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2. Patient-Reported Outcomes in OlympiA: A Phase III, Randomized, Placebo-Controlled Trial of Adjuvant Olaparib in gBRCA1/2 Mutations and High-Risk Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer.

Author

Ganz, Patricia, Bandos, Hanna, Španić, Tanja, Friedman, Sue, Müller, Volkmar, Kuemmel, Sherko, Delaloge, Suzette, Brain, Etienne, Toi, Masakazu, Yamauchi, Hideko, de Dueñas, Eduardo-M, Armstrong, Anne, Im, Seock-Ah, Song, Chuan-Gui, Zheng, Hong, Sarosiek, Tomasz, Sharma, Priyanka, Geng, Cuizhi, Fu, Peifen, Rhiem, Kerstin, Frauchiger-Heuer, Heike, Wimberger, Pauline, tKint de Roodenbeke, Daphné, Liao, Ning, Goodwin, Annabel, Chakiba-Brugère, Camille, Friedlander, Michael, Lee, Keun, Giacchetti, Sylvie, Takano, Toshimi, Henao-Carrasco, Fernando, Virani, Shamsuddin, Valdes-Albini, Frances, Domchek, Susan, Bane, Charles, McCarron, Edward, Mita, Monica, Rossi, Giovanna, Rastogi, Priya, Fielding, Anitra, Gelber, Richard, Scheepers, Elsemieke, Cameron, David, Garber, Judy, Geyer, Charles, and Tutt, Andrew

Subjects
Female, Humans, BRCA1 Protein, BRCA2 Protein, Breast Neoplasms, Fatigue, Mutation, Nausea, Patient Reported Outcome Measures, Phthalazines, Piperazines, Quality of Life, Receptor, ErbB-2, Vomiting
Abstract

PURPOSE: The OlympiA randomized phase III trial compared 1 year of olaparib (OL) or placebo (PL) as adjuvant therapy in patients with germline BRCA1/2, high-risk human epidermal growth factor receptor 2-negative early breast cancer after completing (neo)adjuvant chemotherapy ([N]ACT), surgery, and radiotherapy. The patient-reported outcome primary hypothesis was that OL-treated patients may experience greater fatigue during treatment. METHODS: Data were collected before random assignment, and at 6, 12, 18, and 24 months. The primary end point was fatigue, measured with the Functional Assessment of Chronic Illness Therapy-Fatigue scale. Secondary end points, assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 item, included nausea and vomiting (NV), diarrhea, and multiple functional domains. Scores were compared between treatment groups using mixed model for repeated measures. Two-sided P values

Published
2024

3. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer

Author

Tutt, Andrew NJ, Garber, Judy E, Kaufman, Bella, Viale, Giuseppe, Fumagalli, Debora, Rastogi, Priya, Gelber, Richard D, de Azambuja, Evandro, Fielding, Anitra, Balmaña, Judith, Domchek, Susan M, Gelmon, Karen A, Hollingsworth, Simon J, Korde, Larissa A, Linderholm, Barbro, Bandos, Hanna, Senkus, Elżbieta, Suga, Jennifer M, Shao, Zhimin, Pippas, Andrew W, Nowecki, Zbigniew, Huzarski, Tomasz, Ganz, Patricia A, Lucas, Peter C, Baker, Nigel, Loibl, Sibylle, McConnell, Robin, Piccart, Martine, Schmutzler, Rita, Steger, Guenther G, Costantino, Joseph P, Arahmani, Amal, Wolmark, Norman, McFadden, Eleanor, Karantza, Vassiliki, Lakhani, Sunil R, Yothers, Greg, Campbell, Christine, and Geyer, Charles E

Subjects
Digestive Diseases, Breast Cancer, Cancer, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adult, Antineoplastic Agents, Breast Neoplasms, Chemotherapy, Adjuvant, Disease-Free Survival, Double-Blind Method, Female, Genes, BRCA1, Genes, BRCA2, Germ-Line Mutation, Humans, Mastectomy, Middle Aged, Phthalazines, Piperazines, Poly(ADP-ribose) Polymerase Inhibitors, Receptor, ErbB-2, OlympiA Clinical Trial Steering Committee and Investigators, Receptor, erbB-2, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundPoly(adenosine diphosphate-ribose) polymerase inhibitors target cancers with defects in homologous recombination repair by synthetic lethality. New therapies are needed to reduce recurrence in patients with BRCA1 or BRCA2 germline mutation-associated early breast cancer.MethodsWe conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors who had received local treatment and neoadjuvant or adjuvant chemotherapy. Patients were randomly assigned (in a 1:1 ratio) to 1 year of oral olaparib or placebo. The primary end point was invasive disease-free survival.ResultsA total of 1836 patients underwent randomization. At a prespecified event-driven interim analysis with a median follow-up of 2.5 years, the 3-year invasive disease-free survival was 85.9% in the olaparib group and 77.1% in the placebo group (difference, 8.8 percentage points; 95% confidence interval [CI], 4.5 to 13.0; hazard ratio for invasive disease or death, 0.58; 99.5% CI, 0.41 to 0.82; P

Published
2021

5. Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-PanTumor02 Phase II Trial.

Author

Meric-Bernstam, Funda, Makker, Vicky, Oaknin, Ana, Oh, Do-Youn, Banerjee, Susana, González-Martín, Antonio, Jung, Kyung Hae, Ługowska, Iwona, Manso, Luis, Manzano, Aránzazu, Melichar, Bohuslav, Siena, Salvatore, Stroyakovskiy, Daniil, Fielding, Anitra, Ma, Yan, Puvvada, Soham, Shire, Norah, and Lee, Jung-Yun

Published
2024
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7. Olaparib efficacy in patients with germline BRCA ‐mutated, HER2 ‐negative metastatic breast cancer: Subgroup analyses from the phase III OlympiAD trial

Author

Senkus, Elżbieta, primary, Delaloge, Suzette, additional, Domchek, Susan M., additional, Conte, Pierfranco, additional, Im, Seock‐Ah, additional, Xu, Binghe, additional, Armstrong, Anne, additional, Masuda, Norikazu, additional, Fielding, Anitra, additional, Robson, Mark, additional, and Tung, Nadine, additional

Published
2023
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8. Supplementary Table S1 from Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Laboratory Reference Ranges and Testing Intervals Work Group

Author

Spira, Alexander I., primary, Stewart, Mark D., primary, Jones, Suzanne, primary, Chang, Elaine, primary, Fielding, Anitra, primary, Richie, Nicole, primary, Wood, Laura S., primary, Thompson, Michael A., primary, Jones, Lee, primary, Nair, Abhilasha, primary, Mahal, Brandon A., primary, and Gerber, David E., primary

Published
2023
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9. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial

Author

Ledermann, Jonathan A, Harter, Philipp, Gourley, Charlie, Friedlander, Michael, Vergote, Ignace, Rustin, Gordon, Scott, Clare, Meier, Werner, Shapira-Frommer, Ronnie, Safra, Tamar, Matei, Daniela, Fielding, Anitra, Spencer, Stuart, Rowe, Philip, Lowe, Elizabeth, Hodgson, Darren, Sovak, Mika A, and Matulonis, Ursula

Published
2016
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10. Effect of Itraconazole and Rifampin on the Pharmacokinetics of Olaparib in Patients With Advanced Solid Tumors: Results of Two Phase I Open-label Studies

Author

Dirix, Luc, Swaisland, Helen, Verheul, Henk M.W., Rottey, Sylvie, Leunen, Karin, Jerusalem, Guy, Rolfo, Christian, Nielsen, Dorte, Molife, L. Rhoda, Kristeleit, Rebecca, Vos-Geelen, Judith de, Mau-Sørensen, Morten, Soetekouw, Patricia, van Herpen, Carla, Fielding, Anitra, So, Karen, Bannister, Wendy, and Plummer, Ruth

Published
2016
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11. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial

Author

Ledermann, Jonathan, Harter, Philipp, Gourley, Charlie, Friedlander, Michael, Vergote, Ignace, Rustin, Gordon, Scott, Clare L, Meier, Werner, Shapira-Frommer, Ronnie, Safra, Tamar, Matei, Daniela, Fielding, Anitra, Spencer, Stuart, Dougherty, Brian, Orr, Maria, Hodgson, Darren, Barrett, J Carl, and Matulonis, Ursula

Published
2014
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15. OlympiA: A phase III, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients with germline BRCA1/2 mutations and high-risk HER2-negative early breast cancer.

Author

Tutt, Andrew, primary, Garber, Judy Ellen, additional, Kaufman, Bella, additional, Viale, Giuseppe, additional, Fumagalli, Debora, additional, Rastogi, Priya, additional, Gelber, Richard D., additional, de Azambuja, Evandro, additional, Fielding, Anitra, additional, Balmana Gelpi, Judith, additional, Gelmon, Karen A., additional, Baker, Nigel, additional, Arahmani, Amal, additional, Senkus-Konefka, Elzbieta, additional, Mc Fadden, Eleanor, additional, Karantza, Vassiliki, additional, Lakhani, Sunil R., additional, Yothers, Greg, additional, Campbell, Christine, additional, and Geyer, Charles E., additional

Published
2021
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16. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer

Author

Tutt, Andrew N J, Garber, Judy E, Kaufman, Bella, Viale, Giuseppe, Fumagalli, Debora, Rastogi, Priya, Gelber, Richard D, de Azambuja, Evandro, Fielding, Anitra, Balmaña, Judith, Domchek, Susan M, Gelmon, Karen A, Hollingsworth, Simon J, Korde, Larissa A, Linderholm, Barbro, Bandos, Hanna, Senkus, Elżbieta, Suga, Jennifer M, Shao, Zhimin, Pippas, Andrew W, Nowecki, Zbigniew, Huzarski, Tomasz, Ganz, Patricia A, Lucas, Peter C, Baker, Nigel, Loibl, Sibylle, McConnell, Robin, Piccart, Martine, Schmutzler, Rita, Steger, Guenther G, Costantino, Joseph P, Arahmani, Amal, Wolmark, Norman, McFadden, Eleanor, Karantza, Vassiliki, Lakhani, Sunil R, Yothers, Greg, Campbell, Christine, and Geyer, Charles E

Subjects
610 Medicine & health
Abstract

BACKGROUND Poly(adenosine diphosphate-ribose) polymerase inhibitors target cancers with defects in homologous recombination repair by synthetic lethality. New therapies are needed to reduce recurrence in patients with BRCA1 or BRCA2 germline mutation-associated early breast cancer. METHODS We conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors who had received local treatment and neoadjuvant or adjuvant chemotherapy. Patients were randomly assigned (in a 1:1 ratio) to 1 year of oral olaparib or placebo. The primary end point was invasive disease-free survival. RESULTS A total of 1836 patients underwent randomization. At a prespecified event-driven interim analysis with a median follow-up of 2.5 years, the 3-year invasive disease-free survival was 85.9% in the olaparib group and 77.1% in the placebo group (difference, 8.8 percentage points; 95% confidence interval [CI], 4.5 to 13.0; hazard ratio for invasive disease or death, 0.58; 99.5% CI, 0.41 to 0.82; P

Published
2021
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17. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer

Author

Tutt, Andrew N. J., Garber, Judy E., Kaufman, Bella, Viale, Giuseppe, Fumagalli, Debora, Rastogi, Priya, Gelber, Richard D., de Azambuja, Evandro, Fielding, Anitra, Balmana, Judith, Domchek, Susan M., Gelmon, Karen A., Hollingsworth, Simon J., Korde, Larissa A., Linderholm, Barbro, Bandos, Hanna, Senkus, E., Suga, Jennifer M., Shao, Z., Pippas, Andrew W., Nowecki, Zbigniew, Huzarski, Tomasz, Ganz, Patricia A., Lucas, Peter C., Baker, Nigel, Loibl, Sibylle, McConnell, Robin, Piccart, Martine, Schmutzler, Rita, Steger, Guenther G., Costantino, Joseph P., Arahmani, Amal, Wolmark, Norman, McFadden, Eleanor, Karantza, Vassiliki, Lakhani, Sunil R., Yothers, Greg, Campbell, Christine, Geyer, Charles E., Tutt, Andrew N. J., Garber, Judy E., Kaufman, Bella, Viale, Giuseppe, Fumagalli, Debora, Rastogi, Priya, Gelber, Richard D., de Azambuja, Evandro, Fielding, Anitra, Balmana, Judith, Domchek, Susan M., Gelmon, Karen A., Hollingsworth, Simon J., Korde, Larissa A., Linderholm, Barbro, Bandos, Hanna, Senkus, E., Suga, Jennifer M., Shao, Z., Pippas, Andrew W., Nowecki, Zbigniew, Huzarski, Tomasz, Ganz, Patricia A., Lucas, Peter C., Baker, Nigel, Loibl, Sibylle, McConnell, Robin, Piccart, Martine, Schmutzler, Rita, Steger, Guenther G., Costantino, Joseph P., Arahmani, Amal, Wolmark, Norman, McFadden, Eleanor, Karantza, Vassiliki, Lakhani, Sunil R., Yothers, Greg, Campbell, Christine, and Geyer, Charles E.

Abstract

BACKGROUND Poly(adenosine diphosphate-ribose) polymerase inhibitors target cancers with defects in homologous recombination repair by synthetic lethality. New therapies are needed to reduce recurrence in patients with BRCA1 or BRCA2 germline mutation-associated early breast cancer. METHODS We conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors who had received local treatment and neoadjuvant or adjuvant chemotherapy. Patients were randomly assigned (in a 1:1 ratio) to 1 year of oral olaparib or placebo. The primary end point was invasive disease-free survival. RESULTS A total of 1836 patients underwent randomization. At a prespecified event-driven interim analysis with a median follow-up of 2.5 years, the 3-year invasive disease-free survival was 85.9% in the olaparib group and 77.1% in the placebo group (difference, 8.8 percentage points; 95% confidence interval [CI], 4.5 to 13.0; hazard ratio for invasive disease or death, 0.58; 99.5% CI, 0.41 to 0.82; P<0.001). The 3-year distant disease-free survival was 87.5% in the olaparib group and 80.4% in the placebo group (difference, 7.1 percentage points; 95% CI, 3.0 to 11.1; hazard ratio for distant disease or death, 0.57; 99.5% CI, 0.39 to 0.83; P<0.001). Olaparib was associated with fewer deaths than placebo (59 and 86, respectively) (hazard ratio, 0.68; 99% CI, 0.44 to 1.05; P=0.02); however, the between-group difference was not significant at an interim-analysis boundary of a P value of less than 0.01. Safety data were consistent with known side effects of olaparib, with no excess serious adverse events or adverse events of special interest. CONCLUSIONS Among patients with high-risk, HER2-negative early breast cancer and germline BRCA1 or BRCA2 pathogenic or likely pathogenic variants, adjuvant olaparib af

Published
2021

18. Adjuvant olaparib for patients with BRCA1- Or BRCA2-mutated breast cancer

Author

Tutt, Andrew M, Garber, Judy Ellen, Kaufman, Bella, Viale, Giuseppe, Fumagalli, Debora, Rastogi, Priya, Gelber, Richard, de Azambuja, Evandro, Fielding, Anitra, Balmaña, Judith, Domchek, Susan S.M., Gelmon, Karen K.A., Hollingsworth, Simon S.J., Korde, Larissa, Linderholm, Barbro B.K., Bandos, Hanna, Senkus, Elżbieta, Suga, Jennifer Marie, Shao, Zhimin, Pippas, Andrew A.W., Nowecki, Zbigniew, Huzarski, Tomasz, Ganz, Patricia A, Lucas, Peter P.C., Baker, Nigel, Loibl, Sibylle, McConnell, Robin, Piccart-Gebhart, Martine, Schmutzler, Rita, Steger, Günther G.G., Costantino, Joseph P, Arahmani, Amal, Wolmark, Norman, McFadden, Eleanor, Karantza, Vassiliki, Lakhani, Sunil S.R., Yothers, Greg, Campbell, Christine, Geyer Jr. Charles C.E., Tutt, Andrew M, Garber, Judy Ellen, Kaufman, Bella, Viale, Giuseppe, Fumagalli, Debora, Rastogi, Priya, Gelber, Richard, de Azambuja, Evandro, Fielding, Anitra, Balmaña, Judith, Domchek, Susan S.M., Gelmon, Karen K.A., Hollingsworth, Simon S.J., Korde, Larissa, Linderholm, Barbro B.K., Bandos, Hanna, Senkus, Elżbieta, Suga, Jennifer Marie, Shao, Zhimin, Pippas, Andrew A.W., Nowecki, Zbigniew, Huzarski, Tomasz, Ganz, Patricia A, Lucas, Peter P.C., Baker, Nigel, Loibl, Sibylle, McConnell, Robin, Piccart-Gebhart, Martine, Schmutzler, Rita, Steger, Günther G.G., Costantino, Joseph P, Arahmani, Amal, Wolmark, Norman, McFadden, Eleanor, Karantza, Vassiliki, Lakhani, Sunil S.R., Yothers, Greg, Campbell, Christine, and Geyer Jr. Charles C.E.

Abstract

BACKGROUND Poly(adenosine diphosphate–ribose) polymerase inhibitors target cancers with defects in homologous recombination repair by synthetic lethality. New therapies are needed to reduce recurrence in patients with BRCA1 or BRCA2 germline mutation–associated early breast cancer. METHODS We conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth factor receptor 2 (HER2)–negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors who had received local treatment and neoadjuvant or adjuvant chemotherapy. Patients were randomly assigned (in a 1:1 ratio) to 1 year of oral olaparib or placebo. The primary end point was invasive disease–free survival. RESULTS A total of 1836 patients underwent randomization. At a prespecified event-driven interim analysis with a median follow-up of 2.5 years, the 3-year invasive disease–free survival was 85.9% in the olaparib group and 77.1% in the placebo group (difference, 8.8 percentage points; 95% confidence interval [CI], 4.5 to 13.0; hazard ratio for invasive disease or death, 0.58; 99.5% CI, 0.41 to 0.82; P<0.001). The 3-year distant disease–free survival was 87.5% in the olaparib group and 80.4% in the placebo group (difference, 7.1 percentage points; 95% CI, 3.0 to 11.1; hazard ratio for distant disease or death, 0.57; 99.5% CI, 0.39 to 0.83; P<0.001). Olaparib was associated with fewer deaths than placebo (59 and 86, respectively) (hazard ratio, 0.68; 99% CI, 0.44 to 1.05; P=0.02); however, the between-group difference was not significant at an interim-analysis boundary of a P value of less than 0.01. Safety data were consistent with known side effects of olaparib, with no excess serious adverse events or adverse events of special interest. CONCLUSIONS Among patients with high-risk, HER2-negative early breast cancer and germline BRCA1 or BRCA2 pathogenic or likely pathogenic variants, adjuvant olaparib af, SCOPUS: ar.j, DecretOANoAutActif, info:eu-repo/semantics/published

Published
2021

19. Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Laboratory Reference Ranges and Testing Intervals Work Group

Author

Spira, Alexander I., primary, Stewart, Mark D., additional, Jones, Suzanne, additional, Chang, Elaine, additional, Fielding, Anitra, additional, Richie, Nicole, additional, Wood, Laura S., additional, Thompson, Michael A., additional, Jones, Lee, additional, Nair, Abhilasha, additional, Mahal, Brandon A., additional, and Gerber, David E., additional

Published
2021
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20. Pharmacokinetics and Safety of Olaparib in Patients with Advanced Solid Tumours and Renal Impairment

Author

Rolfo, Christian, de Vos-Geelen, Judith, Isambert, Nicolas, Molife, L Rhoda, Schellens, Jan H M, De Grève, Jacques, Dirix, Luc, Grundtvig-Sørensen, Peter, Jerusalem, Guy, Leunen, Karin, Mau-Sørensen, Morten, Plummer, Ruth, Learoyd, Maria, Bannister, Wendy, Fielding, Anitra, Ravaud, Alain, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Clinical sciences, Medical Genetics, Laboratory for Medical and Molecular Oncology, Interne Geneeskunde, MUMC+: MA Medische Oncologie (9), and RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy

Subjects
Adult, Male, medicine.medical_specialty, PHARMACOKINETICS, No-observed-adverse-effect level, Metabolic Clearance Rate, Urology, Renal function, Administration, Oral, Poly(ADP-ribose) Polymerase Inhibitors, Kidney, olaparib, Piperazines, Olaparib, 03 medical and health sciences, chemistry.chemical_compound, polymerase inhibitor, 0302 clinical medicine, Pharmacokinetics, Neoplasms, Medicine, Advanced Solid Tumours, Humans, Pharmacology (medical), 030212 general & internal medicine, Dosing, Renal Insufficiency, Renal impairment, Aged, Pharmacology, Medicine(all), No-Observed-Adverse-Effect Level, business.industry, Area under the curve, INHIBITOR, Middle Aged, CANCER, Confidence interval, chemistry, Tolerability, 030220 oncology & carcinogenesis, Phthalazines, Female, Safety, business
Abstract

BACKGROUND: Olaparib, a potent oral poly(ADP-ribose) polymerase inhibitor, is partially renally cleared. We investigated the pharmacokinetics and safety of olaparib in patients with mild or moderate renal impairment to provide dosing recommendations. METHODS: This phase I open-label study assessed the pharmacokinetics, safety and tolerability of single-dose, oral 300-mg olaparib tablets in adults (aged 18-75 years) with solid tumours. Patients had normal renal function, or mild or moderate renal impairment (estimated creatinine clearance ≥ 81, 51-80 or 31-50 mL/min, respectively). Blood was collected for 96 h, and urine samples collected for 24 h post-dose. Patients could continue taking olaparib 300 mg twice daily for a long-term safety assessment. RESULTS: Overall, 44 patients received one or more doses of olaparib and 38 were included in the pharmacokinetic assessment. Patients with mild renal impairment had an area under the curve geometric least-squares mean ratio of 1.24 (90% confidence interval 1.06-1.47) and a geometric least-squares mean maximum plasma concentration ratio of 1.15 (90% confidence interval 1.04-1.27) vs. those with normal renal function. In patients with moderate renal impairment, the geometric least-squares mean ratio for the area under the curve was 1.44 (90% confidence interval 1.10-1.89) and for the maximum plasma concentration was 1.26 (90% confidence interval 1.06-1.48) vs. those with normal renal function. No new safety signals were detected in patients with mild or moderate renal impairment. CONCLUSIONS: In patients with mild renal impairment, the small increase in exposure to olaparib was not considered clinically relevant. In patients with moderate renal impairment, exposure to olaparib increased by 44%; thus, these patients should be carefully monitored and the tablet dose should be adjusted to 200 mg twice daily. CLINICAL TRIALS REGISTRATION: NCT01894256.

Published
2019

21. Pharmacokinetics and Safety of Olaparib in Patients with Advanced Solid Tumours and Renal Impairment

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Rolfo, Christian, de Vos-Geelen, Judith, Isambert, Nicolas, Molife, L Rhoda, Schellens, Jan H M, De Grève, Jacques, Dirix, Luc, Grundtvig-Sørensen, Peter, Jerusalem, Guy, Leunen, Karin, Mau-Sørensen, Morten, Plummer, Ruth, Learoyd, Maria, Bannister, Wendy, Fielding, Anitra, Ravaud, Alain, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Rolfo, Christian, de Vos-Geelen, Judith, Isambert, Nicolas, Molife, L Rhoda, Schellens, Jan H M, De Grève, Jacques, Dirix, Luc, Grundtvig-Sørensen, Peter, Jerusalem, Guy, Leunen, Karin, Mau-Sørensen, Morten, Plummer, Ruth, Learoyd, Maria, Bannister, Wendy, Fielding, Anitra, and Ravaud, Alain

Published
2019

24. Long-term efficacy, tolerability and overall survival in patients with platinum-sensitive, recurrent high-grade serous ovarian cancer treated with maintenance olaparib capsules following response to chemotherapy

Author

Friedlander, Michael, primary, Matulonis, Ursula, additional, Gourley, Charlie, additional, du Bois, Andreas, additional, Vergote, Ignace, additional, Rustin, Gordon, additional, Scott, Clare, additional, Meier, Werner, additional, Shapira-Frommer, Ronnie, additional, Safra, Tamar, additional, Matei, Daniela, additional, Shirinkin, Vadim, additional, Selle, Frédéric, additional, Fielding, Anitra, additional, Lowe, Elizabeth S., additional, McMurtry, Emma L., additional, Spencer, Stuart, additional, Rowe, Philip, additional, Mann, Helen, additional, Parry, David, additional, and Ledermann, Jonathan, additional

Published
2018
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25. Clinically significant long-term maintenance treatment with olaparib in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC).

Author

Gourley, Charlie, primary, Friedlander, Michael, additional, Matulonis, Ursula A., additional, Shirinkin, Vadim, additional, Selle, Frédéric, additional, Scott, Clare L., additional, Safra, Tamar, additional, Fielding, Anitra, additional, Rowe, Philip, additional, and Ledermann, Jonathan A., additional

Published
2017
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26. Biological and clinical evidence for somatic mutations in BRCA1 and BRCA2 as predictive markers for olaparib response in high-grade serous ovarian cancers in the maintenance setting

Author

Dougherty, Brian A., primary, Lai, Zhongwu, additional, Hodgson, Darren R., additional, Orr, Maria C.M., additional, Hawryluk, Matthew, additional, Sun, James, additional, Yelensky, Roman, additional, Spencer, Stuart K., additional, Robertson, Jane D., additional, Ho, Tony W., additional, Fielding, Anitra, additional, Ledermann, Jonathan A., additional, and Barrett, J. Carl, additional

Published
2017
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27. Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer

Author

Ledermann, Jonathan A, primary, Harter, Philipp, additional, Gourley, Charlie, additional, Friedlander, Michael, additional, Vergote, Ignace, additional, Rustin, Gordon, additional, Scott, Clare, additional, Meier, Werner, additional, Shapira-Frommer, Ronnie, additional, Safra, Tamar, additional, Matei, Daniela, additional, Fielding, Anitra, additional, Bennett, Bryan, additional, Parry, David, additional, Spencer, Stuart, additional, Mann, Helen, additional, and Matulonis, Ursula, additional

Published
2016
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28. Overall survival (OS) in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC) receiving olaparib maintenance monotherapy: An interim analysis.

Author

Ledermann, Jonathan A., primary, Harter, Philipp, additional, Gourley, Charlie, additional, Friedlander, Michael, additional, Vergote, Ignace, additional, Rustin, Gordon J. S., additional, Scott, Clare L., additional, Meier, Werner, additional, Shapira-Frommer, Ronnie, additional, Safra, Tamar, additional, Matei, Daniela E., additional, Fielding, Anitra, additional, Spencer, Stuart, additional, Rowe, Philip, additional, Lowe, Elizabeth S., additional, and Matulonis, Ursula A., additional

Published
2016
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29. Olaparib maintenance therapy in patients with platinum‐sensitive, relapsed serous ovarian cancer and a BRCA mutation: Overall survival adjusted for postprogression poly(adenosine diphosphate ribose) polymerase inhibitor therapy

Author

Matulonis, Ursula A., primary, Harter, Philipp, additional, Gourley, Charlie, additional, Friedlander, Michael, additional, Vergote, Ignace, additional, Rustin, Gordon, additional, Scott, Clare, additional, Meier, Werner, additional, Shapira‐Frommer, Ronnie, additional, Safra, Tamar, additional, Matei, Daniela, additional, Fielding, Anitra, additional, Spencer, Stuart, additional, Parry, David, additional, Grinsted, Lynda, additional, and Ledermann, Jonathan A., additional

Published
2016
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30. Phase II Study of Olaparib (AZD-2281) After Standard Systemic Therapies for Disseminated Colorectal Cancer

Author

Leichman, Lawrence, primary, Groshen, Susan, additional, O’Neil, Bert H., additional, Messersmith, Wells, additional, Berlin, Jordan, additional, Chan, Emily, additional, Leichman, Cynthia G., additional, Cohen, Steven J., additional, Cohen, Deirdre, additional, Lenz, Heinz-Josef, additional, Gold, Philip, additional, Boman, Bruce, additional, Fielding, Anitra, additional, Locker, Gershon, additional, Cason, Ronald C., additional, Hamilton, Stan R., additional, and Hochster, Howard S., additional

Published
2016
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31. Olaparib Monotherapy in Patients With Advanced Cancer and a Germline BRCA1/2 Mutation

Author

Kaufman, Bella, Shapira-Frommer, Ronnie, Schmutzler, Rita K., Audeh, M. William, Friedlander, Michael, Balmana, Judith, Mitchell, Gillian, Fried, Georgeta, Stemmer, Salomon M., Hubert, Ayala, Rosengarten, Ora, Steiner, Mariana, Loman, Niklas, Bowen, Karin, Fielding, Anitra, Domchek, Susan M., Kaufman, Bella, Shapira-Frommer, Ronnie, Schmutzler, Rita K., Audeh, M. William, Friedlander, Michael, Balmana, Judith, Mitchell, Gillian, Fried, Georgeta, Stemmer, Salomon M., Hubert, Ayala, Rosengarten, Ora, Steiner, Mariana, Loman, Niklas, Bowen, Karin, Fielding, Anitra, and Domchek, Susan M.

Abstract

Purpose Olaparib is an oral poly (ADP-ribose) polymerase inhibitor with activity in germline BRCA1 and BRCA2 (BRCA1/2) -associated breast and ovarian cancers. We evaluated the efficacy and safety of olaparib in a spectrum of BRCA1/2-associated cancers. Patients and Methods This multicenter phase II study enrolled individuals with a germline BRCA1/2 mutation and recurrent cancer. Eligibility included ovarian cancer resistant to prior platinum; breast cancer with >= three chemotherapy regimens for metastatic disease; pancreatic cancer with prior gemcitabine treatment; or prostate cancer with progression on hormonal and one systemic therapy. Olaparib was administered at 400 mg twice per day. The primary efficacy end point was tumor response rate. Results A total of 298 patients received treatment and were evaluable. The tumor response rate was 26.2% (78 of 298; 95% CI, 21.3 to 31.6) overall and 31.1% (60 of 193; 95% CI, 24.6 to 38.1), 12.9% (eight of 62; 95% CI, 5.7 to 23.9), 21.7% (five of 23; 95% CI, 7.5 to 43.7), and 50.0% (four of eight; 95% CI, 15.7 to 84.3) in ovarian, breast, pancreatic, and prostate cancers, respectively. Stable disease >= 8 weeks was observed in 42% of patients (95% CI, 36.0 to 47.4), including 40% (95% CI, 33.4 to 47.7), 47% (95% CI, 34.0 to 59.9), 35% (95% CI, 16.4 to 57.3), and 25% (95% CI, 3.2 to 65.1) of those with ovarian, breast, pancreatic, or prostate cancer, respectively. The most common adverse events (AEs) were fatigue, nausea, and vomiting. Grade >= 3 AEs were reported for 54% of patients; anemia was the most common (17%). Conclusion Responses to olaparib were observed across different tumor types associated with germline BRCA1/2 mutations. Olaparib warrants further investigation in confirmatory studies. (C) 2014 by American Society of Clinical Oncology

Published
2015

32. Randomized, Double-Blind Phase II Trial With Prospective Classification by ATM Protein Level to Evaluate the Efficacy and Tolerability of Olaparib Plus Paclitaxel in Patients With Recurrent or Metastatic Gastric Cancer

Author

Bang, Yung-Jue, primary, Im, Seock-Ah, additional, Lee, Keun-Wook, additional, Cho, Jae Yong, additional, Song, Eun-Kee, additional, Lee, Kyung Hee, additional, Kim, Yeul Hong, additional, Park, Joon Oh, additional, Chun, Hoo Geun, additional, Zang, Dae Young, additional, Fielding, Anitra, additional, Rowbottom, Jacqui, additional, Hodgson, Darren, additional, O'Connor, Mark J., additional, Yin, Xiaolu, additional, and Kim, Woo Ho, additional

Published
2015
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33. Effect of itraconazole and rifampin on the pharmacokinetics of olaparib tablet formulation in patients with advanced solid tumours: Phase I open-label studies.

Author

Plummer, Elizabeth R., primary, Verheul, Henk M.W., additional, Rottey, Sylvie, additional, Leunen, Karin, additional, Jerusalem, Guy Heinrich Maria, additional, Rolfo, Christian D., additional, Nielsen, Dorte L., additional, Molife, L Rhoda, additional, Kristeleit, Rebecca, additional, Vos-Geelen, Judith de, additional, Mau-Sørensen, Morten, additional, Soetekouw, Patricia M.M.B., additional, van Herpen, Carla, additional, Swaisland, Helen, additional, Fielding, Anitra, additional, So, Karen, additional, Bannister, Wendy, additional, and Dirix, Luc, additional

Published
2015
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34. Frequency, severity and timing of common adverse events (AEs) with maintenance olaparib in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC).

Author

Matulonis, Ursula, primary, Friedlander, Michael, additional, Du Bois, Andreas, additional, Gourley, Charlie, additional, Vergote, Ignace, additional, Rustin, Gordon J. S., additional, Scott, Clare L., additional, Meier, Werner, additional, Shapira-Frommer, Ronnie, additional, Safra, Tamar, additional, Matei, Daniela, additional, Fielding, Anitra, additional, McMurtry, Emma, additional, Spencer, Stuart, additional, Mann, Helen, additional, Parry, David, additional, and Ledermann, Jonathan A., additional

Published
2015
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35. Olaparib Monotherapy in Patients With Advanced Cancer and a Germline BRCA1/2 Mutation

Author

Kaufman, Bella, primary, Shapira-Frommer, Ronnie, additional, Schmutzler, Rita K., additional, Audeh, M. William, additional, Friedlander, Michael, additional, Balmaña, Judith, additional, Mitchell, Gillian, additional, Fried, Georgeta, additional, Stemmer, Salomon M., additional, Hubert, Ayala, additional, Rosengarten, Ora, additional, Steiner, Mariana, additional, Loman, Niklas, additional, Bowen, Karin, additional, Fielding, Anitra, additional, and Domchek, Susan M., additional

Published
2015
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36. Olaparib Maintenance Therapy in Patients With Platinum-Sensitive Relapsed Serous Ovarian Cancer

Author

Ledermann, Jonathan, primary, Harter, Philipp, additional, Gourley, Charlie, additional, Friedlander, Michael, additional, Vergote, Ignace, additional, Rustin, Gordon, additional, Scott, Clare L., additional, Meier, Werner, additional, Shapira-Frommer, Ronnie, additional, Safra, Tamar, additional, Matei, Daniela, additional, Fielding, Anitra, additional, Spencer, Stuart, additional, Dougherty, Brian, additional, Orr, Maria, additional, Hodgson, Darren, additional, Barrett, J. Carl, additional, and Matulonis, Ursula, additional

Published
2014
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37. Abstract 2398: Activity of the PARP inhibitor olaparib in ATM-deficient gastric cancer: from preclinical models to the clinic

Author

Hodgson, Darren, primary, Mason, Helen, additional, Oplustilova, Lenka, additional, Harbron, Chris, additional, Yin, Xiaolu, additional, Im, Seock-Ah, additional, Jones, Helen, additional, Zhongwu, Lai, additional, Dougherty, Brian, additional, McLoughlin, Matthew, additional, Bradford, James, additional, Dickinson, Andrew, additional, Fielding, Anitra, additional, Robertson, Jane, additional, Kim, Woo-Ho, additional, Womack, Chris, additional, Gu, Yi, additional, Bang, Yung-Jue, additional, Lau, Alan, additional, Barrett, J. Carl, additional, and O'Connor, Mark J., additional

Published
2014
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38. Analysis of candidate homologous repair deficiency genes in a clinical trial of olaparib in patients (pts) with platinum-sensitive, relapsed serous ovarian cancer (PSR SOC).

Author

Dougherty, Brian, primary, Ledermann, Jonathan A., additional, Lai, Zhongwu, additional, Robertson, Jane D, additional, Ho, Tony, additional, Hodgson, Darren R, additional, O'Connor, Mark J, additional, Fielding, Anitra, additional, Hawryluk, Matthew J., additional, Brennan, Tim, additional, Yelensky, Roman, additional, Sun, James, additional, and Barrett, J. Carl, additional

Published
2014
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40. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer (SOC) and a BRCA mutation (BRCAm).

Author

Ledermann, Jonathan A., primary, Harter, Philipp, additional, Gourley, Charlie, additional, Friedlander, Michael, additional, Vergote, Ignace, additional, Rustin, Gordon J. S., additional, Scott, Clare L., additional, Meier, Werner, additional, Shapira-Frommer, Ronnie, additional, Safra, Tamar, additional, Matei, Daniela, additional, Fielding, Anitra, additional, Macpherson, Euan, additional, Dougherty, Brian, additional, Jürgensmeier, Juliane M., additional, Orr, Maria, additional, and Matulonis, Ursula, additional

Published
2013
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41. Olaparib plus paclitaxel in patients with recurrent or metastatic gastric cancer: A randomized, double-blind phase II study.

Author

Bang, Yung-Jue, primary, Im, Seock-Ah, additional, Lee, Keun-Wook, additional, Cho, Jae Yong, additional, Song, Eun-Kee, additional, Lee, Kyung Hee, additional, Kim, Yeul Hong, additional, Park, Joon Oh, additional, Chun, Hoo Geun, additional, Zang, Dae Young, additional, Fielding, Anitra, additional, Rowbottom, Jacqui, additional, and Kim, Woo Ho, additional

Published
2013
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42. Olaparib monotherapy in patients with advanced cancer and a germ-line BRCA1/2 mutation: An open-label phase II study.

Author

Kaufman, Bella, primary, Shapira-Frommer, Ronnie, additional, Schmutzler, Rita K., additional, Audeh, M. William, additional, Friedlander, Michael, additional, Balmaña, Judith, additional, Mitchell, Gillian, additional, Fried, Georgeta, additional, Bowen, Karin, additional, Fielding, Anitra, additional, and Domchek, Susan M., additional

Published
2013
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43. Cediranib Plus FOLFOX/CAPOX Versus Placebo Plus FOLFOX/CAPOX in Patients With Previously Untreated Metastatic Colorectal Cancer: A Randomized, Double-Blind, Phase III Study (HORIZON II)

Author

Hoff, Paulo M., primary, Hochhaus, Andreas, additional, Pestalozzi, Bernhard C., additional, Tebbutt, Niall C., additional, Li, Jin, additional, Kim, Tae Won, additional, Koynov, Krassimir D., additional, Kurteva, Galina, additional, Pintér, Tamás, additional, Cheng, Ying, additional, van Eyll, Brigitte, additional, Pike, Laura, additional, Fielding, Anitra, additional, Robertson, Jane D., additional, and Saunders, Mark P., additional

Published
2012
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44. Effective Strategies for Management of Hypertension After Vascular Endothelial Growth Factor Signaling Inhibition Therapy: Results From a Phase II Randomized, Factorial, Double-Blind Study of Cediranib in Patients With Advanced Solid Tumors

Author

Langenberg, Marlies H.G., primary, van Herpen, Carla M.L., additional, De Bono, Johann, additional, Schellens, Jan H.M., additional, Unger, Clemens, additional, Hoekman, Klaas, additional, Blum, Hubert E., additional, Fiedler, Walter, additional, Drevs, Joachim, additional, Le Maulf, Florence, additional, Fielding, Anitra, additional, Robertson, Jane, additional, and Voest, Emile E., additional

Published
2009
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45. Randomized, Double-Blind Phase II Trial With Prospective Classification by ATM Protein Level to Evaluate the Efficacy and Tolerability of Olaparib Plus Paclitaxel in Patients With Recurrent or Metastatic Gastric Cancer.

Author

Yung-Jue Bang, Seock-Ah Im, Keun-Wook Lee, Jae Yong Cho, Eun-Kee Song, Kyung Hee Lee, Yeul Hong Kim, Joon Oh Park, Hoo Geun Chun, Dae Young Zang, Fielding, Anitra, Rowbottom, Jacqui, Hodgson, Darren, O'Connor, Mark J., Xiaolu Yin, Woo Ho Kim, Bang, Yung-Jue, Im, Seock-Ah, Lee, Keun-Wook, and Cho, Jae Yong

Published
2015
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46. Efficacy and safety of trastuzumab deruxtecan among patients with HER2-expressing solid tumors: Biomarker and subgroup analyses from the cervical, endometrial, and ovarian cancer cohorts of the DESTINY-PanTumor02 study.

Author

Makker, Vicky, Oaknin, Ana, Manso, Luis, González-Martín, Antonio, Ługowska, Iwona, Meric-Bernstam, Funda, Lorusso, Domenica, Banerjee, Susana, Liao, John, Siena, Salvatore, Lu, Chien-Hsing, Prasongsook, Naiyarat, Melichar, Bohuslav, Fielding, Anitra, Jung, Lindsey, Puvvada, Soham, Michelini, Flavia, and Lee, Jung-Yun

Subjects
*OVARIAN cancer, *SUBGROUP analysis (Experimental design), *BIOMARKERS, *TRASTUZUMAB, *COHORT analysis
Published
2024
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47. Researchers Submit Patent Application, "Methods Of Treating Breast Cancer", for Approval (USPTO 20240269135).

Subjects
COMBINED modality therapy, CANCER chemotherapy, NEOADJUVANT chemotherapy, ADJUVANT chemotherapy, PROGRESSION-free survival, CANCER relapse
Abstract

A patent application has been submitted for methods of treating breast cancer in patients with specific gene mutations. The application describes the use of a drug called olaparib as an adjuvant treatment following surgery and chemotherapy. The drug targets cancers with certain genetic mutations and aims to prevent or delay the recurrence of breast cancer. The application includes claims related to the dosage, duration, and effectiveness of the treatment. Further research and clinical trials are needed to validate the efficacy of this treatment approach. [Extracted from the article]

Published
2024

48. BRD4 and Cancer: going beyond transcriptional regulation.

Author

Donati, Benedetta, Lorenzini, Eugenia, and Ciarrocchi, Alessia

Subjects
BROMODOMAIN-containing proteins, ONCOGENES, GENE expression, CANCER cells, DNA damage
Abstract

BRD4, member of the Bromodomain and Extraterminal (BET) protein family, is largely acknowledged in cancer for its role in super-enhancers (SEs) organization and oncogenes expression regulation. Inhibition of BRD4 shortcuts the communication between SEs and target promoters with a subsequent cell-specific repression of oncogenes to which cancer cells are addicted and cell death. To date, this is the most credited mechanism of action of BET inhibitors, a class of small molecules targeting BET proteins which are currently in clinical trials in several cancer settings. However, recent evidence indicates that BRD4 relevance in cancer goes beyond its role in transcription regulation and identifies this protein as a keeper of genome stability. Indeed, a non-transcriptional role of BRD4 in controlling DNA damage checkpoint activation and repair as well as telomere maintenance has been proposed, throwing new lights into the multiple functions of this protein and opening new perspectives on the use of BETi in cancer. Here we discuss the current available information on non-canonical, non-transcriptional functions of BRD4 and on their implications in cancer biology. Integrating this information with the already known BRD4 role in gene expression regulation, we propose a "common" model to explain BRD4 genomic function. Furthermore, in light of the transversal function of BRD4, we provide new interpretation for the cytotoxic activity of BETi and we discuss new possibilities for a wide and focused employment of these drugs in clinical settings. [ABSTRACT FROM AUTHOR]

Published
2018
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49. The Medical Directory 2015

Author

Brenda Wren and Brenda Wren

Subjects
Medical personnel--Great Britain--Directories
Abstract

First published in 1845, this directory has established an enviable reputation for the quantity and extent of its information on UK-registered medical practitioners. It provides mini career profiles of doctors listed A-Z by surname. Each record contains, if available, full name, primary and other qualifications, professional contact details, current and past appointments, specialty, society memberships, and special interests. Qualification information within the directory is sourced from the General Medical Council (GMC). A full entry contains: name, unique reference number allocated by the GMC, contact details aEURO'usually the main NHS hospital or surgery address for doctors still engaged in medical or clinical practice, primary medical qualification and other qualifications, current and most recent appointments (up to three), specialty and special interests, and up to five society memberships. Brief entries for newly qualified and younger doctors will contain their name, GMC identifier and primary medical qualification.

Published
2015

50. The Medical Directory 2014, 168th Edition

Author

Wren, Brenda and Wren, Brenda

Subjects
Physicians--Directories
Abstract

First published in 1845, this directory has established an enviable reputation for the quantity and extent of its information on UK-registered medical practitioners. It provides mini career profiles of doctors listed A-Z by surname. Each record contains, if available, full name, primary and other qualifications, professional contact details, current and past appointments, specialty, society memberships, and special interests. Qualification information within the directory is sourced from the General Medical Council (GMC). A full entry contains: name, unique reference number allocated by the GMC, contact details – usually the main NHS hospital or surgery address for doctors still engaged in medical or clinical practice, primary medical qualification and other qualifications, current and most recent appointments (up to three), specialty and special interests, and up to five society memberships. Brief entries for newly qualified and younger doctors will contain their name, GMC identifier and primary medical qualification.

Published
2014

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