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Optimizing Role of Chemotherapy in Breast Cancer in COVID Era

Optimizing Role of Chemotherapy in Breast Cancer in COVID Era

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Optimizing Role of Chemotherapy in Breast Cancer in COVID Era

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  1. Optimizing Role of Chemotherapy in Breast Cancer in COVID Era Prof. Hayam Fathy Ghazy MD Med Oncology, NCI, OCMU

  2. History of corona virus disease https://www.labmanager.com/lab-health-and-safety/covid-19-a-history-of-coronavirus-22021

  3. Organizational structure and risk stratification of cancer patient for management during the novel 2019 corona virus disease pandemic Ayun K Cassell et al. ArtifIntell Cancer. Jun 28, 2020; 1(1): 8-18

  4. Breast cancer is the second most common cancer in the world and the most common cancer among women 1,2  • Lifetime risk of developing breast cancer in every woman in the United States is 12.4% or one in eight women.1,3 • In 2012, 1.67 million new cases of breast cancer were identified worldwide, accounting for 25% of all cancers. 1,2 Breast cancer ranks as the 2nd  most frequent cancer in Egypt 4 • Zohre Momenimovahed1,2 and Hamid Salehiniya. Breast Cancer (Dove Med Press). 2019; 11: 151–164. • Ferley J, SoerjomataramI I, Ervik M, Dikshit R, Eser S. GLOBOCAN 2012 v1.0. Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 11. Lyon, France: International Agency for Research on Cancer; 2013. [Google Scholar] • Desantis CE, Ma J, Goding Sauer A, Newman LA, Jemal A. Breast cancer statistics, 2017, racial disparity in mortality by state. CA Cancer J Clin. 2017;67(6):439–448. • Globocan 2008

  5. Risk factors related to the breast cancer in the world ZohreMomenimovahed and Hamid Salehiniya. Breast Cancer (Dove Med Press). 2019; 11: 151–164.

  6. Risk factors related to the breast cancer in the world, cont.. Zohre Momenimovahed1,2 and Hamid Salehiniya. Breast Cancer (Dove Med Press). 2019; 11: 151–164.

  7. Early reports suggest individuals with cancer, especially those who receive systemic anticancer therapy within 14 days of COVID- 19 diagnosis, are more likely to develop severe disease • Many countries have implemented strategies to avoid surges of COVID-19 cases, conserve resources, and protect vulnerable populations from infection. • Cancer centers have rapidly changed models of care by delaying nonurgent surgeries, increasing home-based therapies, and expanding telemedicine. • Numerous organizations and institutions have issued general and disease-specific guidelines for cancer care. • Although COVID-19 cases have already peaked in some locations, they are increasing in others, and secondary surges are anticipated, suggesting that changes in cancer care will not be short lived. • Individuals with metastatic cancer are more likely to require admission for intensive care, undergo mechanical ventilation, and die as a result of COVID-19. • Data also implicate health care settings as a source for SARS-CoV-2 transmission, a finding concerning to patients with cancer who frequent cancer centers. • On March 11, 2020, the World Health Organization declared a pandemic in the setting of  100,000 cases of a new respiratory illness, coronavirus disease 2019 (COVID-19), caused by infection with a novel coronavirus, SARS-CoV-2. • Data regarding COVID-19 and cancer are limited. Jennifer Y, et l. JCO Oncol Pract 16:665-674

  8. For patients with breast cancer, preliminary management recommendations have been proposed by the COVID-19 Pandemic Breast Cancer Consortium • These tiered guidelines prioritize surgery, radiation, and systemic therapy interventions by urgency. • As in nonpandemic circumstances, treatment decisions must consider stage and tumor biology within the context of comorbidities and individual patient goals. • Acknowledging the uncertainties of cancer outcomes and SARS-CoV-2 infection risk associated with treating breast cancer, the John Hopkins Women’s Malignancies Program approach is presented for breast cancer management during the pandemic. • These stage- and subtypespecific algorithms, endorsed by multidisciplinary team and patient advocates, represent a strategy to apply available evidence to optimize breast cancer management during this time. Jennifer Y, et l. JCO Oncol Pract 16:665-674

  9. Biologic Risk Classification for Hormone Receptor–Positive Breast Cancer Jennifer Y, et l. JCO Oncol Pract 16:665-674

  10. Johns Hopkins recommended approach to multidisciplinary care for stage I-III triple-negative invasive breast cancer during the COVID-19 pandemic. Triple negative Clinical stage II/III Clinical stage I Surgery AC-T Pathological stage T1aN0 or T1bN0 Pathological stage T1cN0 Pathological stage T2-T4 and/or N1-3 Surgery Consider omission of adjuvant chemotherapy Recommended chemotherapy Recommended ddAC-T Radiation as indicated, postneoadjuvent Capecitabine if residual disease Radiation as indicated Radiation as indicated Radiation as indicated Jennifer Y, et l. JCO Oncol Pract 16:665-674

  11. Johns Hopkins recommended approach to multidisciplinary care for stage I-III HER2-positive invasive breast cancer during the COVID-19 pandemic HER2positive 3cm and/or N1-N3 ≤ 3cm and N0 Surgery TCH/P Jennifer Y, et l. JCO Oncol Pract 16:665-674

  12. Hormone Receptor positive Johns Hopkins recommended approach to multidisciplinary care for stage I-III hormone receptor–positive invasive breast cancer during the COVID-19 pandemic. Low risk biology* High risk biology* Jennifer Y, et l. JCO Oncol Pract 16:665-674

  13. State of Art of Adjuvant Treatment in Patients With Breast Cancer

  14. TAXOTARE ® Therapeutic Indications in Breast Cancer 1,2 TAXOTARE ® indications in BC: • As single agent for treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. • In combination with doxorubicin and cyclophosphamide as adjuvant treatment of patients with operable node-positive breast cancer. • Summary of product characteristics, last updated on Feb 25, 2020; available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022534s011lbl.pdf, last accessed on March, 10 2021 • Taxotere : EPAR - Product Information, EMA, last updated Dec 2020; available at https://www.ema.europa.eu/en/documents/product-information/taxotere-epar-product-information_en.pdf accessed on Marc 10, 2021

  15. Between June 1997 and December 1999, 1,016 patients were randomly assigned to four cycles of either standard-dose AC (60 and 600 mg/m2, respectively; n=510) or TC (75 and 600 mg/m2, respectively; n =506), administered intravenously every 3 weeks as adjuvant chemotherapy. Radiation therapy (as indicated) and tamoxifen, for patients with hormone receptor–positive disease, administered after completion of chemotherapy.

  16. Docetaxel use in combination with cyclophosphamide was associated with a superior DFS compared with the combination of doxorubicin and cyclophosphamide as for the adjuvant treatment of operable node-positive breast cancer P =.015 Treatment schema. AC, doxorubicin and cyclophosphamide; TC, docetaxel and cyclophosphamide; IV, intravenous. Disease-free survival (DFS). AC, doxorubicin and cyclophosphamide; TC, docetaxel and cyclophosphamide. At 5 years, the DFS rate for patients receiving TC was 86% compared with 80% for patients receiving AC (HR 0.67; 95% CI, 0.50 to 0.94; P =.015) J Clin Oncol 24:5381-5387

  17. Between June 1997 and March 2000, 1,999 patients with operable node-positive breast cancer were randomly assigned to either FEC every 21 days for six cycles, or three cycles of FEC followed by three cycles of docetaxel, both given every 21 days. Hormone-receptor–positive patients received tamoxifen for 5 years after chemotherapy. The primary end point was 5-year disease-free survival (DFS).

  18. DFS defined as the time from randomization until first relapse (local, regional, or distant), contralateral breast cancer, or death from any cause. • OS defined as the time from randomization until death from any cause, and safety. J Clin Oncol 24:5664-5671

  19. First chemotherapy cycle was to be started no more than 42 days after surgery. • Radiotherapy was mandatory after conservative surgery and hormone therapy was given for 5 years if tumors were positive for at least one hormone receptor. J Clin Oncol 24:5664-5671

  20. PACS-01: Sequential adjuvant chemotherapy with FEC followed by docetaxel significantly improves disease-free survival in node-positive breast cancer patients J Clin Oncol 24:5664-5671

  21. PACS-01: Sequential adjuvant chemotherapy with FEC followed by docetaxel significantly improves overall survival in node-positive breast cancer patients Log-rank unadjusted p=0.014 Log-rank adjusted p=0.017 HR = 0.73 [0.56–.94] J Clin Oncol 24:5664-5671

  22. PACS 01: DFS in Subgroups • In the subgroup of patients with more than three involved nodes, the benefit was almost the same showing a 17% reduction in the risk of relapse with FEC-D (P =12) J Clin Oncol 24:5664-5671

  23. PACS 01: Adverse Events Experienced per Patient • Although fewer episodes of severe neutropenia, nausea and vomiting were observed with FEC-D, the higher rate of febrile events occurring mainly during the first D cycle could be prevented with G-CSF primary prophylaxis. J Clin Oncol 24:5664-5671

  24. PACS 01: Adverse Events Experienced per Patient J Clin Oncol 24:5664-5671

  25. Phase III, multicenter, randomized prospective trial on 1491 women with axillary node-positive breast cancer- an Interim analysis of BCIRG001 study (2001) Docetaxel plus doxorubicin and cyclophosphamide (TAC) compared with fluorouracil plus doxorubicin and cyclophosphamide (FAC) as adjuvant chemotherapy for operable node-positive breast cancer Martin M et al. N Engl J Med. 2005; 352:2302- 2313

  26. BCIRG001 Adjuvant chemotherapy with TAC Vs FAC Martin M et al. N Engl J Med. 2005; 352:2302- 2313

  27. BCIRG001 Adjuvant chemotherapy with TAC, as compared with FAC, significantly improves the rates of disease-free and overall survival among women with operable node-positive breast cancer 87% 81% 75% 68% OS DFS Panel A shows the rates of disease-free survival For the 1491 randomly assigned patients included in the intention-to-treat analysis : HR adjusted for nodal status 0.72 (95% CI, 0.59-0.88; P=0.001); HR unadjusted for nodal status, 0.71 (95 % CI, 0.59-0.87; P<0.001), and with the Cox proportional hazards model adjusted for number of positive nodes, age, tumor size, histologic grade, and hormone-receptor and HER2/neu status —0.70 (95% CI, 0.58-0.86; P<0.001 Panel B shows the rates of overall survival For the 1491 randomized patients included in the intention-to-treat analysis, HR adjusted for nodal status: 0.70 (95% CI, 0.53 to 0.91; P=0.008); HR unadjusted for nodal status, 0.69 (95 % CI, 0.52 to 0.90; P=0.005); and with the Cox proportional hazards model, adjusted for the same variables as those listed for Panel A, 0.68 (95% CI, 0.52 to 0.89; P=0.004). Martin M et al. N Engl J Med. 2005; 352:2302- 2313

  28. BCIRG001 /TAX 316 The superiority of TAC over FAC was also observed in all planned subgroup analyses, which included the number of involved axillary lymph nodes, hormone-receptor status, and HER2/neu status, and was independent of menopausal status Martin M et al. N Engl J Med. 2005; 352:2302- 2313

  29. A total of 8 published studies, included 1542 patients Tran Do, et al. Breast Cancer Res Treat. 2015 Oct;153(3):591

  30. Summary of studies evaluated for the FN rate with TC regimen in breast cancer patients Tran Do, et al. Breast Cancer Res Treat. 2015 Oct;153(3):591

  31. Prophylaxis treatment with G-CSF reduced the risk of febrile neutropenia by 92.3 % as compared to those without it 0.005 Forest Plot of the odds ratio of FN rate in early-stage breast cancer patients receiving TC regimen with G-CSF versus without G-CSF prophylaxis. Solid squares represent the odds ratio of each study, with size of the square reflecting the study-specific statistical weight. Horizontal lines represent 95 % CI and solid diamond represents the pooled estimate based on the random effects model (P = 0.005) Tran Do, et al. Breast Cancer Res Treat. 2015 Oct;153(3):591

  32. Key Home Message • Breast cancer ranks as the 2nd  most frequent cancer in Egypt • Since long years, docetaxel has proven efficacy in adjuvant treatment of operable node breast cancer • Docetaxel use in combination with cyclophosphamide was associated with a superior DFS compared with the combination of doxorubicin and cyclophosphamide as for the adjuvant treatment of operable node-positive breast cancer • Sequential adjuvant chemotherapy with FEC followed by docetaxel significantly improves disease-free survival in node-positive breast cancer patients

  33. Key Home Message, Cont.. • Adjuvant chemotherapy with TAC, as compared with FAC, significantly improves the rates of disease-free and overall survival among women with operable node-positive breast cancer • The superiority of TAC over FAC was also observed in all planned subgroup analyses, which included the number of involved axillary lymph nodes, hormone-receptor status, and HER2/neu status, and was independent of menopausal status • Prophylaxis treatment with G-CSF reduced the risk of febrile neutropenia by 92.3 % as compared to those without it

  34. Key Home Message, Cont.. • Individuals with cancer, especially those who receive systemic anticancer therapy within 14 days of COVID- 19 diagnosis, are more likely to develop severe disease. • As in non-pandemic circumstances, treatment decisions must consider stage and tumor biology within the context of comorbidities and individual patient goals. • John Hopkins Women’s Malignancies Program is an important approach for breast cancer management during the pandemic. • Chemotherapy schedules may be modified to reduce accesses to hospital (for instance, using 2- or 3 weekly dosing instead of weekly dosing for selected agents when appropriate).Patients should receive G-CSF growth factor and eventually, antibiotics support to minimize neutropenia, while dexamethasone use should be limited, as appropriate, to reduce immunosuppression.

  35. Thank you

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