Visiting Professor, 4th Oncology Department, Metropolitan Hospital
https://orcid.org/0000-0002-2906-6607
Metropolitan Hospital profile
Google Scholar
elinardou@metropolitan-hospital.gr
Helena Linardou is a medical oncologist and Director of the 4th Oncology Department at Metropolitan Hospital. Her interests include breast and lung cancer, targeted therapies, translational research, hereditary cancer and genetic counselling, melanoma and sarcoma, and she coordinates national and international clinical trials.
Publications
Journal Articles
Kosmidis, P. A., Kosmidis, T., Papadopoulou, K., Korfiatis, N., Vozikis, A., Lampaki, S., Economopoulou, P., Fountzilas, E., Christopoulou, A., Samantas, E., Vagionas, A., Mountzios, G. S., Gkoumas, G., Tsoukalas, N., Athanasiadis, I., Bafaloukos, D., Panopoulos, C., Fountzilas, G., Petrakis, G., & Linardou, H. (2026). Association patterns among patient-reported adverse events in advanced NSCLC: A post-hoc analysis of the CLIMEDIN randomized controlled trial. Journal of Clinical Oncology, 44(16_suppl), e23271. https://doi.org/10.1200/jco.2026.44.16_suppl.e23271
@article{kosmidis2026association,
title = {Association patterns among patient-reported adverse events in advanced NSCLC: A post-hoc analysis of the CLIMEDIN randomized controlled trial},
author = {Paris A. Kosmidis and Thanos Kosmidis and Kyriaki Papadopoulou and Nikolaos Korfiatis and Athanassios Vozikis and Sofia Lampaki and Panagiota Economopoulou and Elena Fountzilas and Athina Christopoulou and E. Samantas and Anastasios Vagionas and Giannis S. Mountzios and Georgios Gkoumas and Nikolaos Tsoukalas and Ilias Athanasiadis and Dimitrios Bafaloukos and C Panopoulos and George Fountzilas and Georgios Petrakis and Helena Linardou},
url = {https://doi.org/10.1200/jco.2026.44.16_suppl.e23271},
doi = {10.1200/jco.2026.44.16_suppl.e23271},
year = {2026},
date = {2026-01-01},
journal = {Journal of Clinical Oncology},
volume = {44},
number = {16_suppl},
pages = {e23271},
publisher = {Lippincott Williams & Wilkins},
abstract = {e23271 Background: CLIMEDIN was a randomized controlled trial of digital support for patients with advanced or metastatic non-small cell lung cancer. Patients received either general adverse event (AE) information (control arm), or personalized support depending on their reported AEs (intervention arm). Given the statistically significant difference found between the AEs reported digitally by patients and those captured directly by clinicians, this post-hoc analysis aims to identify patterns of likely co-occurrence of AEs. Methods: Between March 2022 and December 2024, 188 patients submitted 7046 reports among 22 preselected AEs, captured in the CareAcross platform database. For this analysis these reports were de-identified and structured based on the specific AEs they contained. Association rule mining (apriori algorithm with support thresholds) was used to calculate the conditional probability of an AE subset (“Associated AEs”) being reported given that another subset (“Index AEs”) was reported concurrently. Results: The analysis resulted in 7846 pairs of Associated & Index AE subsets, with up to 7 AEs per subset. The conditional probability of co-occurrence (“Confidence”) ranged from 2.5% to 100%.To make the patterns clinically meaningful and practical, analyses were restricted to subsets of 1-2 AEs, resulting in 1870 combinations. Keeping the pairs with probability > = 80% resulted in 110 records (37 of which with > = 90% probability).The majority (78/110 or 71%) of Associated AEs included Fatigue.Among the AEs that are not immediately available upon clinical examination: Anorexia was correlated with combinations containing dyspnea (with any of rash, constipation, dysphagia, dysgeusia, diarrhea) as well as dysphagia & weight loss. Dysgeusia was correlated with combinations containing anorexia (with any of pruritus, diarrhea), diarrhea (with any of cough, anorexia, dry skin), stomatitis (with any of dry skin, cough) and more.The full list of associations is available upon request.The Table contains the most frequently occurring pairs of 1 or 2 AEs that do not include Fatigue. Conclusions: Analysis of Patient-Reported Outcomes can provide relevant Real World Evidence to support clinicians in completing the view of their patients’ journeys. This can be particularly applicable when information is missing, or AEs cannot be readily evaluated clinically.Data Science and Artificial Intelligence can further help derive actionable insights for clinical care and research. Clinical trial information: 05372081 . Index AEs Associated AEs Confidence (%) Peripheral Neuropathy, Chest Pain Dry Skin 94.7 Dyspnea, Rash Anorexia 93.7 Peripheral Neuropathy, Bone Pain Dry Skin 92.1 Anorexia, Pruritus Dysgeusia 88.7 Peripheral Neuropathy, Chest Pain Bone Pain 88.4 Cough, Diarrhea Dysgeusia 88.2 Weight Loss, Dysphagia Anorexia 88.1 Cough, Diarrhea Dry Skin 87.5 Dyspnea, Rash Dysgeusia, Anorexia 86.3},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
e23271 Background: CLIMEDIN was a randomized controlled trial of digital support for patients with advanced or metastatic non-small cell lung cancer. Patients received either general adverse event (AE) information (control arm), or personalized support depending on their reported AEs (intervention arm). Given the statistically significant difference found between the AEs reported digitally by patients and those captured directly by clinicians, this post-hoc analysis aims to identify patterns of likely co-occurrence of AEs. Methods: Between March 2022 and December 2024, 188 patients submitted 7046 reports among 22 preselected AEs, captured in the CareAcross platform database. For this analysis these reports were de-identified and structured based on the specific AEs they contained. Association rule mining (apriori algorithm with support thresholds) was used to calculate the conditional probability of an AE subset (“Associated AEs”) being reported given that another subset (“Index AEs”) was reported concurrently. Results: The analysis resulted in 7846 pairs of Associated & Index AE subsets, with up to 7 AEs per subset. The conditional probability of co-occurrence (“Confidence”) ranged from 2.5% to 100%.To make the patterns clinically meaningful and practical, analyses were restricted to subsets of 1-2 AEs, resulting in 1870 combinations. Keeping the pairs with probability > = 80% resulted in 110 records (37 of which with > = 90% probability).The majority (78/110 or 71%) of Associated AEs included Fatigue.Among the AEs that are not immediately available upon clinical examination: Anorexia was correlated with combinations containing dyspnea (with any of rash, constipation, dysphagia, dysgeusia, diarrhea) as well as dysphagia & weight loss. Dysgeusia was correlated with combinations containing anorexia (with any of pruritus, diarrhea), diarrhea (with any of cough, anorexia, dry skin), stomatitis (with any of dry skin, cough) and more.The full list of associations is available upon request.The Table contains the most frequently occurring pairs of 1 or 2 AEs that do not include Fatigue. Conclusions: Analysis of Patient-Reported Outcomes can provide relevant Real World Evidence to support clinicians in completing the view of their patients’ journeys. This can be particularly applicable when information is missing, or AEs cannot be readily evaluated clinically.Data Science and Artificial Intelligence can further help derive actionable insights for clinical care and research. Clinical trial information: 05372081 . Index AEs Associated AEs Confidence (%) Peripheral Neuropathy, Chest Pain Dry Skin 94.7 Dyspnea, Rash Anorexia 93.7 Peripheral Neuropathy, Bone Pain Dry Skin 92.1 Anorexia, Pruritus Dysgeusia 88.7 Peripheral Neuropathy, Chest Pain Bone Pain 88.4 Cough, Diarrhea Dysgeusia 88.2 Weight Loss, Dysphagia Anorexia 88.1 Cough, Diarrhea Dry Skin 87.5 Dyspnea, Rash Dysgeusia, Anorexia 86.3
Kosmidis, P. A., Kosmidis, T., Papadopoulou, K., Korfiatis, N., Vozikis, A., Lampaki, S., Economopoulou, P., Fountzila, E., Christopoulou, A., Samantas, E., Vagionas, A., Mountzios, G., Gkoumas, G., Tsoukalas, N., Athanasiadis, I., Bafaloukos, D., Panopoulos, C., Koufaki, M.-I., Petrakis, G., Fountzilas, G., & Linardou, H. (2026). Comprehensive molecular profiling of advanced NSCLC in Greek patients:A prospective HeCOG study. Cancer Treatment and Research Communications, 48, 101310. https://doi.org/10.1016/j.ctarc.2026.101310
@article{kosmidis2026comprehensive,
title = {Comprehensive molecular profiling of advanced NSCLC in Greek patients:A prospective HeCOG study},
author = {Paris A. Kosmidis and Thanos Kosmidis and Kyriaki Papadopoulou and Nikolaos Korfiatis and Athanassios Vozikis and Sofia Lampaki and Panagiota Economopoulou and Elena Fountzila and Athina Christopoulou and E. Samantas and Anastasios Vagionas and Giannis Mountzios and Georgios Gkoumas and Nikolaos Tsoukalas and Ilias Athanasiadis and D. Bafaloukos and Chris Panopoulos and Margarita-Ioanna Koufaki and George Petrakis and Georgios Fountzilas and Helena Linardou},
url = {https://doi.org/10.1016/j.ctarc.2026.101310},
doi = {10.1016/j.ctarc.2026.101310},
year = {2026},
date = {2026-01-01},
journal = {Cancer Treatment and Research Communications},
volume = {48},
pages = {101310},
publisher = {Elsevier BV},
abstract = {BACKGROUND: We report for the first time the molecular landscape and outcome associations from the prospective CLIMEDIN trial in Greece. METHODS: Two hundred patients with newly diagnosed advanced NSCLC (March 2022-October 2023) were enrolled and randomized to standard-of-care education versus additional automated, adverse-event-targeted digital interventions. Within this study baseline testing (EGFR, ALK, PD-L1) was performed in all; 165 tumors underwent comprehensive NGS (Oncomine Comprehensive Assay v3). Primary endpoint was improvement in AEs/QoL; secondary endpoints included ORR, PFS and OS. Associations between genomic alterations and outcomes were explored. RESULTS: Median age was 68 years; 75% male; 52% current smokers; adenocarcinoma 68.5%. Most received chemo-immunotherapy (66%). At data cut-off (December 2025; reverse-Kaplan-Meier median follow-up 36.3 months), median PFS was 9.6 months and median OS was 15.2 months. Across 200 tumors, 495 pathogenic variants (PVs) were identified in 83 genes. Exploratory outcome analyses showed longer OS in EGFR-mutant disease (preserved under parsimonious multivariable adjustment) and a formal KRAS × smoking interaction for OS (interaction P = 0.011). CONCLUSIONS: In this cohort, the molecular profile mirrors other Caucasian series, with clinically relevant enrichment patterns for EGFR and KRAS. ECOG performance status and first line treatment were the dominant prognostic factors in this cohort. A novel KRAS and smoking interaction for overall survival warrants prospective validation.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND: We report for the first time the molecular landscape and outcome associations from the prospective CLIMEDIN trial in Greece. METHODS: Two hundred patients with newly diagnosed advanced NSCLC (March 2022-October 2023) were enrolled and randomized to standard-of-care education versus additional automated, adverse-event-targeted digital interventions. Within this study baseline testing (EGFR, ALK, PD-L1) was performed in all; 165 tumors underwent comprehensive NGS (Oncomine Comprehensive Assay v3). Primary endpoint was improvement in AEs/QoL; secondary endpoints included ORR, PFS and OS. Associations between genomic alterations and outcomes were explored. RESULTS: Median age was 68 years; 75% male; 52% current smokers; adenocarcinoma 68.5%. Most received chemo-immunotherapy (66%). At data cut-off (December 2025; reverse-Kaplan-Meier median follow-up 36.3 months), median PFS was 9.6 months and median OS was 15.2 months. Across 200 tumors, 495 pathogenic variants (PVs) were identified in 83 genes. Exploratory outcome analyses showed longer OS in EGFR-mutant disease (preserved under parsimonious multivariable adjustment) and a formal KRAS × smoking interaction for OS (interaction P = 0.011). CONCLUSIONS: In this cohort, the molecular profile mirrors other Caucasian series, with clinically relevant enrichment patterns for EGFR and KRAS. ECOG performance status and first line treatment were the dominant prognostic factors in this cohort. A novel KRAS and smoking interaction for overall survival warrants prospective validation.
Papadopoulou, K., Kourea, H. P., Goussia, A., Korfiatis, N., Koletsa, T., Tzaida, O., Bobos, M., Batistatou, A., Koumarianou, A., Fatorou, E. A., Pectasides, D. G., Christopoulou, A. N., Linardou, H., Fountzilas, E., Pentheroudakis, G., Koutras, A., Psyrri, A., Gogas, H., & Fountzilas, G. (2026). Profiling of 1491 tumors from four HeCOG early breast cancer (eBC) studies using targeted DNA sequencing and central pathology review. ESMO Open, 11, 107057. https://doi.org/10.1016/j.esmoop.2026.107057
@article{papadopoulou2026profiling,
title = {Profiling of 1491 tumors from four HeCOG early breast cancer (eBC) studies using targeted DNA sequencing and central pathology review},
author = {K. Papadopoulou and H. P. Kourea and A. Goussia and Nikolaos Korfiatis and T. Koletsa and O. Tzaida and M. Bobos and A. Batistatou and A. Koumarianou and E. Aravantinou Fatorou and D. G. Pectasides and A. N. Christopoulou and H. Linardou and E. Fountzilas and G. Pentheroudakis and A. Koutras and A. Psyrri and H. Gogas and G. Fountzilas},
url = {https://doi.org/10.1016/j.esmoop.2026.107057},
doi = {10.1016/j.esmoop.2026.107057},
year = {2026},
date = {2026-01-01},
journal = {ESMO Open},
volume = {11},
pages = {107057},
publisher = {Elsevier BV},
abstract = {Harmonized clinicogenomic cohorts linking tumor genomics to centrally reviewed pathology are essential for biomarker discovery in early breast cancer. We characterized pathogenic variants (PVs) and examined their associations with centrally assessed subtypes across four HeCOG adjuvant trials.},
note = {Conference abstract 101P},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Harmonized clinicogenomic cohorts linking tumor genomics to centrally reviewed pathology are essential for biomarker discovery in early breast cancer. We characterized pathogenic variants (PVs) and examined their associations with centrally assessed subtypes across four HeCOG adjuvant trials.
Kosmidis, P., Kosmidis, T., Papadopoulou, K., Korfiatis, N., Vozikis, A., Lampaki, S., Economopoulou, P., Fountzilas, E., Christopoulou, A., Samantas, E., Vagionas, A., Mountzios, G., Goumas, G., Tsoukalas, N., Athanasiadis, I., Bafaloukos, D., Panopoulos, C., Koufaki, M. I., Fountzilas, G., Petrakis, G., & Linardou, H. (2026). SNF-CLIMEDIN: A Randomized Trial of Digital Support and Intervention in Patients With Advanced Non–Small Cell Lung Cancer. A Hellenic Cooperative Oncology Group Study. JCO Clinical Cancer Informatics, 10(1), e2500234. https://doi.org/10.1200/cci-25-00234
@article{kosmidis2026snf,
title = {SNF-CLIMEDIN: A Randomized Trial of Digital Support and Intervention in Patients With Advanced Non–Small Cell Lung Cancer. A Hellenic Cooperative Oncology Group Study},
author = {P. Kosmidis and Thanos Kosmidis and Kyriaki Papadopoulou and Nikolaos Korfiatis and Athanassios Vozikis and Sofia Lampaki and Panagiota Economopoulou and Elena Fountzilas and Athina Christopoulou and E. Samantas and Anastasios Vagionas and Giannis Mountzios and G. Goumas and Nikolaos Tsoukalas and Ilias Athanasiadis and D. Bafaloukos and Chris Panopoulos and Margarita Ioanna Koufaki and G. Fountzilas and Georgios Petrakis and Helena Linardou},
url = {https://doi.org/10.1200/cci-25-00234},
doi = {10.1200/cci-25-00234},
year = {2026},
date = {2026-01-01},
journal = {JCO Clinical Cancer Informatics},
volume = {10},
number = {1},
pages = {e2500234},
publisher = {Lippincott Williams & Wilkins},
abstract = {PURPOSE This trial aims to investigate the effectiveness of online digital intervention in patients with non–small cell lung cancer (NSCLC) in terms of adverse events (AEs) and quality of life (QoL). METHODS This randomized trial recruited 200 patients with advanced NSCLC (March 2022-October 2023). All patients received standard-of-care precise treatment, predominantly immunochemotherapy. The study was designed to assess AEs and QoL improvement. Through the CareAcross online platform, all patients received information about their disease and treatment and reported any of the 22 predefined AEs at any time. Patients were randomly assigned 1:1 in the intervention (A) and control (B) arm; patients in arm A automatically received, additionally, evidence-based guidance for the reported AEs. EuroQol 5-dimension 5-level responses were collected at baseline and at each treatment cycle. Resulting scores were compared between baseline and after the sixth cycle. In addition, patient case–level hospitalization data were collected and costs were estimated based on reimbursed costs as defined by the Ministry of Health, enabling a post hoc analysis. RESULTS Clinical characteristics were well-balanced. More AEs were reported by patients online versus to their clinicians ( P < .01). Among the 22 AEs, 17 improved more in arm A, with the improvement in rash and stomatitis being statistically significant. In QoL, there was no improvement in any of the five EuroQol 5-Dimension dimensions. Digital intervention was cost-saving with lower mean costs for hospitalization ( P < .001). Overall response rate, progression-free survival, and overall survival were not statistically different between the two arms, ensuring comparable clinical outcome. CONCLUSION Digital oncology tends to improve selected AEs and is cost saving. Patients report, digitally, more informative AEs. Digital oncology can be a complementary tool to the oncology team and warrants further exploration.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
PURPOSE This trial aims to investigate the effectiveness of online digital intervention in patients with non–small cell lung cancer (NSCLC) in terms of adverse events (AEs) and quality of life (QoL). METHODS This randomized trial recruited 200 patients with advanced NSCLC (March 2022-October 2023). All patients received standard-of-care precise treatment, predominantly immunochemotherapy. The study was designed to assess AEs and QoL improvement. Through the CareAcross online platform, all patients received information about their disease and treatment and reported any of the 22 predefined AEs at any time. Patients were randomly assigned 1:1 in the intervention (A) and control (B) arm; patients in arm A automatically received, additionally, evidence-based guidance for the reported AEs. EuroQol 5-dimension 5-level responses were collected at baseline and at each treatment cycle. Resulting scores were compared between baseline and after the sixth cycle. In addition, patient case–level hospitalization data were collected and costs were estimated based on reimbursed costs as defined by the Ministry of Health, enabling a post hoc analysis. RESULTS Clinical characteristics were well-balanced. More AEs were reported by patients online versus to their clinicians ( P < .01). Among the 22 AEs, 17 improved more in arm A, with the improvement in rash and stomatitis being statistically significant. In QoL, there was no improvement in any of the five EuroQol 5-Dimension dimensions. Digital intervention was cost-saving with lower mean costs for hospitalization ( P < .001). Overall response rate, progression-free survival, and overall survival were not statistically different between the two arms, ensuring comparable clinical outcome. CONCLUSION Digital oncology tends to improve selected AEs and is cost saving. Patients report, digitally, more informative AEs. Digital oncology can be a complementary tool to the oncology team and warrants further exploration.
Kosmidis, P., Kosmidis, T., Papadopoulou, K., Korfiatis, N., Vozikis, A., Lampaki, S., Economopoulou, P., Fountzilas, E., Christopoulou, A., Samantas, E., Vagionas, A., Mountzios, G., Goumas, G., Tsoukalas, N., Athanasiadis, I., Bafaloukos, D., Panopoulos, C., Koufaki, M., Fountzilas, G., & Linardou, H. (2025). Frequency of Adverse Events Reported Digitally by Patients With Advanced NSCLC: Analysis From CLIMEDIN, a HeCOG Study. Journal of Thoracic Oncology, 20(10). https://doi.org/10.1016/j.jtho.2025.09.737
@article{kosmidis2025frequency,
title = {Frequency of Adverse Events Reported Digitally by Patients With Advanced NSCLC: Analysis From CLIMEDIN, a HeCOG Study},
author = {P. Kosmidis and T. Kosmidis and Kyriaki Papadopoulou and Nikolaos Korfiatis and Athanassios Vozikis and S. Lampaki and Panagiota Economopoulou and E. Fountzilas and A. Christopoulou and E. Samantas and Anastasios Vagionas and G. Mountzios and G. Goumas and N. Tsoukalas and I. Athanasiadis and D. Bafaloukos and C Panopoulos and Maria Koufaki and G. Fountzilas and H. Linardou},
url = {https://doi.org/10.1016/j.jtho.2025.09.737},
doi = {10.1016/j.jtho.2025.09.737},
year = {2025},
date = {2025-01-01},
journal = {Journal of Thoracic Oncology},
volume = {20},
number = {10},
publisher = {Elsevier BV},
note = {Conference abstract P2.15.26},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Linardou, H., Papadopoulou, K., Korfiatis, N., Goussia, A., Samantas, E., Aravantinos, G., Christopoulou, A., Spathas, N., Fountzilas, E., Psyrri, A., Koliou, G.-A., Meditskou, S., Kosmas, E., Bobos, M., Charchanti, A., Vamvakaris, I., Koumarianou, A., Bafaloukos, D., Kosmidis, P., Fountzilas, G., & Mountzios, G. (2025). Intercalated Avelumab plus platinum-based chemotherapy in patients with Extensive-Stage Small-Cell Lung cancer (PAVE): Final outcome, immunophenotypic and biomarker analysis of a multi-center phase II Hellenic Cooperative Oncology Group study. European Journal of Cancer, 228, 115660. https://doi.org/10.1016/j.ejca.2025.115660
@article{linardou2025intercalated,
title = {Intercalated Avelumab plus platinum-based chemotherapy in patients with Extensive-Stage Small-Cell Lung cancer (PAVE): Final outcome, immunophenotypic and biomarker analysis of a multi-center phase II Hellenic Cooperative Oncology Group study},
author = {Helena Linardou and Kyriaki Papadopoulou and Nikolaos Korfiatis and Anna Goussia and E. Samantas and Gerasimos Aravantinos and Athina Christopoulou and Nikolaos Spathas and Elena Fountzilas and Amanda Psyrri and Georgia-Angeliki Koliou and Soultana Meditskou and Epaminondas Kosmas and Mattheos Bobos and Antonia Charchanti and Ioannis Vamvakaris and Anna Koumarianou and Dimitrios Bafaloukos and P. Kosmidis and George Fountzilas and Giannis Mountzios},
url = {https://doi.org/10.1016/j.ejca.2025.115660},
doi = {10.1016/j.ejca.2025.115660},
year = {2025},
date = {2025-01-01},
journal = {European Journal of Cancer},
volume = {228},
pages = {115660},
publisher = {Elsevier BV},
abstract = {BACKGROUND: Extensive stage small cell lung cancer (ES-SCLC) has poor prognosis, and first-line chemo-immunotherapy is now the standard-of-care. We hypothesized that intercalated immunotherapy administration in-between chemotherapy cycles, at maximal neoantigen release, might enhance immune response and efficacy. METHODS: PAVE is a multicenter phase II study. Patients with untreated ES-SCLC received standard platinum-etoposide every three weeks for 4-6 cycles. Avelumab 10mg/kg was administered every two weeks from cycle 3 until chemotherapy completion, and as maintenance thereafter. The primary endpoint was one-year PFS. Genotyping of FFPE tumors via targeted NGS, assessment of tumor-infiltrating lymphocytes (TILs) and analysis of CD8 and PD-L1, was performed. RESULTS: Between September 2018-September 2020, 55 pts, median age 65.9 years, 67.3 % male, were enrolled. With median follow-up of 10.3 months, 1-year PFS was 12.7 %, median PFS 5.8 months, 1-year OS 38.2 %, median OS 10.3 months. ORR was 69.1 % (CR 5.5 %, PR 63.6 %), median DoR 5.6 months. AEs grade 3-4 occurred in 56 % of patients. QoL, global health status and disease-related symptoms were significantly improved from baseline. The presence of TILs/CD8 in tumour was not significantly associated with survival. All but one tumor carried genetic alterations, with TP53 (89.5 %), RB1 (57.9 %), NOTCH (31.6 %) and MYC (23.7 %) being the most frequently mutated genes. Liver metastases, RB1 or TP53/RB1 co-mutations, no PCI and age > 65 years were negative PFS/ OS prognosticators. There were 10 Long Term Survivors (LTS) identified, the majority < 65 years old and most with ≤ 3 metastatic sites (50 %). Median OS of the LTS was 34.2 months and median PFS 19.9 months. CONCLUSIONS: Intercalated avelumab administration with chemotherapy did not meet the primary endpoint of 1-year PFS. However, our results suggest that this approach demonstrates clinically relevant PFS, DoR, and improved QoL, with overall outcomes similar to those seen with standard frontline chemotherapy in historical controls.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
BACKGROUND: Extensive stage small cell lung cancer (ES-SCLC) has poor prognosis, and first-line chemo-immunotherapy is now the standard-of-care. We hypothesized that intercalated immunotherapy administration in-between chemotherapy cycles, at maximal neoantigen release, might enhance immune response and efficacy. METHODS: PAVE is a multicenter phase II study. Patients with untreated ES-SCLC received standard platinum-etoposide every three weeks for 4-6 cycles. Avelumab 10mg/kg was administered every two weeks from cycle 3 until chemotherapy completion, and as maintenance thereafter. The primary endpoint was one-year PFS. Genotyping of FFPE tumors via targeted NGS, assessment of tumor-infiltrating lymphocytes (TILs) and analysis of CD8 and PD-L1, was performed. RESULTS: Between September 2018-September 2020, 55 pts, median age 65.9 years, 67.3 % male, were enrolled. With median follow-up of 10.3 months, 1-year PFS was 12.7 %, median PFS 5.8 months, 1-year OS 38.2 %, median OS 10.3 months. ORR was 69.1 % (CR 5.5 %, PR 63.6 %), median DoR 5.6 months. AEs grade 3-4 occurred in 56 % of patients. QoL, global health status and disease-related symptoms were significantly improved from baseline. The presence of TILs/CD8 in tumour was not significantly associated with survival. All but one tumor carried genetic alterations, with TP53 (89.5 %), RB1 (57.9 %), NOTCH (31.6 %) and MYC (23.7 %) being the most frequently mutated genes. Liver metastases, RB1 or TP53/RB1 co-mutations, no PCI and age > 65 years were negative PFS/ OS prognosticators. There were 10 Long Term Survivors (LTS) identified, the majority < 65 years old and most with ≤ 3 metastatic sites (50 %). Median OS of the LTS was 34.2 months and median PFS 19.9 months. CONCLUSIONS: Intercalated avelumab administration with chemotherapy did not meet the primary endpoint of 1-year PFS. However, our results suggest that this approach demonstrates clinically relevant PFS, DoR, and improved QoL, with overall outcomes similar to those seen with standard frontline chemotherapy in historical controls.
Kosmidis, P., Kosmidis, T., Papadopoulou, K., Korfiatis, N., Vozikis, A., Lampaki, S., Psyrri, A., Fountzilas, E., Christopoulou, A., Samantas, E., Vagionas, A., Mountzios, G., Gkoumas, G., Tsoukalas, N., Athanasiadis, I., Bafaloukos, D., Panopoulos, C., Koufaki, M. I., Fountzilas, G., & Linardou, H. (2025). SNF-CLIMEDIN: A HECOG prospective randomized trial of digital support and intervention in patients with advanced non-small cell lung cancer (NSCLC)—Final results. Journal of Clinical Oncology, 43(16_suppl), 1515. https://doi.org/10.1200/jco.2025.43.16_suppl.1515
@article{kosmidis2025snf,
title = {SNF-CLIMEDIN: A HECOG prospective randomized trial of digital support and intervention in patients with advanced non-small cell lung cancer (NSCLC)—Final results},
author = {P. Kosmidis and Thanos Kosmidis and Kyriaki Papadopoulou and Nikolaos Korfiatis and Athanassios Vozikis and Sofia Lampaki and Amanda Psyrri and Elena Fountzilas and Athina Christopoulou and E. Samantas and Anastasios Vagionas and Giannis Mountzios and Georgios Gkoumas and Nikolaos Tsoukalas and Ilias Athanasiadis and Dimitrios Bafaloukos and C Panopoulos and Margarita Ioanna Koufaki and George Fountzilas and Helena Linardou},
url = {https://doi.org/10.1200/jco.2025.43.16_suppl.1515},
doi = {10.1200/jco.2025.43.16_suppl.1515},
year = {2025},
date = {2025-01-01},
journal = {Journal of Clinical Oncology},
volume = {43},
number = {16_suppl},
pages = {1515},
publisher = {Lippincott Williams & Wilkins},
abstract = {1515 Background: This trial aims to investigate the feasibility and effectiveness of online digital intervention to NSCLC patients in terms of adverse events (AEs), quality of life (QoL), cost, and the interrelation with clinical and molecular characteristics. Methods: This prospective randomized trial recruited 200 advanced NSCLC patients (3/22-10/23). Final analysis was undertaken in 12/24. All had NGS tissue analysis for 161 genes, and received standard treatment (predominantly immuno-chemotherapy). Through the CareAcross online platform, they received information about their disease and treatment, and periodically reported any of the 22 preplanned AEs. Patients were randomized 1:1 in the Intervention (A) and Control (B) arm; patients in arm A received digitally, additionally, evidence-based guidance for the reported AEs. The study was designed to assess AE improvement (measured per patient as reduction of AEs reported at last contact, compared to those previously reported) and QoL. EQ5D-5L scores were collected. Patient-case level hospitalization data were collected and costs were estimated based on reimbursed cost as defined by the Ministry of Health. Results were correlated with patients’ clinical and molecular characteristics. Results: Clinical and molecular characteristics will be presented during ASCO Congress. Comparing arms A vs B: ORR: 42.1% vs 41.7%; Median PFS: 11m (8.0-15) vs 10m (7.0-13), 1-year PFS: 43% (31%-54%) vs 42% (31%-53%) (p = 0.4). Median OS: 15m (12-20) vs 16m (12-21), 1-year OS: 59% (48%-68%) for both arms (p = 0.9). PFS and OS were improved for those with best responses (p < 0.001). Patients with EGFR mutations had better OS (p = 0.05). The most common AEs reported in both arms were fatigue, cough, anorexia, nausea. More AEs were reported online vs to clinicians (89% vs 68% of patients; p < 0.01). Baseline EQ5D-5L was similar for both arms; when compared with data at best response, Anxiety/Depression showed the biggest difference in improvement for arm A vs B. Among the 22 ΑEs, 17 improved more in arm A, 1 improved equally, and 4 improved more in Arm B. The comparative improvements of rash and stomatitis in arm A vs B were statistically significant (p = 0.0073 & p = 0.0447). The mean hospitalization cost (arm A vs B, in Euros) was 455.4 (95%CI: 91.9-941.5) vs 779.5 (346.6-1328.5) (p < 0.001); the mean diagnostics cost was 20.3 (0.5-50.8) vs 73.3 (1.3-186.1) (p < 0.001). Conclusions: Digital oncology is feasible, cost-effective by reducing hospitalizations and tends to improve QoL (especially anxiety and depression) and most AEs of NSCLC patients regardless of clinical and molecular status. Patients report, digitally, more informative AEs for clinical and research analysis. Through the digital transformation of healthcare, digital oncology can be a complementary tool to the Oncology team and warrants further exploration. Clinical trial information: NCT05372081 .},
note = {Conference abstract},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
1515 Background: This trial aims to investigate the feasibility and effectiveness of online digital intervention to NSCLC patients in terms of adverse events (AEs), quality of life (QoL), cost, and the interrelation with clinical and molecular characteristics. Methods: This prospective randomized trial recruited 200 advanced NSCLC patients (3/22-10/23). Final analysis was undertaken in 12/24. All had NGS tissue analysis for 161 genes, and received standard treatment (predominantly immuno-chemotherapy). Through the CareAcross online platform, they received information about their disease and treatment, and periodically reported any of the 22 preplanned AEs. Patients were randomized 1:1 in the Intervention (A) and Control (B) arm; patients in arm A received digitally, additionally, evidence-based guidance for the reported AEs. The study was designed to assess AE improvement (measured per patient as reduction of AEs reported at last contact, compared to those previously reported) and QoL. EQ5D-5L scores were collected. Patient-case level hospitalization data were collected and costs were estimated based on reimbursed cost as defined by the Ministry of Health. Results were correlated with patients’ clinical and molecular characteristics. Results: Clinical and molecular characteristics will be presented during ASCO Congress. Comparing arms A vs B: ORR: 42.1% vs 41.7%; Median PFS: 11m (8.0-15) vs 10m (7.0-13), 1-year PFS: 43% (31%-54%) vs 42% (31%-53%) (p = 0.4). Median OS: 15m (12-20) vs 16m (12-21), 1-year OS: 59% (48%-68%) for both arms (p = 0.9). PFS and OS were improved for those with best responses (p < 0.001). Patients with EGFR mutations had better OS (p = 0.05). The most common AEs reported in both arms were fatigue, cough, anorexia, nausea. More AEs were reported online vs to clinicians (89% vs 68% of patients; p < 0.01). Baseline EQ5D-5L was similar for both arms; when compared with data at best response, Anxiety/Depression showed the biggest difference in improvement for arm A vs B. Among the 22 ΑEs, 17 improved more in arm A, 1 improved equally, and 4 improved more in Arm B. The comparative improvements of rash and stomatitis in arm A vs B were statistically significant (p = 0.0073 & p = 0.0447). The mean hospitalization cost (arm A vs B, in Euros) was 455.4 (95%CI: 91.9-941.5) vs 779.5 (346.6-1328.5) (p < 0.001); the mean diagnostics cost was 20.3 (0.5-50.8) vs 73.3 (1.3-186.1) (p < 0.001). Conclusions: Digital oncology is feasible, cost-effective by reducing hospitalizations and tends to improve QoL (especially anxiety and depression) and most AEs of NSCLC patients regardless of clinical and molecular status. Patients report, digitally, more informative AEs for clinical and research analysis. Through the digital transformation of healthcare, digital oncology can be a complementary tool to the Oncology team and warrants further exploration. Clinical trial information: NCT05372081 .
Linardou, H., Kosmidis, T., Papadopoulou, K., Korfiatis, N., Vozikis, A., Lampaki, S., Psyrri, A., Fountzilas, E., Christopoulou, A. N., Samantas, E., Vagionas, A., Mountzios, G., Goumas, G., Tsoukalas, N., Athanasiadis, I., Bafaloukos, D., Panopoulos, C., Koufaki, M., Fountzilas, G., & Kosmidis, P. (2024). Analysis of evolution of patient reported side effects during treatment for advanced NSCLC. Annals of Oncology, 35. https://doi.org/10.1016/j.annonc.2024.08.1429
@article{linardou2024analysis,
title = {Analysis of evolution of patient reported side effects during treatment for advanced NSCLC},
author = {H. Linardou and T. Kosmidis and Kyriaki Papadopoulou and Nikolaos Korfiatis and Athanassios Vozikis and S. Lampaki and A. Psyrri and E. Fountzilas and A. N. Christopoulou and Epaminontas Samantas and Anastasios Vagionas and G. Mountzios and G. Goumas and Nikolaos Tsoukalas and I. Athanasiadis and Dimitrios Bafaloukos and C Panopoulos and Maria Koufaki and G. Fountzilas and P. Kosmidis},
url = {https://doi.org/10.1016/j.annonc.2024.08.1429},
doi = {10.1016/j.annonc.2024.08.1429},
year = {2024},
date = {2024-01-01},
journal = {Annals of Oncology},
volume = {35},
publisher = {Elsevier BV},
note = {Conference abstract 1374P},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Mountzios, G., Papadopoulou, K., Korfiatis, N., Goussia, A., Samantas, E., Aravantinos, G., Christopoulou, A., Spathas, N., Fountzilas, E., Psyrri, A., Koliou, G.-A., Kosmas, E., Bobos, M., Charchanti, A., Vamvakaris, I., Koumarianou, A., Bafaloukos, D., Kosmidis, P., Fountzilas, G., & Linardou, H. (2024). Final outcome, immunophenotypic and biomarker analysis of intercalated avelumab plus platinum-based chemotherapy in patients with extensive-stage small cell lung cancer (PAVE): A pilot phase II study of the Hellenic co-operative oncology group. ESMO Open, 9, 102770. https://doi.org/10.1016/j.esmoop.2024.102770
@article{mountzios2024final,
title = {Final outcome, immunophenotypic and biomarker analysis of intercalated avelumab plus platinum-based chemotherapy in patients with extensive-stage small cell lung cancer (PAVE): A pilot phase II study of the Hellenic co-operative oncology group},
author = {Giannis Mountzios and Kyriaki Papadopoulou and Nikolaos Korfiatis and Anna Goussia and Epaminontas Samantas and Gerasimos Aravantinos and Athina Christopoulou and Nikolaos Spathas and Elena Fountzilas and Amanda Psyrri and Georgia-Angeliki Koliou and E. Kosmas and Mattheos Bobos and Antonia Charchanti and Ioannis Vamvakaris and Anna Koumarianou and D. Bafaloukos and P. Kosmidis and George Fountzilas and Helena Linardou},
url = {https://doi.org/10.1016/j.esmoop.2024.102770},
doi = {10.1016/j.esmoop.2024.102770},
year = {2024},
date = {2024-01-01},
journal = {ESMO Open},
volume = {9},
pages = {102770},
publisher = {Elsevier BV},
abstract = {Extensive stage small cell lung cancer (ES-SCLC) is a poor prognosis disease, and first-line chemo-immunotherapy is now the standard-of-care. We hypothesized that intercalated administration of immunotherapy after two induction chemotherapy cycles, at maximal neoantigen release, might enhance immune response and overall efficacy.},
note = {Conference abstract 197MO},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Extensive stage small cell lung cancer (ES-SCLC) is a poor prognosis disease, and first-line chemo-immunotherapy is now the standard-of-care. We hypothesized that intercalated administration of immunotherapy after two induction chemotherapy cycles, at maximal neoantigen release, might enhance immune response and overall efficacy.
Kosmidis, P., Kosmidis, T., Papadopoulou, K., Korfiatis, N., Vozikis, A., Lampaki, S., Psyrri, A., Fountzilas, E., Christopoulou, A., Samantas, E., Vagionas, A., Mountzios, G., Gkoumas, G., Tsoukalas, N., Athanasiadis, I., Bafaloukos, D., Panopoulos, C., Koufaki, M. I., Fountzilas, G., & Linardou, H. (2024). SNF-CLIMEDIN: A prospective randomized trial of digital intervention in patients with advanced NSCLC—A HeCOG study. Journal of Clinical Oncology, 42(16_suppl), 1520. https://doi.org/10.1200/jco.2024.42.16_suppl.1520
@article{kosmidis2024snf,
title = {SNF-CLIMEDIN: A prospective randomized trial of digital intervention in patients with advanced NSCLC—A HeCOG study},
author = {P. Kosmidis and Thanos Kosmidis and Kyriaki Papadopoulou and Nikolaos Korfiatis and Athanassios Vozikis and Sofia Lampaki and Amanda Psyrri and Elena Fountzilas and Athina Christopoulou and E. Samantas and Anastasios Vagionas and Giannis Mountzios and Georgios Gkoumas and Nikolaos Tsoukalas and Ilias Athanasiadis and D. Bafaloukos and C Panopoulos and Margarita Ioanna Koufaki and George Fountzilas and Helena Linardou},
url = {https://doi.org/10.1200/jco.2024.42.16_suppl.1520},
doi = {10.1200/jco.2024.42.16_suppl.1520},
year = {2024},
date = {2024-01-01},
journal = {Journal of Clinical Oncology},
volume = {42},
number = {16_suppl},
pages = {1520},
publisher = {Lippincott Williams & Wilkins},
abstract = {1520 Background: The purpose of this trial is to investigate the effectiveness of online digital intervention to NSCLC patients in terms of quality of life (QoL), cost and the interrelation with clinical and molecular characteristics. Methods: This prospective randomized trial recruited 200 advanced NSCLC patients (3/22-10/23). All had NGS tissue analysis for 161 genes and received standard treatment (predominantly immuno-chemotherapy). Through the CareAcross online platform they received information about their disease and treatment, and periodically reported any of 22 preplanned adverse events (AEs). Patients were randomized 1:1 in the intervention (A) and control (B) arm; patients in arm A received digitally, additionally, evidence-based guidance for the reported AEs. The study was designed to assess QoL improvement (measured per patient as reduction of the number of AEs reported at last contact, compared to those previously reported). EQ5D-5L scores were collected. Patient-case level hospitalizations data were collected and costs were estimated based on reimbursed costs as defined by the Ministry of Health. Results were correlated with patients’ clinical and molecular characteristics. Results: Clinical and molecular characteristics will be presented during ASCO Congress. For all patients, responses were: CR: 2%, PR: 35.5%, SD: 35%, PD: 10.5%. Median PFS was 7.0 months (95%CI: 5-8), 1-year 18% (38%-55%). Median OS: 12 months (11-14), 1-year 47% (38%-55%). No difference was found between the two arms in any of the above, nor in OS in relation to clinical and molecular characteristics. The most common AEs that patients reported were fatigue, cough, anorexia, nausea. More patients submitted AE reports online than their clinicians (89% vs 68% of patients, p<0.01); more AEs were reported per submission, compared to their clinicians. Patients in arm Α reported marginally higher improvement compared to B (77.2% vs 75.7%); 15 of 22 AEs were associated with higher (14) or same (1) improvement in arm A vs B (not statistically significant); of the most common: fatigue (61.3% vs 48.6%), anorexia (86.5% vs 70.2%; p<0.05) and nausea (93.0% vs 87.2%). Baseline EQ5D was similar in both arms; comparing post-treatment (6th cycle) results shows higher improvement in all 5 dimensions in arm A vs B, especially in Anxiety/Depression (final values: 1.9 vs 2.2). The mean AE-related costs in Euros in arm A vs B were: hospitalization: 455.4 (95%CI: 91.9-941.5) vs 779.5 (346.6-1328.5) (p<0.001); diagnostics: 20.3 (0.5-50.8) vs 73.3 (1.3-186.1) (p<0.001). Follow up is ongoing. Conclusions: Digital oncology is feasible, cost-effective by reducing hospitalizations, improves certain AEs and tends to improve QoL of NSCLC patients regardless of clinical and molecular status. Patients report digitally more informative AEs for clinical and research analysis. Online platforms can complement the Oncology team. Clinical trial information: NCT05372081 .},
note = {Conference abstract},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
1520 Background: The purpose of this trial is to investigate the effectiveness of online digital intervention to NSCLC patients in terms of quality of life (QoL), cost and the interrelation with clinical and molecular characteristics. Methods: This prospective randomized trial recruited 200 advanced NSCLC patients (3/22-10/23). All had NGS tissue analysis for 161 genes and received standard treatment (predominantly immuno-chemotherapy). Through the CareAcross online platform they received information about their disease and treatment, and periodically reported any of 22 preplanned adverse events (AEs). Patients were randomized 1:1 in the intervention (A) and control (B) arm; patients in arm A received digitally, additionally, evidence-based guidance for the reported AEs. The study was designed to assess QoL improvement (measured per patient as reduction of the number of AEs reported at last contact, compared to those previously reported). EQ5D-5L scores were collected. Patient-case level hospitalizations data were collected and costs were estimated based on reimbursed costs as defined by the Ministry of Health. Results were correlated with patients’ clinical and molecular characteristics. Results: Clinical and molecular characteristics will be presented during ASCO Congress. For all patients, responses were: CR: 2%, PR: 35.5%, SD: 35%, PD: 10.5%. Median PFS was 7.0 months (95%CI: 5-8), 1-year 18% (38%-55%). Median OS: 12 months (11-14), 1-year 47% (38%-55%). No difference was found between the two arms in any of the above, nor in OS in relation to clinical and molecular characteristics. The most common AEs that patients reported were fatigue, cough, anorexia, nausea. More patients submitted AE reports online than their clinicians (89% vs 68% of patients, p<0.01); more AEs were reported per submission, compared to their clinicians. Patients in arm Α reported marginally higher improvement compared to B (77.2% vs 75.7%); 15 of 22 AEs were associated with higher (14) or same (1) improvement in arm A vs B (not statistically significant); of the most common: fatigue (61.3% vs 48.6%), anorexia (86.5% vs 70.2%; p<0.05) and nausea (93.0% vs 87.2%). Baseline EQ5D was similar in both arms; comparing post-treatment (6th cycle) results shows higher improvement in all 5 dimensions in arm A vs B, especially in Anxiety/Depression (final values: 1.9 vs 2.2). The mean AE-related costs in Euros in arm A vs B were: hospitalization: 455.4 (95%CI: 91.9-941.5) vs 779.5 (346.6-1328.5) (p<0.001); diagnostics: 20.3 (0.5-50.8) vs 73.3 (1.3-186.1) (p<0.001). Follow up is ongoing. Conclusions: Digital oncology is feasible, cost-effective by reducing hospitalizations, improves certain AEs and tends to improve QoL of NSCLC patients regardless of clinical and molecular status. Patients report digitally more informative AEs for clinical and research analysis. Online platforms can complement the Oncology team. Clinical trial information: NCT05372081 .
Linardou, H., Kosmidis, T., Papadopoulou, K., Korfiatis, N., Lampaki, S., Fountzilas, E., Psyrri, A., Vagionas, A., Christopoulou, A., Samantas, E., Athanasiadis, I., Mountzios, G., Tsoukalas, N., Sgouros, J., Koutras, A., Bafaloukos, D., Panopoulos, C., Fountzilas, G., & Kosmidis, P. (2023). Clinical and molecular study with digital support of advanced non-small cell lung cancer patients: SNF-CLIMEDIN, a prospective randomized Hellenic Cooperative Oncology Group (HeCOG) study: Interim analysis. Annals of Oncology, 34. https://doi.org/10.1016/j.annonc.2023.09.2466
@article{linardou2023clinical,
title = {Clinical and molecular study with digital support of advanced non-small cell lung cancer patients: SNF-CLIMEDIN, a prospective randomized Hellenic Cooperative Oncology Group (HeCOG) study: Interim analysis},
author = {Helena Linardou and T. Kosmidis and Kyriaki Papadopoulou and Nikolaos Korfiatis and Sofia Lampaki and Elena Fountzilas and Amanda Psyrri and Anastasios Vagionas and Athina Christopoulou and Epaminontas Samantas and Ilias Athanasiadis and Giannis Mountzios and Nikolaos Tsoukalas and Joseph Sgouros and A. Koutras and D. Bafaloukos and C Panopoulos and George Fountzilas and P. Kosmidis},
url = {https://doi.org/10.1016/j.annonc.2023.09.2466},
doi = {10.1016/j.annonc.2023.09.2466},
year = {2023},
date = {2023-01-01},
journal = {Annals of Oncology},
volume = {34},
publisher = {Elsevier BV},
note = {Conference abstract 1435P},
keywords = {},
pubstate = {published},
tppubtype = {article}
}