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Quality of life (QoL) in metastatic breast cancer patients with maintenance paclitaxel plus gemcitabine (PG) chemotherapy: results from phase III, multicenter, randomized trial of maintenance chemotherapy versus observation (KCSG-BR07-02)

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Abstract

The therapeutic goals are palliative for metastatic breast cancer (MBC) and include prolongation of survival with good quality of life (QoL) and symptom control. The purpose of this study was to examine QoL among women with MBC treated on KCSG-BR07-02 with maintenance of paclitaxel plus gemcitabine (PG) chemotherapy after achieving disease control to initial six cycles of PG chemotherapy or observation. Patients were randomized to either maintenance chemotherapy or observation until progression. QoL was assessed using EORTC QLQ-C30 and BR-23. QoL at each cycle was compared between the two treatment arms using the 2-sample t test. Generalized estimating equation method was used to examine the overall difference between the two treatments in QoL. All reported p-values are 2 sided. There were no statistically significant differences between two arms in most of the component of the EORTC QLQ-C30 and BR-23 (p > 0.05). There was no significant difference between two treatments (p = 0.6094 for QLQ-C30, p = 0.5516 for BR23) at baseline, and there did not exist significant change over the cycle (p = 0.0914 for QLQ-C30, p = 0.7981 for BR23). There was no significant interaction effect between treatment and cycle (p = 0.5543 for QLQ-C30. p = 0.5817 for BR23). Maintenance PG chemotherapy in patients with MBC achieving disease control with an initial six cycles of PG chemotherapy resulted in better PFS and OS compared to observation without impeding QoL.

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Authors and Affiliations

  1. Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 135-710, South Korea

    Yeon Hee Park, Jin Seok Ahn & Young-Hyuck Im

  2. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

    Kyung Hae Jung, Jin-Hee Ahn & Sung-Bae Kim

  3. Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea

    Seock-Ah Im, Do Youn Oh & Sae-Won Han

  4. Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea

    Joo Hyuk Sohn & Soohyeon Lee

  5. Center for Breast Cancer, National Cancer Center, Goyang, South Korea

    Jungsil Ro, In Hae Park & Keun Seok Lee

  6. Biometric Research Branch, National Cancer Center, Goyang, South Korea

    Byung-Ho Nam

  7. Department of Internal Medicine, Seoul National University Bundang Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seongnam, South Korea

    Jee Hyun Kim

  8. Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea

    Seok Yun Kang

  9. Department of Internal Medicine, Inha University School of Medicine, Incheon, South Korea

    Moon Hee Lee

  10. Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Hospital, Seoul, South Korea

    Hee Sook Park

  11. Biostatistics and Clinical Epidemiology Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

    Sook Young Woo & Sin-Ho Jung

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  1. Yeon Hee Park
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Korean Cancer Study Group (KCSG)

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Correspondence to Young-Hyuck Im.

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Park, Y.H., Jung, K.H., Im, SA. et al. Quality of life (QoL) in metastatic breast cancer patients with maintenance paclitaxel plus gemcitabine (PG) chemotherapy: results from phase III, multicenter, randomized trial of maintenance chemotherapy versus observation (KCSG-BR07-02). Breast Cancer Res Treat 152, 77–85 (2015). https://doi.org/10.1007/s10549-015-3450-z

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