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The phase 3 JAVELIN Renal 101 trial (NCT02684006) demonstrated significantly improved progression-free survival (PFS) with first-line avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma (aRCC). We report updated efficacy data from the second interim analysis.Treatment-naive patients with aRCC were randomized (1 : 1) to receive avelumab (10 mg/kg) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary end points were PFS and overall survival (OS) among patients with programmed death ligand 1-positive (PD-L1+) tumors. Key secondary end points were OS and PFS in the overall population.Of 886 patients, 442 were randomized to the avelumab plus axitinib arm and 444 to the sunitinib arm; 270 and 290 had PD-L1+ tumors, respectively. After a minimum follow-up of 13 months (data cut-off 28 January 2019), PFS was significantly longer in the avelumab plus axitinib arm than in the sunitinib arm {PD-L1+ population: hazard ratio (HR) 0.62 [95% confidence interval (CI) 0.490-0.777]}; one-sided P0.0001; median 13.8 (95% CI 10.1-20.7) versus 7.0 months (95% CI 5.7-9.6); overall population: HR 0.69 (95% CI 0.574-0.825); one-sided P0.0001; median 13.3 (95% CI 11.1-15.3) versus 8.0 months (95% CI 6.7-9.8)]. OS data were immature [PD-L1+ population: HR 0.828 (95% CI 0.596-1.151); one-sided P = 0.1301; overall population: HR 0.796 (95% CI 0.616-1.027); one-sided P = 0.0392].Among patients with previously untreated aRCC, treatment with avelumab plus axitinib continued to result in a statistically significant improvement in PFS versus sunitinib; OS data were still immature.NCT02684006.

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38% had no limitations in the assessed domains. Conclusion: The CGAmodel used (7 domains) classified as unfit a high proportion of individuals with limitations in the evaluated domains. However, thismodel also classified as unfit a considerable proportion of individuals who did not present limitations in some domains. As a comprehensive evaluation, CGA must ensure that patients classified as unfit effectively present limitations in the evaluated domains and, at the same time, that those considered as fit, did not have limitations. For this reason, it is important to evaluate different compositions of CGA that could be able to classify the individuals according to their overall health condition the most adequately as possible.

Background High-dose chemotherapy (HDCT) has been shown to circumvent resistance in poor-prognosis germ cell tumors (GCT), mainly for patients whose relapses occur more than 4 weeks after cisplatin-based CT. Patients and methods This multicentric phase II trial was addressed to patients with poor-prognosis non-refractory GCTs. The main objectives were to determine the complete response rate and to monitor treatment-associated toxicities. Patients with adverse prognostic factors failing CT were to receive 2 cycles combining Epirubicin and Paclitaxel (EpiTax), followed by 3 consecutive HDCT [one using a Paclitaxel/Thiotepa association, 2 using the 5-day Ifosfamide-Carboplatine-Etoposide regimen]. Inclusion criteria included seminomatous GCT in relapse after 2 lines of CT, non-seminomatous GCT in relapse after 1 or 2 lines, partial remission after 1 line, primary mediastinal GCT in first relapse. Peripheral blood stem cells were collected after the EpiTax cycles. Results Between 09/2004 and 12/2007, 45 patients were included: 45 received 1 HDCT, 39 two HDCT, 29 patients received the complete protocol. Sixteen patients did not received the entire protocol, 8 (53%) for toxic side effects. Two patients (4.4%) died of toxicities, 17 (37.7%) of disease progression. For a median follow-up time of 26 months (4–51 m), the final overall response rate was 66,7% (CR, 20,6%). The median PFS was 16 months (95%CI, 9-NA) and the median OS was 32 months (95%CI, 32–49). The 2-year PFS was a plateau set up at 50% (95%CI, 32-67%) and the 2-year OS was 71% (95%CI, 52–83%). Conclusion The TAXIF II protocol was highly effective in non-refractory GCT patients failing CT. Disclosure F. Selle: consultancy for roche and Pharmamar. All other authors have declared no conflicts of interest.

Background Study results demonstrated that IFN augments BEV activity and improves median PFS in pts with mRCC. Thus, combination BEV + IFN is a standard first-line treatment option for mRCC. Combining BEV with the mTOR inhibitor EVE may be an efficacious and well-tolerated treatment option. The open-label, phase II RECORD-2 trial compared first-line EVE + BEV and IFN + BEV in mRCC. Patients and methods: Therapy-naive pts with clear cell mRCC and prior nephrectomy were randomized 1:1 to BEV 10 mg/kg IV every 2 weeks with either EVE 10 mg oral daily or IFN (9 MIU SC 3 times/week, if tolerated). Tumour assessments were every 12 weeks. Primary objective was treatment effect on progression-free survival (PFS) per central review based on an estimate of the chance of a subsequent phase III trial success (50% threshold for phase II success). Results In EVE + BEV (n = 182) and IFN + BEV (n = 183) arms, median age was 60/60 years, 76/72% of pts were men, MSKCC risk was favourable/intermediate/poor in 36/57/7% and 36/57/7% of pts, and 43/46% of pts had >2 organs involved, respectively. For EVE + BEV and IFN + BEV, median treatment duration was 8.5/8.3 months, respectively; 23/26% of pts discontinued due to AEs. In EVE + BEV and IFN + BEV arms, median PFS by central review was 9.3/10.0 months (HRIFN/EVE, 0.91; 95% CI, 0.69-1.19; P =0.485), respectively; probability of subsequent phase III success was 5.1%. Results of central and local PFS analysis were consistent. Objective response rate was 27/28% in EVE + BEV and IFN + BEV arms, respectively. Median overall survival (OS) was not reached in the EVE + BEV arm and was 25.9 months (95% CI: 21.1, 30.2) in the IFN + BEV arm. Most frequent AEs (%) were stomatitis (63), proteinuria (49), diarrhoea (39), hypertension (38), and epistaxis (35) in EVE + BEV arm and decreased appetite (45), fatigue (41), proteinuria (37), and pyrexia (35) in IFN + BEV arm. Conclusions In RECORD-2, PFS and tolerability were similar for first-line EVE + BEV and IFN + BEV. Final OS analysis will occur after 2-year follow-up. Disclosure A. Ravaud: Alain Ravaud is a member of global, European, and/or French boards on urological tumors for Pfizer, Novartis, GlaxoSmithKline, Bayer-Schering, and Dendreon, and has received institutional grant support from Pfizer, Novartis, and Roche. O. Anak: Ozlem Anak is an employee of Novartis Pharma AG. D. Pelov: Diana Pelov is an employee of Novartis Pharmaceuticals Corporation. A. Louveau: Anne-Laure Louveau is an employee of Novartis Pharma S.A.S. T. M-H: Tay M-H is a speaker for an advisory board for Novartis Pharmaceuticals Corporation. B. Melichar: Bohuslav Melichar has received honoraria from Novartis and Roche and served on an advisory board for Roche. All other authors have declared no conflicts of interest.

Background a/mUC are associated with poor prognosis and HER2 overexpression is observed in around 10%. T combined with chemotherapy led to improvement of overall survival (OS) in metastatic breast and gastric cancers patients (pts). We investigated efficacy and safety of T combined with gemcitabine (G) and cis- (Ci) or carbo-platinum (Ca) in this population. Methods a/mUC pts were screened for HER2,(IHC: score 3+ or 2+ with positive FISH). Chemotherapy (CT)-naive pts were randomized: Arm A (GCi-Ca) = G (1000 mg/m2 on D1 & 8) and Ci (70 mg/m2) or Ca (AUC 5 on D1 every 3 weeks for 6 cycles with creatinine clearance cut-off > 60 ml/min); Arm B (GCi-CaT)= Arm A + T (8 mg/kg charging dose then 6 mg/kg every cycle until progression). End-points: primary= PFS, secondary= OS, ORR and toxicity. Results Pts were screened from 2003 to 2008: 61 pts (59 HER2-3+ and 2 HER2-2 + /FISH+) were eligible, 32 (52%) and 29 (48%) were randomized in arms A and B, respectively. 52% and 48% received Ci and Ca respectively. Median age: 64 yr, sex-ratio = 54/7; local treatment: surgery = 59 (98%), radiotherapy = 13 (22%), neo/adjuvant CT = 18 (30%). Baseline: ECOG-PS 0-1 = 50 (82%), 2 = 11 (18%); primary disease site: bladder = 54 (89%); locally advanced: 11 (18%), metastatic: 50 (82%); visceral metastasis: 34 (57%). Median cycle number = 6 (range: 3-9). Grade 3/4 toxicities: neutropenia (72%, febrile = 3%), thrombocytopenia (43%), anaemia (38%) were comparable between 2 arms. Dyspnea was mainly observed in GCi-CaT (16.2% vs 3.4%). No toxic death occurred. Median PFS (months = m) was 10.2 [95%CI: 5.2–13.4] and 9.3 [95%CI: 6.5–15.7] (p = 0.7) in the GCi-Ca and GCi-CaT arms, respectively. ORR was 66% and 53% in the GCi-Ca and GCi-CaT arms, respectively. Median OS (m) was 15.7 [95%CI: 10.2–23.7] and 16.8 [95%CI: 6.7–31.2] in the GCi-Ca and GCi-CaT arms, respectively. Longest OS was observed in GCiT sub-group: 28 [95%CI: 12.4–50]. Conclusion HER2 over-expression is rare in a/mUCs. No conclusion could be drawn on PFS due to lack of power. Dyspnea was more frequent in GCi-CaT arm. We hypothesize that trastuzumab could have a synergetic effect with cisplatinum leading to a longer OS. Disclosure S. Oudard: Advisory board or board of directors position to disclose: sanofi aventis, Bayer, Novartis, Roche, Pfizer Compensated relationship to disclose: Roche, Novartis Honoraria to disclose: Sanofi Anventis, Bayer, Novartis, Roche, Pfizer F. Goldwasser: Advisory board: Bayer Novartis Roche Pfizer Amgen Fresenius Compensated consultant role: Novartis Roche Bayer Pfizer Amgen Honoraria: Roche Bayer Pfizer Novartis Research funding: Roche Amgen Bayer Pfizer Nutricia Other: AACR 2012 meeting: Bayer J.P. Machiels: Uncompensated consultant role: Boerhinger Ingelheim; Research funding to disclose: Sanofi; P. Beuzeboc: Compensated consultant role to disclose: Roche Honoraria to disclose: Roche. All other authors have declared no conflicts of interest.

Background: The COVID-19 pandemic is a highly traumatic event that may lead to a greater risk of developing psychological disorders, especially in cancer patients who are more likely to be infected with the virus and to develop complications. The objective of this study was to measure anxiety levels among cancer patient during COVID-19 pandemic and the associated factors including patients’ conditions of lockdown. Methods: A cross-sectional study was conducted among adult cancer patients (hematological and solid tumors) receiving outpatient treatment or during follow-up in a French Comprehensive Cancer Centre. A postal self-administered questionnaire was sent to 4000 patients in June 2020, including Anxiety (Stait Trait), Fear of a cancer recurrence (FCR) as well as questions relative to socio-demographics, management of cancer care during the pandemic and the conditions of lockdown. Results: A total of 1097 patients completed the questionnaire (63.2% female;mean age 64.7 years ±12.3 years, 24.3% haematological cancers). Mean IES-R score was 15.7 ([0-81]) and 14.7% of patients had moderate or severe post-traumatic stress (score ≥33). Mean anxiety score was 39.0 (SD=13.6, range: [20-80]) with 30.5% of patients having anxiety symptoms. In the multivariate analysis we found that anxiety level was significantly increased for younger patients (OR=1.69, 95%IC [1.01-2.82]), female (OR=1.65, 95%IC [1.05-2.59]), patients with a high FCR score (OR=4.90, 95%IC [2.84-8.44]), patients unsatisfied with the current management of their cancer (OR=2.4, 95%IC [1.58-3.66]) and patients afraid of coming to hospital for fear of COVID (OR=2.10, 95%IC [1.32-3.35]). Protective factors against anxiety were staying busy during the lockdown period (OR=0.46, 95%IC [0.30-0.72]) and seeing the positive aspects of lockdown (OR=0.43, 95%IC [0.28-0.66]). Conclusions: These results contribute to a better understanding of the psychological consequences of COVID-19 pandemic in the context of cancer and highlight the need to better support patients at high risk of developing high anxiety levels. Conditions of lockdown are important to contain anxiety among cancer patients. Legal entity responsible for the study: Institut Paoli-Calmettes Marseille France. Funding: Janssen. Disclosure: G. Gravis Mescam: Financial Interests, Institutional, Advisory Board: BMS;Financial Interests, Institutional, Invited Speaker: Janssen;Financial Interests, Institutional, Advisory Board: Janssen;Financial Interests, Institutional, Advisory Board: Pfizer;Financial Interests, Institutional, Invited Speaker: Astellas;Financial Interests, Institutional, Invited Speaker: MSD;Financial Interests, Institutional, Invited Speaker: Astellas;Financial Interests, Institutional, Invited Speaker: Janssen;Financial Interests, Institutional, Advisory Board: Alliance Merck-Pfizer;Financial Interests, Institutional, Advisory Board: AAA;Financial Interests, Institutional, Invited Speaker: Astellas;Financial Interests, Institutional, Invited Speaker: Janssen;Financial Interests, Institutional, Invited Speaker: AMGEN;Financial Interests, Institutional, Invited Speaker: BMS;Financial Interests, Institutional, Advisory Board: Janssen;Financial Interests, Institutional, Invited Speaker: Sanofi;Financial Interests, Institutional, Funding: Janssen;Financial Interests, Institutional, Invited Speaker: BMS;Non-Financial Interests, Principal Investigator: Ipsen;Non-Financial Interests, Principal Investigator: BMS;Non-Financial Interests, Principal Investigator: Merck. All other authors have declared no conflicts of interest.

Background Incidence of MSCC is increasing, paralleling increasing life expectancy of patients (pts). We analyzed pts referred for surgery for MSCC to evaluate scoring system relevance, prognosis factors, efficiency and safety. Methods From 2004 to 2010 148 pts (77 men) with oncologic (84%) and hematological (16 %) diseases had surgery for MSCC. Patients and tumoral characteristics were recorded. Prognostic value of Tomita, Tokuhashi scores, ASA score, Frankel score (FS) and pain was investigated. Results Median age was 60 y (22–87). Lung (17%) and breast cancer (18%), were mainly represented. Multiple extra-bone metastases were observed in 39% of pts. Pain was present in 96% of pts and 66% were hyperalgic (pain score > 6). FS was decreased for 49% of pts and median Karnofsky Performance Scale (KPS) was 70%. Majority had laminectomy with spinal fixation: 73 %. Radiotherapy was done for 68%. Median overall survival (OS) was 8.9 months (IC95: 4.4–13). Tokuhashi but not Tomita score was relevant. Survival predictive accuracy of TS was only 51%. By univariate analyses, moderate pain (p = 0.001), primary breast (p = 0.02) or hematological (p 70 (p Conclusion Surgery for MSCC is associated with limited morbidity, improvement of patients' autonomy and remission of pain. In our study, usual scores seem not relevant, whereas ASA score, KPS and extra-bone metastases are significant survival prognostic factors. Disclosure All authors have declared no conflicts of interest.