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2. Phase 1/2 study of monalizumab plus durvalumab in patients with advanced solid tumors.

Author

Patel, Sandip, Alonso-Gordoa, Teresa, Banerjee, Susana, Wang, Ding, Naidoo, Jarushka, Standifer, Nathan, Palmer, Doug, Cheng, Lin-Yang, Kourtesis, Panagiotis, Ascierto, Maria, Das, Mayukh, Diamond, Jennifer, Hellmann, Matthew, and Carneiro, Benedito

Subjects
Adaptive Immunity, Immunity, Innate, Natural Killer T-Cells, Programmed Cell Death 1 Receptor, Tumor Microenvironment, Female, Humans, Adolescent, Adult, Carcinoma, Non-Small-Cell Lung, Ligands, Lung Neoplasms, Tumor Microenvironment, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized
Abstract

BACKGROUND: The combination of monalizumab (anti-NKG2A/CD94) and durvalumab (anti-programmed death ligand-1) may promote antitumor immunity by targeting innate and adaptive immunity. This phase 1/2 study of monalizumab and durvalumab evaluated safety, antitumor activity, and pharmacodynamics in patients with advanced solid tumors. MAIN BODY: Immunotherapy-naïve patients aged ≥18 years with advanced disease, Eastern Cooperative Oncology Group performance status of 0-1, and 1-3 prior lines of systemic therapy in the recurrent/metastatic setting were enrolled. In part 1 (dose escalation), patients received durvalumab 1500 mg every 4 weeks (Q4W) with increasing doses of monalizumab Q2W/Q4W (n=15). Dose expansion in part 1 included patients with cervical cancer (n=15; durvalumab 1500 mg Q4W and monalizumab 750 mg Q2W) or metastatic microsatellite stable (MSS)-colorectal cancer (CRC) (n=15; durvalumab 1500 mg Q4W and monalizumab 750 mg Q4W). In part 2 (dose expansion), patients with MSS-CRC (n=40), non-small cell lung cancer (NSCLC; n=20), MSS-endometrial cancer (n=40), or ovarian cancer (n=40) received durvalumab 1500 mg Q4W and monalizumab 750 mg Q2W. The primary endpoint was safety. Secondary endpoints included antitumor activity per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1). Exploratory analyses included assessment of T-cell and natural killer (NK) cell activation and proliferation in peripheral blood and the tumor microenvironment (TME). The study enrolled 185 patients (part 1, 45; part 2, 140). No dose-limiting toxicities were observed and the maximum tolerated dose was not reached. In part 2, the most common treatment-related adverse events were fatigue (12.1%), asthenia (9.3%), diarrhea (9.3%), pruritus (7.9%), and pyrexia (7.1%). In the expansion cohorts, response rates were 0% (cervical), 7.7% (MSS-CRC), 10% (NSCLC), 5.4% (ovarian), and 0% (MSS-endometrial). Sustained NK cell activation, CD8+ T-cell proliferation, increased serum levels of CXCL10 (C-X-C motif chemokine ligand 10) and CXCL11, and increased tumor infiltration of CD8+ and granzyme B+ cells were observed. CONCLUSIONS: Although efficacy was modest, monalizumab plus durvalumab was well tolerated and encouraging immune activation was observed in the peripheral blood and TME. TRIAL REGISTRATION NUMBER: NCT02671435.

Published
2024

4. Tisotumab Vedotin in Combination With Carboplatin, Pembrolizumab, or Bevacizumab in Recurrent or Metastatic Cervical Cancer: Results From the innovaTV 205/GOG-3024/ENGOT-cx8 Study.

Author

Madsen, Kristine, Köse, Fatih, Jackson, Amanda, Boere, Ingrid, Scambia, Giovanni, Randall, Leslie, Sadozye, Azmat, Baurain, Jean-François, Gort, Eelke, Zikán, Michal, Denys, Hannelore, Ottevanger, Nelleke, Forget, Frédéric, Mondrup Andreassen, Camilla, Eaton, Lamar, Chisamore, Michael, Viana Nicacio, Leonardo, Soumaoro, Ibrahima, Monk, Bradley, Vergote, Ignace, Van Nieuwenhuysen, Els, OCearbhaill, Roisin, Westermann, Anneke, Lorusso, Domenica, Ghamande, Sharad, Collins, Dearbhaile, Banerjee, Susana, Mathews, Cara, Gennigens, Christine, Cibula, David, and Tewari, Krishnansu

Subjects
Female, Humans, Bevacizumab, Carboplatin, Uterine Cervical Neoplasms, Antineoplastic Combined Chemotherapy Protocols, Neoplasm Recurrence, Local, Lung Neoplasms, Anemia
Abstract

PURPOSE: Tissue factor is highly expressed in cervical carcinoma and can be targeted by tisotumab vedotin (TV), an antibody-drug conjugate. This phase Ib/II study evaluated TV in combination with bevacizumab, pembrolizumab, or carboplatin for recurrent or metastatic cervical cancer (r/mCC). METHODS: This open-label, multicenter study (ClinicalTrials.gov identifier: NCT03786081) included dose-escalation arms that assessed dose-limiting toxicities (DLTs) and identified the recommended phase II dose (RP2D) of TV in combination with bevacizumab (arm A), pembrolizumab (arm B), or carboplatin (arm C). The dose-expansion arms evaluated TV antitumor activity and safety at RP2D in combination with carboplatin as first-line (1L) treatment (arm D) or with pembrolizumab as 1L (arm E) or second-/third-line (2L/3L) treatment (arm F). The primary end point of dose expansion was objective response rate (ORR). RESULTS: A total of 142 patients were enrolled. In dose escalation (n = 41), no DLTs were observed; the RP2D was TV 2 mg/kg plus bevacizumab 15 mg/kg on day 1 once every 3 weeks, pembrolizumab 200 mg on day 1 once every 3 weeks, or carboplatin AUC 5 on day 1 once every 3 weeks. In dose expansion (n = 101), the ORR was 54.5% (n/N, 18/33; 95% CI, 36.4 to 71.9) with 1L TV + carboplatin (arm D), 40.6% (n/N, 13/32; 95% CI, 23.7 to 59.4) with 1L TV + pembrolizumab (arm E), and 35.3% (12/34; 19.7 to 53.5) with 2L/3L TV + pembrolizumab (arm F). The median duration of response was 8.6 months, not reached, and 14.1 months, in arms D, E, and F, respectively. Grade ≥3 adverse events (≥15%) were anemia, diarrhea, nausea, and thrombocytopenia in arm D and anemia in arm F (none ≥15%, arm E). CONCLUSION: TV in combination with bevacizumab, carboplatin, or pembrolizumab demonstrated manageable safety and encouraging antitumor activity in treatment-naive and previously treated r/mCC.

Published
2023

5. Efficacy and safety of rucaparib treatment in patients with BRCA-mutated, relapsed ovarian cancer: final results from Study 10.

Author

Kristeleit, Rebecca, Drew, Yvette, Oza, Amit, Domchek, Susan, Banerjee, Susana, Glasspool, Rosalind, Balmaña, Judith, Chen, Lee-may, Patel, Manish, Burris, Howard, Safra, Tamar, Borrow, Jennifer, Lin, Kevin, Goble, Sandra, Maloney, Lara, and Shapira-Frommer, Ronnie

Subjects
Humans, Female, BRCA2 Protein, Poly(ADP-ribose) Polymerase Inhibitors, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Platinum, Neoplasm Recurrence, Local
Abstract

BACKGROUND: Study 10, a four-part Phase 1/2 study, evaluated oral rucaparib monotherapy in patients with advanced solid tumours. Here we report the final efficacy and safety results in heavily pretreated patients with ovarian cancer who received rucaparib in Study 10 Parts 2A and 2B. METHODS: Parts 2A and 2B (Phase 2 portions) enrolled patients with relapsed, high-grade, platinum-sensitive or platinum-resistant, BRCA-mutated ovarian cancer who had received 2-4 (Part 2A) or 3-4 (Part 2B) prior chemotherapies. Patients received oral rucaparib 600 mg twice daily (starting dose). The primary endpoint was the investigator-assessed objective response rate (ORR) by RECIST v1.1. RESULTS: Fifty-four patients were enrolled: 42 in Part 2A (all had platinum-sensitive disease) and 12 in Part 2B (4 with platinum-sensitive disease; 8 with platinum-resistant disease). ORR was 59.3% (95% CI 45.0-72.4%). The median time to onset of the most common nonhaematological treatment-emergent adverse events (TEAEs) was typically early (

Published
2023

6. British Gynaecological Cancer Society (BGCS) ovarian, tubal and primary peritoneal cancer guidelines: Recommendations for practice update 2024

Author

Moss, Esther, Taylor, Alexandra, Andreou, Adrian, Ang, Christine, Arora, Rupali, Attygalle, Ayoma, Banerjee, Susana, Bowen, Rebecca, Buckley, Lynn, Burbos, Nikos, Coleridge, Sarah, Edmondson, Richard, El-Bahrawy, Mona, Fotopoulou, Christina, Frost, Jonathan, Ganesan, Raji, George, Angela, Hanna, Louise, Kaur, Baljeet, Manchanda, Ranjit, Maxwell, Hillary, Michael, Agnieszka, Miles, Tracey, Newton, Claire, Nicum, Shibani, Ratnavelu, Nithya, Ryan, Neil, Sundar, Sudha, Vroobel, Katherine, Walther, Axel, Wong, Jason, and Morrison, Jo

Published
2024
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7. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial

Author

Gershenson, David M, Miller, Austin, Brady, William E, Paul, James, Carty, Karen, Rodgers, William, Millan, David, Coleman, Robert L, Moore, Kathleen N, Banerjee, Susana, Connolly, Kate, Secord, Angeles Alvarez, O'Malley, David M, Dorigo, Oliver, Gaillard, Stephanie, Gabra, Hani, Slomovitz, Brian, Hanjani, Parviz, Farley, John, Churchman, Michael, Ewing, Ailith, Hollis, Robert L, Herrington, C Simon, Huang, Helen Q, Wenzel, Lari, and Gourley, Charlie

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Clinical Research, Cancer, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Administration, Oral, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Ovarian Epithelial, Female, Humans, MAP Kinase Kinase 1, Middle Aged, Neoplasm Grading, Neoplasm Recurrence, Local, Ovarian Neoplasms, Paclitaxel, Progression-Free Survival, Pyridones, Pyrimidinones, Standard of Care, Treatment Outcome, United Kingdom, United States, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundLow-grade serous carcinoma of the ovary or peritoneum is characterised by MAPK pathway aberrations and its reduced sensitivity to chemotherapy relative to high-grade serous carcinoma. We compared the MEK inhibitor trametinib to physician's choice standard of care in patients with recurrent low-grade serous carcinoma.MethodsThis international, randomised, open-label, multicentre, phase 2/3 trial was done at 84 hospitals in the USA and UK. Eligible patients were aged 18 years or older with recurrent low-grade serous carcinoma and measurable disease, as defined by Response Evaluation Criteria In Solid Tumors version 1.1, had received at least one platinum-based regimen, but not all five standard-of-care drugs, and had received an unlimited number of previous regimens. Patients with serous borderline tumours or tumours containing low-grade serous and high-grade serous carcinoma were excluded. Eligible patients were randomly assigned (1:1) to receive either oral trametinib 2 mg once daily (trametinib group) or one of five standard-of-care treatment options (standard-of-care group): intravenous paclitaxel 80 mg/m2 by body surface area on days 1, 8, and 15 of every 28-day cycle; intravenous pegylated liposomal doxorubicin 40-50 mg/m2 by body surface area once every 4 weeks; intravenous topotecan 4 mg/m2 by body surface area on days 1, 8, and 15 of every 28-day cycle; oral letrozole 2·5 mg once daily; or oral tamoxifen 20 mg twice daily. Randomisation was stratified by geographical region (USA or UK), number of previous regimens (1, 2, or ≥3), performance status (0 or 1), and planned standard-of-care regimen. The primary endpoint was investigator-assessed progression-free survival while receiving randomised therapy, as assessed by imaging at baseline, once every 8 weeks for 15 months, and then once every 3 months thereafter, in the intention-to-treat population. Safety was assessed in patients who received at least one dose of study therapy. This trial is registered with ClinicalTrials.gov, NCT02101788, and is active but not recruiting.FindingsBetween Feb 27, 2014, and April 10, 2018, 260 patients were enrolled and randomly assigned to the trametinib group (n=130) or the standard-of-care group (n=130). At the primary analysis, there were 217 progression-free survival events (101 [78%] in the trametinib group and 116 [89%] in the standard-of-care group). Median progression-free survival in the trametinib group was 13·0 months (95% CI 9·9-15·0) compared with 7·2 months (5·6-9·9) in the standard-of-care group (hazard ratio 0·48 [95% CI 0·36-0·64]; p

Published
2022

9. Development and Validation of the Gene Expression Predictor of High-grade Serous Ovarian Carcinoma Molecular SubTYPE (PrOTYPE)

Author

Talhouk, Aline, George, Joshy, Wang, Chen, Budden, Timothy, Tan, Tuan Zea, Chiu, Derek S, Kommoss, Stefan, San Leong, Huei, Chen, Stephanie, Intermaggio, Maria P, Gilks, Blake, Nazeran, Tayyebeh M, Volchek, Mila, Elatre, Wafaa, Bentley, Rex C, Senz, Janine, Lum, Amy, Chow, Veronica, Sudderuddin, Hanwei, Mackenzie, Robertson, Leong, Samuel CY, Liu, Geyi, Johnson, Dustin, Chen, Billy, Group, AOCS, Alsop, Jennifer, Banerjee, Susana N, Behrens, Sabine, Bodelon, Clara, Brand, Alison H, Brinton, Louise, Carney, Michael E, Chiew, Yoke-Eng, Cushing-Haugen, Kara L, Cybulski, Cezary, Ennis, Darren, Fereday, Sian, Fortner, Renée T, García-Donas, Jesús, Gentry-Maharaj, Aleksandra, Glasspool, Rosalind, Goranova, Teodora, Greene, Casey S, Haluska, Paul, Harris, Holly R, Hendley, Joy, Hernandez, Brenda Y, Herpel, Esther, Jimenez-Linan, Mercedes, Karpinskyj, Chloe, Kaufmann, Scott H, Keeney, Gary L, Kennedy, Catherine J, Köbel, Martin, Koziak, Jennifer M, Larson, Melissa C, Lester, Jenny, Lewsley, Liz-Anne, Lissowska, Jolanta, Lubiński, Jan, Luk, Hugh, Macintyre, Geoff, Mahner, Sven, McNeish, Iain A, Menkiszak, Janusz, Nevins, Nikilyn, Osorio, Ana, Oszurek, Oleg, Palacios, José, Hinsley, Samantha, Pearce, Celeste L, Pike, Malcolm C, Piskorz, Anna M, Ray-Coquard, Isabelle, Rhenius, Valerie, Rodriguez-Antona, Cristina, Sharma, Raghwa, Sherman, Mark E, De Silva, Dilrini, Singh, Naveena, Sinn, Peter, Slamon, Dennis, Song, Honglin, Steed, Helen, Stronach, Euan A, Thompson, Pamela J, Tołoczko, Aleksandra, Trabert, Britton, Traficante, Nadia, Tseng, Chiu-Chen, Widschwendter, Martin, Wilkens, Lynne R, Winham, Stacey J, Winterhoff, Boris, Beeghly-Fadiel, Alicia, Benitez, Javier, Berchuck, Andrew, Brenton, James D, Brown, Robert, and Chang-Claude, Jenny

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Orphan Drug, Genetics, Ovarian Cancer, Women's Health, Cancer Genomics, Precision Medicine, Cancer, Human Genome, 4.2 Evaluation of markers and technologies, Good Health and Well Being, Aged, Algorithms, Cystadenoma, Serous, Female, Gene Expression Regulation, Neoplastic, Humans, Lymphocytes, Tumor-Infiltrating, Middle Aged, Neoplasm Grading, Neoplasm Proteins, Neoplasm, Residual, Ovarian Neoplasms, Transcriptome, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeGene expression-based molecular subtypes of high-grade serous tubo-ovarian cancer (HGSOC), demonstrated across multiple studies, may provide improved stratification for molecularly targeted trials. However, evaluation of clinical utility has been hindered by nonstandardized methods, which are not applicable in a clinical setting. We sought to generate a clinical grade minimal gene set assay for classification of individual tumor specimens into HGSOC subtypes and confirm previously reported subtype-associated features.Experimental designAdopting two independent approaches, we derived and internally validated algorithms for subtype prediction using published gene expression data from 1,650 tumors. We applied resulting models to NanoString data on 3,829 HGSOCs from the Ovarian Tumor Tissue Analysis consortium. We further developed, confirmed, and validated a reduced, minimal gene set predictor, with methods suitable for a single-patient setting.ResultsGene expression data were used to derive the predictor of high-grade serous ovarian carcinoma molecular subtype (PrOTYPE) assay. We established a de facto standard as a consensus of two parallel approaches. PrOTYPE subtypes are significantly associated with age, stage, residual disease, tumor-infiltrating lymphocytes, and outcome. The locked-down clinical grade PrOTYPE test includes a model with 55 genes that predicted gene expression subtype with >95% accuracy that was maintained in all analytic and biological validations.ConclusionsWe validated the PrOTYPE assay following the Institute of Medicine guidelines for the development of omics-based tests. This fully defined and locked-down clinical grade assay will enable trial design with molecular subtype stratification and allow for objective assessment of the predictive value of HGSOC molecular subtypes in precision medicine applications.See related commentary by McMullen et al., p. 5271.

Published
2020

10. Phase 3 MIRASOL (GOG 3045/ENGOT-ov55) trial: Mirvetuximab soravtansine (MIRV) vs. investigator’s choice chemotherapy (ICC) in older patients with platinum-resistant ovarian cancer (PROC) and high folate receptor-alpha (FRα) expression.

Author

Bello, Diana, primary, Van Gorp, Toon, additional, Konecny, Gottfried E., additional, Estévez-García, Purificación, additional, Moroney, John William, additional, Banerjee, Susana N., additional, Myers, Tashanna K. N., additional, Zamagni, Claudio, additional, Parma, Gabriella, additional, Sonnenburg, Daniel W, additional, Roszak, Andrzej, additional, Lalisang, Roy Iqbal, additional, Shapira-Frommer, Ronnie, additional, Klat, Jaroslav, additional, Wang, Yuemei, additional, Method, Michael W., additional, and Moore, Kathleen N., additional

Published
2024
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11. Phase II randomized multi-centre study of neoadjuvant olaparib in patients with platinum sensitive relapsed high grade serous ovarian cancer: The NEO trial.

Author

Lheureux, Stephanie, primary, May, Taymaa, additional, Wilson, Michelle K., additional, Provencher, Diane M., additional, Lau, Susie, additional, Ghatage, Prafull, additional, Weberpals, Johanne I, additional, Banerjee, Susana N., additional, McNeish, Iain A., additional, Dhani, Neesha C., additional, Ferguson, Sarah, additional, Bouchard-Fortier, Genevieve, additional, Pugh, Trevor John, additional, Ye, Xiang Y, additional, Garisto, Sarah, additional, Quintos, Judy, additional, Ramsahai, Janelle, additional, Wong, Horace, additional, Bowering, Valerie, additional, and Oza, Amit M., additional

Published
2024
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12. Genetic data from nearly 63,000 women of European descent predicts DNA methylation biomarkers and epithelial ovarian cancer risk

Author

Yang, Yaohua, Wu, Lang, Shu, Xiang, Lu, Yingchang, Shu, Xiao-Ou, Cai, Qiuyin, Beeghly-Fadiel, Alicia, Li, Bingshan, Ye, Fei, Berchuck, Andrew, Anton-Culver, Hoda, Banerjee, Susana, Benitez, Javier, Bjørge, Line, Brenton, James D, Butzow, Ralf, Campbell, Ian G, Chang-Claude, Jenny, Chen, Kexin, Cook, Linda S, Cramer, Daniel W, deFazio, Anna, Dennis, Joe, Doherty, Jennifer A, Dörk, Thilo, Eccles, Diana M, Edwards, Digna Velez, Fasching, Peter A, Fortner, Renée T, Gayther, Simon A, Giles, Graham G, Glasspool, Rosalind M, Goode, Ellen L, Goodman, Marc T, Gronwald, Jacek, Harris, Holly R, Heitz, Florian, Hildebrandt, Michelle A, Høgdall, Estrid, Høgdall, Claus K, Huntsman, David G, Kar, Siddhartha P, Karlan, Beth Y, Kelemen, Linda E, Kiemeney, Lambertus A, Kjaer, Susanne K, Koushik, Anita, Lambrechts, Diether, Le, Nhu D, Levine, Douglas A, Massuger, Leon F, Matsuo, Keitaro, May, Taymaa, McNeish, Iain A, Menon, Usha, Modugno, Francesmary, Monteiro, Alvaro N, Moorman, Patricia G, Moysich, Kirsten B, Ness, Roberta B, Nevanlinna, Heli, Olsson, Håkan, Onland-Moret, N Charlotte, Park, Sue K, Paul, James, Pearce, Celeste L, Pejovic, Tanja, Phelan, Catherine M, Pike, Malcolm C, Ramus, Susan J, Riboli, Elio, Rodriguez-Antona, Cristina, Romieu, Isabelle, Sandler, Dale P, Schildkraut, Joellen M, Setiawan, Veronica W, Shan, Kang, Siddiqui, Nadeem, Sieh, Weiva, Stampfer, Meir J, Sutphen, Rebecca, Swerdlow, Anthony J, Szafron, Lukasz M, Teo, Soo Hwang, Tworoger, Shelley S, Tyrer, Jonathan P, Webb, Penelope M, Wentzensen, Nicolas, White, Emily, Willett, Walter C, Wolk, Alicja, Woo, Yin Ling, Wu, Anna H, Yan, Li, Yannoukakos, Drakoulis, Chenevix-Trench, Georgia, Sellers, Thomas A, Pharoah, Paul DP, Zheng, Wei, and Long, Jirong

Subjects
Biological Sciences, Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Genetics, Human Genome, Ovarian Cancer, Prevention, Clinical Research, Rare Diseases, Cancer, Aetiology, 2.1 Biological and endogenous factors, Biomarkers, Tumor, Carcinoma, Ovarian Epithelial, Cohort Studies, DNA Methylation, Female, Genetic Predisposition to Disease, Humans, Models, Genetic, Ovarian Neoplasms, Predictive Value of Tests, Risk, White People, Women's Health, Oncology & Carcinogenesis, Biochemistry and cell biology, Oncology and carcinogenesis
Abstract

DNA methylation is instrumental for gene regulation. Global changes in the epigenetic landscape have been recognized as a hallmark of cancer. However, the role of DNA methylation in epithelial ovarian cancer (EOC) remains unclear. In this study, high-density genetic and DNA methylation data in white blood cells from the Framingham Heart Study (N = 1,595) were used to build genetic models to predict DNA methylation levels. These prediction models were then applied to the summary statistics of a genome-wide association study (GWAS) of ovarian cancer including 22,406 EOC cases and 40,941 controls to investigate genetically predicted DNA methylation levels in association with EOC risk. Among 62,938 CpG sites investigated, genetically predicted methylation levels at 89 CpG were significantly associated with EOC risk at a Bonferroni-corrected threshold of P < 7.94 × 10-7. Of them, 87 were located at GWAS-identified EOC susceptibility regions and two resided in a genomic region not previously reported to be associated with EOC risk. Integrative analyses of genetic, methylation, and gene expression data identified consistent directions of associations across 12 CpG, five genes, and EOC risk, suggesting that methylation at these 12 CpG may influence EOC risk by regulating expression of these five genes, namely MAPT, HOXB3, ABHD8, ARHGAP27, and SKAP1. We identified novel DNA methylation markers associated with EOC risk and propose that methylation at multiple CpG may affect EOC risk via regulation of gene expression. SIGNIFICANCE: Identification of novel DNA methylation markers associated with EOC risk suggests that methylation at multiple CpG may affect EOC risk through regulation of gene expression.

Published
2019

13. Weekly dose-dense chemotherapy in first-line epithelial ovarian, fallopian tube, or primary peritoneal cancer treatment (ICON8): overall survival results from an open-label, randomised, controlled, phase 3 trial

Author

Clamp, Andrew R, James, Elizabeth C, McNeish, Iain A, Dean, Andrew, Kim, Jae-Won, O'Donnell, Dearbhaile M, Gallardo-Rincon, Dolores, Blagden, Sarah, Brenton, James, Perren, Tim J, Sundar, Sudha, Lord, Rosemary, Dark, Graham, Hall, Marcia, Banerjee, Susana, Glasspool, Rosalind M, Hanna, C Louise, Williams, Sarah, Scatchard, Kate M, Nam, Helena, Essapen, Sharadah, Parkinson, Christine, McAvan, Lucy, Swart, Ann Marie, Popoola, Babasola, Schiavone, Francesca, Badrock, Jonathan, Fananapazir, Fuad, Cook, Adrian D, Parmar, Mahesh, Kaplan, Richard, and Ledermann, Jonathan A

Published
2022
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15. Top advances of the year: Immunotherapy in endometrial cancer.

Author

Banerjee, Susana and Hasson, Shira Peleg

Subjects
*IMMUNE checkpoint inhibitors, *CANCER patients, *CLINICAL trials, *ENDOMETRIAL cancer, *PATIENT selection
Abstract

In the past year, notable advances were achieved toward improving oncological outcomes in patients with advanced and recurrent endometrial cancer because of reporting of high‐level results of several phase 3 clinical trial combining an immune checkpoint inhibitor with chemotherapy in the first‐line setting. For the first time, patients with recurrent or advanced endometrial cancer have options for treatment that are superior to traditional chemotherapy alone. What remains to be determined is population specificity of these recommendations. All four major studies were in agreement that patients with endometrial cancer with deficient mismatch repair markedly benefited from addition of an immune checkpoint inhibitor for progression‐free survival; some showed preliminary results demonstrating a potential overall survival. Molecular characterization details are needed to determine if and which patients with tumors that are mismatch proficient should receive this new combination approach. Plain Language Summary: Combining an immune checkpoint inhibitor with chemotherapy in the first‐line setting treatment of patients with advanced endometrial cancer improved progression‐free survival, especially in patients with mismatch repair deficiency.Improving patient selection with potential biomarkers of sensitivity and biomarkers of resistance is key in developing the next clinical trials and will assist in directing therapy to the correct patients and minimize toxicity. Significant advancements have been made in the treatment of advanced and recurrent endometrial cancer, with positive results from phase 3 clinical trials combining immune checkpoint inhibitors with chemotherapy in the first‐line setting. These findings offer patients previously limited by traditional chemotherapy alone new treatment options. [ABSTRACT FROM AUTHOR]

Published
2024
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16. 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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17. Adaptive immunity and neutralizing antibodies against SARS-CoV-2 variants of concern following vaccination in patients with cancer: the CAPTURE study

Author

Fendler, Annika, Shepherd, Scott T. C., Au, Lewis, Wilkinson, Katalin A., Wu, Mary, Byrne, Fiona, Cerrone, Maddalena, Schmitt, Andreas M., Joharatnam-Hogan, Nalinie, Shum, Benjamin, Tippu, Zayd, Rzeniewicz, Karolina, Boos, Laura Amanda, Harvey, Ruth, Carlyle, Eleanor, Edmonds, Kim, Del Rosario, Lyra, Sarker, Sarah, Lingard, Karla, Mangwende, Mary, Holt, Lucy, Ahmod, Hamid, Korteweg, Justine, Foley, Tara, Bazin, Jessica, Gordon, William, Barber, Taja, Emslie-Henry, Andrea, Xie, Wenyi, Gerard, Camille L., Deng, Daqi, Wall, Emma C., Agua-Doce, Ana, Namjou, Sina, Caidan, Simon, Gavrielides, Mike, MacRae, James I., Kelly, Gavin, Peat, Kema, Kelly, Denise, Murra, Aida, Kelly, Kayleigh, O’Flaherty, Molly, Dowdie, Lauren, Ash, Natalie, Gronthoud, Firza, Shea, Robyn L., Gardner, Gail, Murray, Darren, Kinnaird, Fiona, Cui, Wanyuan, Pascual, Javier, Rodney, Simon, Mencel, Justin, Curtis, Olivia, Stephenson, Clemency, Robinson, Anna, Oza, Bhavna, Farag, Sheima, Leslie, Isla, Rogiers, Aljosja, Iyengar, Sunil, Ethell, Mark, Messiou, Christina, Cunningham, David, Chau, Ian, Starling, Naureen, Turner, Nicholas, Welsh, Liam, van As, Nicholas, Jones, Robin L., Droney, Joanne, Banerjee, Susana, Tatham, Kate C., O’Brien, Mary, Harrington, Kevin, Bhide, Shreerang, Okines, Alicia, Reid, Alison, Young, Kate, Furness, Andrew J. S., Pickering, Lisa, Swanton, Charles, Gandhi, Sonia, Gamblin, Steve, Bauer, David L. V., Kassiotis, George, Kumar, Sacheen, Yousaf, Nadia, Jhanji, Shaman, Nicholson, Emma, Howell, Michael, Walker, Susanna, Wilkinson, Robert J., Larkin, James, and Turajlic, Samra

Published
2021
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18. Functional antibody and T cell immunity following SARS-CoV-2 infection, including by variants of concern, in patients with cancer: the CAPTURE study

Author

Fendler, Annika, Au, Lewis, Shepherd, Scott T. C., Byrne, Fiona, Cerrone, Maddalena, Boos, Laura Amanda, Rzeniewicz, Karolina, Gordon, William, Shum, Benjamin, Gerard, Camille L., Ward, Barry, Xie, Wenyi, Schmitt, Andreas M., Joharatnam-Hogan, Nalinie, Cornish, Georgina H., Pule, Martin, Mekkaoui, Leila, Ng, Kevin W., Carlyle, Eleanor, Edmonds, Kim, Rosario, Lyra Del, Sarker, Sarah, Lingard, Karla, Mangwende, Mary, Holt, Lucy, Ahmod, Hamid, Stone, Richard, Gomes, Camila, Flynn, Helen R., Agua-Doce, Ana, Hobson, Philip, Caidan, Simon, Howell, Michael, Wu, Mary, Goldstone, Robert, Crawford, Margaret, Cubitt, Laura, Patel, Harshil, Gavrielides, Mike, Nye, Emma, Snijders, Ambrosius P., MacRae, James I., Nicod, Jerome, Gronthoud, Firza, Shea, Robyn L., Messiou, Christina, Cunningham, David, Chau, Ian, Starling, Naureen, Turner, Nicholas, Welsh, Liam, van As, Nicholas, Jones, Robin L., Droney, Joanne, Banerjee, Susana, Tatham, Kate C., Jhanji, Shaman, O’Brien, Mary, Curtis, Olivia, Harrington, Kevin, Bhide, Shreerang, Bazin, Jessica, Robinson, Anna, Stephenson, Clemency, Slattery, Tim, Khan, Yasir, Tippu, Zayd, Leslie, Isla, Gennatas, Spyridon, Okines, Alicia, Reid, Alison, Young, Kate, Furness, Andrew J. S., Pickering, Lisa, Gandhi, Sonia, Gamblin, Steve, Swanton, Charles, Nicholson, Emma, Kumar, Sacheen, Yousaf, Nadia, Wilkinson, Katalin A., Swerdlow, Anthony, Harvey, Ruth, Kassiotis, George, Larkin, James, Wilkinson, Robert J., and Turajlic, Samra

Published
2021
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19. 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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20. Supplementary Table S6 from Olaparib plus Durvalumab, with or without Bevacizumab, as Treatment in PARP Inhibitor-Naïve Platinum-Sensitive Relapsed Ovarian Cancer: A Phase II Multi-Cohort Study

Author

Drew, Yvette, primary, Kim, Jae-Weon, primary, Penson, Richard T., primary, O'Malley, David M., primary, Parkinson, Christine, primary, Roxburgh, Patricia, primary, Plummer, Ruth, primary, Im, Seock-Ah, primary, Imbimbo, Martina, primary, Ferguson, Michelle, primary, Rosengarten, Ora, primary, Steeghs, Neeltje, primary, Kim, Min Hwan, primary, Gal-Yam, Einav, primary, Tsoref, Daliah, primary, Kim, Jae-Hoon, primary, You, Benoit, primary, De Jonge, Maja, primary, Lalisang, Roy, primary, Gort, Eelke, primary, Bastian, Sara, primary, Meyer, Kassondra, primary, Feeney, Laura, primary, Baker, Nigel, primary, Ah-See, Mei-Lin, primary, Domchek, Susan M., primary, and Banerjee, Susana, primary

Published
2024
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21. Supplementary Figure S3 from Olaparib plus Durvalumab, with or without Bevacizumab, as Treatment in PARP Inhibitor-Naïve Platinum-Sensitive Relapsed Ovarian Cancer: A Phase II Multi-Cohort Study

Author

Drew, Yvette, primary, Kim, Jae-Weon, primary, Penson, Richard T., primary, O'Malley, David M., primary, Parkinson, Christine, primary, Roxburgh, Patricia, primary, Plummer, Ruth, primary, Im, Seock-Ah, primary, Imbimbo, Martina, primary, Ferguson, Michelle, primary, Rosengarten, Ora, primary, Steeghs, Neeltje, primary, Kim, Min Hwan, primary, Gal-Yam, Einav, primary, Tsoref, Daliah, primary, Kim, Jae-Hoon, primary, You, Benoit, primary, De Jonge, Maja, primary, Lalisang, Roy, primary, Gort, Eelke, primary, Bastian, Sara, primary, Meyer, Kassondra, primary, Feeney, Laura, primary, Baker, Nigel, primary, Ah-See, Mei-Lin, primary, Domchek, Susan M., primary, and Banerjee, Susana, primary

Published
2024
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22. Supplementary Appendix S1 from Olaparib plus Durvalumab, with or without Bevacizumab, as Treatment in PARP Inhibitor-Naïve Platinum-Sensitive Relapsed Ovarian Cancer: A Phase II Multi-Cohort Study

Author

Drew, Yvette, primary, Kim, Jae-Weon, primary, Penson, Richard T., primary, O'Malley, David M., primary, Parkinson, Christine, primary, Roxburgh, Patricia, primary, Plummer, Ruth, primary, Im, Seock-Ah, primary, Imbimbo, Martina, primary, Ferguson, Michelle, primary, Rosengarten, Ora, primary, Steeghs, Neeltje, primary, Kim, Min Hwan, primary, Gal-Yam, Einav, primary, Tsoref, Daliah, primary, Kim, Jae-Hoon, primary, You, Benoit, primary, De Jonge, Maja, primary, Lalisang, Roy, primary, Gort, Eelke, primary, Bastian, Sara, primary, Meyer, Kassondra, primary, Feeney, Laura, primary, Baker, Nigel, primary, Ah-See, Mei-Lin, primary, Domchek, Susan M., primary, and Banerjee, Susana, primary

Published
2024
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23. Data from Olaparib plus Durvalumab, with or without Bevacizumab, as Treatment in PARP Inhibitor-Naïve Platinum-Sensitive Relapsed Ovarian Cancer: A Phase II Multi-Cohort Study

Author

Drew, Yvette, primary, Kim, Jae-Weon, primary, Penson, Richard T., primary, O'Malley, David M., primary, Parkinson, Christine, primary, Roxburgh, Patricia, primary, Plummer, Ruth, primary, Im, Seock-Ah, primary, Imbimbo, Martina, primary, Ferguson, Michelle, primary, Rosengarten, Ora, primary, Steeghs, Neeltje, primary, Kim, Min Hwan, primary, Gal-Yam, Einav, primary, Tsoref, Daliah, primary, Kim, Jae-Hoon, primary, You, Benoit, primary, De Jonge, Maja, primary, Lalisang, Roy, primary, Gort, Eelke, primary, Bastian, Sara, primary, Meyer, Kassondra, primary, Feeney, Laura, primary, Baker, Nigel, primary, Ah-See, Mei-Lin, primary, Domchek, Susan M., primary, and Banerjee, Susana, primary

Published
2024
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24. Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study

Author

Pujade-Lauraine, Eric, Fujiwara, Keiichi, Ledermann, Jonathan A, Oza, Amit M, Kristeleit, Rebecca, Ray-Coquard, Isabelle-Laure, Richardson, Gary E, Sessa, Cristiana, Yonemori, Kan, Banerjee, Susana, Leary, Alexandra, Tinker, Anna V, Jung, Kyung Hae, Madry, Radoslaw, Park, Sang-Yoon, Anderson, Charles K, Zohren, Fabian, Stewart, Ross A, Wei, Caimiao, Dychter, Samuel S, and Monk, Bradley J

Published
2021
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25. 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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26. 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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27. Baseline clinical predictors of antitumor response to the PARP inhibitor olaparib in germline BRCA1/2 mutated patients with advanced ovarian cancer

Author

Rafii, Saeed, Gourley, Charlie, Kumar, Rajiv, Geuna, Elena, Ang, Joo Ern, Rye, Tzyvia, Chen, Lee-May, Shapira-Frommer, Ronnie, Friedlander, Michael, Matulonis, Ursula, De Greve, Jacques, Oza, Amit M, Banerjee, Susana, Molife, L Rhoda, Gore, Martin E, Kaye, Stan B, and Yap, Timothy A

Subjects
Rare Diseases, Orphan Drug, Cancer, Ovarian Cancer, Clinical Research, Genetics, Breast Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Antineoplastic Agents, BRCA1 Protein, BRCA2 Protein, Female, Germ-Line Mutation, Humans, Middle Aged, Neoplasm Grading, Neoplasm Metastasis, Neoplasm Staging, Ovarian Neoplasms, Phthalazines, Piperazines, Poly(ADP-ribose) Polymerase Inhibitors, Prognosis, Recurrence, Survival Analysis, Treatment Outcome, PARP inhibitor, olaparib, BRCA, ovarian cancer, predictive biomarkers, Oncology and Carcinogenesis
Abstract

BackgroundThe PARP inhibitor olaparib was recently granted Food and Drug Administration (FDA) accelerated approval in patients with advanced BRCA1/2 mutation ovarian cancer. However, antitumor responses are observed in only approximately 40% of patients and the impact of baseline clinical factors on response to treatment remains unclear. Although platinum sensitivity has been suggested as a marker of response to PARP inhibitors, patients with platinum-resistant disease still respond to olaparib.Results108 patients with advanced BRCA1/2 mutation ovarian cancers were included. The interval between the end of the most recent platinum chemotherapy and PARPi (PTPI) was used to predict response to olaparib independent of conventional definition of platinum sensitivity. RECIST complete response (CR) and partial response (PR) rates were 35% in patients with platinum-sensitive versus 13% in platinum-resistant (p

Published
2017

28. Identification of 12 new susceptibility loci for different histotypes of epithelial ovarian cancer.

Author

Phelan, Catherine M, Kuchenbaecker, Karoline B, Tyrer, Jonathan P, Kar, Siddhartha P, Lawrenson, Kate, Winham, Stacey J, Dennis, Joe, Pirie, Ailith, Riggan, Marjorie J, Chornokur, Ganna, Earp, Madalene A, Lyra, Paulo C, Lee, Janet M, Coetzee, Simon, Beesley, Jonathan, McGuffog, Lesley, Soucy, Penny, Dicks, Ed, Lee, Andrew, Barrowdale, Daniel, Lecarpentier, Julie, Leslie, Goska, Aalfs, Cora M, Aben, Katja KH, Adams, Marcia, Adlard, Julian, Andrulis, Irene L, Anton-Culver, Hoda, Antonenkova, Natalia, AOCS study group, Aravantinos, Gerasimos, Arnold, Norbert, Arun, Banu K, Arver, Brita, Azzollini, Jacopo, Balmaña, Judith, Banerjee, Susana N, Barjhoux, Laure, Barkardottir, Rosa B, Bean, Yukie, Beckmann, Matthias W, Beeghly-Fadiel, Alicia, Benitez, Javier, Bermisheva, Marina, Bernardini, Marcus Q, Birrer, Michael J, Bjorge, Line, Black, Amanda, Blankstein, Kenneth, Blok, Marinus J, Bodelon, Clara, Bogdanova, Natalia, Bojesen, Anders, Bonanni, Bernardo, Borg, Åke, Bradbury, Angela R, Brenton, James D, Brewer, Carole, Brinton, Louise, Broberg, Per, Brooks-Wilson, Angela, Bruinsma, Fiona, Brunet, Joan, Buecher, Bruno, Butzow, Ralf, Buys, Saundra S, Caldes, Trinidad, Caligo, Maria A, Campbell, Ian, Cannioto, Rikki, Carney, Michael E, Cescon, Terence, Chan, Salina B, Chang-Claude, Jenny, Chanock, Stephen, Chen, Xiao Qing, Chiew, Yoke-Eng, Chiquette, Jocelyne, Chung, Wendy K, Claes, Kathleen BM, Conner, Thomas, Cook, Linda S, Cook, Jackie, Cramer, Daniel W, Cunningham, Julie M, D'Aloisio, Aimee A, Daly, Mary B, Damiola, Francesca, Damirovna, Sakaeva Dina, Dansonka-Mieszkowska, Agnieszka, Dao, Fanny, Davidson, Rosemarie, DeFazio, Anna, Delnatte, Capucine, Doheny, Kimberly F, Diez, Orland, Ding, Yuan Chun, Doherty, Jennifer Anne, Domchek, Susan M, and Dorfling, Cecilia M

Subjects
AOCS study group, EMBRACE Study, GEMO Study Collaborators, HEBON Study, KConFab Investigators, OPAL study group, Humans, Neoplasms, Glandular and Epithelial, Ovarian Neoplasms, Genetic Predisposition to Disease, Telomere-Binding Proteins, BRCA1 Protein, BRCA2 Protein, Risk Factors, Genotype, Mutation, Polymorphism, Single Nucleotide, Alleles, Female, Meta-Analysis as Topic, Genome-Wide Association Study, Genetic Loci, Carcinoma, Ovarian Epithelial, Genetics, Cancer, Human Genome, Rare Diseases, Prevention, Ovarian Cancer, Aetiology, 2.1 Biological and endogenous factors, Biological Sciences, Medical and Health Sciences, Developmental Biology
Abstract

To identify common alleles associated with different histotypes of epithelial ovarian cancer (EOC), we pooled data from multiple genome-wide genotyping projects totaling 25,509 EOC cases and 40,941 controls. We identified nine new susceptibility loci for different EOC histotypes: six for serous EOC histotypes (3q28, 4q32.3, 8q21.11, 10q24.33, 18q11.2 and 22q12.1), two for mucinous EOC (3q22.3 and 9q31.1) and one for endometrioid EOC (5q12.3). We then performed meta-analysis on the results for high-grade serous ovarian cancer with the results from analysis of 31,448 BRCA1 and BRCA2 mutation carriers, including 3,887 mutation carriers with EOC. This identified three additional susceptibility loci at 2q13, 8q24.1 and 12q24.31. Integrated analyses of genes and regulatory biofeatures at each locus predicted candidate susceptibility genes, including OBFC1, a new candidate susceptibility gene for low-grade and borderline serous EOC.

Published
2017

29. The effect of age on efficacy, safety and patient-centered outcomes with rucaparib: A post hoc exploratory analysis of ARIEL3, a phase 3, randomized, maintenance study in patients with recurrent ovarian carcinoma

Author

Colombo, Nicoletta, Oza, Amit M., Lorusso, Domenica, Aghajanian, Carol, Oaknin, Ana, Dean, Andrew, Weberpals, Johanne I., Clamp, Andrew R., Scambia, Giovanni, Leary, Alexandra, Holloway, Robert W., Gancedo, Margarita Amenedo, Fong, Peter C., Goh, Jeffrey C., O'Malley, David M., Armstrong, Deborah K., Banerjee, Susana, García-Donas, Jesus, Swisher, Elizabeth M., Meunier, Juliette, Cameron, Terri, Maloney, Lara, Goble, Sandra, Bedel, Josh, Ledermann, Jonathan A., and Coleman, Robert L.

Published
2020
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31. Rucaparib for patients with platinum-sensitive, recurrent ovarian carcinoma (ARIEL3): post-progression outcomes and updated safety results from a randomised, placebo-controlled, phase 3 trial

Author

Ledermann, Jonathan A, Oza, Amit M, Lorusso, Domenica, Aghajanian, Carol, Oaknin, Ana, Dean, Andrew, Colombo, Nicoletta, Weberpals, Johanne I, Clamp, Andrew R, Scambia, Giovanni, Leary, Alexandra, Holloway, Robert W, Gancedo, Margarita Amenedo, Fong, Peter C, Goh, Jeffrey C, O'Malley, David M, Armstrong, Deborah K, Banerjee, Susana, García-Donas, Jesus, Swisher, Elizabeth M, Cameron, Terri, Maloney, Lara, Goble, Sandra, and Coleman, Robert L

Published
2020
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36. BRCA2 Polymorphic Stop Codon K3326X and the Risk of Breast, Prostate, and Ovarian Cancers.

Author

Meeks, Huong D, Song, Honglin, Michailidou, Kyriaki, Bolla, Manjeet K, Dennis, Joe, Wang, Qin, Barrowdale, Daniel, Frost, Debra, EMBRACE, McGuffog, Lesley, Ellis, Steve, Feng, Bingjian, Buys, Saundra S, Hopper, John L, Southey, Melissa C, Tesoriero, Andrea, kConFab Investigators, James, Paul A, Bruinsma, Fiona, Campbell, Ian G, Australia Ovarian Cancer Study Group, Broeks, Annegien, Schmidt, Marjanka K, Hogervorst, Frans BL, HEBON, Beckman, Matthias W, Fasching, Peter A, Fletcher, Olivia, Johnson, Nichola, Sawyer, Elinor J, Riboli, Elio, Banerjee, Susana, Menon, Usha, Tomlinson, Ian, Burwinkel, Barbara, Hamann, Ute, Marme, Frederik, Rudolph, Anja, Janavicius, Ramunas, Tihomirova, Laima, Tung, Nadine, Garber, Judy, Cramer, Daniel, Terry, Kathryn L, Poole, Elizabeth M, Tworoger, Shelley S, Dorfling, Cecilia M, van Rensburg, Elizabeth J, Godwin, Andrew K, Guénel, Pascal, Truong, Thérèse, GEMO Study Collaborators, Stoppa-Lyonnet, Dominique, Damiola, Francesca, Mazoyer, Sylvie, Sinilnikova, Olga M, Isaacs, Claudine, Maugard, Christine, Bojesen, Stig E, Flyger, Henrik, Gerdes, Anne-Marie, Hansen, Thomas VO, Jensen, Allen, Kjaer, Susanne K, Hogdall, Claus, Hogdall, Estrid, Pedersen, Inge Sokilde, Thomassen, Mads, Benitez, Javier, González-Neira, Anna, Osorio, Ana, Hoya, Miguel de la, Segura, Pedro Perez, Diez, Orland, Lazaro, Conxi, Brunet, Joan, Anton-Culver, Hoda, Eunjung, Lee, John, Esther M, Neuhausen, Susan L, Ding, Yuan Chun, Castillo, Danielle, Weitzel, Jeffrey N, Ganz, Patricia A, Nussbaum, Robert L, Chan, Salina B, Karlan, Beth Y, Lester, Jenny, Wu, Anna, Gayther, Simon, Ramus, Susan J, Sieh, Weiva, Whittermore, Alice S, Monteiro, Alvaro NA, Phelan, Catherine M, Terry, Mary Beth, Piedmonte, Marion, Offit, Kenneth, Robson, Mark, and Levine, Douglas

Subjects
EMBRACE, kConFab Investigators, Australia Ovarian Cancer Study Group, HEBON, GEMO Study Collaborators, OCGN, PRostate cancer AssoCiation group To Investigate Cancer Associated aLterations in the genome, Humans, Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Neoplasm Invasiveness, Genetic Predisposition to Disease, Lysine, BRCA2 Protein, Codon, Terminator, Logistic Models, Odds Ratio, Risk Assessment, Risk Factors, Heterozygote, Polymorphism, Single Nucleotide, Adult, Aged, Middle Aged, Female, Male, Clinical Research, Prevention, Cancer, Prostate Cancer, Aging, Urologic Diseases, Breast Cancer, Ovarian Cancer, Rare Diseases, Aetiology, 2.1 Biological and endogenous factors, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

The K3326X variant in BRCA2 (BRCA2*c.9976A>T; p.Lys3326*; rs11571833) has been found to be associated with small increased risks of breast cancer. However, it is not clear to what extent linkage disequilibrium with fully pathogenic mutations might account for this association. There is scant information about the effect of K3326X in other hormone-related cancers. Using weighted logistic regression, we analyzed data from the large iCOGS study including 76 637 cancer case patients and 83 796 control patients to estimate odds ratios (ORw) and 95% confidence intervals (CIs) for K3326X variant carriers in relation to breast, ovarian, and prostate cancer risks, with weights defined as probability of not having a pathogenic BRCA2 variant. Using Cox proportional hazards modeling, we also examined the associations of K3326X with breast and ovarian cancer risks among 7183 BRCA1 variant carriers. All statistical tests were two-sided. The K3326X variant was associated with breast (ORw = 1.28, 95% CI = 1.17 to 1.40, P = 5.9x10(-) (6)) and invasive ovarian cancer (ORw = 1.26, 95% CI = 1.10 to 1.43, P = 3.8x10(-3)). These associations were stronger for serous ovarian cancer and for estrogen receptor-negative breast cancer (ORw = 1.46, 95% CI = 1.2 to 1.70, P = 3.4x10(-5) and ORw = 1.50, 95% CI = 1.28 to 1.76, P = 4.1x10(-5), respectively). For BRCA1 mutation carriers, there was a statistically significant inverse association of the K3326X variant with risk of ovarian cancer (HR = 0.43, 95% CI = 0.22 to 0.84, P = .013) but no association with breast cancer. No association with prostate cancer was observed. Our study provides evidence that the K3326X variant is associated with risk of developing breast and ovarian cancers independent of other pathogenic variants in BRCA2. Further studies are needed to determine the biological mechanism of action responsible for these associations.

Published
2016

37. Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer

Author

Moore, Kathleen N., primary, Angelergues, Antoine, additional, Konecny, Gottfried E., additional, García, Yolanda, additional, Banerjee, Susana, additional, Lorusso, Domenica, additional, Lee, Jung-Yun, additional, Moroney, John W., additional, Colombo, Nicoletta, additional, Roszak, Andrzej, additional, Tromp, Jacqueline, additional, Myers, Tashanna, additional, Lee, Jeong-Won, additional, Beiner, Mario, additional, Cosgrove, Casey M., additional, Cibula, David, additional, Martin, Lainie P., additional, Sabatier, Renaud, additional, Buscema, Joseph, additional, Estévez-García, Purificación, additional, Coffman, Lan, additional, Nicum, Shibani, additional, Duska, Linda R., additional, Pignata, Sandro, additional, Gálvez, Fernando, additional, Wang, Yuemei, additional, Method, Michael, additional, Berkenblit, Anna, additional, Bello Roufai, Diana, additional, and Van Gorp, Toon, additional

Published
2023
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38. Supplementary Appendix 1 from Safety, Efficacy, and Biomarker Analyses of Dostarlimab in Patients with Endometrial Cancer: Interim Results of the Phase I GARNET Study

Author

Oaknin, Ana, primary, Pothuri, Bhavana, primary, Gilbert, Lucy, primary, Sabatier, Renaud, primary, Brown, Jubilee, primary, Ghamande, Sharad, primary, Mathews, Cara, primary, O'Malley, David M., primary, Kristeleit, Rebecca, primary, Boni, Valentina, primary, Gravina, Adriano, primary, Banerjee, Susana, primary, Miller, Rowan, primary, Pikiel, Joanna, primary, Mirza, Mansoor R., primary, Dewal, Ninad, primary, Antony, Grace, primary, Dong, Yuping, primary, Zografos, Eleftherios, primary, Veneris, Jennifer, primary, and Tinker, Anna V., primary

Published
2023
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39. Olaparib plus Durvalumab, with or without Bevacizumab, as Treatment in PARP Inhibitor-Naïve Platinum-Sensitive Relapsed Ovarian Cancer: A Phase II Multi-Cohort Study

Author

Drew, Yvette, primary, Kim, Jae-Weon, additional, Penson, Richard T., additional, O'Malley, David M., additional, Parkinson, Christine, additional, Roxburgh, Patricia, additional, Plummer, Ruth, additional, Im, Seock-Ah, additional, Imbimbo, Martina, additional, Ferguson, Michelle, additional, Rosengarten, Ora, additional, Steeghs, Neeltje, additional, Kim, Min Hwan, additional, Gal-Yam, Einav, additional, Tsoref, Daliah, additional, Kim, Jae-Hoon, additional, You, Benoit, additional, de Jonge, Maja, additional, Lalisang, Roy, additional, Gort, Eelke, additional, Bastian, Sara, additional, Meyer, Kassondra, additional, Feeney, Laura, additional, Baker, Nigel, additional, Ah-See, Mei-Lin, additional, Domchek, Susan M., additional, and Banerjee, Susana, additional

Published
2023
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40. Antitumor Activity and Safety of Dostarlimab Monotherapy in Patients With Mismatch Repair Deficient Solid Tumors

Author

André, Thierry, primary, Berton, Dominique, additional, Curigliano, Giuseppe, additional, Sabatier, Renaud, additional, Tinker, Anna V., additional, Oaknin, Ana, additional, Ellard, Susan, additional, de Braud, Filippo, additional, Arkenau, Hendrik-Tobias, additional, Trigo, José, additional, Gravina, Adriano, additional, Kristeleit, Rebecca, additional, Moreno, Victor, additional, Abdeddaim, Cyril, additional, Vano, Yann-Alexandre, additional, Samouëlian, Vanessa, additional, Miller, Rowan, additional, Boni, Valentina, additional, Torres, Antonio Antón, additional, Gilbert, Lucy, additional, Brown, Jubilee, additional, Dewal, Ninad, additional, Dabrowski, Christine, additional, Antony, Grace, additional, Zografos, Eleftherios, additional, Veneris, Jennifer, additional, and Banerjee, Susana, additional

Published
2023
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41. PO007LBA/#1550 Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing solid tumors: results from the cervical, endometrial, and ovarian cancer cohorts of the destiny-PanTumor02 study

Author

Lee, Jung-Yun, primary, Makker, Vicky, additional, Manso, Luis, additional, González-Martín, Antonio, additional, Ługowska, Iwona, additional, Lorusso, Domenica, additional, Banerjee, Susana, additional, Liao, John, additional, Lu, Chien-Hsing, additional, Prasongsook, Naiyarat, additional, Melichar, Bohuslav, additional, Chen, Kai, additional, Mcewen, Robert, additional, Michelini, Flavia, additional, Puvvada, Soham, additional, Meric-Bernstam, Funda, additional, and Oaknin, Ana, additional

Published
2023
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42. PO004LBA/#1515 Efficacy and safety of avutometinib + defactinib in recurrent low-grade serous ovarian cancer following prior systemic therapy

Author

Grisham, Rachel, primary, Aghajanian, Carol, additional, Nieuwenhuysen, Els Van, additional, Rodrigues, Manuel, additional, Ring, Kari, additional, Santin, Alessandro, additional, Colombo, Nicoletta, additional, Prendergast, Emily, additional, Thaker, Premal, additional, Moore, Kathleen, additional, Salinas, Erin, additional, Ray-Coquard, Isabelle, additional, Chon, Hye Sook, additional, Rose, Peter, additional, Oaknin, Ana, additional, Clamp, Andrew, additional, Gandhi, Mitul, additional, Monk, Bradley, additional, Holloway, Robert, additional, Gorp, Toon Van, additional, Fabbro, Michel, additional, Gennigens, Christine, additional, Wojtynek, Nicholas, additional, Lustgarten, Stephanie, additional, and Banerjee, Susana, additional

Published
2023
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44. The peritoneal cancer index as a predictor of complete cytoreduction at primary and interval cytoreductive surgery in advanced ovarian cancer

Author

Fagan, Paula J, primary, Gomes, Nana, additional, Heath, Owen M, additional, Chandrasekaran, Dhivya, additional, Yao, Shih-Ern, additional, Satchwell, Laura, additional, George, Angela, additional, Banerjee, Susana, additional, Sohaib, Aslam, additional, Barton, Desmond P, additional, Nobbenhuis, Marielle, additional, Ind, Thomas, additional, and Butler, John, additional

Published
2023
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45. Supplementary Data 1 from Molecular Results and Potential Biomarkers Identified from the Phase 3 MILO/ENGOT-ov11 Study of Binimetinib versus Physician Choice of Chemotherapy in Recurrent Low-Grade Serous Ovarian Cancer

Author

Grisham, Rachel N., primary, Vergote, Ignace, primary, Banerjee, Susana, primary, Drill, Esther, primary, Kalbacher, Elsa, primary, Mirza, Mansoor Raza, primary, Romero, Ignacio, primary, Vuylsteke, Peter, primary, Coleman, Robert L., primary, Hilpert, Felix, primary, Oza, Amit M., primary, Westermann, Anneke, primary, Oehler, Martin K., primary, Pignata, Sandro, primary, Aghajanian, Carol, primary, Colombo, Nicoletta, primary, Cibula, David, primary, Moore, Kathleen N., primary, del Campo, Josep M., primary, Berger, Regina, primary, Marth, Christian, primary, Sehouli, Jalid, primary, O'Malley, David M., primary, Churruca, Cristina, primary, Kristensen, Gunnar, primary, Clamp, Andrew, primary, Farley, John, primary, Iyer, Gopa, primary, Ray-Coquard, Isabelle, primary, and Monk, Bradley J., primary

Published
2023
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46. Data from Molecular Results and Potential Biomarkers Identified from the Phase 3 MILO/ENGOT-ov11 Study of Binimetinib versus Physician Choice of Chemotherapy in Recurrent Low-Grade Serous Ovarian Cancer

Author

Grisham, Rachel N., primary, Vergote, Ignace, primary, Banerjee, Susana, primary, Drill, Esther, primary, Kalbacher, Elsa, primary, Mirza, Mansoor Raza, primary, Romero, Ignacio, primary, Vuylsteke, Peter, primary, Coleman, Robert L., primary, Hilpert, Felix, primary, Oza, Amit M., primary, Westermann, Anneke, primary, Oehler, Martin K., primary, Pignata, Sandro, primary, Aghajanian, Carol, primary, Colombo, Nicoletta, primary, Cibula, David, primary, Moore, Kathleen N., primary, del Campo, Josep M., primary, Berger, Regina, primary, Marth, Christian, primary, Sehouli, Jalid, primary, O'Malley, David M., primary, Churruca, Cristina, primary, Kristensen, Gunnar, primary, Clamp, Andrew, primary, Farley, John, primary, Iyer, Gopa, primary, Ray-Coquard, Isabelle, primary, and Monk, Bradley J., primary

Published
2023
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50. Efficacy and safety of niraparib as maintenance treatment in older patients (≥ 70 years) with recurrent ovarian cancer: Results from the ENGOT-OV16/NOVA trial

Author

Fabbro, Michel, Moore, Kathleen N., Dørum, Anne, Tinker, Anna V., Mahner, Sven, Bover, Isabel, Banerjee, Susana, Tognon, Germana, Goffin, Frederic, Shapira-Frommer, Ronnie, Wenham, Robert M., Hellman, Kristina, Provencher, Diane, Harter, Philipp, Vázquez, Isabel Palacio, Follana, Philippe, Pineda, Mario J., Mirza, Mansoor R., Hazard, Sebastien J., and Matulonis, Ursula A.

Published
2019
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