| General information |
| Database: | DB01076 |
| Objective: | docetaxel and vinorelbine plus filgrastim with weekly trastuzumab for human epidermal growth factor receptor 2positive, stage IV breast cancer. |
| Authors: | Robert B. Livingston |
| Title: | SWOG S0215: a phase II study of docetaxel and vinorelbine plus filgrastim with weekly trastuzumab for human epidermal growth factor receptor 2positive, stage IV breast cancer. |
| Journal: | Breast Cancer Res Treat |
| Year: | 2011 |
| PMID: | 21826527 |
| Trial Design |
| Clinical Trial Id: | NCT00041067 |
| Agent: | trastuzumab
|
| Target: | Receptor proteintyrosine kinase erbB2
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | docetaxel and vinorelbine plus filgrastim with weekly trastuzumab |
| Study Type: | Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Key Patients Feature: | women aged 18 or greater who had human epidermal growth factor receptor 2positive, stage IV, microscopicallyconfirmed breast carcinoma. human epidermal growth factor receptor 2 status was determined by local immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). Patients with 3+ IHC stain were considered to have human epidermal growth factor receptor 2positive breast cancer without FISH, but otherwise a positive FISH test was required to be eligible. Patients may have had no more than one previous line of chemotherapy for primary disease and must have completed chemotherapy 6 months before study entry. Ongoing hormonal treatment before registration needed to be stopped. They may have received prior anthracycline, hormonal, or radiation therapy (completed 3 weeks prior), but not have been treated with prior docetaxel or vinca alkaloid therapy. Prior cumulative doses of doxorubicin or epirubicin could not have exceeded 360 or 720 mg/m2, respectively. All patients had a Zubrod performance status of 0-2, normal hematologic values (ANC more than and equal to 1, 500/mm3 and platelets more than and equal to 100, 000/mm3), normal renal function, and normal liver function [total bilirubin less than and equal to institutional upper limit of normal (ULN), SGOT (AST) or SGPT (ALT) less than and equal to 1.5 ¡Á ULN, and alkaline phosphatase less than and equal to 2.5 ¡Á ULN]. |
| Biomarker: | human epidermal growth factor receptor 2positive |
| Biomark Analysis: | The combination of trastuzumab, docetaxel, and vinorelbine is effective as firstline chemotherapy in human epidermal growth factor receptor 2positive MBC with minimal toxicity |
| Control Group Info: | single arm |
| Treatment Info: | Docetaxel (60 mg/m2) was given intravenously on Day 1, vinorelbine (27.5 mg/m2) intravenously on Days 8 and 15, and filgrastim (5 lg/kg) on Days 2-21 of a 21day cycle. In addition, patients received weekly infusions of trastuzumab (2 mg/kg) after an initial bolus of 4 mg/kg. |
| Primary End Point: | 1 year overall survival (OS) |
| Secondary End Point: | progression free survival (PFS), response rate, and toxicity. |
| Patients Number: | 74 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Response rate for measurable disease was 84%. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Oneyear PFS was 70% (95% CI 58-79%) with a median of 20 months. |
| Median OS A vs. C: | 1 year OS was 93% (95% CI 84-97%) with a median of 48 months. |
| Adverse Event(agent arm): | Grade 4 toxicities were reported for 19% with neutropenia the most common (15%). The most common grade 3 toxicities (33%) were leucopenia (14%) and fatigue (10%). |
| Conclusions: | The combination of trastuzumab, docetaxel, and vinorelbine is effective as firstline chemotherapy in human epidermal growth factor receptor 2positive MBC with minimal toxicity. Oneyear survival estimates are among the highest reported in this population. |