A Phase Ii Study Of Docetaxel Plus Irinotecan (Dociri) In Chemo-Naive Patients With Non Small Cell Lung Cancer (Nsclc).

7267 Background: To evaluate the efficacy and tolerance of the docetaxel and irinotecan (DOCIRI) combination in chemo-naïve patients with advanced/metastatic NSCLC. Methods: Patients with histologically or cytologically confirmed NSCLC stage IIIB (pleural effusion or supraclavicular lymphadenopathy) and IV, with PS (WHO) 0–2, and measurable disease, were treated with irinotecan (200mg/m2) followed by docetaxel (80mg/m2) on day 1 every 3 weeks and G-CSF (150μg/m2) support (d2-d9). Results: Thirty-nine patients (IIIB n=12; IV n=27) with PS 0 (n=23), 1 (n=15) and 2 (n=1) were enrolled. A total of 173 cycles were administered (median 5cy/pt; range 1–9). Grade 3/4 neutropenia occurred in 4 pts (10%) and febrile neutropenia in 3 (8%). Grade 3/4 diarrhea occurred in 2% of the pts and grade 3/4 myalgias in 6%. Partial response (PR) was achieved (intention-to-treat) in 9 (23%) pts (95% c.i. 9.85–36.30%). Stable (SD) and progressive (PD) disease occurred in 10 (26%) and 20 (52%) pts, respectively. The median time to tumor progression was 3.0 months (range, 1–22.9) and the median survival 10.8 months (range 1.4–22.9). The 1-year survival was 42.3%.Conclusions: The combination DOCIRI is an active and well tolerated front-line chemotherapy regimen for patients with advanced/metastatic NSCLC. No significant financial relationships to disclose.