Randomized open label phase III trial of irinotecan plus capecitabine versus capecitabine monotherapy in patients with metastatic breast cancer previously treated with anthracycline and taxane: Proceed trial (KCSG BR 11-01)

In Hae Park; Seock Ah Im; Kyung Hae Jung; Joo Hyuk Sohn; Yeon Hee Park; Keun Seok Lee; Sung Hoon Sim; Kyong Hwa Park; Jee Hyun Kim; Byung Ho Nam; Hee Jun Kim; Tae Yong Kim; Kyung Hun Lee; Sung Bae Kim; Jin Hee Ahn; Suee Lee; Jungsil Ro

doi:10.4143/crt.2017.562

Randomized open label phase III trial of irinotecan plus capecitabine versus capecitabine monotherapy in patients with metastatic breast cancer previously treated with anthracycline and taxane: Proceed trial (KCSG BR 11-01)

In Hae Park, Seock Ah Im, Kyung Hae Jung, Joo Hyuk Sohn, Yeon Hee Park, Keun Seok Lee, Sung Hoon Sim, Kyong Hwa Park, Jee Hyun Kim, Byung Ho Nam, Hee Jun Kim, Tae Yong Kim, Kyung Hun Lee, Sung Bae Kim, Jin Hee Ahn, Suee Lee, Jungsil Ro

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Abstract

Purpose We investigated whether irinotecan plus capecitabine improved progression-free survival (PFS) compared with capecitabine alone in patients with human epidermal growth factor 2 (HER2) negative and anthracycline and taxane pretreated metastatic breast cancer (MBC). Materials and Methods A total of 221 patients were randomly assigned to irinotecan (80 mg/m ² , days 1 and 8) and capecitabine (1,000 mg/m ² twice a day, days 1-14) or capecitabine alone (1,250 mg/m ² twice a day, days 1-14) every 3 weeks. The primary endpoint was PFS. Results There was no significant difference in PFS between the combination and monotherapy arm (median, 6.4 months vs. 4.7 months; hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.63 to 1.11; p=0.84). In patients with triple-negative breast cancer (TNBC, n=90), the combination significantly improved PFS (median, 4.7 months vs. 2.5 months; HR, 0.58; 95% CI, 0.37 to 0.91; p=0.02). Objective response rate was numerically higher in the combination arm, though it failed to reach statistical significance (44.4% vs. 33.3%, p=0.30). Overall survival did not differ between arms (median, 20.4 months vs. 24.0 months; p=0.63). While grade 3 or 4 neutropenia was more common in the combination arm (39.6% vs. 9.0%), hand-foot syndrome was more often observed in capecitabine arm. Quality of life measurements in global health status was similar. However, patients in the combination arm showed significantly worse symptom scales especially in nausea/vomiting and diarrhea. Conclusion Irinotecan plus capecitabine did not prove clinically superior to single-agent capecitabine in anthracycline- and taxane-pretreated HER2 negative MBC patients. Toxicity profiles of the two groups differed but were manageable. The role of added irinotecan in patients with TNBC remains to be elucidated.

Original language	English
Pages (from-to)	43-52
Number of pages	10
Journal	Cancer Research and Treatment
Volume	51
Issue number	1
DOIs	https://doi.org/10.4143/crt.2017.562
Publication status	Published - 2019 Jan 1

Keywords

Capecitabine
Clinical trial
Irinotecan
Metastatic breast cancer
Progression-free survival

ASJC Scopus subject areas

Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Park, I. H., Im, S. A., Jung, K. H., Sohn, J. H., Park, Y. H., Lee, K. S., Sim, S. H., Park, K. H., Kim, J. H., Nam, B. H., Kim, H. J., Kim, T. Y., Lee, K. H., Kim, S. B., Ahn, J. H., Lee, S., & Ro, J. (2019). Randomized open label phase III trial of irinotecan plus capecitabine versus capecitabine monotherapy in patients with metastatic breast cancer previously treated with anthracycline and taxane: Proceed trial (KCSG BR 11-01). Cancer Research and Treatment, 51(1), 43-52. https://doi.org/10.4143/crt.2017.562

Randomized open label phase III trial of irinotecan plus capecitabine versus capecitabine monotherapy in patients with metastatic breast cancer previously treated with anthracycline and taxane : Proceed trial (KCSG BR 11-01). / Park, In Hae; Im, Seock Ah; Jung, Kyung Hae; Sohn, Joo Hyuk; Park, Yeon Hee; Lee, Keun Seok; Sim, Sung Hoon; Park, Kyong Hwa; Kim, Jee Hyun; Nam, Byung Ho; Kim, Hee Jun; Kim, Tae Yong; Lee, Kyung Hun; Kim, Sung Bae; Ahn, Jin Hee; Lee, Suee; Ro, Jungsil.

In: Cancer Research and Treatment, Vol. 51, No. 1, 01.01.2019, p. 43-52.

Research output: Contribution to journal › Article › peer-review

Park, IH, Im, SA, Jung, KH, Sohn, JH, Park, YH, Lee, KS, Sim, SH, Park, KH, Kim, JH, Nam, BH, Kim, HJ, Kim, TY, Lee, KH, Kim, SB, Ahn, JH, Lee, S & Ro, J 2019, 'Randomized open label phase III trial of irinotecan plus capecitabine versus capecitabine monotherapy in patients with metastatic breast cancer previously treated with anthracycline and taxane: Proceed trial (KCSG BR 11-01)', Cancer Research and Treatment, vol. 51, no. 1, pp. 43-52. https://doi.org/10.4143/crt.2017.562

Park IH, Im SA, Jung KH, Sohn JH, Park YH, Lee KS et al. Randomized open label phase III trial of irinotecan plus capecitabine versus capecitabine monotherapy in patients with metastatic breast cancer previously treated with anthracycline and taxane: Proceed trial (KCSG BR 11-01). Cancer Research and Treatment. 2019 Jan 1;51(1):43-52. https://doi.org/10.4143/crt.2017.562

Park, In Hae ; Im, Seock Ah ; Jung, Kyung Hae ; Sohn, Joo Hyuk ; Park, Yeon Hee ; Lee, Keun Seok ; Sim, Sung Hoon ; Park, Kyong Hwa ; Kim, Jee Hyun ; Nam, Byung Ho ; Kim, Hee Jun ; Kim, Tae Yong ; Lee, Kyung Hun ; Kim, Sung Bae ; Ahn, Jin Hee ; Lee, Suee ; Ro, Jungsil. / Randomized open label phase III trial of irinotecan plus capecitabine versus capecitabine monotherapy in patients with metastatic breast cancer previously treated with anthracycline and taxane : Proceed trial (KCSG BR 11-01). In: Cancer Research and Treatment. 2019 ; Vol. 51, No. 1. pp. 43-52.

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title = "Randomized open label phase III trial of irinotecan plus capecitabine versus capecitabine monotherapy in patients with metastatic breast cancer previously treated with anthracycline and taxane: Proceed trial (KCSG BR 11-01)",

abstract = " Purpose We investigated whether irinotecan plus capecitabine improved progression-free survival (PFS) compared with capecitabine alone in patients with human epidermal growth factor 2 (HER2) negative and anthracycline and taxane pretreated metastatic breast cancer (MBC). Materials and Methods A total of 221 patients were randomly assigned to irinotecan (80 mg/m 2 , days 1 and 8) and capecitabine (1,000 mg/m 2 twice a day, days 1-14) or capecitabine alone (1,250 mg/m 2 twice a day, days 1-14) every 3 weeks. The primary endpoint was PFS. Results There was no significant difference in PFS between the combination and monotherapy arm (median, 6.4 months vs. 4.7 months; hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.63 to 1.11; p=0.84). In patients with triple-negative breast cancer (TNBC, n=90), the combination significantly improved PFS (median, 4.7 months vs. 2.5 months; HR, 0.58; 95% CI, 0.37 to 0.91; p=0.02). Objective response rate was numerically higher in the combination arm, though it failed to reach statistical significance (44.4% vs. 33.3%, p=0.30). Overall survival did not differ between arms (median, 20.4 months vs. 24.0 months; p=0.63). While grade 3 or 4 neutropenia was more common in the combination arm (39.6% vs. 9.0%), hand-foot syndrome was more often observed in capecitabine arm. Quality of life measurements in global health status was similar. However, patients in the combination arm showed significantly worse symptom scales especially in nausea/vomiting and diarrhea. Conclusion Irinotecan plus capecitabine did not prove clinically superior to single-agent capecitabine in anthracycline- and taxane-pretreated HER2 negative MBC patients. Toxicity profiles of the two groups differed but were manageable. The role of added irinotecan in patients with TNBC remains to be elucidated. ",

keywords = "Capecitabine, Clinical trial, Irinotecan, Metastatic breast cancer, Progression-free survival",

author = "Park, {In Hae} and Im, {Seock Ah} and Jung, {Kyung Hae} and Sohn, {Joo Hyuk} and Park, {Yeon Hee} and Lee, {Keun Seok} and Sim, {Sung Hoon} and Park, {Kyong Hwa} and Kim, {Jee Hyun} and Nam, {Byung Ho} and Kim, {Hee Jun} and Kim, {Tae Yong} and Lee, {Kyung Hun} and Kim, {Sung Bae} and Ahn, {Jin Hee} and Suee Lee and Jungsil Ro",

note = "Funding Information: This study was partly funded by Shin Poong Pharmaceuticals Co. Funding Information: We thank the patients, their families, and all investigators who participated in the study. We also thank the Shin Poong pharmaceuticals Co. for providing Irinotecan. This study was supported by NCC Grant No 1210530. Publisher Copyright: {\textcopyright} 2018 Springer New York LLC.All Rights Reserved.",

year = "2019",

month = jan,

day = "1",

doi = "10.4143/crt.2017.562",

language = "English",

volume = "51",

pages = "43--52",

journal = "Cancer Research and Treatment",

issn = "1598-2998",

publisher = "Korean Society for Thoracic and Cardiovascular Surgery",

number = "1",

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TY - JOUR

T1 - Randomized open label phase III trial of irinotecan plus capecitabine versus capecitabine monotherapy in patients with metastatic breast cancer previously treated with anthracycline and taxane

T2 - Proceed trial (KCSG BR 11-01)

AU - Park, In Hae

AU - Im, Seock Ah

AU - Jung, Kyung Hae

AU - Sohn, Joo Hyuk

AU - Park, Yeon Hee

AU - Lee, Keun Seok

AU - Sim, Sung Hoon

AU - Park, Kyong Hwa

AU - Kim, Jee Hyun

AU - Nam, Byung Ho

AU - Kim, Hee Jun

AU - Kim, Tae Yong

AU - Lee, Kyung Hun

AU - Kim, Sung Bae

AU - Ahn, Jin Hee

AU - Lee, Suee

AU - Ro, Jungsil

N1 - Funding Information: This study was partly funded by Shin Poong Pharmaceuticals Co. Funding Information: We thank the patients, their families, and all investigators who participated in the study. We also thank the Shin Poong pharmaceuticals Co. for providing Irinotecan. This study was supported by NCC Grant No 1210530. Publisher Copyright: © 2018 Springer New York LLC.All Rights Reserved.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Purpose We investigated whether irinotecan plus capecitabine improved progression-free survival (PFS) compared with capecitabine alone in patients with human epidermal growth factor 2 (HER2) negative and anthracycline and taxane pretreated metastatic breast cancer (MBC). Materials and Methods A total of 221 patients were randomly assigned to irinotecan (80 mg/m 2 , days 1 and 8) and capecitabine (1,000 mg/m 2 twice a day, days 1-14) or capecitabine alone (1,250 mg/m 2 twice a day, days 1-14) every 3 weeks. The primary endpoint was PFS. Results There was no significant difference in PFS between the combination and monotherapy arm (median, 6.4 months vs. 4.7 months; hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.63 to 1.11; p=0.84). In patients with triple-negative breast cancer (TNBC, n=90), the combination significantly improved PFS (median, 4.7 months vs. 2.5 months; HR, 0.58; 95% CI, 0.37 to 0.91; p=0.02). Objective response rate was numerically higher in the combination arm, though it failed to reach statistical significance (44.4% vs. 33.3%, p=0.30). Overall survival did not differ between arms (median, 20.4 months vs. 24.0 months; p=0.63). While grade 3 or 4 neutropenia was more common in the combination arm (39.6% vs. 9.0%), hand-foot syndrome was more often observed in capecitabine arm. Quality of life measurements in global health status was similar. However, patients in the combination arm showed significantly worse symptom scales especially in nausea/vomiting and diarrhea. Conclusion Irinotecan plus capecitabine did not prove clinically superior to single-agent capecitabine in anthracycline- and taxane-pretreated HER2 negative MBC patients. Toxicity profiles of the two groups differed but were manageable. The role of added irinotecan in patients with TNBC remains to be elucidated.

AB - Purpose We investigated whether irinotecan plus capecitabine improved progression-free survival (PFS) compared with capecitabine alone in patients with human epidermal growth factor 2 (HER2) negative and anthracycline and taxane pretreated metastatic breast cancer (MBC). Materials and Methods A total of 221 patients were randomly assigned to irinotecan (80 mg/m 2 , days 1 and 8) and capecitabine (1,000 mg/m 2 twice a day, days 1-14) or capecitabine alone (1,250 mg/m 2 twice a day, days 1-14) every 3 weeks. The primary endpoint was PFS. Results There was no significant difference in PFS between the combination and monotherapy arm (median, 6.4 months vs. 4.7 months; hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.63 to 1.11; p=0.84). In patients with triple-negative breast cancer (TNBC, n=90), the combination significantly improved PFS (median, 4.7 months vs. 2.5 months; HR, 0.58; 95% CI, 0.37 to 0.91; p=0.02). Objective response rate was numerically higher in the combination arm, though it failed to reach statistical significance (44.4% vs. 33.3%, p=0.30). Overall survival did not differ between arms (median, 20.4 months vs. 24.0 months; p=0.63). While grade 3 or 4 neutropenia was more common in the combination arm (39.6% vs. 9.0%), hand-foot syndrome was more often observed in capecitabine arm. Quality of life measurements in global health status was similar. However, patients in the combination arm showed significantly worse symptom scales especially in nausea/vomiting and diarrhea. Conclusion Irinotecan plus capecitabine did not prove clinically superior to single-agent capecitabine in anthracycline- and taxane-pretreated HER2 negative MBC patients. Toxicity profiles of the two groups differed but were manageable. The role of added irinotecan in patients with TNBC remains to be elucidated.

KW - Capecitabine

KW - Clinical trial

KW - Irinotecan

KW - Metastatic breast cancer

KW - Progression-free survival

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VL - 51

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JO - Cancer Research and Treatment

JF - Cancer Research and Treatment

SN - 1598-2998

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Randomized open label phase III trial of irinotecan plus capecitabine versus capecitabine monotherapy in patients with metastatic breast cancer previously treated with anthracycline and taxane: Proceed trial (KCSG BR 11-01)

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Keywords

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