Report Back from 2023 San Antonio Breast Cancer Symposium (SABCS)
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Curious about the latest information released about Early-Stage Breast Cancer at the annual San Antonio Breast Cancer Symposium? To help explain it all, we are thrilled to have Dr. Sherry Shen, medical oncologist and clinical investigator on the Breast Medicine Service at Memorial Sloan Kettering Cancer Center (MSK), as our presenter. Join us to hear about the different sessions and data that were presented at SABCS.
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Report Back from 2023 San Antonio Breast Cancer Symposium (SABCS)
- 1. SHARE Cancer Support: Early-stage SABCS 2023 update January 8, 2024 Sherry Shen, MD
- 2. 2 Ellis, JCO 2011; Johnston, JCO 2019 Disclosures Research funding (to institution): Merck, Sermonix Pharmaceuticals Honoraria: MJH Life Sciences
- 3. 3 Outline Immunotherapy for ER+ BC: should we add it to neoadjuvant chemotherapy? • KEYNOTE-756: neoadjuvant chemotherapy + Keytruda (pembrolizumab) • CHECKMATE 7FL: neoadjuvant chemotherapy + Opdivo (nivolumab) Adjuvant CDK4/6 inhibitors for ER+ BC: who should get these drugs? • NATALEE: adjuvant Kisqali (ribociclib) updated data ctDNA: how do we go from research to the clinic? Surgery & radiation updates Questions and discussion
- 4. 4 MSK Confidential — do not distribute Neoadjuvant chemotherapy (NACT) Who gets NACT and why? Goals: • To downstage the tumor and decrease surgical morbidity • To allow assessment of response and if needed, escalation of therapy post-operatively • To eradicate micrometastatic disease Therapeutic agents and Indications: • ER+: chemotherapy, depending on operability and if breast conservation is desired • HER2+: chemotherapy + anti-HER2 therapy, for T2+ or N+ • TNBC: chemotherapy + immunotherapy, for T2+ or N+
- 5. 5 O’Shaughnessy J, SABCS 2023 KEYNOTE-756: pembrolizumab and NACT for ER+ BC
- 6. 6 Loi S. SABCS 2023 CHECKMATE 7FL: nivolumab and NACT for ER+ BC
- 7. 7 Loi S. SABCS 2023 Adding immunotherapy to chemotherapy for ER+ BC
- 8. 8 Ellis, JCO 2011; Johnston, JCO 2019 Adding immunotherapy to NACT for ER+ BC Adding immunotherapy to chemotherapy improves pCR rate But does it decrease the risk of recurrence? We will have to wait for more data….. Conclusions
- 9. 9 Lynce F, J Pharma Thera 2018 Adjuvant CDK4/6 inhibitors Abemaciclib is FDA-approved for ER+ BC On October 12, 2021, the Food and Drug Administration approved abemaciclib with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence. This is the first CDK 4/6 inhibitor approved for adjuvant treatment of breast cancer.
- 10. 10 Hortobagyi G, SABCS 2023 NATALEE: adjuvant ribociclib
- 11. 11 Hortobagyi G, SABCS 2023 NATALEE: adjuvant ribociclib
- 12. 12 Harbeck E, ASCO 2023 Adjuvant CDK4/6is: comparing ribociclib & abemaciclib Is there really benefit here? There is cost: A/E & $$ Ribociclib Abemaciclib Differences in patient selection
- 13. 13 Slamon D, ASCO 2023; Johnston SRD, Lancet Oncology 2023; Johnston SRD, JCO 2023 Adjuvant CDK4/6is: comparing ribociclib & abemaciclib Ribociclib 400mg QD 3 on / 1 off Abemaciclib 150mg BID AE Any Grade AE Any Grade Neutropenia 62% Neutropenia 46% Liver toxicity 25% AST/ALT increase 11-20% Nausea 23% Nausea 30% Fatigue 22% Fatigue 41% Diarrhea 14% Diarrhea 84% QTc prolongation 5% Pneumonitis 1.5% ILD 3% VTE 1.4% VTE 2.5% Differences in toxicity
- 14. 14 Adjuvant CDK4/6 inhibitors Conclusions • Abemaciclib is FDA-approved for high-risk early-stage ER+ breast cancer • The NATALEE trial of ribociclib included a slightly different population • Data are promising but exactly who benefits is unclear Unanswered questions • Does everyone who met inclusion criteria need ribociclib (or abemaciclib)? • How can we better select the patient population who would benefit the most? • Does the potential benefit warrant the toxicities (both physical and financial) of taking these drugs for 2-3 years? Conclusions & unanswered questions
- 15. 15 Graff, SABCS 2023; Pusztai SABCS 2023; Elliott SABCS 2023; Janni SABCS 2023 ctDNA updates Neoadjuvant • Most patients have detectable ctDNA prior to neoadjuvant therapy • Baseline ctDNA detection rates are highest in TNBC • Persistence of ctDNA during & after neoadjuvant therapy is prognostic of recurrence Adjuvant • ctDNA can be detected up to 2 years before recurrence, median lead time is a few months • ctDNA detection after adjuvant therapy (chemotherapy or CDK4/6i) is worrisome for recurrence • In high-risk ER+, ctDNA detection rate at 9 years approaches 10% of patients • Serial screening increases detection rates • Even in patients who have persistently negative ctDNA, recurrences happen Is ctDNA clinically useful though? How do we go from research to the clinic?
- 16. 16 Boniface, SABCS 2023; Mamounas, SABS 2023; Jagsi, SABCS 2023 Surgery & radiation updates SENOMAC trial • For 1-2 +SLNs, completion ALND does not decrease recurrence risk • ALND can be safely avoided in these cases NRG Onc / NSABP B-51 / RTOG 1304 • For +LNs that become negative after NACT, axillary radiation does not decrease recurrence risk • Axillary RT maybe can be safely avoided in these cases (analysis not final) IDEA • For postmeno age 50-69 pT1N0 ER+/HER2- Odx <=18, recurrence rates were low without any RT • Large randomized trial of RT vs. no RT in this population ongoing We are learning to de-escalate in appropriate situations! Disclaimer: I’m a medical oncologist!
- 17. 17 Questions?
Editor's Notes
- Surgery and Radiation considerations: what’s the “right amount”? (SENOMAC, NSABP B51, IDEA, SOUND)
- Final pCR analysis (ITT) and first interim EFS analysis 7% discontinuation of any drug on IO arm, 2% discontinuation of any drug on PBO arm
- To complicate all of this, per the SOUND trial SLNB can be avoided in T1 tumors or up to 3cm We could theoretically still give ribo for T2N0 with high genomic risk features BUT FDA may only approve in N+
- To complicate all of this, per the SOUND trial SLNB can be avoided in T1 tumors or up to 3cm We could theoretically still give ribo for T2N0 with high genomic risk features BUT FDA may only approve in N+
- ctDNA positivity prior to neoadjuvant or prior to adjuvant therapy not as meaningful – clearance important Becoming positive from prior negative result is bad Persistent positive is bad ctDNA detection shortly after (neo)adjuvant is infrequent (5%) But in high-risk ER on monarchE trial, 21% became ctDNA+ at 24 months
- SENOMAC: 2766 pts with 1-2 SLNs randomized to no cALND vs. cALND, 36% had mastectomy, 6% had T3, 34% extranodal extension, 84% got nodal RT In 34%, additional non-SLN mets identified on completion ALND After median 3 years f/u, recurrences 3-4% and were not significantly different between groups Confirms ACOSOG Z011 findings NRG Onc / NSABP B-51 / RTOG 1304: 1641 enrolled who completed >=8 wks NACT and achieved ypT0N0 randomized to RNI vs no RNI, median f/u 5 years, 56% HER2+, 23% TNBC, 21% HR+ Interim analysis: no significant diff between groups for locoregional recurrence free interval, DFRI, DFS, OS IDEA: 200 patients postmeno age 50-69 with pT1N0 negative margins ER+/PR+, Odx <=18 planning to take >=5 years ET Median tumor size 1cm, median f/u 5 years, 5-year freedom from recurrence 99%, after 5 years 95-97% NRG BR007 RCT ongoing