291P - PALOMA-2: Neutropenia (NP) Patterns in Patients (Pts) With Estrogen Receptor−Positive (ER+)/Human Epidermal Growth Factor Receptor 2−Negative (HER2...

Date 11 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Anti-Cancer Agents & Biologic Therapy
Complications of Treatment
Breast Cancer, Metastatic
Breast Cancer
Presenter 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
  • 1Dept Of Medical Oncology, Centre Eugène Marquis, 35042 35042 35042 - RENNES CEDEX/FR
  • 2Department Of Obstetrics And Gynecology, Brustzentrum der Universität München (LMU), München/DE
  • 3Department Of Oncology, University of Alberta Cross Cancer Institute, Edmonton/CA
  • 4Department Of Medical Oncology, British Columbia Cancer Agency, V5Z 4E6 - Vancouver/CA
  • 5Department Of Obstetrics And Gynecology, Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universitaet Muenchen, Munich/DE
  • 6Department Of Oncology, University of Calgary, Calgary/CA
  • 7Global Product Development, Statistics, Pfizer Inc, La Jolla/US
  • 8Global Product Development, Clinical, Pfizer Inc, San Francisco/US
  • 9Worldwide Safety And Regulatory, Pfizer Inc, New York/US
  • 10Global Product Development, Clinical, Pfizer s.r.l, Milan/IT
  • 11Department Of Medicine (hematology/oncology), University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco/US
  • 12Division Of Hematology/oncology, David Geffen School of Medicine at UCLA, 90404 - Santa Monica/US

Abstract

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.