Antitumor activity of cediranib in patients with metastatic or recurrent head and neck cancer (HNC) or recurrent non-small cell lung cancer (NSCLC): An open-label exploratory study

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Abstract
6023 Background: Cediranib is an oral, highly potent and selective inhibitor of VEGF signaling, with activity versus VEGFR-1, -2 and -3. FDG-PET has previously been shown to provide early assessment of the effectiveness of anticancer treatment in solid tumors after chemotherapy. The objectives reported here were to assess the effects of cediranib on 1) tumor metabolic activity using FDG-PET (standardized uptake value, SUVmax) and 2) tumor size (RECIST longest diameter). Methods: Eligible pre-treated patients with metastatic or recurrent HNC or NSCLC received cediranib monotherapy 30 mg/day for 3 weeks, or until disease progression or unacceptable toxicity. Patients showing evidence of response (FDG-PET) or clinical benefit at day 22 could continue study treatment and were assessed on days 43 and 71 by RECIST/FDG-PET. Evaluable patients had baseline and at least one post-baseline measurement available. Results: A total of 19 patients were treated; 17 patients had baseline and day 22 FDG-PET and 18 patients had baseline and at least one post-baseline RECIST assessment. Consistent changes in FDG-PET were observed (Table). At days 22, 43 and 71, a total of 5 (29%), 7 (41%) and 6 (35%) patients had ≥25% decrease in SUVmax (FDG metabolic response), respectively. The combined (HNC/NSCLC) best mean % change in tumor size from baseline for all patients was -25.9%. Best responses of PR and SD were seen in 18.8% and 50% of HNC patients, respectively (Table). The most common adverse events were proteinuria (7 [37%]), fatigue, diarrhea and hypertension (each 6 [32%]). Conclusions: This study provided evidence of antitumor activity with cediranib monotherapy as measured by decreases in FDG uptake, reductions in tumor size and RECIST response rate. Cediranib 30 mg/day was generally well tolerated, with a manageable adverse event profile consistent with previous studies. Further studies are warranted in these tumor types. [Table: see text] [Table: see text]