab in patients with immune checkpoint inhibitor (ICI)-relapsed and refractory solid malignancies and dose escalation update.

Author

Muller, Carolyn, primary, Chaney, Marya F., additional, Cohen, Justine Vanessa, additional, Garyantes, Tina, additional, Lin, Jessica Jiyeong, additional, LoRusso, Patricia, additional, Mita, Alain C., additional, Mita, Monica M., additional, Natale, Christopher, additional, Orloff, Marlana M., additional, Papadopoulos, Kyriakos P., additional, Patel, Sapna Pradyuman, additional, and Rodon Ahnert, Jordi, additional

Published
2022
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42. A randomized phase II trial of everolimus and letrozole or hormonal therapy in women with advanced, persistent or recurrent endometrial carcinoma: A GOG Foundation study

Author

Slomovitz, Brian M., primary, Filiaci, Virginia L., additional, Walker, Joan L., additional, Taub, Michael C., additional, Finkelstein, Karen A., additional, Moroney, John W., additional, Fleury, Aimee C., additional, Muller, Carolyn Y., additional, Holman, Laura L., additional, Copeland, Larry J., additional, Miller, David S., additional, and Coleman, Robert L., additional

Published
2022
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43. Drug repurposing from an academic perspective

Author

Oprea, Tudor I., Bauman, Julie E., Bologa, Cristian G., Buranda, Tione, Chigaev, Alexandre, Edwards, Bruce S., Jarvik, Jonathan W., Gresham, Hattie D., Haynes, Mark K., Hjelle, Brian, Hromas, Robert, Hudson, Laurie, Mackenzie, Debra A., Muller, Carolyn Y., Reed, John C., Simons, Peter C., Smagley, Yelena, Strouse, Juan, Surviladze, Zurab, Thompson, Todd, Ursu, Oleg, Waller, Anna, Wandinger-Ness, Angela, Winter, Stuart S., Wu, Yang, Young, Susan M., Larson, Richard S., Willman, Cheryl, and Sklar, Larry A.

Published
2011
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45. A surgical window trial evaluating medroxyprogesterone acetate with or without entinostat in endometrial cancer and validation of biomarkers of cellular response: An NRG Oncology study

Author

Duska, Linda, primary, Filiaci, Virginia, additional, Walker, Joan, additional, Holman, Laura, additional, Hill, Emily, additional, Moore, Richard, additional, Ring, Kari, additional, Pearl, Michael, additional, Muller, Carolyn, additional, Kushnir, Christina, additional, Lankes, Heather, additional, Samuelson, Megan, additional, Carrick, Kelley, additional, KD, Anand Rajan, additional, Rodgers, William, additional, Kohn, Elise, additional, Piekarz, Richard, additional, and Leslie, Kimberly, additional

Published
2021
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47. ROSELLA – GOG-3073 – ENGOT-OV72/MITO: A phase 3 study of relacorilant + nab-paclitaxel vs. nab-paclitaxel in advanced, platinum-resistant ovarian cancer (1241)

Author

Olawaiye, Alexander, Van Gorp, Toon, Monk, Bradley, Novak, Zoltan, O'Malley, David, Oaknin, Ana, Herzog, Thomas, Gladieff, Laurence, Alvarez, Edwin, Korach, Jacob, Chan, John, Nicum, Shibani, Bishop, Erin, Chudecka-Glaz, Anita, Covens, Allan, Muller, Carolyn, Westhoff, Gina, Fishman, David, Dreiling, Lyndah, Pashova, Hristina, Tudor, Iulia Cristina, and Lorusso, Domenica

Published
2023
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