Preview

Опухоли женской репродуктивной системы

Расширенный поиск

ПАЛБОЦИКЛИБ В КОМБИНАЦИИ С ГОРМОНОТЕРАПИЕЙ ПРИ ЛЮМИНАЛЬНОМ HER2-НЕГАТИВНОМ МЕТАСТАТИЧЕСКОМ РАКЕ МОЛОЧНОЙ ЖЕЛЕЗЫ: НОВАЯ ВЫСОКОЭФФЕКТИВНАЯ СТРАТЕГИЯ ЛЕКАРСТВЕННОГО ЛЕЧЕНИЯ

https://doi.org/10.17650/1994-4098-2017-13-3-28-40

Полный текст:

Аннотация

Обзор посвящен новому пероральному таргетному препарату палбоциклибу и его месту в терапии люминального (эстроген-рецептор-позитивного) HER2– метастатического рака молочной железы (РМЖ). Как показали результаты проведенных рандомизированных клинических исследований, включение палбоциклиба в различные режимы гормонотерапии HER2– метастатического РМЖ с экспрессией рецепторов эстрогенов позволило существенно улучшить клинические исходы и повысить показатели выживаемости, частоту объективного ответа, его продолжительность и частоту «клинической пользы» (КП). Выигрыш в отношении выживаемости без прогрессирования болезни при добавлении палбоциклиба к летрозолу в 1-й линии гормонотерапии или к фулвестранту у пациенток с прогрессированием на фоне и после предшествующей эндокринной терапии отмечался во всех подгруппах независимо от клинических характеристик, особенностей течения опухолевого процесса, а также экспрессии молекулярных маркеров, опосредующих развитие гормонорезистентности. Основными нежелательными явлениями, связанными с палбоциклибом, были нейтро-, лейкои тромбоцитопения, но в целом гематологическая токсичность была управляемой, а сама терапия безопасной. Эта стратегия, названная экспертами «терапией прорыва», сочетает в себе доказанную эффективность, хорошую переносимость, позволяет поддерживать высокое качество жизни и должна использоваться у больных эстроген-рецептор-позитивным  HER2– метастатическим РМЖ.

Об авторе

Е. В. Артамонова
ФГБУ «НМИЦ онкологии им. Н. Н. Блохина» Минздрава России
Россия

Елена Владимировна Артамонова.

115478, Москва, Каширское шоссе, 23



Список литературы

1. Злокачественные новообразования в России в 2015 году (Заболеваемость и смертность). Под ред. А. Д. Каприна, В. В. Старинского, Г. М. Петровой. М.: МНИОИ им. П. А. Герцена, 2017. [Malignant tumors in Russia in 2015 (morbidity and mortality). Eds. A. D. Kaprin, V. V. Starinsky, G. M. Petrova. Moscow: MNIOI imeni P. A. Hertzena, 2017. (In Russ.)].

2. Состояние онкологической помощи населению России в 2015 году. Под ред. А. Д. Каприна, В. В. Старинского, Г. В. Петровой. М.: МНИОИ им. П. А. Герцена – филиал ФГБУ «НМИРЦ» Минздрава России, 2016. [State of oncological care in Russia in 2015. Editors: A. D. Kaprin, V. V. Starinskiy, G. V. Petrova. Moscow: MNIOI imeni P. A. Hertzena – filial FGBU “NMIRC” Minzdrava Rossii, 2016. (In Russ.)].

3. Pan H., Gray R.G., Davies C. et al. Predictors of recurrence during years 5–14 in 46,138 women with ER+ breast cancer allocated 5 years only of endocrine therapy (ET). ASCO 2016. J Clin Oncol 2016;34(suppl):abstr 505.

4. Saad E., Katz A., Machado K., Buyse M. Post-Progression Survival (PPS) and Overall Survival (OS) According to Treatment Type in Contemporary Phase III Trials in Advanced Breast Cancer (ABC). SABCS 2009. Abstr 5116.

5. Dawood S., Broglio K., Gonzalez-Angulo AM. et al: Trends in survival over the past two decades among white and black patients with newly diagnosed stage IV breast cancer. J Clin Oncol 2008;26:4891–98. http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-029771.pdf. Accessed April 1, 2013

6. DeVita V., Lawrence T., Rosenberg S. et al. DeVita, Hellman, and Rosenberg’s Cancer: Principles and Practice of oncology. 8th ed. Philadelphia: J.B. Lippincott, 2008. P.1634.

7. Perou C.M. Molecular Stratification of Triple-Negative Breast Cancer. The Oncologist 2011;16(suppl 1):61–70. DOI: 10.1634/theoncologist.2011-S1-61. PMID: 21278442.

8. Rugo H.S., Rumble R.B., Macrae E. et al. Endocrine therapy for hormone receptorpositive metastatic breast cancer: Americane Society of Clinical Oncology guideline. J Clin Oncol 2016;34(25):3069–103. DOI: 10.1200/JCO.2016.67.1487.

9. Wilcken N., Hornbuckle J., Ghersi D. Chemotherapy alone versus endocrine therapy alone for metastatic breast cancer. Cochrane Database Syst Rev 2003;2:CD002747.

10. Llombart-Cussac A., Pivot X.B., Biganzoli L. et al. A prognostic factor (PF) index for overall survival in a HER2-negative endocrineresistant metastatic breast cancer (MBC) population: Analysis from the ATHENA trial. ASCO 2013. J Clin Oncol 2013;31(suppl);abstr 555.

11. Cardoso F., Costa A., Norton L. et al. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Ann Oncol 2014;25(10):1871–88. DOI: 10.1093/annonc/mdu385. PMID: 25234545.

12. Mauri D., Pavlidis N., Polysos NP., Ioannidis JP. Survival with aromatase inhibitors and inactivators versus standard hormonal therapy in advanced breast cancer: meta-analysis. J Natl Cancer Inst 2006;98(18):1285–91. DOI: 10.1093/jnci/djj357. PMID: 16985247.

13. Bonneterre J., Thürlimann B, Robertson JF. Anastrozole versus tamoxifen as first-line therapy for advanced breast cancer in 668 postmenopausal women: results of the tamoxifen or arimidex randomized group efficacy and tolerability study. J Clin Oncol 2000;18:3748–57. DOI: 10.1200/JCO.2000.18.22.3748. PMID: 11078487.

14. Mouridsen H., Gershanovich M., Sun Y. et al. Superior efficacy of letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: results of a phase III study of the International letrozole breast cancer group. J Clin Oncol 2001;19(10):2596–606. DOI: 10.1200/JCO.2001.19.10.2596. PMID: 11352951.

15. Mouridsen H., Gershanovich M., Sun Y. et al. Phase III study of letrozole versus tamoxifen as first-line therapy of advanced breast cancer in postmenopausal women: analysis of survival and update of efficacy from the International letrozole breast cancer group. J Clin Oncol 2003;21(16):2101–2109. DOI: 10.1200/JCO.2003.04.194. PMID: 12775735.

16. Robertson J.F.R., Lindemann J.P.O., Llombart-Cussac A. et al. A comparison of fulvestrant 500 mg with anastrozole as first-line treatment for advanced breast cancer: followup analysis from the «FIRST» study. Presented at: 33rd Annual San Antonio Breast Cancer Symposium; Dec 8-12; 2010; San Antonio, TX, abstr. S1–3.

17. Osborne C.K., Pippen J., Jones S.E. et al. Double-blind, randomi zed tr ial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American Trial. J Clin Oncol 2002;20(16):3386–95. DOI: 10.1200/JCO.2002.10.058. PMID: 12177098.

18. Howell A., Robertson J.F., Quaresma Albano J. et al. Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. J Clin Oncol 2002;20(16):3396–403. DOI: 10.1200/JCO.2002.10.057. PMID: 12177099.

19. Chia S., Gradishar W., Mauriac L. et al. Double-blind, randomized placebo controlled trial of fulvestrant compared with exemestane after prior nonsteroidal aromatase inhibitor therapy in postmenopausal women with hormone receptor-positive, advanced breast cancer: results from EFECT. J Clin Oncol 2008;26(10):1664–70. DOI: 10.1200/JCO.2007.13.5822. PMID: 18316794.

20. Steele N., Zekri J., Coleman R., et al. Exemestane in metastatic breast cancer: effective therapy after third-generation non-steroidal aromatase inhibitor failure. Breast 2006;15:430–6. DOI: 10.1016/j.breast.2005.08.032. PMID: 16236514.

21. Carlini P., Michelotti A., Ferretti G. et al. Clinical evaluation of the use of exemestane as further hormonal therapy after nonsteroidal aromatase inhibitors in postmenopausal metastatic breast cancer patients. Cancer Invest 2007;25(2):102–5. DOI: 10.1080/07357900701224789. PMID: 17453821.

22. Lonning P.E.., Bajetta E., Murray R. et al. Activity of exemestane in metastatic breast cancer after failure of nonsteroidal aromatase inhibitors: a phase II trial. J Clin Oncol 2000;18:2234–44. DOI: 10.1200/JCO.2000.18.11.2234. PMID: 10829043.

23. Baselga J., Campone M., Piccart M. et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med 2012;366:520–29. DOI: 10.1056/NEJMoa1109653. PMID: 22149876.

24. The Nobel Prize in Physiology or Medicine 2001. Avaiable at: www.nobelprize.org/nobel_prizes/medicine/laureates/2001/?google_referrer = mail.ru.

25. Hanahan D., Weinberg R.A. Hallmarks of cancer: the next generation. Cell 2011;144:646–74. DOI: 10.1016/j.cell.2011.02.013. PMID: 21376230.

26. Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature 2012;490:61–70. DOI: 10.1038/nature11412./ PMID: 23000897.

27. Hirama T., Koeffler H.P. Role of the Cyclin-Dependent Kinase Inhibitors in the Development of Cancer. Blood 1995;86:841–54. PMID: 7620180.

28. Fry D.W., Harvey P.J., Keller P.R. et al. Specific Inhibition of cyclin-dependent kinase 4/6 by PD 0332991 and associated antitumor activity in human tumor xenografts. Mol Cancer Ther 2004;3:1427-1437. PMID: 15542782.

29. Choi Y.J., Anders L. Signaling through cyclin D-dependent kinases. Oncogene 2014;33:1890–903. DOI: 10.1038/onc.2013.137. PMID: 23644662.

30. Finn R.S., Dering J., Conklin D. et al. PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitro. Breast Cancer Res 2009;11(5):R77. DOI: 10.1186/bcr2419. PMID: 19874578.

31. Lamb R., Lehn S., Rogerson L., Clarke R.B., Landberg G. Cell cycle regulators cyclin D1 and CDK4/6 have estrogen receptor-dependent divergent functions in breast cancer migration and stem cell-like activity. Cell Cycle. 2013;12(15):2384–94. DOI: 10.4161/cc.25403. PMID: 23839043.

32. Finn R.S., Crown J.P., Lang I. et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol 2015;16(1):25–35. DOI: 10.1016/S1470-2045(14)71159-3. PMID: 25524798.

33. Finn R.S., Crown J.P., Ettl J. et al. Efficacy and safety of palbociclib in combination with letrozole as first-line treatment of ER-positive, HER2-negative, advanced breast cancer: expanded analyses of subgroups from randomized pivotal trial PALOMA-1/TRIO-18. Breast Cancer Res 2016;18:67. DOI 10.1186/s13058-016-0721-5. PMID: 27349747.

34. Finn R.S., Crown J.P., Lang I. et al. Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole vs letrozole alone for first-line treatment of ER+ / HER2- advanced breast cancer (PALOMA-1; TRIO-18). J Clin Oncol 2017;35(suppl):abstr.1001.

35. Finn R.S., Martin M., Rugo H.S. et al. PALOMA-2: primary results from a phase III trial of palbociclib (P) with letrozole (L) compared with letrozole alone in postmenopausal women with ER+/HER2- advanced breast cancer (ABC). J Clin Oncol 2016;34(suppl):abstr. 507.

36. Finn R.S., Martin M., Rugo H.S. et al. Palbociclib and letrozole in advanced breast cancer . N Engl J Med 2016;375:1925–36. 10.1056/NEJMoa1607303. PMID: 27959613.

37. Finn R.S., Dieras V., Rugo H.S. et al. Palbociclib (PAL) + letrozole (L) as first-line (1L) therapy (tx) in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): efficacy and safety across patient (pt) subgroups. J Clin Oncol 2017;35(suppl):abstr.1039.

38. Turner N.C., Ro J., Andre F. et al. Palbociclib in hormone-receptor-positive advanced breast cancer. N Engl J Med 2015;373(3):209–19. DOI: 10.1056/NEJMoa1505270.

39. Cristofanilli M., Turner N.C., Bondarenko I. et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, doubleblind, phase 3 randomised controlled trial. Lancet Oncol 2016;17:425–39. DOI: 10.1016/S1470-2045(15)00613-0. PMID: 26947331.

40. Turner NC C, André F, Cristofanilli M. et al. Treatment postprogression in women with endocrine-resistant HR+/HER2- advanced breast cancer who received palbociclib plus fulvestrant in PALOMA-3. Presented at SABCS 2016; San Antonio, Texas, USA (Poster 4-22-06).

41. Turner N.C., Jiang Y., O'Leary B. et al. Efficacy of palbociclib plus fulvestrant (P+F) in patients (pts) with metastatic breast cancer (MBC) and ESR1 mutations (mus) in circulating tumor DNA (ctDNA). J Clin Oncol 2016;34(suppl);abstr.512.

42. Harbeck N., Iyer S., Cristofanilli M. et al. Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial. Ann Oncol 2016;27(6):1047–54. DOI: 10.1093/annonc/mdw139. PMID: 27029704.

43. Verma S., Bartlett C.H., Schnell P. et al. Palbociclib in combination with fulvestrant inwomen with hormone receptor-positive/HER2-negativeadvancedmetastaticbreast cancer: detailed safety analysis from a multicenter, randomized, placebo-controlled, phase III study (PALOMA-3). Oncologyst 2016;21(10):1165–75. DOI: 10.1634/theoncologist.2016-0097. PMID: 27368881.

44. Diéras V., Rugo H.S., Gelmon K. et al. Long-term safety of palbociclib in combination with endocrine therapy in treatment-naive and previously treated women with HR+HER2– advanced breast cancer: A pooled analysis from randomized phase 2 and 3 studies. Poster presented at SABCS 2016 [abstract no. P4–22-07 plus poster]. Cancer Res 2017;77(4 Suppl).

45. Dhakal A., Matthews Ch., Zhang F. et al. Outcome of palbociclib based therapy in hormone receptor positive metastatic breast cancer patients after treatment with everolimus. J Clin Oncol 2017;35(suppl);abstr.1054.


Для цитирования:


Артамонова Е.В. ПАЛБОЦИКЛИБ В КОМБИНАЦИИ С ГОРМОНОТЕРАПИЕЙ ПРИ ЛЮМИНАЛЬНОМ HER2-НЕГАТИВНОМ МЕТАСТАТИЧЕСКОМ РАКЕ МОЛОЧНОЙ ЖЕЛЕЗЫ: НОВАЯ ВЫСОКОЭФФЕКТИВНАЯ СТРАТЕГИЯ ЛЕКАРСТВЕННОГО ЛЕЧЕНИЯ. Опухоли женской репродуктивной системы. 2017;13(3):28-40. https://doi.org/10.17650/1994-4098-2017-13-3-28-40

For citation:


Artamonova E.V. PALBOCICLIB IN COMBINATION WITH HORMONE THERAPY FOR LUMINAL HER2-NEGATIVE METASTATIC BREAST CANCER: NEW HIGHLY EFFECTIVE STRATEGY OF DRUG TREATMENT. Tumors of female reproductive system. 2017;13(3):28-40. (In Russ.) https://doi.org/10.17650/1994-4098-2017-13-3-28-40

Просмотров: 182


Creative Commons License
Контент доступен под лицензией Creative Commons Attribution 4.0 License.


ISSN 1994-4098 (Print)
ISSN 1999-8627 (Online)