Phase II trial of docetaxel and gefitinib as first-line therapy for elderly patients with advanced non-small cell lung cancer (ANSCLC)

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7342 Background: Currently chemotherapy with two cytotoxic drugs is considered standard treatment for ANSCLC. We hypothesized that doublet therapy with a cytotoxic drug (docetaxel) and an EGFRTKI (gefitinib) will yield a more favorable toxicity profile but without compromising efficacy. We report here the preliminary data from an on going phase II trial combining docetaxel and gefitinib in elderly (≥ 70 years) patients with ANSCLC. Methods: Previously untreated patients were eligible. Docetaxel was administered at a dose of 75mg/m2 on day 1. Gefitinib was administered orally daily at a dose of 250 mg starting on day 1. Treatment was repeated every 21 days. The RECIST criteria were used to measure response.Functional status was assessed using the Lawton and Brodys Instrumental Activities of Daily Living(IADL). The Cumulative Illness Rating Scale adapted to Geriatric patients (CIRS-G) was used to assess comorbidities. Results: From August 2003 to November 2003 12 patients have been enrolled on this trial. Eleven patients are assessable for toxicity and 10 patients are assessable for response. Patients characteristics are the following M/F = 9/3; Median age 74 years (range 70 to 82 years); ECOG PS 0/1= 4/8 and Stage IV/IIIB = 11/1. Preliminary response rate is 50% out of 10 evaluable patients; CR=0, PR=5(50%). SD=3 (30%), PD=2(20%). Most common treatment related non-hematologic adverse events were fatigue, rash and diarrhea all of which grade 1 or 2. Most common hematologic adverse events were grade II neutropenia and grade II anemia. Serious adverse events include 4 hospitalizations; 1 each for DVT, non-neutropenic staphylococcal pneumonia and non-neutropenic bacterial pneumonia and COPD exacerbation. No episode of febrile neutropenia has been reported to date. Three deaths have occurred so far two from progressive disease and one from bacterial pneumonia. Conclusions: Preliminary analysis suggests that the combination of docetaxel and gefitinib appears be promising with a favorable toxicity profile in a population of elderly patients with ANSCLC. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Aventis Aventis; AstraZeneca