Somatostatin, retinoids, melatonin, vitamin D, bromocriptine, and cyclophosphamide in advanced non-small-cell lung cancer patients with low performance status.
Study Design
- نوع الدراسة
- Controlled Clinical Trial
- حجم العينة
- 28
- التدخل
- Somatostatin, retinoids, melatonin, vitamin D, bromocriptine, and cyclophosphamide in advanced non-small-cell lung cancer patients with low performance status. Daily combination of somatostatin, retinoids, melatonin, vitamin D, bromocriptine, and cyclophospham
- المقارن
- Placebo
- اتجاه التأثير
- Positive
- خطر التحيز
- High
Abstract
BACKGROUND: The prognosis of low performance status (PS) patients with advanced non-small-cell-lung cancer (NSCLC) is dismal. In these patients, we have determined the survival, clinical benefits, and toxicity of a multidrug regimen, based on cyclophosphamide and biotherapeutical agents. METHODS: Patients with a diagnosis of stage IIIB or stage IV NSCLC, no previous surgery or chemoradiotherapy, and an Eastern Cooperative Oncology Group (ECOG) PS equal to or greater than 2 received a daily combination of somatostatin, retinoids, melatonin, vitamin D, bromocriptine, and cyclophosphamide. RESULTS: Twenty-eight (28) patients were enrolled. The median age was 64 years (range, 35-74). The PS was 2 and 3 in 78.6% and 21.4% of patients, respectively. The median overall survival (intent-to-treat analysis) was 12.9 months (range, 1.5-33.5 months), The overall survival rates at 1 and 2 years were 51.2% and 21.1%, respectively. The side-effects were very mild, mostly consisting of diarrhoea, nausea/vomiting, and drowsiness of grade 1-2. Most patients experienced an improvement of both respiratory (cough and dyspnoea) and general (pain, fatigue, and insomnia) symptoms. CONCLUSIONS: Low PS patients with advanced NSCLC may benefit from a combination of somatostatin, retinoids, melatonin, vitamin D, bromocriptine, and cyclophosphamide, in terms of survival and quality of life, with very low side-effects.
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