Elsevier

Phytomedicine

Volume 70, 15 April 2020, 153218
Phytomedicine

Efficacy and safety of curcumin in combination with paclitaxel in patients with advanced, metastatic breast cancer: A comparative, randomized, double-blind, placebo-controlled clinical trial

https://doi.org/10.1016/j.phymed.2020.153218 Get rights and content
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Highlights

  • This is the first clinical study to explore the efficacy and safety of administering curcumin intravenously in combination with chemotherapy in the treatment of cancer patients.

Abstract

Background

: The clinical efficacy of curcumin has not yet been established for the treatment of cancer, despite a large body of evidence from numerous preclinical studies suggesting the therapeutic potential of curcumin, particularly in a synergistic combination with paclitaxel. The main obstacle in using curcumin for adjunctive cancer therapy is its low bioavailability via oral administration.

Purpose

: We assessed the efficacy and safety of intravenous curcumin infusion in combination with paclitaxel in patients with metastatic and advanced breast cancer.

Study Design

: A randomized, double-blind, placebo-controlled, parallel-group comparative clinical study was conducted.

Methods

: A total of 150 women with advanced and metastatic breast cancer were randomly assigned to receive either paclitaxel (80 mg/m2) plus placebo or paclitaxel plus curcumin (CUC-1®, 300 mg solution, once per week) intravenously for 12 weeks with 3 months of follow-up. The primary outcome was determined based on the objective response rate (ORR), as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). The secondary outcomes were progression-free survival (PFS), time to tumor progression (TTP), time to tumor treatment failure (TTTF), safety, and quality of life.

Results

: The intention-to-treat (ITT) analysis revealed that the ORR of curcumin was significantly higher than that of the placebo (51% vs. 33%, p < 0.01) at 4 weeks of follow-up. The difference between the groups was even greater when only patients who had completed the treatment (61% vs. 38%, odds ratio ==2.64, p < 0.01) were included. A superior effect of curcumin vs placebo was observed in both patients who had completed the treatment and all patients included in the ITT analysis, 3 months after termination of the treatment. No other significant differences were observed between the curcumin and the placebo groups, except for fatigue (3 vs. 10 patients, respectively; odds ratio ==3.7, p = 0.05). However, the patients’ self-assessed overall physical performance was significantly higher with curcumin than the placebo during the treatment and at the end of the follow-up, suggesting better tolerance in the curcumin group.

Conclusions

: Overall, treatment with curcumin in combination with paclitaxel was superior to the paclitaxel-placebo combination with respect to ORR and physical performance after 12 weeks of treatment. Intravenously administered curcumin caused no major safety issues and no reduction in quality of life, and it may be beneficial in reducing fatigue.

Advances in knowledge

: This is the first clinical study to explore the efficacy and safety of administering curcumin intravenously in combination with chemotherapy in the treatment of cancer patients.

Graphical abstract

Intravenous administration of curcumin in combination with paclitaxel was superior to that of the paclitaxel-placebo combination with respect to ORR and physical performance after 12 weeks of treatment in patients with advanced and metastatic breast cancer. Intravenous administration of curcumin yielded no major safety concerns and no reduction in the quality of life but may be beneficial in reducing fatigue.

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Keywords

Curcumin
Paclitaxel
Breast cancer
Clinical trial

Abbreviations

AE
adverse event
CRF
case report form
CR
complete response
EC
ethics committee
GCP
Good Clinical Practice
ECOG
Eastern Cooperative Oncology Group
ICD
International Classification of Diseases
DFS
disease-free survival
MBC
metastatic breast cancer
ORR
objective response rate
OR
objective response
PD
progressive disease
PR
partial response
RECIST
Response Evaluation Criteria in Solid Tumors
TTP
time to progression
PFS
progression-free survival
SD
stable disease
TTF
time-to-treatment failure

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