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

Naruto Taira; Kosuke Kashiwabara; Junji Tsurutani; Masahiro Kitada; Masato Takahashi; Hiroaki Kato; Yuichiro Kikawa; Eiko Sakata; Yoichi Naito; Yoshie Hasegawa; Tsuyoshi Saito; Tsutomu Iwasa; Tsutomu Takashima; Tomohiko Aihara; Hirofumi Mukai; Fumikata Hara

doi:10.1007/s12282-021-01290-5

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

Breast Cancer. 2022 Jan;29(1):131-143. doi: 10.1007/s12282-021-01290-5. Epub 2021 Sep 7.

Authors

Naruto Taira¹, Kosuke Kashiwabara², Junji Tsurutani³, Masahiro Kitada⁴, Masato Takahashi⁵, Hiroaki Kato⁶, Yuichiro Kikawa⁷, Eiko Sakata⁸, Yoichi Naito⁹, Yoshie Hasegawa¹⁰, Tsuyoshi Saito¹¹, Tsutomu Iwasa¹², Tsutomu Takashima¹³, Tomohiko Aihara¹⁴, Hirofumi Mukai⁹, Fumikata Hara¹⁵

Affiliations

¹ 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.
² Clinical Research Promotion Center, University of Tokyo Hospital, Tokyo, Japan.
³ Advanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.
⁴ Breast Disease Center, Asahikawa Medical University Hospital, Hokkaido, Japan.
⁵ Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Hokkaido, Japan.
⁶ Department of Breast Surgery, Teine Keijinkai Hospital, Hokkaido, Japan.
⁷ Department of Breast Surgery, Kansai Medical University Hospital, Osaka, Japan.
⁸ Department of Breast Surgery, Niigata City General Hospital, Niigata, Japan.
⁹ Department of Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.
¹⁰ Department of Breast Surgery, Hirosaki Municipal Hospital, Aomori, Japan.
¹¹ Department of Breast Surgery, Japanese Red Cross Saitama Hospital, Saitama, Japan.
¹² Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan.
¹³ Department of Breast and Endocrine Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan.
¹⁴ Breast Center, Aihara Hospital, Osaka, Japan.
¹⁵ Breast Oncology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.

Abstract

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: Patients with HER2-negative MBC were randomly assigned to three different doses of q3w nab-PTX (SD 260 mg/m² vs. MD: 220 mg/m² vs. LD 180 mg/m²). QoL was assessed at baseline and during the second, fourth and sixth courses of treatment using the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane), Cancer Fatigue Scale (CFS) and EuroQol 5-Dimension (EQ-5D). Comparisons were performed with mixed-model repeated measures (MMRM).

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: QoL of patients treated with 220 or 180 mg/m² of q3w nab-PTX was significantly better than that of patients treated with 260 mg/m².

Trial registration: 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.

Keywords: CIPN; Chemotherapy; Fatigue; Metastatic breast cancer; Nab-paclitaxel; QoL.

Publication types

Clinical Trial, Phase II
Multicenter Study
Randomized Controlled Trial

MeSH terms

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*

Substances

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