Breast Cancer Trials Flashcards
NSABP B 4
- MRM vs Total mastectomy with radiation vs Total mastectomy alone
- 40 % clinically node negative, node positive after dissection
- 18 % mastectomy alone with nodal recurrence (median 14 months)
- No increase distant met rate
NSABP B 6
- (MRM) vs (lumpectomy + ax dissection) vs (lumpectomy + ax dissection + ax radiation)
- < 4 cm tumors
- BCS equivalent to MRM
- Radiation reduces LR by 2/3
- NO OS benefit
NSABP B13
- Surgery alone vs. surgery plus adjuvant chemotherapy in N0 patients with HR neg tumors
- Improved disease-free survival rate for adjuvant chemotherapy group
NSABP B14
- Surgery alone vs. surgery plus adjuvant tamoxifen in node-negative patients with estrogen receptor-positive tumors
- Improved disease-free survival rate for adjuvant tamoxifen group
NSABP B18
Does Neoadjuvant AC vs adjuvant AC increase lumpectomy rate
Yes it does
NSABP B21
- Lumpectomy plus tamoxifen vs. lumpectomy plus tamoxifen plus XRT vs. lumpectomy plus XRT for node-negative tumors <1 cm
- Combination of XRT and tamoxifen was more effective than either alone in reducing ipsilateral breast tumor recurrence
NSABP B32
- (Lumpectomy + SNLB and Ax dissection) vs (Lumpectomy + SNLB and Ax dissection only for positive node)
- No difference in any measure if SLN negative
NSABP B51
- Radiation vs no radiation in patients who are node negative after NACT (initially node positive)
- Only T1-T3 and N1
- No difference in RFS, DFS at 5 yrs
Create X trial?
- Adjuvant Capecitabine after nCT for TNBC
- Improves DFS
- Improves OS in triple neg
- Most improvement in triple negative
Keynote 522 TNBC?
Stage 2 and 3 TNBC higher PCR with Chemo + Pembro
Olympia trial?
PARP inhibitor (Olaparib) improves DFS in BRCA
APHINITY trial?
- TCHP vs TCH adjuvant for early breast cancer
- Improvement with TCHP
KATHERINE trial?
- Adjuvant TDM1 improves DFS after nCHT for HER2 positive cancer vs adjuvant anti-HERa agents alone
- T1c and above included
- Dual anti HER allowed
AMAROS
- Ax dissection vs radiation for T1-T2, N0 with any positive SLN
* 33% additional positive nodes on ALND after SLN - Equal outcomes, less side effects with radiation
- Mastectomy also included
ACOSOG Z011exclusions
Neoadjuvant therapy
Matted nodes
Extranodal extension
3 or more positive
ACOZOG Z010
Significance of axillary micromets and bone marrow mets by IHC in H&E negative LN
10 % positive by IHC, no OS impact
3 % bone marrow positive, reduces OS
ACOZOG Z1071
- Accuracy of SNLB after NACT in node positive
- FNR primary end point
- 2 or more SLN identified in 81%
* FNR 12.6% - PCR 41%
ALLIANCE A11202 (ongoing)
- Axillary radiation and RNI vs Ax dissection and RNI in patients with positive SLN after NACT
IDEA trial (Individualized decisions for endocrine therapy alone)
- Non randomized single arm
- Non inferiority of omiting radiation in low risk HR+ tumors in patients 50-69 yrs
- <2 cm, HRpos, low oncotype <18, high compliance with endocrine therapy
5 and 3.6 percent 5 yr recurrence
NSABP P1
High risk ( Gail >1.66% in 5 years, LCIS or post menopausal)
Tamoxifen 20 mg QD for 5 yrs vs placebo
Tamoxifen reduces invasive cancers (49%) and invasive HR+ cancer (69%)
NSABP P2
Raloxifene vs Tamoxifen in post menopausal (Gail >1.66%)
Raloxifene 76% as effective
Much fewer side effects
TEXT and SOFT trials
- AI + Ovarian suppression superior to Tamoxifen + ovarian suppression
- HR+ breast cancer in premenopausal women
ATAC
- AI superior to Tamoxifen in HR + post menopausal
CALOR trial
- Chemo for recurrence improves prognosis
- Especially if recurrence is triple neg
