Mucosal injury is the consequence of biologic events coupled with the influence of the oral envir... more Mucosal injury is the consequence of biologic events coupled with the influence of the oral environment and microbiome 1. Oral mucositis is one of the most common toxicities of chemoradiation therapies 2. Incidence and severity varies by chemoradiation regimens, radiation fıelds, and tumor site. The influence of mucositis on quality of life is greater among patients than the medical literature would suggest 2, 3. Lack of experience in evaluating treatment toxicities is a daily problem in cancer patients. The aim of this study was to assess the efficacy of Verbascoside's (Mucosyte®) 4 oral solution on mucositis in cancer patients.
BackgroundThe prognosis for patients with metastatic rhabdomyosarcoma (RMS) remains largely unsat... more BackgroundThe prognosis for patients with metastatic rhabdomyosarcoma (RMS) remains largely unsatisfactory despite the adoption of intensive multimodal therapy. To assess the role of different treatments adopted over the years, we retrospectively analyzed a cohort of patients <21 years old with metastatic RMS, treated from 1990 to 2020 at a referral center for pediatric sarcomas.MethodsPatients were treated using a multimodal approach that included surgery, radiotherapy, and chemotherapy (both high‐dose chemotherapy and maintenance therapy in some cases). The type of radiotherapy administered was categorized as radical (to all sites of disease); partial (to at least one, but not all sites of disease); or none. A landmark analysis was used to examine the impact of radiotherapy on survival, that is, patients who had an event before day 221 were excluded from the analysis.ResultsThe series included 80 patients. Event‐free survival (EFS) and overall survival (OS) rates at 5 years were 17.3% and 21.3%, respectively. Survival was significantly associated with radiotherapy to metastatic sites, and with the radiotherapy category. In particular, 5‐year EFS and OS rates were 70.6% and 76.0% for patients given radical radiotherapy, and 4.8% and 10.7%, respectively, for those given partial radiotherapy or none. Using the Cox multivariable analysis, OS correlated significantly with radiotherapy category.ConclusionsWhile confirming the poor overall outcome of patients with metastatic RMS, this study identified radiotherapy—when given to all sites of disease (including metastases)—as the main variable influencing survival.
Each year approximately 35,000 children and adolescents are diagnosed with cancer in Europe. Five... more Each year approximately 35,000 children and adolescents are diagnosed with cancer in Europe. Five-year survival rates have improved and now reach 80% in most European countries, thanks to a combination of chemotherapy, radiotherapy, and surgery. To date, there are more than 44,000 Italians still living several years after being diagnosed with cancer in developmental age. The risk of premature morbidity and mortality for cancer survivors is well known and documented. Approximately 60% of survivors of cancer in childhood and adolescence have at least one chronic health condition in later life, and more than one in four develop severe or life-threatening disorders. Among the various long-term iatrogenic sequelae of cancer treatments, the most worrisome are second malignant neoplasms. We reported on our mono-institutional experiences of screening and treating secondary breast cancer, secondary thyroid cancer and secondary osteosarcoma. Recommendations on the surveillance needed for cancer survivors because of the risk of late effects of their disease or its treatment suggest that discussing the potential problems early on can be crucial to a patient’s future health. These considerations and our consolidated experience strengthen our conviction that survivors of cancer in childhood and adolescence who develop second malignant neoplasms should be treated at highly-specialized centers. Multidisciplinary care requires close communications and high levels of up-to-date professional expertise. This challenging area of health care is also changing rapidly because cancer survivorship is a work in progress, but we cannot wait for definitive conclusions on many aspects because this will take decades, especially for pediatric patients.
This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY
Basal cell carcinoma (BCC) is the most common malignant tumor of the skin. Despite the indolent n... more Basal cell carcinoma (BCC) is the most common malignant tumor of the skin. Despite the indolent nature, metastatic BCC can occur, albeit rarely. Metastasis to the bone is very rare. From its approval, mBCC patients are treated with vismodegib, a selective hedgehog pathway inhibitor. Unfortunately, in recent period, it was demonstrated an emergence of drug resistance, due to Smoothened (SMO) mutation. To date, several groups are studying the effectiveness of immunotherapy in BCC. Clinical trials with Immune Checkpoint Inhibitors are ongoing. We report the rare case of a man with multiple bony metastasis, with a resistance to vismodegib, and we evaluated all manuscripts in literature reporting bone metastasis. Moreover, we review all the manuscripts in literature reporting bone metastasis, and we summarize the main therapeutic strategies, and the further perspectives.
Background. First-line therapies for medulloblastoma(MBL) are obtaining higher survival-rates whi... more Background. First-line therapies for medulloblastoma(MBL) are obtaining higher survival-rates while decreasing late-effects, but treatment at relapse is not standardized. We report the experience with MBL re-irradiation(re-RT), its timing and outcome in different clinical settings and tumor groups. Methods. Patient’s staging/treatment at diagnosis, histotypes/molecular subgroups, relapse site/s, re-treatments outcome are reported. Results. Patients were 25, median age 11.4 years, 8 had metastases, three LCA histotype. According to 2016-2021 WHO-classification, 14 had SHH subgroup tumors(6 TP53 mutated,1 + MYC and 1 + NMYC amplification), 11 non-WNT/non-SHH (2 with MYC/MYCN amplification).Thirteen had received HART-CSI, 11 standard-CSI, one HFRT; all post-radiation chemotherapy(CT), 16 also pre-RT. Median time to relapse (local-LR in 9, distant-DR in 14, LR+DR in two) was 26 months. Fourteen patients were re-operated, in 5 excising single DR-sites, thereafter 3 received CT, two after...
BackgroundPatients with rhabdomyosarcoma (RMS) whose disease relapses have little chance of being... more BackgroundPatients with rhabdomyosarcoma (RMS) whose disease relapses have little chance of being cured, so front‐line treatments are usually followed up with surveillance imaging in an effort to detect any recurrences as early as possible, and thereby improve post‐relapse outcomes. The real benefit of such routine surveillance imaging in RMS remains to be demonstrated, however. This retrospective, single‐center study examines how well surveillance imaging identifies recurrent tumors and its impact on post‐relapse survival.MethodsThe analysis concerned 79 patients <21 years old treated between 1985 and 2020 whose initially localized RMS relapsed. Clinical findings, treatment modalities, and survival were analyzed, comparing patients whose relapse was first suspected from symptoms they developed (clinical symptoms group) with those whose relapse was identified by radiological surveillance (routine imaging group).ResultsTumor relapses came to light because of clinical symptoms in 42 cases, and on routine imaging in 37. The time to relapse was much the same in the two groups. The median overall survival (OS) and 5‐year OS rate were, respectively, 10 months and 12.6% in the clinical symptoms group, and 11 months and 27.5% in the routine imaging group (p‐value .327). Among patients with favorable prognostic scores, survival was better for those in the routine imaging group (5‐year OS 75.0% vs. 33.0%, p‐value .047).ConclusionIt remains doubtful whether surveillance imaging has any real impact on RMS relapse detection and patients’ post‐relapse survival. Further studies are needed to establish the most appropriate follow‐up recommendations, taking the potentially negative effects of regular radiological exams into account.
Open access journal of oncology and medicine, Mar 26, 2021
Background: Ipilimumab is an option in Metastatic Melanoma patients in case of disease progressio... more Background: Ipilimumab is an option in Metastatic Melanoma patients in case of disease progression after antiPD1 treatment and BRAF+MEK inhibitors administration (for BRAF mutated melanoma). We evaluate the prognostic role of some relevant clinical or laboratories parameters for Ipilimumab used in late line after AntiPD1 progression to define patients that benefit most from Ipilimumab monotherapy in this setting. Methods: A retrospective multicenter study was conducted in 8 Italian Oncology Centers, evaluating metastatic melanoma patients treated with Ipilimumab after AntiPD1 and/or BRAF plus Mek inhibitors progression. Endpoints were overall survival (OS) and Progression free survival (PFS), Kaplan Mayer and Cox regression were applied for survival analysis. Results: Among patients that received AntiPD1 and-or Bramber inhibitors, 54 were treated with Ipilimumab monotherapy in 2nd/3rd line. Before Ipilimumab treatment, Number of metastatic sites were equal or less than 3 in 22 (40,7%) patients, ECOG Performance status was 0 in 32 (59%) patients, baseline LDH levels were within normal range in 25 (46,3%) patients, NLR (neutrophile/lymphocyte ratio) was equal or less than 0.7 in 33 (59%) patients. In Univariate analysis, ECOG PS 0 and NLR<0.7 resulted statistically significant good prognostic. In multivariate analysis for PFS, only NLR maintained statistically significance, while in multivariate analysis for OS both ECOG PS and NLR maintained a statistical significance. A score was counted for each patient considering the sum of number of negative factors associated with OS worse prognosis (ECOG PS>0, NLR more than 0.7). For patients with SCORE 0,1,2 median OS was respectively 11.4, 7.87 and 2.77 (p value<0.0001). Conclusions: ECOG PS 0 and NLR<0.7 resulted prognostic factors associated with favorable OS of metastatic melanoma patients treated with Ipilimumab after AntiPD1 progression. Subgroup with all these factors has a better prognosis. These data can help treatment choice and should be evaluated prospectively.
Background Ipilimumab (Ip) is an option in Metastatic Melanoma (MM) patients (pt) in case of dise... more Background Ipilimumab (Ip) is an option in Metastatic Melanoma (MM) patients (pt) in case of disease progression after antiPD1 (AP) treatment and BRAF+MEK inhibitors (BMi) administration (for BRAF mutated melanoma). Clinical trial are evaluating potential Ip-based combinations in 2nd/3rd line setting. Many studies underline the role of some parameters (as LDH, ECOG PS, Neutrophile/Leucocyte ratio) as progostic factors for immunotherapy used in first-line. We evaluate the prognostic role of some relevant clinical or laboratoristic parameters for Ip used in late line after AP, Bmi, in order to define pt that benefit most from Ip monotherapy in this setting. Methods A retrospective multicenter study was conducted in 8 Italian Oncology Centers, evaluating MM pt treated with Ip after AP and/or BMi. Endpoints were OS and PFS, Kaplan Mayer and Cox regression were applied for survival analysis. Results Among 200 pt that received AP or Bmi, 48 were eligible for Ip administration in 2nd/3rd line. Before Ip treatment, ECOG PS was 0 in 21 pt, number of metastatic sites was less then 3 in 14 pt, LDH was within normal range in 19 pt, NLR ratio (= baseline neutrophils/total leukocytes) was less then 0.7 in 28 pt: in univariate analysis, only ECOG PS and NLR resulted significantly associated with better PFS and OS. For pt with ECOG PS 0 or 1 medianPFS was 3.2, 2.3 month respectively (p value 0.0066; HR 0.377 IC95% 0.186-0.762), median OS was 12.1, 4.0 respectively (p value 0.0016 HR 0.287 IC95% 0.132-0.622). For pt with NLR &amp;amp;amp;amp;amp;amp;amp;amp;lt;0,7 or &amp;amp;amp;amp;amp;amp;amp;amp;gt; 0,7 medianPFS was 3.2, 2.0 month respectively (p value 0.002 HR 0.241 IC95% 0.0978-0.593), median OS was 7.63, 2.67 respectively (p value 0.0037 HR 0.251 IC95% 0.0986-0.0637) A score was counted for each pt considering the number of favorable basal factors present (ECOG PS 0, NLR&amp;amp;amp;amp;amp;amp;amp;amp;lt;0.7), from 0 to 2. For pt with SCORE 0,1,2 medianPFS was 4.8, 2.4, 1.4 month respectively (p value 0.0009), median OS was 25.6, 5.8, 1.9 respectively (p value &amp;amp;amp;amp;amp;amp;amp;amp;lt;0.0001). Conclusions ECOG PS 0, NLR &amp;amp;amp;amp;amp;amp;amp;amp;lt;0.7, resulted prognostic factors associated with favorable PFS and OS of MM pt treated with Ip after AP or BMi progression. Subgroup with all these factors has a better prognosis. These data can help treatment choice and should be evaluated prospectively. Legal entity responsible for the study Italian Melanoma Intergroup. Funding Has not received any funding. Disclosure R. Marconcini: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: La Roche; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD; Honoraria (self), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy: Incyte; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Ipsen. All other authors have declared no conflicts of interest.
Summary of baseline characteristics’ distribution after the propensity score matching procedure b... more Summary of baseline characteristics’ distribution after the propensity score matching procedure between patients on diabetes medications and those who were not receiving diabetes medications (ratio 1:2, caliper 0.1).
Kaplan-Meier survival estimates according to the receipt of no diabetes medication, other diabete... more Kaplan-Meier survival estimates according to the receipt of no diabetes medication, other diabetes medications/insulin therapy only, and metformin therapy (either alone or in combinations). A) Overall Survival whole cohort; patients not receiving diabetes medications: 18.9 months (95%CI: 15.9-21.6; 684 events), patients on other diabetes medications/insulin therapy only: 19.3 months (95%CI: 11.6-22.9; 48 events), patients on metformin: 12.3 months (95%CI: 9.8-15.9; 100 events). B) Progression Free Survival whole cohort; patients not receiving diabetes medications: 8.2 months (95%CI: 7.1-9.4; 872 events), patients on other diabetes medications/insulin therapy only: 10.7 months (95%CI: 6.7-11.6; 61 events), patients on metformin: 7.9 months (95%CI: 5.1-10.1; 124 events).
Summary of baseline characteristics’ distribution between patients on other oral antidiabetic dru... more Summary of baseline characteristics’ distribution between patients on other oral antidiabetic drugs/insulin only and those who were not on diabetes medications.
Kaplan-Meier survival estimates according to the receipt of other diabetes medications and insuli... more Kaplan-Meier survival estimates according to the receipt of other diabetes medications and insulin therapy. A) Overall Survival whole cohort; patients on other oral antidiabetic drugs and insulin therapy: 17.5 months (95%CI: 12.8-20.9; 82 events), patients not receiving other oral diabetes medications and insulin therapy 17.8 months (95%CI: 15.4 – 19.7; 750 events). B) Progression Free Survival whole cohort; other oral diabetes medications and insulin therapy: 8.2 months (95%CI: 6.2-11.4; 106 events), patients not receiving other oral diabetes medications and insulin therapy: 8.1 months (95%CI: 7.1 – 9.2; 951 events).
Mucosal injury is the consequence of biologic events coupled with the influence of the oral envir... more Mucosal injury is the consequence of biologic events coupled with the influence of the oral environment and microbiome 1. Oral mucositis is one of the most common toxicities of chemoradiation therapies 2. Incidence and severity varies by chemoradiation regimens, radiation fıelds, and tumor site. The influence of mucositis on quality of life is greater among patients than the medical literature would suggest 2, 3. Lack of experience in evaluating treatment toxicities is a daily problem in cancer patients. The aim of this study was to assess the efficacy of Verbascoside's (Mucosyte®) 4 oral solution on mucositis in cancer patients.
BackgroundThe prognosis for patients with metastatic rhabdomyosarcoma (RMS) remains largely unsat... more BackgroundThe prognosis for patients with metastatic rhabdomyosarcoma (RMS) remains largely unsatisfactory despite the adoption of intensive multimodal therapy. To assess the role of different treatments adopted over the years, we retrospectively analyzed a cohort of patients &lt;21 years old with metastatic RMS, treated from 1990 to 2020 at a referral center for pediatric sarcomas.MethodsPatients were treated using a multimodal approach that included surgery, radiotherapy, and chemotherapy (both high‐dose chemotherapy and maintenance therapy in some cases). The type of radiotherapy administered was categorized as radical (to all sites of disease); partial (to at least one, but not all sites of disease); or none. A landmark analysis was used to examine the impact of radiotherapy on survival, that is, patients who had an event before day 221 were excluded from the analysis.ResultsThe series included 80 patients. Event‐free survival (EFS) and overall survival (OS) rates at 5 years were 17.3% and 21.3%, respectively. Survival was significantly associated with radiotherapy to metastatic sites, and with the radiotherapy category. In particular, 5‐year EFS and OS rates were 70.6% and 76.0% for patients given radical radiotherapy, and 4.8% and 10.7%, respectively, for those given partial radiotherapy or none. Using the Cox multivariable analysis, OS correlated significantly with radiotherapy category.ConclusionsWhile confirming the poor overall outcome of patients with metastatic RMS, this study identified radiotherapy—when given to all sites of disease (including metastases)—as the main variable influencing survival.
Each year approximately 35,000 children and adolescents are diagnosed with cancer in Europe. Five... more Each year approximately 35,000 children and adolescents are diagnosed with cancer in Europe. Five-year survival rates have improved and now reach 80% in most European countries, thanks to a combination of chemotherapy, radiotherapy, and surgery. To date, there are more than 44,000 Italians still living several years after being diagnosed with cancer in developmental age. The risk of premature morbidity and mortality for cancer survivors is well known and documented. Approximately 60% of survivors of cancer in childhood and adolescence have at least one chronic health condition in later life, and more than one in four develop severe or life-threatening disorders. Among the various long-term iatrogenic sequelae of cancer treatments, the most worrisome are second malignant neoplasms. We reported on our mono-institutional experiences of screening and treating secondary breast cancer, secondary thyroid cancer and secondary osteosarcoma. Recommendations on the surveillance needed for cancer survivors because of the risk of late effects of their disease or its treatment suggest that discussing the potential problems early on can be crucial to a patient’s future health. These considerations and our consolidated experience strengthen our conviction that survivors of cancer in childhood and adolescence who develop second malignant neoplasms should be treated at highly-specialized centers. Multidisciplinary care requires close communications and high levels of up-to-date professional expertise. This challenging area of health care is also changing rapidly because cancer survivorship is a work in progress, but we cannot wait for definitive conclusions on many aspects because this will take decades, especially for pediatric patients.
This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY
Basal cell carcinoma (BCC) is the most common malignant tumor of the skin. Despite the indolent n... more Basal cell carcinoma (BCC) is the most common malignant tumor of the skin. Despite the indolent nature, metastatic BCC can occur, albeit rarely. Metastasis to the bone is very rare. From its approval, mBCC patients are treated with vismodegib, a selective hedgehog pathway inhibitor. Unfortunately, in recent period, it was demonstrated an emergence of drug resistance, due to Smoothened (SMO) mutation. To date, several groups are studying the effectiveness of immunotherapy in BCC. Clinical trials with Immune Checkpoint Inhibitors are ongoing. We report the rare case of a man with multiple bony metastasis, with a resistance to vismodegib, and we evaluated all manuscripts in literature reporting bone metastasis. Moreover, we review all the manuscripts in literature reporting bone metastasis, and we summarize the main therapeutic strategies, and the further perspectives.
Background. First-line therapies for medulloblastoma(MBL) are obtaining higher survival-rates whi... more Background. First-line therapies for medulloblastoma(MBL) are obtaining higher survival-rates while decreasing late-effects, but treatment at relapse is not standardized. We report the experience with MBL re-irradiation(re-RT), its timing and outcome in different clinical settings and tumor groups. Methods. Patient’s staging/treatment at diagnosis, histotypes/molecular subgroups, relapse site/s, re-treatments outcome are reported. Results. Patients were 25, median age 11.4 years, 8 had metastases, three LCA histotype. According to 2016-2021 WHO-classification, 14 had SHH subgroup tumors(6 TP53 mutated,1 + MYC and 1 + NMYC amplification), 11 non-WNT/non-SHH (2 with MYC/MYCN amplification).Thirteen had received HART-CSI, 11 standard-CSI, one HFRT; all post-radiation chemotherapy(CT), 16 also pre-RT. Median time to relapse (local-LR in 9, distant-DR in 14, LR+DR in two) was 26 months. Fourteen patients were re-operated, in 5 excising single DR-sites, thereafter 3 received CT, two after...
BackgroundPatients with rhabdomyosarcoma (RMS) whose disease relapses have little chance of being... more BackgroundPatients with rhabdomyosarcoma (RMS) whose disease relapses have little chance of being cured, so front‐line treatments are usually followed up with surveillance imaging in an effort to detect any recurrences as early as possible, and thereby improve post‐relapse outcomes. The real benefit of such routine surveillance imaging in RMS remains to be demonstrated, however. This retrospective, single‐center study examines how well surveillance imaging identifies recurrent tumors and its impact on post‐relapse survival.MethodsThe analysis concerned 79 patients &lt;21 years old treated between 1985 and 2020 whose initially localized RMS relapsed. Clinical findings, treatment modalities, and survival were analyzed, comparing patients whose relapse was first suspected from symptoms they developed (clinical symptoms group) with those whose relapse was identified by radiological surveillance (routine imaging group).ResultsTumor relapses came to light because of clinical symptoms in 42 cases, and on routine imaging in 37. The time to relapse was much the same in the two groups. The median overall survival (OS) and 5‐year OS rate were, respectively, 10 months and 12.6% in the clinical symptoms group, and 11 months and 27.5% in the routine imaging group (p‐value .327). Among patients with favorable prognostic scores, survival was better for those in the routine imaging group (5‐year OS 75.0% vs. 33.0%, p‐value .047).ConclusionIt remains doubtful whether surveillance imaging has any real impact on RMS relapse detection and patients’ post‐relapse survival. Further studies are needed to establish the most appropriate follow‐up recommendations, taking the potentially negative effects of regular radiological exams into account.
Open access journal of oncology and medicine, Mar 26, 2021
Background: Ipilimumab is an option in Metastatic Melanoma patients in case of disease progressio... more Background: Ipilimumab is an option in Metastatic Melanoma patients in case of disease progression after antiPD1 treatment and BRAF+MEK inhibitors administration (for BRAF mutated melanoma). We evaluate the prognostic role of some relevant clinical or laboratories parameters for Ipilimumab used in late line after AntiPD1 progression to define patients that benefit most from Ipilimumab monotherapy in this setting. Methods: A retrospective multicenter study was conducted in 8 Italian Oncology Centers, evaluating metastatic melanoma patients treated with Ipilimumab after AntiPD1 and/or BRAF plus Mek inhibitors progression. Endpoints were overall survival (OS) and Progression free survival (PFS), Kaplan Mayer and Cox regression were applied for survival analysis. Results: Among patients that received AntiPD1 and-or Bramber inhibitors, 54 were treated with Ipilimumab monotherapy in 2nd/3rd line. Before Ipilimumab treatment, Number of metastatic sites were equal or less than 3 in 22 (40,7%) patients, ECOG Performance status was 0 in 32 (59%) patients, baseline LDH levels were within normal range in 25 (46,3%) patients, NLR (neutrophile/lymphocyte ratio) was equal or less than 0.7 in 33 (59%) patients. In Univariate analysis, ECOG PS 0 and NLR<0.7 resulted statistically significant good prognostic. In multivariate analysis for PFS, only NLR maintained statistically significance, while in multivariate analysis for OS both ECOG PS and NLR maintained a statistical significance. A score was counted for each patient considering the sum of number of negative factors associated with OS worse prognosis (ECOG PS>0, NLR more than 0.7). For patients with SCORE 0,1,2 median OS was respectively 11.4, 7.87 and 2.77 (p value<0.0001). Conclusions: ECOG PS 0 and NLR<0.7 resulted prognostic factors associated with favorable OS of metastatic melanoma patients treated with Ipilimumab after AntiPD1 progression. Subgroup with all these factors has a better prognosis. These data can help treatment choice and should be evaluated prospectively.
Background Ipilimumab (Ip) is an option in Metastatic Melanoma (MM) patients (pt) in case of dise... more Background Ipilimumab (Ip) is an option in Metastatic Melanoma (MM) patients (pt) in case of disease progression after antiPD1 (AP) treatment and BRAF+MEK inhibitors (BMi) administration (for BRAF mutated melanoma). Clinical trial are evaluating potential Ip-based combinations in 2nd/3rd line setting. Many studies underline the role of some parameters (as LDH, ECOG PS, Neutrophile/Leucocyte ratio) as progostic factors for immunotherapy used in first-line. We evaluate the prognostic role of some relevant clinical or laboratoristic parameters for Ip used in late line after AP, Bmi, in order to define pt that benefit most from Ip monotherapy in this setting. Methods A retrospective multicenter study was conducted in 8 Italian Oncology Centers, evaluating MM pt treated with Ip after AP and/or BMi. Endpoints were OS and PFS, Kaplan Mayer and Cox regression were applied for survival analysis. Results Among 200 pt that received AP or Bmi, 48 were eligible for Ip administration in 2nd/3rd line. Before Ip treatment, ECOG PS was 0 in 21 pt, number of metastatic sites was less then 3 in 14 pt, LDH was within normal range in 19 pt, NLR ratio (= baseline neutrophils/total leukocytes) was less then 0.7 in 28 pt: in univariate analysis, only ECOG PS and NLR resulted significantly associated with better PFS and OS. For pt with ECOG PS 0 or 1 medianPFS was 3.2, 2.3 month respectively (p value 0.0066; HR 0.377 IC95% 0.186-0.762), median OS was 12.1, 4.0 respectively (p value 0.0016 HR 0.287 IC95% 0.132-0.622). For pt with NLR &amp;amp;amp;amp;amp;amp;amp;amp;lt;0,7 or &amp;amp;amp;amp;amp;amp;amp;amp;gt; 0,7 medianPFS was 3.2, 2.0 month respectively (p value 0.002 HR 0.241 IC95% 0.0978-0.593), median OS was 7.63, 2.67 respectively (p value 0.0037 HR 0.251 IC95% 0.0986-0.0637) A score was counted for each pt considering the number of favorable basal factors present (ECOG PS 0, NLR&amp;amp;amp;amp;amp;amp;amp;amp;lt;0.7), from 0 to 2. For pt with SCORE 0,1,2 medianPFS was 4.8, 2.4, 1.4 month respectively (p value 0.0009), median OS was 25.6, 5.8, 1.9 respectively (p value &amp;amp;amp;amp;amp;amp;amp;amp;lt;0.0001). Conclusions ECOG PS 0, NLR &amp;amp;amp;amp;amp;amp;amp;amp;lt;0.7, resulted prognostic factors associated with favorable PFS and OS of MM pt treated with Ip after AP or BMi progression. Subgroup with all these factors has a better prognosis. These data can help treatment choice and should be evaluated prospectively. Legal entity responsible for the study Italian Melanoma Intergroup. Funding Has not received any funding. Disclosure R. Marconcini: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: La Roche; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD; Honoraria (self), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy: Incyte; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Ipsen. All other authors have declared no conflicts of interest.
Summary of baseline characteristics’ distribution after the propensity score matching procedure b... more Summary of baseline characteristics’ distribution after the propensity score matching procedure between patients on diabetes medications and those who were not receiving diabetes medications (ratio 1:2, caliper 0.1).
Kaplan-Meier survival estimates according to the receipt of no diabetes medication, other diabete... more Kaplan-Meier survival estimates according to the receipt of no diabetes medication, other diabetes medications/insulin therapy only, and metformin therapy (either alone or in combinations). A) Overall Survival whole cohort; patients not receiving diabetes medications: 18.9 months (95%CI: 15.9-21.6; 684 events), patients on other diabetes medications/insulin therapy only: 19.3 months (95%CI: 11.6-22.9; 48 events), patients on metformin: 12.3 months (95%CI: 9.8-15.9; 100 events). B) Progression Free Survival whole cohort; patients not receiving diabetes medications: 8.2 months (95%CI: 7.1-9.4; 872 events), patients on other diabetes medications/insulin therapy only: 10.7 months (95%CI: 6.7-11.6; 61 events), patients on metformin: 7.9 months (95%CI: 5.1-10.1; 124 events).
Summary of baseline characteristics’ distribution between patients on other oral antidiabetic dru... more Summary of baseline characteristics’ distribution between patients on other oral antidiabetic drugs/insulin only and those who were not on diabetes medications.
Kaplan-Meier survival estimates according to the receipt of other diabetes medications and insuli... more Kaplan-Meier survival estimates according to the receipt of other diabetes medications and insulin therapy. A) Overall Survival whole cohort; patients on other oral antidiabetic drugs and insulin therapy: 17.5 months (95%CI: 12.8-20.9; 82 events), patients not receiving other oral diabetes medications and insulin therapy 17.8 months (95%CI: 15.4 – 19.7; 750 events). B) Progression Free Survival whole cohort; other oral diabetes medications and insulin therapy: 8.2 months (95%CI: 6.2-11.4; 106 events), patients not receiving other oral diabetes medications and insulin therapy: 8.1 months (95%CI: 7.1 – 9.2; 951 events).
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