6个月曲妥珠单抗对比1年曲妥珠单抗疗效文献解读(柳叶刀2019)
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The primary end point disease-free survival
IF=59.102
2019.06
Background
Adjuvant trastuzumab significantly improves outcomes for patients with HER2-positive early breastcancer. The standard treatment duration is 12 months but shorter treatment could provide similar efficacy while reducing toxicities and cost.
TIPS
In the 2019 St. Gallen International Breast Cancer Expert Vote, the voting results on the duration of trastuzumab adjuvant therapy were similar to previous years. 89.9% of the experts chose trastuzumab adjuvant therapy for 1 year
*PERSEPHONE is the largest trastuzumab duration comparison study for early breast cancer and the only one to show non-inferiority for the primary endpoint of reduced duration adjuvant trastuzumab.
Outcome
4 years
DFS:12 months（89.8％）vs 6 months（89.4％） A 0.4% absolute difference in DFS
OS :12 months（94.8％）vs 6 months（93.8％） A 1% absolute difference in OS
Conclusion
*PERSEPHONE showed non-inferiority for 6 months of trastuzumab compared with 12 months
*Fewer cardiac events and other toxic effects occurred with 6-month treatment and, therefore, the balance of risk and benefit favours shorter treatment
Fra Baidu bibliotek
PATIENTS AND METHODS
2045(12 months) VS
2043( 6 months)
PATIENTS AND METHODS
HR Positive :69% Median Age :56 years Nodal Status:Negative 58-59% Tumour size :≤2（47%）2-5（45%） Tumour grade:III 63-65% Menopausal Status:Pm 52-56%
EARLY BREAST CANCER
ARTICLE SOURCE
6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year
disease-free survival results of a randomised phase 3 non-inferiority trial
Outcome
During the first 6 months of treatment:proportions of patients with low LVEF were 7% in both groups During months 7–12 :The 12-month group (8%) vs The 6-month group (5%) p=0·0003
IF=59.102
2019.06
Background
Adjuvant trastuzumab significantly improves outcomes for patients with HER2-positive early breastcancer. The standard treatment duration is 12 months but shorter treatment could provide similar efficacy while reducing toxicities and cost.
TIPS
In the 2019 St. Gallen International Breast Cancer Expert Vote, the voting results on the duration of trastuzumab adjuvant therapy were similar to previous years. 89.9% of the experts chose trastuzumab adjuvant therapy for 1 year
*PERSEPHONE is the largest trastuzumab duration comparison study for early breast cancer and the only one to show non-inferiority for the primary endpoint of reduced duration adjuvant trastuzumab.
Outcome
4 years
DFS:12 months（89.8％）vs 6 months（89.4％） A 0.4% absolute difference in DFS
OS :12 months（94.8％）vs 6 months（93.8％） A 1% absolute difference in OS
Conclusion
*PERSEPHONE showed non-inferiority for 6 months of trastuzumab compared with 12 months
*Fewer cardiac events and other toxic effects occurred with 6-month treatment and, therefore, the balance of risk and benefit favours shorter treatment
Fra Baidu bibliotek
PATIENTS AND METHODS
2045(12 months) VS
2043( 6 months)
PATIENTS AND METHODS
HR Positive :69% Median Age :56 years Nodal Status:Negative 58-59% Tumour size :≤2（47%）2-5（45%） Tumour grade:III 63-65% Menopausal Status:Pm 52-56%
EARLY BREAST CANCER
ARTICLE SOURCE
6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year
disease-free survival results of a randomised phase 3 non-inferiority trial
Outcome
During the first 6 months of treatment:proportions of patients with low LVEF were 7% in both groups During months 7–12 :The 12-month group (8%) vs The 6-month group (5%) p=0·0003