Clinical trials of docetaxel - TrialResults-center.org

pathology

Demonstrated benefit and harm

advanced breast cancer (metastatic)

versus combination chemotherapy

No demonstrated result for efficacy

Trial	control	p<0.05	harm	NS
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0

Trial	Treatments	Patients	Method
304 Study Group, 1999	docetaxel 100 mg/m2 intravenously (i.v.) every 3 weeks (n=203) vs. mitomycin 12 mg/m2 i.v. every 6 weeks plus vinblastine 6 mg/m2 i.v. every 3 weeks (n=189)	patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy	open-label Sample size: 203/189 Primary endpoint: FU duration:
Sjostrom, 1999	Docetaxel at a dose of 100 mg/m2 every 3 weeks (n=143) vs. sequential methotrexate and 5-fluorouracil (n=139)	patients with advanced breast cancer who had failed previous anthracycline treatment	Sample size: 143/139 Primary endpoint: FU duration:
TXT Group, 2002	docetaxel (100 mg m(-2)) every 3 weeks (n=-9) vs. 5-fluorouracil+vinorelbine: 5-fluorouracil (750 mg m(-2) per day continuous infusion) D1-5 plus vinorelbine (25 mg m(-2)) D1 and D5 of each 3-week cycle (n=-9)	patients with metastatic breast cancer after failure of neo/adjuvant or one line of palliative anthracycline-based chemotherapy	Sample size: -9/-9 Primary endpoint: FU duration:
Bontenbal, 2005	AT (doxorubicin 50 mg/m(2) and docetaxel 75 mg/m2) (n=-9) vs. FAC (fluorouracil 500 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2); (n=-9)	first-line chemotherapy in patients with metastatic breast cancer:	Sample size: -9/-9 Primary endpoint: FU duration:
Blohmer, 2010	ED (epirubicin 75 mg/m(2) and docetaxel 75 mg/m(2)) (n=-9) vs. EC (epirubicin 90 mg/m(2) and cyclophosphamide 600 mg/m(2)). (n=-9)	first-line therapy for women with metastatic breast cancer	Sample size: -9/-9 Primary endpoint: FU duration:
Bonneterre, 2004	docetaxel 75 mg m(-2) plus epirubicin 75 mg m(-2) (n=-9) vs. 5-fluorouracil 500 mg m(-2) plus epirubicin 75 mg m(-2) and cyclophosphamide 500 mg m(-2) intravenously once every 3 weeks for up to eight cycles (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
HERNATA, 2011	docetaxel 100 mg/m(2) day 1 (n=-9) vs. vinorelbine 30 to 35 mg/m(2) on days 1 and 8 (n=-9)	first-line therapy of metastatic or locally advanced human epidermal growth factor receptor 2-positive breast cancer	Sample size: -9/-9 Primary endpoint: FU duration:
JCOG, 2005	(n=-9) vs. (n=-9)	first-line chemotherapy in metastatic breast cancer	Sample size: -9/-9 Primary endpoint: FU duration:

advanced breast cancer (metastatic)

versus Every three weeks regimen

No demonstrated result for efficacy

meta-analysis

lung cancer (metastatic)

versus

No demonstrated result for efficacy

meta-analysis

Trial	control	p<0.05	harm	NS
	T1 vs T0
DISTAl 01 (Gridelli) , 2004	weekly docetaxel vs 3-weekly docetaxel
Camps	weekly docetaxel vs 3-weekly docetaxel
Schuette	weekly docetaxel vs 3-weekly docetaxel
Gervais	weekly docetaxel vs 3-weekly docetaxel
Lai	weekly docetaxel vs 3-weekly docetaxel
Chen	weekly docetaxel vs 3-weekly docetaxel
TAX 317 (Shepherd) 100mg/m2, 2000	docetaxel vs
TAX 320 100mg/m2, 2000	docetaxel vs
Esteban, 2003	paclitaxel 80mg/m2 vs m2docetaxel 36 mg/

Trial	Treatments	Patients	Method
REVEL, 2014	(n=-9) vs. (n=-9)	patients with squamous or non-squamous NSCLC who had progressed during or after a first-line platinum-based chemotherapy regimen	double-blind Sample size: -9/-9 Primary endpoint: Overall Survival FU duration:
DISTAl 01 (Gridelli) , 2004	(n=220) vs. (n=0)	patients with advanced NSCLC patients, < or =75 years, ECOG PS < or =2	Sample size: 220/0 Primary endpoint: FU duration:
Camps	docetaxel 36 mg/m(2) given weekly (1W arm) for 6 weeks followed by 2 weeks of rest (n=-9) vs. docetaxel 75 mg/m(2) administered every 3 weeks (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
Schuette	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
Gervais	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
Lai	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
Chen	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
TAX 317 (Shepherd) 100mg/m2, 2000	docetaxel 100 mg/m(2) (n=-9) vs. best supportive care (n=-9) 3 arms: docetaxel 100 mg/m(2), 75 mg/m(2), best supportive care	Patients with performance statuses of 0 to 2 and stage IIIB/IV non-small-cell lung cancer	Sample size: -9/-9 Primary endpoint: FU duration:
TAX 320 100mg/m2, 2000	docetaxel 100 mg/m(2) (D100) or 75 mg/m(2) (D75) (n=373) vs. control regimen of vinorelbine or ifosfamide (n=0) 3 arms : docetaxel 100 mg/m(2) (D100), docetaxel 75 mg/m(2) (D75), control	patients with advanced non-small-cell lung cancer who had previously failed platinum-containing chemotherapy	Sample size: 373/0 Primary endpoint: FU duration:
Esteban, 2003	paclitaxel 80 mg/m2 as a 1 h weekly infusion for 6 weeks followed by a 2-week rest (n=36) vs. docetaxel 36 mg/m2 as a 1 h weekly infusion for 6 weeks followed by a 2-week rest. (n=35)	patients with NSCLC previously treated with platinum-based chemotherapy	Sample size: 36/35 Primary endpoint: FU duration:

Docetaxel Taxanes Description Results NMA

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Docetaxel Taxanes
Description Results NMA