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Олапариб в поддерживающем режиме лечения больных раком яичников с платиночувствительным рецидивом
Олапариб в поддерживающем режиме лечения больных раком яичников с платиночувствительным рецидивом
Хохлова С.В. Олапариб в поддерживающем режиме лечения больных раком яичников с платиночувствительным рецидивом. Современная Онкология. 2017; 19 (3): 13–18.
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Аннотация
Рак яичников (РЯ) является пятым наиболее распространенным видом рака у женщин в развитых странах. Несмотря на успехи в лечении эпителиального РЯ: улучшении техник и повышении агрессивности оперативных вмешательств, появлении новых цитостатиков, таргетных препаратов, – показатели общей выживаемости (ОВ) остаются неудовлетворительными (5-летняя выживаемость составляет 38%), и остается острая потребность в разработке новых терапевтических агентов для улучшения результатов лечения женщин с этим заболеванием.
Олапариб является первым ингибитором поли(АДФ-рибоза)-полимеразы (PARP), который продемонстрировал высокую эффективность лечения у больных РЯ при наличии мутаций в генах BRCA и одобрен в качестве поддерживающей монотерапии для лечения пациенток с платиночувствительным рецидивом BRCA-ассоциированного РЯ. В этом обзоре излагается информация об эффективности и токсичности олапариба, приводятся практические рекомендации по его применению.
В статье основное внимание уделяется токсическим действиям препарата, которые могут возникнуть при терапии олапарибом, и даются рекомендации по их управлению. Тошнота, рвота, усталость и анемия являются наиболее часто сообщаемыми побочными эффектами в клинических исследованиях олапариба, обычно встречаются в легкой и умеренной степени и носят преходящий характер. При правильном приеме и своевременном контроле за побочными эффектами можно контролировать многие токсические действия.
Ключевые слова: рак яичников, BRCA, олапариб.
Olaparib is the first poly (ADP-ribose) polymerase (PARP) inhibitor, which demonstrates the high efficacy of treatment patients with OC associated with mutations in the BRCA genes. And olaparib is approved as a maintenance monotherapy in the treatment of women with platinum sensitive recurrent BRCA-associated OC. This review deals with the information concerning the efficiency and toxicity of olaparib, showing practical guidance on the application. The article focuses on the toxic effects of the drug, which can occur during olaparib therapy, and shows the guidance on management of the disease. Nausea, vomiting, fatigue and anemia are the most commonly reported side effects of olaparib application in clinical studies. Side effects are usually recorded in mild to moderate degree and nondurable. Using proper application and timely monitoring for side effects one can control many toxic actions.
Key words: ovarian cancer, BRCA, olaparib.
Олапариб является первым ингибитором поли(АДФ-рибоза)-полимеразы (PARP), который продемонстрировал высокую эффективность лечения у больных РЯ при наличии мутаций в генах BRCA и одобрен в качестве поддерживающей монотерапии для лечения пациенток с платиночувствительным рецидивом BRCA-ассоциированного РЯ. В этом обзоре излагается информация об эффективности и токсичности олапариба, приводятся практические рекомендации по его применению.
В статье основное внимание уделяется токсическим действиям препарата, которые могут возникнуть при терапии олапарибом, и даются рекомендации по их управлению. Тошнота, рвота, усталость и анемия являются наиболее часто сообщаемыми побочными эффектами в клинических исследованиях олапариба, обычно встречаются в легкой и умеренной степени и носят преходящий характер. При правильном приеме и своевременном контроле за побочными эффектами можно контролировать многие токсические действия.
Ключевые слова: рак яичников, BRCA, олапариб.
________________________________________________
Olaparib is the first poly (ADP-ribose) polymerase (PARP) inhibitor, which demonstrates the high efficacy of treatment patients with OC associated with mutations in the BRCA genes. And olaparib is approved as a maintenance monotherapy in the treatment of women with platinum sensitive recurrent BRCA-associated OC. This review deals with the information concerning the efficiency and toxicity of olaparib, showing practical guidance on the application. The article focuses on the toxic effects of the drug, which can occur during olaparib therapy, and shows the guidance on management of the disease. Nausea, vomiting, fatigue and anemia are the most commonly reported side effects of olaparib application in clinical studies. Side effects are usually recorded in mild to moderate degree and nondurable. Using proper application and timely monitoring for side effects one can control many toxic actions.
Key words: ovarian cancer, BRCA, olaparib.
Полный текст
Список литературы
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2. National Cancer Institute. SEER Stat Fact Sheets: Ovary Cancer. Available at: http://seer.cancer.gov/ statfacts/html/ovary.html. Accessed April 21, 2016.
3. Press JZ, DeLuca A, Boyd Netal. Ovariancarcinomaswith genetic and epigenetic BRCA1 loss have distinct molecular abnormalities. BMC Cancer 2008; 8: 17.
4. Cancer Genome Atlas Research Network. Integrated ge- nomic analyses of ovarian carcinoma. Nature 2011; 474: 609–15.
5. Daniels MS, Babb SA, King RH et al. Underestimation of risk of a BRCA1 or BRCA2 mutation in women with high-grade serous ovarian cancer by BRCAPRO: a multi-institution study. J Clin Oncol 2014; 32: 1249– 55.
6. Patel AG, Sarkaria JN, Kaufmann SH. Nonhomologous end joining drives poly(ADP-ribose) polymerase (PARP) inhibitor lethality in homologous recombination-deficient cells. Proc Natl Acad Sci U S A 2011; 108: 3406–11.
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9. Farmer H, McCabe N, Lord CJ et al. Targeting the DNA repair defect in BRCA mutant cells as a therapeutic strategy. Nature 2005; 434: 917–21.
10. Ledermann J, Harter P, Gourley C et al. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med 2012; 366: 1382–92.
11. Ledermann J, Harter P, Gourley C et al. 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. Lancet Oncol 2014; 15: 852–61.
12. Ledermann JA, Harter P, Gourley C et al. Overall sur-vival (OS) in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC) receiving olaparib maintenance monotherapy: an interim analysis. J Clin Oncol 2016; 34(Suppl. 15): abst 5501.
13. Matulonis U, Harter P, Gourley C et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer and a BRCA mutation: overall survival adjusted for post-progression PARP inhibitor therapy. Cancer 2016; 122: 1844–52.
14. Ledermann J, Harter P, Gourley C et al. Health-related quality of life (HRQoL) during olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer (PSR SOC) and a BRCA mutation (BRCAm). European Society for Medical Oncology.
15. Rolfo C, Swaisland H, Leunen K et al. Effect of food on the pharmacokinetics of olaparib after oral dosing of the capsule formulation in patients with advanced solid tumors. Adv Ther 2015; 32: 510–22.
16. AstraZeneca. LYNPARZA. US label. 2016.
17. Banerjee S, Ledermann J, Matulonis U et al. Managementof nausea and vomiting during treatment with the capsule (CAP) and tablet (TAB) formulations of the PARP inhibitor olaparib. European Cancer Congress; 25–29 September 2015, Vienna, Austria; abst 2759.
18. Matulonis U, Friedlander M, du Bois A et al. Frequency, severity and timing of common adverse events (AEs) with maintenance olaparib in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC). J Clin Oncol 2015; 33 (Suppl. 15): abst 5550.
19. Sanchez RI, Wang RW, Newton DJ et al. Cytochrome P450 3A4 is the major enzyme involved in the metabolism of the substance P receptor antagonist aprepitant. Drug Metab Dispos 2004; 32: 1287–92.
20. Hong JH, Omur-Ozbek P, Stanek BT et al. Taste and odor abnormalities in cancer patients. J Support Oncol 2009; 7: 58–65.
21. Hovan AJ, Williams PM, Stevenson-Moore P et al. A systematic review of dysgeusia induced by cancer therapies. Support Care Cancer 2010; 18: 1081–7.
22. Berteretche MV, Dalix AM, d’Ornano AM et al. Decreased taste sensitivity in cancer patients under chemotherapy. Support Care Cancer 2004; 12: 571–6.
23. Rehwaldt M, Wickham R, Purl S et al. Self-care strategies to cope with taste changes after chemotherapy. Oncol Nurs Forum 2009; 36: E47–56.
2. National Cancer Institute. SEER Stat Fact Sheets: Ovary Cancer. Available at: http://seer.cancer.gov/ statfacts/html/ovary.html. Accessed April 21, 2016.
3. Press JZ, DeLuca A, Boyd Netal. Ovariancarcinomaswith genetic and epigenetic BRCA1 loss have distinct molecular abnormalities. BMC Cancer 2008; 8: 17.
4. Cancer Genome Atlas Research Network. Integrated ge- nomic analyses of ovarian carcinoma. Nature 2011; 474: 609–15.
5. Daniels MS, Babb SA, King RH et al. Underestimation of risk of a BRCA1 or BRCA2 mutation in women with high-grade serous ovarian cancer by BRCAPRO: a multi-institution study. J Clin Oncol 2014; 32: 1249– 55.
6. Patel AG, Sarkaria JN, Kaufmann SH. Nonhomologous end joining drives poly(ADP-ribose) polymerase (PARP) inhibitor lethality in homologous recombination-deficient cells. Proc Natl Acad Sci U S A 2011; 108: 3406–11.
7. Scott CL, Swisher EM, Kaufmann SH. Poly (ADP-ribose) polymerase inhibitors: recent advances and future development. J Clin Oncol 2015; 33: 1397–406.
8. Murai J, Huang SY, Das BB et al. Trapping of PARP1 and PARP2 by clinical PARP inhibitors. Cancer Res 2012; 72: 5588–99.
9. Farmer H, McCabe N, Lord CJ et al. Targeting the DNA repair defect in BRCA mutant cells as a therapeutic strategy. Nature 2005; 434: 917–21.
10. Ledermann J, Harter P, Gourley C et al. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med 2012; 366: 1382–92.
11. Ledermann J, Harter P, Gourley C et al. 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. Lancet Oncol 2014; 15: 852–61.
12. Ledermann JA, Harter P, Gourley C et al. Overall sur-vival (OS) in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC) receiving olaparib maintenance monotherapy: an interim analysis. J Clin Oncol 2016; 34(Suppl. 15): abst 5501.
13. Matulonis U, Harter P, Gourley C et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer and a BRCA mutation: overall survival adjusted for post-progression PARP inhibitor therapy. Cancer 2016; 122: 1844–52.
14. Ledermann J, Harter P, Gourley C et al. Health-related quality of life (HRQoL) during olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer (PSR SOC) and a BRCA mutation (BRCAm). European Society for Medical Oncology.
15. Rolfo C, Swaisland H, Leunen K et al. Effect of food on the pharmacokinetics of olaparib after oral dosing of the capsule formulation in patients with advanced solid tumors. Adv Ther 2015; 32: 510–22.
16. AstraZeneca. LYNPARZA. US label. 2016.
17. Banerjee S, Ledermann J, Matulonis U et al. Managementof nausea and vomiting during treatment with the capsule (CAP) and tablet (TAB) formulations of the PARP inhibitor olaparib. European Cancer Congress; 25–29 September 2015, Vienna, Austria; abst 2759.
18. Matulonis U, Friedlander M, du Bois A et al. Frequency, severity and timing of common adverse events (AEs) with maintenance olaparib in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC). J Clin Oncol 2015; 33 (Suppl. 15): abst 5550.
19. Sanchez RI, Wang RW, Newton DJ et al. Cytochrome P450 3A4 is the major enzyme involved in the metabolism of the substance P receptor antagonist aprepitant. Drug Metab Dispos 2004; 32: 1287–92.
20. Hong JH, Omur-Ozbek P, Stanek BT et al. Taste and odor abnormalities in cancer patients. J Support Oncol 2009; 7: 58–65.
21. Hovan AJ, Williams PM, Stevenson-Moore P et al. A systematic review of dysgeusia induced by cancer therapies. Support Care Cancer 2010; 18: 1081–7.
22. Berteretche MV, Dalix AM, d’Ornano AM et al. Decreased taste sensitivity in cancer patients under chemotherapy. Support Care Cancer 2004; 12: 571–6.
23. Rehwaldt M, Wickham R, Purl S et al. Self-care strategies to cope with taste changes after chemotherapy. Oncol Nurs Forum 2009; 36: E47–56.
2. National Cancer Institute. SEER Stat Fact Sheets: Ovary Cancer. Available at: http://seer.cancer.gov/ statfacts/html/ovary.html. Accessed April 21, 2016.
3. Press JZ, DeLuca A, Boyd Netal. Ovariancarcinomaswith genetic and epigenetic BRCA1 loss have distinct molecular abnormalities. BMC Cancer 2008; 8: 17.
4. Cancer Genome Atlas Research Network. Integrated ge- nomic analyses of ovarian carcinoma. Nature 2011; 474: 609–15.
5. Daniels MS, Babb SA, King RH et al. Underestimation of risk of a BRCA1 or BRCA2 mutation in women with high-grade serous ovarian cancer by BRCAPRO: a multi-institution study. J Clin Oncol 2014; 32: 1249– 55.
6. Patel AG, Sarkaria JN, Kaufmann SH. Nonhomologous end joining drives poly(ADP-ribose) polymerase (PARP) inhibitor lethality in homologous recombination-deficient cells. Proc Natl Acad Sci U S A 2011; 108: 3406–11.
7. Scott CL, Swisher EM, Kaufmann SH. Poly (ADP-ribose) polymerase inhibitors: recent advances and future development. J Clin Oncol 2015; 33: 1397–406.
8. Murai J, Huang SY, Das BB et al. Trapping of PARP1 and PARP2 by clinical PARP inhibitors. Cancer Res 2012; 72: 5588–99.
9. Farmer H, McCabe N, Lord CJ et al. Targeting the DNA repair defect in BRCA mutant cells as a therapeutic strategy. Nature 2005; 434: 917–21.
10. Ledermann J, Harter P, Gourley C et al. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med 2012; 366: 1382–92.
11. Ledermann J, Harter P, Gourley C et al. 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. Lancet Oncol 2014; 15: 852–61.
12. Ledermann JA, Harter P, Gourley C et al. Overall sur-vival (OS) in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC) receiving olaparib maintenance monotherapy: an interim analysis. J Clin Oncol 2016; 34(Suppl. 15): abst 5501.
13. Matulonis U, Harter P, Gourley C et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer and a BRCA mutation: overall survival adjusted for post-progression PARP inhibitor therapy. Cancer 2016; 122: 1844–52.
14. Ledermann J, Harter P, Gourley C et al. Health-related quality of life (HRQoL) during olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer (PSR SOC) and a BRCA mutation (BRCAm). European Society for Medical Oncology.
15. Rolfo C, Swaisland H, Leunen K et al. Effect of food on the pharmacokinetics of olaparib after oral dosing of the capsule formulation in patients with advanced solid tumors. Adv Ther 2015; 32: 510–22.
16. AstraZeneca. LYNPARZA. US label. 2016.
17. Banerjee S, Ledermann J, Matulonis U et al. Managementof nausea and vomiting during treatment with the capsule (CAP) and tablet (TAB) formulations of the PARP inhibitor olaparib. European Cancer Congress; 25–29 September 2015, Vienna, Austria; abst 2759.
18. Matulonis U, Friedlander M, du Bois A et al. Frequency, severity and timing of common adverse events (AEs) with maintenance olaparib in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC). J Clin Oncol 2015; 33 (Suppl. 15): abst 5550.
19. Sanchez RI, Wang RW, Newton DJ et al. Cytochrome P450 3A4 is the major enzyme involved in the metabolism of the substance P receptor antagonist aprepitant. Drug Metab Dispos 2004; 32: 1287–92.
20. Hong JH, Omur-Ozbek P, Stanek BT et al. Taste and odor abnormalities in cancer patients. J Support Oncol 2009; 7: 58–65.
21. Hovan AJ, Williams PM, Stevenson-Moore P et al. A systematic review of dysgeusia induced by cancer therapies. Support Care Cancer 2010; 18: 1081–7.
22. Berteretche MV, Dalix AM, d’Ornano AM et al. Decreased taste sensitivity in cancer patients under chemotherapy. Support Care Cancer 2004; 12: 571–6.
23. Rehwaldt M, Wickham R, Purl S et al. Self-care strategies to cope with taste changes after chemotherapy. Oncol Nurs Forum 2009; 36: E47–56.
________________________________________________
2. National Cancer Institute. SEER Stat Fact Sheets: Ovary Cancer. Available at: http://seer.cancer.gov/ statfacts/html/ovary.html. Accessed April 21, 2016.
3. Press JZ, DeLuca A, Boyd Netal. Ovariancarcinomaswith genetic and epigenetic BRCA1 loss have distinct molecular abnormalities. BMC Cancer 2008; 8: 17.
4. Cancer Genome Atlas Research Network. Integrated ge- nomic analyses of ovarian carcinoma. Nature 2011; 474: 609–15.
5. Daniels MS, Babb SA, King RH et al. Underestimation of risk of a BRCA1 or BRCA2 mutation in women with high-grade serous ovarian cancer by BRCAPRO: a multi-institution study. J Clin Oncol 2014; 32: 1249– 55.
6. Patel AG, Sarkaria JN, Kaufmann SH. Nonhomologous end joining drives poly(ADP-ribose) polymerase (PARP) inhibitor lethality in homologous recombination-deficient cells. Proc Natl Acad Sci U S A 2011; 108: 3406–11.
7. Scott CL, Swisher EM, Kaufmann SH. Poly (ADP-ribose) polymerase inhibitors: recent advances and future development. J Clin Oncol 2015; 33: 1397–406.
8. Murai J, Huang SY, Das BB et al. Trapping of PARP1 and PARP2 by clinical PARP inhibitors. Cancer Res 2012; 72: 5588–99.
9. Farmer H, McCabe N, Lord CJ et al. Targeting the DNA repair defect in BRCA mutant cells as a therapeutic strategy. Nature 2005; 434: 917–21.
10. Ledermann J, Harter P, Gourley C et al. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med 2012; 366: 1382–92.
11. Ledermann J, Harter P, Gourley C et al. 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. Lancet Oncol 2014; 15: 852–61.
12. Ledermann JA, Harter P, Gourley C et al. Overall sur-vival (OS) in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC) receiving olaparib maintenance monotherapy: an interim analysis. J Clin Oncol 2016; 34(Suppl. 15): abst 5501.
13. Matulonis U, Harter P, Gourley C et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer and a BRCA mutation: overall survival adjusted for post-progression PARP inhibitor therapy. Cancer 2016; 122: 1844–52.
14. Ledermann J, Harter P, Gourley C et al. Health-related quality of life (HRQoL) during olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer (PSR SOC) and a BRCA mutation (BRCAm). European Society for Medical Oncology.
15. Rolfo C, Swaisland H, Leunen K et al. Effect of food on the pharmacokinetics of olaparib after oral dosing of the capsule formulation in patients with advanced solid tumors. Adv Ther 2015; 32: 510–22.
16. AstraZeneca. LYNPARZA. US label. 2016.
17. Banerjee S, Ledermann J, Matulonis U et al. Managementof nausea and vomiting during treatment with the capsule (CAP) and tablet (TAB) formulations of the PARP inhibitor olaparib. European Cancer Congress; 25–29 September 2015, Vienna, Austria; abst 2759.
18. Matulonis U, Friedlander M, du Bois A et al. Frequency, severity and timing of common adverse events (AEs) with maintenance olaparib in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC). J Clin Oncol 2015; 33 (Suppl. 15): abst 5550.
19. Sanchez RI, Wang RW, Newton DJ et al. Cytochrome P450 3A4 is the major enzyme involved in the metabolism of the substance P receptor antagonist aprepitant. Drug Metab Dispos 2004; 32: 1287–92.
20. Hong JH, Omur-Ozbek P, Stanek BT et al. Taste and odor abnormalities in cancer patients. J Support Oncol 2009; 7: 58–65.
21. Hovan AJ, Williams PM, Stevenson-Moore P et al. A systematic review of dysgeusia induced by cancer therapies. Support Care Cancer 2010; 18: 1081–7.
22. Berteretche MV, Dalix AM, d’Ornano AM et al. Decreased taste sensitivity in cancer patients under chemotherapy. Support Care Cancer 2004; 12: 571–6.
23. Rehwaldt M, Wickham R, Purl S et al. Self-care strategies to cope with taste changes after chemotherapy. Oncol Nurs Forum 2009; 36: E47–56.
Авторы
С.В.Хохлова*
ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н.Блохина» Минздрава России. 115478, Россия, Москва, Каширское ш., д. 23
*svkhokhlova@mail.ru
N.N.Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation. 115478, Russian Federation, Moscow, Kashirskoe sh., d. 23
*svkhokhlova@mail.ru
ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н.Блохина» Минздрава России. 115478, Россия, Москва, Каширское ш., д. 23
*svkhokhlova@mail.ru
________________________________________________
N.N.Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation. 115478, Russian Federation, Moscow, Kashirskoe sh., d. 23
*svkhokhlova@mail.ru
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