Abstract 328P
Background
The standard chemotherapy strategy for metastatic breast cancer is continuation of the same regimen until progression, but dose-dependent effects, such as chemotherapy-induced peripheral neuropathy (CIPN) or fatigue, can be problematic. The purpose of this study was to examine the benefit of switching to a maintenance strategy with endocrine therapy (ET) compared to continuation of chemotherapy, using an assessment of patient-reported outcomes (PROs).
Methods
Patients without disease progression after induction chemotherapy [4-6 cycles of weekly paclitaxel (wPTX) + bevacizumab (BV)] were randomized to a group with continuation of the same regimen (group C) or to a maintenance group with a switch to ET+BV until progression and retreatment with wPTX+BV upon progression (group M). The primary endpoint was time to failure of the treatment strategy (TFS). PROs were assessed at randomization, and 2 and 4 months and 1 and 2 years after randomization using the FACT-B, EQ-5D, Patient Neurotoxicity Questionnaire, HADS, and Cancer Fatigue Scale.
Results
Of 125 patients who responded to induction chemotherapy, 63 and 62 were assigned to groups C and M, respectively. The TFS was 8.87 months in group C and 16.82 months in group M (hazard ratio=0.51, p<0.001; reported by Saji at SABCS2019). Analysis using a mixed effects model for repeated measures showed a significant difference in the FACT-B trial outcome index (p=0.004), and the mean changes of Physical Well-Being (PWB) in group M were significantly better than those in group C at 2 months (p=0.015) and 4 months (p=0.028). The rate of severe motor CIPN at 1 year was lower in group M than in group C (5.1% vs. 26.1%, p=0.017). There was a significant difference in the fatigue scale (p=0.048), and the mean changes of the affective sub-score in group M were significantly better than those in group C at 2 months (p=0.006) and 4 months (p=0.010).
Conclusions
A switch to maintenance strategy with ET+BV after induction with wPTX+BV can significantly improve PWB and fatigue and prevent serious CIPN.
Clinical trial identification
UMIN000012179; NCT01989780.
Editorial acknowledgement
Legal entity responsible for the study
Japan Breast Cancer Research Group.
Funding
Chugai Pharmaceutical Co., LTD.
Disclosure
S. Saji: Honoraria (self), Research grant/Funding (self): Chugai; Honoraria (self), Research grant/Funding (self): Kyowa Kirin; Honoraria (self), Research grant/Funding (self): Eli Lilly; Honoraria (self), Research grant/Funding (self): AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): MSD; Honoraria (self), Research grant/Funding (self): Novartis; Honoraria (self), Research grant/Funding (self): Eisai; Honoraria (self), Research grant/Funding (self): Takeda; Research grant/Funding (self): Taiho. S. Morita: Honoraria (self): AstraZeneca; Honoraria (self): Bristol-Myers Squibb Company; Honoraria (self): Chugai; Honoraria (self): Eisai; Honoraria (self): Eli Lilly; Honoraria (self): MSD; Honoraria (self): Pfizer; Honoraria (self): Taiho. T. Takano: Honoraria (self), Research grant/Funding (self): Daiichi-Sankyo; Honoraria (self), Research grant/Funding (self): Chugai; Honoraria (self), Research grant/Funding (self): Kyowa Kirin; Honoraria (self), Research grant/Funding (self): Eisai; Research grant/Funding (self): Ono; Research grant/Funding (self): BMS; Research grant/Funding (self): MSD; Research grant/Funding (self): Merck Serono; Research grant/Funding (self): Tahiho; Research grant/Funding (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Eli Lilly; Honoraria (self): Celltrion Healthcare. M. Takada: Honoraria (self): Chugai; Honoraria (self): AstraZenaca; Honoraria (self): Pfizer; Honoraria (self): Eli Lilly; Honoraria (self): Daiichi Sankyo; Honoraria (self): Kyowa-Kirin; Honoraria (self), Research grant/Funding (self): Eisai; Honoraria (self), Research grant/Funding (self): Nihon Kayaku; Honoraria (self): Takeda. T. Toyama: Honoraria (self), Research grant/Funding (self): Novartis; Honoraria (self), Research grant/Funding (self): Chugai; Honoraria (self), Research grant/Funding (self): Eisai; Research grant/Funding (self): AstraZeneca; Honoraria (self), Research grant/Funding (self): Eli Lilly; Honoraria (self), Research grant/Funding (self): Kyowa Kirin; Honoraria (self), Research grant/Funding (self): Taiho; Honoraria (self), Research grant/Funding (self): Daiichi Sankyo; Honoraria (self), Research grant/Funding (self): Nihon Kayaku; Honoraria (self), Research grant/Funding (self): Pfizer; Honoraria (self), Research grant/Funding (self): Takeda. Y. Kikawa: Honoraria (self): Eisai; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Lilly; Honoraria (self): Taiho; Honoraria (self): Chugai. T. Fujisawa: Research grant/Funding (self): Chugai; Research grant/Funding (self): Eli Lily. M. Kashiwaba: Honoraria (self): Chugai; Honoraria (self): Novartis; Honoraria (self): Kyowa-Kirin; Honoraria (self): Pfizer; Honoraria (self): AstraZeneca; Honoraria (self): Daiichi Sankyo; Honoraria (self): Taiho; Honoraria (self): Eisai. T. Ishida: Research grant/Funding (self): Taiho; Honoraria (self), Research grant/Funding (self): Eisai; Honoraria (self): Kyowa Kirin; Honoraria (self), Research grant/Funding (self): Chugai; Honoraria (self): Pfizer. R. Nakamura: Honoraria (self): Chugai; Honoraria (self): Eli Lily; Honoraria (self): AstraZeneca; Honoraria (self): Daiichi Sankyo; Honoraria (self): Eisai; Honoraria (self): Novartis. Y. Yamamoto: Honoraria (self), Research grant/Funding (self): Daiichi Sankyo; Honoraria (self), Research grant/Funding (self): Eisai; Honoraria (self), Research grant/Funding (self): Eli Lilly; Honoraria (self), Research grant/Funding (self): Takeda; Honoraria (self): Sysmex; Honoraria (self): GE Health Care Japan; Research grant/Funding (self): AstraZeneca; Honoraria (self), Research grant/Funding (self): Pfizer; Honoraria (self), Research grant/Funding (self): Novartis; Honoraria (self), Research grant/Funding (self): Nihon Kayaku; Honoraria (self), Research grant/Funding (self): Kyowa-Kirin; Honoraria (self), Research grant/Funding (self): Taiho; Honoraria (self), Research grant/Funding (self): Chugai. U. Toh: Honoraria (self): Chugai; Honoraria (self): Kyowa Kirin; Honoraria (self): Daiichi Sankyo; Honoraria (self): Taiho; Honoraria (self): Nihon Kayaku ; Honoraria (self): Eisai. H. Iwata: Honoraria (self): AstraZeneca; Honoraria (self): Daiichi Sankyo; Honoraria (self), Research grant/Funding (self): Novartis; Research grant/Funding (self): MSD; Honoraria (self), Research grant/Funding (institution): Eli Lilly; Honoraria (self): Kyowa Kirin; Honoraria (self): Pfizer; Honoraria (self), Research grant/Funding (self): Chugai. N. Masuda: Honoraria (self), Research grant/Funding (institution): Chugai; Research grant/Funding (institution): AstraZeneca; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self), Research grant/Funding (self): Elli-Lilly; Honoraria (self), Research grant/Funding (institution): Eisai; Honoraria (self), Research grant/Funding (institution): Takeda; Honoraria (self), Research grant/Funding (institution): Kyowa-Kirin; Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution): Daiichi Sankyo. S. Ohno: Honoraria (self): Chugai; Honoraria (self): AstraZeneca; Honoraria (self), Research grant/Funding (self): Eisai; Honoraria (self), Research grant/Funding (self): Taiho; Honoraria (self): Pfizer; Honoraria (self): Eli Lilly; Honoraria (self): Kyowa Kirin; Honoraria (self): Nihon Kayaku. M. Toi: Honoraria (self), Research grant/Funding (self): Chugai; Honoraria (self), Research grant/Funding (self): Takeda; Honoraria (self), Research grant/Funding (self): Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Kyowa-Kirin; Honoraria (self), Research grant/Funding (self): Taiho; Research grant/Funding (institution): JBCRG association; Honoraria (self), Research grant/Funding (self): Eisai; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Daiichi-Sankyo; Honoraria (self), Research grant/Funding (self): AstraZeneca; Honoraria (self): Eli Lilly; Honoraria (self): MSD; Honoraria (self): Genomic Health; Honoraria (self): Novartis; Honoraria (self), Advisory/Consultancy: Konica Minolta; Research grant/Funding (self): Astellas; Advisory/Consultancy: BMS; Honoraria (self), Research grant/Funding (self): Shimadzu; Honoraria (self): Yakult; Honoraria (self), Research grant/Funding (self): Nihon Kayaku; Research grant/Funding (self): AFI technologies; Advisory/Consultancy: Athenex Oncology. All other authors have declared no conflicts of interest.