| 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 |
Abraxane was well tolerated, with significantly improved safety profile versus paclitaxel despite the fact that higher doses of paclitaxel (1,338 mg/m² versus 1,100 mg/m²) are delivered with Abraxane. Nonhematologic toxicities =/>Grade 3 occurred in 15 (3%) patients with Abraxane and in 56 (11%) patients with paclitaxel. Grade 4 hematologic toxicities occurred in 49 (11%) patients treated with Abraxane with Grade 4 neutropenia occurring in 23 (5%) patients and thrombocytopenia in 21 (5%) patients, compared to 98 (22%) patients experiencing Grade 4 hematologic toxicities with paclitaxel, with Grade 4 neutropenia occurring in 5 (1%) patients and thrombocytopenia in 4 (1%).
|
-->
| 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 |
The vinorelbine regimen was associated with significantly less Grade 3/4 leukopenia, febrile neutropenia, infection, fever, neuropathy, nail changes, and edema. A significantly higher overall incidence of Grade 3/4 toxicity was observed in the docetaxel arm (81% versus 51%, p<0.0001), and 20.1% of patients in the docetaxel arm discontinued treatment because of toxicity, compared with 6.5% of patients in the vinorelbine arm (p<0.001).
|
-->
