PO-074: Utilisation of Tc99m-Tilmanocept to Assess Sentinel Lymph Node Status in HNSCC Patients

4th ICHNO instruments help surgeons in improving surgical accuracy and post-operative parametres in conservative surgery, however we suggest to use cold instruments for the resection of the glottic plane and the crico-thyroid memebrane in order to avoid possible surgical artifacts liked to thermal damage. PO-073 LOW DOSE FRACTIONATED RADIOTHERAPY IN ASSOCIATION TO INDUCTION CHEMOTHERAPY IN LOCALLY ADVANCED H&N CANCER N. Dinapoli1, R. Autorino1, G.C. Mattiucci1, M. Balducci1, M. Rigante2, J. Galli2, F. Bussu2, V. Valentini1, G. Paludetti2, F. Miccichè1 1 Università Cattolica del Sacro Cuore, Radiation Oncology Department, Rome, Italy 2 Università Cattolica del Sacro Cuore, Otorhinolaryngoiatry, Rome, Italy Purpose/Objective: To analyze the efficacy and the feasibility of induction chemotherapy (ICT) with low-dose fractionated radiotherapy (LDR) compared to ICT alone prior to chemoradiation (CRT) in locally advanced head and neck squamous cell carcinoma. Materials and Methods: Between September 2008 and November 2011, 59 patients, with locally advanced stage III and IV squamous cell carcinoma of head & neck cancer, received three courses of induction chemotherapy with docetaxel (75 mg/mq), cisplatin (75 mg/mq) and 5fluoruracil (750 mg/mq/day on days 1-5) followed by radiotherapy plus two or three cycles of concurrent cisplatin 100 mg/mq (Group A). Twenty-nine of this patients received low dose fractionated radiotherapy concomitantly to induction chemotherapy (Group B). Treatment courses, hematological data and other parameters were also investigated. Results: Three cycles of ICT were administered in all patients: only one (Group B) received two cycle because of high hematological toxicity. After neoadjuvant therapy completation, clinical tumor response was observed in 49 patients (83%); patients undergone low dose radiotherapy showed better complete remission (p=0.08). Grade > 3 toxicity with dose reduction occurred in 5 patients (8%). Median time from the final cycle of TPF to starting radiotherapy was 21 days. All patients received radical radiotherapy; one, two and three cycles of concurrent cisplatin was delivered in 0 (0.0%), 17 (58.6%), 10 (41.4%) patients of Group A and 1 (3.5%), 28 (96.5%), 0 (0.0%) patients of Group B, respectively. With a median follow-up of 23.5 months (range 2-47), one-year local control was 62% and 82% for Group A and Group B, respectively (p=0.05). No difference was observed in terms of overall survival and disease free-survival between the two groups (p=0.9 and 0.8). Toxicity during chemo-radiation was acceptable in both groups without difference, specially, in terms of hematological toxicity (p=0.76). We found a correlation between hematological toxicity > G3 and local control (p=0.03). Conclusions: Low dose fractionated radiotherapy in association with ICT prior to CRT is tolerable, with encouraging efficacy in terms of response and local control, in locally advanced head and neck squamous cell carcinoma. Further investigation is warrented to confirm these data. PO-074 UTILISATION OF TC99M-TILMANOCEPT TO ASSESS SENTINEL LYMPH NODE STATUS IN HNSCC PATIENTS S.Y. Lai1, A. Agrawal2, F.J. Civantos3 1 University of Texas MD Anderson Cancer Center, Head and Neck Surgery, Houston TX, USA 2 Ohio State University, Head and Neck Surgery, Columbus OH, USA 3 University of Miami, Head and Neck Surgery, Miami FL, USA

S31 Purpose/Objective: A phase 3, prospective, multiinstitutional, open-label, single arm trial is ongoing to assess the utility and accuracy of Tc99m-tilmanocept (TCPT) for the intraoperative identification of sentinel lymph nodes (SLNs) in patients (pts) with confirmed cutaneous and intraoral head and neck squamous cell carcinoma (HNSCC). The results from three clinical sites were pooled for preliminary evaluation. Materials and Methods: Pts were enrolled with a diagnosis of cutaneous or intraoral HNSCC (T1-T4, N0, and M0). The primary objective was to determine the false negative rate (FNR) associated with TCPT-identified SLNs relative to the pathological status of non-SLNs (NSLNSs) in the elective neck dissection (END). Secondary measures of efficacy included diagnostic performance and rates of SLN detection. Pt safety was evaluated through observation of adverse events, clinical laboratory tests, vital signs, electrocardiograms and physical examinations. Results: A total of 46 pts (76% male, 24% female) have been injected with TCPT and completed surgery at three clinical sites. 43 pts had an intraoral primary tumor and 3 pts had a cutaneous tumor. There were 16 T1 lesions (35%), 25 T2 (54%), 3 T3 (7%), and 2 T4 (4%); with 41% (19/46) of pts being positive for pathology after central processing. TCPT localized in 96% (44/46) of pts. 4.7 SLNs and 27.1 NSLNs for pathology positive pts vs. 3.3 SLNs and 36.2 NSLNs for pathology negative pts with TCPT. A total of 182 SLNs (38 level I, 74 level II, 45 level III, 17 level IV, 7 level V, and 3 parotid) were identified intraoperatively and excised (0-11 SLNs /pt, median 4, average 5.0). A total of 1492 END nodes were excised (7-72 NSLNs /pt, median 30, average 32.4). All intraoperative TCPT findings were predictive of the END findings and led to correct pt staging. The overall negative predictive value (NPV) for TCPT was 1.00. TCPT demonstrated that SLN status was highly predictive and consistent with the status of the neck for clinical stage (T1T4) and tumor location (tongue: 58%, floor of mouth: 18%, and other: 26%). There was no difference between same (22/46, 48%) and next day (24/46, 52%) surgery relative to timing of TCPT injection. TCPT had a 0% FNR overall (zero false negatives of 19 known positives). Conclusions: This preliminary evaluation at three clinical study centers demonstrates the utility, predictive value, and safety of Tc99m-tilmanocept. In 46 patients, SLNs were predictive of NSLN pathology status. With a 0% FNR and a NPV of 1.00, Tc99m-tilmanocept accurately identifies SLNs and is likely to be predictive of occult pathological status. These findings demonstrate the ability of Tc99m-tilmanocept to identify those lymph nodes, which have the highest probability of containing tumor metastases, while potentially decreasing surgical morbidity.

POSTER: MOLECULAR TARGETED THERAPIES PO-075 THE EXTREME REGIMEN FOR RECURRENT/METASTATIC HNSCC: TREATMENT OUTCOME IN A SINGLE INSTITUTION COHORT C.D. Lynggaard1, C.A. Kristensen1, M.H. Therkildsen2, L. Specht1 1 The Finsen Center - Rigshospitalet, Department of Oncology, Copenhagen, Denmark 2 Rigshospitalet, Department of Pathology, Copenhagen, Denmark Purpose/Objective: The results of the phase III EXTREME trial showed that the combination of 5– Fluorouacil (5- FU), cisplatin and cetuximab significantly prolonged median progression free survival from 3.3 months to 5.6 and overall median survival from 7.4 months to 10.1 months of patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC). The efficacy and toxicity of the