Randomized Phase II Study Comparing Gemcitabine Plus Dacarbazine Versus Dacarbazine Alone in Patients With Previously Treated Soft Tissue Sarcoma: A Spanish Group for Research on Sarcomas Study
| Autor: | Andres Poveda, Joaquin Fra, Javier Martinez-Trufero, Jordi Rubió, Juan Antonio Carrasco, Auxiliadora Gómez-España, J. Buesa, Javier Martín, Andrés Meana, Antonio Lopez-Pousa, Nuria Lainez, Raquel Andrés, Ricardo Cubedo, Ana de Juan, Josefina Cruz, Xavier Garcia-del-Muro, Antonio Casado, Carlos Pericay, Joan Maurel |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Adolescent Gastrointestinal Diseases Dacarbazine Urology Salvage therapy Phases of clinical research Antineoplastic Agents Soft Tissue Neoplasms Kaplan-Meier Estimate Deoxycytidine Disease-Free Survival Drug Administration Schedule Young Adult chemistry.chemical_compound Antineoplastic Combined Chemotherapy Protocols medicine Humans Aged Proportional Hazards Models Salvage Therapy business.industry Soft tissue sarcoma Hazard ratio Sarcoma Middle Aged medicine.disease Hematologic Diseases Gemcitabine Surgery Treatment Outcome Oncology chemistry Spain Female Chemical and Drug Induced Liver Injury business medicine.drug |
| Zdroj: | JOURNAL OF CLINICAL ONCOLOGY r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau instname |
| ISSN: | 1527-7755 0732-183X |
| Popis: | Purpose To assess the activity and toxicity of the combination of gemcitabine plus dacarbazine (DTIC) in patients with advanced soft tissue sarcoma (STS) in a randomized, multicenter, phase II study using DTIC alone as a control arm. Patients and Methods Patients with previously treated advanced STS were randomly assigned to receive either fixed-dose rate gemcitabine (10 mg/m2/min) at 1,800 mg/m2 followed by DTIC at 500 mg/m2 every 2 weeks, or DTIC alone at 1,200 mg/m2 every 3 weeks. The primary end point of the study was progression-free rate (PFR) at 3 months. Results From November 2005 to September 2008, 113 patients were included. PFR at 3 months was 56% for gemcitabine plus DTIC versus 37% for DTIC alone (P = .001). Median progression-free survival was 4.2 months versus 2 months (hazard ratio [HR], 0.58; 95% CI, 0.39 to 0.86; P = .005), and median overall survival was 16.8 months versus 8.2 months (HR, 0.56; 95% CI, 0.36 to 0.90; P = .014); both favored the arm of gemcitabine plus DTIC. Gemcitabine plus DTIC was also associated with a higher objective response or higher stable disease rate than was DTIC alone (49% v 25%; P = .009). Severe toxicities were uncommon, and treatment discontinuation for toxicity was rare. Granulocytopenia was the more common serious adverse event, but febrile neutropenia was uncommon. Asthenia, emesis, and stomatitis were the most frequent nonhematologic effects. Conclusion The combination of gemcitabine and DTIC is active and well tolerated in patients with STS, providing in this phase II randomized trial superior progression-free survival and overall survival than DTIC alone. This regimen constitutes a valuable therapeutic alternative for these patients. |
| Databáze: | OpenAIRE |
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