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会議資料 (279 ページ)
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| 出典情報 | 医療上の必要性の高い未承認薬・適応外薬検討会議（第68回 5／25）《厚生労働省》 |
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要望番号；IV-159
cancer （CLEOPATRA）: end-of-study results from a double-blind, randomized,
placebo-controlled, phase 3 study. Lancet Oncol 2020;21:519-30.
12）Von Minckwitz G 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;23:2676-85.
13）Sparano JA, et al. Long-term follow-up of the E1199 phase III trial evaluating the role of taxane
and schedule in operable breast cancer. J Clin Oncol 2015；33：2353 - 60.
14）Eiermann W,et al. Phase III study of doxorubicin/cyclophosphamide with concomitant versus
sequential docetaxel as adjuvant treatment in patients with human epidermal growth factor receptor
2-normal, node-positive breast cancer: BCIRG-005 trial. J Clin Oncol 2011;29:3877-84.
15）Slamon D, et al.Adjuvant trastuzumab in HER2-positive breast cancer.N Engl J Med
2011;365:1273-83.
16）Gianni L, 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; 13: 25–32
17）Untch M, et al. Neoadjuvant treatment with trastuzumab in HER2-positive breast cancer: results
from the GeparQuattro study. J Clin Oncol 2010;28:2024-31.
18）Von Minckwitz G, et al. Neoadjuvant chemotherapy and bevacizumab for HER2-negative breast
cancer.N Engl J Med 2012;366:299-309.
19）Nitz U et al. West German Study PlanB Trial: Adjuvant Four Cycles of Epirubicin and
Cyclophosphamide Plus Docetaxel Versus Six Cycles of Docetaxel and Cyclophosphamide in
HER2-Negative Early Breast Cancer. J Clin Oncol 2019;37:799-808.
20）Joensuu H, Kellokumpu-Lehtinen PL, Bono P, et al. Adjuvant Docetaxel or Vinorelbine with or
without Trastuzumab for Breast Cancer. N Engl J Med 2006;354:809-20.
21） Hirata T, et al. A Multicenter Study of Docetaxel at a Dose of 100 mg/m2 in Japanese Patients
with Advanced or Recurrent Breast Cancer. Intern Med 2020;60: 1183-90.
22）阿部 元、他：乳癌術後補助化学療法としての FEC100 Followed by Docetaxel 100 の認容
性の検討: JPn J Cancer Chemother 2010;37:1483-87.
23）中村 清吾、他：原発乳癌に対する FEC followed by docetaxel 100 mg / m2 併用療法による
術前化学療法の検討 – JBCRG02 –：乳癌の臨床 2008;23:111-7.
24）Early Breast Cancer Trialists' Collaborative Group （EBCTCG）. Increasing the dose intensity of
chemotherapy by more frequent administration or sequential scheduling: a patient-level
meta-analysis of 37 298 women with early breast cancer in 26 randomized trials. Lancet
2019;393:1440-52.
25）Fujii T, et al. Effectiveness of an Adjuvant Chemotherapy Regimen for Early-Stage Breast Cancer:
A Systematic Review and Network Meta-analysis. JAMA Oncol 2015;1:1311-18.
26）Ghersi D,et al. Taxanecontaining regimens for metastatic breast cancer. Cochrane Database Syst
46
279/370
cancer （CLEOPATRA）: end-of-study results from a double-blind, randomized,
placebo-controlled, phase 3 study. Lancet Oncol 2020;21:519-30.
12）Von Minckwitz G 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;23:2676-85.
13）Sparano JA, et al. Long-term follow-up of the E1199 phase III trial evaluating the role of taxane
and schedule in operable breast cancer. J Clin Oncol 2015；33：2353 - 60.
14）Eiermann W,et al. Phase III study of doxorubicin/cyclophosphamide with concomitant versus
sequential docetaxel as adjuvant treatment in patients with human epidermal growth factor receptor
2-normal, node-positive breast cancer: BCIRG-005 trial. J Clin Oncol 2011;29:3877-84.
15）Slamon D, et al.Adjuvant trastuzumab in HER2-positive breast cancer.N Engl J Med
2011;365:1273-83.
16）Gianni L, 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; 13: 25–32
17）Untch M, et al. Neoadjuvant treatment with trastuzumab in HER2-positive breast cancer: results
from the GeparQuattro study. J Clin Oncol 2010;28:2024-31.
18）Von Minckwitz G, et al. Neoadjuvant chemotherapy and bevacizumab for HER2-negative breast
cancer.N Engl J Med 2012;366:299-309.
19）Nitz U et al. West German Study PlanB Trial: Adjuvant Four Cycles of Epirubicin and
Cyclophosphamide Plus Docetaxel Versus Six Cycles of Docetaxel and Cyclophosphamide in
HER2-Negative Early Breast Cancer. J Clin Oncol 2019;37:799-808.
20）Joensuu H, Kellokumpu-Lehtinen PL, Bono P, et al. Adjuvant Docetaxel or Vinorelbine with or
without Trastuzumab for Breast Cancer. N Engl J Med 2006;354:809-20.
21） Hirata T, et al. A Multicenter Study of Docetaxel at a Dose of 100 mg/m2 in Japanese Patients
with Advanced or Recurrent Breast Cancer. Intern Med 2020;60: 1183-90.
22）阿部 元、他：乳癌術後補助化学療法としての FEC100 Followed by Docetaxel 100 の認容
性の検討: JPn J Cancer Chemother 2010;37:1483-87.
23）中村 清吾、他：原発乳癌に対する FEC followed by docetaxel 100 mg / m2 併用療法による
術前化学療法の検討 – JBCRG02 –：乳癌の臨床 2008;23:111-7.
24）Early Breast Cancer Trialists' Collaborative Group （EBCTCG）. Increasing the dose intensity of
chemotherapy by more frequent administration or sequential scheduling: a patient-level
meta-analysis of 37 298 women with early breast cancer in 26 randomized trials. Lancet
2019;393:1440-52.
25）Fujii T, et al. Effectiveness of an Adjuvant Chemotherapy Regimen for Early-Stage Breast Cancer:
A Systematic Review and Network Meta-analysis. JAMA Oncol 2015;1:1311-18.
26）Ghersi D,et al. Taxanecontaining regimens for metastatic breast cancer. Cochrane Database Syst
46
279/370