ABSTRACT
BACKGROUND: The aim of this single-arm phase II study was to evaluate the efficacy, feasibility, and safety of the gemcitabine-carboplatin-paclitaxel combination as neoadjuvant chemotherapy in patients with operable non-small cell lung cancer (NSCLC). METHODS: Patients with stage IB, II, or IIIA NSCLC were given three cycles of chemotherapy followed by tumor resection. Each 21-day cycle consisted of gemcitabine 1000 mg/m on days 1 and 8, carboplatin AUC 5 on day 1, and paclitaxel 175 mg/m on day 1. RESULTS: Forty-four patients were enrolled: 18.2% of patients had stage IB, 15.9% had stage II, and 65.9% had stage IIIA NSCLC. All patients received three cycles of treatment. The clinical tumor response rate was 76.2% (32 of 42 patients; 95% CI, 60.5-87.9%). Thirty-six patients had a complete tumor resection, five of whom had a complete pathological response with no viable tumor cells in the resected tumor on histological examination. Median time to progression was 13.6 months (95% CI, 8.9, >16 months), and 26 of 44 patients (59.1%) had progressed. The 1-year disease-free survival rate was 53.6% (95% CI, 38.7-68.5%), and the 1-year survival rate was 86.0% (95% CI, 75.7-96.4%). Grade 3 and 4 neutropenia each occurred in 38.6% of patients, and grade 3 infection occurred in 2.3% of patients; grade 3 and 4 thrombocytopenia occurred in 25.0% and 0% of patients, respectively. CONCLUSION: The gemcitabine-carboplatin-paclitaxel combination showed promising efficacy and seemed to be safe and feasible as neoadjuvant chemotherapy in patients with operable-stage NSCLC.
Subject(s)
Antineoplastic Agents/therapeutic use , Carboplatin/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Deoxycytidine/analogs & derivatives , Immunosuppressive Agents/therapeutic use , Lung Neoplasms/drug therapy , Paclitaxel/therapeutic use , Adult , Aged , Antineoplastic Agents/administration & dosage , Carboplatin/administration & dosage , Carcinoma, Non-Small-Cell Lung/mortality , Carcinoma, Non-Small-Cell Lung/pathology , Deoxycytidine/administration & dosage , Deoxycytidine/therapeutic use , Drug Therapy, Combination , Female , Follow-Up Studies , Humans , Immunosuppressive Agents/administration & dosage , Lung Neoplasms/mortality , Lung Neoplasms/pathology , Male , Middle Aged , Neoadjuvant Therapy/methods , Neoplasm Staging , Paclitaxel/administration & dosage , Ribonucleotide Reductases/antagonists & inhibitors , Severity of Illness Index , Survival Rate/trends , GemcitabineABSTRACT
BACKGROUND: G-CSF is used to enhance hematopoietic recovery after autologous stem cell transplantation (ASCT), but the optimal dose of G-CSF during engraftment has not been established. The medical cost of ASCT is a serious financial burden in developing countries, and G-CSF is the most costly drug used in this procedure. We evaluated whether a lower, vial-size fitted dose of lenograstim is clinically equivalent to a higher fixed dose. STUDY DESIGN AND METHODS: A prospective randomized study was performed on 33 patients (11 non-Hodgkin's lymphoma, 8 multiple myeloma, 14 breast cancer) undergoing ASCT. Patients were randomly administered 100 micro g or 250 micro g lenograstim daily starting on the next day of ASCT, with a minimum infusion of 3 x 10(6) CD34+ cells per kg. RESULTS: For both lenograstim doses, median time to neutrophil engraftment was 9 days and median time to PLT engraftment was 11 days. Episodes of clinically documented infections were 10 per 379 patient-days in the 100 microg per day group and 10 per 320 patient-days in the 250 microg per day group. There were no between-group differences in requirements for transfusion of RBCs or PLTs. Duration of hospitalization was 16 days for the 100 microg per day group and 17 days for the 250 microg per day group. Daily lenograstim dose per patient's body weight and total amount of lenograstim used during ASCT were both significantly lower in the 100 microg per day group. CONCLUSION: Administration of 100 microg per day of lenograstim showed comparable clinical efficacy to 250 microg per day lenograstim for immediate hematopoietic recovery after ASCT. Use of the lower dose was associated with lower overall lenograstim usage and lower cost.
Subject(s)
Graft Survival/drug effects , Granulocyte Colony-Stimulating Factor/administration & dosage , Hematopoietic Stem Cell Transplantation/methods , Recombinant Proteins/administration & dosage , Adolescent , Adult , Blood Cell Count , Blood Platelets , Breast Neoplasms/complications , Breast Neoplasms/therapy , Dose-Response Relationship, Drug , Female , Granulocyte Colony-Stimulating Factor/economics , Hematologic Neoplasms/complications , Hematologic Neoplasms/therapy , Hematopoietic Stem Cell Transplantation/adverse effects , Humans , Infections/chemically induced , Kinetics , Length of Stay , Lenograstim , Male , Middle Aged , Neutrophils , Recombinant Proteins/economics , Transplantation, Autologous , Treatment OutcomeABSTRACT
The efficacy and toxicity of weekly low dose chemotherapy using paclitaxel and cisplatin were evaluated in 22 chemotherapy-naïve patients with non-small cell lung cancer (NSCLC). Paclitaxel (40 mg/m(2) by 1 h infusion) and cisplatin (20 mg/m(2) by 1 h infusion) were administered weekly without interruption. With a median of 16 cycles of weekly chemotherapy, objective response rate was 40.9% (95% confidence interval, 18.6-63.2%). Stable disease and progressive disease categories accounted for 40.9 and 18.2%, respectively. The median response duration was 3 months (1-12 months). Myelosuppression was not noted and non-hematologic toxicities were mild. This study indicates that weekly low dose chemotherapy using paclitaxel and cisplatin could be given safely to the patients with NSCLC and showed a promising response rate.
