ObjectivesCancer incidence and mortality have been increasing both globally and in Greece. The aim of this study was to quantify the health benefits and budget impact of including anti-PD-(L)1’s in three early-stage cancer indications, adjuvant melanoma stage IIB/C and III, adjuvant renal cell carcinoma, and perioperative triple-negative breast cancer.MethodsA Markov model approach was used to predict clinical outcomes and costs throughout the average patient pathway over a 10-year time horizon. The model includes two scenarios: (1) using anti-PD-(L)1’s for patients with early-stage and metastatic disease (ESD scenario) versus (2) treatment with the previous standard of care in the early-stage and anti-PD-(L)1’s only in the metastatic disease setting (reference scenario). Estimated outcomes include life-years (LYs), quality-adjusted life-years (QALYs), events or recurrences, productive LYs lost for patients and caregivers, active treatments administered for metastatic disease, deaths, and costs. The model inputs included efficacy data from clinical trials, Greek data on market shares, projected eligible patients, and the respective costs.ResultsResults indicate the following in the ESD scenario: a reduction of 1,722 (25%) recurrences, 881 (24%) deaths, an increase of 5,555 (11%) LYs without recurrence, an increase of productive LYs by 901 (16%) and 2,363 QALYs gained (4%), and a decrease of 1,782 (27%) in active treatments for the metastatic disease setting. The average incremental budget impact per patient per annum was €31,853 throughout the 10-year time horizon of the model from 2023 to 2032.ConclusionResults indicate that adjuvant/perioperative treatments could provide a significant benefit to patients with cancer, with a manageable additional cost for the healthcare system. The estimations of the model demonstrate a strong call to action for policymakers to enhance access to innovative treatments, since benefits arise for patients, their caregivers, and society as a whole through increased productivity gains.

Background The study aimed to evaluate real-world effectiveness and toxicity data of trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG) in pretreated patients with metastatic breast cancer (mBC). Patients and methods A retrospective multicenter review of medical records of patients with mBC treated with T-DXd and/or SG at 24 Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG) was carried out. Patients with triple-negative BC (TNBC), HER2-positive, and/or hormone receptor (HR)-positive mBC who received at least one cycle of T-DXd and/or SG in any line of treatment were included. The primary endpoint was the toxicity rate of each drug. Results From January 2020 to April 2024, 312 patients received treatment; 226 (72.4%) received T-DXd and 60 (19.2%) SG, while 26 (8.3%) patients received both agents. Adverse events (AEs) were reported in 57.1% of patients treated with T-DXd and 56.6% of patients treated with SG. The most common AEs were nausea (28.1%) and fatigue (22.5%) among patients treated with T-DXd, and fatigue (20.7%) and neutropenia (12.6%) among those treated with SG. Toxicity-related discontinuation was reported in 12 (8.8%) and 2 (3.2%) patients, respectively, who received T-DXd and SG. Interstitial lung disease was observed in 17 (6.9%) patients treated with T-DXd. The 12-month progression-free survival (PFS) rate was 69.6 [interquartile range (IQR) 61.4-79] in patients with HER2-positive and 46.5 (IQR 28.6-46.5) in patients with HER2-low mBC receiving T-DXd. In patients with TNBC receiving SG, the 12-month PFS rate was 16.2 (IQR 8.1-32.4), whereas in patients with HR-positive/HER2-negative mBC, it was 23.6 (IQR 13.8-40.3). Conclusions Real-world data on the use of T-DXd and SG in patients with mBC provide significant clinical insights into the toxicity and effectiveness of each agent.

PURPOSEThe pan-cancer presence of microsatellite instability (MSI)-positive tumors demonstrates its clinical utility as an agnostic biomarker for identifying immunotherapy-eligible patients. Additionally, MSI is a hallmark of Lynch syndrome (LS), the most prevalent cancer susceptibility syndrome among patients with colorectal and endometrial cancer. Therefore, MSI-high results should inform germline genetic testing for cancer-predisposing genes. However, in clinical practice, such analysis is frequently disregarded.METHODSA next-generation sequencing (NGS)-based technique was used for MSI analysis in 4,553 patients with various tumor types. Upon request, somatic BRAF gene analysis was conducted. In addition, hereditary testing of cancer-associated genes was performed in MSI-high cases using a capture-based NGS protocol. MLH1 promoter methylation analysis was conducted retrospectively in patients with colorectal and endometrial cancer to further investigate the origin of MSI at the tumor level.RESULTSThe MSI positivity rate for the entire cohort was 5.27%. Endometrial, gastric, colorectal, urinary tract, and prostate cancers showed the highest proportion of MSI-high cases (15.69%, 8.54%, 7.40%, 4.55%, and 3.19%, respectively). A minority of 45 patients (22.73%) among the MSI-high cases underwent germline testing to determine whether the mismatch repair pathway deficiency was inherited. 24.44% of those who performed the genetic test carried a pathogenic variant in an LS-associated gene. Three MSI-high individuals had non-LS gene alterations, including BRCA1, BRCA2, and CDKN2A pathogenic variants, indicating the presence of non-LS-associated gene alterations among MSI-high patients.CONCLUSIONAlthough MSI analysis is routinely performed in clinical practice, as many as 77% of MSI-high patients do not undergo LS genetic testing, despite international guidelines strongly recommending it. BRAF and MLH1 methylation analysis could shed light on the somatic origin of MSI in 42.50% of the MSI-high patients; however, MLH1 analysis is barely ever requested in clinical practice.

Poly(ADP-ribose) polymerase inhibitors (PARPi) target the DNA repair pathways and have been established in epithelial ovarian cancer (EOC) as maintenance therapy inducing prolonged survival. However, recently published data showed that PARPi may increase the risk of therapy-related myeloid neoplasms (t-MN) including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Herein, we investigated the incidence, characteristics, and management of t-MN among EOC patients after exposure to PARPi in a Greek Cancer Center. We analyzed 112 consecutive EOC patients treated with PARPi with a median age of 58 years (range 28-84). Olaparib and Niraparib were used in 90 and 22 patients, respectively. The median number of previous chemotherapy lines and duration of treatment with PARPi were 2 (range 1-9) lines and 12 (range 2-24) months, respectively. The incidence of t-MN among patients treated with PARPi was 3.57% (4/112). Patients with t-MN were distributed as follows: t-MDS: 1, t-MDS/AML: 1, t-AML: 2. We observed adverse cytogenetic features in t-MN patients leading to dismal prognosis. In conclusion, in accordance with previous real-world reports, we confirm a notable risk for t-MN in EOC patients treated with PARPi. As PARPi are an emerging therapy for many neoplasms, there is an unmet clinical need to identify patients who are considered at high risk for developing t-MN post-therapy with PARPi in order to introduce potential preventive strategies.

Background/Aim: Nivolumab is an FDA-approved immune checkpoint inhibitor (ICI) for patients with advanced, pre-treated non-small cell lung cancer (NSCLC). However, treatment profiles and patient outcomes often differ in routine clinical practice while the financial impact of approved therapies is largely unknown. In this study, we investigated the efficacy, tolerability, and economic impact of nivolumab in real-world settings (RWS) in Greece. Patients and Methods: Patients diagnosed with advanced pre-treated NSCLC, receiving nivolumab were recruited from October 2015 until November 2019 across 18 different clinical centers in Greece. Endpoints included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Cost analysis was conducted using a third-party public-payer perspective (National Organization for Healthcare Services Provision; EOPYY). Results: A total of 346 patients, median age 66.5 years, were included. With 43.4 months median follow-up, median PFS was 7.8 months and median OS 15.8 months. The 1-year OS rate was 56.5%, 2-year OS 38.8%, and 3-year OS 27.3%. The ORR was 29.5% and DCR 58.7%, with a median response duration of 26.8 months. Patients with objective response were more likely to experience long-term survival (HR=0.14, p<0.001). Only 8.4% of patients experienced grade 3-4 adverse events. The presence of immune-related adverse events was associated with improved OS (HR=0.77, p=0.043). Nivolumab-associated economic burden accounted for €2,214.10 per cycle for each patient, mainly attributed to drug-acquisition costs. Conclusion: This is the first report of real-world efficacy, safety, and economic burden of nivolumab in pre-treated patients with NSCLC in Greece. Indirectly compared to clinical trials, nivolumab was associated with improved efficacy in RWS, further supporting its use in clinical practice and providing insights on clinical prognosticators. The main cost component affecting the nivolumab economic burden was drug-acquisition costs, while toxicity-associated cost was negligible.

Cancer pain requires careful comprehensive patient evaluation and an appropriate and personalized clinical approach by a trained multidisciplinary team. The proper assessment of breakthrough cancer pain (BTcP) is part of an all-inclusive multidimensional evaluation of the patient. The aim of this narrative review is to explore the relationship between high-rate BTcP, which strongly impacts health- related quality of life and tumour characteristics, in the face of novel approaches that should provide guidance for future clinical practice. The presentation of short, emblematic clinical reports also promotes knowledge of BTcP, which, despite the availability of numerous therapeutic approaches, remains underdiagnosed and undertreated. This article is part of the Management of breakthrough cancer pain Special Issue: https://www.drugsincontext.com/special_issues/management-of-breakthrough-cancer-pain.

Several tumor types have been efficiently treated with PARP inhibitors (PARPis), which are now approved for the treatment of ovarian, breast, prostate, and pancreatic cancers. The BRCA1/2 genes and mutations in many additional genes involved in the HR pathway may be responsible for the HRD phenomenon. The aim of the present study was to investigate the association between genomic loss of heterozygosity (gLOH) and alterations in 513 genes with targeted and immuno-oncology therapies in 406 samples using an NGS assay. In addition, the %gLOHs of 24 samples were calculated using the Affymetrix technology in order to compare the results obtained via the two methodologies. HR variations occurred in 20.93% of the malignancies, while BRCA1/2 gene alterations occurred in 5.17% of the malignancies. The %LOH was highly correlated with alterations in the BRCA1/2 genes, since 76.19% (16/21) of the BRCA1/2 positive tumors had a high %LOH value (p = 0.007). Moreover, the LOH status was highly correlated with the TP53 and KRAS statuses, but there was no association with the TMB value. Lin's concordance correlation coefficient for the 24 samples simultaneously examined via both assays was 0.87, indicating a nearly perfect agreement. In conclusion, the addition of gLOH analysis could assist in the detection of additional patients eligible for treatment with PARPis.

Background/Aim: Real-world data on the EGFR mutational profile upon progression after first/second-generation EGFR-TKI treatment in patients with advanced non-small-cell lung cancer (NSCLC) and treatment strategies employed thereon are needed. Patients and Methods: This observational study was conducted in 23 hospital-based lung cancer Centers in Greece (protocol code: D133FR00126). Ninety-six eligible patients were consecutively enrolled between July-2017 and September-2019. Re-biopsy was performed in 18 of 79 patients who tested T790M-negative in liquid biopsy after progression in the first-line (1L) setting. Results: Of the study population, 21.9% tested T790M-positive, while 72.9% proceeded to 2L treatment, mainly comprising of a third -generation EGFR-TKI (48.6%), a switch to chemotherapy (30.0%), or chemo-immunotherapy (17.1%). The objective response rate (ORR) in 2L was 27.9% in T790M-negative and 50.0% in T790M-positive patients. Of evaluable patients, 67.2% experienced disease progression; median progression -free survival (PFS) was 5.7 and 10.0 months among T790M-negative and positive patients, respectively. Among T790M-negative patients, longer median PFS and post-progression survival were observed with third-generation EGFR-TKI treatment. Conclusion: Mutational status and treatment strategy were identified as critical determinants of clinical outcomes in the 2L-setting of EGFR-mutated NSCLC patients in real-world settings in Greece, with early diagnosis, appropriate molecular testing and high-efficacy treatments at first lines positively affecting ORR and PFS.

PIK3CA mutations have been identified in approximately up to 40% of breast cancer cases and PIK3CA targeting has already been incorporated in treatment algorithms, especially in the second line of ER+/HER2- patients. HeSMO launched a national program to provide PIK3CA mutation testing, which is officially not reimbursed, with the aim to identify mutations in the PIK3CA gene, and, therefore, lead to more therapeutic options. All HR+/HER2- patients with a diagnosis of metastatic breast cancer were eligible to participate in this program. The result of the test was obtained using the COBAS® PIK3CA method, a diagnostic test specifically designed to detect mutations in the PIK3CA gene in tumor tissue samples (FFPE) attained by biopsy or surgically, which detects 17 different mutations in the PIK3CA gene, including the most commonly occurring in Exons 9 and 20. From June 2022 to March 2023, 149 patients from across the country were tested within this program. Sixty one (61) patients (40.94%) were detected with mutation in PIK3CA gene and 88 (59.06%) without mutation (Table). 23 patients had Exon 9 mutations (37.70%), 33 in Exon 20 (54.10%), and 8 had mutations in the remaining Exons 1, 4 and 7 (13.11%). In 1 sample 4 mutations were detected: (Exon 7/9/20), and 2 mutations in another 2 samples (Exon 9: E545X, Q546X and Exons 1/20), while in all other samples just 1 mutation was detected in each. Table: 439PPIK3CA mutation results of HeSMO’s programExonMutationSamplesMutation percentage in all patients detected with PIK3CA gene mutation (61)Mutation percentage in all patients tested (149)Exon 1R88Q23,28%1,34%Exon 4N345K34,92%2,01%Exon 7C420R34,92%2,01%Exon 9E542K711,48%4,70%Exon 9E545X1219,67%8,05%Exon 9Q546X23,28%1,34%Exon 9E545X, Q546X11,64%0,67%Exon 9E542K, E545X11,64%0,67%Exon 20H1047X3252,46%21,48%Exon 20G1049R11,64%0,67% Open table in a new tab In our series, 40.94% of the patients tested, were detected with mutations in PIK3CA gene, in accordance with published data. Apart from the significant implications for treatment possibilities in a substantial patients’ population, these results provide valuable epidemiological data and strengthen our efforts for reimbursement of PIK3CA mutation testing in Greece.

Background/Aim: This study aimed to provide real-world safety and effectiveness data of everolimus (EVE) plus exemestane (EXE) in estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2–) advanced breast cancer (aBC). Patients and Methods: This prospective observational study was conducted by 19 hospital-based oncologists in Greece. Eligible patients were treated with EVE+EXE in the first-line setting; EVE was initiated according to the approved label. Results: Overall, 75 eligible patients (mean age: 66.9 years; visceral metastases: 49.3%; bone-only metastases: 37.3%) were included in the effectiveness analyses. Over a median (interquartile range) of 12.1 months (range=4.2-20.5 months) of EVE treatment, the median progression-free survival was 18.0 months and the overall response rate was 22.7%. Among patients that received ≥1 EVE dose (n=80), the incidence of EVE-related adverse events was 72.5% (serious: 55.0%); stomatitis (22.5%), fatigue (22.5%), pneumonitis (18.8%); and cough (18.8%) were the most common. Conclusion: In the routine care in Greece, EVE demonstrates clinical benefit and a predictable safety profile.

The current state of the SARS-CoV-2 pandemic is an equilibrium between expanding vaccine coverage on the one hand, and emergence of variants of concern which compromise vaccine effectiveness and enhance viral transmission on the other. Inequity in vaccine distribution, primarily an ethical issue, challenges this equilibrium, as industrialized countries prepare to administer a third booster dose to their population. Solid tumor cancer patients typically respond well to initial full vaccination and someone could argue that they should not be prioritized for an adjuvant third dose, since protection from severe disease has largely been achieved with the two-dose regimen. Nevertheless, their immune status is dynamic and not all of them exhibit an adequate immune response. A booster third dose is necessary for the inadequate responders, while it will result in better protection of all patients from mild disease as well, which if presented could have ominous consequences due to their overall frailty, and their need to adhere to strict therapeutic schemes. International scientific and public health communities should develop approaches that allow for wide immediate vaccination coverage of the developing world, in parallel with administration of adjuvant doses to solid tumor cancer patients (and other at-risk categories) of the developed nations, in order to avoid prolonging the pandemic, which will be prospectively against cancer patients' best interest.

Purpose: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are the preferred first-line option for patients with advanced, EGFR-mutant non-small cell lung cancer (NSCLC). Afatinib, a second-generation irreversible EGFR-TKI, has been exten-sively used in Greece in this setting; however, real-world data regarding molecular epide-miology and financial implications of afatinib use are lacking. Materials and Methods: This was an observational, non-interventional, multicenter, retro-spective cohort study, based on real-world data collected from the medical charts/records of patients treated with afatinib between 15/03/2015 and 25/06/2020 and were recorded on a web-based data capture system. Cox models were used to assess the prognostic significance of clinicopathological parameters with respect to clinical outcomes of interest. Cost analysis was conducted from a public third-payer perspective, and only direct medical costs reim-bursed by the payer were considered. Results: A total of 59 patients were treated with afatinib for their EGFR mutation-positive advanced NSCLC; the median age was 61 years (range: 37-91). Performance status was zero in 61%, and brain metastases were present in 13.6%. Forty-four patients (74.6%) had a deletion in exon 19 only, while nine (15.3%) had a mutation in exon 21, 8 of them in L858R and one in L861Q. At a median follow-up of 41.8 months (95% CI 35.9-51.4), the median PFS was 14.3 months (95% CI 12.2-16.4), and the median OS was 29 months (95% CI 25.6-33.4). Corresponding values for patients with deletion 19 only were 14.3 months (95% CI 11.5-18.5) and 28.1 months (95% CI 21.1-32.6), respectively. The mean expendi-ture for the treatment of each patient equals euro 25,333.68; with euro 21,865.06 being attributed to drug acquisition costs, euro 3325.35 to monitoring costs and euro 143.27 to adverse event treatment-related costs. Conclusion: Long-term data in the real-world setting in Greece confirm activity, tolerability and cost-effectiveness of afatinib as first-line treatment of patients with advanced EGFR-mutant NSCLC. Clinical Trial Registration: Clinicaltrials.gov NCT04640870.

Data on the safety and efficacy of immune checkpoint inhibitors (ICI) in patients with concurrent autoimmune diseases (AID) are limited. We performed a retrospective multicenter review of medical records of patients with cancer and underlying AID who received ICI. The primary endpoint was progression-free survival (PFS). Among 123 patients with pre-existing AID who received ICI, the majority had been diagnosed with non-small cell lung cancer (NSCLC, 68.3%) and melanoma (14.6%). Most patients had a rheumatologic (43.9%), or an endocrine disorder (21.1%). Overall, 74 (60.2%) patients experienced an immune-related adverse event (irAE) after ICI initiation, AID flare (25.2%), or new irAE (35%). Frequent irAEs included thyroiditis, dermatitis and colitis. ICI was permanently discontinued due to unacceptable (8.1%) or fatal (0.8%) toxicity. In patients with NSCLC, corticosteroid treatment at the initiation of immunotherapy was associated with poor PFS (HR = 2.78, 95% CI 1.40–5.50, p = 0.003). The occurrence of irAE was associated with increased PFS (HR = 0.48, 95% CI 0.25–0.92, p = 0.026). Both parameters maintained their independent prognostic significance. ICI in patients with cancer and pre-existing AID is associated with manageable toxicity that infrequently requires treatment discontinuation. However, since severe AID flare might occur, expected ICI efficacy and toxicity must be balanced. NCT04805099

CureCancer is a patient-centered/patient-driven digital tool integrated in the routine oncology practice. Patients self-create their medical profile, record their symptoms and communicate them to health care professionals (HCPs). We aimed to assess the tool's feasibility and patients' satisfaction. 14 Centers participated, starting from 02.2020. COVID-19 epidemic period was included. Patients signed consent to upload their data, report their symptoms and complete 2 questionnaires. Results following the completion of the 1st questionnaire are reported. 78 patients were enrolled and 68 (87%) uploaded their data to date; 60 of 68 (88%), 30 males and 30 females, median age 53 years, completed the 1st questionnaire. Thirty-seven (61.6%) were University graduates. Cancer types included breast cancer (21.6%), Head/Neck cancer, pancreatic cancer and other cancers. Ten patients reported "other", 4 reported multiple cancers, 28 had metastatic disease and 45 active treatment. Registration and use of the platform was reported as "very to very much" easy by 52 (86.6%) and 50 (83.3%) patients, respectively. File uploading was "very to very much" easy for 33 (55%) patients; 49 (81.6%) preferred the digital way and 50 (83.3%) will introduce it to others. Patients highlighted that CureCancer improved communication with HCPs, increased their sense of safety, facilitated treatment adherence and interventions at distance, particularly when outside the Cancer Center and during the COVID-19 pandemic, reduced the number of visits, time and out-of-pocket expenses. Benefits liked best were easy data access, improved communication and sense of safety. CureCancer use was feasible, increased communication with HCPs, patients' sense of safety, treatment adherence and medical interventions at distancing, reduced visits and saved time and money. Continuing integration of CureCancer to embed PROs in routine cancer care is expected to improve treatment outcomes within or outside the Cancer Center and in pandemics and to reduce costs.

Background We evaluated real-world clinical outcomes and toxicity data and assessed treatment-related costs in patients with advanced breast cancer who received treatment with cyclin-dependent kinase inhibitors (CDKi). Patients and methods We conducted a prospective-retrospective analysis of patients with advanced hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who received a CDKi, in combination with endocrine therapy, at any line of treatment. The primary endpoint was progression-free survival (PFS). Cost analysis was conducted from a public third-payer (National Organization for Healthcare Services Provision (EOPYY)) perspective, assessing only costs related to direct medical care, including drug therapy costs and adverse drug reaction (ADR)-related costs. Results From July 2015 to October 2019, 365 women received endocrine therapy combined with CDKi; median age was 61 years, postmenopausal 290 (80.6%) patients. CDKi were administered as first-line treatment in 149 (40.9%) patients, second-line treatment in 96 (26.4%) and third-line treatment and beyond in 119 (32.7%) patients. The most common adverse events were neutropenia, anaemia, thrombocytopenia and fatigue. Grade 3-4 adverse events occurred in 86 (23.6%) patients, whereas 8 (2.2%) patients permanently discontinued treatment due to toxicity. The median PFS for patients who received CDKi as first-line, second-line and third-line treatment and beyond was 18.7, 12 and 7.4 months, respectively. The median overall survival since the initiation of CDKi treatment was 29.9 months (95% CI: 23.0-not yet reached (NR)). The mean pharmaceutical therapy cost estimated per cycle was 2 724.12 euro for each patient, whereas the main driver of the ADR-related costs was haematological adverse events. Conclusions Treatment with CDKi was well tolerated, with a low drug discontinuation rate. Patients who received CDKi as first-line treatment had improved PFS and OS compared with second-line treatment and beyond. The main component of direct medical costs assessed in the cost analysis comprises CDKi pharmaceutical therapy costs.

The objective of this cross-sectional study is to compare the prevalence of sexual dysfunction in premenopausal women with breast cancer in Greece, who receive adjuvant endocrine therapy with either tamoxifen or aromatase inhibitors (AI), with or without ovarian function suppression (OFS). A second endpoint is to investigate and compare the incidence of genitourinary symptoms and conditions. A questionnaire was distributed on hardcopy and through an online platform from November 2018 to March 2019, to Greek-speaking women of 18 years of age or older, who had been receiving adjuvant endocrine therapy for breast cancer for at least three months and were deemed premenopausal/perimenopausal at diagnosis. The questionnaire included investigator-generated items regarding demographics, sexual and gynecologic history, as well as validated instruments for sexual functioning and urogenital tract disorders (FSFI, QLQ-BR23, UDI-6 and PFIQ-7). Of the 108 received responses, 70 were considered eligible for analysis. Most participants were currently on treatment with tamoxifen/OFS (N=35). Women on AI/OFS reported great deterioration of their sex life compared to women on tamoxifen with OFS (p=0.001). Sexual dysfunction was evident in 74% (N=49) of our participants, as defined by the cutoff value of 26 for the FSFI total score (median: 17.45, IQR=26.18). In particular, women on AI/OFS had significantly lower scores compared to those on tamoxifen with (20.8, 95%CI [14.58;22.67] vs 8.8, 95%CI [4.86;13.60], p=0.040) and without OFS (19.95, 95%CI [13;22.91] vs 8.8, 95%CI [4.86;13.60], p=0.039). Sexual enjoyment of women on AI/OFS was significantly affected compared to women on tamoxifen with or without OFS (p=0.019 and p=0.020, respectively). No differences in vaginal atrophy symptoms or gynecologic conditions were detected. Sexual dysfunction is highly prevalent in premenopausal women on endocrine therapy, especially in those treated with aromatase inhibitors and ovarian function suppression. Health professionals should promote discussions with their patients in order to decide the optimal treatment choice.

The objective of this study was to conduct a cost-effectiveness analysis of everolimus versus axitinib for the treatment of metastatic RCC (mRCC) in Greece. Everolimus and axitinib were the only approved therapies with category 1 recommendation for second-line treatment of metastatic renal cell carcinoma (RCC) following TKI therapy, according to NCCN guidelines, by the time this analysis was conducted (Dec. 2015).

The NCCN Kidney Cancer Panel lists pazopanib and sunitinib as category 1 options for first-line treatment for stage IV renal cell carcinoma (RCC) patient. The aim of this study was to evaluate the cost-effectiveness of pazopanib vs sunitinib as first-line treatment of metastatic RCC (mRCC) from a Greek third-party payer's perspective. A 3-state partitioned survival model was used. Estimates of progression free survival (PFS) and overall survival (OS) were from the COMPARZ trial. Utility values were based on adverse events in COMPARZ and EQ-5D data from the VEG105192 trial. Cost inputs included drug acquisition and other treatment related costs including physician visits and lab and radiology tests. Resource use data were collected by DELPHI method from an expert panel of clinicians from private and public hospitals in Greece. A 5-year time horizon was used consistent with the maximum duration of follow-up in the final analysis of OS in COMPARZ. The incremental cost-effectiveness ratio (ICER) was calculated. A threshold of €35,000 per QALY gained was used, per WHO Guidelines. Deterministic and probabilistic sensitivity analyses (DSA and PSA) were conducted. In the base case, pazopanib was less costly and more effective ("dominant") compared with sunitinib, with €3,676 lower lifetime costs per patient and 0.058 greater discounted QALYs (€25,464 vs €29,140 and 1.617 vs 1.558). DSA and PSA suggest these results are robust. In DSA, pazopanib was dominant for different assumptions regarding PFS and utilities (Table). In 66% of PSA simulations, pazopanib was projected to yield more QALYs and lower costs vs sunitinb. The probability that pazopanib is cost-effective vs sunitinib was estimated to be 90% given the ICER threshold.Tabled 1ScenarioIncremental CostsIncremental QALYsICERBase case (IRC PFS)-€3,6760.058DominantInvestigator-assessed PFS-€2,8040.059Dominant Open table in a new tab Pazopanib is likely to be dominant compared with sunitinib as first-line treatment of mRCC in the Greek healthcare setting.