Gemcitabine in Brief versus Prolonged Low-Dose Infusion, both Combined with Cisplatin, for Advanced Non-small Cell Lung Cancer: A Randomized Phase II Clinical Trial

摘要: Objective Gemcitabine in low dose prolonged infusion is a treatment with documented activity against variety of tumors. We here report the first randomized trial to compare standard brief and low-dose gemcitabine. Patients Methods Eligible patients had non-small cell lung cancer stage IIIB (wet) or IV, Karnofsky performance status 100 70 (Eastern Cooperative Oncology Group 0–2), measurable disease, were chemonaive fulfilled criteria for chemotherapy. In arm A (standard treatment), gemcitabine was given at 1250 mg/m 2 20 30 minutes B (prolonged infusion) 250 6 hours infusion. All received on days 1 8 cisplatin 75 day 3-week cycle four cycles, followed by two cycles as monotherapy. Results total 249 (188 men 61 women, median age 58 years) between (125 patients) (124 patients). Adenocarcinoma (53.9%) predominant histologic type; 92% IV. The groups balanced prognostic factors; however, group fewer significant weight loss no patient second malignancy after radiotherapy brain metastases. Grade 3 greater toxicity rare: anemia 0.8 3.2%, neutropenia 21.6 22.6%, thrombocytopenia 0 1.6%, nausea/vomiting 4 8.1% arms B, respectively. Alopecia seen 54.5% compared 9.7% A. No died treatment-related toxicity. During 5, 47.7% 60.7% reported improved well-being, before complete remission, 32.8% partial responses, 48% minimal responses stable 13.6% progressions, 5.6% not evaluable. For corresponding figures are follows: remission 0.8%, 46% (for overall response rate 46.8%), disease 36.3%, progression 12.1%, evaluable 4.8%. Median progression-free survival 5.5 6.0 months, 10.1 10.0 1-year 46.6 41.1% 71 squamous carcinoma, seems superior A, higher (51.3 versus 35.5%), longer (6.2 4.9 months), (11.3 8.5 months). However, because small number patients, these differences did reach level statistical significance. Conclusion advanced cancer, combination has comparable Low-dose may be preferred incurable among economically deprivileged patients. addition, apparent carcinoma opens new perspectives deserves further research.