Quality of life in a randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel in patients with metastatic breast cancer.

Albumins / administration & dosage Antineoplastic Agents, Phytogenic / administration & dosage Breast Neoplasms / drug therapy Dose-Response Relationship, Drug Female Humans Japan Middle Aged Paclitaxel / administration & dosage Quality of Life
CIPN Chemotherapy Fatigue Metastatic breast cancer Nab-paclitaxel QoL

Journal

Breast cancer (Tokyo, Japan)
ISSN: 1880-4233
Titre abrégé: Breast Cancer
Pays: Japan
ID NLM: 100888201

Informations de publication

Date de publication:
Jan 2022
Historique:
received: 05 06 2021
accepted: 25 08 2021
pubmed: 8 9 2021
medline: 10 2 2022
entrez: 7 9 2021
Statut: ppublish

Résumé

To report our findings on quality of life (QoL) in a randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel (q3w nab-PTX) in patients with metastatic breast cancer (MBC). Patients with HER2-negative MBC were randomly assigned to three different doses of q3w nab-PTX (SD 260 mg/m A total of 141 patients were enrolled in the parent study, and 136 (96%) (44, 45 and 47 in the SD, MD, and LD groups) were included in the analysis. MMRM analysis showed that the difference from the baseline FACT-Taxane trial outcome index at MD and LD were significantly higher than that at SD (MD vs. SD P < 0.001, LD vs. SD P < 0.001). Differences from baseline for FACT-Taxane total, physical and emotional well-being, and taxane subscale scores at MD and LD were also higher than at SD. The difference from baseline for the CFS score at LD was lower than at SD (P = 0.013) and those for EQ-5D utility scores at MD and LD were higher than at SD (MD vs. SD P = 0.011, LD vs. SD P < 0.001). QoL of patients treated with 220 or 180 mg/m The protocol was registered at the website of the University Hospital Medical Information Network (UMIN), Japan (protocol ID: UMIN000015516), on 01/11/2014. Details are available at the following address: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017916.

Sections du résumé

BACKGROUND BACKGROUND
To report our findings on quality of life (QoL) in a randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel (q3w nab-PTX) in patients with metastatic breast cancer (MBC).
METHODS METHODS
Patients with HER2-negative MBC were randomly assigned to three different doses of q3w nab-PTX (SD 260 mg/m
RESULTS RESULTS
A total of 141 patients were enrolled in the parent study, and 136 (96%) (44, 45 and 47 in the SD, MD, and LD groups) were included in the analysis. MMRM analysis showed that the difference from the baseline FACT-Taxane trial outcome index at MD and LD were significantly higher than that at SD (MD vs. SD P < 0.001, LD vs. SD P < 0.001). Differences from baseline for FACT-Taxane total, physical and emotional well-being, and taxane subscale scores at MD and LD were also higher than at SD. The difference from baseline for the CFS score at LD was lower than at SD (P = 0.013) and those for EQ-5D utility scores at MD and LD were higher than at SD (MD vs. SD P = 0.011, LD vs. SD P < 0.001).
CONCLUSION CONCLUSIONS
QoL of patients treated with 220 or 180 mg/m
TRIAL REGISTRATION BACKGROUND
The protocol was registered at the website of the University Hospital Medical Information Network (UMIN), Japan (protocol ID: UMIN000015516), on 01/11/2014. Details are available at the following address: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017916.

Identifiants

DOI: 10.1007/s12282-021-01290-5 PMID: 34491513 PMC: PMC8421464
pubmed: 34491513
doi: 10.1007/s12282-021-01290-5
pii: 10.1007/s12282-021-01290-5
pmc: PMC8421464
doi:

Substances chimiques

130-nm albumin-bound paclitaxel 0
Albumins 0
Antineoplastic Agents, Phytogenic 0
Paclitaxel P88XT4IS4D

Types de publication

Clinical Trial, Phase II Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

131-143

Commentaires et corrections

Type : ErratumIn

Informations de copyright

© 2021. The Japanese Breast Cancer Society.

Références

Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005;31:7794–803. https://doi.org/10.1200/JCO.2005.04.937 .
doi: 10.1200/JCO.2005.04.937
Nakamura S, Iwata H, Funato Y, Ito K. Ito Y [Results of a drug use investigation of nanoparticle albumin-bound paclitaxel for breast cancer]. Gan To Kagaku Ryoho. 2015;42:447–55.
pubmed: 25963691
Hara F, Takashima T, Tsurutani J, Saito T, Taira N, Kashiwabara K, et al. Randomized, optimal dose finding, phase II study of tri-weekly nab-paclitaxel in patients with metastatic breast cancer (ABROAD). J Clin Trials. 2016;6:267. https://doi.org/10.4172/2167-0870.1000267 .
doi: 10.4172/2167-0870.1000267
Tsurutani J, Hara F, Kitada M, Takahashi M, Kikawa Y, Kato H, et al. Randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel in patients with metastatic breast cancer. Breast. 2020;55:63–8. https://doi.org/10.1016/j.breast.2020.12.002 .
doi: 10.1016/j.breast.2020.12.002 pubmed: 33341707 pmcid: 7753189
Cella D, Peterman A, Hudgens S, Webster K, Socinski MA. Measuring the side effects of taxane therapy in oncology: the functional assessment of cancer therapy-taxane (FACT-taxane). Cancer. 2003;98:822–31. https://doi.org/10.1002/cncr.11578 .
doi: 10.1002/cncr.11578 pubmed: 12910528
Brooks R. EuroQol: the current state of play. Health Policy. 1996;37:58–72. https://doi.org/10.1016/0168-8510(96)00822-6 .
doi: 10.1016/0168-8510(96)00822-6
Tsuchiya A, Ikeda S, Ikegami N, Nishimura S, Sakai I, Fukuda T, et al. Estimating an EQ-5D population value set: the case of Japan. Health Econ. 2002;11:341–53. https://doi.org/10.1002/hec.673 .
doi: 10.1002/hec.673 pubmed: 12007165
Okuyama T, Akechi T, Kugaya A, Okamura H, Shima Y, Maruguchi M, et al. Development and validation of the Cancer Fatigue Scale: a brief, three-dimensional, self-rating scale for assessment of fatigue in cancer patients. J Pain Symptom Manag. 2000;19:5–14. https://doi.org/10.1016/s0885-3924(99)00138-4 .
doi: 10.1016/s0885-3924(99)00138-4
Mols F, Beijers T, Vreugdenhil G, van de Poll-Franse L. Chemotherapy-induced peripheral neuropathy and its association with quality of life: a systematic review. Support Care Cancer. 2014;22:2261–9. https://doi.org/10.1007/s00520-014-2255-7 .
doi: 10.1007/s00520-014-2255-7 pubmed: 24789421
Cavaletti G, Marmiroli P. Chemotherapy-induced peripheral neurotoxicity. Nat Rev Neurol. 2010;6:657–66. https://doi.org/10.1038/nrneurol.2010.160 .
doi: 10.1038/nrneurol.2010.160 pubmed: 21060341
Parness J, Horwitz SB. Taxol binds to polymerized tubulin in vitro. J Cell Biol. 1981;91:479–87. https://doi.org/10.1083/jcb.91.2.479 .
doi: 10.1083/jcb.91.2.479 pubmed: 6118377 pmcid: 2111958
Schiff PB, Fant J, Horwitz SB. Promotion of microtubule assembly in vitro by taxol. Nature. 1979;277:665–7. https://doi.org/10.1038/277665a0 .
doi: 10.1038/277665a0 pubmed: 423966
Roytta M, Raine CS. Taxol-induced neuropathy: further ultrastructural studies of nerve fibre changes in situ. J Neurocytol. 1985;14:157–75. https://doi.org/10.1007/BF01150269 .
doi: 10.1007/BF01150269 pubmed: 2861255
Cook BM, Wozniak KM, Proctor DA, Bromberg RB, Wu Y, Slusher BS, et al. Differential morphological and biochemical recovery from chemotherapy-induced peripheral neuropathy following paclitaxel, ixabepilone, or eribulin treatment in mouse sciatic nerves. Neurotox Res. 2018;34:677–92. https://doi.org/10.1007/s12640-018-9929-8 .
doi: 10.1007/s12640-018-9929-8 pubmed: 30051419
Yardley DA. nab-Paclitaxel mechanisms of action and delivery. J Control Release. 2013;170:365–72. https://doi.org/10.1016/j.jconrel.2013.05.041 .
doi: 10.1016/j.jconrel.2013.05.041 pubmed: 23770008
Desai N, Trieu V, Yao Z, Louie L, Ci S, Yang A, et al. Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of cremophor-free, albumin-bound paclitaxel, ABI-007, compared with cremophor-based paclitaxel. Clin Cancer Res. 2006;12:1317–24. https://doi.org/10.1158/1078-0432.CCR-05-1634 .
doi: 10.1158/1078-0432.CCR-05-1634 pubmed: 16489089
Rugo HS, Barry WT, Moreno-Aspitia A, Lyss AP, Cirrincione C, Leung E, et al. Randomized phase III trial of paclitaxel once per week compared with nanoparticle albumin-bound nab-paclitaxel once per week or ixabepilone with bevacizumab as first-line chemotherapy for locally recurrent or metastatic breast cancer: CALGB 40502/NCCTG N063H (Alliance). J Clin Oncol. 2015;33:2361–9. https://doi.org/10.1200/JCO.2014.59.5298 .
doi: 10.1200/JCO.2014.59.5298 pubmed: 26056183 pmcid: 4500830
Bower JE. Cancer-related fatigue: mechanisms, risk factors, and treatments. Nat Rev Clin Oncol. 2014;11:597–609. https://doi.org/10.1038/nrclinonc.2014.127 .
doi: 10.1038/nrclinonc.2014.127 pubmed: 25113839 pmcid: 4664449
Lawrence DP, Kupelnick B, Miller K, Devine D, Lau J. Evidence report on the occurrence, assessment, and treatment of fatigue in cancer patients. J Natl Cancer Inst Monogr. 2004;32:40–50. https://doi.org/10.1093/jncimonographs/lgh027 .
doi: 10.1093/jncimonographs/lgh027
Takashima T, Mukai H, Hara F, Matsubara N, Saito T, Takano T, SELECT BC Study Group, et al. Taxanes versus S-1 as the first-line chemotherapy for metastatic breast cancer (SELECT BC): an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol. 2015;17:90–8. https://doi.org/10.1016/S1470-2045(15)00411-8 .
doi: 10.1016/S1470-2045(15)00411-8 pubmed: 26617202
Seruga B, Templeton AJ, Badillo FE, Ocana A, Amir E, Tannock IF. Under-reporting of harm in clinical trials. Lancet Oncol. 2016;17:e209–19. https://doi.org/10.1016/S1470-2045(16)00152-2 .
doi: 10.1016/S1470-2045(16)00152-2 pubmed: 27301048
Shimozuma K, Ohashi Y, Takeuchi A, Aranishi T, Morita S, Kuroi K, et al. Feasibility and validity of the Patient Neurotoxicity Questionnaire during taxane chemotherapy in a phase III randomized trial in patients with breast cancer: N-SAS BC 02. Support Care Cancer. 2019;17:1483–91. https://doi.org/10.1007/s00520-009-0613-7 .
doi: 10.1007/s00520-009-0613-7
Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, et al. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol. 2006;7:903–9. https://doi.org/10.1016/S1470-2045(06)70910-X .
doi: 10.1016/S1470-2045(06)70910-X pubmed: 17081915
LeBlanc TW, Abernethy AP. Patient-reported outcomes in cancer care: hearing the patient voice at greater volume. Nat Rev Clin Oncol. 2017;14:763–72. https://doi.org/10.1038/nrclinonc.2017.153 .
doi: 10.1038/nrclinonc.2017.153 pubmed: 28975931
Tamura K, Inoue K, Masuda N, Takao S, Kashiwaba M, Tokuda Y, et al. Randomized phase II study of nab-paclitaxel as first-line chemotherapy in patients with HER2-negative metastatic breast cancer. Cancer Sci. 2017;108:987–94. https://doi.org/10.1111/cas.13221 .
doi: 10.1111/cas.13221 pubmed: 28256066 pmcid: 5448660

Auteurs

Naruto Taira (N)

Department of Breast and Endocrine Surgery, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan. ntaira@md.okayama-u.ac.jp.
ORCID: 0000-0003-4266-1117

Kosuke Kashiwabara (K)

Clinical Research Promotion Center, University of Tokyo Hospital, Tokyo, Japan.

Junji Tsurutani (J)

Advanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.

Masahiro Kitada (M)

Breast Disease Center, Asahikawa Medical University Hospital, Hokkaido, Japan.

Masato Takahashi (M)

Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Hokkaido, Japan.

Hiroaki Kato (H)

Department of Breast Surgery, Teine Keijinkai Hospital, Hokkaido, Japan.

Yuichiro Kikawa (Y)

Department of Breast Surgery, Kansai Medical University Hospital, Osaka, Japan.

Eiko Sakata (E)

Department of Breast Surgery, Niigata City General Hospital, Niigata, Japan.

Yoichi Naito (Y)

Department of Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.

Yoshie Hasegawa (Y)

Department of Breast Surgery, Hirosaki Municipal Hospital, Aomori, Japan.

Tsuyoshi Saito (T)

Department of Breast Surgery, Japanese Red Cross Saitama Hospital, Saitama, Japan.

Tsutomu Iwasa (T)

Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan.

Tsutomu Takashima (T)

Department of Breast and Endocrine Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan.

Tomohiko Aihara (T)

Breast Center, Aihara Hospital, Osaka, Japan.

Hirofumi Mukai (H)

Department of Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.

Fumikata Hara (F)

Breast Oncology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

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Classifications MeSH

questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Albumines › Quality of life in a randomized phase II study...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Antinéoplasiques › Antinéoplasiques d'origine végétale › Quality of life in a randomized phase II study...
questionsmedicales.fr › Maladies de la peau et du tissu conjonctif › Maladies de la peau › Maladies du sein › Tumeurs du sein › Quality of life in a randomized phase II study...
questionsmedicales.fr › Phénomènes physiologiques › Phénomènes pharmacologiques et toxicologiques › Phénomènes toxicologiques › Relation dose-effet des médicaments › Quality of life in a randomized phase II study...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Quality of life in a randomized phase II study...
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questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Quality of life in a randomized phase II study...
questionsmedicales.fr › Composés chimiques organiques › Hydrocarbures › Terpènes › Diterpènes › Taxoïdes › Paclitaxel › Quality of life in a randomized phase II study...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Mesures épidémiologiques › Démographie › État de santé › Qualité de vie › Quality of life in a randomized phase II study...