Risultati di uno studio combinato di fase II sul microcitoma polmonare

In two years 62 patients (pts) have been recruited for a phase II study: 57/62 were evaluable since they were affected by pulmonary small cell lung cancer (SGLC). They ware characterized as follows: males (M)/females (F) 44/13. 23 with limited disease (LD), 34 with extended disease (ED). The therapeutic program consisted in induction chemotherapy (phase "A") with 4-iphosphamide 2.5 g/m² + epirubicin 30 mg/m² (ist o 3rd day every 21 days, 4 cycles) and in the consolidation chemotherapy (phase "B") with carboplatinum 300 mg/m² (1st day) + VP-16 120 mg/m2 (1 st to 3 rd day every 21 days, 4 cycles). The LD pts responding after phase "A" have been submitted to thoracic radiotherapy /(RT) 40 Gy concomitant to phase "B". The LD pts completely responding (RC) after the therapeutic program have been submitted to prophylactic panencephalic irradiation (30 Gy). After the phase "A", 75% objective responses (RO) have been recorded (20% RC, 55% partial responses= RP). The responses were independent from the disease extension (p>0.05) and a significant increase of response has been observed in the passage from phase "A" to phase "B" therapy (p=0.039). The mean survival time was 13.5 months (LD vs ED = 15 vs 10 months, p=0.08), with a mean progression time of 6 months (LD vs ED= 7 vs 5 months, p=0.023). This scheme has been shown useful and effective in the therapy of SCLC. Its limitation is due to the fact that two non cross-resistant associated to concomitant RT schedules do not relevantly improve the overall survival. The results are in the range of those obtained by the most credited therapy schemes reported by the international literature.