ABSTRACT
BACKGROUND: Vinorelbine and docetaxel are active single agents in the treatment of nonsmall cell lung carcinoma (NSCLC) and may provide enhanced activity when combined in a dose-dense fashion. The efficacy and safety of this combination was assessed when it was administered every 14 days with Filgrastim support in a community practice setting. METHODS: This open-label study was conducted at 12 community oncology practices in the United States. Sixty-one chemotherapy-naive patients with Stage IIIB/IV NSCLC received vinorelbine 45 mg/m2 followed by docetaxel 60 mg/m2 on Day 1 and Filgrastim 5 mcg/kg beginning on Day 2, with cycles repeated every 14 days. RESULTS: Among 61 enrolled patients, 44% of patients had either a complete or partial response as their best response, and 27% of patients had confirmed complete or partial responses. The median time to confirmed response was 1.9 months (95% confidence interval [95% CI], 0.9-2.3 mos), and the median duration of confirmed response was 6.0 months (95% CI, 3.1-14.4 mos). The median time to disease progression was 4.9 months (95% CI, 3.8-5.8 mos). With a median follow-up of 14.3 months, the median survival was 12.9 months (95% CI, 8.1-14.3 mos), and the 1-year survival rate was 56% (95% CI, 43-69%). The relative dose intensity was 94% for vinorelbine and 93% for docetaxel. Febrile neutropenia occurred in 9 patients (15%) and during 9 of 351 cycles (3%). CONCLUSIONS: It was possible to administer dose-dense vinorelbine and docetaxel chemotherapy with Filgrastim support, beginning in the first cycle, to patients with NSCLC who were treated in a community practice setting.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Lung Neoplasms/drug therapy , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Disease-Free Survival , Docetaxel , Drug Administration Schedule , Female , Filgrastim , Granulocyte Colony-Stimulating Factor/administration & dosage , Humans , Male , Middle Aged , Recombinant Proteins , Survival Rate , Taxoids/administration & dosage , Vinblastine/administration & dosage , Vinblastine/analogs & derivatives , VinorelbineABSTRACT
We evaluated the results of high-dose therapy (HDT) and autologous hematopoietic stem cell transplantation (ASCT) in patients with relapsed or primary refractory Hodgkin's disease (HD), using a previously reported prognostic model based on the presence of three poor prognostic factors at the start of salvage therapy/preparative regimen: B symptoms, extranodal disease and the duration of last complete response of less than 1 year. Based on this model, the patients were divided into low-risk and high-risk groups. Between 1993 and 2001, 24 patients with HD were treated with HDT and ASCT. Eighteen of the 24 patients had 0-1 risk factors (low-risk group) and 6 patients had 2-3 risk factors (high-risk group). Using Kaplan-Meier analysis, after a median follow-up of 40.5 months, the progression-free survival (PFS) was 48%, and the overall survival (OS) was 55%. PFS in the low-risk group was 56%, and in the high-risk group 17% (p < 0.001). OS in the low-risk group was 68% and in the high-risk group it was 18% (p < 0.001). The 100-day transplant-related mortality for the entire group was 16%. Our results are comparable to those reported in previous clinical trials for patients with refractory and relapsed HD treated with HDT and ASCT. The use of a prognostic model appears useful for predicting the outcome of HDT and ASCT for HD patients, and may play an important role in choosing the appropriate therapy for these patients.
Subject(s)
Antineoplastic Agents/therapeutic use , Hodgkin Disease/therapy , Models, Statistical , Stem Cell Transplantation , Adolescent , Adult , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/adverse effects , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Carmustine/administration & dosage , Carmustine/adverse effects , Cyclophosphamide/administration & dosage , Cyclophosphamide/adverse effects , Dose-Response Relationship, Drug , Etoposide/administration & dosage , Etoposide/adverse effects , Female , Hodgkin Disease/drug therapy , Humans , Male , Middle Aged , Prognosis , Stem Cell Transplantation/adverse effects , Treatment OutcomeABSTRACT
Allogeneic stem cell transplantation (SCT) is the treatment of choice for selected patients with chronic myeloid leukemia (CML). However, it is associated with a high risk of treatment-related mortality (TRM) and morbidity. To assist in decision making about transplantation, a simple scoring system to assess the risk is needed. We analyzed the utility of a scoring system, first reported by the European Group for Blood and Marrow Transplantation (EBMT). We analyzed the data from 31 patients who underwent allogeneic transplantation at our institution, using the EBMT scoring system. It was based on five pretransplant risk factors: donor type, stage of disease at time of transplantation, age of recipient, sex of donor and recipient, and interval between diagnosis and transplant. Seventeen patients had a risk score of 0-2, and 14 patients had a score of 3-7. Using Kaplan-Meier analysis, the estimated 4-year leukemia-free (LFS) and overall survival (OS) for patients with a score of 0-2 were 47 and 53%, respectively. In contrast, the estimated 4-year LFS and OS for patients with a score of 3-7 were 10.5 and 10.5%, respectively. Four-year TRM was 47% for the low-risk group (0-2), and 85% for the high-risk group (3- 7). This simple scoring system may play an important role in predicting the outcome of allogeneic SCT, and in choosing the appropriate therapy for patients with CML.
