A phase II trial of cetuximab as therapy for recurrent non-small cell lung cancer (NSCLC): Final results

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Abstract
7036 Background: A phase II trial was conducted to evaluate the activity of single agent cetuximab in patients (pts) with recurrent NSCLC. Preliminary data was previously reported (Lynch, et al, abstract 7084, ASCO 2004). Methods: Pts with stage IIIB/IV NSCLC with recurrent or metastatic disease following ≥1 prior regimen, including a prior platinum, were enrolled on the study. Pts had an ECOG PS of 0 or 1 and were stratified based on the presence or absence of the EGF receptor. The EGFR undetectable pt strata was closed due to lack of available pts. Pts received an initial cetuximab dose of 400 mg/m2 on Day 1 of Cycle 1, followed by weekly doses of 250 mg/m2 until disease progression or unacceptable toxicity. A cycle was defined as 4 weeks. Response rate (RR) was determined for the total population. Pts were also assessed for time to disease progression (TTP), survival, and safety. Results: Between May 2003 and March 2004, 66 pts were enrolled: male/female 42/24; median age of 63 years (range, 39–79); EGFR detectable 60; ECOG 0/1 28/37; stage IIIB/IV 10/56. Histology included adenocarcinoma 36; squamous cell 14; large cell 6; and other 10. Smoking history included 13 pts who had never smoked, 45 prior smokers and 8 current smokers, with a median of 45 pack years. Number of prior regimens: 1 (28); 2 (26); 3 (9); >3 (3). The median number of cycles of cetuximab received was 2 (range 1–14). Responses in the 60 evaluable pts included PR 2; SD 15; PD 36; for an overall RR of 3.3% (95% CI 0.41–11.53%) and a disease control rate of 28%. The median TTP was 2.3 months and median survival was 8.1 months. The 6 month survival rate was 63% and the 1-yr survival was 43%. Of the 66 pts enrolled, 33 remain alive. The most commonly reported toxicity was rash 77% (Gr.3 6.1%). Grade 3/4 toxicities included dyspnea 15%, fatigue 13.6%, infections 9%, gastrointestinal 6%, back pain 4.5%, HSRs 3%, and pleural effusions 3%. Mutational analysis was performed on 39/43 available samples. Three pts were found to have mutations (2 del746–750 (both SD) and 1 L861Q (PD). Conclusions: Single agent Cetuximab is well tolerated and its role in the treatment of NSCLC along with chemotherapy is under investigation. The relationship between EGFR mutations and response to cetuximab remains unclear.

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