Objectives: In the CheckMate 067 clinical trial NIVO+IPI regimen and NIVO monotherapy were shown to significantly improve progression-free survival (PFS) compared with IPI monotherapy (median PFS was 11.5, 6.9, and 2.9 months for NIVO+IPI, NIVO, and IPI respectively) in AM patients, but little is known regarding the healthcare costs of these newer therapies. The aim of this study was to compare the total melanoma-specific healthcare costs in CheckMate 067 with the standard of care (SOC) therapies in first-line AM treatment. MethOds: The Truven MarketScan database (MarketScan; April 2011-June 2013) was used to identify cost (in 2015 US$) of the current melanoma SOC. Patient-level data from CheckMate 067 were used to derive resource utilization for NIVO+IPI regimen and NIVO monotherapydue to the lack of real-world data at the time of analysis. Unit costs from MarketScan were applied to resources from CheckMate 067 to derive healthcare costs for NIVO+IPI regimen and NIVO monotherapy. All melanoma-specific healthcare costs (including drug, inpatient, outpatient, procedures, laboratory and emergency room costs) occurring during the first year of treatment were aggregated for each treatment and adjusted for censoring. A cost comparison analysis was then performed. Results: Ipilimumab (33%), vemurafenib (19%), temozolomide (16%), interleukin (11%) and interferon (6%) were the most widely prescribed drugs with 12-month total melanoma healthcare costs of $194k, $153k, $155k, $259k and $70k, respectively. The corresponding total melanoma healthcare costs for CheckMate 067 arms were $212k for IPI monotherapy, $234k for NIVO+IPI regimen and $172k for NIVO monotherapy. cOnclusiOns: These results suggests that NIVO+IPI regimen and NIVO monotherapy provide significant added clinical benefit at a marginally higher or even at a lower cost compared with IPI in previously untreated AM patients. Compared with IPI healthcare costs, NIVO+IPI regimen healthcare costs were only 10% higher, while NIVO monotherapy healthcare costs were 19% lower.

epidemiologic outlook and medical resources used in diagnosis, 1st/2nd/3rd and 4th lines of treatment, monitoring, palliative care and adverse events. Based on these results, diagnosis cost per patient was estimated as 723.39 TL and the annual costs of 1st/2nd/3rd and 4th lines of treatment per patient were estimated as 3,497.14 TL, 4,329.94 TL, 11,857.97 TL and 5,367.87 TL respectively. The annual monitoring costs of 1st/2nd/3rd and 4th lines of treatment per patient were estimated as 2,451.55 TL, 2,818.92 TL, 2,581.92 TL and 2,769.14 TL respectively. The annual costs of palliative care and adverse events per patient were estimated as 302.61 TL and 1,122.20 TL. Considering all these cost items, average annual cost per patient was found as 10,015.50 TL. ConClusions: The study revealed that there are different treatment approaches for HR+/HER2-post menopausal advanced/metastatic breast cancer treatment in Turkey. Total treatment costs to public payer have been calculated, taking into account all direct medical costs including adverse events, revealing differences between treatment lines.

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Introduction Patients with similar local advanced breast cancer (LABC) could respond different to neoadjuvant chemotherapy (NC). Luminal HER2(-) tumors have pathologic complete response (pCR) by 5-7%. Ki67, tumor grade and hormonal receptors, could be helpful but not enough to choice between NC vs. initial surgery. Response to drugs depends on enzymes involved in absorption, distribution, metabolism and elimination (ADME); the drug-metabolizing enzyme and transporter platform (DMET), could identify 1936 single nucleotide polymorphism (SNP) from 225 genes involved in ADME proccess. Objective To identify predictive factors to pCR in patients with Luminal HER2(-) LABC underwent NC, to distinguish wish patients could have a real benefit from NC. Material and Methods This is a prospective nested case control study (1:4) with LABC patients, pure invasive ductal carcinoma Luminal HER2(-) subtypes, and sequential NC (anthracyclines and taxanes). Cases were defined as patients with pCR (Residual Cancer Burden=0), and controls those without pCR. SNPs were evaluated from DNA of leucocytes using DMET microarrays by Affymetrix. Bivariate analyses were used as appropriate. Microarrays were processed by the DMET analyzer console. OR and 95%CI were used to test association between pCR and variables with a non-conditional logistic regression analysis; p value ≤0.05 was considered statistically significant (two-sided). Results From 2005 to 2014, of 3762 treated patients, 287 women met inclusion criteria. We included 117 patients, 21 cases and 96 controls. Patients with pCR were 5 years younger than controls (45.4 vs 49.4), have more grade-3 tumors, (66.7 vs 22.3%), more Luminal B subtypes (90.5 vs 64.6%), lower expression of estrogen receptor (60 vs 80%) and higher Ki67 expression (65 vs 12%), all with p≤0.05. No differences in toxicity existed between groups. In an initial screening procedure, 13 SNPs were identified, but only 4 SNPs (4 genes) are known to participate in ADME of antineoplastic agents. All pCR cases did not have the C/C allelic variant in the rs2072671 SNP (CDA gene); while in rs1883322 SNP (PPARD gene) all had T/T variant SNPs identified in DMET microarray known to participate with antineoplastic agentsGENESNPAllelic variantpCR, n=21No pCR, n=96pDPYDrs17376848T/T13 (61.9%)83 (86.4%)0.007  C/T8 (38.1%)11 (11.4%) CDArs2072671A/A6 (28.5%)51 (53.1%)0.013  A/C15 (71.4%)36 (37.5%)   C/C09 (9.3%) PPARDrs1883322T/T21 (100%)69 (71.8%)0.022  C/T022 (22.9%)   C/C05 (5.2%) GSTM3rs7483A/A7 (33.3%)20 (20.8%)0.024  A/G13 (61.9%)43 (44.7%)   G/G1 (4.7%)33 (34.3%) pCR= pathologic complete response After logistic regression analysis, pCR predictive factors were the presence of grade-3 tumors OR=6.66 (95%CI=1.67-26.56), Ki67 ≥14% OR=15.45 (95%CI=1.71–138.86), premenopausal status OR=6.540 (95%CI=1.50–28.38) and A/A or A/G allele in rs7483 SNP (GSTM3 gene) OR=19.16 (95%CI=1.97–185.93). Conclusions Genetic variability encoded in the DMET-chip, could be helpful as a predictive factor of pCR in patients with Luminal HER2(-) LABC, but only in combination with other factors such as grade-3 tumors, elevated Ki67, and premenopausal status. Citation Format: Ruvalcaba-Limon E, Rodriguez-Cuevas S, Hidalgo-Miranda A, Villa-Romero A, Bautista-Piña V, Rebollar-Vega R, Fernandez-Lopez JC, Morales-Vasquez F. Predictive factors of pathologic complete response to neoadjuvant chemotherapy in patients with Luminal HER2(-) local advanced breast cancer using the DMET microarray [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P6-09-18.