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
© 2016 Elsevier Inc.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...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Journal Article |
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2017
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| Online Access: | http://hdl.handle.net/20.500.11937/58481 |
| _version_ | 1848760271450931200 |
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| author | Cinieri, S. Chan, Arlene Altundag, K. Vandebroek, A. Tubiana-Mathieu, N. Barnadas, A. Dodyk, P. Lazzarelli, S. Botha, M. Rauch, D. Villanova, G. Coskun, U. |
| author_facet | Cinieri, S. Chan, Arlene Altundag, K. Vandebroek, A. Tubiana-Mathieu, N. Barnadas, A. Dodyk, P. Lazzarelli, S. Botha, M. Rauch, D. Villanova, G. Coskun, U. |
| author_sort | Cinieri, S. |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | © 2016 Elsevier Inc.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. |
| first_indexed | 2025-11-14T10:13:08Z |
| format | Journal Article |
| id | curtin-20.500.11937-58481 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| last_indexed | 2025-11-14T10:13:08Z |
| publishDate | 2017 |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-584812017-11-24T05:46:57Z 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, S. Chan, Arlene Altundag, K. Vandebroek, A. Tubiana-Mathieu, N. Barnadas, A. Dodyk, P. Lazzarelli, S. Botha, M. Rauch, D. Villanova, G. Coskun, U. © 2016 Elsevier Inc.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. 2017 Journal Article http://hdl.handle.net/20.500.11937/58481 10.1016/j.clbc.2016.06.014 restricted |
| spellingShingle | Cinieri, S. Chan, Arlene Altundag, K. Vandebroek, A. Tubiana-Mathieu, N. Barnadas, A. Dodyk, P. Lazzarelli, S. Botha, M. Rauch, D. Villanova, G. Coskun, U. 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | http://hdl.handle.net/20.500.11937/58481 |