dc.contributor.author | Gnant, M | |
dc.contributor.author | Dueck, AC | |
dc.contributor.author | Frantal, S | |
dc.contributor.author | Martin, M | |
dc.contributor.author | Burstein, HJ | |
dc.contributor.author | Greil, R | |
dc.contributor.author | Fox, P | |
dc.contributor.author | Wolff, AC | |
dc.contributor.author | Chan, A | |
dc.contributor.author | Winer, EP | |
dc.contributor.author | Pfeiler, G | |
dc.contributor.author | Miller, KD | |
dc.contributor.author | Colleoni, M | |
dc.contributor.author | Suga, JM | |
dc.contributor.author | Rubovsky, G | |
dc.contributor.author | Bliss, JM | |
dc.contributor.author | Mayer, IA | |
dc.contributor.author | Singer, CF | |
dc.contributor.author | Nowecki, Z | |
dc.contributor.author | Hahn, O | |
dc.contributor.author | Thomson, J | |
dc.contributor.author | Wolmark, N | |
dc.contributor.author | Amillano, K | |
dc.contributor.author | Rugo, HS | |
dc.contributor.author | Steger, GG | |
dc.contributor.author | Hernando Fernández de Aránguiz, B | |
dc.contributor.author | Haddad, TC | |
dc.contributor.author | Perelló, A | |
dc.contributor.author | Bellet, M | |
dc.contributor.author | Fohler, H | |
dc.contributor.author | Metzger Filho, O | |
dc.contributor.author | Jallitsch-Halper, A | |
dc.contributor.author | Solomon, K | |
dc.contributor.author | Schurmans, C | |
dc.contributor.author | Theall, KP | |
dc.contributor.author | Lu, DR | |
dc.contributor.author | Tenner, K | |
dc.contributor.author | Fesl, C | |
dc.contributor.author | DeMichele, A | |
dc.contributor.author | Mayer, EL | |
dc.contributor.author | PALLAS groups and investigators, | |
dc.date.accessioned | 2022-04-13T08:59:28Z | |
dc.date.available | 2022-04-13T08:59:28Z | |
dc.date.issued | 2022-01-20 | |
dc.identifier.citation | Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022, 40 (3), pp. 282 - 293 | |
dc.identifier.issn | 0732-183X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5080 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.doi | 10.1200/jco.21.02554 | |
dc.identifier.doi | 10.1200/jco.21.02554 | |
dc.description.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. | |
dc.format | Print-Electronic | |
dc.format.extent | 282 - 293 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | LIPPINCOTT WILLIAMS & WILKINS | |
dc.rights.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
dc.subject | PALLAS groups and investigators | |
dc.subject | Humans | |
dc.subject | Breast Neoplasms | |
dc.subject | Disease Progression | |
dc.subject | Piperazines | |
dc.subject | Pyridines | |
dc.subject | Antineoplastic Agents, Hormonal | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Protein Kinase Inhibitors | |
dc.subject | Neoplasm Staging | |
dc.subject | Disease-Free Survival | |
dc.subject | Chemotherapy, Adjuvant | |
dc.subject | Neoadjuvant Therapy | |
dc.subject | Mastectomy | |
dc.subject | Prospective Studies | |
dc.subject | Time Factors | |
dc.subject | Middle Aged | |
dc.subject | Female | |
dc.subject | Progression-Free Survival | |
dc.title | Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03). | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2021-11-04 | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1200/jco.21.02554 | |
dc.relation.isPartOf | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | |
pubs.issue | 3 | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit | |
pubs.publication-status | Published | |
pubs.volume | 40 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Clinical Trials & Statistics Unit | |
dc.contributor.icrauthor | Bliss, Judith | |