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Background Routine Electronic Monitoring of HRQoL (REMOQOL) in daily clinical care with real-time feedback to physicians could help to manage treatment-related toxicities, to personalize supportive care, and to assess the treatment benefit from the patients’ point of view. Physicians’ satisfaction with REMOQOL was evaluated in two French clinical trials (CT) assessing its feasibility. Methods Physicians’ satisfaction was evaluated in two CT: QOLIBRY a monocentric CT for breast, lung and colorectal cancers, and QUANARIE a multicentric CT involving 8 centres of France for renal cancer. Patients were invited to complete before each visit the EORTC QLQ-C30 questionnaire, cancer site-specific modules and selected items related to treatments, using the CHES software on tablets and/or computers at the hospital or at home. During the visit, the physicians had real-time access to visual summaries of HRQoL scores evolution. Physicians’ satisfaction was evaluated with a questionnaire specifically designed for these CT. The questionnaire addressed 43 items and aimed to evaluate if REMOQOL was a useful tool for the physician and the usability of the CHES software. Results Between September 2016 and March 2019, 45 physicians included 249 patients (QOLIBRY n = 193, QUANARIE n = 56). Twenty-six (58%) physicians completed the survey. Among them, 18 (69%) looked at the HRQoL results. HRQoL results helped to better understand the patient’s medical condition for 11 (61%) of the physicians. Discussion about HRQoL results with the patient was easy (n = 15; 83%) and REMOQOL improved communication with patients (n = 8; 44%). Physicians declared that REMOQOL helped them to adapt patient’s management (n = 10; 56%) and to support supportive care prescription (n = 8; 44%) without extending the time of consultations (n = 12; 67%). Seventy-three per cent (n = 19) would agree to integrate REMOQOL for all patients in their daily practice. Conclusions Physicians used REMOQOL as a complementary tool and were globally satisfied. However, information about the objectives, trainings and recommendations for using HRQoL results in routine are essentials and must be enhanced to involve all the physicians. Clinical trial identification QOLIBRY: NCT02844608 QUANARIE: NCT03062410. Legal entity responsible for the study University Hospital of Besancon. Funding Novartis. Disclosure G. Mouillet: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (self): Amgen; Honoraria (self): BMS; Honoraria (self): Roche; Honoraria (self), Travel / Accommodation / Expenses: Ipsen; Honoraria (self), Travel / Accommodation / Expenses: Astellas. A. Thiery-Vuillemin: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: Janssen; Honoraria (self), Honoraria (institution): Novartis; Honoraria (self), Honoraria (institution): Ipsen; Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: Roche/Genentech; Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Honoraria (institution): Astellas Pharma. E. Curtit: Honoraria (self): Roche; Honoraria (self): Novartis; Honoraria (self): Eisai; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer. G. Eberst: Honoraria (self): MSD; Honoraria (self): BMS; Honoraria (self): Boeringher Ingelheim; Honoraria (self): Roche; Honoraria (self): AstraZeneca. P. Barthelemy: Advisory / Consultancy: Novartis; Advisory / Consultancy: BMS; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Roche; Advisory / Consultancy: MSD; Advisory / Consultancy: Janssen; Advisory / Consultancy: Sanofi; Honoraria (self): Astellas. L. Geoffrois: Travel / Accommodation / Expenses: Merck; Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: BMS. A. Anota: Honoraria (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self): BMS; Honoraria (self): Roche. All other authors have declared no conflicts of interest.

International audience; BACKGROUND: The standard treatment of patients with metastatic germ-cell tumor (GCT) relapsing after first-line chemotherapy is based on a cisplatin and ifosfamide-containing three-drug regimen, which usually yields a complete response (CR) rate \textless50%. As gemcitabine consistently displayed activity in patients with advanced GCT and as synergy with cisplatin was reported, we integrated this drug into the salvage triplet regimen and assessed its activity in this phase II study. PATIENTS AND METHODS: The GIP regimen consisted in gemcitabine 1000 mg/m(2) day 1 and 5, ifosfamide 1200 mg/m(2)/day day 1-5, cisplatin 20 mg/m(2)/day day 1-5, and granulocyte colony-stimulating factor 263 mug/day day 7-15, repeated every 3 weeks for four cycles. Eligibility criteria were that patients had favorable prognostic factors to conventional-dose salvage chemotherapy including a testis primary tumor and a previous CR to first-line chemotherapy for metastatic disease. The primary end point was the CR rate and a two-stage Simon design was used. RESULTS: Thirty-seven patients were accrued and 29 (78%) achieved a favorable response, including a CR in 20 (54%) and a partial response with normalization of tumor markers (PRm-) in 9 (24%). With a median follow-up of 53 months (13-81), the 2-year overall survival rate is 73% (57%-84%) and the continuous progression-free survival rate is 51% (35%-66%). Myelosuppression was the main toxicity including febrile neutropenia in 8 (22%) patients and 18 (50%) cases required platelet infusion. No grade 3 and 4 peripheral neurotoxicity or renal toxicity occurred. Two patients died of treatment-related toxicity, one of them with cancer progression. CONCLUSION: In a multicenter context, four cycles of the GIP regimen achieved a high CR rate in patients with relapsed testicular GCT. The GIP regimen avoided severe neurotoxicity and yielded a high survival rate. CLINICAL TRIAL NUMBER: NCT00127049.

Background Uveal melanomas (UM) are BRAF-wild type tumors associated with dismal prognosis for which no systemic therapy is active. We report our experience with immune checkpoint inhibitors (ICI) in metastatic UM patients. Methods Ambispective cohort of metastatic UM patients treated with ICI in eight French centers. Response rate, progression-free survival (PFS) and overall survival were retrieved. Results 206 evaluable patients started their first ICI treatment between December 2012 and January 2019. The population consisted of 98 men and 108 women. Median age was 57.5 yo (19; 82). Seventy-four patients had been enucleated, 131 had received proton beam therapy, one had received brachytherapy. The median time to first metastasis was 29.4 months (0-380.4). ICI were first prescribed in first-line in 68 patients, in second-line in 79 patients, in third-line or more in 80 patients. One hundred forty-four patients received pembrolizumab (63%), 58 nivolumab (25%) and 21 ipilimumab (9%). Metastatic sites at initiation of ICI were liver, lung, skin, and bone for 201, three, one and one patients, respectively. Liver was the sole metastatic site in 201 patients. Patients received a median number of four ICI infusions (1-60+). Treatment was suspended because of immune side effects in 21 patients. Nine objective responses were observed (four complete and five partial responses; 4.4%) including one patient with a hypermutated, MBD4-deficient tumor. Fifty-seven patients showed stable disease as best response (27.7%). Median PFS in the whole cohort was 4.1 months (0; 30.4) in 1st line, 4.9 months (0; 42,6) in 2nd line and 3.1 (1; 17.,3) months in 3rd line. Median PFS was 4.1 months in the ICI-resistant population and 27.4 months in the ICI-sensitive population (log-rank p-test Conclusions ICI are associated with a low response rate in UM but with longer PFS and a trend for longer overall survival in ICI-sensitive tumors. Immunotherapies should be investigated in this disease. ICI-sensitive cases are currently being explored to identify biomarkers of response. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

Background Nivolumab is a standard of care in patients (pts) with metastatic clear cell renal cell carcinoma (mccRCC) after failure of prior anti-angiogenic tyrosine-kinase inhibitors (TKIs). We evaluated the impact of corticosteroids (CS) during nivolumab in pts with mccRCC as part of a prospective clinical trial. Methods We conducted an ancillary study of the GETUG-AFU 26 NIVOREN study (NCT03013335), a multicenter prospective phase II safety study of nivolumab in mccRCC after progression on anti-angiogenic TKIs. Patients receiving CS at nivolumab initiation were excluded. Overall survival (OS) and progression free survival (PFS) of pts exposed to CS (≥ 10 mg of prednisone equivalents) or not during nivolumab were assessed. To overcome immortal time bias, we used two different landmark analysis methods. We first excluded pts who progressed or died before specified landmark timepoints (12 and 16 weeks). In a second method, patients treated with CS before landmark timepoints (12 and 16 and 24 weeks) were used to evaluate the effect of an early exposition to CS. Results Among the 665 evaluable pts, with a median follow up of 23.9 months, 113 (17 %) were exposed to CS during nivolumab, mainly to treat immune-related adverse events of any grade (74%). Other indications included infections (15%), complications of radiotherapy and chronic obstructive pulmonary disease. Median time to the first CS treatment was 21.6 weeks. Using a landmark at 12 weeks, OS rate at 12 months were 85.6% and 73.5% in pts exposed or not to CS [hazard ratio (HR), 0.57; p = 0.0017]. PFS rate at 12 months were 61.1% and 41.6% in pts exposed or not to CS (HR, 0.63; p = 0.0065). Landmark analyses at 16 weeks showed similar results. With the second landmark method, no differences in PFS or OS were observed between groups at 12 and 16 weeks. With a landmark set at 24 weeks, OS was similar in pts exposed or not to CS (HR, 1.14; p = 0.55). Conclusions The use of CS during nivolumab in mccRCC is not associated with a detrimental effect on survival outcomes. The positive association of corticosteroid use for irAEs with outcomes was not confirmed by second landmark modalities. Immortal time bias should be carefully considered when studying time-dependent variable. Clinical trial identification NCT03013335. Legal entity responsible for the study UNICANCER. Funding Bristol-Myers Squibb. Disclosure M. Gross-Goupil: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis. B. Laguerre: Honoraria (self), Travel / Accommodation / Expenses: BMS; Honoraria (self), Travel / Accommodation / Expenses: Pfizer; Honoraria (self): Novartis; Honoraria (self): Ipsen. P. Barthelemy: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Janssen-Cilag; Honoraria (self), Advisory / Consultancy: Sanofi. S. Negrier: Honoraria (self): Pfizer; Honoraria (self): Bms; Honoraria (self): Novartis; Honoraria (self): IPSEN; Honoraria (self): Euspharma. L. Geoffrois: Honoraria (self), Travel / Accommodation / Expenses: MSD; Honoraria (self), Travel / Accommodation / Expenses: BMS; Honoraria (self): Ipsen; Honoraria (self): Novartis; Travel / Accommodation / Expenses: Merck. S. Ladoire: Advisory / Consultancy, Travel / Accommodation / Expenses: BMS. M. Laramas: Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: SANOFI; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Speaker Bureau / Expert testimony: BMS; Speaker Bureau / Expert testimony: Amgen; Speaker Bureau / Expert testimony: IPSEN; Speaker Bureau / Expert testimony: Janssen; Travel / Accommodation / Expenses: Eisai. S. Oudard: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bayer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Ipsen. B. Escudier: Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Roche; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Eusa; Advisory / Consultancy, Research grant / Funding (institution): Avevo; Advisory / Consultancy, Research grant / Funding (institution): Pfizer. L. Albiges: Advisory / Consultancy, Compensated to institution: Pfizer; Advisory / Consultancy, Compensated to institution: Novartis; Advisory / Consultancy, Compensated to institution: BMS; Advisory / Consultancy, Compensated to institution: Ipsen; Advisory / Consultancy, Compensated to institution: Roche; Advisory / Consultancy, Compensated to institution: MSD; Advisory / Consultancy, Compensated to institution: AstraZeneca. All other authors have declared no conflicts of interest.

Background HNSCC occurring in previously irradiated area have a poor prognosis. With immunotherapy, the inhibition of negative regulators of immune checkpoints programmed cell death ligand-1 (PD-L1) and CD8+ tumor-infiltrating lymphocytes (TILs) have been of greatest importance for antitumor immune response. Yet, the immune landscape of pretreated area remains poorly documented and should be investigated, especially since locoregional recurrences have recently been described as a predominant site of hyperprogression. We aimed to assess the tumoral microenvironment in terms of biomarkers for tumor immune response in irradiated area compared to de novo tumors. Methods This retrospective monocentric study analyzed 100 HNSCC tumor tissues from patients who had undergone surgery between January 2010 and November 2017. We compared the immune microenvironment in 50 de novo tumors and 50 tumor recurrence occurring within irradiated area. Formalin-fixed and paraffin embedded tumor tissue samples were reviewed by an experimented pathologist for immunohistochemistry. We assessed p16 status, CD3+ and CD8+ TILs and PD-L1 expression on tumor and immune cells, in stromal and intratumoral components. Results The density of CD3+ TILs was significantly lower, whether in intratumoral or stromal region within irradiated areas (p = 0.003 and p = 0.020 respectively). The expression of CD8+ TILs was not significantly different between the two cohorts. The percentage of tumor cells expressing PD-L1 TC (TPS=1%) was significantly lower in tumours developed within irradiated area than in de novo tumors (56.0% vs 86.0%) (p Conclusions There were persistence of cytotoxic cells and lower expression of PD-L1 and CD3+ TILs in tumors within irradiated area. This study provides first hypothesis to explain the fact that these lesions are less responsive to immunotherapy although they may still have antitumor capacity. The assessment of predictive biomarkers in patients treated by immunotherapy in randomized trials is required. Legal entity responsible for the study Dr Lionnel Geoffrois. Funding Has not received any funding. Disclosure C. Borel: Honoraria (self): Merck; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: BMS. L. Geoffrois: Honoraria (self), Travel / Accommodation / Expenses: MSD; Honoraria (self), Travel / Accommodation / Expenses: BMS; Honoraria (self): Ipsen; Honoraria (self): Novartis; Travel / Accommodation / Expenses: Merck Serono. All other authors have declared no conflicts of interest.

Background The main challenges in patients (pts) > = 70y are to cope with the treatment benefit/risk ratio and tumor related symptoms; no standard systemic treatment has been validated. With GERICO-GORTEC groups, we developed a large prospective clinical program named ELAN to improve the management of elderly HNSCC using an adapted geriatric evaluation feasible in daily practice and to set new standards of care for these pts. We report the results of ELAN FIT and UNFIT trials dedicated to elderly R/M HNSCC pts. Table: 1110O . ELAN-FIT trial ELAN-UNFIT trial N = 82 Carbo-5FU-cetux (n = 78) CX arm (n = 41) MTX arm (n = 41) Pts PS ECOG 0-1 (n = 47) (2 arms together) Pts PS ECOG 2 (n = 35) (2 arms together) Adverse events > =grade 4 24% 27% 22% 13% 40% Objective response rate At W12: 38% (central review) 12% 15% 13% 14% OS median (months) 14.7 (95%CI=11.0-18.2) 4.6 (95%CI=2.4-7.3) 4.6 (95%CI=2.3-7.7) 7.3 (95%CI=4.6-9.6) 2.1 (95%CI=1.5-3.2) 1-year OS rate 58% (95%CI=46%-68%) 22.5% (95% CI=12.3%-37.5%) 14.6% (95% CI=6.9%-28.4%) 27.7% (95% CI=16.9%-41.8%) 5.9% (95% CI=1.6%-19.1%) PFS median (months) 7.1 (95%CI=5.5-8.2) 2.4 (95%CI=1.5-3.8) 2.8 (95%CI=1.6-4.2) 3.8 (95%CI=2.6-5.5) 1.5 (95%CI=1.2-2.3) 1-year PFS rate 24.5% (95%CI=15.5%-34.6%) 7.5% (95% CI=2.6%-19.9%) 7.3% (95% CI=2.5%-19.4%) 12.8% (95% CI=6.0%-25.2%) 0% Methods To be included in one of the 2 trials, 1st line R/M SCCHN pts > = 70y must first be enrolled in ELAN-ONCOVAL study where they were classified as fit or unfit, using the ELAN geriatric evaluation (EGE). Comprehensive Geriatric Assessment was optional. Fit pts were proposed to be enrolled in the 2-stage phase II ELAN-FIT trial, which evaluated the cetuximab-carboplatin-5FU (EXTREME) combination in terms of efficacy (objective response at 12 weeks) and safety assessed by lack of grade > =4 toxicity and lack of loss of independence. Unfit pts were proposed to be enrolled in the randomized phase III ELAN-UNFIT trial, that compared 2 monotherapies, cetuximab (Cx) 500 mg/m² every 2 weeks versus weekly methotrexate (MTX) 40 mg/m² in terms of failure free survival (failures are progression, treatment stop, loss > = 2 points in Activities in Daily Living scale or death). Results 160 pts were enrolled in the trials. The UNFIT trial was stopped after futility analysis. Main results are shown in the table. Conclusions Fit elderly pts as selected using EGE, benefited from carboplatin based EXTREME regimen, with promising overall survival (OS), which compares favourably with that of younger pts. For unfit elderly pts, there was no efficacy difference of Cx and MTX. PS ECOG 2 pts did not benefit from systemic treatment. New therapeutic options should be explored for ECOG 0-1 unfit elderly pts. Clinical trial identification ELAN-UNFIT: NCT01884623 ELAN-FIT: NCT01864772. Legal entity responsible for the study Gustave Roussy and GORTEC. Funding INCA PAIR, Merck, Sandoz, GEMLUC-GEFLUC. Disclosure J. Guigay: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Advisory / Consultancy: Innate Pharma; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Merck. C. Even: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Advisory / Consultancy: Innate Pharma. L. Geoffrois: Honoraria (self), Travel / Accommodation / Expenses: BMS; Honoraria (self), Travel / Accommodation / Expenses: MSD; Honoraria (self): Ipsen; Honoraria (self): Novartis; Travel / Accommodation / Expenses: Merck Serono. C. Sire: Travel / Accommodation / Expenses: Merck. J. Fayette: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: Innate; Honoraria (self), Advisory / Consultancy: Biogen. F. Peyrade: Advisory / Consultancy: MSD; Advisory / Consultancy: Merck. P. Debourdeau: Non-remunerated activity/ies: Pfizer; Honoraria (self): Leo Pharma; Honoraria (self): Bayer. Y. Pointreau: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: MSD. All other authors have declared no conflicts of interest.

Aim: Sunitinib is a front-line standard of care in mRCC patients. Several studies have shown that a 2nd line with a TKI after sunitinib progression is an effective treatment in mRCC. We assessed the efficacy and tolerability of a sunitinib rechallenge in 3rd line or more after progression with other therapies. Methods: All mRCC patients (pts) initiating a sunitinib rechallenge in 3rd line or more between January 2006 and May 2013 in the 18 French participating centres were enrolled. Patient characteristics, disease characteristics, tolerability, treatment modalities and outcomes of all therapeutic lines (sunitinib in 1st line, treatment received before rechallenge, sunitinib rechallenge) where retrospectively and/or prospectively recorded. All of these data come from a partial analysis on available data in May 2014 and will be updated with the final analysis (August 2014) at the ESMO congress. Results: Fifty pts treated with sunitinib rechallenge have been analysed. Seventy four percent of pts were male, mean age at diagnosis was 59.3 years, 98% had a clear cell mRCC, ECOG PS was 0-1 in 92.6% pts and 96% had had a prior radical nephrectomy. Ninety six percent of pts had favourable or intermediate risk per MSKCC criteria in 1st line. Sunitinib was started at 50mg 4/2 in 87.5% and 34.7% pts in 1st line and at rechallenge, respectively and at 37.5mg 4/2 in 10.4% and 53.1%. Sunitinib in 1st line produced an ORR of 52.1%, and a median PFS of 18.4 months [CI95%, 12.4 – 23.7]. Most pts (83.3%) discontinued initial sunitinib for disease progression. Rechallenge began a median of 15 months after discontinuation of initial sunitinib treatment. The majority of pts (63.3%) received sunitinib rechallenge in 4th line and 20.4%, 12.2%, 4.1% received sunitinib in 3rd, 5th, 6th line respectively. Treatments received in between were: 82.6% TKI, 97.8% mTOR and both 80.4%. Upon sunitinib rechallenge, 17.1% of pts achieved a partial response with a median PFS of 7.6 months [95%CI, 4.4-9.7]. The overall survival was 61.9 months [95%CI, 55.5 – 74.5]. Substantial new toxicity or significantly increased severity of prior toxicity was not observed during rechallenge. Conclusions: These data show that sunitinib rechallenge has potential benefits and is tolerated in mRCC patients. They suggest that disease progression on initial sunitinib is not associated with absolute resistance to therapy. Disclosure: S. Oudard: Consultant or AdvisoryRole; Entity: Sanofi, Novartis, Roche, Bayer, Keocyt, Amgen, Relationship: Myself, compensation: Compensated, Honoraria, Entity: Sanofi, Novartis, Roche, Bayer, Keocyt, Amgen, Pfizer, Relationship: Myself; L. Geoffrois: consultant or advisory role, entity : Roche, Merck Serono, Novartis, Compenstion : Honoraria; A. Guillot: consultant or advisory board : Sanofi, Janssen, Astellas. H. Boyle: honoraria: Sanofi, Pfizer, Jansen, Novartis, Pierre Fabre \"travel to meetings': Sanofi, Pfizer, Jansen, Novartis; M. Baciuchka Palmaro: Consultant and AdvisoryRole : sanofi, novartis, GSK Compensated honoriara: Sandoz, pierre fabre, novartis, teva, hospira clinical trials (PI or sub investigator) : Pfizer,GSK,Medimmune,Daichi Sankyo,BMS,Roche,Novartis,PUMA Biotechnology,ESAI; B. Laguerre: Honoraira : Sanofi, Astellas, Ipsen, Bayer, GSK, Novartis; E. Legouffe: Board avec Novartis. Essais cliniques avec Roche, Novartis. Soutiens pour la recherche de la part de Pfizer; N. Mahi: Pfizer employee. All other authors have declared no conflicts of interest.