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Poster display session

4016 - PALOMA-2: Neutropenia (NP) Patterns in Patients (Pts) With Estrogen Receptor−Positive (ER+)/Human Epidermal Growth Factor Receptor 2−Negative (HER2–) First-Line Advanced Breast Cancer (ABC) Receiving Palbociclib + Letrozole (P+L)

Date

11 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Supportive Care and Symptom Management;  Breast Cancer

Presenters

Véronique Diéras

Citation

Annals of Oncology (2017) 28 (suppl_5): v74-v108. 10.1093/annonc/mdx365

Authors

V. Diéras1, N. Harbeck2, A.A. Joy3, K.A. Gelmon4, J. Ettl5, S. Verma6, D. Lu7, E.R. Gauthier8, P. Schnell9, A. Mori10, H.S. Rugo11, R.S. Finn12

Author affiliations

  • 1 Dept Of Medical Oncology, Centre Eugène Marquis, 35042 35042 35042 - RENNES CEDEX/FR
  • 2 Department Of Obstetrics And Gynecology, Brustzentrum der Universität München (LMU), München/DE
  • 3 Department Of Oncology, University of Alberta Cross Cancer Institute, Edmonton/CA
  • 4 Department Of Medical Oncology, British Columbia Cancer Agency, V5Z 4E6 - Vancouver/CA
  • 5 Department Of Obstetrics And Gynecology, Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universitaet Muenchen, Munich/DE
  • 6 Department Of Oncology, University of Calgary, Calgary/CA
  • 7 Global Product Development, Statistics, Pfizer Inc, La Jolla/US
  • 8 Global Product Development, Clinical, Pfizer Inc, San Francisco/US
  • 9 Worldwide Safety And Regulatory, Pfizer Inc, New York/US
  • 10 Global Product Development, Clinical, Pfizer s.r.l, Milan/IT
  • 11 Department Of Medicine (hematology/oncology), University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco/US
  • 12 Division Of Hematology/oncology, David Geffen School of Medicine at UCLA, 90404 - Santa Monica/US
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Resources

Abstract 4016

Background

PALOMA-2 demonstrated efficacy of P+L vs placebo (PBO) + L in pts with treatment-naive ER+/HER2– ABC (Finn NEJM 2016). We describe clinical patterns of hematologic adverse events (AEs), with an emphasis on NP, in pts receiving P+L.

Methods

Postmenopausal women (N = 666) with no prior systemic therapy for ABC were randomized 2:1 to receive P+L (P, 125 mg/d, 3 wk on/1 wk off; L, 2.5 mg/d continuously) or PBO+L (L, 2.5 mg/d continuously) until disease progression, unacceptable toxicity, or consent withdrawal. Hematological AEs are reported based on lab results.

Results

As of 2/26/2016, median follow-up was 23.0 mo in pts receiving P+L (n = 444). Median age of P+L pts was 62.0 (range, 30–89) years; ECOG status was 0, 1, and 2 in 57.9%, 40.1%, and 2.0%, respectively; and 213 (48.0%) received prior chemotherapy. 423 (95.3%) P+L pts experienced any grade (gr) NP, including 298 (70.4%) with gr 3/4 NP, manageable with dose modification. Among pts with gr 3/4 NP, 65 (15.4%), 41 (9.7%), and 192 (45.4%) experienced 1, 2, or ≥ 3 episodes, respectively. 92 (20.7%) and 84 (18.9%) pts experienced 3–5 episodes of any grade anemia and thrombocytopenia, respectively. Median (range) times to first episode of gr ≥ 3 NP, anemia, and thrombocytopenia were 28.0 d (12 − 854 [median duration, 31.5]), 182.0 d (14 − 760 [11.5]), and 283.5 d (21 − 617 [26.5]), respectively. Although NP is associated with increased risk of infection, the rate of gr 3/4 infections was 3.5% in P+L pts with NP. Of pts with gr 3/4 NP, 68.8% did not have any overlapping infections. Febrile NP was reported in 1.8% of P+L pts and did not result in therapy discontinuation. In univariate analysis, risk of developing gr 3/4 NP was associated with Asian ethnicity (P=0.0002) and low baseline absolute neutrophil counts (P

Conclusions

NP occurred early during therapy, and was manageable with dose modification. Febrile NP was reported in 1.8% of P+L pts and did not result in therapy discontinuation. Withholding dose, or dose reduction does not negatively impact PFS. Funding, Pfizer.

Clinical trial identification

NCT01740427

Legal entity responsible for the study

Pfizer Inc

Funding

Pfizer Inc

Disclosure

V. Diéras: Consulting and advisory role: Genentech, Lilly, Pfizer, AbbVie, Novartis Pharma KK, Roche-Peru. Speakers bureau: Pfizer, Novartis Pharma KK, Roche-Peru. N. Harbeck: Honoraria: Lilly, Novartis, Pfizer. A.A. Joy: Honoraria: Pfizer, Novartis, Roche, Eli Lilly, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim. Consulting or Advisory: Pfizer, Novartis, Roche, Eli Lilly, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim. K.A. Gelmon: Consulting or Advisory Role: Pfizer, Novartis, AstraZeneca, NanoString Technologies, Merck. J. Ettl: Honoraria: Pfizer, Novartis Pharma KK, Roche-Peru. Consulting or advisory role: Pfizer, Novartis Pharma KK. Speakers bureau: Pfizer, Novartis Pharma KK, Roche KK. S. Verma: Consulting and advisory role: Genentech/Roche, Lilly, Pfizer, Novartis, Amgen. D. Lu, E.R. Gauthier, P. Schnell, A. Mori: Pfizer employee and shareholder. H.S. Rugo: Speakers bureau and honoraria: Genomic Health. Research funding: Plexxikon Macrogenics, OBI Pharma, Eisai, Pfizer, Novartis, Lilly, GlaxoSmithKline, Genentech, Celsion, Merck, Clovis Oncology. R.S. Finn: Honoraria: Bayer, Pfizer, Bristol-Myers Squibb, Novartis, Eisai. Consulting or advisory role: Pfizer, Bayer, Novartis, Bristol-Myers Squibb, Merck. Research funding: Pfizer.

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