Breast Cancer (Invasive) Treatment Regimens

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BREAST CANCER (INVASIVE) TREATMENT REGIMENS

Clinical Trials: The National Comprehensive Cancer Network recommends cancer patient participation in clinical trials as the gold standard for treatment.

Cancer therapy selection, dosing, administration, and the management of related adverse events can be a complex process that should be handled by an experienced healthcare team. Clinicians must choose and verify treatment options based on the individual patient; drug dose modifications and supportive care interventions should be administered accordingly. The cancer treatment regimens below may include both U.S. Food and Drug Administration-approved and unapproved indications/regimens. These regimens are only provided to supplement the latest treatment strategies.

These Guidelines are a work in progress that may be refined as often as new significant data becomes available. The NCCN Guidelines® are a consensus statement of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines® is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient's care or treatment. The NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

Neoadjuvant/Adjuvant Chemotherapya,b,c,d,e,f

NOTE: All recommendations are category 2A unless otherwise indicated.

Preferred Regimens for HER2-negative Disease1

REGIMEN

DOSING

Dose-dense AC followed by paclitaxel (Category 1)2,g

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 14 days for 4 cycles (all cycles are with myeloid growth factor support; refer to NCCN Guidelines for Myeloid Growth Factors), followed by:

Day 1: Paclitaxel 175mg/m2 via 3-hour IV infusion.

Repeat cycle every 14 days for 4 cycles (all cycles are with myeloid growth factor support).

Dose-dense AC followed by weekly paclitaxel (Category 1)2,g

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 14 days for 4 cycles, followed by:

Day 1: Paclitaxel 80mg/m2 via 1-hour IV infusion weekly for 12 weeks.

TC (Category 1)3

Day 1: Docetaxel 75mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles (all cycles are with myeloid growth factor support).

Useful in Certain Circumstances

Dose-dense AC (Category 1)2

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 14 days for 4 cycles (all cycles are with myeloid growth factor support).

AC followed by weekly paclitaxel (Category 1)8

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, followed by:

Day 1: Paclitaxel 80mg/m2 by 1-hour IV infusion weekly for 12 weeks.

CMF (Category 1)6

Days 1–14: Cyclophosphamide 100mg/m2 orally

Days 1 and 8: Methotrexate 40mg/m2 IV

Days 1 and 8: 5-fluorouracil 600mg/m2 IV.

Repeat cycle every 28 days for 6 cycles.

AC (Category 2B)4

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles.

Other Recommended Regimens

AC followed by docetaxel (Category 1)7

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, followed by:

Day 1: Docetaxel 100mg/m2 IV.

Repeat cycle every 21 days for 4 cycles.

EC (Category 1)9

Day 1: Epirubicin 100mg/m2 IV

Day 1: Cyclophosphamide 830mg/m2 IV.

Repeat cycle every 21 days for 8 cycles.

TAC (Category 1)5

Day 1: Docetaxel 75mg/m2 IV

Day 1: Doxorubicin 50mg/m2 IV

Day 1: Cyclophosphamide 500mg/m2 IV.

Repeat cycle every 21 days for 6 cycles (all cycles are with myeloid growth factor support).

Preferred Regimens for HER2-positive Disease

REGIMEN

DOSING

AC followed by paclitaxel + trastuzumab10,h,i

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, followed by:

Paclitaxel 80mg/m2 via 1-hour IV infusion weekly for 12 weeks, with:

Trastuzumab 4mg/kg IV with first dose of paclitaxel, followed by:

Trastuzumab 2mg/kg IV weekly to complete 1 year of treatment.

As an alternative, trastuzumab 6mg/kg IV every 21 days may be used following the completion of paclitaxel, and given to complete 1 year of trastuzumab treatment.

AC followed by paclitaxel + trastuzumab + pertuzumab10,h,i

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, followed by:

Day 1: Pertuzumab 840mg IV followed by 420mg IV

Day 1: Trastuzumab 8mg/kg IV followed by 6mg/kg IV

Days 1, 8, and 15: Paclitaxel 80mg/m2 IV.

Repeat cycle every 21 days for 4 cycles.

Day 1: Trastuzumab 6mg/kg IV.

Repeat cycle every 21 days to complete 1 year of trastuzumab therapy.

Dose-dense AC followed by paclitaxel + trastuzumab11,h,i

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 14 days for 4 cycles, followed by:

Day 1: Paclitaxel 175mg/m2 via 3-hour IV infusion.

Repeat cycle every 14 days for 4 cycles, plus:

Trastuzumab 4mg/kg IV with first dose of paclitaxel, followed by:

Trastuzumab 2mg/kg IV weekly to complete 1 year of treatment.

As an alternative, trastuzumab 6mg/kg IV every 21 days may be used following the completion of paclitaxel, and given to complete 1 year of trastuzumab treatment.

Paclitaxel + trastuzumab12,j

Day 1: Paclitaxel 80mg/m2 IV weekly for 12 weeks with

Trastuzumab 4mg/kg IV with first dose of paclitaxel followed by:

Trastuzumab 2mg/kg IV weekly to complete 1 year of treatment OR

Trastuzumab 6mg/kg IV every 21 days for 1 year following the completion of paclitaxel.

TCH13,i

Day 1: Docetaxel 75mg/m2 IV

Day 1: Carboplatin AUC 6mg min/mL IV.

Repeat cycle every 21 days for 6 cycles, with:

Trastuzumab 4mg/kg IV week 1, followed by 2mg/kg IV for 17 weeks, followed by:

Trastuzumab 6mg/kg IV every 21 days to complete 1 year of trastuzumab therapy.

OR

Trastuzumab 8mg/kg IV week 1, followed by:

Trastuzumab 6mg/kg IV every 21 days to complete 1 year of trastuzumab therapy.

TCH chemotherapy + pertuzumab14,i

Day 1: Trastuzumab 8mg/kg IV followed by 6mg/kg IV

Day 1: Pertuzumab 840mg IV followed by 420mg IV

Day 1: Docetaxel 75mg/m2 IV

Day 1: Carboplatin AUC 6mg min/mL IV.

Repeat cycle every 21 days for 6 cycles, followed by:

Trastuzumab 6mg/kg IV every 21 days to complete 1 year of trastuzumab therapy.

Useful in Certain Circumstances

Docetaxel + cyclophosphamide + trastuzumab15,i

Day 1: Docetaxel 75mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, with:

Trastuzumab 4mg/kg IV week 1, followed by:

Trastuzumab 2mg/kg IV weekly for 11 weeks, followed by:

Trastuzumab 6mg/kg IV every 21 days to complete 1 year of trastuzumab therapy.

OR

Trastuzumab 8mg/kg IV week 1, followed by:

Trastuzumab 6mg/kg IV every 21 days to complete 1 year of treatment.

Other Recommended Regimens

AC followed by docetaxel + trastuzumab12,h,i

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, followed by:

Day 1: Docetaxel 100mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, with:

Trastuzumab 4mg/kg IV week 1, followed by 2mg/kg IV weekly for 11 weeks, followed by:

Trastuzumab 6mg/kg IV every 21 days to complete 1 year of trastuzumab therapy.

AC followed by docetaxel + trastuzumab + pertuzumab16,h,i

Day 1: Doxorubicin 60mg/m2 IV

Day 1: Cyclophosphamide 600mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, followed by:

Day 1: Pertuzumab 840mg IV followed by 420mg IV

Day 1: Trastuzumab 8mg/kg IV followed by 6mg/kg IV

Day 1: Docetaxel 75–100mg/m2 IV.

Repeat cycle every 21 days for 4 cycles, followed by:

Trastuzumab 6mg/kg IV every 21 days to complete 1 year of trastuzumab therapy.

(Revised 7/2018)

© 2018 Haymarket Media, Inc.

a The selection, dosing, and administration of anticancer agents and the management of associated toxicities are complex. Modifications of drug dose and schedule and initiation of supportive care interventions are often necessary because of expected toxicities and individual patient variability, prior treatment, and comorbidity. The optimal delivery of anticancer agents therefore requires a healthcare delivery team experienced in the use of anticancer agents and the management of associated toxicities in patients with cancer.

b Retrospective evidence suggests that anthracycline-based chemotherapy regimens may be superior to nonanthracycline-based regimens in patients with HER2-positive tumors.

c Randomized clinical trials demonstrate that the addition of a taxane to anthracycline-based chemotherapy provides an improved outcome.

d CMF and radiation therapy may be given concurrently, or the CMF may be given first. All other chemotherapy regimens should be given prior to radiotherapy.

e Chemotherapy and endocrine therapy used as adjuvant therapy should be given sequentially with endocrine therapy following chemotherapy.

f Nab-paclitaxel may be substituted for paclitaxel or docetaxel due to medical necessity (ie, hypersensitivity reaction). If substituted for weekly paclitaxel or docetaxel, then the weekly dose of nab-paclitaxel should not exceed 125mg/m2.

g It would be acceptable to change the administration sequence to paclitaxel followed by dose-dense AC.

h Trastuzumab given in combination with an anthracycline is associated with significant cardiac toxicity. Concurrent use of trastuzumab and pertuzumab with an anthracycline should be avoided.

i Evaluate left ventricular ejection fraction (LVEF) before and during treatment. Although the optimal frequency of LVEF assessment during adjuvant trastuzumab therapy is not known, the FDA recommends LVEF measurements every 3 months during treatment.

j Paclitaxel + trastuzumab may be considered for patients with low-risk, T1, N0, M0, HER2-positive disease, particularly those not eligible for other standard adjuvant regimens due to comorbidities.

References

  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.1.2018. Available at: http://www.nccn.org/ professionals/physician_gls/pdf/breast.pdf. Accessed July 12, 2018.

  2. Citron ML, Berry DA, Cirrincione C, et al. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol. 2003;21(8):1431–1439. Erratum in: J Clin Oncol. 2003;21(11):2226.

  3. Jones S, Holmes F, O'Shaughnessey J, et al. Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide: 7-year follow-up of US Oncology Research trial 9735. J Clin Oncol. 2009;27(8):1177–1183.

  4. Fisher B, Brown AM, Dimitrov NV, et al. Two months of doxorubicin-cyclophosphamide with and without interval reinduction therapy compared with six months of cyclophosphamide, methotrexate, and fluorouracil in positive-node breast cancer patients with tamoxifen-nonresponsive tumors: results from NSABP B-15. J Clin Oncol. 1990;8(9):1483–1496.

  5. Goldhirsch A, Colleoni M, Coates AS, et al. Adding adjuvant CMF chemotherapy to either radiotherapy or tamoxifen: are all CMFs alike? The International Breast Cancer Study Group (IBCSG). Ann Oncol. 1998;9(5):489–493.

  6. Sparano JA, Wang M, Martino S, et al. Weekly paclitaxel in adjuvant treatment of breast cancer. N Engl J Med. 2008; 358(16):1663–1671.

  7. von Minckwitz G, Raab G, Caputo A, et al. Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the ­GEPARDUO study of the German Breast Group. J Clin Oncol. 2005;23(12):2676–2685.

  8. Piccart MJ, Di Leo A, Beauduin M, et al. Phase III trial com­par­ing two dose levels of epirubicin combined with cyclo­­phos­pha­mide with cyclophosphamide, methotrexate, and ­fluorouracil in node-positive breast cancer. J Clin Oncol. 2001;19(12):3103–3110.

  9. Martin M, Pienkowski T, Mackey J, et al. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005;352(22): 2302–2313.

10. Romond EH, Perez EZ, Bryant J, et al. Trastuzumab plus ­adjuvant chemotherapy for operable HER2 positive breast cancer. N Engl J Med. 2005;353(16):1673–1684.

11. Dang C, Fornier M, Sugarman S, et al. The safety of dose-dense doxorubicin and cyclophosphamide followed by paclitaxel with trastuzumab in HER-2/neu overexpressed/amplified breast cancer. J Clin Oncol. 2008;26(8):1216–1222.

12. Tolaney S, Barry W, Dang C, et al. Adjuvant paclitaxel and trastuzumab for node-negative HER2-positive breast cancer. N Engl J Med. 2015;372:134-141.

13. Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365(14): 1273–1283.

14. Schneeweiss A, Chia S, Hickish T, et al. Pertuzumab plus trastuzumab in combination with standard neoadjuvant ­anthracycline–containing and anthracycline-free chemo­therapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (­TRYPHAENA). Ann Oncol. 2013;24(9):2278–2284.

15. Jones SE, Collea R, Paul D, et al. Adjuvant docetaxel and cyclophosphamide plus trastuzumab in patients with HER2-amplified early stage breast cancer: a single-group, open- label, phase 2 study. Lancet Oncol. 2013;14(11):1121–1128.

16. Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomized multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13(1):25–32.

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