Simplified gemcitabine and platin regimen for NSCLC to be used in the neoadjuvant setting

Abstract

17155 Background: Platin (P) salts and Gemcitabine (G) are used for NSCLC. GP regimens frequently included G on day 1, 8 and 15; P on day 2; every 28 days. However, the third G dose often is omitted because of myelo-toxicity, with a consistent no respect of the intended drugs’ doses. We devised a simplified regimen, based on two Day-Hospital admissions per cycle (c), with G on day 1 and 8; P after G on day 8; every 21 days. Aim of study: a high RR within the first 3 c.s for a GP regimen for neoadjuvant therapy. Methods: This prospective, multi-centre investigation included G (1500 mg/m2) on day 1 and 8, and P (100 mg/m2) on day 8 immediately following G, on a 3-weeks-c. Eligible criteria: age 18 to 75 years, NSCLC histologically, no previous chemotherapy, KPS 50%, WBC ≥ 4.0 × 109/L, platelet ≥100 × 109/L and normal kidney-liver function. QoL evaluation: 46 out of 95 valuable patients. Restaging procedures: repeated 3 and 6 c.s. Results: Out of 105 patients, 95 had at least 3 c.s and 59 of them had further 3 c.s. Myelo-toxicity ≥ G3 was mainly neuthropoenia, easily amenable with symptomatic and GCSF therapies; PNS toxicity occurred in 17.9% of patients. QoL was ameliorated (p < 0.05). Therapy was tolerable; gave RR was 52.3% after 3 c.s (Intention-to-treat analysis) and 57.9% in 95 valuable patients after at least 3 therapy c.s. In the 95 valuable patients over the first 42 days, i.e. after 2 c.s and just before the third c., 10 c.s out of 190 were delayed by one week, with a dose intensity reduction of 5.29%. Conclusions: This two Day-Hospital admissions regimen is at least as good as more complex GP regimens, with an appreciable RR after 3c.s; it may be proponed in the neoadjuvant setting. Acknowledgments: Present work was part of studies program of, and partly supported by, AOI (Associazione Oncologia Italiana, Padova, Italy). No significant financial relationships to disclose.