Early switch to a docetaxel-cisplatin (DP) doublet allows higher conversion to response for patients (pts) with advanced NSCLC in stable disease (SD) after 2 courses of gemcitabine-cisplatin (GP): Preliminary results of a pilot study.

7276 Background: For non-responding pts, no more than 4 courses of a platinum doublet are currently recommended (Pfister et al. JCO 04). Better results might be achieved using different approaches for specific pt subsets (i.e. elderly, PS 2). Based on both the low rate of conversion to response expected continuing the same chemotherapy for pts in SD after 2 courses of GP and the potential hazard of an early discontinuation of P (Novello, ASCO 04 abs. 7069), the present study was designed.,To evaluate the impact of an early switch of P-doublets in pts with advanced NSCLC showing a SD after 2 courses of GP (G 1250 mg/m2 days 1+8, P 75 mg/m2 day 2), 16 eligible pts were switched to ≥2 courses of DP (D 75 mg/m2 and P 75 mg/m2 both on day 1, with CSF primary prophylaxis). Main characteristics were: Age (median): 68 yrs (54-78); M/F: 13/3; ECOG-PS 0/1-2: 4/12; Stage IIIB/IV: 3/10; Histology adeno/others: 7/9.,After 2 courses of DP, 5/16 pts (31%) were converted to a PR, 6 remained in SD and 5 progressed. After the 4th course, an additional conversion was seen, for an overall response of 37% (6/16). Median PFS and survival were 6 and 13 mos., respectively. The 1-yr survival was 52%. Main toxicity (G3/4) with sequential DP was greater than with GP, including (% of pts): neutropenia 14% (with no febrile event), anemia and stomatitis 6%, G1-2 asthenia 50%, G1 fluid retention 6%. Dose reductions were required in 32% of courses (18/55).,These preliminary results suggest that for pts in SD after 2 courses of chemotherapy this approach is feasible, allowing a promising improvement of response with a conversion rate (37%) greater than expected maintaining the same regimen according to the Novello's phase III trial (6%). Outcome data also compare favourably with those expected for pts in SD (12 mos.; Hoang WCLC 2003 abs O-274). Although the 2 step of the trial design continues to the target sample, these preliminary findings may generate hypothesis to be tested in larger randomized trials. (partly supported by AMAN-onlus) [Table: see text].