© 2006 European Society for Medical Oncology
symposium article |
Simplified gemcitabine and platin regimen in patients with advanced or metastatic non-small cell lung cancer (NSCLC) to be proposed as neoadjuvant therapy
1 Medical Oncology, 1st floor IOV-IRCCS, Padova; 2 Oncology Units of Udine, 3 Aviano (PN), and 4 Latisana (UD) Hospitals, 5 Division of Chest Disease, Padua Hospital, Italy
Correspondence to: Prof. G. Cartei, UOC Medicine Oncology 1st floor, National Cancer Institute of Veneto, IOV-IRCCS, Busonera Hospital, Via Gattamelata 64, 35128 Padova (PD), Italy. Tel: +39-0498215900; Fax: +39-0498215902; E-mail: giuseppe.cartei{at}unipd.it
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 1st 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/m2) 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.