Simplified gemcitabine and platin regimen in patients with advanced or metastatic non-small cell lung cancer (NSCLC) to be proposed as neoadjuvant therapy.

Background: Chemotherapy of non-small-cell lung cancer (NSCLC) has been improved by the use of cis-platin ( P) and the pyrimidine antimetabolite gemcitabine ( G) ( 2',2'- difluorodeoxycytidine). GP regimens currently used in Italy for NSCLC were and are mainly based on G day 1, 8 and 15; P on day 2, every 28 days ( 4 Day-Hospital admissions per cycle). However, the third G dose is frequently omitted because of myelo-toxicity, with a consistent dose decrease of both G and P in comparison with the intended dose. The 24-h lag time from 1(st) G and P has not reasonable clinical pharmacology base. Aim of the study: To have a simplified GP regimen based on two Day-Hospital admissions per cycle, with G on day 1 and 8, P after G on day 8; every 21 days, with the goal to use it in the neoadjuvant setting. Material and methods: The study was designed as a controlled, prospective, multicentre investigation, based on G ( 1500 mg/m(2)) on day 1 and 8, and P ( 100 mg/m2) on day 8 immediately following G, administered on a 3-week cycle. Quality of life (EORTC) was valuated in 46 patients out of 95 valuable patients. Restaging procedures were repeated after the 3rd and the 6th cycle. Results: Enrolled patients were 105 ( stage IV: 63: IIIB: 29; IIIA: 13). GP cycles were 488 ( 1 to 6 per patient) 95 patients had at least 3 cycles and 59 of them had further 3 cycles. Myelotoxicity >= g3 was mainly neuthropoenia, easily amenable with symptomatic and GCSF therapies ( 12.6% neuthropoenic fever); PNS toxicity occurred in 17.9% of patients. QoL was ameliorated ( P < 0.05). Therapy was tolerable and gave a Response Rate ( RR) of 52.3% after 3 cycles ( Intention-to-treat analysis) and of 57.9% in 95 valuable patients who received at least 3 therapy cycles. Conclusion: Present results confirm a good efficacy and/or synergism of G to P, with G on day 1 and 8 and P on day 8. This two day-hospital admissions regimen is at least as good as more complex GP regimens, and may be proposed in the neoadjuvant setting.