Phase II, multicentre, randomised trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine as first-line chemotherapy in patients with HER2-negative metastatic breast cancer

Yeon Hee Park, Seock Ah Im, Sung Bae Kim, Joo Hyuk Sohn, Keun Seok Lee, Yee Soo Chae, Ki Hyeong Lee, Jee Hyun Kim, Young Hyuck Im, Ji Yeon Kim, Tae Yong Kim, Kyung Hun Lee, Jin Hee Ahn, Gun Min Kim, In Hae Park, Soo Jung Lee, Hye Sook Han, Se Hyun Kim, Kyung Hae Jung

Research output: Contribution to journalArticle

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Abstract

Background Paclitaxel plus gemcitabine (PG) combination chemotherapy is a preferred chemotherapeutic regimen for patients with metastatic breast cancer (MBC). Eribulin mesylate is a halichondrin non-taxane inhibitor of microtubule dynamics. A recent pooled analysis with eribulin showed improved overall survival (OS) in various MBC patient subgroups pretreated with anthracycline and taxane. Furthermore, eribulin may have less neurotoxicity than paclitaxel. Patients and methods This study was a prospective randomised phase II, open-label, two-arm, multicentre study comparing eribulin plus gemcitabine (EG) with PG chemotherapy as a first-line treatment for patients with human epidermal growth factor receptor 2-negative MBC. We hypothesised that EG chemotherapy would not be inferior to PG chemotherapy. The primary end-point was progression-free survival (PFS), which was estimated to be 70% at 6 months for each arm. The secondary end-points were as follows: OS, neuropathic scale, toxicity and clinical benefit rate. Results A total of 118 patients (median age: 50, 24–66) were enrolled between March 2015 and March 2016 and were randomly assigned to PG (n = 59) or EG (n = 59) chemotherapy. The mean number of metastatic sites was 3 (range 1–8). The 6-month PFS rates for both arms were 72% for EG and 73% for PG (P = 0.457). There was no significant difference in OS between the two groups (not reached versus 21.2 months, P = 0.2234). The median number of chemotherapy cycles for both groups was 10 for EG and 8 for PG (range 2–32). Clinical benefit rates were 44% for EG and 49% for PG. Major toxicities were neutropenia and neurotoxicity. Grade II or above neurotoxicity was more common with PG than with EG (13.6% for EG versus 45.8% for PG, P < 0.0001). Conclusion EG chemotherapy had similar clinical benefits to PG chemotherapy in terms of PFS but less neurotoxicity. Trial registration KCSG BR13-11; ClinicalTrials.gov, NCT02263495.

Original languageEnglish
Pages (from-to)385-393
Number of pages9
JournalEuropean Journal of Cancer
Volume86
DOIs
StatePublished - Nov 2017

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eribulin
gemcitabine
Paclitaxel
Multicenter Studies
Breast Neoplasms
Drug Therapy
Disease-Free Survival

Keywords

  • Chemotherapy
  • Eribulin
  • Gemcitabine
  • Metastatic breast cancer
  • Paclitaxel

Cite this

Park, Yeon Hee ; Im, Seock Ah ; Kim, Sung Bae ; Sohn, Joo Hyuk ; Lee, Keun Seok ; Chae, Yee Soo ; Lee, Ki Hyeong ; Kim, Jee Hyun ; Im, Young Hyuck ; Kim, Ji Yeon ; Kim, Tae Yong ; Lee, Kyung Hun ; Ahn, Jin Hee ; Kim, Gun Min ; Park, In Hae ; Lee, Soo Jung ; Han, Hye Sook ; Kim, Se Hyun ; Jung, Kyung Hae. / Phase II, multicentre, randomised trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine as first-line chemotherapy in patients with HER2-negative metastatic breast cancer. In: European Journal of Cancer. 2017 ; Vol. 86. pp. 385-393.
@article{418850bb93754d28aea5051b12889c1c,
title = "Phase II, multicentre, randomised trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine as first-line chemotherapy in patients with HER2-negative metastatic breast cancer",
abstract = "Background Paclitaxel plus gemcitabine (PG) combination chemotherapy is a preferred chemotherapeutic regimen for patients with metastatic breast cancer (MBC). Eribulin mesylate is a halichondrin non-taxane inhibitor of microtubule dynamics. A recent pooled analysis with eribulin showed improved overall survival (OS) in various MBC patient subgroups pretreated with anthracycline and taxane. Furthermore, eribulin may have less neurotoxicity than paclitaxel. Patients and methods This study was a prospective randomised phase II, open-label, two-arm, multicentre study comparing eribulin plus gemcitabine (EG) with PG chemotherapy as a first-line treatment for patients with human epidermal growth factor receptor 2-negative MBC. We hypothesised that EG chemotherapy would not be inferior to PG chemotherapy. The primary end-point was progression-free survival (PFS), which was estimated to be 70{\%} at 6 months for each arm. The secondary end-points were as follows: OS, neuropathic scale, toxicity and clinical benefit rate. Results A total of 118 patients (median age: 50, 24–66) were enrolled between March 2015 and March 2016 and were randomly assigned to PG (n = 59) or EG (n = 59) chemotherapy. The mean number of metastatic sites was 3 (range 1–8). The 6-month PFS rates for both arms were 72{\%} for EG and 73{\%} for PG (P = 0.457). There was no significant difference in OS between the two groups (not reached versus 21.2 months, P = 0.2234). The median number of chemotherapy cycles for both groups was 10 for EG and 8 for PG (range 2–32). Clinical benefit rates were 44{\%} for EG and 49{\%} for PG. Major toxicities were neutropenia and neurotoxicity. Grade II or above neurotoxicity was more common with PG than with EG (13.6{\%} for EG versus 45.8{\%} for PG, P < 0.0001). Conclusion EG chemotherapy had similar clinical benefits to PG chemotherapy in terms of PFS but less neurotoxicity. Trial registration KCSG BR13-11; ClinicalTrials.gov, NCT02263495.",
keywords = "Chemotherapy, Eribulin, Gemcitabine, Metastatic breast cancer, Paclitaxel",
author = "Park, {Yeon Hee} and Im, {Seock Ah} and Kim, {Sung Bae} and Sohn, {Joo Hyuk} and Lee, {Keun Seok} and Chae, {Yee Soo} and Lee, {Ki Hyeong} and Kim, {Jee Hyun} and Im, {Young Hyuck} and Kim, {Ji Yeon} and Kim, {Tae Yong} and Lee, {Kyung Hun} and Ahn, {Jin Hee} and Kim, {Gun Min} and Park, {In Hae} and Lee, {Soo Jung} and Han, {Hye Sook} and Kim, {Se Hyun} and Jung, {Kyung Hae}",
year = "2017",
month = "11",
doi = "10.1016/j.ejca.2017.10.002",
language = "English",
volume = "86",
pages = "385--393",
journal = "European Journal of Cancer",
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Phase II, multicentre, randomised trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine as first-line chemotherapy in patients with HER2-negative metastatic breast cancer. / Park, Yeon Hee; Im, Seock Ah; Kim, Sung Bae; Sohn, Joo Hyuk; Lee, Keun Seok; Chae, Yee Soo; Lee, Ki Hyeong; Kim, Jee Hyun; Im, Young Hyuck; Kim, Ji Yeon; Kim, Tae Yong; Lee, Kyung Hun; Ahn, Jin Hee; Kim, Gun Min; Park, In Hae; Lee, Soo Jung; Han, Hye Sook; Kim, Se Hyun; Jung, Kyung Hae.

In: European Journal of Cancer, Vol. 86, 11.2017, p. 385-393.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase II, multicentre, randomised trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine as first-line chemotherapy in patients with HER2-negative metastatic breast cancer

AU - Park, Yeon Hee

AU - Im, Seock Ah

AU - Kim, Sung Bae

AU - Sohn, Joo Hyuk

AU - Lee, Keun Seok

AU - Chae, Yee Soo

AU - Lee, Ki Hyeong

AU - Kim, Jee Hyun

AU - Im, Young Hyuck

AU - Kim, Ji Yeon

AU - Kim, Tae Yong

AU - Lee, Kyung Hun

AU - Ahn, Jin Hee

AU - Kim, Gun Min

AU - Park, In Hae

AU - Lee, Soo Jung

AU - Han, Hye Sook

AU - Kim, Se Hyun

AU - Jung, Kyung Hae

PY - 2017/11

Y1 - 2017/11

N2 - Background Paclitaxel plus gemcitabine (PG) combination chemotherapy is a preferred chemotherapeutic regimen for patients with metastatic breast cancer (MBC). Eribulin mesylate is a halichondrin non-taxane inhibitor of microtubule dynamics. A recent pooled analysis with eribulin showed improved overall survival (OS) in various MBC patient subgroups pretreated with anthracycline and taxane. Furthermore, eribulin may have less neurotoxicity than paclitaxel. Patients and methods This study was a prospective randomised phase II, open-label, two-arm, multicentre study comparing eribulin plus gemcitabine (EG) with PG chemotherapy as a first-line treatment for patients with human epidermal growth factor receptor 2-negative MBC. We hypothesised that EG chemotherapy would not be inferior to PG chemotherapy. The primary end-point was progression-free survival (PFS), which was estimated to be 70% at 6 months for each arm. The secondary end-points were as follows: OS, neuropathic scale, toxicity and clinical benefit rate. Results A total of 118 patients (median age: 50, 24–66) were enrolled between March 2015 and March 2016 and were randomly assigned to PG (n = 59) or EG (n = 59) chemotherapy. The mean number of metastatic sites was 3 (range 1–8). The 6-month PFS rates for both arms were 72% for EG and 73% for PG (P = 0.457). There was no significant difference in OS between the two groups (not reached versus 21.2 months, P = 0.2234). The median number of chemotherapy cycles for both groups was 10 for EG and 8 for PG (range 2–32). Clinical benefit rates were 44% for EG and 49% for PG. Major toxicities were neutropenia and neurotoxicity. Grade II or above neurotoxicity was more common with PG than with EG (13.6% for EG versus 45.8% for PG, P < 0.0001). Conclusion EG chemotherapy had similar clinical benefits to PG chemotherapy in terms of PFS but less neurotoxicity. Trial registration KCSG BR13-11; ClinicalTrials.gov, NCT02263495.

AB - Background Paclitaxel plus gemcitabine (PG) combination chemotherapy is a preferred chemotherapeutic regimen for patients with metastatic breast cancer (MBC). Eribulin mesylate is a halichondrin non-taxane inhibitor of microtubule dynamics. A recent pooled analysis with eribulin showed improved overall survival (OS) in various MBC patient subgroups pretreated with anthracycline and taxane. Furthermore, eribulin may have less neurotoxicity than paclitaxel. Patients and methods This study was a prospective randomised phase II, open-label, two-arm, multicentre study comparing eribulin plus gemcitabine (EG) with PG chemotherapy as a first-line treatment for patients with human epidermal growth factor receptor 2-negative MBC. We hypothesised that EG chemotherapy would not be inferior to PG chemotherapy. The primary end-point was progression-free survival (PFS), which was estimated to be 70% at 6 months for each arm. The secondary end-points were as follows: OS, neuropathic scale, toxicity and clinical benefit rate. Results A total of 118 patients (median age: 50, 24–66) were enrolled between March 2015 and March 2016 and were randomly assigned to PG (n = 59) or EG (n = 59) chemotherapy. The mean number of metastatic sites was 3 (range 1–8). The 6-month PFS rates for both arms were 72% for EG and 73% for PG (P = 0.457). There was no significant difference in OS between the two groups (not reached versus 21.2 months, P = 0.2234). The median number of chemotherapy cycles for both groups was 10 for EG and 8 for PG (range 2–32). Clinical benefit rates were 44% for EG and 49% for PG. Major toxicities were neutropenia and neurotoxicity. Grade II or above neurotoxicity was more common with PG than with EG (13.6% for EG versus 45.8% for PG, P < 0.0001). Conclusion EG chemotherapy had similar clinical benefits to PG chemotherapy in terms of PFS but less neurotoxicity. Trial registration KCSG BR13-11; ClinicalTrials.gov, NCT02263495.

KW - Chemotherapy

KW - Eribulin

KW - Gemcitabine

KW - Metastatic breast cancer

KW - Paclitaxel

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U2 - 10.1016/j.ejca.2017.10.002

DO - 10.1016/j.ejca.2017.10.002

M3 - Article

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AN - SCOPUS:85032514631

VL - 86

SP - 385

EP - 393

JO - European Journal of Cancer

JF - European Journal of Cancer

SN - 0959-8049

ER -