SENTINA Trial
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Journal discussion regarding inel Node Biopsy after Neoadjuvant Chemotherapy in Breast Cancers
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SENTINA Trial
- 1. JOURNAL CLUB SENTINA TRIAL Dr. D. Pradeep MCh Postgraduate TN Govt Multi Super Speciality Hospital Chennai 28 Dec 2018
- 2. Background ■ Optimum timing of SLNB for breast cancer patients treated with NACT is uncertain ■ SENTINA (SENTinel NeoAdjuvant) – evaluate a specific algorithm for timing of SLNB in patients undergoing NACT 12/28/2018
- 3. Need for Study ■ Nodal stage after Neoadjuvant chemotherapy reflects prognosis more accurately than does initial axillary status ■ Previous cohort studies done in SLNB after NACT are retrospective ■ Metaanalyses show detection rates of 63-100% and false negative rates of 0-39% ■ To provide reliable data for feasibility and accuracy of SLNB in different settings before and after NACT. 12/28/2018
- 4. Evidence So Far ■ Khan et al – detection rate for second SLNB after NACT was 97% and false negative rate 4.5% ■ Prospective multicenter study – detection rate of SLNB after NACT was 94.6% and 81.5% for cN0 and cN+ status. 12/28/2018
- 5. Objectives ■ Primary outcome – Accuracy of SLB after NACT for patients who converted from cN+ to cN0 ■ Secondary outcome – Comparison of detection rate of SLNB before and after NACT – False negative rate and detection rate of second SLNB after removal of SLN 12/28/2018
- 6. Definition ■ False negative rate = No of patients with negative SLN and one or more positive non sentinel LNs / No of patients with at least one involved LN among people at least one SLN detected ■ Successful SLN detection – Surgical removal of one or more lymph nodes visualized by lymphatic mapping 12/28/2018
- 7. Trial Methodology ■ 4 arm, Prospective Multicentre cohort study ■ 103 centres in Germany and Austria ■ Patients with breast cancer who are scheduled for 6 cycles of Anthracycline based regimen ■ Arms decided according to clinical axillary nodal status (both by palpation and ultrasound) 12/28/2018
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- 9. SLNB procedure ■ Use of radiocolloid and preoperative lymphoscintigraphy necessary for all patients ■ Additional blue dye was optional ■ Site of injection individual choice ■ Dose and volume within limits ■ Slicing of nodes at 2.0 to 3.0mm intervals – paraffin embedded & step sectioning of slices at intervals <500um ■ IHC not required 12/28/2018
- 10. Nodal status assessment ■ Palpation and ultrasound shows no suspicious nodes – cN0 ■ Palpable nodes – but ultrasound Normal sized nodes with regular morphology of hilum and cortex – cN0 ■ Suspicious nodes – Ultrasound (cortex asymmetry or loss of hilum relation hilum:cortex ratio >2:1 or total loss) ■ USG guided FNA or CNB recommended (not mandatory) ■ If reported negative, taken as cN0 and SLNB done 12/28/2018
- 11. Statistical Workup ■ FNR of 7% in arms B and C based on validation trial ■ Calculated sample size of at least 196 in every arm ■ Expect 13% of entire study population will have positive axillary status in arm B and 14% in arm C resulting in total number of 1508 patients ■ To compare rates across groups – Pearson chi square test ■ Fisher exact test for FNR and detection rate ■ Wilcoxon and Kruskal-wallis test – compare the number of detected SLNs between 2 groups ■ Multivariate regression to find factors that affected detection rate and FNR 12/28/2018
- 12. Of 2234, 1737 entered in trial 2009 to 2012 103 centres Median 8 per insititute cN0 1022 pts 59% cN+ 715 pts 41% SLNB done pN0 662 pts 65% pN+ 360 pts 35% NACT cN0 592 pts 83% cN+ 123 pts 17% 12/28/2018
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- 20. Arm B Arm C Successful SLNB 219 patients 474 patients ypN0 155 (70.8%) 248 (52.3%) ypN+ 64 (29.2%) 226 (47.7%) False Negative rate 51.6% 14.2% Median no of resected non sentinel LNs 11 13 LN involvement restricted to SLN 45 (70.3%) 131 (58%) 12/28/2018
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- 22. Strengths ■ Strict standardization of SLNB procedure ■ Predefined chemotherapy regimens 12/28/2018
- 23. Limitations ■ FNR of arm A cannot be obtained as they were excluded from Axillary dissection ■ Restricted lymph node assessment to palpation and ultrasound ■ SLNB after neoadjuvant chemotherapy technically more challenging 12/28/2018
- 24. Our Study Comparison Second SLNB detection rate 66% 97% Khan et al Second SLNB False negative rate 51.6% 4.5% Khan et al cN+ to cN0 post NACT SLNB detection rate 80.2% 81.5% Classe et al cN+ to cN0 post NACT False negative rate 14.2% 15% Classe et al FNR based on no of LNs One node – 24.3% Two nodes – 18.5% One node – 17.7% Two nodes – 10% (NSABP B32) Addition of blue dye to radiocolloid in arm C Detection rates 77.4% to 87.6% improvement 78.1% to 87.6% Mamounas et al Addition of blue dye to radiocolloid in arm C False negative rate 8.6% for combined vs 16% for radiocolloid 10.8% for combined vs 20% for radiocolloid (ACOSOG Z1071) 12/28/2018
- 25. Concerns ■ Neoadjuvant chemotherapy – Impairs lymphatic drainage – Tumor regression in axilla could follow a non uniform pattern ■ Second SLNB – Additional node involvement cannot be detected once primary drainage has been destroyed 12/28/2018
- 26. Conclusion ■ SLNB less reliable (inferior detection rates and accuracy) if undertaken after neoadjuvant chemotherapy who are cN+ to cN0 ■ Use of combined tracer might improve FNR ■ Accuracy of SLNB is closely related to number of sentinel nodes removed ■ Still Unclear – lower FNR with combined tracer due to mapping technique or additional nodal harvest ■ No difference in detection rate and FNR for patients confirmed by FNA or CNB compared with exclusive clinical assessment in arm C 12/28/2018
- 27. Ideas ■ Need for addressing the clinical effect of increased FNR after NACT 12/28/2018
- 28. Similar Trials ■ ACOSOG Z1071 Trial published in 2013 – 756 pts from 136 institutions – Primary aim – FNR after NACT for SLNB – cN+ to cN0 after NACT – SLN identification rate 92.9% – False negative rate 12.6% – But <10% when 2 or more SLNs removed 12/28/2018
- 29. Similar Trials ■ SN FNAC (Sentinel Node biopsy aFter Neoadjuvant Chemotherapy in biopsy proven cN+) ■ To find out accuracy of SLNB after NACT setting ■ Identification rate 87.6% ■ False negative rate 13.3% ■ IHC mandatory in this trial, so with IHC positivity, FNR is reduced to 8.4% 12/28/2018
- 30. Ongoing Trials ■ Second biopsy of Axillary Sentinel node in Local recurrence of breast cancer after mastectomy and first negative sentinel node ■ 2012 to ongoing 12/28/2018
- 31. Ongoing Trials ■ Towards plannable breast surgery: Diagnostic accuracy of microbubble enhanced Iodine-125 seed localization of the sentinel lymph node. (NTR 3690) ■ 2012 to ongoing 12/28/2018
- 32. Ongoing Trials ■ MAGSTAR Trial ■ 2015 to ongoing ■ Magnetic vs Standard technique of axillary mapping ■ Magnetic tracer and Magnetometer (Sentimag) 12/28/2018