Michael Gnant1,2, Amylou C Dueck3, Sophie Frantal2, Miguel Martin4,5, Hal J Burstein6, Richard Greil7, Peter Fox8, Antonio C Wolff9, Arlene Chan10, Eric P Winer6, Georg Pfeiler1,11, Kathy D Miller12, Marco Colleoni13, Jennifer M Suga14, Gabor Rubovsky15, Judith M Bliss16, Ingrid A Mayer17, Christian F Singer1,11, Zbigniew Nowecki18, Olwen Hahn19, Jacqui Thomson20, Norman Wolmark21, Kepa Amillano22, Hope S Rugo23, Guenther G Steger1, Blanca Hernando Fernández de Aránguiz5,24, Tufia C Haddad25, Antonia Perelló26, Meritxell Bellet27, Hannes Fohler2, Otto Metzger Filho5,28, Anita Jallitsch-Halper2, Kadine Solomon28, Céline Schurmans29, Kathy P Theall30, Dongrui R Lu31, Kathleen Tenner25, Christian Fesl2, Angela DeMichele32, Erica L Mayer5. 1. Medical University of Vienna, Comprehensive Cancer Center, Vienna, Austria. 2. ABCSG, Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria. 3. Alliance Statistics and Data Center and Mayo Clinic, Phoenix, AZ. 4. Hospital General Universitario Gregorio Marañón, Madrid, Spain. 5. GEICAM Spanish Breast Cancer Group, Madrid, Spain. 6. Dana-Farber Cancer Institute, Boston, MA. 7. Department of Internal Medicine III with Haematology, Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Oncologic Center, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center of Clinical Cancer and Immunology Trials; Cancer Cluster Salzburg, Salzburg, Austria. 8. Central West Cancer Care Centre, Orange Health Service, Orange, NSW, Australia. 9. Johns Hopkins University, Baltimore, MD. 10. Breast Cancer Research Centre-WA & Curtin University, Perth, Australia. 11. Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna, Austria. 12. Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN. 13. IEO, European Institute of Oncology, IRCCS, Milan, Italy. 14. Kaiser Permanente Vallejo Medical Center, Vallejo, CA. 15. National Institute of Oncology, Budapest, Hungary. 16. The Institute of Cancer Research, London, United Kingdom. 17. Vanderbilt University Medical Center, Nashville, TN. 18. The Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland. 19. University of Chicago, Chicago, IL. 20. Peninsula Health, Melbourne, Australia. 21. NSABP Foundation, Inc, and The UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA. 22. Hospital Universitari Sant Joan de Reus, Reus, Spain. 23. University of California San Francisco Comprehensive Cancer Center, San Francisco, CA. 24. Hospital Universitario de Burgos, Burgos, Spain. 25. Mayo Clinic, Rochester, MN. 26. Hospital Universitari Son Espases, Palma de Mallorca, Spain. 27. Vall d'Hebron Institute of Oncology, Barcelona, Spain. 28. Alliance Foundation Trials, Boston, MA. 29. BIG, Brussels, Belgium. 30. Pfizer, Cambridge, MA. 31. Pfizer, La Jolla, CA. 32. University of Pennsylvania, Philadelphia, PA.
Abstract
PURPOSE: Palbociclib is a cyclin-dependent kinase 4 and 6 inhibitor approved for advanced breast cancer. In the adjuvant setting, the potential value of adding palbociclib to endocrine therapy for hormone receptor-positive breast cancer has not been confirmed. PATIENTS AND METHODS: In the prospective, randomized, phase III PALLAS trial, patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer were randomly assigned to receive 2 years of palbociclib (125 mg orally once daily, days 1-21 of a 28-day cycle) with adjuvant endocrine therapy or adjuvant endocrine therapy alone (for at least 5 years). The primary end point of the study was invasive disease-free survival (iDFS); secondary end points were invasive breast cancer-free survival, distant recurrence-free survival, locoregional cancer-free survival, and overall survival. RESULTS: Among 5,796 patients enrolled at 406 centers in 21 countries worldwide over 3 years, 5,761 were included in the intention-to-treat population. At the final protocol-defined analysis, at a median follow-up of 31 months, iDFS events occurred in 253 of 2,884 (8.8%) patients who received palbociclib plus endocrine therapy and in 263 of 2,877 (9.1%) patients who received endocrine therapy alone, with similar results between the two treatment groups (iDFS at 4 years: 84.2% v 84.5%; hazard ratio, 0.96; CI, 0.81 to 1.14; P = .65). No significant differences were observed for secondary time-to-event end points, and subgroup analyses did not show any differences by subgroup. There were no new safety signals for palbociclib in this trial. CONCLUSION: At this final analysis of the PALLAS trial, the addition of adjuvant palbociclib to standard endocrine therapy did not improve outcomes over endocrine therapy alone in patients with early hormone receptor-positive breast cancer.
PURPOSE: Palbociclib is a cyclin-dependent kinase 4 and 6 inhibitor approved for advanced breast cancer. In the adjuvant setting, the potential value of adding palbociclib to endocrine therapy for hormone receptor-positive breast cancer has not been confirmed. PATIENTS AND METHODS: In the prospective, randomized, phase III PALLAS trial, patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer were randomly assigned to receive 2 years of palbociclib (125 mg orally once daily, days 1-21 of a 28-day cycle) with adjuvant endocrine therapy or adjuvant endocrine therapy alone (for at least 5 years). The primary end point of the study was invasive disease-free survival (iDFS); secondary end points were invasive breast cancer-free survival, distant recurrence-free survival, locoregional cancer-free survival, and overall survival. RESULTS: Among 5,796 patients enrolled at 406 centers in 21 countries worldwide over 3 years, 5,761 were included in the intention-to-treat population. At the final protocol-defined analysis, at a median follow-up of 31 months, iDFS events occurred in 253 of 2,884 (8.8%) patients who received palbociclib plus endocrine therapy and in 263 of 2,877 (9.1%) patients who received endocrine therapy alone, with similar results between the two treatment groups (iDFS at 4 years: 84.2% v 84.5%; hazard ratio, 0.96; CI, 0.81 to 1.14; P = .65). No significant differences were observed for secondary time-to-event end points, and subgroup analyses did not show any differences by subgroup. There were no new safety signals for palbociclib in this trial. CONCLUSION: At this final analysis of the PALLAS trial, the addition of adjuvant palbociclib to standard endocrine therapy did not improve outcomes over endocrine therapy alone in patients with early hormone receptor-positive breast cancer.
Authors: Ilana Schlam; Paolo Tarantino; Stefania Morganti; Filipa Lynce; Dario Trapani; Erica L Mayer; Ana C Garrido-Castro; Ada Waks; Sara M Tolaney Journal: Drugs Date: 2022-10-07 Impact factor: 11.431
Authors: Nina Ditsch; Achim Wöcke; Michael Untch; Christian Jackisch; Ute-Susann Albert; Maggie Banys-Paluchowski; Ingo Bauerfeind; Jens-Uwe Blohmer; Wilfried Budach; Peter Dall; Eva Maria Fallenberg; Peter A Fasching; Tanja N Fehm; Michael Friedrich; Bernd Gerber; Oleg Gluz; Nadia Harbeck; Jörg Heil; Jens Huober; Hans H Kreipe; David Krug; Thorsten Kühn; Sherko Kümmel; Cornelia Kolberg-Liedtke; Sibylle Loibl; Diana Lüftner; Michael Patrick Lux; Nicolai Maass; Christoph Mundhenke; Ulrike Nitz; Tjoung-Won Park-Simon; Toralf Reimer; Kerstin Rhiem; Achim Rody; Marcus Schmidt; Andreas Schneeweiss; Florian Schütz; Hans-Peter Sinn; Christine Solbach; Erich-Franz Solomayer; Elmar Stickeler; Christoph Thomssen; Isabell Witzel; Volkmar Müller; Wolfgang Janni; Marc Thill Journal: Breast Care (Basel) Date: 2022-05-05 Impact factor: 2.268
Authors: Grace M Choong; Savannah Liddell; Roberto A Leon Ferre; Ciara C O'Sullivan; Kathryn J Ruddy; Tufia C Haddad; Timothy J Hobday; Prema P Peethambaram; Minetta C Liu; Matthew P Goetz; Karthik V Giridhar Journal: Breast Cancer Res Treat Date: 2022-08-31 Impact factor: 4.624
Authors: Georg Pfeiler; Angela DeMichele; Amylou C Dueck; Christian Fesl; Michael Gnant; Erica L Mayer Journal: Lancet Oncol Date: 2022-02 Impact factor: 41.316