Breast conserving surgery for early breast cancer: Single institutional experience

1. Breast conserving surgery for early breast cancer: Single institutional experience Dr Neetesh Kumar Sinha Department of Cancer Surgery VMMC & Safdarjung Hospital New Delhi

2. Introduction • Surgery for operable breast cancer has evolved a long way since W. Halsted first described radical mastectomy. • Because of the wide acceptance of the Halstedian dogma, a relatively large number of randomized clinical trials were conducted comparing mastectomy and Breast-Conserving Therapy (BCT), and they demonstrated equivalent survival. • The long-term stability of this equivalence was confirmed by the 20-year follow-up reports of the two largest studies, the Milan I and NSABP B-06 trials.[1-2]

3. Intro… • At present, most common surgical options for operable breast cancer are modified radical mastectomy (MRM) with or without reconstruction and breast conservation surgery (BCS). • Choice of the procedure depends on – • surgeon’s training, • patient’s desire, • size of the tumor to breast ratio, • presence of contraindications for conservation and • availability of radiotherapy facilities.

4. Intro… • At present, breast conservation treatment (BCT) comprises • BCS and • whole breast radiotherapy with or without systemic therapy.

5. Intro… • The advantages of BCS over MRM – • better body image, • sexual functioning and • better psychological adjustment. [3-5]

6. BCT is the standard of care for early breast cancer in the west.[6-10] But in India, BCT is not popular among the surgeons (11-23% vs. > 60-70% in west).[11] Intro…

7. At our Institute BCT is being offered to breast cancer patients from the year 2001. Studies from India with respect to outcome of breast conservation are sparse. There are also concerns regarding reproducibility of excellent results achieved in western women in Indian women owing to inherent differences in tumor stage, biology and quality of care. [12] Here we are reporting our experience with the BCS and BCT. Intro…

8. The study comprised of retrospective collection of prospective data of patients who underwent BCT from 2001 until 2011. All patients diagnosed with breast cancer were evaluated with bilateral breast mammogram, a chest X-ray, liver function tests including alkaline phosphatase and complete blood counts. Bone scan was done only for symptomatic patients or patients with elevated ALP or node positive patients. Once staging work-up is done, all patients were evaluated by a multidisciplinary team for suitability of BCT. Those with contraindications were excluded. Others were offered the option of either MRM or BCT. Those who desired conservation were included. Materials and Methods

9. Materi… • The patients with larger tumors, desiring to conserve breast were offered NACT. • All 21 patients who opted for BCS underwent wide local excision and axillary dissection. The standard surgical principles described elsewhere were followed [Table 1]. [13]

11. Wide Local Excision

12. Materi… • After surgery all patients who had not received or completed NACT, received adjuvant chemotherapy. • After completion of systemic chemotherapy all patients received 50-55 Gy of whole breast radiotherapy with a tumor bed boost of 9-12 Gy in daily 2 Gy fractions for 5 days in a week over 5-6 weeks. • After completing radiotherapy, hormonal treatment was initiated for patients with receptor positive or unknown status.

13. Materi… Details like age, menopausal status, site and size of the tumor, histology, pTNM, adjuvant/neoadjuvant treatment, margin status, nodal yield, hormone receptor status, Her 2 neu complications of treatment, locoregional and distant failures were recorded and disease-free survival (DFS) and OS calculated. Cosmetic outcome was also studied.

14. Materi… After completion of treatment, patients were called 2 monthly in first year, 3 monthly in second year and then every 6 monthly for follow-up. At each visit evaluation included detailed history, physical examination and symptom directed investigations. Post-BCT baseline mammogram was obtained 6 months to 1 year after completion of radiotherapy and annually thereafter. Women receiving tamoxifen were referred for annual gynecological examination.

15. Statistical methods • Statistical analysis - SPSS version 21 software for Windows and MS office 10. • Local recurrence - any histological or cytologically confirmed recurrence in the treated breast or overlying skin. • DFS -the period from date of surgery to local, regional or systemic relapse and overall survival as interval from date of diagnosis to death or last contact with the patient. • Disease-free and cumulative survival curves were estimated using Kalpan-Meir survival analysis. • A P-value of 0.05 or less - considered statistically significant.

16. Results • Total 21 patients underwent BCS during the study period. Total number of mastectomy during the same period was 473 in the department; hence BCS rate was 4.25%. • Median follow-up period was 54 months and mean 66 months (ranged from 12 to 152 months).

17. Res… Median age - 50 years

18. Res…

19. Res…

20. Res…

21. Res… Excision biopsy was done in 3 patients, which were done outside.

22. Res… Average nodal yield was 10.5 (range 1-16), median 11, lower yield coming mainly from cN0 and NACT group.

23. Res…

24. Res… Out of 4 patients of positive margin, two opted for mastectomy, one patient underwent re-excision, while another refused re-excision, who was treated with higher radiation boost to tumor bed.

25. Res… Most of the wound-related complications occurred in patients receiving tumor bed boost.

26. Res…

27. Res…

28. Res…

29. Res…

30. Cosmetic Outcome Excellent outcome Poor outcome

31. Res…

32. Res… Overall survival was 86%. The 10-year DFS for whole group was 90%, 87% for node negative and 92% for node-positive group (P=0.85). On univariate analysis none of the factors found to have association with DFS.

33. Res… Overall 10-year survival for whole group

34. Res…

35. Discussion In India BCT still not popular due to -advanced stage at presentation, cost of treatment, lack of appropriate equipments and facilities, physician’s and patient’s awareness.[1,14,15] In our study low socioeconomic status of patients and higher rate of referred cases of locally advanced cancer from primary and secondary centers are probably the two most important factors of very low rate (4.25%) of BCS.

36. Discu… The local recurrence rate at a median follow-up period of 54 months was 5%. Two patients had developed systemic disease without any local recurrence. In most of the reported series of both MRM and BCS, the 10-year local recurrence rates ranging from 8% to 19% were commonly reported. [17] This emphasizes the concept that, type of local treatment rarely determines the OS.

37. Discu… The factors known to increase the risk of local recurrence - young age, family history, status of resection margin, Tumor Grade, histologic Type, presence of extensive intraductal component and the Lymphatic/Vascular Invasion . [8,16] But in the present study as the total number of events was small, we could not find any statistically significant association.

38. Discu… Complication rate in the present study was 29%. Higher rates are probably influenced by the wound breakage in patients receiving tumor bed boost. Several studies have reported overall complication rates of 10-30 %.[18,19]

39. Discu… After BCS, breast asymmetry can be a major concern. Patient-related risk factors - younger age, larger body habitus, larger tumor size, and tumor position, specifically superior medial tumors and inferior lateral tumors. Treatment related risk factors - tumor re-excision, seroma and breast irradiation. [20-22]

40. Discu… In the present study the cosmetic outcome was excellent or satisfactory in 14 (74%) and poor in 5 (26%). But the cosmetic outcome was poor in 4 (57%) of total 7 patient with tumor size >4 cm, while only patient who underwent re-excision had poor cosmetic outcome.

41. Discu… In the present study nearly 33% of the patients received NACT and then underwent BCS. pCRwas 25%. The reported pCR rates vary between 3 and 34 %, rates are higher when the complete course of chemotherapy is completed before surgery. [23-25]

42. Discu… Routine pre-chemotherapy tumor localization - metallic clips, slow clearing dyes, tattooing or, placing central scar has been used to facilitate identification of original tumor site after CR as described in various literature. [26, 27] In our study we have used pre-NACT tumor mapping and radiological record.

43. Conclusions The BCS rate is still very low at tertiary centers in government sector, probably due to very low socioeconomic status of patient and advance stage at presentation. Oncological outcome of BCS in Indian population is similar to standard BCS outcome reported elsewhere, with proper selection of patients, strict adherence to R0 resection and adjuvant radiotherapy & systemic therapy. The rate of cosmetic outcome is very good in patients of tumor size less than 4 cm and in patients who do not require re-excision.

44. References • Agarwal G, Ramakant P. Breast Cancer Care in India: The Current Scenario and the Challenges for the Future. Breast Care (Basel) 2008; 3:21-7. • Agarwal G, Ramakant P, Forgach ER, et al. Breast cancer care in developing countries. World J Surg 2009; 33:2069-76. • Raina V, Bhutani M, Bedi R, Sharma A, Deo SV, Shukla NK, et al. Clinical features and prognostic factors of early breast cancer at a major centre in North India. Indian J Cancer 2005; 42:36-41. • Keynes G. Conservative treatment of breast cancer. Br J Surg 1932;19:415-80. • Atkins H, Hayward JL, Klugman DJ, Wayte AB. Treatment of early breast cancer: A report after ten years of a clinical trial. Br Med J 1972;2:423-9. • Mustakallio S. Conservative treatment of breast carcinoma- Review of 25 years follow up. ClinRadiol 1972;23:110-6. • Hayward JL. The Guy’s trial of treatments of early breast cancer. World J Surg 1977;1:314-6. • Veronesi U, Zurrida S. Optimal surgical treatment of breast cancer. Oncologist 1996;1:340-6. • Veronesi U, Banfi A, Salvadore B, Luini A, Saccozzi R, Zucali R, et al. Breast conservation is the treatment of choice in small breast cancer: Long term results of a randomized trial. Eur J Cancer 1990;26:668-70. • Van Dongen JA, Voogd AC, Fentiman IS, Legrand C, Sylvester RJ, Tong D, et al. Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. J Natl Cancer Inst 2000;92:1143-50.

45. Refer.. • Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med 2002;347:1233-41. • Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, et al. Twenty-year follow- up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med 2002;347:1227-32. • Blichert-Toft M, Nielsen M, Düring M, Møller S, Rank F, Overgaard M, et al. Long-term results of breast conserving surgery vs. mastectomy for early stage invasive breast cancer: 20-year followup of the Danish randomized DBCG-82TM protocol. ActaOncologica 2008;47:672-81. • Kiebert GM, de Haes JC, van de Velde CJ. The impact of breastconserving treatment and mastectomy on the quality of life of earlystage breast cancer patients: A review. J ClinOncol 1991;9:1059-70. • Rowland JH, Desmond KA, Meyerowitz BE, Belin TR, Wyatt GE, Ganz PA. Role of breast reconstructive surgery in physical and emotional outcomes among breast cancer survivors. J Natl Cancer Inst 2000;92:1422-9. • Markopoulos C, Tsaroucha AK, Kouskos E, Mantas D, Antonopoulou Z, Karvelis S. Impact of Breast Cancer Surgery on the Self-esteem and Sexual Life of Female Patients. J Int Med Res 2009;37:182-8. • Dinshaw KA, Sarin R, Budrukkar A, Shrivastava SK, Deshpande DD, Chinoy RF, et al. Safety and Feasibility of Breast Conserving Therapy in Indian Women: Two Decades of Experience at Tata Memorial Hospital. J SurgOncol 2006;94:105-13. • Morrow M, Strom EA, Bassett LW, Dershaw DD, Fowble B, Giuliano A, et al. Standard for Breast Conservation Therapy in the Management of Invasive Breast Carcinoma. CA Cancer J Clin 2002;52;277-300. • Goel AK, Seenu V, Shukla NK, Raina V. Breast cancer presentation at a regional cancer centre. Natl Med J India 1995;8:6-9. • Morrow M, White J, Moughan J, Owen J, Pajack T, Sylvester J, et al. Factors Predicting the Use of Breast-Conserving Therapy in Stage I and II Breast Carcinoma. J ClinOncol 2001;19:2254-62.

46. Refer… • Narendra H, Ray S. Breast conserving surgery for breast cancer: Single institutional experience from Southern India. Indian J Cancer 2011;48:415-22. • Leest MV, Evers L, Sangen MJ, Poortmans PM, Poll-Franse LV, Vulto AJ, et al. The Safety of Breast-Conserving Therapy in Patients With Breast Cancer Aged 40 Years or less. Cancer 2007;109:1957-64. • Hashemi E, Kaviani A, Najafi M, Ebrahimi M, Hooshmand H, Montazeri A. Seroma formation after surgery for breast cancer. World J SurgOncol 2004;2:44. • Vitug FA, Newman LA. Complications in Breast Surgery. SurgClin N Am 2007;87:431-51. • Waljee JF, Hu ES, Newman LA, Alderman AK. Predictors of Breast Asymmetry after Breast-Conserving Operation for Breast Cancer. J Am CollSurg 2008;206:274-80. • Churgin S, Isakov R, Yetman R. Reconstruction options following breast conservation therapy. Cleve Clin J Med 2008;75:S24-9. • Clough KB, Lewis JS, Couturaud B, Fitoussi A, Nos C, Falcou MC. Oncoplastic Techniques Allow Extensive Resections for Breast- Conserving Therapy of Breast Carcinomas. Ann Surg 2003; 237:26-34. • Hage JA, Velde CJ, Julien JP, Hulin MT, Vandervelden C, Duchateau L. Preoperative Chemotherapy in Primary Operable Breast Cancer: Results From the European Organization for Research and Treatment of Cancer Trial 10902. J ClinOncol 2001;19:4224-37.

47. THANK U