Final Results of the Randomized Phase II NorCap-CA223 Trial Comparing First-Line All-Oral Versus Taxane-Based Chemotherapy for HER2-Negative Metastatic Breast Cancer

Saverio Cinieri, Arlene Chan, Kadri Altundag, An Vandebroek, Nicole Tubiana-Mathieu, Agusti Barnadas, Patricia Dodyk, Silvia Lazzarelli, Michiel Botha, Daniel Rauch, Gustavo Villanova, Ugur Coskun

Research output: Contribution to journalArticle

Abstract

This randomized phase II trial compared first-line all-oral vinorelbine/capecitabine, gemcitabine/paclitaxel, and gemcitabine/docetaxel for HER2-negative metastatic breast cancer. Disease control rates (primary end point) were 73%, 78%, and 80%, respectively; median progression-free survival was 7.6, 9.0, and 11.4 months; median overall survival was 30 to 31 months with all regimens. All-oral vinorelbine/capecitabine is an active first-line regimen, and avoids alopecia and frequent intravenous administrations. Background The purpose of this study was to evaluate the efficacy of 3 first-line chemotherapy combination regimens for HER2-negative metastatic breast cancer (mBC). Patients and Methods In this open-label, 3-arm, randomized phase II trial, patients were randomized to all-oral NORCAP (vinorelbine/capecitabine), GEMPAC (gemcitabine/paclitaxel), or GEMDOC (gemcitabine/docetaxel) as first-line chemotherapy for HER2-negative mBC. Stratification factors were center, previous (neo)adjuvant anthracycline, and age. The primary end point was disease control rate (DCR; complete or partial response, or stable disease for ≥3 months). Results The DCR was 73% (95% confidence interval [CI], 59-85) with NORCAP (36 of 49 patients), 78% (95% CI, 64-88) with GEMPAC (39 of 50 patients), and 80% (95% CI, 66-90) with GEMDOC (40 of 50 patients). Objective response rates were 33% (16 of 49 patients), 24% (12 of 50 patients), and 50% (25 of 50 patients), respectively; median progression-free survival was 7.6, 9.0, and 11.4 months, respectively. Median overall survival was 30 to 31 months with all regimens. The most common Grade ≥3 adverse event with each regimen was neutropenia (24 patients [50%], 23 patients [46%], and 43 patients [86%], respectively). The most common nonhematological Grade ≥3 adverse event was fatigue. Grade 2 alopecia occurred in 36 patients (72%) who received GEMPAC and 38 patients (76%) who received GEMDOC, but only 4 patients (8%) who received NORCAP. There was no evidence of a detrimental effect of NORCAP on quality of life. Conclusion All-oral NORCAP is an active first-line chemotherapy regimen and might be offered as an alternative to first-line taxane-based therapy for HER2-negative mBC, particularly if patients wish to avoid alopecia or frequent intravenous administrations.

Original languageEnglish
Pages (from-to)91-99.e1
JournalClinical Breast Cancer
Volume17
Issue number2
DOIs
Publication statusPublished - Apr 1 2017
Externally publishedYes

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gemcitabine
Breast Neoplasms
Drug Therapy
docetaxel
Paclitaxel
Alopecia
taxane
Confidence Intervals
Intravenous Administration
Disease-Free Survival
Survival
Anthracyclines
Combination Drug Therapy
Neutropenia
Fatigue

Keywords

  • Capecitabine
  • Combination chemotherapy
  • Oral chemotherapy
  • Oral vinorelbine
  • Taxane doublet

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Final Results of the Randomized Phase II NorCap-CA223 Trial Comparing First-Line All-Oral Versus Taxane-Based Chemotherapy for HER2-Negative Metastatic Breast Cancer. / Cinieri, Saverio; Chan, Arlene; Altundag, Kadri; Vandebroek, An; Tubiana-Mathieu, Nicole; Barnadas, Agusti; Dodyk, Patricia; Lazzarelli, Silvia; Botha, Michiel; Rauch, Daniel; Villanova, Gustavo; Coskun, Ugur.

In: Clinical Breast Cancer, Vol. 17, No. 2, 01.04.2017, p. 91-99.e1.

Research output: Contribution to journalArticle

Cinieri, S, Chan, A, Altundag, K, Vandebroek, A, Tubiana-Mathieu, N, Barnadas, A, Dodyk, P, Lazzarelli, S, Botha, M, Rauch, D, Villanova, G & Coskun, U 2017, 'Final Results of the Randomized Phase II NorCap-CA223 Trial Comparing First-Line All-Oral Versus Taxane-Based Chemotherapy for HER2-Negative Metastatic Breast Cancer', Clinical Breast Cancer, vol. 17, no. 2, pp. 91-99.e1. https://doi.org/10.1016/j.clbc.2016.06.014
Cinieri, Saverio ; Chan, Arlene ; Altundag, Kadri ; Vandebroek, An ; Tubiana-Mathieu, Nicole ; Barnadas, Agusti ; Dodyk, Patricia ; Lazzarelli, Silvia ; Botha, Michiel ; Rauch, Daniel ; Villanova, Gustavo ; Coskun, Ugur. / Final Results of the Randomized Phase II NorCap-CA223 Trial Comparing First-Line All-Oral Versus Taxane-Based Chemotherapy for HER2-Negative Metastatic Breast Cancer. In: Clinical Breast Cancer. 2017 ; Vol. 17, No. 2. pp. 91-99.e1.
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abstract = "This randomized phase II trial compared first-line all-oral vinorelbine/capecitabine, gemcitabine/paclitaxel, and gemcitabine/docetaxel for HER2-negative metastatic breast cancer. Disease control rates (primary end point) were 73{\%}, 78{\%}, and 80{\%}, respectively; median progression-free survival was 7.6, 9.0, and 11.4 months; median overall survival was 30 to 31 months with all regimens. All-oral vinorelbine/capecitabine is an active first-line regimen, and avoids alopecia and frequent intravenous administrations. Background The purpose of this study was to evaluate the efficacy of 3 first-line chemotherapy combination regimens for HER2-negative metastatic breast cancer (mBC). Patients and Methods In this open-label, 3-arm, randomized phase II trial, patients were randomized to all-oral NORCAP (vinorelbine/capecitabine), GEMPAC (gemcitabine/paclitaxel), or GEMDOC (gemcitabine/docetaxel) as first-line chemotherapy for HER2-negative mBC. Stratification factors were center, previous (neo)adjuvant anthracycline, and age. The primary end point was disease control rate (DCR; complete or partial response, or stable disease for ≥3 months). Results The DCR was 73{\%} (95{\%} confidence interval [CI], 59-85) with NORCAP (36 of 49 patients), 78{\%} (95{\%} CI, 64-88) with GEMPAC (39 of 50 patients), and 80{\%} (95{\%} CI, 66-90) with GEMDOC (40 of 50 patients). Objective response rates were 33{\%} (16 of 49 patients), 24{\%} (12 of 50 patients), and 50{\%} (25 of 50 patients), respectively; median progression-free survival was 7.6, 9.0, and 11.4 months, respectively. Median overall survival was 30 to 31 months with all regimens. The most common Grade ≥3 adverse event with each regimen was neutropenia (24 patients [50{\%}], 23 patients [46{\%}], and 43 patients [86{\%}], respectively). The most common nonhematological Grade ≥3 adverse event was fatigue. Grade 2 alopecia occurred in 36 patients (72{\%}) who received GEMPAC and 38 patients (76{\%}) who received GEMDOC, but only 4 patients (8{\%}) who received NORCAP. There was no evidence of a detrimental effect of NORCAP on quality of life. Conclusion All-oral NORCAP is an active first-line chemotherapy regimen and might be offered as an alternative to first-line taxane-based therapy for HER2-negative mBC, particularly if patients wish to avoid alopecia or frequent intravenous administrations.",
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T1 - Final Results of the Randomized Phase II NorCap-CA223 Trial Comparing First-Line All-Oral Versus Taxane-Based Chemotherapy for HER2-Negative Metastatic Breast Cancer

AU - Cinieri, Saverio

AU - Chan, Arlene

AU - Altundag, Kadri

AU - Vandebroek, An

AU - Tubiana-Mathieu, Nicole

AU - Barnadas, Agusti

AU - Dodyk, Patricia

AU - Lazzarelli, Silvia

AU - Botha, Michiel

AU - Rauch, Daniel

AU - Villanova, Gustavo

AU - Coskun, Ugur

PY - 2017/4/1

Y1 - 2017/4/1

N2 - This randomized phase II trial compared first-line all-oral vinorelbine/capecitabine, gemcitabine/paclitaxel, and gemcitabine/docetaxel for HER2-negative metastatic breast cancer. Disease control rates (primary end point) were 73%, 78%, and 80%, respectively; median progression-free survival was 7.6, 9.0, and 11.4 months; median overall survival was 30 to 31 months with all regimens. All-oral vinorelbine/capecitabine is an active first-line regimen, and avoids alopecia and frequent intravenous administrations. Background The purpose of this study was to evaluate the efficacy of 3 first-line chemotherapy combination regimens for HER2-negative metastatic breast cancer (mBC). Patients and Methods In this open-label, 3-arm, randomized phase II trial, patients were randomized to all-oral NORCAP (vinorelbine/capecitabine), GEMPAC (gemcitabine/paclitaxel), or GEMDOC (gemcitabine/docetaxel) as first-line chemotherapy for HER2-negative mBC. Stratification factors were center, previous (neo)adjuvant anthracycline, and age. The primary end point was disease control rate (DCR; complete or partial response, or stable disease for ≥3 months). Results The DCR was 73% (95% confidence interval [CI], 59-85) with NORCAP (36 of 49 patients), 78% (95% CI, 64-88) with GEMPAC (39 of 50 patients), and 80% (95% CI, 66-90) with GEMDOC (40 of 50 patients). Objective response rates were 33% (16 of 49 patients), 24% (12 of 50 patients), and 50% (25 of 50 patients), respectively; median progression-free survival was 7.6, 9.0, and 11.4 months, respectively. Median overall survival was 30 to 31 months with all regimens. The most common Grade ≥3 adverse event with each regimen was neutropenia (24 patients [50%], 23 patients [46%], and 43 patients [86%], respectively). The most common nonhematological Grade ≥3 adverse event was fatigue. Grade 2 alopecia occurred in 36 patients (72%) who received GEMPAC and 38 patients (76%) who received GEMDOC, but only 4 patients (8%) who received NORCAP. There was no evidence of a detrimental effect of NORCAP on quality of life. Conclusion All-oral NORCAP is an active first-line chemotherapy regimen and might be offered as an alternative to first-line taxane-based therapy for HER2-negative mBC, particularly if patients wish to avoid alopecia or frequent intravenous administrations.

AB - This randomized phase II trial compared first-line all-oral vinorelbine/capecitabine, gemcitabine/paclitaxel, and gemcitabine/docetaxel for HER2-negative metastatic breast cancer. Disease control rates (primary end point) were 73%, 78%, and 80%, respectively; median progression-free survival was 7.6, 9.0, and 11.4 months; median overall survival was 30 to 31 months with all regimens. All-oral vinorelbine/capecitabine is an active first-line regimen, and avoids alopecia and frequent intravenous administrations. Background The purpose of this study was to evaluate the efficacy of 3 first-line chemotherapy combination regimens for HER2-negative metastatic breast cancer (mBC). Patients and Methods In this open-label, 3-arm, randomized phase II trial, patients were randomized to all-oral NORCAP (vinorelbine/capecitabine), GEMPAC (gemcitabine/paclitaxel), or GEMDOC (gemcitabine/docetaxel) as first-line chemotherapy for HER2-negative mBC. Stratification factors were center, previous (neo)adjuvant anthracycline, and age. The primary end point was disease control rate (DCR; complete or partial response, or stable disease for ≥3 months). Results The DCR was 73% (95% confidence interval [CI], 59-85) with NORCAP (36 of 49 patients), 78% (95% CI, 64-88) with GEMPAC (39 of 50 patients), and 80% (95% CI, 66-90) with GEMDOC (40 of 50 patients). Objective response rates were 33% (16 of 49 patients), 24% (12 of 50 patients), and 50% (25 of 50 patients), respectively; median progression-free survival was 7.6, 9.0, and 11.4 months, respectively. Median overall survival was 30 to 31 months with all regimens. The most common Grade ≥3 adverse event with each regimen was neutropenia (24 patients [50%], 23 patients [46%], and 43 patients [86%], respectively). The most common nonhematological Grade ≥3 adverse event was fatigue. Grade 2 alopecia occurred in 36 patients (72%) who received GEMPAC and 38 patients (76%) who received GEMDOC, but only 4 patients (8%) who received NORCAP. There was no evidence of a detrimental effect of NORCAP on quality of life. Conclusion All-oral NORCAP is an active first-line chemotherapy regimen and might be offered as an alternative to first-line taxane-based therapy for HER2-negative mBC, particularly if patients wish to avoid alopecia or frequent intravenous administrations.

KW - Capecitabine

KW - Combination chemotherapy

KW - Oral chemotherapy

KW - Oral vinorelbine

KW - Taxane doublet

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