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A Multicenter Phase II Trial of Vinorelbine Plus Gemcitabine in Previously Untreated Inoperable (Stage IIIB/IV) Non-small Cell Lung Cancer
- Source :
- Chest. 117:1583-1589
- Publication Year :
- 2000
- Publisher :
- Elsevier BV, 2000.
-
Abstract
- Study objective: Vinorelbine and gemcitabine are two active single agents used in the treatment of non-small cell lung cancer (NSCLC). A clinical trial was conducted to evaluate the efficacy and toxicity of vinorelbine plus gemcitabine in patients with inoperable (stage IIIB or IV) NSCLC. Design: A multicenter phase II study. Vinorelbine, 20 mg/m 2 , was given as a 10-min IV infusion, followed by a 30-min IV infusion of gemcitabine, 800 mg/m 2 , on days 1, 8, and 15 of each 28-day cycle. Patients and measurements: From March 1998 to August 1998, 40 patients were enrolled in the study. The efficacy and toxicity of the treatment were recorded. Results: All patients are evaluable for treatment response and toxicity profile. Two patients achieved a complete response, and 27 patients achieved a partial response, with an overall response rate of 72.5% (95% confidence interval, 58.7 to 86.3%). Median survival time was 11 months. The significant (World Health Organization grade, 3/4) toxicities were myelosuppression, including leukopenia (47.5% of patients), anemia (17.5% of patients), and thrombocytopenia (12.5% of patients). However, febrile neutropenia occurred in three patients and accounted for one treatment-related death. Fatigue, or flu-like syndrome, occurred in 17 patients, and the symptoms were reversed spontaneously 1 to 2 days after injection in 10 patients. Another seven patients needed dose reduction to ameliorate symptoms. Interstitial pneumonitis occurred in six patients who recovered after steroid treatment. No patient suffered from grade 3 or 4 nausea/vomiting. Conclusion: The combination of vinorelbine and gemcitabine in patients with advanced NSCLC is a highly active non-cisplatin-containing regimen with an acceptable toxicity profile. (CHEST 2000; 117:1583‐1589)
- Subjects :
- Adult
Male
Pulmonary and Respiratory Medicine
Antimetabolites, Antineoplastic
medicine.medical_specialty
Lung Neoplasms
Palliative care
medicine.medical_treatment
Phases of clinical research
Vinblastine
Critical Care and Intensive Care Medicine
Vinorelbine
Deoxycytidine
Gastroenterology
Drug Administration Schedule
Carcinoma, Non-Small-Cell Lung
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Infusions, Intravenous
Lung cancer
Aged
Aged, 80 and over
Chemotherapy
Dose-Response Relationship, Drug
business.industry
Palliative Care
Middle Aged
medicine.disease
Antineoplastic Agents, Phytogenic
Gemcitabine
Surgery
Regimen
Female
Cardiology and Cardiovascular Medicine
business
Febrile neutropenia
medicine.drug
Subjects
Details
- ISSN :
- 00123692
- Volume :
- 117
- Database :
- OpenAIRE
- Journal :
- Chest
- Accession number :
- edsair.doi.dedup.....a882189a320b66ecd070d6c33d8a71f3