Monthly gemcitabine (days 1, 8 and 15) plus cisplatin (days 1-3) in advanced non-small cell lung cancer: A phase II study

On the basis of the reported efficacy of gemcitabine plus cisplatin in patients with non-small cell lung cancer (NSCLC), this combination has been selected to be given as our first-line service regimen for advanced or metastatic disease. Patients recruitment was almost unlimited: no exclusion criteria were made, except for disease-related Karnofsky's performance status below 50%, the presence of central nervous system or spinal involvement by uncontrolled metastases, or creatinine clearance below 50 ml/min. Cisplatin 30 mg/m²/day on days 1-3 and gemcitabine 1250 mg/m²/day on days 1, 8 and 15 every 4 weeks were given on an outpatient schedule to consecutive patients with locally advanced or metastatic NSCLC. Forty-three successive NSCLC patients with histologically or cytologically proven disease were treated. Adenocarcinoma was diagnosed in 35% of cases, squamous cell carcinoma in 60% and broncho-alveolar type in 5%. Smoking was mentioned by 63% of the patients. Numerous medical problems were recorded in 75% of the patients. Stage IIIB was observed in 10 of 43 patients, while metastatic disease was found in the rest. All the patients, except for two, were symptomatic. Two patients achieved complete response (5%) and 16 achieved partial response (37%), yielding an overall objective response rate of 42%. Minimal response was observed in seven patients (16%) and disease stabilization in 7%. Adding the objective response rate to the minimal response and stabilization rates, the disease-control (progression-free) rate reaches 65%. The time to progression ranged from 0 to 69 weeks in all the patients. The overall survival of the group ranged from 4 to 98 weeks, with a median of 45 weeks. Clinical benefit response was observed mainly in patients who also achieved an objective response. We conclude that outpatient cisplatin plus gemcitabine combination is feasible, efficacious and justified in patients with advanced or metastatic NSCLC. (C) 2000 Lippincott Williams and Wilkins.