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Poster display session

4297 - Effects of neratinib (N) on health-related quality of life (HRQoL) in early-stage HER2+ breast cancer (BC): longitudinal analyses from the phase III ExteNET trial

Date

11 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Breast Cancer

Presenters

Suzette Delaloge

Citation

Annals of Oncology (2017) 28 (suppl_5): v43-v67. 10.1093/annonc/mdx362

Authors

S. Delaloge1, Y. Ye2, D. Cella3, M. Buyse4, A. Chan5, C. Barrios6, F.A. Holmes7, J. Mansi8, H. Iwata9, B. Ejlertsen10, B. Moy11, G. von Minckwitz12, S. Chia13, M. Gnant14, S. Smichkoska15, A. Ciceniene16, S. Moran17, A.H. Auerbach18, L. Fallowfield19, M. Martin Jimenez20

Author affiliations

  • 1 Medical Oncology, Institut Gustave Roussy, 94800  - Villejuif/FR
  • 2 Statistics, Puma Biotechnology Inc., Los Angeles/US
  • 3 Department Of Medical Social Sciences, Northwestern University, Chicago/US
  • 4 Drug Development, International Drug Development Institute (IDDI), 94109 - San Francisco/US
  • 5 Medical Oncology, Breast Cancer Research Centre-Western Australia and Curtin University, Perth/AU
  • 6 Medical Oncology, Pontifical Catholic University of Rio Grande do Sul School of Medicine, Porto Alegre/BR
  • 7 Medical Oncology, Texas Oncology, Houston/US
  • 8 Medical Oncology, Guy’s and St Thomas’ NHS Foundation Trust and Biomedical Research Centre, King’s College London, London/GB
  • 9 Medical Oncology, Aichi Cancer Center, Chikusa-ku, Nagoya/JP
  • 10 Clinical Oncology, Rigshospitalet, Copenhagen/DK
  • 11 Medical Oncology, Massachusetts General Hospital Cancer Center, Boston/US
  • 12 Medical Oncology, German Breast Group, 63263 - Neu-Isenburg/DE
  • 13 Medical Oncology, British Columbia Cancer Agency, Vancouver/CA
  • 14 Surgical Oncology, Comprehensive Cancer Centre, Medical University of Vienna, Vienna/AT
  • 15 Medical Oncology, University Clinic for Radiotherapy and Oncology, Ss Cyril and Methodius University of Skopje, Skopje/MK
  • 16 Medical Oncology, Oncology Institute of Vilnius University, Vilnius/LT
  • 17 Clinical Research And Development, Puma Biotechnology Inc., Los Angeles/US
  • 18 N/a, Puma Biotechnology Inc., Los Angeles/US
  • 19 Sussex Health Outcomes Research & Education In Cancer (shore-c), Brighton & Sussex Medical School, University of Sussex, Brighton/GB
  • 20 Medical Oncology, Hospital General Universitario Gregorio Marañón, Madrid/ES
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Resources

Abstract 4297

Background

The international, randomized, placebo (P)-controlled phase III ExteNET trial (NCT00878709) showed that N for 1 y after trastuzumab-based adjuvant therapy significantly improved 2-y invasive disease-free survival in early HER2+ BC patients (pts) (HR 0.67; 95% CI 0.50–0.91; p = 0.0091) [Chan et al. Lancet Oncol 2016]. Detailed longitudinal evaluation of HRQoL was an exploratory endpoint of ExteNET.

Methods

2840 pts received N 240 mg/d or P for 1 yr. Pts completed FACT-B and EQ-5D questionnaires at baseline and months (M) 1, 3, 6, 9, and 12. Changes in scores from baseline were compared between groups using ANCOVA with no imputation for missing values. Sensitivity analyses using alternative methods were applied. Changes in HRQoL scores were considered to be clinically meaningful if greater than minimal clinically important differences (MCID) reported in the literature.

Results

2407 pts were evaluable for FACT-B (N, n = 1171; P, n = 1236), and 2427 for EQ-5D (N, n = 1186; P, n = 1241). Compliance with questionnaires exceeded 85%. N was associated with decreased HRQoL scores at M1 vs P, after which between-group differences diminished (Table). They were consistently less than MCIDs, except for physical well-being (PWB) subscale at M1. BC subscale (BCS) showed small improvements with N at M3–M9, all less than MCIDs. Different sensitivity methods did not alter the results.Table:

177P

Adjusted mean difference in change from baseline:
ScaleMCID range N vs P
M1M3M6M9M12
FACT-B total7–8–2.9*0.1–0.6–0.5–0.8
TOI-PFB5–6–2.6*–0.3–0.7–0.4–1.0*
TOI-ESB5–601.2*0.60.50.4
PWB2–3–2.4*–1.1*–1.0*–0.9*–1.1*
BCS2–30.30.7*0.4*0.6*0.2
EQ-5D index0.09–0.10–0.02*–0–000
EQ health state7–10–2.7*0.1–1.3*–0.7–0.4

For baseline score;

*

Statistically significant at p 

Conclusions

N was associated with decreased HRQoL, in particular in PWB, at M1, possibly due to N-related diarrhea. Based on their small magnitude, differences observed after M1 in PWB favoring P and in BCS favoring N, may not be clinically important.

Clinical trial identification

NCT00878709

Legal entity responsible for the study

Wyeth, Pfizer and Puma Biotechnology

Funding

Puma Biotechnology

Disclosure

S. Delaloge: Grants and personal fees from Roche and GSK. Y. Ye: Employment: Puma Biotechnology Inc. M. Buyse: Employee and shareholder of IDDI. A. Chan: Personal fees for educational meetings from Pfizer, Amgen. Non-financial support from Puma Biotechnology outside the submitted work. C. Barrios: Grants from Amgen, AstraZeneca, Boehringer Ingelheim, Novartis, Pfizer, Roche, Celgene, Sanofi, Lilly, Puma. Personal fees from GSK, Novartis, Pfizer, Roche, Eisai. B. Ejlertsen: Grants to institution from NanoString, Novartis, and Roche, outside the submitted work. Travel support for educational meetings from AstraZeneca and Celgene. G. von Minckwitz: Research funding to the institution from Amgen, Roche, Novartis, Celgene, Teva, AstraZeneca, Myriad Genetics, AbbVie and Vifor Pharma. M. Gnant: Grants from Sanofi-Aventis, Novartis, Roche, GSK, Pfizer, Smith Medical. Personal fees from Novartis, AstraZeneca, Accelsiors, Eisai. S. Moran, A.H. Auerbach: Employment and stock options: Puma Biotechnology Inc. All other authors have declared no conflicts of interest.

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