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Поддерживающая терапия при раке яичников
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Pokataev I.A., Tyulyandin S.A. Перевод названия. Journal of Modern Oncology. 2016; 18 (2): 81–87.
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Ключевые слова: рак яичников, поддерживающая терапия при первичном раке яичников, поддерживающая терапия при рецидивах рака яичников, мутация brca, brca-ассоциированный рак яичников, олапариб.
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Surgery is the main treatment for patients suffering from ovarian cancer. But, the therapy successes of this pathology have been primarily associated with the effective drug treatment in recent years. New drugs and chemotherapy regimens have significantly changed the principles of medicinal treatment of the disease and helped to add supportive part of therapy. Supportive therapy was considered inappropriate due to limited efficacy and high toxicity 5 years ago.
Key words: ovarian cancer, supportive therapy for primary ovarian cancer, supportive therapy for recurrent ovarian cancer, BRCA mutation, BRCA-associated ovarian cancer, olaparib.
2. Markman M, Rothman R, Hakes T et al. Second-line platinum therapy in patients with ovarian cancer previously treated with cisplatin. J Clin Oncol 1991; 9 (3): 389–93.
3. Blackledge G, Lawton F, Redman C, Kelly K. Response of patients in phase II studies of chemotherapy in ovarian cancer: implications for patient treatment and the design of phase II trials. Br J Cancer 1989; 59 (4): 650–3.
4. Gore ME, Fryatt I, Wiltshaw E, Dawson T. Treatment of relapsed carcinoma of the ovary with cisplatin or carboplatin following initial treatment with these compounds. Gynecol Oncol 1990; 36 (2): 207–11.
5. Тюляндина А.С. Лекарственное лечение рака яичников. Практич. онкология. 2014; 15 (4): 168–75. / Tiuliandina A.S. Lekarstvennoe lechenie raka iaichnikov. Praktich. onkologiia. 2014; 15 (4): 168–75. [in Russian]
6. Bookman MA, Brady MF, McGuire et al. Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer:
A phase III trial of the Gynecologic Cancer InterGroup. J Clin Oncol 2009; 27: 1419–25.
7. Pignata S, Scambia G, Ferrandina G et al. Carboplatin Plus Paclitaxel Versus Carboplatin Plus Pegylated Liposomal Doxorubicin As First-Line Treatment for Patients With Ovarian Cancer: The MITO-2 Randomized Phase III Trial. J Clin Oncol 2011; 29: 1–11.
8. Pignata S, Scambia G, Raspagliesi F et al. The MITO8 phase III international multicenter randomized study testing the effect on survival of prolonging platinum-free interval (PFI) in patients with ovarian cancer (OC) recurring between 6 and 12 months after previous platinum-based chemotherapy: A collaboration of MITO, MANGO, AGO, BGOG, ENGOT, and GCIG. Clin Oncol 2016; 34 (Suppl.; abstr. 5505).
9. Katz ME, Schwartz PE, Kapp DS et al. Epithelial carcinoma of the ovary: current strategies. Ann Int Med 1981; 95: 98–111.
10. Young PC, Chabner BA, Hubbard SP et al. Advanced ovarian adenocarcinoma: a prospective clinical trial of melphalan (LPAM) versus combination chemotherapy. New Engl J Med 1978; 299: 1261–6.
11. Greene MH, Boice JD Jr., Greer BE et al. Acute nonlymphocytic leukemia after therapy with alkylating agents for ovarian cancer: a study of five randomized trials. New Engl J Med 1982; 307: 1416–21.
12. Travis LB, Curtin RE, Boice JDJr et al. Second malignant neoplasms among long-term survivors of ovarian cancer. Cancer Res 1996; 56: 1564–70.
13. Lambert HE, Rustin GJ, Gregory WM et al. A randomized trial of five versus eight courses of cisplatin or carboplatin in advanced epithelial ovarian carcinoma. A North Thames Ovary Group Study. Ann Oncol 1997; 8: 327–33.
14. Bertelsen K, Jakobsen A, Stroyer J et al. A prospective randomized comparison of 6 and 12 cycles of cyclophosphamide, adriamycin, and cisplatin in advanced epithelial ovarian cancer: a Danish Ovarian Study Group trial (DACOVA). Gynecol Oncol 1993; 49: 30–6.
15. Hakes TB, Chalas E, Hoskins WJ et al. Randomized prospective trial of 5 versus 10 cycles of cyclophosphamide, doxorubicin, and cisplatin in advanced ovarian carcinoma. Gynecol Oncol 1992; 45: 284–9.
16. Markman M. Maintenance chemotherapy in the management of epithelial ovarian cancer. Cancer Metastasis Rev 2015; 34 (1): 11–7.
17. Markman M, Liu PY, Wilczynski S et al. Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer after complete response to platinum and paclitaxel-based chemotherapy: a Southwest Oncology Group and Gynecologic Oncology Group trial. J Clin Oncol 2003; 21: 2460–5.
18. Mannel RS, Brady MF, Kohn EC et al. A randomized phase III trial of IV carboplatin and paclitaxel × 3 courses followed by observation versus weekly maintenance low-dose paclitaxel in patients with early-stage ovarian carcinoma: A Gynecologic Oncology Group Study. Gynecol Oncol 2011; 122 (1): 89–94.
19. Bocci G, Di Paolo A, Danesi R. The pharmacological bases of the antiangiogenic activity of paclitaxel. Angiogenesis 2013; 16: 481–92.
20. Oza AM, Cook AD, Pfisterer J et al. Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial. Lancet Oncol 2015; 16: 928–36.
21. Robert A. Burger, MD, Mark F et al. Incorporation of Bevacizumab in the Primary Treatment of Ovarian Cancer. N Engl J Med 2011; 365: 2473–83.
22. Du Bois A, Floquet A, Kim JW et al. Randomized, double-blind, phase III trial of pazopanib versus placebo in women who have progressed after first-line chemotherapy for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer: results of an international Intergroup trial (AGO-OVAR 16). J Clin Oncol 2013; 31 (Suppl.; LBA 5503).
23. Du Bois A, Kristensen G, Ray-Coquard I et al. AGO-OVAR 12: a randomized placebo-controlled GCIG/ENGOT-Intergroup phase III trial of standard frontline chemotherapy +/− nintedanib for advanced ovarian cancer. Abstracts from the 18th International Meeting of the European Society of Gynaecological Oncology (ESGO), 19–22 October 2013, Liverpool, UK. Int J Gynecol Cancer 2013; 23 (8 Suppl. 1).
24. Yokoyama Y, Mizunuma H. Recurrent epithelial ovarian cancer and hormone therapy. World J Clin Cases 2013; 1 (6): 187–90.
25. Gershenson D, Bodurka D, Coleman R et al. Hormonal maintenance therapy for women with low grade serous carcinoma of the ovary or peritoneum. J Clin Oncol 2016; 34 (Suppl.; abstr. 5502).
26. Munstedt K, Steen J, Knauf AG et al. Steroid hormone receptors and long term survival in invasive ovarian cancer. Cancer 2000; 89: 1783–91.
27. Berek J, Taylor P, McGuire W et al. Oregovomab maintenance monoimmunotherapy does not improve outcomes in advanced ovarian cancer. J Clin Oncol 2009; 27: 418–25.
28. Sabbatini P, Harter P, Scambia G et al. Abagovomab as maintenance therapy in patients with epithelial ovarian cancer: a phase III trial of the AGO OVAR, COGI, GINECO, and GEICO – The MIMOSA Study. J Clin Oncol 2013; 31: 1554–61.
29. Vergote IB, Jimeno A, Joly F et al. Randomized phase III study of erlotinib versus observation in patients with no evidence of disease progression after first-line platin-based chemotherapy for ovarian carcinoma: a European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group, and Gynecologic Cancer Intergroup study. J Clin Oncol 2014; 32: 320–6.
30. Любченко Л.Н., Батенева Е.И., Абрамов И.С. и др. Наследственный рак молочной железы и яичников. Злокачественные опухоли. 2013; 2: 53–61. / Liubchenko L.N., Bateneva E.I., Abramov I.S. i dr. Nasledstvennyi rak molochnoi zhelezy i iaichnikov. Zlokachestvennye opukholi. 2013; 2: 53–61. [in Russian]
31. Тюляндина А.С. Настоящее и будущее таргетной терапии в первой линии лечения рака яичников. Фарматека. 2013; 8: 39–42. / Tiuliandina A.S. Nastoiashchee i budushchee targetnoi terapii v pervoi linii lecheniia raka iaichnikov. Farmateka. 2013; 8: 39–42. [in Russian]
32. Soegaard M, Kjaer SK, Cox M et al. BRCA1 and BRCA2 mutation prevalence and clinical characteristics of a population-based series of ovarian cancer cases from Denmark. Clin Cancer Res 2008; 14 (12): 3761–7.
33. Aghajanian C, Goff B, Nycum LR et al. Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer. Gynecol Oncol 2015; 139 (1): 10–6.
34. Pujade-Lauraine E, Hilpert F Weber B et al. Bevacizumab Combined With Chemotherapy for Platinum-Resistant Recurrent Ovarian Cancer: The AURELIA Open-Label Randomized Phase III Trial. J Clin Oncol 2014; 32: 4014–25.
35. Ledermann JA, Embleton AC, Raja F et al. Cediranib in patients with relapsed platinum-sensitive ovarian cancer (ICON6): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2016; 387 (10023): 1066–74.
36. Monk BJ, Poveda A, Vergote I et al. Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlledphase 3 trial. Lancet Oncol 2014; 15 (8): 799–808.
37. Committee for Medicinal Products for Human Use. Lynparza (olaparib). 23 October 2014. EMA/CHMP/632090/2014. http://www.ema. europa.eu/ema/index.jsp ?curl= pages/medicines/human/medicines/003726/smops/Positive/human_smop_000744.jsp&mid=WC0b01ac058001d127
38. 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.
39. Ledermann J, Harter P, Gourley C et al. Overall survival (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.; abstr. 5501).
40. 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 Postprogression Poly(Adenosine Diphosphate Ribose) Polymerase Inhibitor Therapy. Cancer. In print.
41. Hall GD, Brown JM, Coleman RE et al. Maintenance treatment with interferon for advanced ovarian cancer: results of the Northern and Yorkshire Gynecology Group randomized phase III study. Brit J Cancer 2004; 91: 621–6.
42. Alberts DS, Hannigan EV, Liu PY et al. Randomized trial of adjuvant intraperitoneal alpha-interferon in stage III ovarian cancer patients who have no evidence of disease after primary surgery and chemotherapy: an intergroup study. Gynecol Oncol 2006; 100: 133–8.
43. The Cancer Genome Atlas Research Network. Integrated genomic analyses of ovarian Carcinoma. Nature 2011; 474: 609–15.
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1. Tiuliandin S.A., Den'gina N.V., Kolomiets L.A. i dr. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu raka iaichnikov. Zlokachestvennye opukholi. 2015; 4 (Spetsvypusk): 116–26. [in Russian]
2. Markman M, Rothman R, Hakes T et al. Second-line platinum therapy in patients with ovarian cancer previously treated with cisplatin. J Clin Oncol 1991; 9 (3): 389–93.
3. Blackledge G, Lawton F, Redman C, Kelly K. Response of patients in phase II studies of chemotherapy in ovarian cancer: implications for patient treatment and the design of phase II trials. Br J Cancer 1989; 59 (4): 650–3.
4. Gore ME, Fryatt I, Wiltshaw E, Dawson T. Treatment of relapsed carcinoma of the ovary with cisplatin or carboplatin following initial treatment with these compounds. Gynecol Oncol 1990; 36 (2): 207–11.
5. Tiuliandina A.S. Lekarstvennoe lechenie raka iaichnikov. Praktich. onkologiia. 2014; 15 (4): 168–75. [in Russian]
6. Bookman MA, Brady MF, McGuire et al. Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer:
A phase III trial of the Gynecologic Cancer InterGroup. J Clin Oncol 2009; 27: 1419–25.
7. Pignata S, Scambia G, Ferrandina G et al. Carboplatin Plus Paclitaxel Versus Carboplatin Plus Pegylated Liposomal Doxorubicin As First-Line Treatment for Patients With Ovarian Cancer: The MITO-2 Randomized Phase III Trial. J Clin Oncol 2011; 29: 1–11.
8. Pignata S, Scambia G, Raspagliesi F et al. The MITO8 phase III international multicenter randomized study testing the effect on survival of prolonging platinum-free interval (PFI) in patients with ovarian cancer (OC) recurring between 6 and 12 months after previous platinum-based chemotherapy: A collaboration of MITO, MANGO, AGO, BGOG, ENGOT, and GCIG. Clin Oncol 2016; 34 (Suppl.; abstr. 5505).
9. Katz ME, Schwartz PE, Kapp DS et al. Epithelial carcinoma of the ovary: current strategies. Ann Int Med 1981; 95: 98–111.
10. Young PC, Chabner BA, Hubbard SP et al. Advanced ovarian adenocarcinoma: a prospective clinical trial of melphalan (LPAM) versus combination chemotherapy. New Engl J Med 1978; 299: 1261–6.
11. Greene MH, Boice JD Jr., Greer BE et al. Acute nonlymphocytic leukemia after therapy with alkylating agents for ovarian cancer: a study of five randomized trials. New Engl J Med 1982; 307: 1416–21.
12. Travis LB, Curtin RE, Boice JDJr et al. Second malignant neoplasms among long-term survivors of ovarian cancer. Cancer Res 1996; 56: 1564–70.
13. Lambert HE, Rustin GJ, Gregory WM et al. A randomized trial of five versus eight courses of cisplatin or carboplatin in advanced epithelial ovarian carcinoma. A North Thames Ovary Group Study. Ann Oncol 1997; 8: 327–33.
14. Bertelsen K, Jakobsen A, Stroyer J et al. A prospective randomized comparison of 6 and 12 cycles of cyclophosphamide, adriamycin, and cisplatin in advanced epithelial ovarian cancer: a Danish Ovarian Study Group trial (DACOVA). Gynecol Oncol 1993; 49: 30–6.
15. Hakes TB, Chalas E, Hoskins WJ et al. Randomized prospective trial of 5 versus 10 cycles of cyclophosphamide, doxorubicin, and cisplatin in advanced ovarian carcinoma. Gynecol Oncol 1992; 45: 284–9.
16. Markman M. Maintenance chemotherapy in the management of epithelial ovarian cancer. Cancer Metastasis Rev 2015; 34 (1): 11–7.
17. Markman M, Liu PY, Wilczynski S et al. Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer after complete response to platinum and paclitaxel-based chemotherapy: a Southwest Oncology Group and Gynecologic Oncology Group trial. J Clin Oncol 2003; 21: 2460–5.
18. Mannel RS, Brady MF, Kohn EC et al. A randomized phase III trial of IV carboplatin and paclitaxel × 3 courses followed by observation versus weekly maintenance low-dose paclitaxel in patients with early-stage ovarian carcinoma: A Gynecologic Oncology Group Study. Gynecol Oncol 2011; 122 (1): 89–94.
19. Bocci G, Di Paolo A, Danesi R. The pharmacological bases of the antiangiogenic activity of paclitaxel. Angiogenesis 2013; 16: 481–92.
20. Oza AM, Cook AD, Pfisterer J et al. Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial. Lancet Oncol 2015; 16: 928–36.
21. Robert A. Burger, MD, Mark F et al. Incorporation of Bevacizumab in the Primary Treatment of Ovarian Cancer. N Engl J Med 2011; 365: 2473–83.
22. Du Bois A, Floquet A, Kim JW et al. Randomized, double-blind, phase III trial of pazopanib versus placebo in women who have progressed after first-line chemotherapy for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer: results of an international Intergroup trial (AGO-OVAR 16). J Clin Oncol 2013; 31 (Suppl.; LBA 5503).
23. Du Bois A, Kristensen G, Ray-Coquard I et al. AGO-OVAR 12: a randomized placebo-controlled GCIG/ENGOT-Intergroup phase III trial of standard frontline chemotherapy +/− nintedanib for advanced ovarian cancer. Abstracts from the 18th International Meeting of the European Society of Gynaecological Oncology (ESGO), 19–22 October 2013, Liverpool, UK. Int J Gynecol Cancer 2013; 23 (8 Suppl. 1).
24. Yokoyama Y, Mizunuma H. Recurrent epithelial ovarian cancer and hormone therapy. World J Clin Cases 2013; 1 (6): 187–90.
25. Gershenson D, Bodurka D, Coleman R et al. Hormonal maintenance therapy for women with low grade serous carcinoma of the ovary or peritoneum. J Clin Oncol 2016; 34 (Suppl.; abstr. 5502).
26. Munstedt K, Steen J, Knauf AG et al. Steroid hormone receptors and long term survival in invasive ovarian cancer. Cancer 2000; 89: 1783–91.
27. Berek J, Taylor P, McGuire W et al. Oregovomab maintenance monoimmunotherapy does not improve outcomes in advanced ovarian cancer. J Clin Oncol 2009; 27: 418–25.
28. Sabbatini P, Harter P, Scambia G et al. Abagovomab as maintenance therapy in patients with epithelial ovarian cancer: a phase III trial of the AGO OVAR, COGI, GINECO, and GEICO – The MIMOSA Study. J Clin Oncol 2013; 31: 1554–61.
29. Vergote IB, Jimeno A, Joly F et al. Randomized phase III study of erlotinib versus observation in patients with no evidence of disease progression after first-line platin-based chemotherapy for ovarian carcinoma: a European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group, and Gynecologic Cancer Intergroup study. J Clin Oncol 2014; 32: 320–6.
30. Liubchenko L.N., Bateneva E.I., Abramov I.S. i dr. Nasledstvennyi rak molochnoi zhelezy i iaichnikov. Zlokachestvennye opukholi. 2013; 2: 53–61. [in Russian]
31. Tiuliandina A.S. Nastoiashchee i budushchee targetnoi terapii v pervoi linii lecheniia raka iaichnikov. Farmateka. 2013; 8: 39–42. [in Russian]
32. Soegaard M, Kjaer SK, Cox M et al. BRCA1 and BRCA2 mutation prevalence and clinical characteristics of a population-based series of ovarian cancer cases from Denmark. Clin Cancer Res 2008; 14 (12): 3761–7.
33. Aghajanian C, Goff B, Nycum LR et al. Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer. Gynecol Oncol 2015; 139 (1): 10–6.
34. Pujade-Lauraine E, Hilpert F Weber B et al. Bevacizumab Combined With Chemotherapy for Platinum-Resistant Recurrent Ovarian Cancer: The AURELIA Open-Label Randomized Phase III Trial. J Clin Oncol 2014; 32: 4014–25.
35. Ledermann JA, Embleton AC, Raja F et al. Cediranib in patients with relapsed platinum-sensitive ovarian cancer (ICON6): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2016; 387 (10023): 1066–74.
36. Monk BJ, Poveda A, Vergote I et al. Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlledphase 3 trial. Lancet Oncol 2014; 15 (8): 799–808.
37. Committee for Medicinal Products for Human Use. Lynparza (olaparib). 23 October 2014. EMA/CHMP/632090/2014. http://www.ema. europa.eu/ema/index.jsp ?curl= pages/medicines/human/medicines/003726/smops/Positive/human_smop_000744.jsp&mid=WC0b01ac058001d127
38. 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.
39. Ledermann J, Harter P, Gourley C et al. Overall survival (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.; abstr. 5501).
40. 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 Postprogression Poly(Adenosine Diphosphate Ribose) Polymerase Inhibitor Therapy. Cancer. In print.
41. Hall GD, Brown JM, Coleman RE et al. Maintenance treatment with interferon for advanced ovarian cancer: results of the Northern and Yorkshire Gynecology Group randomized phase III study. Brit J Cancer 2004; 91: 621–6.
42. Alberts DS, Hannigan EV, Liu PY et al. Randomized trial of adjuvant intraperitoneal alpha-interferon in stage III ovarian cancer patients who have no evidence of disease after primary surgery and chemotherapy: an intergroup study. Gynecol Oncol 2006; 100: 133–8.
43. The Cancer Genome Atlas Research Network. Integrated genomic analyses of ovarian Carcinoma. Nature 2011; 474: 609–15.
ФГБУ Российский онкологический научный центр им. Н.Н.Блохина Минздрава России. 115478, Россия, Москва, Каширское ш., д. 23
*Pokia@mail.ru
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I.A.Pokataev*, S.A.Tyulyandin
N.N.Blokhin Russian Cancer Research Center of the Ministry of Health of the Russian Federation. 115478, Russian Federation, Moscow, Kashirskoe sh., d. 23
*Pokia@mail.ru