Somatostatin, retinoids, melatonin, vitamin D, bromocriptine, and cyclophosphamide in advanced non-small-cell lung cancer patients with low performance status.
अध्ययन डिज़ाइन
- अध्ययन प्रकार
- Controlled Clinical Trial
- नमूना आकार
- 28
- जनसंख्या
- Patients with stage IIIB/IV NSCLC, ECOG PS ≥2, no prior surgery or chemoradiotherapy; median age 64 years
- हस्तक्षेप
- 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
- तुलनित्र
- no comparator (single-arm)
- प्राथमिक परिणाम
- Overall survival, clinical benefit, toxicity
- प्रभाव की दिशा
- Positive
- पूर्वाग्रह का जोखिम
- High
सारांश
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.
संक्षेप में
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.