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Background: Pathogenic BRCA1/2 mutations currently serve as the main biomarker of homologous recombination deficiency (HRD) for PARP inhibitor (PARPi) selection, which have also been reported to correlate with the efficacy of platinum (Pt) chemotherapy. However, patients without BRCA1/2 alterations can also present HRD phenotype through other mechanisms and might benefit from PARPi or Pt chemotherapy.Methods: HRD score of tumor samples from 199 patients (Cohort I: ovarian, breast, pancreatic, prostate, and uterine cancers) were evaluated by targeted next-generation sequencing (NGS) (GeneseeqPrimeÒ HRD). A cohort of 416 independent solid tumor patients (Cohort II) were further analyzed for exploring HRD score distribution, while another cohort of 84 high-grade serous ovarian cancer patients (Cohort III) who received Pt chemotherapy were analyzed for investigating the predictive value of HRD score in treatment efficacy.Results: HRD score, combining loss of heterozygosity (LOH), telomeric allelic imbalance (TAI), and large-scale station transitions (LST), of Cohort I ranges from 0 to 107, 32% of which harbor BRCA1/2-deficiency (pathogenic mutations with LOH, 2 pathogenic mutations, or homozygous deletion). HRD score 38 was defined as HRDpositive that accounts for approximately 95% of the BRCA1/2-deficient cases. In Cohort II, 14% of them were BRCA1/2-deficient with a median HRD score of 67 which was significantly higher than that of the BRCA1/2-sufficient ones (28; p<0.001). In BRCA1/2-wildtype subgroup, 37% of patients have HRD scores38 (51%, 42%, and 8% for ovarian, breast, and pancreatic cancers). In Cohort III, patients with a platinumfree interval (PFI) of over 6 months (Pt-sensitive) have significantly higher HRD scores than Pt-resistant patients (median: 55 vs 34, p¼0.04). In BRCA1/2-wildtype patients, a significantly longer PFS was observed when HRD38 than those with HRD<38 (median: 17.8 vs 11.8 months, p¼0.04).Conclusions: Our study reported an HRD evaluation pipeline based on targeted NGS in diverse cancer types, and HRD38 was chosen to define HRD-positive status, which correlates with better clinical outcomes of Pt-chemotherapy.

e20513 Background: Chemotherapy-induced anemia (CIA) treatment requires transfusion, or epoietin administration. Elderly patients (pts) may experience severe complications from CIA, with fatigue and cardiovascular events. Methods: ORHEO (place of biOsimilaRs in the therapeutic management of anemia secondary to chemotherapy in HaEmatology and Oncology) was a post-marketing, observational, prospective, multicentric study. Adult CIA (Hb<110g/l) pts with solid tumors, lymphomas or myelomas and eligible for epoetin alpha biosimilar (EAB) treatment were included to receive EAB according to drugs approval recommendations. Recorded data included demographics, performance status, blood count and iron load profile. Safety (NCI-CTC V2.0) and efficacy were also assessed. The primary study endpoint was the rate of responders (defined as increase in Hb levels to 100 g/l or at least 10 g/l since inclusion visit, or reaching target Hb set at start of study, without any blood transfusions in the 3 weeks prior to measurement) at +3 months (M+3). Other endpoints included safety, patterns of treatment interruption and rate of responders at +6 months (M+6). Here we present data for the elderly (>= 70 years old) pts. Results: 1,009 pts (54.3% male, 45.7% female) >= 70 y.o. were included in this analysis. Median age was 77 y, range [70-93]. At baseline, 36.3, 57.8 and 3.4% of pts had respectively grade 1, 2 and 3 anemia. Iron supplementation was given in 9.9 (oral) and 16.0% (IV) of pts. At M+3, 84.0% of pts were responders (IC95% 81.4-86.3). Moreover, respectively 241 pts (23.8%) and 139 pts (13.7%) had stopped EAB permanently or temporarily, mainly because of efficacy (45.2 and 79.1% respectively); other reasons were side-effects (2.9 and 0.7% respectively), lack of efficacy (7.0 and 4.3%), and unspecified reason (44.8 and 15.8%). Similar results were observed at M+6 with 86.8% of responders. 17.0% of pts reported side effects (all grades); the most frequent were thromboembolic events (4.5%). No EAB-related death was reported. 94.6% of pts reported being satisfied with EAB therapy at M+3 and M+6 and willing to restart if needed. Conclusions: EAB therapy is efficacious on CIA management in elderly pts with low toxicity.

9564 Background: Chemotherapy may induce anemia with potentially severe consequences. The ORHEO (place of biOsimilaRs in the therapeutic management of anaemia secondary to chemotherapy in HaEmatology and Oncology) study examined the efficacy and safety of epoetin alfa biosimilars (EABs) for the treatment of chemotherapy-induced anemia (CIA) in the clinical setting. Methods: ORHEO was a multicenter, observational, prospective, post-marketing study conducted in France. Patients with CIA (Hb <110g/L) >18 years old, with solid tumors, lymphomas or myelomas and eligible for epoetin alfa treatment were included in the study; they received EAB as prescribed by their physician. Baseline patient characteristics and anemia-related data including baseline and target Hb level epoetin treatment, adverse events and any other concomitant treatments prescribed were recorded. The primary endpoint was the rate of responders (defined as an increase in Hb levels to 100 g/L or at least 10 g/L since inclusion visit, or reaching target Hb set at start of study, without any blood transfusions in the 3 weeks prior to measurement) at +3 months (M3). Other endpoints included rate of responders at +6 months (M6) and safety endpoints. Results: 2310 patients (51.43 % male, 48.57 % female) from 232 centers were included in this study. At baseline 79.6% had solid tumors, 13.0% lymphomas and 7.4% myelomas. Median age was 68 y (range: 18–93). Mean baseline Hb level was 96 g/L with a target Hb level of >= 120 g/L for 52.7% of patients. Almost all (99.9%) received the biosimilar epoetin zeta (median dose 30,000 IU/week) with 26.6% receiving additional iron supplementation. A total of 2056 and 1664 patients had at least one Hb level value at M3 and M6 respectively. The rate of response was 81.6% and 86.5% at M3 and M6, respectively. In total, 17.0% of treated patients reported clinically relevant adverse events (all grades), the most common being infections (5.0%) and thromboembolic events (3.5%). Transfusion rates were reported as 9.4% and 5.8% at M3 and M6, respectively. No EAB-related deaths were reported. Conclusions: EAB was effective and well-tolerated in the management of CIA. Clinical trial information: NCT01626547.