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2. Gene expression profiling of mucinous ovarian tumors and comparison with upper and lower gastrointestinal tumors identifies markers associated with adverse outcomes.

Author

Meagher, Nicola S, Gorringe, Kylie L, Wakefield, Matthew, Bolithon, Adelyn, Pang, Chi Nam Ignatius, Chiu, Derek S, Anglesio, Michael S, Mallitt, Kylie-Ann, Doherty, Jennifer A, Harris, Holly R, Schildkraut, Joellen M, Berchuck, Andrew, Cushing-Haugen, Kara L, Chezar, Ksenia, Chou, Angela, Tan, Adeline, Alsop, Jennifer, Barlow, Ellen, Beckmann, Matthias W, Boros, Jessica, Bowtell, David DL, Group, for the AOCS, Brand, Alison H, Brenton, James D, Campbell, Ian, Cheasley, Dane, Cohen, Joshua, Cybulski, Cezary, Elishaev, Esther, Erber, Ramona, Farrell, Rhonda, Fischer, Anna, Fu, Zhuxuan, Gilks, Blake, Gill, Anthony J, Initiative, for the Australian Pancreatic Genome, Gourley, Charlie, Grube, Marcel, Harnett, Paul R, Hartmann, Arndt, Hettiaratchi, Anusha, Høgdall, Claus K, Huzarski, Tomasz, Jakubowska, Anna, Jimenez-Linan, Mercedes, Kennedy, Catherine J, Kim, Byoung-Gie, Kim, Jae-Weon, Kim, Jae-Hoon, Klett, Kayla, Koziak, Jennifer M, Lai, Tiffany, Laslavic, Angela, Lester, Jenny, Leung, Yee, Li, Na, Liauw, Winston, Lim, Belle WX, Linder, Anna, Lubiński, Jan, Mahale, Sakshi, Mateoiu, Constantina, McInerny, Simone, Menkiszak, Janusz, Minoo, Parham, Mittelstadt, Suzana, Morris, David, Orsulic, Sandra, Park, Sang-Yoon, Pearce, Celeste Leigh, Pearson, John V, Pike, Malcolm C, Quinn, Carmel M, Mohan, Ganendra Raj, Rao, Jianyu, Riggan, Marjorie J, Ruebner, Matthias, Salfinger, Stuart, Scott, Clare L, Shah, Mitul, Steed, Helen, Stewart, Colin JR, Subramanian, Deepak, Sung, Soseul, Tang, Katrina, Timpson, Paul, Ward, Robyn L, Wiedenhoefer, Rebekka, Thorne, Heather, Investigators, for the kConFab, Cohen, Paul A, Crowe, Philip, Fasching, Peter A, Gronwald, Jacek, Hawkins, Nicholas J, Høgdall, Estrid, Huntsman, David G, James, Paul A, Karlan, Beth Y, and Kelemen, Linda E

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Ovarian Cancer, Rare Diseases, Cancer, Digestive Diseases, Genetics, 4.1 Discovery and preclinical testing of markers and technologies, Detection, screening and diagnosis, Female, Humans, Neoplasm Staging, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Adenocarcinoma, Mucinous, Prognosis, Gastrointestinal Neoplasms, AOCS Group, Australian Pancreatic Genome Initiative, kConFab Investigators, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeAdvanced-stage mucinous ovarian carcinoma (MOC) has poor chemotherapy response and prognosis and lacks biomarkers to aid stage I adjuvant treatment. Differentiating primary MOC from gastrointestinal (GI) metastases to the ovary is also challenging due to phenotypic similarities. Clinicopathologic and gene-expression data were analyzed to identify prognostic and diagnostic features.Experimental designDiscovery analyses selected 19 genes with prognostic/diagnostic potential. Validation was performed through the Ovarian Tumor Tissue Analysis consortium and GI cancer biobanks comprising 604 patients with MOC (n = 333), mucinous borderline ovarian tumors (MBOT, n = 151), and upper GI (n = 65) and lower GI tumors (n = 55).ResultsInfiltrative pattern of invasion was associated with decreased overall survival (OS) within 2 years from diagnosis, compared with expansile pattern in stage I MOC [hazard ratio (HR), 2.77; 95% confidence interval (CI), 1.04-7.41, P = 0.042]. Increased expression of THBS2 and TAGLN was associated with shorter OS in MOC patients (HR, 1.25; 95% CI, 1.04-1.51, P = 0.016) and (HR, 1.21; 95% CI, 1.01-1.45, P = 0.043), respectively. ERBB2 (HER2) amplification or high mRNA expression was evident in 64 of 243 (26%) of MOCs, but only 8 of 243 (3%) were also infiltrative (4/39, 10%) or stage III/IV (4/31, 13%).ConclusionsAn infiltrative growth pattern infers poor prognosis within 2 years from diagnosis and may help select stage I patients for adjuvant therapy. High expression of THBS2 and TAGLN in MOC confers an adverse prognosis and is upregulated in the infiltrative subtype, which warrants further investigation. Anti-HER2 therapy should be investigated in a subset of patients. MOC samples clustered with upper GI, yet markers to differentiate these entities remain elusive, suggesting similar underlying biology and shared treatment strategies.

Published
2022

6. Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer.

Author

Coleman, Robert, Spirtos, Nick, Enserro, Danielle, Herzog, Thomas, Sabbatini, Paul, Armstrong, Deborah, Kim, Jae-Weon, Park, Sang-Yoon, Kim, Byoung-Gie, Nam, Joo-Hyun, Fujiwara, Keiichi, Walker, Joan, Casey, Ann, Alvarez Secord, Angeles, Rubin, Steve, Chan, John, DiSilvestro, Paul, Davidson, Susan, Cohn, David, Basen-Engquist, Karen, Huang, Helen, Brady, Mark, Mannel, Robert, and Tewari, Krishnansu

Subjects
Aged, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Carboplatin, Combined Modality Therapy, Cytoreduction Surgical Procedures, Female, Humans, Middle Aged, Neoplasm Recurrence, Local, Neoplasms, Glandular and Epithelial, Ovarian Neoplasms, Paclitaxel, Quality of Life, Reoperation, Survival Analysis
Abstract

BACKGROUND: Secondary surgical cytoreduction in women with platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian-tube (ovarian) cancer is widely practiced but has not been evaluated in phase 3 investigation. METHODS: We randomly assigned patients with recurrent ovarian cancer who had received one previous therapy, had an interval during which no platinum-based chemotherapy was used (platinum-free interval) of 6 months or more, and had investigator-determined resectable disease (to no macroscopic residual disease) to undergo secondary surgical cytoreduction and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Adjuvant chemotherapy (paclitaxel-carboplatin or gemcitabine-carboplatin) and use of bevacizumab were at the discretion of the investigator. The primary end point was overall survival. RESULTS: A total of 485 patients underwent randomization, 240 to secondary cytoreduction before chemotherapy and 245 to chemotherapy alone. The median follow-up was 48.1 months. Complete gross resection was achieved in 67% of the patients assigned to surgery who underwent the procedure. Platinum-based chemotherapy with bevacizumab followed by bevacizumab maintenance was administered to 84% of the patients overall and was equally distributed between the two groups. The hazard ratio for death (surgery vs. no surgery) was 1.29 (95% confidence interval [CI], 0.97 to 1.72; P = 0.08), which corresponded to a median overall survival of 50.6 months and 64.7 months, respectively. Adjustment for platinum-free interval and chemotherapy choice did not alter the effect. The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively). Surgical morbidity at 30 days was 9%; 1 patient (0.4%) died from postoperative complications. Patient-reported quality of life decreased significantly after surgery but did not differ significantly between the two groups after recovery. CONCLUSIONS: In this trial involving patients with platinum-sensitive, recurrent ovarian cancer, secondary surgical cytoreduction followed by chemotherapy did not result in longer overall survival than chemotherapy alone. (Funded by the National Cancer Institute and others; GOG-0213 ClinicalTrials.gov number, NCT00565851.).

Published
2019

7. Safety and tolerability of durvalumab + carboplatin/paclitaxel followed by durvalumab ± olaparib in patients with newly diagnosed advanced or recurrent endometrial cancer (EC) in the DUO-E/GOG-3041/ENGOT-EN10 trial.

Author

Thomes Pepin, Jessica, primary, Chon, Hye Sook, additional, Sundborg, Michael J., additional, Gold, Michael A., additional, Kim, Byoung-Gie, additional, Blank, Stephanie V., additional, Liu, Ji-Hong, additional, McCollum, Michael, additional, Mori, Masahiko, additional, Moore, Kathleen N., additional, Rivera Diaz, Julian, additional, de Padua, Charles Andreé Joseph, additional, Martínez-García, Jerónimo, additional, Papadimitriou, Christos, additional, Gri an, Karin, additional, Póka, Róbert, additional, Kowgier, Matthew, additional, Oscroft, Emma, additional, Van Nieuwenhuysen, Els, additional, and Westin, Shannon Neville, additional

Published
2024
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8. Durvalumab + carboplatin/paclitaxel (CP) followed by durvalumab ± olaparib as first-line treatment for newly diagnosed advanced or recurrent endometrial cancer (EC) in DUO-E: Results by BRCA1/BRCA2 mutation (BRCAm) status.

Author

Van Nieuwenhuysen, Els, primary, Baurain, Jean-Francois, additional, Chon, Hye Sook, additional, Thomes Pepin, Jessica, additional, Sundborg, Michael J., additional, Gold, Michael A., additional, Kim, Byoung-Gie, additional, Blank, Stephanie V., additional, Liu, Ji-Hong, additional, McCollum, Michael, additional, Mori, Masahiko, additional, Jonuškienė, Goda, additional, Moore, Kathleen N., additional, Novák, Zoltán, additional, Ramos, Pedro, additional, de Padua, Charles Andreé Joseph, additional, Gil-Martin, Marta, additional, Kowgier, Matthew, additional, del Rosario, Paula Michelle, additional, and Westin, Shannon Neville, additional

Published
2024
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9. An open label, single arm phase II, multicenter trial of durvalumab and BVAC-C, in patients with HPV 16- or 18-positive cervical cancer and failure of first-line platinum-based chemotherapy (DURBAC).

Author

Choi, Chel Hun, primary, Kim, Byoung-Gie, additional, Lee, Jeong-Won, additional, Kim, Tae-Joong, additional, Lee, Yoo-Young, additional, Cho, Duck, additional, Park, Byoung-Kwan Hun, additional, Song, Sang Yong, additional, Kim, Dae-Yeon, additional, Kim, Kidong, additional, Kim, Hee Seung, additional, Lee, Jung-Yun, additional, Lim, Myong Cheol, additional, Jeon, Insu, additional, Song, By-yeong, additional, Shin, Kwang-Soo, additional, Kim, Wuhyun, additional, and Kang, Chang-Yuil, additional

Published
2024
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10. Genome-wide association studies identify susceptibility loci for epithelial ovarian cancer in east Asian women

Author

Lawrenson, Kate, Song, Fengju, Hazelett, Dennis J, Kar, Siddhartha P, Tyrer, Jonathan, Phelan, Catherine M, Corona, Rosario I, Rodríguez-Malavé, Norma I, Seo, Ji-Hei, Adler, Emily, Coetzee, Simon G, Segato, Felipe, Fonseca, Marcos AS, Amos, Christopher I, Carney, Michael E, Chenevix-Trench, Georgia, Choi, Jiyeob, Doherty, Jennifer A, Jia, Weihua, Jin, Gang J, Kim, Byoung-Gie, Le, Nhu D, Lee, Juyeon, Li, Lian, Lim, Boon K, Adenan, Noor A, Mizuno, Mika, Park, Boyoung, Pearce, Celeste L, Shan, Kang, Shi, Yongyong, Shu, Xiao-Ou, Sieh, Weiva, Group, The Australian Ovarian Cancer Study, Thompson, Pamela J, Wilkens, Lynne R, Wei, Qingyi, Woo, Yin L, Yan, Li, Karlan, Beth Y, Freedman, Matthew L, Noushmehr, Houtan, Goode, Ellen L, Berchuck, Andrew, Sellers, Thomas A, Teo, Soo-Hwang, Zheng, Wei, Matsuo, Keitaro, Park, Sue, Chen, Kexin, Pharoah, Paul DP, Gayther, Simon A, and Goodman, Marc T

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Biotechnology, Human Genome, Ovarian Cancer, Genetics, Prevention, Clinical Research, Rare Diseases, Cancer, 2.1 Biological and endogenous factors, Aetiology, Asian People, Base Sequence, Carcinoma, Ovarian Epithelial, Case-Control Studies, Female, Genetic Predisposition to Disease, Genome-Wide Association Study, Humans, Polymorphism, Single Nucleotide, Quantitative Trait Loci, Genome-wide association study, Asian ancestry, Epithelial ovarian cancer, Enhancer, eQTL, Gene regulation, Australian Ovarian Cancer Study Group, Paediatrics and Reproductive Medicine, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis, Reproductive medicine
Abstract

ObjectiveGenome-wide association studies (GWASs) for epithelial ovarian cancer (EOC) have focused largely on populations of European ancestry. We aimed to identify common germline variants associated with EOC risk in Asian women.MethodsGenotyping was performed as part of the OncoArray project. Samples with >60% Asian ancestry were included in the analysis. Genotyping was performed on 533,631 SNPs in 3238 Asian subjects diagnosed with invasive or borderline EOC and 4083 unaffected controls. After imputation, genotypes were available for 11,595,112 SNPs to identify associations.ResultsAt chromosome 6p25.2, SNP rs7748275 was associated with risk of serous EOC (odds ratio [OR] = 1.34, P = 8.7 × 10-9) and high-grade serous EOC (HGSOC) (OR = 1.34, P = 4.3 × 10-9). SNP rs6902488 at 6p25.2 (r2 = 0.97 with rs7748275) lies in an active enhancer and is predicted to impact binding of STAT3, P300 and ELF1. We identified additional risk loci with low Bayesian false discovery probability (BFDP) scores, indicating they are likely to be true risk associations (BFDP

Published
2019

12. Polygenic risk modeling for prediction of epithelial ovarian cancer risk

Author

Dareng, Eileen O., Tyrer, Jonathan P., Barnes, Daniel R., Jones, Michelle R., Yang, Xin, Aben, Katja K. H., Adank, Muriel A., Agata, Simona, Andrulis, Irene L., Anton-Culver, Hoda, Antonenkova, Natalia N., Aravantinos, Gerasimos, Arun, Banu K., Augustinsson, Annelie, Balmaña, Judith, Bandera, Elisa V., Barkardottir, Rosa B., Barrowdale, Daniel, Beckmann, Matthias W., Beeghly-Fadiel, Alicia, Benitez, Javier, Bermisheva, Marina, Bernardini, Marcus Q., Bjorge, Line, Black, Amanda, Bogdanova, Natalia V., Bonanni, Bernardo, Borg, Ake, Brenton, James D., Budzilowska, Agnieszka, Butzow, Ralf, Buys, Saundra S., Cai, Hui, Caligo, Maria A., Campbell, Ian, Cannioto, Rikki, Cassingham, Hayley, Chang-Claude, Jenny, Chanock, Stephen J., Chen, Kexin, Chiew, Yoke-Eng, Chung, Wendy K., Claes, Kathleen B. M., Colonna, Sarah, Cook, Linda S., Couch, Fergus J., Daly, Mary B., Dao, Fanny, Davies, Eleanor, de la Hoya, Miguel, de Putter, Robin, Dennis, Joe, DePersia, Allison, Devilee, Peter, Diez, Orland, Ding, Yuan Chun, Doherty, Jennifer A., Domchek, Susan M., Dörk, Thilo, du Bois, Andreas, Dürst, Matthias, Eccles, Diana M., Eliassen, Heather A., Engel, Christoph, Evans, Gareth D., Fasching, Peter A., Flanagan, James M., Fortner, Renée T., Machackova, Eva, Friedman, Eitan, Ganz, Patricia A., Garber, Judy, Gensini, Francesca, Giles, Graham G., Glendon, Gord, Godwin, Andrew K., Goodman, Marc T., Greene, Mark H., Gronwald, Jacek, Hahnen, Eric, Haiman, Christopher A., Håkansson, Niclas, Hamann, Ute, Hansen, Thomas V. O., Harris, Holly R., Hartman, Mikael, Heitz, Florian, Hildebrandt, Michelle A. T., Høgdall, Estrid, Høgdall, Claus K., Hopper, John L., Huang, Ruea-Yea, Huff, Chad, Hulick, Peter J., Huntsman, David G., Imyanitov, Evgeny N., Isaacs, Claudine, Jakubowska, Anna, James, Paul A., Janavicius, Ramunas, Jensen, Allan, Johannsson, Oskar Th., John, Esther M., Jones, Michael E., Kang, Daehee, Karlan, Beth Y., Karnezis, Anthony, Kelemen, Linda E., Khusnutdinova, Elza, Kiemeney, Lambertus A., Kim, Byoung-Gie, Kjaer, Susanne K., Komenaka, Ian, Kupryjanczyk, Jolanta, Kurian, Allison W., Kwong, Ava, Lambrechts, Diether, Larson, Melissa C., Lazaro, Conxi, Le, Nhu D., Leslie, Goska, Lester, Jenny, Lesueur, Fabienne, Levine, Douglas A., Li, Lian, Li, Jingmei, Loud, Jennifer T., Lu, Karen H., Lubiński, Jan, Mai, Phuong L., Manoukian, Siranoush, Marks, Jeffrey R., Matsuno, Rayna Kim, Matsuo, Keitaro, May, Taymaa, McGuffog, Lesley, McLaughlin, John R., McNeish, Iain A., Mebirouk, Noura, Menon, Usha, Miller, Austin, Milne, Roger L., Minlikeeva, Albina, Modugno, Francesmary, Montagna, Marco, Moysich, Kirsten B., Munro, Elizabeth, Nathanson, Katherine L., Neuhausen, Susan L., Nevanlinna, Heli, Yie, Joanne Ngeow Yuen, Nielsen, Henriette Roed, Nielsen, Finn C., Nikitina-Zake, Liene, Odunsi, Kunle, Offit, Kenneth, Olah, Edith, Olbrecht, Siel, Olopade, Olufunmilayo I., Olson, Sara H., Olsson, Håkan, Osorio, Ana, Papi, Laura, Park, Sue K., Parsons, Michael T., Pathak, Harsha, Pedersen, Inge Sokilde, Peixoto, Ana, Pejovic, Tanja, Perez-Segura, Pedro, Permuth, Jennifer B., Peshkin, Beth, Peterlongo, Paolo, Piskorz, Anna, Prokofyeva, Darya, Radice, Paolo, Rantala, Johanna, Riggan, Marjorie J., Risch, Harvey A., Rodriguez-Antona, Cristina, Ross, Eric, Rossing, Mary Anne, Runnebaum, Ingo, Sandler, Dale P., Santamariña, Marta, Soucy, Penny, Schmutzler, Rita K., Setiawan, V. Wendy, Shan, Kang, Sieh, Weiva, Simard, Jacques, Singer, Christian F., Sokolenko, Anna P., Song, Honglin, Southey, Melissa C., Steed, Helen, Stoppa-Lyonnet, Dominique, Sutphen, Rebecca, Swerdlow, Anthony J., Tan, Yen Yen, Teixeira, Manuel R., Teo, Soo Hwang, Terry, Kathryn L., Terry, Mary Beth, Thomassen, Mads, Thompson, Pamela J., Thomsen, Liv Cecilie Vestrheim, Thull, Darcy L., Tischkowitz, Marc, Titus, Linda, Toland, Amanda E., Torres, Diana, Trabert, Britton, Travis, Ruth, Tung, Nadine, Tworoger, Shelley S., Valen, Ellen, van Altena, Anne M., van der Hout, Annemieke H., Van Nieuwenhuysen, Els, van Rensburg, Elizabeth J., Vega, Ana, Edwards, Digna Velez, Vierkant, Robert A., Wang, Frances, Wappenschmidt, Barbara, Webb, Penelope M., Weinberg, Clarice R., Weitzel, Jeffrey N., Wentzensen, Nicolas, White, Emily, Whittemore, Alice S., Winham, Stacey J., Wolk, Alicja, Woo, Yin-Ling, Wu, Anna H., Yan, Li, Yannoukakos, Drakoulis, Zavaglia, Katia M., Zheng, Wei, Ziogas, Argyrios, Zorn, Kristin K., Kleibl, Zdenek, Easton, Douglas, Lawrenson, Kate, DeFazio, Anna, Sellers, Thomas A., Ramus, Susan J., Pearce, Celeste L., Monteiro, Alvaro N., Cunningham, Julie, Goode, Ellen L., Schildkraut, Joellen M., Berchuck, Andrew, Chenevix-Trench, Georgia, Gayther, Simon A., Antoniou, Antonis C., and Pharoah, Paul D. P.

Published
2022
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14. Overall Survival With Maintenance Olaparib at a 7-Year Follow-up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial

Author

DiSilvestro, Paul, Banerjee, Susana, Colombo, Nicoletta, Scambia, Giovanni, Kim, Byoung-Gie, Oaknin, Ana, Friedlander, Michael, Lisyanskaya, Alla, Floquet, Anne, Leary, Alexandra, Sonke, Gabe S., Gourley, Charlie, Oza, Amit, González-Martín, Antonio, Aghajanian, Carol, Bradley, William, Mathews, Cara, Liu, Joyce, McNamara, John, Lowe, Elizabeth S., Ah-See, Mei-Lin, and Moore, Kathleen N.

Published
2023
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15. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Banerjee, Susana, Moore, Kathleen N, Colombo, Nicoletta, Scambia, Giovanni, Kim, Byoung-Gie, Oaknin, Ana, Friedlander, Michael, Lisyanskaya, Alla, Floquet, Anne, Leary, Alexandra, Sonke, Gabe S, Gourley, Charlie, Oza, Amit, González-Martín, Antonio, Aghajanian, Carol, Bradley, William H, Holmes, Eileen, Lowe, Elizabeth S, and DiSilvestro, Paul

Published
2021
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16. Efficacy and safety of BVAC-C in HPV type 16- or 18–positive cervical carcinoma who failed 1st platinum-based chemotherapy: a phase I/IIa study

Author

Choi, Chel Hun, primary, Lee, Jeong-Won, additional, Bae, Duk-Soo, additional, Kang, Eun-Suk, additional, Cho, Duck, additional, Kim, Yong-Man, additional, Kim, Kidong, additional, Kim, Jae-Weon, additional, Kim, Hee Seung, additional, Kim, Young-Tae, additional, Lee, Jung-Yun, additional, Lim, Myong Cheol, additional, Oh, Taegwon, additional, Song, Boyeong, additional, Jeon, Insu, additional, Park, Myunghwan, additional, Kim, Wu Hyun, additional, Kang, Chang-Yuil, additional, and Kim, Byoung-Gie, additional

Published
2024
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19. Risk Factors Affecting Clinical Outcomes of Low-risk Early-stage Human Papillomavirus–Associated Endocervical Adenocarcinoma Treated by Surgery Alone: Application of Silva Pattern

Author

Bae, Bong Kyung, primary, Bae, Hyunsik, additional, Cho, Won Kyung, additional, Kim, Byoung-Gie, additional, Choi, Chel Hun, additional, Kim, Tae-Joong, additional, Lee, Yoo-Young, additional, Lee, Jeong-Won, additional, Kim, Hyun-Soo, additional, and Park, Won, additional

Published
2024
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22. DOMENICA study (GINECO-EN105b/ENGOT-en13): randomized phase III trial in MMR deficient (MMRd) endometrial cancer (EC) patients comparing chemotherapy (CT) alone versus dostarlimab in first line advanced/metastatic setting (APGOT-EN1)

Author

Choi, Chel Hun, primary, Ray-Coquard, Isabelle, additional, Rubio, Maria Jesus, additional, Paoletti, Xavier, additional, Hudson, Emma, additional, Lorusso, Domenica, additional, Hasler-Strub, Ursula, additional, Vardar, Mehmet Ali, additional, Lheureux, Stéphanie, additional, Gorp, Toon Van, additional, Tan, David Shao Peng, additional, Trillsch, Fabian, additional, Eberst, Lauriane, additional, Lescure, Céline, additional, Hardy-Bessard, Anne-Claire, additional, Chaix, Marie, additional, Kim, Byoung-Gie, additional, Kim, JaeWeon, additional, Park, JeongYeol, additional, Lee, Jung-Yun, additional, Lim, MyongCheol, additional, Kim, Kidong, additional, Cho, Hyun-Woong, additional, and Joly, Florence, additional

Published
2024
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25. Final primary analysis in the original cohort of KGOG3046/TRU-D: a phase II study of durvalumab and tremelimumab with front-line neoadjuvant chemotherapy in patients with advanced-stage ovarian cancer

Author

Park, Junsik, primary, Lee, Jungbok, additional, Lim, Myong Cheol, additional, Kim, Byoung-Gie, additional, Kim, Jae-Weon, additional, Kim, Sunghoon, additional, Choi, Chel Hun, additional, Kim, Hee Seung, additional, Park, Sang Yoon, additional, and Lee, Jung-Yun, additional

Published
2024
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26. Durvalumab with or without tremelimumab plus chemotherapy in HRR non-mutated, platinum-resistant ovarian cancer (KGOG 3045): a phase II umbrella trial

Author

Kim, Se Ik, primary, Joung, Je-Gun, additional, Kim, Yoo-Na, additional, Park, Junsik, additional, Park, Eunhyang, additional, Kim, Jae-Weon, additional, Kim, Sunghoon, additional, Choi, Chel Hun, additional, Kim, Hee Seung, additional, Kim, Byoung-Gie, additional, and Lee, Jung-Yun, additional

Published
2024
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27. GX-188E DNA Vaccine Plus Pembrolizumab as a 2nd Line Treatment for HPV 16- and/or 18-Positive, PD-L1 All-Comer Recurrent or Advanced Cervical Cancer: A Prospective, Multicenter, Single-Arm, Phase II Clinical Trial

Author

Lim, Myong Cheol, primary, Choi, Youn Jin, additional, Hur, Soo-Young, additional, Kim, Yong-Man, additional, No, Jae Hong, additional, Kim, Byoung-Gie, additional, Cho, Chi Heum, additional, Kim, Sunghoon, additional, Jeong, Dae Hoon, additional, Lee, Jae-Kwan, additional, Kim, Ji Hyun, additional, Choi, Yoon-Jeong, additional, Woo, Jung Won, additional, Sung, Young Chul, additional, and Park, Jong Sup, additional

Published
2024
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28. Initial experience with the enhanced recovery after surgery (ERAS) protocols in gynecologic surgery at an urban academic tertiary medical center

Author

Kim, Won-Ji, primary, Noh, Joseph J., additional, Bang, Yu-Jeong, additional, Yang, Mi-Yeon, additional, Kim, Joo-Hyun, additional, Park, Chun-Ho, additional, Song, Hyun-Ju, additional, Kim, Ji-Min, additional, Choi, Chel-Hun, additional, Kim, Tae-Joong, additional, Lee, Jeong-Won, additional, Kim, Byoung-Gie, additional, Min, Jeong-Jin, additional, Kim, Chung Su, additional, Hahm, Tae Soo, additional, and Lee, Yoo-Young, additional

Published
2024
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29. Analysis of East Asia Subgroup in Study 309/KEYNOTE-775: Lenvatinib plus pembrolizumab versus treatment of physician’s choice chemotherapy in patients with previously treated advanced or recurrent endometrial cancer

Author

Yonemori, Kan, primary, Fujiwara, Keiichi, additional, Hasegawa, Kosei, additional, Yunokawa, Mayu, additional, Ushijima, Kimio, additional, Suzuki, Shiro, additional, Shikama, Ayumi, additional, Minobe, Shinichiro, additional, Usami, Tomoka, additional, Kim, Jae-Weon, additional, Kim, Byoung-Gie, additional, Wang, Peng-Hui, additional, Chang, Ting-Chang, additional, Yamamoto, Keiko, additional, Han, Shirong, additional, McKenzie, Jodi, additional, Orlowski, Robert J., additional, Miura, Takuma, additional, Makker, Vicky, additional, and Man Kim, Yong, additional

Published
2024
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30. Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial

Author

Friedlander, Michael, Moore, Kathleen N, Colombo, Nicoletta, Scambia, Giovanni, Kim, Byoung-Gie, Oaknin, Ana, Lisyanskaya, Alla, Sonke, Gabe S, Gourley, Charlie, Banerjee, Susana, Oza, Amit, González-Martín, Antonio, Aghajanian, Carol, Bradley, William H, Liu, Joyce, Mathews, Cara, Selle, Frédéric, Lortholary, Alain, Lowe, Elizabeth S, Hettle, Robert, Flood, Emuella, Parkhomenko, Elena, and DiSilvestro, Paul

Published
2021
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31. Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial

Author

Korach, Jacob, Huzarski, Tomasz, Byrski, Tomasz, Pautier, Patricia, Friedlander, Michael, Harter, Philipp, Colombo, Nicoletta, Pignata, Sandro, Scambia, Giovanni, Nicoletto, Maria, Nussey, Fiona, Clamp, Andrew, Penson, Richard, Oza, Amit, Poveda Velasco, Andrés, Rodrigues, Manuel, Lotz, Jean-Pierre, Selle, Frédéric, Ray-Coquard, Isabelle, Provencher, Diane, Prat Aparicio, Aleix, Vidal Boixader, Laura, Scott, Clare, Tamura, Kenji, Yunokawa, Mayu, Lisyanskaya, Alla, Medioni, Jacques, Pécuchet, Nicolas, Dubot, Coraline, De La Motte Rouge, Thibault, Kaminsky, Marie-Christine, Weber, Béatrice, Lortholary, Alain, Parkinson, Christine, Ledermann, Jonathan, Williams, Sarah, Banerjee, Susana, Cosin, Jonathan, Hoffman, James, Plante, Marie, Covens, Allan, Sonke, Gabe, Joly, Florence, Floquet, Anne, Hirte, Holger, Amit, Amnon, Park-Simon, Tjoung-Won, Matsumoto, Koji, Tjulandin, Sergei, Hoon Kim, Jae, Gladieff, Laurence, Sabbatini, Roberto, O'Malley, David, Timmins, Patrick, Kredentser, Daniel, Laínez Milagro, Nuria, Barretina Ginesta, Maria Pilar, Tibau Martorell, Ariadna, Gómez De Liaño Lista, Alfonso, Ojeda González, Belén, Mileshkin, Linda, Mandai, Masaki, Boere, Ingrid, Ottevanger, Petronella, Nam, Joo-Hyun, Filho, Elias, Hamizi, Salima, Cognetti, Francesco, Warshal, David, Dickson-Michelson, Elizabeth, Kamelle, Scott, McKenzie, Nathalie, Rodriguez, Gustavo, Armstrong, Deborah, Chalas, Eva, Celano, Paul, Behbakht, Kian, Davidson, Susan, Welch, Stephen, Helpman, Limor, Fishman, Ami, Bruchim, Ilan, Sikorska, Magdalena, Słowińska, Anna, Rogowski, Wojciech, Bidziński, Mariusz, Śpiewankiewicz, Beata, Casado Herraez, Antonio, Mendiola Fernández, César, Gropp-Meier, Martina, Saito, Toshiaki, Takehara, Kazuhiro, Enomoto, Takayuki, Watari, Hidemichi, Choi, Chel Hun, Kim, Byoung-Gie, Weon Kim, Jae, Hegg, Roberto, Vergote, Ignace, Poveda, Andrés, Ledermann, Jonathan A, Asher, Rebecca, Penson, Richard T, Oza, Amit M, Baldoni, Alessandra, Sonke, Gabe S, Kim, Jae-Hoon, Filho, Elias Abdo, Milenkova, Tsveta, Lowe, Elizabeth S, Rowe, Phil, and Pujade-Lauraine, Eric

Published
2021
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33. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial.

Author

Coleman, Robert L, Brady, Mark F, Herzog, Thomas J, Sabbatini, Paul, Armstrong, Deborah K, Walker, Joan L, Kim, Byoung-Gie, Fujiwara, Keiichi, Tewari, Krishnansu S, O'Malley, David M, Davidson, Susan A, Rubin, Stephen C, DiSilvestro, Paul, Basen-Engquist, Karen, Huang, Helen, Chan, John K, Spirtos, Nick M, Ashfaq, Raheela, and Mannel, Robert S

Subjects
Humans, Neoplasms, Glandular and Epithelial, Peritoneal Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Neoplasm Recurrence, Local, Paclitaxel, Carboplatin, Antineoplastic Combined Chemotherapy Protocols, Disease-Free Survival, Survival Rate, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Young Adult, Cytoreduction Surgical Procedures, Bevacizumab, Carcinoma, Ovarian Epithelial, Neoplasms, Glandular and Epithelial, Neoplasm Recurrence, Local, and over, Carcinoma, Ovarian Epithelial, Oncology & Carcinogenesis, Oncology and Carcinogenesis
Abstract

BackgroundPlatinum-based chemotherapy doublets are a standard of care for women with ovarian cancer recurring 6 months after completion of initial therapy. In this study, we aimed to explore the roles of secondary surgical cytoreduction and bevacizumab in this population, and report the results of the bevacizumab component here.MethodsThe multicentre, open-label, randomised phase 3 GOG-0213 trial was done in 67 predominantly academic centres in the USA (65 centres), Japan (one centre), and South Korea (one centre). Eligible patients were adult women (aged ≥18 years) with recurrent measurable or evaluable epithelial ovarian, primary peritoneal, or fallopian tube cancer, and a clinical complete response to primary platinum-based chemotherapy, who had been disease-free for at least 6 months following last infused cycle of platinum. Patients were randomly assigned (1:1) to standard chemotherapy (six 3-weekly cycles of paclitaxel [175 mg/m2 of body surface area] and carboplatin [area under the curve 5]) or the same chemotherapy regimen plus bevacizumab (15 mg/kg of bodyweight) every 3 weeks and continued as maintenance every 3 weeks until disease progression or unacceptable toxicity. Individuals who participated in both the bevacizumab objective and surgical objective (which is ongoing) were randomly assigned (1:1:1:1) to receive either of these two chemotherapy regimens with or without prior secondary cytoreductive surgery. Randomisation for the bevacizumab objective was stratified by treatment-free interval and participation in the surgical objective. The primary endpoint was overall survival, analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00565851.FindingsBetween Dec 10, 2007, and Aug 26, 2011, 674 women were enrolled and randomly assigned to standard chemotherapy (n=337) or chemotherapy plus bevacizumab (n=377). Median follow-up at the end of the trial on Nov 5, 2014, was 49·6 months in each treatment group (IQR 41·5-62·2 for chemotherapy plus bevacizumab; IQR 40·8-59·3 for chemotherapy), at which point 415 patients had died (214 in the chemotherapy group and 201 in the chemotherapy plus bevacizumab group). Based on pretreatment stratification data, median overall survival in the chemotherapy plus bevacizumab group was 42·2 months (95% CI 37·7-46·2) versus 37·3 months (32·6-39·7) in the chemotherapy group (hazard ratio [HR] 0·829; 95% CI 0·683-1·005; p=0·056). We identified incorrect treatment-free interval stratification data for 45 (7%) patients (equally balanced between treatment groups); a sensitivity analysis of overall survival based on the audited treatment-free interval stratification data gave an adjusted HR of 0·823 (95% CI 0·680-0·996; p=0·0447). In the safety population (all patients who initiated treatment), 317 (96%) of 325 patients in the chemotherapy plus bevacizumab group had at least one grade 3 or worse adverse event compared with 282 (86%) of 332 in the chemotherapy group; the most frequently reported of these in the chemotherapy plus bevacizumab group compared with the chemotherapy group were hypertension (39 [12%] vs two [1%]), fatigue (27 [8%] vs eight [2%]), and proteinuria (27 [8%] vs none). Two (1%) treatment-related deaths occurred in the chemotherapy group (infection [n=1] and myelodysplastic syndrome [n=1]) compared with nine (3%) in the chemotherapy plus bevacizumab group (infection [n=1], febrile neutropenia [n=1], myelodysplastic syndrome [n=1], secondary malignancy [n=1]; deaths not classified with CTCAE terms: disease progression [n=3], sudden death [n=1], and not specified [n=1]).InterpretationThe addition of bevacizumab to standard chemotherapy, followed by maintenance therapy until progression, improved the median overall survival in patients with platinum-sensitive recurrent ovarian cancer. Although the intention-to-treat analysis for overall survival was not significant, our sensitivity analysis based on corrected treatment-free interval stratification indicates that this strategy might be an important addition to the therapeutic armamentarium in these patients.FundingNational Cancer Institute and Genentech.

Published
2017

34. AIM2CERV: a randomized phase III study of adjuvant AXAL immunotherapy following chemoradiation in patients who have high-risk locally advanced cervical cancer (HRLACC)

Author

Herzog, Thomas, Backes, Floor J, Copeland, Larry, Del Pilar Estevez Diz, Maria, Hare, Thomas W, Huh, Warner, Kim, Byoung-Gie, Moore, Kathleen M, Small, William, Oaknin, Ana, Tewari, Krishnansu S, and Monk, Bradley J

Abstract

BackgroundPatients with HRLACC experience a 50% chance of disease recurrence/death following cisplatin-based chemoradiation (CCRT) plus brachytherapy, and represent a group with a significant unmet needfor new treatments. Persistent infection with oncogenic strains of human papillomavirus (HPV) is the most common cause of CC, and provides rationale for therapeutic targeting of HPV. Axalimogenefilolisbac (AXAL/ADXS11-001) is an irreversibly attenuated Listeria monocytogenes-listeriolysin O immunotherapy that secretes a HPV E7 fusion protein that induces HPV-specific cytotoxic T cell generation and reduces immune tolerance in the tumor microenvironment. Previousstudies demonstrated AXAL was well tolerated and associated with objective tumor response and survival benefits in patients with recurrent/metastatic CC. AXAL has received FDA Fast Track Designation for the treatment of HRLACC.

Published
2016

35. Pembrolizumab plus GX-188E therapeutic DNA vaccine in patients with HPV-16-positive or HPV-18-positive advanced cervical cancer: interim results of a single-arm, phase 2 trial

Author

Youn, Jin Won, Hur, Soo-Young, Woo, Jung Won, Kim, Yong-Man, Lim, Myong Cheol, Park, Sang Yoon, Seo, Sang Soo, No, Jae Hong, Kim, Byoung-Gie, Lee, Jae-Kwan, Shin, So Jin, Kim, Kyungun, Chaney, Marya F, Choi, Yoon-Jeong, Suh, You Suk, Park, Jong Sup, and Sung, Young Chul

Published
2020
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37. Prediction of final pathology depending on preoperative myometrial invasion and grade assessment in low-risk endometrial cancer patients: A Korean Gynecologic Oncology Group ancillary study.

Author

Jang, Dong-hoon, Lee, Hyun-Gyu, Lee, Banghyun, Kang, Sokbom, Kim, Jong-Hyeok, Kim, Byoung-Gie, Kim, Jae-Weon, Kim, Moon-Hong, Chen, Xiaojun, No, Jae Hong, Lee, Jong-Min, Kim, Jae-Hoon, Watari, Hidemich, Kim, Seok Mo, Kim, Sung Hoon, Seong, Seok Ju, Jeong, Dae Hoon, and Kim, Yun Hwan

Subjects
GYNECOLOGIC oncology, ENDOMETRIAL cancer, CANCER patients, MACHINE learning, PREDICTION models, PATHOLOGY
Abstract

Objectives: Fertility-sparing treatment (FST) might be considered an option for reproductive patients with low-risk endometrial cancer (EC). On the other hand, the matching rates between preoperative assessment and postoperative pathology in low-risk EC patients are not high enough. We aimed to predict the postoperative pathology depending on preoperative myometrial invasion (MI) and grade in low-risk EC patients to help extend the current criteria for FST. Methods/Materials: This ancillary study (KGOG 2015S) of Korean Gynecologic Oncology Group 2015, a prospective, multicenter study included patients with no MI or MI <1/2 on preoperative MRI and endometrioid adenocarcinoma and grade 1 or 2 on endometrial biopsy. Among the eligible patients, Groups 1–4 were defined with no MI and grade 1, no MI and grade 2, MI <1/2 and grade 1, and MI <1/2 and grade 2, respectively. New prediction models using machine learning were developed. Results: Among 251 eligible patients, Groups 1–4 included 106, 41, 74, and 30 patients, respectively. The new prediction models showed superior prediction values to those from conventional analysis. In the new prediction models, the best NPV, sensitivity, and AUC of preoperative each group to predict postoperative each group were as follows: 87.2%, 71.6%, and 0.732 (Group 1); 97.6%, 78.6%, and 0.656 (Group 2); 71.3%, 78.6% and 0.588 (Group 3); 91.8%, 64.9%, and 0.676% (Group 4). Conclusions: In low-risk EC patients, the prediction of postoperative pathology was ineffective, but the new prediction models provided a better prediction. [ABSTRACT FROM AUTHOR]

Published
2024
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41. TP003/#1557 An open label, single arm, multicenter trial of durvalumab and BVAC-C, in patients with HPV 16 or 18 positive cervical cancer (DURBAC)

Author

Choi, Chel Hun, primary, Kim, Byoung Gie, additional, Lee, Jeong-Won, additional, Kim, Tae-Joong, additional, Lee, Yoo Young, additional, Cho, Duck, additional, Park, Byoung-Kwan, additional, Song, Sang Yong, additional, Kim, Dae-Yeon, additional, Kim, Kidong, additional, Kim, Hee Seung, additional, Lee, Jung-Yun, additional, Lim, Myong Cheol, additional, Kim, Wu_Hyun, additional, and Kang, Chang Yuil, additional

Published
2023
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49. EP138/#520 Prediction of final pathology depending on preoperative myometrial invasion and grade assessment in low risk endometrial cancer patients: a Korean gynecologic oncology group ancillary study

Author

Lee, Bang-Hyun, primary, Kang, Sokbom, additional, Kim, Jong-Hyeok, additional, Kim, Byoung Gie, additional, Kim, Jae-Weon, additional, Kim, Moon-Hong, additional, Chen, Xiaojun, additional, No, Jae-Hong, additional, Lee, Jong-Min, additional, Kim, Jae-Hoon, additional, Watari, Hidemichi, additional, Kim, Seok Mo, additional, Kim, Sunghoon, additional, Seong, Seok Ju, additional, Jeong, Dae Hoon, additional, and Kim, Yun Hwan, additional

Published
2023
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50. PR008/#805 Efficacy and safety of BVAC-C in HPV type 16 or 18 positive cervical carcinoma who failed 1st platinum based chemotherapy: a phase I/IIA study

Author

Choi, Chel Hun, primary, Lee, Jeong-Won, additional, Kang, Eun-Suk, additional, Cho, Duck, additional, Kim, Yong-Man, additional, Kim, Kidong, additional, Kim, Jae-Weon, additional, Kim, Hee Seung, additional, Kim, Young Tae, additional, Lee, Jung-Yun, additional, Lim, Myong Cheol, additional, Kang, Chang Yuil, additional, and Kim, Byoung Gie, additional

Published
2023
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