Abstract
Background:
In high-risk hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC), nanoparticle albumin-bound (nab)-paclitaxel (PAC) showed promising efficacy versus solvent-based (sb)-PAC in neoadjuvant trials. However, the optimal chemotherapy regimen and impact of pCR on survival in HR+/HER2- EBC are still unclear. In the WSG ADAPT HR+/HER2- chemotherapy trial, we saw a significantly higher pathological complete response (pCR) in the neoadjuvant cohort. Here, we present final survival results from the chemotherapy part of the ADAPT HR+/HER2- trial utilizing clinical risk or Oncotype DX® recurrence score (RS) and endocrine therapy (ET) response (by post-endocrine Ki-67 after 2-4 weeks of induction standard ET) for therapy stratification.
Methods: Within the WSG-ADAPT trial (NCT01779206), high-risk HR+/HER2- EBC patients were randomized to (neo)adjuvant 4 x sb-PAC 175 mg/m2 q2w or 8 x nab-PAC 125 mg/m2 q1w, followed by 4 x EC (90 mg/m2 / 600 mg) q2w.
Inclusion criteria for the chemotherapy trial comprised: (i) c/pN0-1, RS 12-25, and post-ET Ki-67 >10 %; (ii) cN0-1 with RS >25. Patients with cN2-3 or G3, baseline Ki-67 >40 %, and tumor size >1 cm were allowed to be included without RS and/or ET response-testing. 2,242 patients were required to test superiority of 8 x nab-PAC weekly vs. 4 x PAC q2w regarding iDFS after 317 invasive events or 5 years of completed follow-up.
Results: 2,233 patients were randomized (1,129 / 1,104), median age was 51.0/ 51.0, clinical (in neoadjuvant chemotherapy-treated patients) or pathological N2-3 status was 19.5 % vs. 18.3 %, RS >25 occurred in 48.2 % vs. 50.7 % of the patients, and G3 tumors in 56.1 % vs. 57.5 %; ET-responders were 22 % in each treatment arm. Survival results: There was a trend for nab-Pac towards a better 5y-iDFS (85.7% versus 82.9%) compared to sb-Pac (p-value 0.054) (primary endpoint). DFS (5y 84.9 vs. 81.7%, p=.035) and RFS (5y 86.9% vs. 84.0%, p-value 0.041) showed a significant advantage with nab-Pac. Interestingly, preplanned subgroup analysis showed a benefit for nab-Pac in patients with a RS <=25, which mainly corresponds to ET non-responders (5y-iDFS nab-Pac 89.5% vs. sb-Pac 84.5%, p-value: 0.011), but not for RS>25 (5y 82.9 vs. 82.7%) . Current analysis showed no significant advantage with regard to the dDFS (5y 87.1 vs. 84.8%, p=0.13) and OS (5y 94.0 vs. 92.9%; p-value 0.387).
No new safety signals were observed so far. Details will be presented at the meeting.
Conclusions: WSG ADAPT HR+/HER2- is the largest prospective study so far, which compared two taxane-based dose-dense regimens in patients selected by RS and endocrine response. nab-Pac seems to be superior to sb-PAC in particular in patients with endocrine-non-responsive tumors.
These results will help to further optimize chemotherapy in the different prognostic subgroups of high-risk HR+/HER2- EBC.
Contact Information
Sherko.Kuemmel@kem-med.com
In high-risk hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC), nanoparticle albumin-bound (nab)-paclitaxel (PAC) showed promising efficacy versus solvent-based (sb)-PAC in neoadjuvant trials. However, the optimal chemotherapy regimen and impact of pCR on survival in HR+/HER2- EBC are still unclear. In the WSG ADAPT HR+/HER2- chemotherapy trial, we saw a significantly higher pathological complete response (pCR) in the neoadjuvant cohort. Here, we present final survival results from the chemotherapy part of the ADAPT HR+/HER2- trial utilizing clinical risk or Oncotype DX® recurrence score (RS) and endocrine therapy (ET) response (by post-endocrine Ki-67 after 2-4 weeks of induction standard ET) for therapy stratification.
Methods: Within the WSG-ADAPT trial (NCT01779206), high-risk HR+/HER2- EBC patients were randomized to (neo)adjuvant 4 x sb-PAC 175 mg/m2 q2w or 8 x nab-PAC 125 mg/m2 q1w, followed by 4 x EC (90 mg/m2 / 600 mg) q2w.
Inclusion criteria for the chemotherapy trial comprised: (i) c/pN0-1, RS 12-25, and post-ET Ki-67 >10 %; (ii) cN0-1 with RS >25. Patients with cN2-3 or G3, baseline Ki-67 >40 %, and tumor size >1 cm were allowed to be included without RS and/or ET response-testing. 2,242 patients were required to test superiority of 8 x nab-PAC weekly vs. 4 x PAC q2w regarding iDFS after 317 invasive events or 5 years of completed follow-up.
Results: 2,233 patients were randomized (1,129 / 1,104), median age was 51.0/ 51.0, clinical (in neoadjuvant chemotherapy-treated patients) or pathological N2-3 status was 19.5 % vs. 18.3 %, RS >25 occurred in 48.2 % vs. 50.7 % of the patients, and G3 tumors in 56.1 % vs. 57.5 %; ET-responders were 22 % in each treatment arm. Survival results: There was a trend for nab-Pac towards a better 5y-iDFS (85.7% versus 82.9%) compared to sb-Pac (p-value 0.054) (primary endpoint). DFS (5y 84.9 vs. 81.7%, p=.035) and RFS (5y 86.9% vs. 84.0%, p-value 0.041) showed a significant advantage with nab-Pac. Interestingly, preplanned subgroup analysis showed a benefit for nab-Pac in patients with a RS <=25, which mainly corresponds to ET non-responders (5y-iDFS nab-Pac 89.5% vs. sb-Pac 84.5%, p-value: 0.011), but not for RS>25 (5y 82.9 vs. 82.7%) . Current analysis showed no significant advantage with regard to the dDFS (5y 87.1 vs. 84.8%, p=0.13) and OS (5y 94.0 vs. 92.9%; p-value 0.387).
No new safety signals were observed so far. Details will be presented at the meeting.
Conclusions: WSG ADAPT HR+/HER2- is the largest prospective study so far, which compared two taxane-based dose-dense regimens in patients selected by RS and endocrine response. nab-Pac seems to be superior to sb-PAC in particular in patients with endocrine-non-responsive tumors.
These results will help to further optimize chemotherapy in the different prognostic subgroups of high-risk HR+/HER2- EBC.
Contact Information
Sherko.Kuemmel@kem-med.com
Background:
In high-risk hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC), nanoparticle albumin-bound (nab)-paclitaxel (PAC) showed promising efficacy versus solvent-based (sb)-PAC in neoadjuvant trials. However, the optimal chemotherapy regimen and impact of pCR on survival in HR+/HER2- EBC are still unclear. In the WSG ADAPT HR+/HER2- chemotherapy trial, we saw a significantly higher pathological complete response (pCR) in the neoadjuvant cohort. Here, we present final survival results from the chemotherapy part of the ADAPT HR+/HER2- trial utilizing clinical risk or Oncotype DX® recurrence score (RS) and endocrine therapy (ET) response (by post-endocrine Ki-67 after 2-4 weeks of induction standard ET) for therapy stratification.
Methods: Within the WSG-ADAPT trial (NCT01779206), high-risk HR+/HER2- EBC patients were randomized to (neo)adjuvant 4 x sb-PAC 175 mg/m2 q2w or 8 x nab-PAC 125 mg/m2 q1w, followed by 4 x EC (90 mg/m2 / 600 mg) q2w.
Inclusion criteria for the chemotherapy trial comprised: (i) c/pN0-1, RS 12-25, and post-ET Ki-67 >10 %; (ii) cN0-1 with RS >25. Patients with cN2-3 or G3, baseline Ki-67 >40 %, and tumor size >1 cm were allowed to be included without RS and/or ET response-testing. 2,242 patients were required to test superiority of 8 x nab-PAC weekly vs. 4 x PAC q2w regarding iDFS after 317 invasive events or 5 years of completed follow-up.
Results: 2,233 patients were randomized (1,129 / 1,104), median age was 51.0/ 51.0, clinical (in neoadjuvant chemotherapy-treated patients) or pathological N2-3 status was 19.5 % vs. 18.3 %, RS >25 occurred in 48.2 % vs. 50.7 % of the patients, and G3 tumors in 56.1 % vs. 57.5 %; ET-responders were 22 % in each treatment arm. Survival results: There was a trend for nab-Pac towards a better 5y-iDFS (85.7% versus 82.9%) compared to sb-Pac (p-value 0.054) (primary endpoint). DFS (5y 84.9 vs. 81.7%, p=.035) and RFS (5y 86.9% vs. 84.0%, p-value 0.041) showed a significant advantage with nab-Pac. Interestingly, preplanned subgroup analysis showed a benefit for nab-Pac in patients with a RS <=25, which mainly corresponds to ET non-responders (5y-iDFS nab-Pac 89.5% vs. sb-Pac 84.5%, p-value: 0.011), but not for RS>25 (5y 82.9 vs. 82.7%) . Current analysis showed no significant advantage with regard to the dDFS (5y 87.1 vs. 84.8%, p=0.13) and OS (5y 94.0 vs. 92.9%; p-value 0.387).
No new safety signals were observed so far. Details will be presented at the meeting.
Conclusions: WSG ADAPT HR+/HER2- is the largest prospective study so far, which compared two taxane-based dose-dense regimens in patients selected by RS and endocrine response. nab-Pac seems to be superior to sb-PAC in particular in patients with endocrine-non-responsive tumors.
These results will help to further optimize chemotherapy in the different prognostic subgroups of high-risk HR+/HER2- EBC.
Contact Information
Sherko.Kuemmel@kem-med.com
In high-risk hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC), nanoparticle albumin-bound (nab)-paclitaxel (PAC) showed promising efficacy versus solvent-based (sb)-PAC in neoadjuvant trials. However, the optimal chemotherapy regimen and impact of pCR on survival in HR+/HER2- EBC are still unclear. In the WSG ADAPT HR+/HER2- chemotherapy trial, we saw a significantly higher pathological complete response (pCR) in the neoadjuvant cohort. Here, we present final survival results from the chemotherapy part of the ADAPT HR+/HER2- trial utilizing clinical risk or Oncotype DX® recurrence score (RS) and endocrine therapy (ET) response (by post-endocrine Ki-67 after 2-4 weeks of induction standard ET) for therapy stratification.
Methods: Within the WSG-ADAPT trial (NCT01779206), high-risk HR+/HER2- EBC patients were randomized to (neo)adjuvant 4 x sb-PAC 175 mg/m2 q2w or 8 x nab-PAC 125 mg/m2 q1w, followed by 4 x EC (90 mg/m2 / 600 mg) q2w.
Inclusion criteria for the chemotherapy trial comprised: (i) c/pN0-1, RS 12-25, and post-ET Ki-67 >10 %; (ii) cN0-1 with RS >25. Patients with cN2-3 or G3, baseline Ki-67 >40 %, and tumor size >1 cm were allowed to be included without RS and/or ET response-testing. 2,242 patients were required to test superiority of 8 x nab-PAC weekly vs. 4 x PAC q2w regarding iDFS after 317 invasive events or 5 years of completed follow-up.
Results: 2,233 patients were randomized (1,129 / 1,104), median age was 51.0/ 51.0, clinical (in neoadjuvant chemotherapy-treated patients) or pathological N2-3 status was 19.5 % vs. 18.3 %, RS >25 occurred in 48.2 % vs. 50.7 % of the patients, and G3 tumors in 56.1 % vs. 57.5 %; ET-responders were 22 % in each treatment arm. Survival results: There was a trend for nab-Pac towards a better 5y-iDFS (85.7% versus 82.9%) compared to sb-Pac (p-value 0.054) (primary endpoint). DFS (5y 84.9 vs. 81.7%, p=.035) and RFS (5y 86.9% vs. 84.0%, p-value 0.041) showed a significant advantage with nab-Pac. Interestingly, preplanned subgroup analysis showed a benefit for nab-Pac in patients with a RS <=25, which mainly corresponds to ET non-responders (5y-iDFS nab-Pac 89.5% vs. sb-Pac 84.5%, p-value: 0.011), but not for RS>25 (5y 82.9 vs. 82.7%) . Current analysis showed no significant advantage with regard to the dDFS (5y 87.1 vs. 84.8%, p=0.13) and OS (5y 94.0 vs. 92.9%; p-value 0.387).
No new safety signals were observed so far. Details will be presented at the meeting.
Conclusions: WSG ADAPT HR+/HER2- is the largest prospective study so far, which compared two taxane-based dose-dense regimens in patients selected by RS and endocrine response. nab-Pac seems to be superior to sb-PAC in particular in patients with endocrine-non-responsive tumors.
These results will help to further optimize chemotherapy in the different prognostic subgroups of high-risk HR+/HER2- EBC.
Contact Information
Sherko.Kuemmel@kem-med.com
(Neo)adjuvant nab-PAC weekly vs sb-PAC q2w, followed by EC q2w, in genomically or clinically high-risk HR+/HER- early breast cancer according to ET-response: final survival results from the WSG ADAPT-HR+/HER2- chemotherapy-trial
Sherko Kuemmel
Abstract
Background:
In high-risk hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC), nanoparticle albumin-bound (nab)-paclitaxel (PAC) showed promising efficacy versus solvent-based (sb)-PAC in neoadjuvant trials. However, the optimal chemotherapy regimen and impact of pCR on survival in HR+/HER2- EBC are still unclear. In the WSG ADAPT HR+/HER2- chemotherapy trial, we saw a significantly higher pathological complete response (pCR) in the neoadjuvant cohort. Here, we present final survival results from the chemotherapy part of the ADAPT HR+/HER2- trial utilizing clinical risk or Oncotype DX® recurrence score (RS) and endocrine therapy (ET) response (by post-endocrine Ki-67 after 2-4 weeks of induction standard ET) for therapy stratification.
Methods: Within the WSG-ADAPT trial (NCT01779206), high-risk HR+/HER2- EBC patients were randomized to (neo)adjuvant 4 x sb-PAC 175 mg/m2 q2w or 8 x nab-PAC 125 mg/m2 q1w, followed by 4 x EC (90 mg/m2 / 600 mg) q2w.
Inclusion criteria for the chemotherapy trial comprised: (i) c/pN0-1, RS 12-25, and post-ET Ki-67 >10 %; (ii) cN0-1 with RS >25. Patients with cN2-3 or G3, baseline Ki-67 >40 %, and tumor size >1 cm were allowed to be included without RS and/or ET response-testing. 2,242 patients were required to test superiority of 8 x nab-PAC weekly vs. 4 x PAC q2w regarding iDFS after 317 invasive events or 5 years of completed follow-up.
Results: 2,233 patients were randomized (1,129 / 1,104), median age was 51.0/ 51.0, clinical (in neoadjuvant chemotherapy-treated patients) or pathological N2-3 status was 19.5 % vs. 18.3 %, RS >25 occurred in 48.2 % vs. 50.7 % of the patients, and G3 tumors in 56.1 % vs. 57.5 %; ET-responders were 22 % in each treatment arm. Survival results: There was a trend for nab-Pac towards a better 5y-iDFS (85.7% versus 82.9%) compared to sb-Pac (p-value 0.054) (primary endpoint). DFS (5y 84.9 vs. 81.7%, p=.035) and RFS (5y 86.9% vs. 84.0%, p-value 0.041) showed a significant advantage with nab-Pac. Interestingly, preplanned subgroup analysis showed a benefit for nab-Pac in patients with a RS <=25, which mainly corresponds to ET non-responders (5y-iDFS nab-Pac 89.5% vs. sb-Pac 84.5%, p-value: 0.011), but not for RS>25 (5y 82.9 vs. 82.7%) . Current analysis showed no significant advantage with regard to the dDFS (5y 87.1 vs. 84.8%, p=0.13) and OS (5y 94.0 vs. 92.9%; p-value 0.387).
No new safety signals were observed so far. Details will be presented at the meeting.
Conclusions: WSG ADAPT HR+/HER2- is the largest prospective study so far, which compared two taxane-based dose-dense regimens in patients selected by RS and endocrine response. nab-Pac seems to be superior to sb-PAC in particular in patients with endocrine-non-responsive tumors.
These results will help to further optimize chemotherapy in the different prognostic subgroups of high-risk HR+/HER2- EBC.
Contact Information
Sherko.Kuemmel@kem-med.com
In high-risk hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC), nanoparticle albumin-bound (nab)-paclitaxel (PAC) showed promising efficacy versus solvent-based (sb)-PAC in neoadjuvant trials. However, the optimal chemotherapy regimen and impact of pCR on survival in HR+/HER2- EBC are still unclear. In the WSG ADAPT HR+/HER2- chemotherapy trial, we saw a significantly higher pathological complete response (pCR) in the neoadjuvant cohort. Here, we present final survival results from the chemotherapy part of the ADAPT HR+/HER2- trial utilizing clinical risk or Oncotype DX® recurrence score (RS) and endocrine therapy (ET) response (by post-endocrine Ki-67 after 2-4 weeks of induction standard ET) for therapy stratification.
Methods: Within the WSG-ADAPT trial (NCT01779206), high-risk HR+/HER2- EBC patients were randomized to (neo)adjuvant 4 x sb-PAC 175 mg/m2 q2w or 8 x nab-PAC 125 mg/m2 q1w, followed by 4 x EC (90 mg/m2 / 600 mg) q2w.
Inclusion criteria for the chemotherapy trial comprised: (i) c/pN0-1, RS 12-25, and post-ET Ki-67 >10 %; (ii) cN0-1 with RS >25. Patients with cN2-3 or G3, baseline Ki-67 >40 %, and tumor size >1 cm were allowed to be included without RS and/or ET response-testing. 2,242 patients were required to test superiority of 8 x nab-PAC weekly vs. 4 x PAC q2w regarding iDFS after 317 invasive events or 5 years of completed follow-up.
Results: 2,233 patients were randomized (1,129 / 1,104), median age was 51.0/ 51.0, clinical (in neoadjuvant chemotherapy-treated patients) or pathological N2-3 status was 19.5 % vs. 18.3 %, RS >25 occurred in 48.2 % vs. 50.7 % of the patients, and G3 tumors in 56.1 % vs. 57.5 %; ET-responders were 22 % in each treatment arm. Survival results: There was a trend for nab-Pac towards a better 5y-iDFS (85.7% versus 82.9%) compared to sb-Pac (p-value 0.054) (primary endpoint). DFS (5y 84.9 vs. 81.7%, p=.035) and RFS (5y 86.9% vs. 84.0%, p-value 0.041) showed a significant advantage with nab-Pac. Interestingly, preplanned subgroup analysis showed a benefit for nab-Pac in patients with a RS <=25, which mainly corresponds to ET non-responders (5y-iDFS nab-Pac 89.5% vs. sb-Pac 84.5%, p-value: 0.011), but not for RS>25 (5y 82.9 vs. 82.7%) . Current analysis showed no significant advantage with regard to the dDFS (5y 87.1 vs. 84.8%, p=0.13) and OS (5y 94.0 vs. 92.9%; p-value 0.387).
No new safety signals were observed so far. Details will be presented at the meeting.
Conclusions: WSG ADAPT HR+/HER2- is the largest prospective study so far, which compared two taxane-based dose-dense regimens in patients selected by RS and endocrine response. nab-Pac seems to be superior to sb-PAC in particular in patients with endocrine-non-responsive tumors.
These results will help to further optimize chemotherapy in the different prognostic subgroups of high-risk HR+/HER2- EBC.
Contact Information
Sherko.Kuemmel@kem-med.com
Background:
In high-risk hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC), nanoparticle albumin-bound (nab)-paclitaxel (PAC) showed promising efficacy versus solvent-based (sb)-PAC in neoadjuvant trials. However, the optimal chemotherapy regimen and impact of pCR on survival in HR+/HER2- EBC are still unclear. In the WSG ADAPT HR+/HER2- chemotherapy trial, we saw a significantly higher pathological complete response (pCR) in the neoadjuvant cohort. Here, we present final survival results from the chemotherapy part of the ADAPT HR+/HER2- trial utilizing clinical risk or Oncotype DX® recurrence score (RS) and endocrine therapy (ET) response (by post-endocrine Ki-67 after 2-4 weeks of induction standard ET) for therapy stratification.
Methods: Within the WSG-ADAPT trial (NCT01779206), high-risk HR+/HER2- EBC patients were randomized to (neo)adjuvant 4 x sb-PAC 175 mg/m2 q2w or 8 x nab-PAC 125 mg/m2 q1w, followed by 4 x EC (90 mg/m2 / 600 mg) q2w.
Inclusion criteria for the chemotherapy trial comprised: (i) c/pN0-1, RS 12-25, and post-ET Ki-67 >10 %; (ii) cN0-1 with RS >25. Patients with cN2-3 or G3, baseline Ki-67 >40 %, and tumor size >1 cm were allowed to be included without RS and/or ET response-testing. 2,242 patients were required to test superiority of 8 x nab-PAC weekly vs. 4 x PAC q2w regarding iDFS after 317 invasive events or 5 years of completed follow-up.
Results: 2,233 patients were randomized (1,129 / 1,104), median age was 51.0/ 51.0, clinical (in neoadjuvant chemotherapy-treated patients) or pathological N2-3 status was 19.5 % vs. 18.3 %, RS >25 occurred in 48.2 % vs. 50.7 % of the patients, and G3 tumors in 56.1 % vs. 57.5 %; ET-responders were 22 % in each treatment arm. Survival results: There was a trend for nab-Pac towards a better 5y-iDFS (85.7% versus 82.9%) compared to sb-Pac (p-value 0.054) (primary endpoint). DFS (5y 84.9 vs. 81.7%, p=.035) and RFS (5y 86.9% vs. 84.0%, p-value 0.041) showed a significant advantage with nab-Pac. Interestingly, preplanned subgroup analysis showed a benefit for nab-Pac in patients with a RS <=25, which mainly corresponds to ET non-responders (5y-iDFS nab-Pac 89.5% vs. sb-Pac 84.5%, p-value: 0.011), but not for RS>25 (5y 82.9 vs. 82.7%) . Current analysis showed no significant advantage with regard to the dDFS (5y 87.1 vs. 84.8%, p=0.13) and OS (5y 94.0 vs. 92.9%; p-value 0.387).
No new safety signals were observed so far. Details will be presented at the meeting.
Conclusions: WSG ADAPT HR+/HER2- is the largest prospective study so far, which compared two taxane-based dose-dense regimens in patients selected by RS and endocrine response. nab-Pac seems to be superior to sb-PAC in particular in patients with endocrine-non-responsive tumors.
These results will help to further optimize chemotherapy in the different prognostic subgroups of high-risk HR+/HER2- EBC.
Contact Information
Sherko.Kuemmel@kem-med.com
In high-risk hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC), nanoparticle albumin-bound (nab)-paclitaxel (PAC) showed promising efficacy versus solvent-based (sb)-PAC in neoadjuvant trials. However, the optimal chemotherapy regimen and impact of pCR on survival in HR+/HER2- EBC are still unclear. In the WSG ADAPT HR+/HER2- chemotherapy trial, we saw a significantly higher pathological complete response (pCR) in the neoadjuvant cohort. Here, we present final survival results from the chemotherapy part of the ADAPT HR+/HER2- trial utilizing clinical risk or Oncotype DX® recurrence score (RS) and endocrine therapy (ET) response (by post-endocrine Ki-67 after 2-4 weeks of induction standard ET) for therapy stratification.
Methods: Within the WSG-ADAPT trial (NCT01779206), high-risk HR+/HER2- EBC patients were randomized to (neo)adjuvant 4 x sb-PAC 175 mg/m2 q2w or 8 x nab-PAC 125 mg/m2 q1w, followed by 4 x EC (90 mg/m2 / 600 mg) q2w.
Inclusion criteria for the chemotherapy trial comprised: (i) c/pN0-1, RS 12-25, and post-ET Ki-67 >10 %; (ii) cN0-1 with RS >25. Patients with cN2-3 or G3, baseline Ki-67 >40 %, and tumor size >1 cm were allowed to be included without RS and/or ET response-testing. 2,242 patients were required to test superiority of 8 x nab-PAC weekly vs. 4 x PAC q2w regarding iDFS after 317 invasive events or 5 years of completed follow-up.
Results: 2,233 patients were randomized (1,129 / 1,104), median age was 51.0/ 51.0, clinical (in neoadjuvant chemotherapy-treated patients) or pathological N2-3 status was 19.5 % vs. 18.3 %, RS >25 occurred in 48.2 % vs. 50.7 % of the patients, and G3 tumors in 56.1 % vs. 57.5 %; ET-responders were 22 % in each treatment arm. Survival results: There was a trend for nab-Pac towards a better 5y-iDFS (85.7% versus 82.9%) compared to sb-Pac (p-value 0.054) (primary endpoint). DFS (5y 84.9 vs. 81.7%, p=.035) and RFS (5y 86.9% vs. 84.0%, p-value 0.041) showed a significant advantage with nab-Pac. Interestingly, preplanned subgroup analysis showed a benefit for nab-Pac in patients with a RS <=25, which mainly corresponds to ET non-responders (5y-iDFS nab-Pac 89.5% vs. sb-Pac 84.5%, p-value: 0.011), but not for RS>25 (5y 82.9 vs. 82.7%) . Current analysis showed no significant advantage with regard to the dDFS (5y 87.1 vs. 84.8%, p=0.13) and OS (5y 94.0 vs. 92.9%; p-value 0.387).
No new safety signals were observed so far. Details will be presented at the meeting.
Conclusions: WSG ADAPT HR+/HER2- is the largest prospective study so far, which compared two taxane-based dose-dense regimens in patients selected by RS and endocrine response. nab-Pac seems to be superior to sb-PAC in particular in patients with endocrine-non-responsive tumors.
These results will help to further optimize chemotherapy in the different prognostic subgroups of high-risk HR+/HER2- EBC.
Contact Information
Sherko.Kuemmel@kem-med.com
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