Microsoft PowerPoint - Primary Chemotherapy against Triple Negative Luminal B Operable Breast Cancer[読み取り専用]
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1 Primary Chemotherapy against Triple Negative & Luminal B Operable Breast Cancer 杏雲堂病院腫瘍内科河野勤 Randomised clinical studies addressing the sequence of anthracyclines and taxanes in early BC Wildiers et al. Lancet oncology(2010) 11:
2 Primary treatment against operable breast cancer in Kyoundo Luminal A premenopausal CEF100x4 postmenopausal AI TAM (CYP2D6 wt) HER2 Luminal B Basal like Doc75+Tmab x4 CEF100x4 Doc75x4 CEF100x4 Doc75x4 CEF100x4 Which is the best sequence? Taxane Weekly PTX 80 Doc 100 q3wks Doc 75 q3wks Abraxane 260 q3wks Abraxane qwk Anthracycline AC(60/600) EC(90/830) CEF(500/100/500) 2
3 PTX 175 q3wks vs Abraxane 260 q3wks MBC 1 st line J Clin Oncol 23: 7794, 2005 Doc100 vs Abraxane MBC 1 st line 300mg/ m2 q3wks 100mg/ m2 qwk 150mg/ m2 qwk 300mg/ m2 q3wks 150mg/ m2 qwk 300mg/ m2 q3wks 150mg/ m2 qwk Doc 100 Doc mg/ m2 qwk 100mg/ m2 qwk Independent radiologist assessed investigator assessed J Clin Oncol 27: 3611,
4 2009 ASCO Primary treatment against operable breast cancer in Kyoundo Luminal A premenopausal CEF100x4 postmenopausal AI TAM (CYP2D6 wt) HER2 Doc75+Tmab x4 CEF100x4 Luminal B Abraxane CEF100x4 Basal like Abraxane CEF100x4 pcr rate 25~30%? 4
5 pcr 62%!! 5
6 Efficacy of gemcitabine and cisplatin (GP) as first line combination therapy in patients with triple negative metastatic breast cancer: Preliminary results report of a phase II trial. J Clin Oncol 28:15s, 2010 (suppl; abstr 1100) Background: Triple negative breast cancer (TNBC) contributes to the poor prognosis. Only a few studies have revealed that cisplatin based therapy may be effective for this subtype of breast cancer. The objective of this study was to evaluate doublet with gemcitabine/cisplatin (GP) as first line therapy in patients with metastatic TNBC. Methods: This is a single institutional phase II trial. The primary endpoint was progression free survival (PFS). Eligible subjects were aging from 18 to 75 years old, with no prior chemotherpay for MBC, with tumors negative for ER, PR, or HER2, with at least one measurable disease according to the RECIST criteria, with ECOG PS of 0 1, and with adequate organ function. Patients received 21 day cycles of gemcitabine (1,000mg/m 2 ) on days 1, 8 and cisplatin (25 mg/m 2 ) on days 1 3. Treatment was continued until disease progression or unacceptable toxicity or up to 8 cycles. Response rate was evaluated every six weeks. Results: As of Nov. 2009, 65 patients had been enrolled with a planned sample size of 80 patients. The first 45 patients had completed the treatment and were analyzed. A median age was 48 years. 42 patients had received adjuvant chemotherapy (39 patients with anthracycline and/or taxane). The median number of GP treatment cycles was six. The median PFS was 6.2 months (95% CI: ). The response rate was 62.2% (28/45, 95% CI: 47.5% 77%); stable disease was 31.1% (14/45); progressive disease was 6.7% (3/45). G3/4 toxicities were neutropenia 40% (18pts); thrombocytopenia 33.3% (15pts); fatigue 17.8% (8pts); anorexia 15.6% (7pts); anemia 13.3% (6pts); nausea/vomiting 8.9% (4pts). The chemotherapy doses were reduced in 13.3% (6 pts) because of toxicity. Conclusions: This preliminary analysis demonstrated that GP regimen as first line chemotherapy is highly effective and safe in patients with TNBC. 6
7 CDDP < MVAC = GC against advanced urothelial carcinoma MTX 30mg/ m2 day1, 15, 22 VCR 3mg/ m2 day2, 15, 22 ADM 30mg/ m2 day2 CDDP 70mg/ m2 day % CDDP 70mg/ m2 GEM 1000mg/ m2 day1, 8, 15 CDDP 70mg/ m2 day2 CDDP or CBDCA? 7
8 CDDP+Paclitaxel vs CBDCA+Paclitaxel in NSCLC CDDP/PTX CBDCA/PTX CDDP/PTX CBDCA/PTX 15 CDDP + Pem vs CBDCA + Pem Randomized phase II study n=130 NSCLC(Non-sq 80%) stage IIIB/IV PS 0-1 median age MST 1 年生存率 奏効率 G3/4 toxicity % 32% 45% % 20% 55% Pem+Cis Pem+Cb+Bev???? Survival time (month) Nagel et al. ASCO
9 CDDP vs CBDCA in other cancers Ovarian Cancer PTX+CDDP vs PTX+CBDCA (AUC 7.5) Germ Cell Tumor BEP vs CEB (AUC 5) CDDP=CBDCA CDDP>>CBDCA Neoadjuvant platinum based chemotherapy (CT) for triplenegative locally advanced breast cancer (LABC): Retrospective analysis of 125 patients. J Clin Oncol 27:15s, 2009 (suppl; abstr 625) Background: Triple negative breast cancer (TNBC), defined by lack of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2, accounts for 15 20% of all breast cancers and is associated with poor prognosis. There is no consensus regarding optimal CT for treatment of such patients. Preclinical data suggests TNBC may be sensitive to platinums because of deficiencies in BRCA associated DNA repair. The aim of this study was to evaluate pathologic complete response (pcr) and overall survival (OS) in patients with TNBC treated with neoadjuvant platinum based CT. Methods: We identified 674 patients with LABC who received neoadjuvant CT between January 1999 and June 2008 at University of Miami. Of these, 125 (18.5%) had histopathologic confirmation of TNBC. All patients received neoadjuvant platinum salts + docetaxel. 76 (61%) also received neoadjuvant AC, while 42 (34%) received adjuvant AC. pcr was defined as no residual invasive disease in breast and axilla. OS was calculated according to Kaplan Meier. Results: Demographics: median age 50 (28 86 years). 60% premenopausal. TNM stage distribution: T1 0.9%, T2 5.2%, T3 53.4%, T4 40.5%, N0 25.0%, N1 36.2%, N2 35.4%, N3 3.4%, M0 100%, inflammatory 11%, median tumor size = 9.5 cm. Follow up duration ranged from 0.3 to 8.9 years. pcr was observed in 42 of 125 patients (34%; 95% CI 26 43%). Among patients receiving neoadjuvant AC, 30 of 76 (40%; 95% CI 28 51%) had pcr, while amongst those receiving adjuvant AC, 12 of 42 (29%, 95% CI 16 45%) had pcr at the time of definitive surgery. Patients achieving pcr had significantly higher OS (5 yr rate = 73% in pcr, vs. 49% in non pcr; p < 0.001). OS in TNBC patients receiving cisplatin/docetaxel was significantly superior to those receiving carboplatin/docetaxel (11 mortality events out of 78 patients receiving cisplatin based CT vs 24 out of 47 receiving carboplatin based CT logrank p = 0.001). Conclusions: To date, this is the largest single institution cohort of locally advanced TNBC uniformly treated with platinum+docetaxel based CT regimens. Platinum/docetaxel based neoadjuvant CT provided high rates of pcr and excellent OS for women with locally advanced TNBC. 9
10 CDDP / CBDCA therapeutic ratio 1 NSCLC Urothelial Head & Neck Luminal B? Ovary TNBC? GCT low Platinum sensitivity high Which is the best sequence? Gemcitabine Platinum GEM+CDDP? Anthracycline AC(60/600) EC(90/830) CEF(500/100/500) 10
11 Example of recommended hydration NCCN Chemotherapy Order Template min Pre hydration 500ml 15 min Mannitol g 20% mannitol mL 60 min 60 min CDDP Post hydration 500ml 5% dextrose 0.45% NaCL Total 1000mL KCL 20mEq MgSO4 8mEq(1g) Day 2 以降は補液なし 21 シスプラチン ( ランダ R ) を含むレジメンにおける輸液の標準化 NCCNのオーダーテンプレートに準拠 前後の補液は生食としシスプラチンの-Cl 基が-OH 基に変換されにくくすることで腎毒性を軽減 (Ann Inter Med 100: 19, 1984) マグネシウムによる腎保護効果 (Br J Cancer 54: 19, 1986, Eur J Cancer 44: 2608, 2008) 生食急速投与とマンニットール投与により投与前後 4 時間の尿量を最低 100ml/h 以上に保つ (Tumori 93: 138, 2007, Cancer Chemother Pharmacol 23: 243, 1989, 腫瘍内科 5(3): 347, 2010) 腎毒性が強いのは遊離型 Pt 11
12 腎障害を最小化する CDDP の投与方法 メイン 側管 生食 500 ml カリウム 10 meq マグネシウム 20 meq 生食 500 ml カリウム 10 meq 2 時間 輸液ポンプ 250ml/h + 250ml/h マンニットール ランダ + 生食 150ml ( 全量を 500ml に調整 遮光 ) 30 分 輸液ポンプ 300ml/h 1 時間 ( 自然滴下 ) 生食 500 ml カリウム 10 meq 生食 500 ml カリウム 10 meq 2 時間 輸液ポンプ 250ml/h + 250ml/h Day2 以降補液なし 12
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