Beverly Moy1, Mafalda Oliveira2, Cristina Saura2, William Gradishar3, Sung-Bae Kim4, Adam Brufsky5, Sara A Hurvitz6, Larisa Ryvo7, Daniele Fagnani8, Sujith Kalmadi9, Paula Silverman10, Suzette Delaloge11, Jesus Alarcon12, Ava Kwong13, Keun Seok Lee14, Peter Cher Siang Ang15, Samuel Guan Wei Ow16, Sung-Chao Chu17, Richard Bryce18, Kiana Keyvanjah18, Judith Bebchuk18, Bo Zhang18, Nina Oestreicher18, Ron Bose19, Nancy Chan20. 1. Massachusetts General Hospital Cancer Center, 55 Fruit Street, Boston, MA, 02114, USA. bmoy@mgh.harvard.edu. 2. Vall D'Hebron University Hospital, Vall D'Hebron Institute of Oncology, Barcelona, Spain. 3. Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL, USA. 4. Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. 5. Magee-Womens Hospital of UPMC, Pittsburgh, PA, USA. 6. University of California Los Angeles/Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA. 7. Assuta Ashdod Medical Center, Ashdod, Israel. 8. Azienda Socio-Sanitaria Territoriale Di Vimercate, Vimercate, Italy. 9. Ironwood Cancer and Research Center, Chandler, AZ, USA. 10. University Hospitals Cleveland Medical Center, Cleveland, OH, USA. 11. Gustave Roussy, Villejuif, France. 12. Servicio de Oncologia, Hospital Universitario Son Espases, Palma de Mallorca, Balearic Islands, Spain. 13. Department of Surgery, Queen Mary Hospital, Hong Kong, Hong Kong. 14. National Cancer Center, Gyeonggi-do, Republic of Korea. 15. Gleneagles Medical Centre, Singapore, Singapore. 16. National University Cancer Institute, Singapore, Singapore. 17. Hualien Tzu Chi Medical Center, Hualien, Taiwan. 18. Puma Biotechnology Inc., Los Angeles, CA, USA. 19. Washington University School of Medicine, St. Louis, MO, USA. 20. Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Abstract
PURPOSE: To characterize health-related quality of life (HRQoL) in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) from the NALA phase 3 study. METHODS: In NALA (NCT01808573), patients were randomized 1:1 to neratinib + capecitabine (N + C) or lapatinib + capecitabine (L + C). HRQoL was assessed using seven prespecified scores from the European Organisation for Research and Treatment of Cancer Quality Of Life Questionnaire core module (QLQ-C30) and breast cancer-specific questionnaire (QLQ-BR23) at baseline and every 6 weeks. Descriptive statistics summarized scores over time, mixed models evaluated differences between treatment arms, and Kaplan-Meier methods were used to assess time to deterioration in HRQoL scores of ≥ 10 points. RESULTS: Of the 621 patients randomized in NALA, patients were included in the HRQoL analysis if they completed baseline and at least one follow-up questionnaire. The summary, global health status, physical functioning, fatigue, constipation, and systemic therapy side effects scores were stable over time with no persistent differences between treatment groups. There were no differences in time to deterioration (TTD) for the QLQ-C30 summary score between treatment arms; the hazard ratio (HR) for N + C vs. L + C was 0.94 (95% CI 0.63-1.40). Only the diarrhea score worsened significantly more in the N + C arm as compared to the L + C arm, and this remained over time (HR for TTD for N + C vs. L + C was 1.71 [95% CI 1.32-2.23]). CONCLUSION: In NALA, patients treated with N + C maintained their global HRQoL over time, despite a worsening of the diarrhea-related scores. These results may help guide optimal treatment selection for HER2-positive MBC.
RCT Entities:
PURPOSE: To characterize health-related quality of life (HRQoL) in patients with humanepidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) from the NALA phase 3 study. METHODS: In NALA (NCT01808573), patients were randomized 1:1 to neratinib + capecitabine (N + C) or lapatinib + capecitabine (L + C). HRQoL was assessed using seven prespecified scores from the European Organisation for Research and Treatment of Cancer Quality Of Life Questionnaire core module (QLQ-C30) and breast cancer-specific questionnaire (QLQ-BR23) at baseline and every 6 weeks. Descriptive statistics summarized scores over time, mixed models evaluated differences between treatment arms, and Kaplan-Meier methods were used to assess time to deterioration in HRQoL scores of ≥ 10 points. RESULTS: Of the 621 patients randomized in NALA, patients were included in the HRQoL analysis if they completed baseline and at least one follow-up questionnaire. The summary, global health status, physical functioning, fatigue, constipation, and systemic therapy side effects scores were stable over time with no persistent differences between treatment groups. There were no differences in time to deterioration (TTD) for the QLQ-C30 summary score between treatment arms; the hazard ratio (HR) for N + C vs. L + C was 0.94 (95% CI 0.63-1.40). Only the diarrhea score worsened significantly more in the N + C arm as compared to the L + C arm, and this remained over time (HR for TTD for N + C vs. L + C was 1.71 [95% CI 1.32-2.23]). CONCLUSION: In NALA, patients treated with N + C maintained their global HRQoL over time, despite a worsening of the diarrhea-related scores. These results may help guide optimal treatment selection for HER2-positive MBC.
Entities:
Keywords:
HER2-positive; Health-related quality of life; Metastatic breast cancer; Neratinib
Authors: Catherine C Smith; Aaron D Viny; Evan Massi; Cyriac Kandoth; Nicholas D Socci; Franck Rapaport; Matthieu Najm; Juan S Medina-Martinez; Elli Papaemmanuil; Theodore C Tarver; Henry H Hsu; Mai H Le; Brian West; Gideon Bollag; Barry S Taylor; Ross L Levine; Neil P Shah Journal: Clin Cancer Res Date: 2021-06-08 Impact factor: 12.531
Authors: Diogo Mendes; Carlos Alves; Noémia Afonso; Fátima Cardoso; José Luís Passos-Coelho; Luís Costa; Sofia Andrade; Francisco Batel-Marques Journal: Breast Cancer Res Date: 2015-11-17 Impact factor: 6.466