Abstract
Background: . Optimal therapy after breast conserving surgery (BCS) in older adults with low-risk early breast cancer (BC) is controversial. This study compares the effects of radiation therapy (RT) and endocrine therapy (ET) as exclusive treatments on health-related quality of life (HRQoL) and ipsilateral breast tumour recurrence (IBTR) rate in women aged ≥70 years with stage I luminal-like BC.
Methods. EUROPA (NCT04134598) is a phase 3, randomized, controlled trial. Women with early luminal-like BC (ER/PgR ≥10%, HER2 negative, Ki-67 index ≤20%, pT1ab N0/Nx, any grade or pT1c, grade 1-2), were 1:1 randomized after BCS to receive exclusive ET or exclusive RT. Central randomization was stratified by G8 health status (≤14 vs >14) and age at baseline (70–79 vs ≥80 years). The study coprimary endpoints are 2-year HRQoL as assessed by the global health status (GHS) scale of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and 5-year IBTR rate. Secondary endpoints are locoregional recurrence (LRR), contralateral BC (CBC), distant metastases (DM), BC specific- (BCSS), and overall-survival (OS) rates, adverse events, individual scale scores from QLQ-C30, QLQ-BR45, QLQ-ELD14 EORTC modules up to 5 years after treatment. We present the pre-planned interim HRQoL analysis results after at least 152 patients reached the 2-year HRQoL assessment. Data were analysed by intention to treat, using repeated mixed-effects methods.
Results: Between Feb 2021 and June 2024, 734 patients were enrolled and 731 randomly assigned to receive RT (n=365) or ET (n=366); 78.9% of the planned 926 patients from 21 centres. In the current interim analysis, the RT and ET arms included 104 and 103 patients, respectively. Age distribution was similar across treatment arms (74% aged 70-79 and 26% aged 80+ years); G8 scores were comparable (40% ≤14 and 60% scoring >14). At baseline, RT arm (n=104) had a mean GHS score of 71.9 (SD 19.05), while ET arm (n=99) had a mean score of 75.5 (SD 19.34). RT arm showed mean changes of -1.1 (24-month, SD 18.80) as compared to -10.0 (24-month, SD 25.80) of ET arm. Significant factors influencing GHS score changes were treatment type (p=0.045) and baseline GHS value (p<0.0001). Concerning adjusted mean GHS score reductions, for RT arm the mean changes were -3.77 (3-month; p=0.0452), -0.59 (6-month; p=0.7420), -4.33 (12-month; p=0.0333), and -3.40 (24-month; p=0.1314). For ET arm, mean changes were -6.45 (3-month; p=0.0015), -5.38 (6-month; p=0.0043), -6.60 (12-month; p=0.0025), and -9.79 (24-month; p<0.0001). The adjusted mean differences between RT and ET arms at 24 months showed a significant difference of 6.39 favouring RT arm (95%CI 0.14 to 12.65; p=0.0453). ET resulted in a more significant decline at 24 months in most of the functional and symptom scales of the QLQ-C30 questionnaire compared to RT. No IBTR, LRR, or DM events were reported in either group. CBC events occurred in 2 RT arm patients (1.9%) and 1 ET arm patient (1%). Deaths were 4 (3.8%) in RT arm and 2 (1.9%) in ET arm, none BC-related.
Conclusions. ET patients had significantly reduced HRQoL over 24 months compared to RT patients. These findings will help shared decision-making while awaiting final study results.
Methods. EUROPA (NCT04134598) is a phase 3, randomized, controlled trial. Women with early luminal-like BC (ER/PgR ≥10%, HER2 negative, Ki-67 index ≤20%, pT1ab N0/Nx, any grade or pT1c, grade 1-2), were 1:1 randomized after BCS to receive exclusive ET or exclusive RT. Central randomization was stratified by G8 health status (≤14 vs >14) and age at baseline (70–79 vs ≥80 years). The study coprimary endpoints are 2-year HRQoL as assessed by the global health status (GHS) scale of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and 5-year IBTR rate. Secondary endpoints are locoregional recurrence (LRR), contralateral BC (CBC), distant metastases (DM), BC specific- (BCSS), and overall-survival (OS) rates, adverse events, individual scale scores from QLQ-C30, QLQ-BR45, QLQ-ELD14 EORTC modules up to 5 years after treatment. We present the pre-planned interim HRQoL analysis results after at least 152 patients reached the 2-year HRQoL assessment. Data were analysed by intention to treat, using repeated mixed-effects methods.
Results: Between Feb 2021 and June 2024, 734 patients were enrolled and 731 randomly assigned to receive RT (n=365) or ET (n=366); 78.9% of the planned 926 patients from 21 centres. In the current interim analysis, the RT and ET arms included 104 and 103 patients, respectively. Age distribution was similar across treatment arms (74% aged 70-79 and 26% aged 80+ years); G8 scores were comparable (40% ≤14 and 60% scoring >14). At baseline, RT arm (n=104) had a mean GHS score of 71.9 (SD 19.05), while ET arm (n=99) had a mean score of 75.5 (SD 19.34). RT arm showed mean changes of -1.1 (24-month, SD 18.80) as compared to -10.0 (24-month, SD 25.80) of ET arm. Significant factors influencing GHS score changes were treatment type (p=0.045) and baseline GHS value (p<0.0001). Concerning adjusted mean GHS score reductions, for RT arm the mean changes were -3.77 (3-month; p=0.0452), -0.59 (6-month; p=0.7420), -4.33 (12-month; p=0.0333), and -3.40 (24-month; p=0.1314). For ET arm, mean changes were -6.45 (3-month; p=0.0015), -5.38 (6-month; p=0.0043), -6.60 (12-month; p=0.0025), and -9.79 (24-month; p<0.0001). The adjusted mean differences between RT and ET arms at 24 months showed a significant difference of 6.39 favouring RT arm (95%CI 0.14 to 12.65; p=0.0453). ET resulted in a more significant decline at 24 months in most of the functional and symptom scales of the QLQ-C30 questionnaire compared to RT. No IBTR, LRR, or DM events were reported in either group. CBC events occurred in 2 RT arm patients (1.9%) and 1 ET arm patient (1%). Deaths were 4 (3.8%) in RT arm and 2 (1.9%) in ET arm, none BC-related.
Conclusions. ET patients had significantly reduced HRQoL over 24 months compared to RT patients. These findings will help shared decision-making while awaiting final study results.
Background: . Optimal therapy after breast conserving surgery (BCS) in older adults with low-risk early breast cancer (BC) is controversial. This study compares the effects of radiation therapy (RT) and endocrine therapy (ET) as exclusive treatments on health-related quality of life (HRQoL) and ipsilateral breast tumour recurrence (IBTR) rate in women aged ≥70 years with stage I luminal-like BC.
Methods. EUROPA (NCT04134598) is a phase 3, randomized, controlled trial. Women with early luminal-like BC (ER/PgR ≥10%, HER2 negative, Ki-67 index ≤20%, pT1ab N0/Nx, any grade or pT1c, grade 1-2), were 1:1 randomized after BCS to receive exclusive ET or exclusive RT. Central randomization was stratified by G8 health status (≤14 vs >14) and age at baseline (70–79 vs ≥80 years). The study coprimary endpoints are 2-year HRQoL as assessed by the global health status (GHS) scale of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and 5-year IBTR rate. Secondary endpoints are locoregional recurrence (LRR), contralateral BC (CBC), distant metastases (DM), BC specific- (BCSS), and overall-survival (OS) rates, adverse events, individual scale scores from QLQ-C30, QLQ-BR45, QLQ-ELD14 EORTC modules up to 5 years after treatment. We present the pre-planned interim HRQoL analysis results after at least 152 patients reached the 2-year HRQoL assessment. Data were analysed by intention to treat, using repeated mixed-effects methods.
Results: Between Feb 2021 and June 2024, 734 patients were enrolled and 731 randomly assigned to receive RT (n=365) or ET (n=366); 78.9% of the planned 926 patients from 21 centres. In the current interim analysis, the RT and ET arms included 104 and 103 patients, respectively. Age distribution was similar across treatment arms (74% aged 70-79 and 26% aged 80+ years); G8 scores were comparable (40% ≤14 and 60% scoring >14). At baseline, RT arm (n=104) had a mean GHS score of 71.9 (SD 19.05), while ET arm (n=99) had a mean score of 75.5 (SD 19.34). RT arm showed mean changes of -1.1 (24-month, SD 18.80) as compared to -10.0 (24-month, SD 25.80) of ET arm. Significant factors influencing GHS score changes were treatment type (p=0.045) and baseline GHS value (p<0.0001). Concerning adjusted mean GHS score reductions, for RT arm the mean changes were -3.77 (3-month; p=0.0452), -0.59 (6-month; p=0.7420), -4.33 (12-month; p=0.0333), and -3.40 (24-month; p=0.1314). For ET arm, mean changes were -6.45 (3-month; p=0.0015), -5.38 (6-month; p=0.0043), -6.60 (12-month; p=0.0025), and -9.79 (24-month; p<0.0001). The adjusted mean differences between RT and ET arms at 24 months showed a significant difference of 6.39 favouring RT arm (95%CI 0.14 to 12.65; p=0.0453). ET resulted in a more significant decline at 24 months in most of the functional and symptom scales of the QLQ-C30 questionnaire compared to RT. No IBTR, LRR, or DM events were reported in either group. CBC events occurred in 2 RT arm patients (1.9%) and 1 ET arm patient (1%). Deaths were 4 (3.8%) in RT arm and 2 (1.9%) in ET arm, none BC-related.
Conclusions. ET patients had significantly reduced HRQoL over 24 months compared to RT patients. These findings will help shared decision-making while awaiting final study results.
Methods. EUROPA (NCT04134598) is a phase 3, randomized, controlled trial. Women with early luminal-like BC (ER/PgR ≥10%, HER2 negative, Ki-67 index ≤20%, pT1ab N0/Nx, any grade or pT1c, grade 1-2), were 1:1 randomized after BCS to receive exclusive ET or exclusive RT. Central randomization was stratified by G8 health status (≤14 vs >14) and age at baseline (70–79 vs ≥80 years). The study coprimary endpoints are 2-year HRQoL as assessed by the global health status (GHS) scale of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and 5-year IBTR rate. Secondary endpoints are locoregional recurrence (LRR), contralateral BC (CBC), distant metastases (DM), BC specific- (BCSS), and overall-survival (OS) rates, adverse events, individual scale scores from QLQ-C30, QLQ-BR45, QLQ-ELD14 EORTC modules up to 5 years after treatment. We present the pre-planned interim HRQoL analysis results after at least 152 patients reached the 2-year HRQoL assessment. Data were analysed by intention to treat, using repeated mixed-effects methods.
Results: Between Feb 2021 and June 2024, 734 patients were enrolled and 731 randomly assigned to receive RT (n=365) or ET (n=366); 78.9% of the planned 926 patients from 21 centres. In the current interim analysis, the RT and ET arms included 104 and 103 patients, respectively. Age distribution was similar across treatment arms (74% aged 70-79 and 26% aged 80+ years); G8 scores were comparable (40% ≤14 and 60% scoring >14). At baseline, RT arm (n=104) had a mean GHS score of 71.9 (SD 19.05), while ET arm (n=99) had a mean score of 75.5 (SD 19.34). RT arm showed mean changes of -1.1 (24-month, SD 18.80) as compared to -10.0 (24-month, SD 25.80) of ET arm. Significant factors influencing GHS score changes were treatment type (p=0.045) and baseline GHS value (p<0.0001). Concerning adjusted mean GHS score reductions, for RT arm the mean changes were -3.77 (3-month; p=0.0452), -0.59 (6-month; p=0.7420), -4.33 (12-month; p=0.0333), and -3.40 (24-month; p=0.1314). For ET arm, mean changes were -6.45 (3-month; p=0.0015), -5.38 (6-month; p=0.0043), -6.60 (12-month; p=0.0025), and -9.79 (24-month; p<0.0001). The adjusted mean differences between RT and ET arms at 24 months showed a significant difference of 6.39 favouring RT arm (95%CI 0.14 to 12.65; p=0.0453). ET resulted in a more significant decline at 24 months in most of the functional and symptom scales of the QLQ-C30 questionnaire compared to RT. No IBTR, LRR, or DM events were reported in either group. CBC events occurred in 2 RT arm patients (1.9%) and 1 ET arm patient (1%). Deaths were 4 (3.8%) in RT arm and 2 (1.9%) in ET arm, none BC-related.
Conclusions. ET patients had significantly reduced HRQoL over 24 months compared to RT patients. These findings will help shared decision-making while awaiting final study results.
Exclusive endocrine therapy or radiation therapy in women aged 70+ years with luminal-like early breast cancer (EUROPA): preplanned interim analysis of a randomized phase 3 trial
Icro Meattini
Abstract
Background: . Optimal therapy after breast conserving surgery (BCS) in older adults with low-risk early breast cancer (BC) is controversial. This study compares the effects of radiation therapy (RT) and endocrine therapy (ET) as exclusive treatments on health-related quality of life (HRQoL) and ipsilateral breast tumour recurrence (IBTR) rate in women aged ≥70 years with stage I luminal-like BC.
Methods. EUROPA (NCT04134598) is a phase 3, randomized, controlled trial. Women with early luminal-like BC (ER/PgR ≥10%, HER2 negative, Ki-67 index ≤20%, pT1ab N0/Nx, any grade or pT1c, grade 1-2), were 1:1 randomized after BCS to receive exclusive ET or exclusive RT. Central randomization was stratified by G8 health status (≤14 vs >14) and age at baseline (70–79 vs ≥80 years). The study coprimary endpoints are 2-year HRQoL as assessed by the global health status (GHS) scale of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and 5-year IBTR rate. Secondary endpoints are locoregional recurrence (LRR), contralateral BC (CBC), distant metastases (DM), BC specific- (BCSS), and overall-survival (OS) rates, adverse events, individual scale scores from QLQ-C30, QLQ-BR45, QLQ-ELD14 EORTC modules up to 5 years after treatment. We present the pre-planned interim HRQoL analysis results after at least 152 patients reached the 2-year HRQoL assessment. Data were analysed by intention to treat, using repeated mixed-effects methods.
Results: Between Feb 2021 and June 2024, 734 patients were enrolled and 731 randomly assigned to receive RT (n=365) or ET (n=366); 78.9% of the planned 926 patients from 21 centres. In the current interim analysis, the RT and ET arms included 104 and 103 patients, respectively. Age distribution was similar across treatment arms (74% aged 70-79 and 26% aged 80+ years); G8 scores were comparable (40% ≤14 and 60% scoring >14). At baseline, RT arm (n=104) had a mean GHS score of 71.9 (SD 19.05), while ET arm (n=99) had a mean score of 75.5 (SD 19.34). RT arm showed mean changes of -1.1 (24-month, SD 18.80) as compared to -10.0 (24-month, SD 25.80) of ET arm. Significant factors influencing GHS score changes were treatment type (p=0.045) and baseline GHS value (p<0.0001). Concerning adjusted mean GHS score reductions, for RT arm the mean changes were -3.77 (3-month; p=0.0452), -0.59 (6-month; p=0.7420), -4.33 (12-month; p=0.0333), and -3.40 (24-month; p=0.1314). For ET arm, mean changes were -6.45 (3-month; p=0.0015), -5.38 (6-month; p=0.0043), -6.60 (12-month; p=0.0025), and -9.79 (24-month; p<0.0001). The adjusted mean differences between RT and ET arms at 24 months showed a significant difference of 6.39 favouring RT arm (95%CI 0.14 to 12.65; p=0.0453). ET resulted in a more significant decline at 24 months in most of the functional and symptom scales of the QLQ-C30 questionnaire compared to RT. No IBTR, LRR, or DM events were reported in either group. CBC events occurred in 2 RT arm patients (1.9%) and 1 ET arm patient (1%). Deaths were 4 (3.8%) in RT arm and 2 (1.9%) in ET arm, none BC-related.
Conclusions. ET patients had significantly reduced HRQoL over 24 months compared to RT patients. These findings will help shared decision-making while awaiting final study results.
Methods. EUROPA (NCT04134598) is a phase 3, randomized, controlled trial. Women with early luminal-like BC (ER/PgR ≥10%, HER2 negative, Ki-67 index ≤20%, pT1ab N0/Nx, any grade or pT1c, grade 1-2), were 1:1 randomized after BCS to receive exclusive ET or exclusive RT. Central randomization was stratified by G8 health status (≤14 vs >14) and age at baseline (70–79 vs ≥80 years). The study coprimary endpoints are 2-year HRQoL as assessed by the global health status (GHS) scale of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and 5-year IBTR rate. Secondary endpoints are locoregional recurrence (LRR), contralateral BC (CBC), distant metastases (DM), BC specific- (BCSS), and overall-survival (OS) rates, adverse events, individual scale scores from QLQ-C30, QLQ-BR45, QLQ-ELD14 EORTC modules up to 5 years after treatment. We present the pre-planned interim HRQoL analysis results after at least 152 patients reached the 2-year HRQoL assessment. Data were analysed by intention to treat, using repeated mixed-effects methods.
Results: Between Feb 2021 and June 2024, 734 patients were enrolled and 731 randomly assigned to receive RT (n=365) or ET (n=366); 78.9% of the planned 926 patients from 21 centres. In the current interim analysis, the RT and ET arms included 104 and 103 patients, respectively. Age distribution was similar across treatment arms (74% aged 70-79 and 26% aged 80+ years); G8 scores were comparable (40% ≤14 and 60% scoring >14). At baseline, RT arm (n=104) had a mean GHS score of 71.9 (SD 19.05), while ET arm (n=99) had a mean score of 75.5 (SD 19.34). RT arm showed mean changes of -1.1 (24-month, SD 18.80) as compared to -10.0 (24-month, SD 25.80) of ET arm. Significant factors influencing GHS score changes were treatment type (p=0.045) and baseline GHS value (p<0.0001). Concerning adjusted mean GHS score reductions, for RT arm the mean changes were -3.77 (3-month; p=0.0452), -0.59 (6-month; p=0.7420), -4.33 (12-month; p=0.0333), and -3.40 (24-month; p=0.1314). For ET arm, mean changes were -6.45 (3-month; p=0.0015), -5.38 (6-month; p=0.0043), -6.60 (12-month; p=0.0025), and -9.79 (24-month; p<0.0001). The adjusted mean differences between RT and ET arms at 24 months showed a significant difference of 6.39 favouring RT arm (95%CI 0.14 to 12.65; p=0.0453). ET resulted in a more significant decline at 24 months in most of the functional and symptom scales of the QLQ-C30 questionnaire compared to RT. No IBTR, LRR, or DM events were reported in either group. CBC events occurred in 2 RT arm patients (1.9%) and 1 ET arm patient (1%). Deaths were 4 (3.8%) in RT arm and 2 (1.9%) in ET arm, none BC-related.
Conclusions. ET patients had significantly reduced HRQoL over 24 months compared to RT patients. These findings will help shared decision-making while awaiting final study results.
Background: . Optimal therapy after breast conserving surgery (BCS) in older adults with low-risk early breast cancer (BC) is controversial. This study compares the effects of radiation therapy (RT) and endocrine therapy (ET) as exclusive treatments on health-related quality of life (HRQoL) and ipsilateral breast tumour recurrence (IBTR) rate in women aged ≥70 years with stage I luminal-like BC.
Methods. EUROPA (NCT04134598) is a phase 3, randomized, controlled trial. Women with early luminal-like BC (ER/PgR ≥10%, HER2 negative, Ki-67 index ≤20%, pT1ab N0/Nx, any grade or pT1c, grade 1-2), were 1:1 randomized after BCS to receive exclusive ET or exclusive RT. Central randomization was stratified by G8 health status (≤14 vs >14) and age at baseline (70–79 vs ≥80 years). The study coprimary endpoints are 2-year HRQoL as assessed by the global health status (GHS) scale of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and 5-year IBTR rate. Secondary endpoints are locoregional recurrence (LRR), contralateral BC (CBC), distant metastases (DM), BC specific- (BCSS), and overall-survival (OS) rates, adverse events, individual scale scores from QLQ-C30, QLQ-BR45, QLQ-ELD14 EORTC modules up to 5 years after treatment. We present the pre-planned interim HRQoL analysis results after at least 152 patients reached the 2-year HRQoL assessment. Data were analysed by intention to treat, using repeated mixed-effects methods.
Results: Between Feb 2021 and June 2024, 734 patients were enrolled and 731 randomly assigned to receive RT (n=365) or ET (n=366); 78.9% of the planned 926 patients from 21 centres. In the current interim analysis, the RT and ET arms included 104 and 103 patients, respectively. Age distribution was similar across treatment arms (74% aged 70-79 and 26% aged 80+ years); G8 scores were comparable (40% ≤14 and 60% scoring >14). At baseline, RT arm (n=104) had a mean GHS score of 71.9 (SD 19.05), while ET arm (n=99) had a mean score of 75.5 (SD 19.34). RT arm showed mean changes of -1.1 (24-month, SD 18.80) as compared to -10.0 (24-month, SD 25.80) of ET arm. Significant factors influencing GHS score changes were treatment type (p=0.045) and baseline GHS value (p<0.0001). Concerning adjusted mean GHS score reductions, for RT arm the mean changes were -3.77 (3-month; p=0.0452), -0.59 (6-month; p=0.7420), -4.33 (12-month; p=0.0333), and -3.40 (24-month; p=0.1314). For ET arm, mean changes were -6.45 (3-month; p=0.0015), -5.38 (6-month; p=0.0043), -6.60 (12-month; p=0.0025), and -9.79 (24-month; p<0.0001). The adjusted mean differences between RT and ET arms at 24 months showed a significant difference of 6.39 favouring RT arm (95%CI 0.14 to 12.65; p=0.0453). ET resulted in a more significant decline at 24 months in most of the functional and symptom scales of the QLQ-C30 questionnaire compared to RT. No IBTR, LRR, or DM events were reported in either group. CBC events occurred in 2 RT arm patients (1.9%) and 1 ET arm patient (1%). Deaths were 4 (3.8%) in RT arm and 2 (1.9%) in ET arm, none BC-related.
Conclusions. ET patients had significantly reduced HRQoL over 24 months compared to RT patients. These findings will help shared decision-making while awaiting final study results.
Methods. EUROPA (NCT04134598) is a phase 3, randomized, controlled trial. Women with early luminal-like BC (ER/PgR ≥10%, HER2 negative, Ki-67 index ≤20%, pT1ab N0/Nx, any grade or pT1c, grade 1-2), were 1:1 randomized after BCS to receive exclusive ET or exclusive RT. Central randomization was stratified by G8 health status (≤14 vs >14) and age at baseline (70–79 vs ≥80 years). The study coprimary endpoints are 2-year HRQoL as assessed by the global health status (GHS) scale of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and 5-year IBTR rate. Secondary endpoints are locoregional recurrence (LRR), contralateral BC (CBC), distant metastases (DM), BC specific- (BCSS), and overall-survival (OS) rates, adverse events, individual scale scores from QLQ-C30, QLQ-BR45, QLQ-ELD14 EORTC modules up to 5 years after treatment. We present the pre-planned interim HRQoL analysis results after at least 152 patients reached the 2-year HRQoL assessment. Data were analysed by intention to treat, using repeated mixed-effects methods.
Results: Between Feb 2021 and June 2024, 734 patients were enrolled and 731 randomly assigned to receive RT (n=365) or ET (n=366); 78.9% of the planned 926 patients from 21 centres. In the current interim analysis, the RT and ET arms included 104 and 103 patients, respectively. Age distribution was similar across treatment arms (74% aged 70-79 and 26% aged 80+ years); G8 scores were comparable (40% ≤14 and 60% scoring >14). At baseline, RT arm (n=104) had a mean GHS score of 71.9 (SD 19.05), while ET arm (n=99) had a mean score of 75.5 (SD 19.34). RT arm showed mean changes of -1.1 (24-month, SD 18.80) as compared to -10.0 (24-month, SD 25.80) of ET arm. Significant factors influencing GHS score changes were treatment type (p=0.045) and baseline GHS value (p<0.0001). Concerning adjusted mean GHS score reductions, for RT arm the mean changes were -3.77 (3-month; p=0.0452), -0.59 (6-month; p=0.7420), -4.33 (12-month; p=0.0333), and -3.40 (24-month; p=0.1314). For ET arm, mean changes were -6.45 (3-month; p=0.0015), -5.38 (6-month; p=0.0043), -6.60 (12-month; p=0.0025), and -9.79 (24-month; p<0.0001). The adjusted mean differences between RT and ET arms at 24 months showed a significant difference of 6.39 favouring RT arm (95%CI 0.14 to 12.65; p=0.0453). ET resulted in a more significant decline at 24 months in most of the functional and symptom scales of the QLQ-C30 questionnaire compared to RT. No IBTR, LRR, or DM events were reported in either group. CBC events occurred in 2 RT arm patients (1.9%) and 1 ET arm patient (1%). Deaths were 4 (3.8%) in RT arm and 2 (1.9%) in ET arm, none BC-related.
Conclusions. ET patients had significantly reduced HRQoL over 24 months compared to RT patients. These findings will help shared decision-making while awaiting final study results.
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