乳癌化療指引. Breast Cancer

Transcription

1 乳癌化療指引 103 年 12 月第五版 年, 第一至四版 注意事項 : 本院癌症團隊基於實證醫學制定此化學治療指引 : 本院癌症團隊基於實證醫學制定此化學治療指引, 實證醫學之結論源自臨床詴驗, 實證醫學之結論源自臨床詴驗, 惟參與臨床詴驗之研究對象多以 70 歲以下之病人為主, 故建議 70 歲以上病人接受治療時, 應依據病人實際臨床狀況進行抗癌藥物劑量之調整!

2 健保藥品給付限制註記說明 : (!) : 健保有條件給付該藥品, 詳參閱最新之健保給付規定 ($) : 健保尚未給付該藥品用於此癌症化療, 詳參閱最新之健保給付規定 ( 資料彙整日期 ) Non-trastuzumab Containing Combinations Primary/adjuvant therapy TAC chemotherapy 1 Docetaxel 75 mg/m 2 IV day 1 Doxorubicin 50 mg/ m 2 IV day 1 Cyclophosphamide 500 mg/m 2 IV day 1 Repeat every 21 days for 6 cycles. (All cycles are with G-CSF support dose) ($) Dose-dense AC followed by Paclitaxel chemotherapy 2 Doxorubicin 60 mg/m 2 IV day 1 Repeat every 14 days for 4 cycles. followed by Paclitaxel 80 mg/m 2 IV on D1 (!) Repeat weekly for 12 cycles (All cycles are with G-CSF support dose) ($)

3 AC followed by paclitaxel chemotherapy 3 Doxorubicin 60 mg/m 2 IV day 1 Repeat every 21 days for 4 cycles. Paclitaxel 80 mg/m2 by 1h IV infusion weekly for 12 wks. (!) AC followed by docetaxel chemotherapy 3 Doxorubicin 60 mg/m 2 IV on day 1 Repeat every 21 days for 4 cycles. Docetaxel 75 mg/m 2 IV on day 1 (!) Repeat every 21 days for 4 cycles

4 TC chemotherapy 4 Docetaxel 75 mg/m 2 IV day 1 Repeat every 21 days for 4 cycles (All cycles are with filgrastim support). ($) AC/EC chemotherapy 5.6 Doxorubicin 60 mg/m 2 IV day 1 (or Epirubicin 90 mg/m 2 IV on D1) Cyclophosphamide 600 mg/m2 IV day 1 Repeat every 21 days for 4 cycles. FAC chemotherapy with/out paclitaxel Fluorouracil 500 mg/m2 IV day day 1 & 8 Doxorubicin 50 mg/m 2 IV day 1 Cyclophosphamide 500 mg/m 2 IV day 1 Repeat every 21 days for 6 cycles. ± Paclitaxel 80 mg/m 2 by 1 h IV infusion weekly for 12 wks. CMF chemotherapy 9 Cyclophosphamide 100 mg/m 2 PO days 1-14 Methotrexate 40 mg/m 2 IV days 1 & 8 5-Fluorouracil 600 mg/m 2 IV days 1 & 8 Repeat every 28 days for 6 cycles.

5 FEC followed by docetaxel chemotherapy 10 5-Fluorouracil 500 mg/m 2 IV days 1 Epirubicin 100 mg/m 2 IV day 1 Cyclophosphamide 500 mg/m 2 IV day 1 Repeat every 21 days for 3 cycles. Docetaxel 100 mg/m 2 IV day 1 Repeat every 21 days for 3 cycles. FEC chemotherapy by weekly paclitaxel 11 5-Fluorouracil 600 mg/m 2 IV day 1 Epirubicin 90 mg/m 2 IV on D1 Repeat every 21 days for 4 cycles. : Paclitaxel 100 mg/m 2 IV infusion weekly for 8 wks (! )

6 Reference: 1. Adjuvant Docetaxel for Node-Positive Breast Cancer. N Engl J. Med 352: (2005) 2. Evaluation of anemia, neutropenia and skin toxicities in standard or dose-dense doxorubicin/cyclophosphamide (AC)-paclitaxel or docetaxel adjuvant chemotherapy in breast cancer. Ann Oncol.;16(2): (2005) 3. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med.;358(16): (2008) 4. Extended follow-up and analysis by age of the US Oncology Adjuvant Trial 9735: Docetaxwl/cyclophophamide is associated with an overall survival benefit compared to doxorubicin/cyclophosphamide and is well tolerated in women 65 or older. San Antonio Breast Cancer Symposium. Abstract 12, 2007 (NCCN Guidelines Invasive Breast Cancer Version ) 5. Fisher B, Brown AM, Dimitrov NV, et al. Two months of doxorubicin-cyclophosphamide with and without interval reinduction therapy compared with 6 months of cyclophosphamide, methotrexate, and fluorouracil in positive-node breast cancer patients with tamoxifen-nonresponsive tumors: results from the National Surgical Adjuvant Breast and Bowel Project B-15. J Clin Oncol 1990;8: J Clin Oncol 2001;19: Buzdar AU, Kau SW, Smith TL, Hortobagyi GN. Ten-year results of FAC adjuvant chemotherapy trial in breast cancer. Am J Clin Oncol 1989;12; Assikis V, Buzdar A, Yang Y, et al: A phase III trial of sequential adjuvant chemotherapy for operable breast carcinoma: final analysis with 10-year follow-up. Cancer 2003;97: Randomized trial of intensive cyclophosphamide, epirubicin, and fluorouracil chemotherapy compared with cyclophosphamide, methotrexate, and fluorouracil in premenopausal women with node-positive breast cancer. National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol.; 16: (1998) J Clin Oncol 2006; 24: Sequential Adjuvant Epirubicin-Based and Docetaxel Chemotherapy for Node-Positive Breast Cancer Patients:The FNCLCC PACS 01 Trial 11. Randomized Phase 3 Trial of Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Paclitaxel for Early Breast Cancer J Natl Cancer Inst 2008;100:

7 Trastuzumab Containing Combinations Primary/adjuvant therapy Cardiac monitoring at baseline, 3, 6, and 9 mo. AC followed by T chemotherapy with Trastuzumab 1-2 Doxorubicin 60 mg/m 2 IV day 1 Repeat every 21 days for 4 cycles. Paclitaxel 80 mg/m 2 by 1h IV weekly for 12 wks (! ) With Trastuzumab 4 mg/kg IV with first dose of paclitaxel (! ) Trastuzumab 2 mg/kg IV weekly to complete 1 year of treatment. (! ) (As an alternative, trastuzumab 8 mg/kg IV as loading dose and maintainance with 6 mg/kg IV every 3 wk may be used following the completion of paclitaxel, and given to complete 1 y of trastuzumab treatment.) AC followed by T chemotherapy with trastuzumab + pertuzumab Doxorubicin 60 mg/m 2 IV day 1 Repeat every 21 days for 4 cycles. : Pertuzumab 840 mg IV day 1 followed by 420 mg IV ($) Trastuzumab 8 mg/kg IV day 1 followed by 6 mg/kg IV (! ) Paclitaxel 80 mg/m 2 IV days 1, 8, and 15 (! ) Repeat every 21 days for 4 cycles Trastuzumab 6 mg/kg IV day 1 (! )

8 Repeat every 21 days to complete 1 y of trastuzumab therapy Breast Cancer

9 Dose-dense AC followed by paclitaxel chemotherapy with trastuzumab 3-4 Doxorubicin 60 mg/m 2 IV day 1 Repeat every 14 days for 4 cycles. Paclitaxel 175 mg/m 2 by 3h IV day 1 (! ) Repeat every 14 days for 4 cycles. (All cycles are with filgrastim support). With Trastuzumab 4 mg/kg IV with first dose of paclitaxel. (! ) Trastuzumab 2 mg/kg IV weekly to complete 1 y of treatment. (! ) (As an alternative, trastuzumab 8 mg/kg IV as loading dose and maintainance with 6 mg/kg IV every 3 wk may be used following the completion of paclitaxel, and given to complete 1 y of trastuzumab treatment.) TCH chemotherapy 5 Docetaxel 75 mg/m 2 IV day 1 (! ) Carboplatin AUC 6 IV day 1 (! ) Repeat every 21 days for 6 cycles With Trastuzumab 4 mg/kg wk 1. (! ) Trastuzumab 2 mg/kg for 17 wks. Trastuzumab 6 mg/kg IV every 3 wks to complete 1 year of trastuzumab therapy.

10 TCH chemotherapy + pertuzumab 6 Trastuzumab 8 mg/kg IV day 1 followed by 6 mg/kg IV (! ) Pertuzumab 840 mg IV day 1 followed by 420 mg IV ($) Docetaxel 75 mg/m 2 IV day 1 (! ) Carboplatin AUC 6 IV day 1 (! ) Repeat every 21 days for 6 cycles : Trastuzumab 6 mg/kg IV every 21 days to complete 1 y of trastuzumab therapy AC followed by docetaxel chemotherapy with trastuzumab 7-9 Doxorubicin 60 mg/m 2 IV day 1 Repeat every 21 days for 4 cycles. Docetaxel 75 mg/m 2 IV day 1 (! ) Repeat every 21 days for 4 cycles With Trastuzumab 4 mg/kg wk 1. (! ) Trastuzumab 2 mg/kg IV weekly for 11 wks. Trastuzumab 6 mg/kg IV every 21 days to complete 1 year of trastuzumab therapy. (As an alternative, trastuzumab 8 mg/kg IV as loading dose and maintainance with 6 mg/kg IV every 3 wk may be used following the completion of docetaxel, and given to complete 1 y of trastuzumab treatment.)

11 AC followed by docetaxel chemotherapy with trastuzumab and pertuzumab Doxorubicin 60 mg/m 2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Repeat every 21 days for 4 cycles : Pertuzumab 840 mg IV day 1 followed by 420 mg IV ($) Trastuzumab 8 mg/kg IV day 1 followed by 6 mg/kg IV (! ) Docetaxel 75 mg/m 2 IV day 1 (! ) Repeat every 21 days for 4 cycles : Trastuzumab 6 mg/kg IV every 21 days to complete 1 y of trastuzumab therapy Paclitaxel + Trastuzumab 12 Paclitaxel 80 mg/m 2 IV weekly for 12 weeks (! ) With Trastuzumab 4 mg/kg wk 1. followed by 2 mg/kg IV weekly for 11 wks. (! ) Trastuzumab 6 mg/kg IV every 21 days to complete 1 year of trastuzumab therapy. (As an alternative, trastuzumab 8 mg/kg IV as loading dose and maintainance with 6 mg/kg IV every 3 wk may be used following the completion of docetaxel, and given to complete 1 y of trastuzumab treatment.) Chemotherapy followed by trastuzumab Approved adjuvant chemotherapy regimen for at least 4 cycles Trastuzumab 8 mg/kg IV wk 1 (! )

12 Trastuzumab 6 mg/kg IV every 21 days for 1 y. Breast Cancer

13 Reference: 1. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med.;358(16): (2008) 2. Multicentric, randomized phase III trial of two different adjuvant chemotherapy regimens plus three versus twelve months of trastuzumab in patients with HER2- positive breast cancer (Short-HER Trial; NCT ). Clin Breast Cancer.;8(5): (2008) 3. Dang C, Fomier M, Sugarman S, et al. The safety of dose-dense doxorubicin and cyclophosphamide followed by paclitaxel with trastuzumab in HER2/neu over expressed/amplified breast cancer. J Clin Oncol. 2008;26(8): Multicentric, randomized phase III trial of two different adjuvant chemotherapy regimens plus three versus twelve months of trastuzumab in patients with HER2- positive breast cancer (Short-HER Trial; NCT ). Clin Breast Cancer.;8(5): (2008) 5. Clinical efficacy of taxane-trastuzumab combination regimens for HER-2-positive metastatic breast cancer. Oncologist.;13(5): (2008) 6. 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: Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med 2011;365: Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med.;358(16): (2008) 9. Multicentric, randomized phase III trial of two different adjuvant chemotherapy regimens plus three versus twelve months of trastuzumab in patients with HER2- positive breast cancer (Short-HER Trial; NCT ). Clin Breast Cancer.;8(5): (2008) year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet.;369(9555): (2007) 11. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med ; 353: (2005) 12. Tolaney S, Barry W, Dang C, et al: A phase II study of paclitaxel(t) and trastuzumab(h) (APT trial) for node-negative, HER2-positive breast cancer(bc). [abstract]. San Antonin Breast Cancer Symposium 2013; Abstract S1-04

14 Primary/adjuvant therapy regimen Cardiac monitoring at baseline, 3, 6, and 9 mo. FEC chemotherapy followed by pertuzumab + trastuzumab + docetaxel 1 Fluorouracil 500 mg/m 2 IV day 1 Epirubicin 100 mg/m 2 IV day 1 Repeat every 21 days for 3 cycles : Pertuzumab 840 mg IV day 1 followed by 420 mg IV ($) Trastuzumab 8 mg/kg IV day 1 followed by 6 mg/kg IV (! ) Docetaxel mg/m 2 IV day 1 (! ) Repeat every 21 days for 3 cycles : Trastuzumab 6 mg/kg IV every 21 days to complete 1 y of trastuzumab therapy FEC chemotherapy followed by pertuzumab + trastuzumab + paclitaxel Fluorouracil 500 mg/m 2 IV day 1 Epirubicin 100 mg/m 2 IV day 1 Repeat every 21 days for 3 cycles : Pertuzumab 840 mg IV day 1 followed by 420 mg IV ($) Trastuzumab 8 mg/kg IV day 1 followed by 6 mg/kg IV (! ) Paclitaxel 80 mg/m 2 IV days 1, 8, and 15 (! ) Repeat every 21 days for 3 cycles, :

15 Trastuzumab 6 mg/kg IV every 21 days to complete 1 y of trastuzumab therapy Primary/neo-adjuvant therapy regimen Pertuzumab + trastuzumab + docetaxel followed by FEC chemotherapy 2 neoadjuvant therapy Pertuzumab 840 mg IV day 1 followed by 420 mg IV ($) Trastuzumab 8 mg/kg IV day 1 followed by 6 mg/kg IV (! ) Docetaxel mg/m 2 IV day 1 (! ) Repeat every 21 days for 4 cycles adjuvant therapy Fluorouracil 600 mg/m 2 IV day 1 Epirubicin 90 mg/m 2 IV day 1 Repeat every 21 days for 3 cycles : Trastuzumab 6 mg/kg IV every 21 days to complete 1 y of trastuzumab therapy Pertuzumab + trastuzumab + paclitaxel followed by FEC chemotherapy 2 neoadjuvant therapy Pertuzumab 840 mg IV day 1 followed by 420 mg IV ($) Trastuzumab 8 mg/kg IV day 1 followed by 6 mg/kg IV (! ) Paclitaxel 80 mg/m 2 IV days 1, 8, and 15 (! ) Repeat every 21 days for 4 cycles, followed by adjuvant therapy Fluorouracil 600 mg/m 2 IV day 1 Epirubicin 90 mg/m 2 IV day 1

16 Repeat every 21 days for 3 cycles, : Trastuzumab 6 mg/kg IV every 21 days to complete 1 y of trastuzumab therapy Breast Cancer

17 Reference 1. 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: 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 randomised multicentre, open-label, phase 2 trial. Lancet Oncol 2012 Jan;13(1):25-32