Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16)

Sung Hoon Sim, In Hae Park, Kyung Hae Jung, Sung Bae Kim, Jin Hee Ahn, Kyung Hun Lee, Seock Ah Im, Young Hyuck Im, Yeon Hee Park, Joohyuk Sohn, Yu Jung Kim, Suee Lee, Hee Jun Kim, Yee Soo Chae, Kyong Hwa Park, Byung Ho Nam, Keun Seok Lee, Jungsil Ro

Research output: Contribution to journalArticle

Abstract

Background: The continuum of anti-HER2 agents is a standard treatment of HER2 + metastatic breast cancer (MBC). This study evaluated the efficacy of lapatinib plus vinorelbine in patients progressed on both trastuzumab and lapatinib treatments. Methods: A total of 149 patients were randomly assigned to lapatinib with vinorelbine (LV) (n = 75; lapatinib, 1000 mg daily; vinorelbine 20 mg/m2 D1, D8 q3w) or vinorelbine (V) (n = 74; 30 mg/m2 D1, D8 q3w). The primary endpoint was progression-free survival (PFS) rate at 18 weeks. Results: The median number of previous anti-HER2 therapies was 2 (range 2–5). There was no significant difference in PFS rate at 18 weeks between LV and V arms (45.9% vs 38.9%, p = 0.40). ORR was 19.7% in LV arm, and 16.9% in V arm (p = 0.88). PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61–1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72–1.58). Toxicity profiles were similar in both arms and all were manageable. Conclusions: Lapatinib plus vinorelbine treatment was tolerable; however, it failed to demonstrate the clinical benefits over vinorelbine alone in patients with HER2 + MBC after progression on both trastuzumab and lapatinib. Clinical trial registration: ClinicalTrials.gov number NCT01730677.

Original languageEnglish
Pages (from-to)985-990
Number of pages6
JournalBritish Journal of Cancer
Volume121
Issue number12
DOIs
StatePublished - 10 Dec 2019

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Breast Neoplasms
Disease-Free Survival
Therapeutics
Survival Rate
lapatinib
Trastuzumab
vinorelbine
Clinical Trials

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Sim, Sung Hoon ; Park, In Hae ; Jung, Kyung Hae ; Kim, Sung Bae ; Ahn, Jin Hee ; Lee, Kyung Hun ; Im, Seock Ah ; Im, Young Hyuck ; Park, Yeon Hee ; Sohn, Joohyuk ; Kim, Yu Jung ; Lee, Suee ; Kim, Hee Jun ; Chae, Yee Soo ; Park, Kyong Hwa ; Nam, Byung Ho ; Lee, Keun Seok ; Ro, Jungsil. / Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16). In: British Journal of Cancer. 2019 ; Vol. 121, No. 12. pp. 985-990.
@article{cd74a5f105974a8a89db6f9a0bbcfe4e,
title = "Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16)",
abstract = "Background: The continuum of anti-HER2 agents is a standard treatment of HER2 + metastatic breast cancer (MBC). This study evaluated the efficacy of lapatinib plus vinorelbine in patients progressed on both trastuzumab and lapatinib treatments. Methods: A total of 149 patients were randomly assigned to lapatinib with vinorelbine (LV) (n = 75; lapatinib, 1000 mg daily; vinorelbine 20 mg/m2 D1, D8 q3w) or vinorelbine (V) (n = 74; 30 mg/m2 D1, D8 q3w). The primary endpoint was progression-free survival (PFS) rate at 18 weeks. Results: The median number of previous anti-HER2 therapies was 2 (range 2–5). There was no significant difference in PFS rate at 18 weeks between LV and V arms (45.9{\%} vs 38.9{\%}, p = 0.40). ORR was 19.7{\%} in LV arm, and 16.9{\%} in V arm (p = 0.88). PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95{\%} CI 0.61–1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95{\%} CI 0.72–1.58). Toxicity profiles were similar in both arms and all were manageable. Conclusions: Lapatinib plus vinorelbine treatment was tolerable; however, it failed to demonstrate the clinical benefits over vinorelbine alone in patients with HER2 + MBC after progression on both trastuzumab and lapatinib. Clinical trial registration: ClinicalTrials.gov number NCT01730677.",
author = "Sim, {Sung Hoon} and Park, {In Hae} and Jung, {Kyung Hae} and Kim, {Sung Bae} and Ahn, {Jin Hee} and Lee, {Kyung Hun} and Im, {Seock Ah} and Im, {Young Hyuck} and Park, {Yeon Hee} and Joohyuk Sohn and Kim, {Yu Jung} and Suee Lee and Kim, {Hee Jun} and Chae, {Yee Soo} and Park, {Kyong Hwa} and Nam, {Byung Ho} and Lee, {Keun Seok} and Jungsil Ro",
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Sim, SH, Park, IH, Jung, KH, Kim, SB, Ahn, JH, Lee, KH, Im, SA, Im, YH, Park, YH, Sohn, J, Kim, YJ, Lee, S, Kim, HJ, Chae, YS, Park, KH, Nam, BH, Lee, KS & Ro, J 2019, 'Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16)', British Journal of Cancer, vol. 121, no. 12, pp. 985-990. https://doi.org/10.1038/s41416-019-0618-z

Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16). / Sim, Sung Hoon; Park, In Hae; Jung, Kyung Hae; Kim, Sung Bae; Ahn, Jin Hee; Lee, Kyung Hun; Im, Seock Ah; Im, Young Hyuck; Park, Yeon Hee; Sohn, Joohyuk; Kim, Yu Jung; Lee, Suee; Kim, Hee Jun; Chae, Yee Soo; Park, Kyong Hwa; Nam, Byung Ho; Lee, Keun Seok; Ro, Jungsil.

In: British Journal of Cancer, Vol. 121, No. 12, 10.12.2019, p. 985-990.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16)

AU - Sim, Sung Hoon

AU - Park, In Hae

AU - Jung, Kyung Hae

AU - Kim, Sung Bae

AU - Ahn, Jin Hee

AU - Lee, Kyung Hun

AU - Im, Seock Ah

AU - Im, Young Hyuck

AU - Park, Yeon Hee

AU - Sohn, Joohyuk

AU - Kim, Yu Jung

AU - Lee, Suee

AU - Kim, Hee Jun

AU - Chae, Yee Soo

AU - Park, Kyong Hwa

AU - Nam, Byung Ho

AU - Lee, Keun Seok

AU - Ro, Jungsil

PY - 2019/12/10

Y1 - 2019/12/10

N2 - Background: The continuum of anti-HER2 agents is a standard treatment of HER2 + metastatic breast cancer (MBC). This study evaluated the efficacy of lapatinib plus vinorelbine in patients progressed on both trastuzumab and lapatinib treatments. Methods: A total of 149 patients were randomly assigned to lapatinib with vinorelbine (LV) (n = 75; lapatinib, 1000 mg daily; vinorelbine 20 mg/m2 D1, D8 q3w) or vinorelbine (V) (n = 74; 30 mg/m2 D1, D8 q3w). The primary endpoint was progression-free survival (PFS) rate at 18 weeks. Results: The median number of previous anti-HER2 therapies was 2 (range 2–5). There was no significant difference in PFS rate at 18 weeks between LV and V arms (45.9% vs 38.9%, p = 0.40). ORR was 19.7% in LV arm, and 16.9% in V arm (p = 0.88). PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61–1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72–1.58). Toxicity profiles were similar in both arms and all were manageable. Conclusions: Lapatinib plus vinorelbine treatment was tolerable; however, it failed to demonstrate the clinical benefits over vinorelbine alone in patients with HER2 + MBC after progression on both trastuzumab and lapatinib. Clinical trial registration: ClinicalTrials.gov number NCT01730677.

AB - Background: The continuum of anti-HER2 agents is a standard treatment of HER2 + metastatic breast cancer (MBC). This study evaluated the efficacy of lapatinib plus vinorelbine in patients progressed on both trastuzumab and lapatinib treatments. Methods: A total of 149 patients were randomly assigned to lapatinib with vinorelbine (LV) (n = 75; lapatinib, 1000 mg daily; vinorelbine 20 mg/m2 D1, D8 q3w) or vinorelbine (V) (n = 74; 30 mg/m2 D1, D8 q3w). The primary endpoint was progression-free survival (PFS) rate at 18 weeks. Results: The median number of previous anti-HER2 therapies was 2 (range 2–5). There was no significant difference in PFS rate at 18 weeks between LV and V arms (45.9% vs 38.9%, p = 0.40). ORR was 19.7% in LV arm, and 16.9% in V arm (p = 0.88). PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61–1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72–1.58). Toxicity profiles were similar in both arms and all were manageable. Conclusions: Lapatinib plus vinorelbine treatment was tolerable; however, it failed to demonstrate the clinical benefits over vinorelbine alone in patients with HER2 + MBC after progression on both trastuzumab and lapatinib. Clinical trial registration: ClinicalTrials.gov number NCT01730677.

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U2 - 10.1038/s41416-019-0618-z

DO - 10.1038/s41416-019-0618-z

M3 - Article

C2 - 31690831

AN - SCOPUS:85074795875

VL - 121

SP - 985

EP - 990

JO - British Journal of Cancer

JF - British Journal of Cancer

SN - 0007-0920

IS - 12

ER -