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Ribociclib in breast cancer

Ge-Bu usually discusses new drugs that are going to be frequently used after a recent registration. Hence, one might not expect it to discuss a new drug like ribociclib, as this drug is to be used for metastasised breast cancer, and always in combination with an aromatase inhibitor or an anti-oestrogen drug. Although ribociclib will be prescribed by oncologists, many other non-oncological care providers might be confronted with the advantages and disadvantages of this type of, usually very costly, medication. The use of ribociclib, which is also very expensive, is undisputed in oncological practice, at least for the right indications. The conclusion of the present article is that ribociclib should be given a drug rating of ‘+/-’, as trials have only proven a progression-free survival of about 9 months, when combined with anti-hormone drugs. There is as yet insufficient evidence for improved overall survival. In addition, there is a need for more suitably designed research into the quality of life.

  • Registration studies of ribociclib in combination with hormonal therapy have found a progression-free survival among women with locally advanced or metastasised breast cancer that was about 9 months longer than with anti-hormone drugs alone.
  • No conclusions can as yet be drawn about the effect on the total survival of adding ribociclib to anti-hormone drugs, as the follow-up in the trials of this drug was too short.
  • Practitioners need to be aware of the finding in the registration trials that over 50% of the patients had to have their ribociclib dosage reduced because of adverse effects.
  • For the time being, Ge-Bu gives the expensive ribociclib a drug rating of ‘+/-’, as its use in the treatment of invasive breast cancer only has proven added value in terms of longer progression-free survival, while its value in terms of overall survival or improved quality of life has not yet been proven.

  1. Cardoso F, Senkus E, Costa A, Papadopoulos E, Aapro M, Andre F, et al. 4th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4)dagger. Ann Oncol. 2018;29(8):1634-57.
  2. European Medicines Agengy. Productinformatie Kisquali 2017 [Available from:
  3. Schwartz LH, Litiere S, de Vries E, Ford R, Gwyther S, Mandrekar S, et al. RECIST 1.1-Update and clarification: From the RECIST committee. Eur J Cancer. 2016;62:132-7.
  4. Cardoso F, Costa A, Senkus E, Aapro M, Andre F, Barrios CH, et al. 3rd ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 3). Ann Oncol. 2017;28(1):16-33.
  5. Baselga J, Campone M, Piccart M, Burris HA, 3rd, Rugo HS, Sahmoud T, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012;366(6):520-9.
  6. Dickson MA. Molecular pathways: CDK4 inhibitors for cancer therapy. Clin Cancer Res. 2014;20(13):3379-83.
  7. Rocca A, Farolfi A, Bravaccini S, Schirone A, Amadori D. Palbociclib (PD 0332991) : targeting the cell cycle machinery in breast cancer. Expert Opin Pharmacother. 2014;15(3):407-20.
  8. Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, et al. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med. 2016;375(18):1738-48.
  9. Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018;29(7):1541-7.
  10. Tripathy D, Im SA, Colleoni M, Franke F, Bardia A, Harbeck N, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018;19(7):904-15.
  11. Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, et al. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3. J Clin Oncol. 2018;36(24):2465-72.
  12. College ter Beoordeling Geneesmiddelen. Kisqali 200 mg filmomhulde tabletten [Available from:
  13. Zorginstituut Nederland. Ribociclib (versie 2, 12 juni 2018) 2018 [Available from: 
  14. Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie. Kennisbank 2018 [Available from:
  15. Verma S, O'Shaughnessy J, Burris HA, Campone M, Alba E, Chandiwana D, et al. Health-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: results from MONALEESA-2. Breast Cancer Res Treat. 2018;170(3):535-45.

The literature refers to the Dutch text


  • Frank Warnders, Lisanne L. Krens