Narrative Medicine: A Digital Diary in the Management of Patients with Bone and Soft Tissue Sarcoma-A Multidisciplinary Pilot Study.

Although patient narratives have been increasingly introduced in various fields of medicine, a standard method in clinical practice is still lacking. The objectives of this pilot study were to evaluate the feasibility and usefulness of a digital narrative diary integrated into the care pathway of patients with bone sarcoma and limb soft tissue sarcoma both from the patients' and the healthcare professionals' (HCPs) perspectives. A digital platform, DNMLAB, was designed to obtain guided narratives from patients during their pathway of care in compliance with confidentiality and data protection laws. The diary was used for patients, often young, facing a rare and impactful disease that is difficult to manage and with few opportunities to share experiences. The multidisciplinary team shared the narratives and integrated them into the patient's treatment pathway. Narrative prompts were adequate for the care pathway. Patients correctly considered the diary as a shared area to think about their condition, and HCPs considered it "a shared area growing at each meeting with the patient". The main advantages reported by patients were increased awareness, the opportunity to express their opinion on cures and important personal needs and the perception of better taking charge (score ≥ 4.6). The main advantages of HCP were improved communication, therapeutic alliance, and deeper knowledge of patients. This study confirmed the authors' previous experiences, showing that a digital narrative process is feasible and useful for oncology clinical practice according to patients and HCPs.

Quality of life and emotional distress in sarcoma patients diagnosed during COVID-19 pandemic: a supplementary analysis from the SarCorD study.

Background: The COVID-19 outbreak had a negative psychological impact on cancer patients. In this study, we analyzed emotional distress and quality of life in patients diagnosed with sarcoma during the first year of the pandemic compared to the previous year. Methods: We retrospectively enrolled patients with soft tissue, bone sarcoma, and aggressive benign musculoskeletal diseases diagnosed during the pandemic (COVID group) or the year before (control group) at the IRCCS Regina Elena National Cancer Institute in Rome. Patients who had undergone a psychological assessment with the EORTC QLQ-C30 and the Distress Thermometer at diagnosis were included in the final analysis. We analyzed whether there is a difference in the various domains of quality of life between the two groups and whether there are changes over time in each group. Results: We enrolled 114 patients (72 control group; 42 COVID group), affected by soft tissue (64%), bone sarcoma (29%), and aggressive benign musculoskeletal diseases (7%). We did not observe significant differences in the health-related quality of life domains in the control and COVID groups, except for the financial domain (p = 0.039), with 9.7% vs. 23.8% of patients with a score > 0 in the control and COVID groups, respectively. We observed emotional distress at diagnosis in 48.6% of patients in the control group vs. 69.0% in the COVID group (p = 0.034). In the control group, we observed an improvement in physical function (p = 0.043) and in QoL (p = 0.022), while in the COVID group, we observed a deterioration in role function (p = 0.044) during follow-up. In the COVID group, 22.2% of patients were concerned about COVID-19, 61.1% by tumor, 91.1% stated that the pandemic worsened their subjective perception of cancer, and 19.4% perceived that their quality of care had worsened. Conclusion: We observed a higher level of distress among patients diagnosed during the pandemic compared to the year before, probably due to the increased concern for both infection and cancer, the worsened perception of health status, and the perception of a poorer quality of health care.

The impact of the COVID-19 pandemic on diagnosis and treatment of patients with soft tissue and bone sarcomas or aggressive benign musculoskeletal diseases: A single-center retrospective study (SarCorD study).

Background: The COVID-19 pandemic led to a rapid reorganization of healthcare activities, leading to reduced access to clinics, interruption of screenings, and treatment schedule modifications in several cancer types. Few data are available on sarcomas. We analyzed COVID-19-related diagnostic delay in a sarcoma referral center in Italy. Methods: We retrospectively enrolled in this study patients with histological diagnosis of soft tissue or bone sarcoma and aggressive benign musculoskeletal diseases obtained during the first year of the pandemic (Covid group) or the year before (Control group) and followed at the Regina Elena National Cancer Institute in Rome. The primary endpoint was the time from the first symptom to histological diagnosis. Results: We evaluated 372 patients, 185 of whom were eligible for primary endpoint analysis (92 patients in the Control group and 93 patients in the Covid group). The patients were affected by soft tissue sarcoma in most cases (63.0% and 66.7% in Covid and Control groups, respectively). We observed a diagnostic delay in the Covid group with a median time from the first symptom to the definitive histological diagnosis of 103.00 days (95% CI 92.77-113.23) vs. 90.00 days (95% CI 69.49-110.51) in the Control group (p = 0.024), but not a delay in treatment beginning (151 days, 95% CI 132.9-169.1 vs. 144 days, 95% CI 120.3-167.7, respectively, p = 0.208). No differences in stage at diagnosis were observed (12% vs. 16.5% of patients with metastatic disease at diagnosis in the Covid and Control groups, respectively, p = 0.380). Progression-free survival (p = 0.897) and overall survival (p = 0.725) were comparable in the subgroup of patients affected by soft tissue sarcoma. Conclusions: A delay in sarcoma diagnosis but not in starting treatment has been observed during the first year of the COVID-19 pandemic. Nevertheless, no difference in stage at diagnosis or in terms of survival has been observed.

Malignant Transformation of Giant Cell Tumour of Bone: A Review of Literature and the Experience of a Referral Centre.

Giant cell tumour of bone (GCTB) is a benign, locally aggressive primary bone neoplasm that represents 5% of all bone tumours. The principal treatment approach is surgery. Although generally GCTB is considered only a locally aggressive disease, it can metastasise, and lung metastases occur in 1-9% of patients. To date, only the use of denosumab has been approved as medical treatment for GCTB. Even more rarely, GCTB undergoes sarcomatous transformation into a malignant tumour (4% of all GCTB), but history of this malignant transformation is unclear and unpredictable. Considering the rarity of the event, the data in the literature are few. In this review, we summarise published data of GCTB malignant transformation and we analyse three cases of malignant transformation of GCTB, evaluating histopathology, genetics, and radiological aspects. Despite the rarity of this event, we conclude that a strict follow up is recommended to detect early malignant transformation.

First-Line Osimertinib in Patients with EGFR-Mutant Advanced Non-Small Cell Lung Cancer: Outcome and Safety in the Real World: FLOWER Study.

BACKGROUND: Osimertinib became the standard treatment for patients with untreated EGFR-mutant advanced non-small cell lung cancer (aNSCLC) following results reported in the phase III randomized FLAURA trial. Because of strict exclusion criteria, patient populations included in pivotal trials are only partially representative of real-world patients. METHODS: We designed an observational, prospective, multicenter study enrolling patients with EGFR-mutant aNSCLC receiving first-line osimertinib to evaluate effectiveness, safety, and progression patterns in the real-world. RESULTS: At data cutoff, 126 White patients from nine oncology centers were included. At diagnosis, 16 patients (12.7%) had a performance status (PS) ≥2 and 38 (30.2%) had brain metastases. Overall response rate (ORR) was 73%, disease control rate (DCR) 96.0%. After a median follow-up of 12.3 months, median time to treatment discontinuation (mTTD) was 25.3 months, median progression-free-survival (mPFS) was 18.9 months and median overall survival (mOS) was not reached (NR). One hundred and ten patients (87%) experienced adverse events (AEs), 42 (33%) of grade 3-4, with venous thromboembolism (VTE) as the most common (n = 10, 7.9%). No difference in rates of VTE was reported according to age, PS, comorbidity, and tumor load. We observed longer mTTD in patients without symptoms (NR vs. 18.8 months) and with fewer than three metastatic sites at diagnosis (NR vs. 21.4 months). Patients without brain metastases experienced longer mPFS (NR vs. 13.3 months). No difference in survival outcome was observed according to age, comorbidity, and type of EGFR mutation. Isolated progression and progression in fewer than three sites were associated with longer time to treatment discontinuation (TTD). CONCLUSION: Osimertinib confirmed effectiveness and safety in the real world, although thromboembolism was more frequent than previously reported.

Narrative Medicine: A Digital Diary in the Management of Bone and Soft Tissue Sarcoma Patients. Preliminary Results of a Multidisciplinary Pilot Study.

BACKGROUND: Guidelines for the implementation of narrative medicine in clinical practice exist; however, in Italy, no standard methodology is currently available for the management of oncological patients. Since 2017, at the "Regina Elena" National Cancer Institute, studies using "digital narrative diaries" (DNMLAB platform) have been carried out; this article focuses on a pilot, uncontrolled, real-life study aiming to evaluate the utility of DNM integrated with the care pathway of patients with bone and limb soft tissue sarcomas. METHODS: Adult patients completed the diary during treatment or follow-up by writing their narrative guided by a set of narrative prompts. The endpoints were: (a) patients' opinions about therapeutic alliance, awareness, and coping ability; (b) healthcare professionals' (HCPs') opinions about communication, therapeutic alliance, and information collection. Open- and closed-ended questions (Likert score: 1-5) were used to assess the items. RESULTS: At the interim analysis of data from seven patients and five HCPs, DNM was shown to improve: (a) the expression of patients' point of view, the perception of effective taking charge, disease awareness, and self-empowerment (score: 4.8/5); (b) patients' communication, relationships, and illness knowledge (score: 4.6-4.8/5). CONCLUSIONS: The preliminary results supported the need to integrate patients' narratives with clinical data and encourage further research.

Neoadjuvant immune checkpoint inhibitors in high-risk stage III melanoma.

The success of immunotherapy and targeted therapy for metastatic melanoma has generated considerable interest in the adjuvant setting, even though high-risk stage III melanoma (with or without in-transit metastases) still holds a substantial probability of relapse, despite surgical resection and available adjuvant treatments. Based on preclinical and clinical trials in resectable melanoma, immune checkpoint inhibitors can enhance anti-tumor immunity by activating antigen-specific T cells found in the primary site. These tumor-reactive T cells continue to exert their anti-tumor effects on remaining neoplastic cells after resection of the primary tumor, potentially preventing relapses from reoccurring. Several trials in the neoadjuvant setting have been conducted for melanoma patients using checkpoint inhibitors with promising early data, showing an improvement of operability and clinical outcomes. Hence, in this study, we review and discuss the available published and ongoing clinical trials to explore the scientific background behind immunotherapy in the neoadjuvant context.

Prognostic Value of Pre-Treatment [18F]FDG PET/CT Texture Analysis in Undifferentiated Soft-Tissue Sarcoma.

BACKGROUND: Undifferentiated soft-tissue sarcomas (USTS) are one of the most common sarcoma histotypes in adults. The standard of care is surgical excision plus adjuvant radiotherapy, while the use of perioperative chemotherapy is still controversial. The aim of this study was to investigate the value of pre-treatment [18F]FDG PET/CT conventional metrics and textural features in predicting disease-free survival (DFS) and overall survival (OS) in patients with USTS of the limbs and trunk. METHODS: [18F]FDG PET/CT scans of 51 consecutive patients with locally advanced USTS were retrospectively evaluated. Conventional and textural PET parameters were analysed and tested as predictive factors for DFS and OS. RESULTS: During a median follow up of 50.7 months, 23 (45.1%) and 29 (56.9%) patients had death or disease progression, respectively. Univariate analysis revealed a significant association for perioperative treatment, PET volumetric parameters and the textural feature GLCM_correlation with DFS and OS. In multivariate analysis, perioperative treatment and GLCM_correlation were the only independent factors, allowing stratification of the population into three different prognostic classes. CONCLUSION: GLCM_correlation can identify USTS at high risk of relapse and death, thus helping to optimize the perioperative treatment of patients.

Mediastinal lymph node metastasis as a single expression of disease relapse in Ewing's sarcoma: multidisciplinary approach of two consecutive cases.

Ewing's sarcoma of the bone is a rare, highly aggressive tumor that typically affects children and young adults. Progress in the treatment of Ewing's sarcoma has improved survival from about 10%, before the introduction of chemotherapy, to about 75% today for patients with localized tumors. On the contrary, metastatic disease still has a poor prognosis, and a multidisciplinary approach is essential to improve the outcome. Molecular techniques and new imaging modalities are affecting the diagnosis and classification of patients with Ewing's sarcoma. The most frequent sites of metastases in Ewing's sarcoma include lungs, bones and bone marrow. Lymph nodes are a rare site of metastatic spread, particularly in the mediastinum. In this report, we present two consecutive cases of patients with Ewing's Sarcoma, diagnosed, and treated at our institute. We focused particularly on the rarity of the atypical presentation of the disease and on the synergistic strategy to adopt as a model of networking in treating patients with rare diseases.

Nodal Upstaging Evaluation After Robotic-Assisted Lobectomy for Early-Stage Non-small Cell Lung Cancer Compared to Video-Assisted Thoracic Surgery and Thoracotomy: A Retrospective Single Center Analysis.

Introduction: The standard surgical procedures for patients with early-stage NSCLC is lobectomy-associated radical lymphadenectomy performed by using the thoracotomy approach. In the last few years, minimally invasive techniques have increasingly strengthened their role in lung cancer treatment, especially in the early stage of the disease. Although the lobectomy technique has been accepted, controversy still surrounds lymph node dissection. In our study, we analyze the rate of upstaging early non-small cell lung cancer patients who underwent radical surgical treatment using the robotic and the VATS techniques compared to the standard thoracotomy approach. Methods and Materials: We retrospectively reviewed patients who underwent a lobectomy and radical lymphadenectomy at our Institute between 2010 and 2019. We selected 505 patients who met the inclusion criteria of the study: 237 patients underwent robotic surgery, 158 patients had thoracotomy, and 110 patients were treated with VATS. We analyzed the demographic features between the groups as well as the nodal upstaging rate after pathological examination, the number of dissected lymph nodes and the ratio of dissected lymph nodes to metastatic lymph nodes of the three groups. Results: The patients of the three groups were homogenous with respect to age, sex, and histology. The postoperative major morbidity rate was significantly higher in the thoracotomy group, and hospital stay was significantly longer. The percentage of the mediastinal nodal upstaging rate and the number of dissected lymph nodes was significantly higher in the robotic group compared with the VATS group. The ratio of dissected lymph nodes to metastatic lymph nodes was significantly lower compared with the VATS group and the thoracotomy group. Discussion: The prognostic impact of the R(un) status is still highly debated. A surgical approach that allows better results in terms of resection has still not been defined. Our results show that robotic surgery is a safe and feasible approach especially regarding the accuracy of mediastinal lymphadenectomy. These findings can lead to defining a more precise pathological stage of the disease and, if necessary, to more accurate postoperative treatment.

Case Report: Rechallenge With BRAF and MEK Inhibitors in Metastatic Melanoma: A Further Therapeutic Option in Salvage Setting?

BACKGROUND: The combination of BRAF and MEK inhibitors represents the standard of care treatment for patients with metastatic BRAF-mutated melanoma, notwithstanding the high frequency of emergent resistance. Moreover, therapeutic options outside clinical trials are scarce when patients have progressed after both targeted therapy and therapy with immune checkpoint inhibitors. In this article, we report our experience with targeted therapy rechallenging with BRAF and MEK inhibitors in patients with metastatic BRAF-mutated melanoma after progression with kinase inhibitors and immunotherapy. METHODS: Four patients with metastatic BRAF-mutated melanoma were rechallenged with BRAF and MEK inhibitors after progression with targeted therapy and subsequent immunotherapy (checkpoint inhibitors). RESULTS: Two patients (one of them was heavily pretreated) had partial response over 36 months (with local treatment on oligoprogression disease) and 10 months, respectively. A third patient with multisite visceral disease and high serum levels of lactate dehydrogenase had a short-lived clinical benefit rapidly followed by massive progression of disease (early progressor). The fourth patient, currently on treatment with BRAF/MEK inhibitors, is showing a clinical benefit and radiological stable disease over 3 months of therapy. Adverse events were manageable, similar to those reported during the first targeted therapy; the treatment was better tolerated at rechallenge compared with the first treatment by two out of four patients.

[18F]FDG PET/CT quantitative parameters for the prediction of histological response to induction chemotherapy and clinical outcome in patients with localised bone and soft-tissue Ewing sarcoma.

OBJECTIVE: The application of [18F]FDG PET/CT in predicting histologic response to induction chemotherapy in patients with Ewing sarcoma (EWS) has been proposed using the values of pre-post treatment SUVmax as a referral parameter, although with heterogeneous results. The aim of this retrospective study was to evaluate the diagnostic accuracy of [18F]FDG PET/CT volumetric parameters (metabolic tumour volume (MTV) and total lesion glycolysis (TLG)) as compared to SUVmax to predict response to chemotherapy and clinical outcome in patients with localised EWS of bone and soft-tissue. METHODS: Twenty-eight patients with non-metastatic EWS of bone (n = 20) and soft tissues (n = 8) who underwent a [18F]FDG PET/CT scan before (PET1) and after induction chemotherapy (PET2) were enclosed in the analysis. Values of PET metrics (SUVmax, MTV, TLG) at diagnosis and after neoadjuvant chemotherapy as well as the percentage change between PET1 and PET2 (ΔSUV, ΔMTV and ΔTLG) were correlated to histological response and to progression-free survival (PFS). RESULTS: ΔTLG (cut-off: -60%) is the best predictor for histologic response with 100% sensitivity and 77.8% specificity. MTV1 > 33.4 cm3 and TLG1 > 112 were also associated with a favourable histologic response (sensitivity 80% and specificity 77.8% for both). On multivariate analysis, SUV2 (> 3.3) and ΔTLG (< -18%) were independent predictors of worse PFS. CONCLUSIONS: [18F]FDG PET/CT could accurately predict histologic response to neoadjuvant chemotherapy in patients with EWS, also showing a possible prognostic value for future disease relapse. KEY POINTS: • The variation of the PET parameter tumour lesion glycolysis (TLG) can predict the histologic response to induction chemotherapy (sensitivity 100%, specificity 77.8%), in patients with Ewing sarcoma. • The percentage variation of TLG and the value of the SUVmax at PET scan after chemotherapy show a prognostic role for future disease relapse. The combination of both the parameters identifies three prognostic classes of patients with low, intermediate and high risk of disease relapse.

Symptoms and their implications on quality of life and psychological distress in sarcoma patients.

The aim of this study was to investigate symptoms, their variation over time and their relationship with quality of life (QoL)/psychological distress in sarcoma patients, as few data regarding QoL and psychological distress in this set of patients are currently available. A total of 188 sarcoma patients from an Italian referral center were involved. Symptoms and financial difficulties were evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire from the first treatment and over the follow-up period, up to 6 years. The authors found that patients with sarcoma experience several symptoms, especially fatigue and pain, which may dramatically worsen QoL and psychological distress. In conclusion, patients with sarcoma often experience fatigue, pain and financial difficulties, which negatively impacts QoL and psychological distress. To ameliorate overall QoL, proper control of symptoms is necessary.

Impact of Clinical Response to Neoadjuvant Chemotherapy in the Era of Robot Assisted Radical Cystectomy: Results of a Single-Center Experience.

BACKGROUND: Response to neoadjuvant chemotherapy (NACT) has been proven to be an established prognostic factor after open radical cystectomy (ORC). We evaluated the impact of NACT on survival outcomes of a single-institution robotic radical cystectomy (RARC) series. METHODS: From January 2012 to June 2020, 79 patients were identified. Baseline, demographic, perioperative, and pathologic data were described. Kaplan-Meier with the log-rank test was used to compare overall survival (OS) differences between complete, partial, and no-NACT responders, respectively. Univariable and multivariable regression analyses were performed to identify predictors of OS. RESULTS: Complete, partial, and absent response to NACT were recorded in 43 (54.4%), 21 (19%), and 15 (26.6%) patients, respectively. A complete response to NACT displayed a trend toward significant higher OS (p = 0.03). In univariable analysis, significant predictors of lower OS were hypertension (HR 3.37; CI 95% 1.31-8.62; p = 0.01); advanced nodal involvement (HR 2.41; CI 95% 0.53-10.9; p < 0.001); and incomplete response to NACT (HR 0.41; CI 95% 0.18-0.95; p = 0.039). In multivariable analysis, the only independent predictor of worse OS was advanced pathologic N stages (HR 10.1; CI: 95% CI 2.3-44.3; p = 0.002). CONCLUSIONS: Complete response to NACT is associated with increased OS probability, but significant nodal residual disease remains the only independent predictor of OS after RARC.

The Real-Life Journey of Elderly Patients in Soft Tissue and Bone Sarcomas: A Retrospective Analysis from a Sarcoma Referral Center.

The high complexity of multimodality treatment frequently results in undertreatment of elderly sarcoma patients, and this may be one of the factors that influence their prognosis. We describe the real-life approach to a population of patients aged over 70 with both soft tissue (STS) and bone sarcomas (BS) followed by our Sarcoma Disease Management Team from 2012 to 2017. One-hundred and twenty-three patients with a median age of 77 years (range: 70-92) were identified. STS were the most common histological subtypes (94%) and the grade was high in 79/123 patients (64%). At diagnosis, 88% of patients had localized disease (LD) and 12% were metastatic (MD). Overall, 96% of patients with LD underwent surgery, 46/54 (85%) with high grade STS patients underwent complementary radiotherapy, and 10/54 (19%) received adjuvant treatments. Twelve out of 33 patients who relapsed (36%) underwent local therapies. Seventeen (52%) and eight (24%) patients were treated with first-line and second-line medical treatments, respectively. Tolerability to systemic treatments was fairly good. Overall, 21% of the patients with advanced disease were candidates for best supportive care alone. Our case series of elderly patients with both STS and BS shows that personalized multidisciplinary treatment can nevertheless be offered to this frail population in order to control the evolution of disease.

PTEN Function at the Interface between Cancer and Tumor Microenvironment: Implications for Response to Immunotherapy.

Mounting preclinical and clinical evidence indicates that rewiring the host immune system in favor of an antitumor microenvironment achieves remarkable clinical efficacy in the treatment of many hematological and solid cancer patients. Nevertheless, despite the promising development of many new and interesting therapeutic strategies, many of these still fail from a clinical point of view, probably due to the lack of prognostic and predictive biomarkers. In that respect, several data shed new light on the role of the tumor suppressor phosphatase and tensin homolog on chromosome 10 (PTEN) in affecting the composition and function of the tumor microenvironment (TME) as well as resistance/sensitivity to immunotherapy. In this review, we summarize current knowledge on PTEN functions in different TME compartments (immune and stromal cells) and how they can modulate sensitivity/resistance to different immunological manipulations and ultimately influence clinical response to cancer immunotherapy.

Comparison of 18F-FDG PET/CT Criteria for the Prediction of Therapy Response and Clinical Outcome in Patients With Metastatic Melanoma Treated With Ipilimumab and PD-1 Inhibitors.

: Immunotherapy currently represents one of the most effective therapies in metastatic melanoma. However, its indirect antineoplastic activity through the immune system has raised relevant challenges for diagnostic imaging in the evaluation of the response to treatment. PURPOSE: The aim of this retrospective study was to compare the diagnostic accuracy of different F-FDG PET/CT criteria to predict therapy response and clinical outcome in melanoma patients treated with immune checkpoint inhibitors. PATIENTS AND METHODS: Fifty-seven patients with metastatic melanoma treated with ipilimumab (n = 25; group 1) or with PD-1 inhibitors (n = 32; group 2) who performed an F-FDG PET/CT scan before treatment (PET0) and 12 to 18 weeks later (PET1) were retrospectively evaluated. Response at PET1 was evaluated according to RECIST 1.1, EORTC, PERCIMT (PET Response Evaluation Criteria for Immunotherapy), and by percentage change of metabolic tumor volume (MTV) and total lesion glycolysis of up to 5 target lesions. Performance of each criterion at PET1 to predict clinical benefit at 6 months since starting immunotherapy was assessed and correlated to progression-free survival. RESULTS: In group 1, the best predictor of therapy response was MTV combined with PERCIMT criteria (accuracy, 0.96). In group 2, overlapping results were found for EORTC, MTV, and total lesion glycolysis (accuracy, 0.97). The reliability of the above parameters was also confirmed in the progression-free survival analysis. CONCLUSIONS: F-FDG PET/CT performed after 3 to 4 months since starting immunotherapy can correctly evaluate response to treatment and can also able to predict long-term clinical outcome. Performance of F-FDG PET/CT and criteria for response assessment is influenced by the class of treatment.

Sarcoma patients' quality of life from diagnosis to yearly follow-up: experience from an Italian tertiary care center.

Aim: To investigate sarcoma patients' perception of quality of life and psychosocial distress across the different disease's stages. Patients & methods: Total 329 sarcoma patients were monitored from diagnosis up to a maximum of six consecutive follow-up visits. Results: Functional status worsened over time with the lowest value after surgery and a full recovery not earlier than the second follow-up visit. Married and single patients exhibited similar quality of life pattern. High levels of psychological distress were observed from diagnosis to active treatment periods with a progressive improvement during follow-up. Psychological distress pattern over time varied by marital status and age. Conclusion: Our study suggests the importance of integrating psychosocial care to medical therapy across the entire sarcoma journey.

Economic burden of patients affected by non-small cell lung cancer (NSCLC): the LIFE study.

PURPOSE: Non-small cell lung cancer (NSCLC) is a condition with significant clinical burden for patients and relevant economic impact. Limited evidence exists on the management costs of NSCLC patients, especially in the late phases of the disease. The main objective of this analysis was to evaluate the economic impact of clinical management of NSCLC patients in the Italian population. METHODS: This evaluation was an economic analysis of the observational and multicentre study LIFE, which described the therapeutic approach in routine clinical practice for NSCLC patients, progressing after first-line treatment. This study evaluated resource consumption in different Italian hospitals, including specialist visits, hospitalizations, accesses to first aid, pharmacological treatment, laboratory tests and palliative care. The National Healthcare Service perspective was adopted. RESULTS: In this study, N = 191 patients enrolled in the LIFE study were included. Patients were aged 64.2 years and were predominantly males (66%). In the different line of treatments, monthly costs of patients ranged between €1471 (first line) and €1788 (third line). The overall healthcare cost over the average period of observation (16.4 months) was €25,859 per patient. Overall, oncology therapy was the cost driver, although the composition of medical costs changed across the different lines of treatment, with costs for concomitant medication and palliative care being predominant in late phase of the disease. CONCLUSIONS: The economic burden of NSCLC is extremely high during the overall period of treatment, and a significant level of care is required in each stage of the disease.

Prognostic model for advanced breast carcinoma with luminal subtype and impact of hormonal maintenance: Implications for post-progression and conditional survival.

BACKGROUND: The aim of this analysis was to develop and validate a prognostic model for advanced breast cancer (ABC) with luminal subtype based on the combination of clinical, pathological and therapeutic predictors to provide a practical tool to evaluate patients' prognosis. METHODS: Clinical and pathological data were retrospectively correlated to progression-free and overall survival (PFS/OS) using a Cox model. Significant treatment variables were adjusted with the propensity score analysis. A continuous score to identify risk classes was derived according to model ratios. The performance of the risk-class model was tested for post-progression survival (PPS) and conditional survival (CS) as well. RESULTS: Data from 335 patients (3 institutions) were gathered (median follow-up 58 months). At multivariate analysis Ki67, Performance Status (PS) and number of metastatic sites were significant predictors for PFS, whereas Ki67, PS, brain metastases, PFS after 1st-line therapy, number of chemotherapy lines, hormonal therapy and maintenance were significant predictors for OS. The hormonal maintenance resulted to be prognostic after adjustment with propensity score analysis. A two-class model significantly differentiated low-risk and high-risk patients for 2-year PFS (31.5% and 11.0%, p < 0.0001), and 3-years OS (57.1% and 4.8%, p < 0.0001). A three-class model separated low risk, intermediate-risk, and high-risk patients for 2-year PFS (40.8%, 24.4%, and 11.0%, p < 0.0001) and 3-year OS (68.1%, 24.8%, and 4.8%, p < 0.0001). Both models equally discriminate the luminal ABC prognosis in terms of PPS and CS. CONCLUSIONS: A risk stratification model including 'easy-to-obtain' clinical, pathological and therapeutic parameters accurately separates luminal ABC patients into different risk classes.