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The standard first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma is cisplatin-based chemotherapy, but taxanes can also be beneficial after progression or in patients not eligible for cisplatin. The objective of this retrospective study was to evaluate paclitaxel in this population. We reviewed 66 patients who were treated with paclitaxel at a single institution (Lyon, France) between January 2003 and November 2008. Paclitaxel was administered as first, second or more line of treatment; alone or in combination with carboplatin or cetuximab; every 3 weeks (175 mg/m(2)) or weekly (80 mg/m(2)). Forty-six (70%) patients received paclitaxel as first-line therapy after relapse and 26 (39%) patients as monotherapy. The objective response rate was 30% [95% confidence interval (CI): 20-43%]; 37% (95% CI: 23-52%) in the first line after relapse, and 20% (95% CI: 4-48%) in the second line. Rates were 19% (95% CI: 7-39%) after monotherapy and 36% (95% CI: 20-55%) after combination with carboplatin. Two of the six patients receiving cetuximab had a partial response. The overall survival of all patients was 7.2 months (95% CI: 5.2-8.8). Paclitaxel can be used in symptomatic patients. Although no improvement of overall survival can be expected, paclitaxel treatment is safe and achieves interesting response rates.

6021 Background: Afatinib, a pan-HER irreversible tyrosine kinase inhibitor, demonstrated limited antitumor activity compared to methotrexate in unselected recurrent and/or metastatic HNSCC patients (LUX-HN1, Machiels et al, Lancet Oncol 2015). The UNICANCER (GEP 11) PREDICTOR study’s objective was to identify predictive and pharmacodynamic biomarkers of biological activity and efficacy of afatinib (EUDRACT N° 2010-024046-29). Methods: This open-label, randomized, multicentric, controlled, phase II study included untreated patients with operable T2-4N0-2M0 HNSCC of the oral cavity, pharynx and larynx, with a PS < 2, adequate organ function and LVEF > 50%. Patients were randomized (2:1) to: oral afatinib (A) 40mg/day (d) for 14-28d or no treatment (NT). Patients had pre-treatment tumor biopsies, tumor imaging, and PET CT scan, with a 2nd tumor imaging before surgery and a PET scan at D15. Adverse events were classified by NCI CTCAE criteria. Based on the biological primary endpoint of tumor reduction the sample size was designed to identify biomarkers associated with a 20% difference between the study arms. Results: 61 patients were included (A: 41/NT: 20). 2 patients in the NT arm were not analyzed (consent withdrawal, no surgery). 7 patients in arm A received < 14d of treatment, including 6 patients with unacceptable toxicity. Afatinib-related toxicities were: grade (G)1 37%, G2 41%, G3 7%, G4 5%, and G5 0%. G≥3 toxicities were mainly gastrointestinal. Partial responses (RECIST1.1) were observed in 3 patients (7.3%) in arm A versus none in the NT arm (p = 0.018). Progressive disease was not observed in arm A versus 3 (16.6%) in the NT arm. Partial responses on PET CT scan by PERCIST were observed in 15/31 evaluable patients (48%) in arm A versus 1/15 (6.7%) in the NT arm (p = 0.005). Conclusions: Afatinib given to HNSCC patients in the preoperative setting is safe and is associated with improved response according to RECIST1.1 and PERCIST compared to no treatment. Clinical trial information: NCT01415674.

Background. In external radiotherapy, the use ofleaded intraoral devices to shield adjacent tissues is welldescribed, but stabilization of the mandible is often realizedwith standard bite blocks, which do not allow a good stabiliza-tion of the mandible.Methods and Results. A 40-year-old patient presentingwith a local recurrence of a tumor of the floor of the mouthunderwent external radiotherapy. To shield the maxilla duringmandibular irradiation and to ensure mandible and tongueimmobility during external radiotherapy, a custom-made devicewas realized. The apparatus consists of a polymethylmethacry-late resin plate and 2 wedges. Only 2 steps are needed.Conclusion. The realization is simple and cheap, the appa-ratus is comfortable, and modifications are easy. It can beused in all patients, except in patients with totally mandibularedentulous with severe bone resorption. VV C 2009 WileyPeriodicals, Inc. Head Neck 31: 1528–1530, 2009Keywords: external radiotherapy; maxilla; reproducibility;tongue-shielding; spacer

International audience; Background: The combination platinum, 5-fluorouracil (5-FU) and cetuximab is the standard first-line regimen of recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC). Due to the toxicity of this treatment, alternative therapies are often offered to patients. The aim of this study was to evaluate the overall survival obtained with a first line chemotherapy adapted to patients functional status and the administration of all active drugs within successive lines of chemotherapy.Methods: This series included a total of 194 patients with recurrent and/or metastatic HNSCC treated from 2006 to 2011 in a single institution where the administration of successive lines of chemotherapies has been the standard clinical approach. Treatment was administered according to clinical practice guidelines.Results: Most patients received at least two treatment lines. Only 11 patients (6%) were treated with a combination of cisplatin, 5-FU and cetuximab in front line, but most patients received at least one platinum-based regimen (n = 154 patients, 78%); 162 (82%) received taxanes, 36 (18%) received 5-FU, 27 (14%) received capecitabine, 67 (34%) received methotrexate and 134 (68%) received cetuximab. The median overall survival was 9.8 months (95% CI: 8.1-11.4 months) and reached 13.1 months among the subgroup of 131 patients eligible for inclusion in a clinical trial.Conclusion: The survival outcomes of patients treated in the first-line setting with chemotherapy regimens adapted to their functional status, followed by several subsequent regimens were comparable with published outcomes of patients treated by platinum, 5-FU and cetuximab.

No specific study has evaluated the role of neoadjuvant DCF (docetaxel, cisplatin, 5-fluorouracil) followed by radiotherapy in pyriform sinus cancer, which are often included in studies focusing on laryngeal and hypopharyngeal cancer. We assessed the proportion of patients treated sequentially for a pyriform sinus cancer with a preserved larynx. Overall survival, event-free survival (EFS), survival with 'local control', and treatment tolerance were assessed as well. We retrospectively reviewed 88 patients with advanced pyriform sinus squamous cell carcinoma treated with DCF between 2005 and 2010. After induction, radiation could be potentiated with cetuximab or cisplatin. Most patients (82%) had been treated with organ preservation intent. The response rate to DCF was 85%, including 42% with complete response. Primary tumor was operated in 13 patients (eight with total laryngectomy). Radiotherapy had been delivered to 78 (89%) patients (30 with cisplatin, 39 with cetuximab). Potentiation had been achieved as planned in 52 and 79% of patients treated with cisplatin and cetuximab, respectively. Twenty-three local and three neck recurrences were found. Median overall survival was 16.8 months and 38.3% at 3 years. EFS at 3 years was 29.1% with a hazard ratio for partial responders versus nonresponders of 0.18 (P

Neoadjuvant TPF (docetaxel, cisplatin, 5-fluorouracil), followed by radiotherapy or chemoradiotherapy with weekly carboplatin, increases overall survival and organ preservation. We assessed whether TPF could be used in routine practice and whether radiotherapy potentiated with cisplatin or cetuximab was feasible and could increase survival. We retrospectively reviewed 157 patients with advanced head and neck squamous cell carcinoma treated with TPF in four French institutions between May 2005 and March 2009. After induction, operable patients had undergone surgery and were irradiated, and potentiated in some cases with cetuximab or cisplatin. Most patients (79%) had been treated with organ preservation strategies. The two most common sites were the hypopharynx (34%) and the oropharynx (30%). The response rate to TPF was 84%, including 26% with a complete response. Radiotherapy had been provided to 144 (92%) patients (of whom 17 had received radiotherapy alone, 46 had received q3w cisplatin, 30 had received q1w cisplatin, and 37 had received cetuximab). Potentiation had been achieved as planned in 59, 63, and 62% of patients treated with q3w cisplatin, q1w cisplatin, and cetuximab, respectively. After a median follow-up of 39.9 months, the median overall survival was 43 months. No significant difference was observed in progression-free survival or overall survival according to the type of potentiation. This study confirms the efficacy and tolerability of TPF induction, followed by chemoradiation, with outcomes similar to those for patients irradiated without induction. The best potentiation of radiotherapy after induction has not yet been determined.

UNLABELLED The objective of this study was to evaluate the efficacy and tolerability of capecitabine as a single agent in the treatment of recurrent/metastatic head and neck squamous cell carcinoma. Patients were treated with oral capecitabine according to good clinical practice. Efficacy and safety outcomes were analyzed retrospectively. The response and adverse events rates and their exact confidence intervals (CIs) were calculated. Survival distributions were estimated using the Kaplan-Meier method. Twenty-nine patients were included in the study. Twenty-five patients (86%) had received at least three previous lines of chemotherapy. The disease control rate was 48% (95% CI: 29-67%). The median progression-free survival was 2.0 months (95% CI: 0.1-3.9 months) and the median overall survival was 7.0 months (95% CI: 4.1-9.9 months). Hand-foot syndrome, fatigue, and mucositis were the most frequent severe side effects. No patient died, and only three patients discontinued treatment because of side effects. Capecitabine seems to be an active and well-tolerated regimen, even in heavily pretreated, frail patients. LEVEL OF EVIDENCE 2C 'Outcomes Research'.

The addition of cetuximab (CTX) to the combination of cisplatin and 5-fluorouracil increases the overall survival (OS) in recurrent/metastatic head and neck squamous cell carcinoma. Only a few patients are eligible for this treatment because of its toxicity. The combination of CTX and paclitaxel (TXL) could be included in sequential treatment strategies. Patients were treated with CTX (400/250 mg/m) and TXL (60-80 mg/m) weekly until disease progression or unacceptable toxicity. Efficacy and safety outcomes were determined retrospectively. A total of 42 patients were included in this analysis. The overall response rate was 38% [95% confidence interval (CI); 23-53%]. The disease control rate with TXL and CTX combination was 74%. Seven (17%) patients progressed before the first evaluation. The median progression-free survival was 3.9 months [95% CI; 3.1-4.7 months] and the median OS was 7.6 months [95% CI; 5.3-9.9 months]. Neurotoxicity and skin rash were the most frequent grade≥2 toxicities, reported in 17 and 12% of patients, respectively. Previous chemotherapy seems to be associated with a lower response rate and progression-free survival but not with the OS. The combination of CTX and TXL was an active and well-tolerated treatment in this series of patients with a poor prognosis and who were mostly symptomatic.

Jérôme Fayette,1 Yann Molin,1 Emilie Lavergne,2 Xavier Montbarbon,3 Séverine Racadot,3 Marc Poupart,4 Antoine Ramade,5 Philippe Zrounba,6 Philippe Ceruse,7 Pascal Pommier31Department of Medicine, 2Biostatistics Unit, 3Department of Radiotherapy, Centre Léon Bérard, University of Lyon, 4Department of Surgery, Hôpital Croix-Rousse, 5Department of Surgery, Hôpital Edouard Herriot, 6Department of Surgery, Centre Léon Bérard, University of Lyon, Lyon, France; 7Department of Surgery, Centre Hospitalier Lyon-Sud, Université de Lyon, Pierre-Bénite, FranceBackground: Despite its toxicity, cisplatin every 3 weeks (q3w) is the standard potentiation of chemo-radiotherapy for head and neck squamous cell carcinoma. This study aimed to determine whether weekly cisplatin (q1w) could be a safe and effective alternative.Patients and methods: Two hundred and sixty-two patients with head and neck squamous cell carcinoma, irradiated in our institution with cisplatin (q1w or q3w) between January 2004 and December 2008, were retrospectively included. Overall survival (OS) and progression-free survival (PFS) were evaluated. Survival distributions were estimated by Kaplan–Meier method and compared using the log-rank test. Prognostic effect of chemo-radiotherapy was explored using Cox model.Results:A total of 165 and 97 patients received q1w and q3w cisplatin, respectively. Median age, stage at diagnosis, alcohol consumption, intensity-modulated radiation therapyuse, median weight, and renal failure before radiotherapy were significantly different, showing lower risk in the q3w group. Q3w cisplatin was found to be more toxic in terms of weight loss, renal failure, worse chemotherapy plan completion, and grade 3/4 mucositis and dermatitis, with more patients requiring analgesics, secondary hospitalization, and radiotherapy interruption (≥3 days), and patients affected by long-term toxicities. With a median follow-up of 73 months (95% confidence interval [CI] [68.9–76.2]), OS was found to be significantly better with q3w (5 years OS: 62.3%; 95% CI [51.6–71.3]) than with q1w cisplatin (5 years OS: 52.6%; 95% CI [44.5–60.0]) (log-rank P=0.0146). More number of patients treated according to the q1w schedule experienced a recurrence: 47.3% vs 30.9% (P=0.009). Thus, the PFS for q3w schedule was found to be globally better (5 years PFS: 55.8%; 95% CI [45.0–65.3]) than for q1w schedule (5 years PFS: 43.6%; 95% CI [35.9–51.0]) (log-rank P=0.0161). However, both multivariate analyses, OS and PFS, produce no significant hazard ratio for chemo-radiotherapy modality once adjusted on unbalanced covariates according to the descriptive analysis.Conclusion: Though q1w seemed to be safer than q3w according to the descriptive analysis, multivariate analyses failed to conclude about its efficiency. Therefore, we conclude that the q3w schedule should remain the standard and prospective comparisons are needed. Keywords: head and neck cancer, radiotherapy potentiation, chemoradiation, cisplatin

Purpose: To evaluate the role of interstitial brachytherapy as an exclusive radiotherapy modality for primary T1-T2 squamous cell carcinomas (SCC) of the velotonsillar area. Methods and Materials: Between 1992 and 2000, 44 patients with T1-T2 SCC of the tonsil (n = 36) and soft palate (n = 8) were treated to the primary with brachytherapy alone (37 patients) or after a limited resection (7 patients). Eight patients had prior external beam radiation therapy (EBRT) for previous head-and-neck carcinoma. Nineteen patients had initial neck dissection. The mean brachytherapy dose was 58.7 Gy, and the mean reference dose rate and Ir-192 linear activity were 58.2 cGy/h and 1.51 mCi/cm respectively. Results: With a 75-month median follow-up, 1 patient recurred locally. Isolated nodal relapses occurred in 4 patients, none of whom had initial neck dissection, and salvage therapy was successful in 2. Five-year overall and progression-free survival rates were 76% and 68%, respectively. Full-course radiation therapy was possible in 7 of 12 patients who developed a second primary head-and-neck carcinoma. Late toxicity was limited to 6 mild soft-tissue necroses, and was significantly associated with previous surgery to the primary and high linear activity. Conclusions: Exclusive brachytherapy for T1-T2 velotonsillar carcinomas is safe and effective, and permits definitive reirradiation for a second head-and-neck cancer. Initial neck dissection should be performed for optimal selection for exclusive brachytherapy.

Purpose To assess local control, survival, and clinical and dosimetric prognostic factors in 25 patients with locally advanced maxillary or ethmoid sinus carcinoma treated by three-dimensional conformal radiotherapy (RT). Methods and materials Surgery was performed in 22 patients and was macroscopically complete in 16. Seven patients received chemotherapy (concomitant with RT in four). The following quality indexes were defined for the 95% and 90% isodoses: tumor conformity index, normal tissue conformity index, and global conformity index. Results The median radiation dose to the planned treatment volume was 63 Gy, with a minimal dose of 60 Gy, except in 2 patients whose cancer progressed during RT. The maximal doses tolerated by the structures involved in vision were respected, except for tumors that involved the optic nerve. After a median follow-up of 25 months, 14 local tumor recurrences developed. The major prognostic factors were central nervous system involvement by disease and the presence of nonresectable tumors. The radiation dose and tumor conformity index value were not significant prognostic indicators. Two patients died of acute infectious toxicity, and two developed late ipsilateral ocular toxicity. Conclusion Improving local control remains the main challenge in RT for paranasal tumors.

But de la presentation Evaluer la faisabilite de la prise en charge des panendoscopies des Voies Aerodigestives Superieures (VADS) en ambulatoire. Materiel et methodes Etude retrospective monocentrique de janvier 2011 a mai 2013 sur les 449 patients ayant beneficie d’une panendoscopie des VADS en dehors d’un contexte d’urgence. Resultats 255 panendoscopies ont ete realisees en ambulatoire (groupe 1) et 194 en hospitalisation conventionnelle (groupe 2). 4 cas de conversion imprevues ambulatoire/hospitalisation conventionnelle ont ete rapportes (1,5 %) : 1 patient seul la nuit suivant la chirurgie, 1 pneumopathie febrile, 1 hyperthermie sans porte d’entree retrouvee et une dyspnee laryngee postoperatoire immediate. La duree de sejour est de 1 nuit dans 10 % des cas et de 2 nuits dans 61 % des cas dans le groupe 2. Il n’existe pas de difference statistiquement significative entre les 2 groupes en ce qui concerne l’âge, le sexe, le stade TNM, la localisation lesionnelle, le stade tumoral, le type de bilan, les antecedents de Radiotherapie, la distance kilometrique entre le domicile et le centre, le score ASA, le score APFEL, le score de Detsky. Le motif ayant pousse a une hospitalisation conventionnelle le plus frequemment retrouve est dans 73 cas (38 %) le refus du patient a la realisation de la chirurgie ambulatoire. Les autres motifs correspondent aux criteres de la Haute Autorite de sante (HAS). Conclusion La panendoscopie des VADS est un examen permettant la prise en charge des patients en ambulatoire avec un taux faible de conversion chez des patients selectionnes selon les criteres HAS. Une meilleure information du patient devrait permettre de diminuer les hospitalisations pour ce geste et de developper l’ambulatoire dans les services de cancerologie ORL, pour repondre aux directives gouvernementales.

But de la presentation Etude de la transition epithelio-mesenchymateuse (TEM) au cours de la tumorigenese des cancers de la cavite orale. Materiel et methodes Evaluation, dans 86 biopsies de leucoplasies orales avec suivi disponible, 76 carcinomes epidermoides de la cavite orale reseques inclus dans le Tumor Cancer Genome Atlas (TCGA) et 60 lignees cellulaires de cancers des voies aerodigestives superieures, d’une signature d’expression de la TEM et du niveau d’expression de ZEB1&2, TWIST1&2 et SNAI1&2, facteurs de transcription impliques dans la TEM, paradigme de la plasticite cellulaire. Le profil d’expression des microRNAs de la famille miR200, puissants regulateurs negatifs de ZEB1&2, a egalement ete analyse dans 20 biopsies de leucoplasie orale, chez des patients ayant ( n = 10) ou n’ayant pas developpe un carcinome epidermoide de la cavite orale. Resultats Les niveaux d’expression des marqueurs epitheliaux et mesenchymateux etaient inversement correles, que ce soit dans les leucoplasies orales, les carcinomes epidermoides de la cavite buccale ou les lignees cellulaires. Etonnamment, l’expression d’une majorite de marqueurs mesenchymateux, en particulier le recepteur tyrosine kinase AXL, etaient generalement associes a un risque diminue de developper un cancer chez des patients atteints de leucoplasie orale. L’expression des genes ZEB1&2 et SNAI1&2 etait inversement correlee. Un niveau eleve d’expression de SNAI2 et faible de ZEB1 au sein de la leucoplasie orale etaient associes a un developpement plus frequent de cancer (log-rank p = 0,0086). L’expression des microRNAs de la famille de miR200 etait en general associee au developpement de cancer. Un total de 10 % des lignees cellulaires et 38 % des carcinomes epidermoides de la cavite orale avaient un profil phenotypique mesenchymateux. Dans les cancers, le profil mesenchymateux etait associe a l’envahissement ganglionnaire ( p = 0,0015). Conclusion En raison de leur accessibilite, les leucoplasies orales representent un modele interessant pour l’etude de la plasticite cellulaire. SNAI2 et ZEB1 pourraient avoir des roles opposes au cours du developpement des cancers de la cavite buccale. L’expression de marqueurs de la TEM pourrait avoir un effet protecteur aux stades precoces de la tumorigenese de la cavite orale. La validation experimentale de ces observations est en cours.

e17018 Background: DCF is the standard chemotherapy for induction in LASCCHN. Its toxicity reserves it to younger patients (pts) without comorbidity and of PS 0-1. In gastric cancer mDCF demonstrat...

Purpose: To assess the possibility to deliver a high and homogeneous irradiation with respect to maximal tolerated dose to the visual pathways for paranasal sinus and nasal cavity tumors. Methods and Materials: Forty patients with advanced stage malignant tumors were treated with postoperative (30) or primary (10 patients) conformal radiotherapy (CRT). Five patients were previously irradiated. Six to 15 individually shaped isocentric noncoplanar field arrangements, using a multileaf collimator were designed. Dose–volume histograms (DVH) for the planning target volumes (PTV) and the optic pathways were analyzed in 31 cases. Results: Median and maximal delivered doses to the PTV were 60 (±3) and 66 (±4) Gy. Dose distributions for critical organs are detailed. Median follow-up was 19 months (3 to 48). Local, nodal, and metastatic recurrences occurred in 8, 2, and 7 cases, respectively. Major prognostic factor for local recurrences was central nervous system (CNS) involvement. One patient died of meningitis. Two patients developed cataract, and 1 patient ipsilateral blindness due to vascular glaucoma. Conclusion: CRT for locally advanced paranasal sinus and nasal cavity tumors enables the delivery of high homogeneous doses to the PTV with respect to critical organs, with a low toxicity and a high local control.

e17011 Background: Only few studies report organ preservation in piriform sinus carcinomas (PSC), with no publication on induction chemotherapy (IC) with docetaxel, cisplatine, 5FU (DCF) followed by radiotherapy plus cisplatin (RTCis) or cetuximab (RTCet). We assessed compliance, survival and organ preservation after IC by DCF followed by RTCis or RTCet in a retrospective multicentric review of patients (pts) with advanced PSC. Methods: We analyzed retrospectively 88 pts with advanced PSC treated between 2005 and 2011 in 3 tertiary care centers with organ preservation protocol strategy ongoing in each center. DCF was followed by RTCet (56.5%) in 1 center and by RTCis(42%) in the 2 others. Primary endpoints were acute toxicity and compliance to IC and RTCis compliance compared with RTCet. Secondary endpoints were overall survival (OS), disease free survival (DFS) and laryngectomy free survival (LFS). Results: Within the 88 pts, 21.6% were stage III and 72.7% stage IV; 81% completed the full course of IC. For 64.8% of pts no toxicity was reported. The main side effect observed was neutropenia (18.2%). Two deaths (2%) were directly related to the IC. Concerning the radiotherapy, 59% of the pts had full dose concomitant cisplatin versus 85% with cetuximab (pstage IV, p

6056 Background: Q3w CT is standard RT potentiation for HNSCC but its toxicity requires to look for new treatment’s modalities. The aim was to explore if q1w CT could be a safe and effective alternative. Methods: Patients (pts) treated by chemoradiation (CT-RT) for a HNSCC were retrospectively included. Study population was first described. Then overall (OS) and progression-free survival since the RT onset were performed. Survival distributions were estimated by Kaplan-Meier method and compared between CT groups using the Log-Rank test. Prognostic effect of CT group was explored using Cox model. Results: 266 pts treated between January 2004 and December 2008 were included: 170 and 96 pts respectively received q1w and q3w CT. At diagnosis, 46% had oropharynx lesions, 20% larynx, 17% hypopharynx and 14% oral cavity. 70% pts experienced surgery, 39% CT induction and a median dose of radiation of 64 Gy without any significant difference between CT groups. However, median age at diagnosis was significantly different between q1w and q3w CT (58 vs 54, p= 3 days (8% vs 2%, p=0.037) and had long-term toxicities (24% vs 12%, p=0.014). With a median follow-up of 42 months 95% CI [36.8-48.8], a trend in favour of q3w CT was found:2-years OS of 83% (95% CI [73-90]) vs 74% (95% CI [66-80]), p=0.089. However, after adjustment on prognostic factors CT group was not significantly associated with OS nor with PFS. Conclusions: Q1w RT-CT is safer than q3w and may be as efficient. Follow-up data will be updated to reinforce efficacy results.

e17012 Background: This study aimed to assess compliance and survival after induction chemotherapy (IC) with docetaxel, cisplatin, fluorouracil (DCF) followed by radiotherapy plus cisplatin (RTCis) or radiotherapy plus cetuximab (RTCet) in a retrospective multicentric series of 121 patients with locally advanced oropharyngeal cancer. One of the issues of these chemotherapy regimens is the toxicity that adversely affects the compliance to the concomitant radiochemotherapy treatment. We also evaluated feasibility and completion of radiochemotherapy treatment comparing efficacy and toxicity between RTCet and RTCis. Methods: Multicentric retrospective review of 121 consecutive patients with non resectable or non operable oropharyngeal carcinomas treated between 2005 and 2011 in 3 tertiary care centers with protocol ongoing in each center. In one center DCF, is followed by RTCet, in the 2 other centers, DCF is followed by RTCis. Primary endpoints were acute toxicity of IC and compliance to the RTCis compared with RTCet. Secondary endpoints were overall survival, disease free survival and locoregional control. Results: Within the 121 patients, 20.7% were stage III and 79.3% were stage IV. 81.8% of the patients completed the full course of IC. 50% of the patients had full dose concomitant cisplatin versus 77% of the patients that had full dose concomitant cetuximab (p=0.017). Mean follow up was 23.5 months. Median overal survival was 20.7 months, median disease free survival was 18.6 months. The 3 and 5 year overall survival rates were respectively 52.5% and 46.4%. The 3 and 5 year disease free survival rates were 44.2% and 38.3%. The only significant factor affecting survival was IC response (p

e16036 Background: With the standard first line association platinum 5FU and cetuximab, median overall survival (OS) for RMHNSCC was 10.1 months (95% CI [8.6 – 11.2]) (N Engl J Med. 359:1116). Due to the toxicity of this treatment we often offer alternative therapy to our pts. This work aimed to evaluate impact of different 1st line treatment on OS. Methods: With the standard first line association platinum 5FU and cetuximab, median overall survival (OS) for RMHNSCC was 10.1 months (95% CI [8.6 – 11.2]) (N Engl J Med. 359:1116). Due to the toxicity of this treatment we often offer alternative therapy to our pts. This work aimed to evaluate impact of different 1st line treatment on OS. Results: At initiation of palliative chemotherapy, median age was 62 [29-87]; PS was 0, 1, 2, 3 in 13%, 59%, 16% and 11% of pts, respectively. First line chemotherapy consists in combination cisplatin+taxanes (CIST) 24%, caboplatin+taxanes (CART) 33%, cisplatin or carboplatin without taxanes (NOT) 15% or others (OTH) 28%. Median OS was estimated to 9.6 months CI95%=[8.1-11.4], with 39% of pts; CI95%=[32-47] still alive at 1-year. Second line of treatment has been initiated in 61% of pts. Some of them have even been able to have up to 3, 4 or more than 4 lines of treatment in 19%, 11% and 4% of pts, respectively. In the subgroup analysis, which represents a population similar to those included in [ref1], first line chemotherapy was CIST, CART, NOT or OTH in 30%, 30%, 18% and 22%, respectively. Median OS was 13.0 months, CI95%=[11.2-17.7] reaching up to 15.3 months for CIST subgroup. Second line of treatment was initiated in 73% of pts, with 20%, 15% and 5% of pts having a third, a fourth, and a fifth line, respectively. Conclusions: We can reach for unselected pts the best OS published in phase III studies. The use in first line of combination of platinum and taxanes, followed by monotherapies with cetuximab, capecitabine and methotrexate allows reaching OS of 13 months.

e16006 Background: nTPF is a standard induction chemotherapy for LAHNSCC but only proposed to patients (pts) in good health, younger than 70 years, without comorbidities including important weight ...

5549 Background: Platinum-based chemotherapy is the current standard in first line treatment of RMHNSCC. CTX is known to be efficient alone (objective response rate ORR=10-13%) or combined with pla...

e17047 Background: For relapse or metastatic SCCHN the standard treatment is the combination of cisplatin and 5FU that showed higher response rate than methotrexate but similar overall survival. Cetuximab demonstrated in a phase III (N Engl J Med. 2008;359:1116) its efficacy and paclitaxel showed efficacy in a phase II study (Cancer. 1998;82:2270). The objective of this study was to evaluate paclitaxel (P) in our institution in various situations. Methods: We retrospectively reviewed 56 pts with relapse or metastatic SSCHN treated with P in a single institution in Lyon (France) between June 2002 and February 2008. P was administered in first line for locally advanced disease, in first line for relapsed or metastatic disease, or in second or more line. P was administered q1w or q3w, alone or in combination with carboplatin or cetuximab. Results: Median age was 59 years (36–84) at the beginning of paclitaxel. Localizations of primitive tumor: oral cavity (14%), oropharynx (30%), hypopharynx (39%) larynx (7%), rhinopharynx (4%), or other (6%). All patients received adequate initial treatment with surgery and/or radiotherapy, 47% had have neoadjuvant chemotherapy (71% with cddp-5fu, but 5 pts received P). Five patients received P as neoadjuvant treatment. Among 52 evaluable patients, 33 received P in first line of treatment after relapse, 12 in second line. Monotherapy was administered to 20 patients and 22 received P combined with carboplatin, and 1 with cetuximab. For all patients, objective response rate (OR) was 30.8% (95% CI 18.7–45.1%). In first line of relapse, OR was 39.4% (95% CI 22.9–57.9%) and 16.7% (95% CI 2.1–18.4%) in second line. In monotherapy OR was 30.0% (95% CI 11.9–54.3%) and 36.4% (95% CI 17.2–59.3%) in combination with carboplatin. The overall survival (OS) of all patients was 6.3 months (95% CI 3.9–7.9 m), and 7.7 m (95% CI 3.9–11 m) and 5.2 m (95% CI 2.8–7.9 m) in first and second line, respectively. There is no difference in OS between monotherapy and combination: 6.1 m (95% CI 3.9–7.9 m) and 5.3 m (95% CI 3.9–7.9 m), respectively. Conclusions: P did not improve overall survival but showed interesting response rate in relapsed patients who are often symptomatic. Recent studies suggest high potentialities in combination with EGFR inhibitors. No significant financial relationships to disclose.

6074 Background: nTPF, followed by RT or radiochemotherapy (CRT) with weekly carboplatin (N Engl J Med 2007;357: 1695 and 1705) increased overall survival (OS) and organ preservation. We determine toxicity and efficacy of nTPF in unselected pts, then CRT with P or cetuximab (Cx). Methods: We retrospectively reviewed 123 pts with head and neck cancer (5 M+) treated with nTPF (T and P 75 mg/m2, both d1, F 750 mg/m2/d, d1–5) q 3 wks, for 3 or 4 cycles in three institutions in Lyon (France) between May 2005 and August 2007. Surgery was performed for operable patients in case of PD or insufficient response. Results: Median age was 56 years [32–78]. Localizations: oral cavity (9%), oropharynx (27%), hypopharynx (33%) larynx (19%), rhinopharynx (5%) or other (7%). Two pts died after 1st cycle of nTPF, 1 after 2nd and 2 during RT. After the first cycle, despite systematic use of G-CSF, 23% of pts displayed grade 3–4 neutropenia, with 14% of febrile neutropenia; 24% reversible elevation of creatinine, 7% grade 3–4...