Regimen 1
Nab-paclitaxel (Abraxane) + Carboplatin
Regimen 2
Paclitaxel + Carboplatin
Details

Phase III (begin 10/07, closed 7/09) USA, Canada
non-small cell lung cancer (nsclc), advanced (Stage III) or metastatic (Stage IV), first line
Enrollment: 1,050 patients (arm 1=525, arm 2=525)  

Protocol ID: CA031; NCT00540514

Link to Protocol  

OR: Abraxane=33%; paclitaxel=25% (p=0.005) by IRR, a 31% improvement, for 1.31 response ratio (RR) or Abraxane=37%; paclitaxel=30% (p=0.008) by investigator review, a 26% improvement, for an RR of 1.26; ia subset of squamous cell carcinoma patients Abraxane=41% versus paclitaxel=24% (p<0.001) for a 67% improvement and an RR of 1.67. .

University of North Carolina Lineberger Comprehensive Cancer Center

• Socinski MA, ASCO10, Abs. LBA7511

Regimen 1
Docetaxel (Taxotere) + Trastuzumab (Herceptin)
Regimen 2
Vinorelbine (Navelbine) + Trastuzumab (Herceptin)
Details

Phase III (begin 5/05, closed 3/10) USA, Europe (Denmark, Norway, Sweden)
breast cancer, locally advanced or metastatic, HEr2-positive, chemotherapy-naive
Enrollment: 284 patients
Eval Tox: 284 patients (metastatic disease=96%) followed for a median duration of 2.5 years
Eval Resp: 284 patients (metastatic disease=96%) followed for a median duration of 2.5 years  

Protocol ID: HERNATA; NCT00430001

Link to Protocol  

OR: 59.3% in both groups
Median TTP: 15.3 months in the vinorelbine arm and 12.4 months in the docetaxel arm, a nonsignificant difference
1-year: 88% in both arms
OS: 39 months in the vinorelbine arm and 36 months in the docetaxel arm

Danish Breast Cancer Cooperative Group

• Andersson M, etal, 2010 European Breast Cancer Conference (EBCC10), Abs. 8N.