1. Basis and Outcome of Axillary Dissection for Node Negative Axilla Gurpreet Singh Dept. Of Surgery P.G.I.M.E.R. These Power Point presentations are free to download only for academic purposes, with due acknowledgements to authors and this website.

2. Moynihan stated at the turn of the last century that "surgery of malignant disease is not the surgery of organs; it is the anatomy of the lymphatic system...“

3. Rationale for ALND in Breast Cancer Accurate staging Regional control of the disease Prognostic information Influence of the information on the adjuvant therapy Improved survival

4. Need for Revaluation of ALND Screening mammography Adjuvant systemic therapy to node negative patients Financial implications of ALND –Saving of OT time –Saving in admission costs Complications of ALND

5. 50% to 70% of patients undergoing ALND will have some complaints Early Skin erythema Seroma Wound infection

6. Complications of ALND Delayed Shoulder motion (17%) Arm edema (16%) Pain (25%) Intercostobrachial nerve numbness (78%)

7. Patients Perception of Complications of ALND Ann Surg 2004;240: 1–6

8. Staging

9. Frequency of Tumor + Nodes No. of patients T1aT1bT1cT2 Silverstein10313173244 McGee307712233354 Giuliano259101330- Cady570-173144 Average49377193251 World J Surg 2001; 25:761–766

10. Staging of the Axilla Clinical examination Imaging methods Preoperative prediction of nodal involvement Axillary node sampling Sentinel lymph node biopsy

11. Local Control

12. Axillary Failure in Clinically Node – Patients: No Axillary Treatment

13. Axillary Failure in Clinically Node – Patients: Axillary RT

14. Adjuvant Treatment

15. Will ALND Change Treatment Two hundred eighty-two women with clinically negative axillae were analyzed using a model treatment algorithm Systemic therapy was assigned with and without data from axillary dissection Treatment shifts based on axillary dissection data were scored

16. Will ALND Change Treatment For women 50 to 60 years of age, –10% with tumors <1 cm, –17% with tumors 1 to 2 cm with positive prognostic features –4% with poor prognostic features For women older than 60 years –3% of those with tumors <1 cm –none of those with tumors >1 cm Ann Surg 1997, 226: 279-287

17. Is Axillary Lymph Node Dissection Indicated for Early-Stage Breast Cancer? A Decision Analysis Two examples Patient A is 60 years old, with a primary tumor size between 0.5 and 1 cm Patient B is 38 years old, with a primary tumor size between 3 and 4 cm Both have ER-positive tumors and clinically negative axillae Parmigiani; J Clin Oncol 1999, 17:1465

18. Additional Life Expectancy

19. Survival

20. Halsted –centrifugal spread of breast cancer –radical surgical approach to encompass all local and regional disease Fisher –“breast cancer is a systemic disease involving a complex spectrum of host- tumor interactions and variations in effective local treatment are unlikely to affect survival substantially”

21. Long Term Survival In radical mastectomy series, it has been shown that long-term survival is possible in patients who do not receive adjuvant systemic treatment –Among 1458 patients, 43% were free of cancer at 30-years follow-up –Among 1425 patients with positive axillary nodes, 30% of patients were alive at 25 years follow-up Cancer 1974; 33: 1145 – 50 Mastologı´a Dina´mica 1995: 421 – 30

22. Long Term Survival Mammographic screening for women > 50 years reduces breast cancer mortality by around 30% Post-operative radiotherapy reduces mortality rates Lancet 2000; 355:1757-70 J Clin Oncol 2000; 18:1220-29

23. NSABP – 04 Trial (1971-1974) 1079 women with clinically negative axillae –radical mastectomy –total mastectomy without axillary dissection but with postoperative irradiation –total mastectomy plus axillary dissection only if their nodes became positive None of the women received adjuvant systemic therapy N Engl J Med 2002;347:567-75

24. Distribution of All First Events

25. Criticism of NSABP-04 35% of the patients randomized to receive total mastectomy alone had a limited axillary dissection as well. Of the patients who actually had a total mastectomy, 21% had an axillary recurrence compared with 12% of patients who had 1-5 nodes removed and 0% for those who had 6 or more nodes removed Breast Cancer Res Treat 1985; 5:17

26. Criticism of NSABP-04 The conclusion to be derived from the B-04 study is not that ALND does not have any effect on survival but that the study does not have enough patients to detect this benefit Curr Probl Surg 1995; 32: 257

27. Breast Cancer Survival According to Number of Nodes Removed SEER database of 72,102 patients with breast cancer who –had been diagnosed in 1988 or later –were aged 40–79 years at diagnosis –had a single primary lesion –had 0 to 3 positive lymph nodes Cases were separated into –age groups (40 to 49 and 50 to 79 years) –node-negative cases and those with 1-3 positive nodes Krag, Ann Surg Oncol 2003 10:1152

28. Survival According to Nodes Excised

29. Hazard Ratio Per 5 Nodes Removed

30. The Impact of Prophylactic Axillary Node Dissection on Breast Cancer Survival—A Bayesian Meta-Analysis Six randomized controlled trials were identified, consisting of nearly 3000 patients and spanning four decades Orr, Ann Surg Oncol, 1999 6:109

31. The Impact of Prophylactic Axillary Node Dissection on Breast Cancer Survival—A Bayesian Meta-Analysis TRIALYEARNo.% St-I%N+ Copenhagen1951-5742568- Guy’s I1961-713706054 SES1964-714985541 B-041971-7472710039 Guy’s II1971-7525810031 Curie1982-8765810018

32. The Impact of Prophylactic Axillary Node Dissection on Breast Cancer Survival—A Bayesian Meta-Analysis All six trials showed that prophylactic axillary node dissection improved survival, ranging from 4% to 16%, corresponding to a risk reduction of 7%-46% Combining the six trials showed an average survival benefit of 5.4% (95% CI 5 2.7-8.0) Orr, Ann Surg Oncol, 1999 6:109

33. Hellman - Spectrum Theory –Breast cancer is a heterogeneous disease presenting a spectrum ranging from a disease that remains locoregional throughout its course to a disease which is systemic when first detected –Based on this assumption, prophylactic axillary dissection seems to be beneficial to a certain proportion of patients

34. Conclusions Significant number of clinically N0 patients are pN1 Adjuvant therapy may be different for N0 and N1 patients Excellent local control with ALND or RT Possibility of survival advantage

35. Maximizing Benefits Identify patients who are pN1 and treat them with ALND SLNB is one method for doing this Drawbacks –False negative