Abstract
5547 Background: EGFR is expressed in 70% of salivary gland carcinomas (SGC). Investigations of anti EGFR treatment seems rational. Aim: To assess activity of C225 in patients with RMSGCs in terms of clinical benefit (CB), defined as occurrence of objective response (CR or PR) or stable disease (SD) for at least 6 months. To correlate treatment outcome with skin toxicity degree and EGFR analysis. Methods: One prior chemotherapy regimen was allowed, except for pts with adenoid cystic carcinoma (ACC) and acinic cell carcinoma for whom 2 lines were allowed. Prior exposure to targeted treatment was not allowed. C225 (Erbitux) was administered iv weekly at 400 mg/mq followed by 250 mg/mq until disease progression, major toxicity or voluntary discontinuation. MRI or CT and PET scan were performed every 6 weeks q4, and q12 thereafter. RECIST response criteria and CTC 3.0. were adopted. Results: From April to December 2005, 30 RMSGCs pts (20 F/10 M; median age 50 yrs), 50% with major SGC, were enrolled. Histotypes were: 23 ACC; 2 mucoepidermoid; 3 myoephitelial; 1 cystadenocarcinoma and 1 acinic cell carcinoma. Thirteen pts (43%) received prior chemotherapy. Localregional (LR) and metastatic (M) disease was present in 13 cases, M in 12, and LR in 5. A median number of 11 drug administration (range 2–31) was given. G2 skin toxicity was recorded in 24 cases. G2 fatigue in 2. At a median FU of 6 months (range 0–8), 2 pts died of PD. Of 22 pts evaluable for response with ≥ 3 months of potential FU, there were 11 SD, 9 PD, while 2 pts refused to continue after 1 months. Currently, 7 of these pts are progression-free at ≥ than 6 months, qualifying for CB definition according to study protocol. Preliminary EGFR analysis showed a high or intermediate expression score in 5 (3 ACC, 1 acinic cell, 1 cistoadenocarcinoma) out of 7 cases, no gene amplification nor chromosome 7 polisomy were found in 3 of 3 analysed ACC. PET results are under evaluation. Conclusions: Hints of activity of C225 in RMSGCs were observed. The early analysis for the CB rate in 23 pts is planned for April 2006, when all of them will have a potential follow-up of ≥ 6 months, and results thereof will be reported. [Table: see text]
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