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DOI: 10.1055/s-0041-1742080
Practical Consensus Recommendations for Optimizing Risk versus Benefit of Chemotherapy in Patients with HR Positive Her2 Negative Early Breast Cancer in India
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Abstract
Breast cancer is a public health challenge globally as well as in India. Improving outcome and cure requires appropriate biomarker testing to assign risk and plan treatment. Because it is documented that significant ethnic and geographical variations in biological and genetic features exist worldwide, such biomarkers need to be validated and approved by authorities in the region where these are intended to be used. The use of western guidelines, appropriate for the Caucasian population, can lead to inappropriate overtreatment or undertreatment in Asia and India. A virtual meeting of domain experts discussed the published literature, real-world practical experience, and results of opinion poll involving 185 oncologists treating breast cancer across 58 cities of India. They arrived at a practical consensus recommendation statement to guide community oncologists in the management of hormone positive (HR-positive) Her2-negative early breast cancer (EBC). India has a majority (about 50%) of breast cancer patients who are diagnosed in the premenopausal stage (less than 50 years of age). The only currently available predictive test for HR-positive Her2-negative EBC that has been validated in Indian patients is CanAssist Breast. If this test gives a score indicative of low risk (< 15.5), adjuvant chemotherapy will not increase the chance of metastasis-free survival and should not be given. This is applicable even during the ongoing COVID-19 pandemic.
Keywords
avoiding financial distress - avoiding toxicity - COVID-19 - low- and middle-income countries - personalized therapy - precision oncology - saving livesPublikationsverlauf
Artikel online veröffentlicht:
31. Dezember 2021
© 2021. MedIntel Services Pvt Ltd. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
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References
- 1 Youlden DR, Cramb SM, Yip CH, Baade PD. Incidence and mortality of female breast cancer in the Asia-Pacific region. Cancer Biol Med 2014; 11 (02) 101-115
- 2 Madhav MR, Nayagam SG, Biyani K. et al Epidemiologic analysis of breast cancer incidence, prevalence, and mortality in India: protocol for a systematic review and meta-analyses. Medicine (Baltimore 2018; 97 (52) e13680 doi: 10.1097/MD.0000000000013680, PMID: 30593138
- 3 Malvia S, Bagadi SA, Dubey US, Saxena S. Epidemiology of breast cancer in Indian women. Asia Pac J Clin Oncol 2017; 13 (04) 289-295 DOI: 10.1111/ajco.12661.
- 4 Kokiwar PR, Kumar HB, Mubashare A. Epidemiological and clinical profile of breast cancer patients at a tertiary care hospital in South India. J Cancer Res Ther 2011; 7 (01) 95 http://www.cancerjournal.net/text.asp?2011/7/1/95/80445 [serial online]
- 5 Sharma D, Singh G. Breast cancer in young women: a retrospective study from tertiary care center of north India. South Asian J Cancer 2017; 6 (02) 51-53 DOI: 10.4103/2278-330X.208859.
- 6 Nair N, Shet T, Parmar V. et al Breast cancer in a tertiary cancer center in India - An audit, with outcome analysis. Indian J Cancer 2018; 55 (01) 16-22 DOI: 10.4103/ijc.IJC_484_17.
- 7 Doval DC, Radhakrishna S, Tripathi R. et al A multi-institutional real world data study from India of 3453 non-metastatic breast cancer patients undergoing upfront surgery. Sci Rep 2020; 10 (01) 5886 DOI: 10.1038/s41598-020-62618-3.
- 8 Shet T. Improving accuracy of breast cancer biomarker testing in India. Indian J Med Res 2017; 146 (04) 449-458 DOI: 10.4103/ijmr.IJMR_896_16.
- 9 Parikh P, Puri T. Personalized medicine: lung cancer leads the way. Indian J Cancer 2013; 50 (02) 77-79
- 10 Aggarwal S, Vaid A, Ramesh A. et al Practical consensus recommendations on management of HR + ve early breast cancer with specific reference to genomic profiling. South Asian J Cancer 2018; 7 (02) 96-101 DOI: 10.4103/sajc.sajc_110_18.
- 11 Monticciolo DL, Helvie MA, Hendrick RE. Current issues in the overdiagnosis and overtreatment of breast cancer. Am J Roentgenol 2018; 210 (02) 285-291
- 12 Parikh PM, Hingmire SS, Bhavesh P. et al Oncology Gold Standard™ consensus statement on counseling patients for molecular testing and personalized cancer care. Int J Mol Immuno Oncol 2017; 2: 47-57 doi: DOI: 10.18203/issn.2456-3994.IntJMolImmunoOncol20172642.
- 13 Parikh PM, Narayanan P, Vora A. et al Conflict of interest disclosure and interpretation - rest assured the medical professional in the audience is perceptive, alert and smart. Int J Med Sci 2019; 71: 4-8 DOI: 10.25259/IJMS_12_2019.
- 14 Bapna A, Patni S, Patni N. A retrospective analysis of hormone receptor profile in breast cancer patients from a tertiary cancer center in Western part of India and study their relationship with Her 2 Neu (IHC+FISH), age and menopausal States. Prensa Med Argent 2018; 105: 1-7 10.41720032-745X.1000353
- 15 Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005; 365 (9472) 1687-1717
- 16 Allemani C, Weir HK, Carreira H. et al CONCORD Working Group. Global surveillance of cancer survival 1995-2009: analysis of individual data for 25,676,887 patients from 279 population-based registries in 67 countries (CONCORD-2. Lancet 2015; 385 (9972) 977-1010
- 17 Baik SH, Gallo LC, Wells KJ. Patient navigation in breast cancer treatment and survivorship: a systematic review. J Clin Oncol 2016; 34 (30) 3686-3696
- 18 Regan MM, Francis PA, Pagani O. et al Absolute benefit of adjuvant endocrine therapies for premenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer: TEXT and SOFT trials. J Clin Oncol 2016; 34 (19) 2221-2231 DOI: 10.1200/JCO.2015.64.3171.
- 19 Bedard PL, Cardoso F. Can some patients avoid adjuvant chemotherapy for early-stage breast cancer. ? Nat Rev Clin Oncol 2011; 8 (05) 272-279
- 20 Chavez-MacGregor M, Clarke CA, Lichtensztajn DY. et al Delayed initiation of adjuvant chemotherapy among patients with breast cancer. JAMA Oncol 2016; 2 (03) 322-329
- 21 Brazda A, Estroff J, Euhus D. et al Delays in time to treatment and survival impact in breast cancer. Ann Surg Oncol 2010; 17 (Suppl. 03) 291-296
- 22 Bhattacharyya GS, Doval DC, Desai CJ. et al Overview of breast cancer and implications of overtreatment of early-stage breast cancer: an Indian perspective. JCO Glob Oncol 2020; 6: 789-798 doi: 10.1200/GO.20.00033 PMID: 32511068
- 23 McLaughlin JM, Anderson RT, Ferketich AK. et al Effect on survival of longer intervals between confirmed diagnosis and treatment initiation among low-income women with breast cancer. J Clin Oncol 2012; 30 (36) 4493-4500
- 24 Regan MM, Pagani O, Francis PA. SOFT and TEXT Investigators and International Breast Cancer Study Group. et al Predictive value and clinical utility of centrally assessed ER, PgR, and Ki-67 to select adjuvant endocrine therapy for premenopausal women with hormone receptor-positive, HER2-negative early breast cancer: TEXT and SOFT trials. Breast Cancer Res Treat 2015; 154 (02) 275-286 DOI: 10.1007/s10549-015-3612-z.
- 25 Ellis MJ, Tao Y, Luo J. et al Outcome prediction for estrogen receptor-positive breast cancer based on postneoadjuvant endocrine therapy tumor characteristics. J Natl Cancer Inst 2008; 100 (19) 1380-1388
- 26 Zhang Y, Schnabel CA, Schroeder BE. et al Breast cancer index identifies early-stage estrogen receptor-positive breast cancer patients at risk for early- and late-distant recurrence. Clin Cancer Res 2013; 19 (15) 4196-4205
- 27 Shin DW, Cho J, Kim SY. et al Delay to curative surgery greater than 12 weeks is associated with increased mortality in patients with colorectal and breast cancer but not lung or thyroid cancer. Ann Surg Oncol 2013; 20 (08) 2468-2476
- 28 Ho PJ, Cook AR, Binte Mohamed Ri NK. et al Impact of delayed treatment in women diagnosed with breast cancer: a population-based study. Cancer Med 2020; 9 (07) 2435-2444 DOI: 10.1002/cam4.2830.
- 29 Yang M, Rajan S, Issa AM. Cost effectiveness of gene expression profiling for early stage breast cancer: a decision-analytic model. Cancer 2012; 118 (20) 5163-5170
- 30 Henry NL, Somerfield MR, Abramson VG. et al Role of patient and disease factors in adjuvant systemic therapy decision making for early-stage, operable breast cancer: update of the ASCO Endorsement of the Cancer Care Ontario Guideline. J Clin Oncol 2019; 37 (22) 1965-1977
- 31 Cardoso F, Kyriakides S, Ohno S. ESMO Guidelines Committee. Electronic address:. et al clinicalguidelines@esmo.org Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2019; 30 (08) 1194-1220 DOI: 10.1093/annonc/mdz173.
- 32 Telli ML, Gradishar WJ, Ward JH. NCCN Guidelines Updates: Breast Cancer. J Natl Compr Canc Netw 2019; 17 (5.5) 552-555 DOI: 10.6006/jnccn.20195006.
- 33 Keam B, Im SA, Lim Y. et al Clinical usefulness of AJCC response criteria for neoadjuvant chemotherapy in breast cancer. Ann Surg Oncol 2013; 20 (07) 2242-2249
- 34 Sparano JA, Gray RJ, Ravdin PM. et al Clinical and genomic risk to guide the use of adjuvant therapy for breast cancer. N Engl J Med 2019; 380 (25) 2395-2405
- 35 Smith EC, Ziogas A, Anton-Culver H. Delay in surgical treatment and survival after breast cancer diagnosis in young women by race/ethnicity. JAMA Surg 2013; 148 (06) 516-523
- 36 Thase ME, Parikh SV, Rothschild AJ. et al Impact of pharmacogenomics on clinical outcomes for patients taking medications with gene-drug interactions in a randomized controlled trial. J Clin Psychiatry 2019; 80 (06) 119-129 doi: DOI: 10.4088/JCP.19m12910.
- 37 Badwe RA, Gangawal S, Mittra I. et al Clinico-pathological features and prognosis of breast cancer in different religious communities in India. Indian J Cancer 1990; 27 (04) 220-228
- 38 Na KY, Kim KS, Lee JE. et al The 70-gene prognostic signature for Korean breast cancer patients. J Breast Cancer 2011; 14 (01) 33-38
- 39 Ishitobi M, Goranova TE, Komoike Y. et al Clinical utility of the 70-gene MammaPrint profile in a Japanese population. Jpn J Clin Oncol 2010; 40 (06) 508-512
- 40 Albain GJ, Sparano A, et al. Race, ethnicity and clinical outcomes in hormone receptor-positive, HER2-negative, node-negative breast cancer: results from the TAILORx trial. Oral presentation at: 2018 San Antonio Breast Cancer Symposium; December 4–8, 2018; San Antonio, TX. Abstract GS4–07.(https://www.ajmc.com/view)
- 41 Cardoso F, van’t Veer LJ, Bogaerts J. MINDACT Investigators. et al 70-gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med 2016; 375 (08) 717-729
- 42 Filipits M, Rudas M, Jakesz R. et al EP Investigators. A new molecular predictor of distant recurrence in ER-positive, HER2-negative breast cancer adds independent information to conventional clinical risk factors. Clin Cancer Res 2011; 17 (18) 6012-6020
- 43 Piccart MJ, Poncet C, Cardoso F, et al. Should age be integrated together with clinical and genomic risk for adjuvant chemotherapy decision in early luminal breast cancer? MINDACT results compared to those of TAILOR-X. Presented at: San Antonio Breast Cancer Symposium; December 10–14, 2019; San Antonio, TX. Abstract GS4–05. ( https://www.ajmc.com/view/survival-consistent-for-women-with-early-stage-breast-cancer-despite-surgery-delays)
- 44 Cardoso F, van’t Veer L, Poncet C. et al MINDACT: Long-term results of the large prospective trial testing the 70-gene signature MammaPrint as guidance for adjuvant chemotherapy in breast cancer patients. J Clin Oncol 2020; 38 (15_suppl) 506-506 DOI: 10.1200/JCO.2020.38.15_suppl.506.
- 45 Dowsett M, Turner N. Estimating risk of recurrence for early breast cancer: integrating clinical and genomic risk. Available at: https://repository.icr.ac.uk/bitstream/handle/internal/3136/JCO%20C%20and%20C%20revised%207%20Nov%2018%20(clean).pdf?sequence=6. Accessed December 30 2021
- 46 Petkov VI, Kurian AW, Jakubowski DM. et al Abstract P3–07–01: Breast cancer-specific mortality (BCSM) in patients age 50 years or younger with node-positive (N+) breast cancer (BC) treated based on the 21-gene assay in clinical practice. Available at: https://clpmag.com/diagnostic-technologies/molecular-diagnostics/real-world-studies-support-utility-of-oncotype-dx-to-guide-chemotherapy-treatment-for-breast-cancer/. Accessed on December 30 2021
- 47 Fayaz S, Eissa HE, Demian GA. Implications of the 21-gene recurrence score assay (Oncotype DX) on adjuvant treatment decisions in ER-positive early-stage breast cancer patients: experience of Kuwait Cancer Control Center. J Egypt Natl Canc Inst 2020; 32 (01) 13 DOI: 10.1186/s43046-020-00025-5.
- 48 Schildgen V, Warm M, Brockmann M, Schildgen O. Oncotype DX Breast Cancer recurrence score resists inter-assay reproducibility with RT2-Profiler Multiplex RT-PCR. Sci Rep 2019; 9 (01) 20266 . doi: 10.1038/s41598-019-56910-0. PMID: 31889145; PMCID: PMC6937305
- 49 Orucevic A, Bell JL, King M. et al Nomogram update based on TAILORx clinical trial results - Oncotype DX breast cancer recurrence score can be predicted using clinicopathologic data. Breast 2019; 46: 116-125 DOI: 10.1016/j.breast.2019.05.006.
- 50 Agarwal G, Pradeep PV, Aggarwal V. et al Spectrum of breast cancer in Asian women. World J Surg 2007; 31 (05) 1031-1040
- 51 Yeo W, Ueno T, Lin CH. Asian Breast Cancer Cooperative Group. et al Treating HR+/HER2- breast cancer in premenopausal Asian women: Asian Breast Cancer Cooperative Group 2019 Consensus and position on ovarian suppression. Breast Cancer Res Treat 2019; 177 (03) 549-559 DOI: 10.1007/s10549-019-05318-5.
- 52 Jung M, Choi EH, Nam CM. et al Application of the adjuvant! Online model to Korean breast cancer patients: an assessment of prognostic accuracy and development of an alternative prognostic tool. Ann Surg Oncol 2013; 20 (08) 2615-2624 DOI: 10.1245/s10434-013-2956-z.
- 53 Parikh PM, Aggarwal S, Hingmire S. Editorial. South Asian J Cancer 2018; 7 (02) 67-68
- 54 Batra A, Patel A, Gupta VG. et al Oncotype DX: where does it stand in India?. J Glob Oncol 2019; 5: 1-2
- 55 Sarin R, Rath GK, Kumar S, et al. Consensus document for management of breast cancer 2016. http://cancerindia.org.in/wp-content/uploads/2017/11/Breast_Cancer.pdf. Accessed October 23, 2020
- 56 Parikh PM, Singh R. Why we should rely only on molecular tests based on Indian data. Int J Mol Immuno Oncol 2020; 5: 44-46
- 57 Wang SY, Chen T, Dang W. et al Incorporating tumor characteristics to maximize 21-gene assay utility: a cost-effectiveness analysis. J Natl Compr Canc Netw 2019; 17 (01) 39-46 https://jnccn.org/view/journals/jnccn/17/1/article-p39.xml Accessed August 24, 2020
- 58 Bhoo-Pathy N, Yip CH, Hartman M. et al Adjuvant! Online is overoptimistic in predicting survival of Asian breast cancer patients. Eur J Cancer 2012; 48 (07) 982-989
- 59 Wong HS, Subramaniam S, Alias Z. et al The predictive accuracy of PREDICT: a personalized decision-making tool for Southeast Asian women with breast cancer. Medicine (Baltimore 2015; 94 (08) e593
- 60 Engelhardt EG, Garvelink MM, de Haes JH. et al Predicting and communicating the risk of recurrence and death in women with early-stage breast cancer: a systematic review of risk prediction models. J Clin Oncol 2014; 32 (03) 238-250
- 61 Patil P, Bakre MM, Basavaraj C. et al Can Assist breast: an affordable breast cancer prognostic test validated on Asian patients. Journal of Clinical Oncology 2020; 38 (15_suppl) 541-541
- 62 Attuluri AK, Serkad CPV, Gunda A. et al Analytical validation of CanAssist-Breast: an immunohistochemistry based prognostic test for hormone receptor positive breast cancer patients. BMC Cancer 2019; 19 (01) 249 DOI: 10.1186/s12885-019-5443-5.
- 63 Bakre MM, Ramkumar C, Attuluri AK. et al Clinical validation of an immunohistochemistry-based CanAssist-Breast test for distant recurrence prediction in hormone receptor-positive breast cancer patients. Cancer Med 2019; 8 (04) 1755-1764 DOI: 10.1002/cam4.2049.
- 64 Ramkumar C, Buturovic L, Malpani S. et al Development of a novel proteomic risk-classifier for prognostication of patients with early-stage hormone receptor-positive breast cancer. Biomark Insights 2018; 13: 1177271918789100 DOI: 10.1177/1177271918789100.
- 65 Sengupta AK, Gunda A, Malpani S. et al Comparison of breast cancer prognostic tests CanAssist Breast and Oncotype DX. Cancer Med 2020; 9 (21) 7810-7818
- 66 Sankaran S, Dikshit JB, Prakash SvC, Mallikarjuna SE, Somashekhar SP, Patil S, Kumar R, Prasad K, Shet D, Bakre MM. CanAssist Breast Impacting Clinical Treatment Decisions in Early-Stage HR+ Breast Cancer Patients: Indian Scenario. Indian J Surg Oncol 2021; 12 (Suppl. 01) 21-29 . doi: 10.1007/s13193-019-01014-4. Epub 2019 Dec 9. PMID: 33994724; PMCID: PMC8119549
- 67 Sheng JY, Santa-Maria CA, Mangini N. et al Management of breast cancer during the COVID-19 pandemic: a stage-and subtype-specific approach. JCO Oncol Pract 2020; 16 (10) 665-674
- 68 Krishnamurthy A. Breast cancer prognostic tools: a promising Indian option. Int J Mol Immuno Oncol 2020; 5: 47-48