Quality of life outcomes including neuropathy-associated scale from a phase II, multicenter, randomized trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine as first-line chemotherapy for HER2-negative metastatic breast cancer: Korean Cancer Study Group Trial (KCSG BR13-11)

Cancer Commun (Lond). 2019 May 28;39(1):29. doi: 10.1186/s40880-019-0375-7.

Abstract

Background: A phase II clinical trial of the comparison between eribulin plus gemcitabine (EG) and paclitaxel plus gemcitabine (PG) as first-line chemotherapy for patients with metastatic breast cancer (MBC) found that the EG regimen was less neurotoxic, but was similar in efficacy to the PG regimen. In the present study, we analyzed functional assessment of cancer therapy-taxane (FACT-Taxane) questionnaires from patients in this clinical trial to determine their quality of life (QoL).

Methods: QoL was assessed using the Korean version of the FACT-Taxane questionnaires. After baseline assessment, QoL was assessed every 2 cycles for 12 cycles and every 3 cycles thereafter. The linear mixed model was used to evaluate the difference in QoL between the EG and PG arms.

Results: Of the 118 enrolled patients, 117 responded to the FACT-Taxane questionnaires at baseline, 1 in the PG arm did not. Baseline QoL scores were not different between the EG and PG arms. During treatment, taxane subscale scores were significantly higher in the PG arm than in the EG arm after 2-13 cycles of chemotherapy (all P < 0.05), except for the 11th cycle. Neuropathy-specific analysis showed that patients in the PG arm had earlier and more severe neuropathic symptoms than those in the EG arm (P < 0.001).

Conclusions: In our QoL analysis, the EG regimen delayed and decreased neuropathy as compared with the PG regimen. Therefore, eribulin would be a reasonable substitute for paclitaxel as first-line chemotherapy for MBC.

Keywords: Eribulin; Functional assessment of cancer therapy-taxane questionnaires; Metastatic breast cancer; Neuropathy; Paclitaxel; Quality of life.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / pathology
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Female
  • Furans / administration & dosage*
  • Furans / adverse effects
  • Gemcitabine
  • Humans
  • Ketones / administration & dosage*
  • Ketones / adverse effects
  • Paclitaxel / administration & dosage*
  • Paclitaxel / adverse effects
  • Peripheral Nervous System Diseases / chemically induced
  • Quality of Life*
  • Receptor, ErbB-2
  • Republic of Korea
  • Surveys and Questionnaires

Substances

  • Furans
  • Ketones
  • Deoxycytidine
  • ERBB2 protein, human
  • Receptor, ErbB-2
  • eribulin
  • Paclitaxel
  • Gemcitabine