1570 The compatibility of biosimilar filgrastim under cytotoxic chemotherapy in the treatment of malignant diseases: VENICE study

Abstracts (ESMO2012, lecture 15450) that these conditions were separately able to discriminate patients in “Good”, “Intermediate” and “Poor” risk groups. But the joint impact of these two conditions had not been studied so far and was addressed in this study. Methods: Patients (pts) included in a toxicity anticipating program (blood samples and patient reported outcomes) between 2008 and 2011 at the HEGP hospital (Paris, France). F was graded according to CTC-NCI: 0=none, 1=mild, 2=moderate, 3=severe, 4=3+long-term condition and A as Hb(g/dl): 0: 12, 1: [10−12[, 2: [10−8], 3: [9; 8[ and 4: <8. Fatigue and anemia scores were calculated as weighted means over the whole chemotherapy period. Cox regression was used to calculate risk of death given: age, primary tumor site, disease stage and categorized F and A scores. Internal validation using 1000 bootstrap samples and external validation were performed. Results: 661 pts subject to at least 1 F and A assessments were eligible. Median age=64.9 y, sex-ratio=1.1, more frequent tumor type (%): lung: 25, breast: 21, urogenital: 21, gynecological: 13, H&N: 12. OS (m, 95% CI) was 27.8 (26.2–29.4). Median follow-up was 26.7m (25.5– 27.9). F and A scores ranged from 0 to 3 (both median=1, IQR=0.8 and 0.75 respectively). Co-occurrence of F and A was measured using a concordance distance between F and A scores: 296 pts (44.8%) had no difference (identical F and A scores), 315 pts (47.6%) had a 1 unit difference and 50pts (7.5%) had a 2 unit’s difference. A new prognostic model taking into account the joint occurrence of F and A led to 3 risk groups: “Good” (n = 336): score=0−1 (reference group) with median OS=42m, “Intermediate” (n = 310): score=2−3 with HR = 2.91 and median OS=14m and “Poor” (n = 24): score=4 with HR = 14.25 and median OS=3m. Therefore, the co-occurrence of F and A was strongly associated with a very bad prognosis, and both conditions should be considered and corrected separately at the clinic. The model was internally and externally validated on a cohort of 197 new pts. Conclusion: This study emphasized the additive negative impact of fatigue and anemia on survival in cancer patients. No conflict of interest. 1569 POSTER Benefit of a lower dose of Epoetin Theta (ET) in real life for the treatment of chemotherapy-induced anemia (CIA) R. Bugat1 , M.E. Rouge1 , J.L. Mouysset2 , D. Badinand3 , E. Assaf4 , E. Fleck5 , S. Guita6 , S. Hussam7 , O. Benbrahim8 , W. Askoul9 . 1 Oncology University Institute Oncopole, Medical Oncology, Toulouse, France; 2 Rambot Proven¸cale clinics, Medical Oncology, Aix, France; 3 Timone University Hospital, Medical Oncology, Marseille, France; 4 Henri Mondor ´ Hospital APHP, Medical Oncology, Creteil, France; 5 Saint Louis Hospital La Rochelle, Medical oncology, La Rochelle, France; 6 Teva laboratory, ´ Oncology Medical Affairs, Paris, La Defense, France; 7 University Hospital of Brest, Medical Oncology, Brest, France; 8 Regional Hospital Center of Orleans, Medical Hematology, Orleans, France; 9 Radiotherapy Center, Radiotherapy department, Montargis, France Background: CIA is still frequent in cancer patients with a negative impact on general condition and quality of life. It is therefore essential to correct anaemia to improve both quality of life and anti-cancer chemotherapies compliance. Erythropoiesis-stimulating agents (ESA) have proven efficacy in improving hemoglobin (Hb) levels and reducing blood transfusion, however, adjusting the lowest ESA dose remains important to avoid side effects as recommended in US and European guidelines. Methods: French prospective, multi-center observational study, assessing minimal effective dose (20 000 IU) administration of ET in patients with CIA associated to non myeloid malignancy. The primary outcome measure was the proportion of patients achieving Hb level [10−12 g/dL] target at week 8 (w8) as defined by the physicians at baseline. Study measurements included ET dose, changes in Hb levels from baseline and therapeutic strategies that could participate to the achievement of the Hb target level. Results: From March 2012 to July 2013, 847 patients were included, >18 years (mean age 66.8 years − 51.7% female) with CIA in association to solid tumour (ST) (80.87%) and hematologic malignancies (HM) (19.13%). The most frequent ST cancers were: lung (28.32%) and gastrointestinal (25.5%) while in HM: non Hodgkin Lymphoma (53%) and multiple myeloma (24%). Most of the patients were treated with combination chemotherapy, mainly platinium based (36,64%). Patients were almost all treated ambulatory (86.07%) with ET. Mean baseline Hb was 9.54 g/dL and 40% of patients having moderate anemia (Hb 8−9.5 g/dL). As global response, Hb target level was achieved in 77.7% (11.05 g/dL) at w8 and 86.56% (11.39) at w12. With regards to the Hb level targeted by physicians (mean 11.7±0.6 g/dL), it has been achieved in 24.5% [95% CI 21,2−28,2] of patients at w8 [day 56±10], this rate was slightly higher in patients who had Hb 9.5 g/dL at baseline (26.38%). Overall mean change in Hb

S227 level was 1.44±1.30 and 1.78±1.43 g/dL at w8 and w12, respectively. Hb response was maintained in 51.04% [95% CI: 46.6–55.5] one month after treatment discontinuation. Patients received oral or IV iron in 13.85% and 10.89%, respectively and antithrombotics in 45.69%. Univariate analysis did not identify any potential prognostic factors to achieve targeted Hb level. Transfusion rate were 17.86% at w8. Conclusion: The lower dose of ET 20,000 IU weekly is an effective treatment of anaemia in patients with ST and HM. Moreover, the Hb response seemed sustainable one month after ET therapy discontinuation. These findings are in accordance with the current US and European guidelines for treatment of CIA. No conflict of interest. 1570 POSTER The compatibility of biosimilar filgrastim under cytotoxic chemotherapy in the treatment of malignant diseases: VENICE study B. Otremba1 , C. Salat2 , O. Stoetzer2 , K. Kittel3 , C. Maucksch4 . 1 Onkologische Praxis Oldenburg/Delmenhorst, Standort Oldenburg, ¨ Oldenburg, Germany; 2 Hamato-Onkologische Schwerpunktpraxis, Praxis Munchen, ¨ Munchen, ¨ Germany; 3 Praxisklinik Brustzentrum, Standort 4 Lichtenberg, Berlin, Germany; Hospira Deutschland GmbH, Medical Affairs, Munchen, ¨ Germany Background: Febrile neutropenia (FN) is a serious, frequent complication of cytotoxic chemotherapy (CT). Biosimilar filgrastim (Nivestim™, Hospira Inc.) is a granulocyte-colony stimulating factor (G-CSF) licensed for the treatment of neutropenia and FN induced by myelosuppressive CT. The primary aim of the VENICE study was to observe the tolerability, safety and efficacy of preventative treatment using Nivestim™ in patients receiving CT for cancer. The study focused particularly on the incidence of adverse events as well as overall hospitalisation and hospitalization due to FN and/or infection over a 6 month period. Material and Methods: The VENICE study was a prospective, noninterventional, longitudinal, multicentre study conducted in Germany. Consenting patients with solid tumors or malignant hematologic tumors except for chronic myeloid leukaemia (CML) or myelodysplastic syndrome (MDS) for whom cytotoxic chemotherapy and treatment with Nivestim™ was planned were enrolled in the study. Data collection included demographic data, clinical characteristics, Nivestim™ treatment-related data on efficacy and safety, such as adverse events (AEs), including FN and hospitalizations. Patients were monitored for 1−6 CT cycles with three visits at inclusion, during treatment, and following CT. Results: 386 adult patients undergoing cytotoxic chemotherapy were treated prophylactically with Nivestim™ in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced FN. Overall, 386 patients were enrolled in the study and 81% were female. Mean age ± SD was 60.3±12.13 years with 39% of the patients age >65 years. 338 patients (88%) had solid tumours and 49 (13%) had haematological malignancies. The majority (64%) of patients received biosimilar filgrastim as a primary prophylaxis and 36% as secondary prophylaxis. At inclusion, 97% of patients had no prior FN; 43% had prior CT. Of the 382 patients evaluated in the safety analysis, 24 (6%) had at least one hospitalization with a median stay of 10 days. 2% of patients were hospitalized due to FN or infection. For 6% of the patients the chemotherapy was delayed due to febrile neutropenia. During the study, 51.3% of patients experienced 1 AE; AEs were reported with similar frequency in patients with hematologic malignancies (55%), breast cancer (51%) and other solid tumours (50%). 8% of patients reported bone pain and 12% had an infection. Conclusions: The VENICE observational study was designed to evaluate the use of Nivestim™ according to label-mandated posology for the administration of G-CSF and thereby provided additional real world data on supportive care for cancer patients. Biosimilar filgrastim (Nivestim™) was effective and well-tolerated in both the primary and secondary prophylactic setting in patients undergoing CT for solid tumours and haematological malignancies. Conflict of interest: Corporate-sponsored Research: Hospira sponsored the VENICE study, data analysis and medical writing assistance was provided by AMS − Advanced Medical Services GmbH, Mannheim, Germany and was supported by Hospira. BO, CS, OS and KK have no conflicts of interest to declare. CM is employed by Hospira and may own stock or options. Dr. Nancy Eby and Aneurin Ellis, AMS − Advanced Medical Services GmbH, Mannheim, Germany provided data analysis and medical writing services that was funded by Hospira Deutschland GmbH. NE and AE declare no conflict of interest.