scholarly journals [177Lu]Lu-DOTA-TATE versus standard of care in adult patients with gastro-enteropancreatic neuroendocrine tumours (GEP-NETs): a cost-consequence analysis from an Italian hospital perspective

2021 ◽  
Author(s):  
Francesca Spada ◽  
Davide Campana ◽  
Giuseppe Lamberti ◽  
Riccardo Laudicella ◽  
Renato Dellamano ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Neuroendocrine Tumours ◽  
Treatment Options ◽  
Somatostatin Analogs ◽  
Treatment Decision ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Adult Patients ◽  
Hospital Perspective ◽  
Cost Consequence

Abstract Purpose To assess and compare clinical outcomes and costs, to the Italian healthcare system, of three therapeutic options approved in the management of adult patients with gastro-enteropancreatic neuroendocrine tumours (GEP-NETs). Methods We compared the efficacy, safety, and costs of [177Lu]Lu-DOTA-TATE, everolimus (both originator and generic products), and sunitinib in patients with advanced GEP-NETs (NET G1 and G2) that had progressed following treatment with somatostatin analogs (SSAs). A cost-consequence model was developed and validated by a panel of clinical experts from three NET reference centres in Italy. The clinical outcomes included in the model were median progression-free survival and the incidence of grade 3 or 4 adverse events (AEs), as reported in pivotal clinical trials. The costs for acquisition and administration of each treatment, and of managing AEs, were calculated from the perspective of the Italian national health service. Treatment costs per progression-free month were calculated separately for patients with NETs of pancreatic (PanNETs; all three treatments) and gastrointestinal (GI-NETs; [177Lu]Lu-DOTA-TATE and everolimus only) origin. Results In patients with PanNETs, total costs per progression-free month were €2989 for [177Lu]Lu-DOTA-TATE, €4975 for originator everolimus, €3472 for generic everolimus, and €5337 for sunitinib. In patients with GI-NETs, total costs per progression-free month were €3189 for [177Lu]Lu-DOTA-TATE, €4990 for originator everolimus, and €3483 for generic everolimus. Conclusions [177Lu]Lu-DOTA-TATE was associated with lower costs per progression-free month versus relevant treatment options in patients with GI-NETs or PanNETs (NET G1–G2; progressed following SSA treatment), although acquisition and administration costs are higher. These findings provide further economic arguments in the overall context of treatment decision-making.

[177Lu]Lu-DOTA-TATE Versus Standard of Care in Adult Patients With Gastro-Enteropancreatic Neuroendocrine Tumours (GEP-NETS): A Cost-Consequence Analysis From an Italian Hospital Perspective

2021 ◽  
Author(s):  
Francesca Spada ◽  
Davide Campana ◽  
Giuseppe Lamberti ◽  
Riccardo Laudicella ◽  
Renato Dellamano ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Neuroendocrine Tumours ◽  
Treatment Options ◽  
Treatment Decision ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Somatostatin Analogues ◽  
Adult Patients ◽  
Hospital Perspective ◽  
Cost Consequence

Abstract Purpose To assess and compare clinical outcomes and costs, to the Italian healthcare system, of three therapeutic options approved in the management of adult patients with gastro-enteropancreatic neuroendocrine tumours (GEP-NETs). Methods We compared the efficacy, safety and costs of [177Lu]Lu-DOTA-TATE, everolimus (both originator and generic products) and sunitinib in patients with advanced GEP-NETs (NET G1 and G2) that had progressed following treatment with somatostatin analogues (SSAs). A cost-consequence model was developed and validated by a panel of clinical experts from three NET reference centres in Italy. The clinical outcomes included in the model were median progression-free survival and the incidence of grade 3 or 4 adverse events (AEs), as reported in pivotal clinical trials. The costs for acquisition and administration of each treatment, and of managing AEs, were calculated from the perspective of the Italian national health service. Treatment costs per progression-free month were calculated separately for patients with NETs of pancreatic (PanNETs; all three treatments) and gastrointestinal (GI-NETs; [177Lu]Lu-DOTA-TATE and everolimus only) origin. Results In patients with PanNETs, total costs per progression-free month were €2989 for [177Lu]Lu-DOTA-TATE, €4975 for originator everolimus, €3472 for generic everolimus, and €5337 for sunitinib. In patients with GI-NETs, total costs per progression-free month were €3189 for [177Lu]Lu-DOTA-TATE, €4990 for originator everolimus, and €3483 for generic everolimus. Conclusions [177Lu]Lu-DOTA-TATE was associated with lower costs per progression-free month versus relevant treatment options in patients with GI-NETs or PanNETs (NET G1–G2; progressed following SSA treatment), although acquisition and administration costs are higher. These findings provide further economic arguments in the overall context of treatment decision making.

Evolution of standard of care therapies used for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): A real-world analysis of patient health records from 2016 to 2019.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18728-e18728
Author(s):  
Nabil F. Saba ◽  
Soham Shukla ◽  
Kathleen M. Aguilar ◽  
Marc S. Ballas ◽  
Kelly Bell ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Real World ◽  
Data Extraction ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Treatment Discontinuation ◽  
Health Records ◽  
Treatment Regimens ◽  
Community Oncology ◽  
Oncology Practice

e18728 Background: The R/M HNSCC treatment landscape has evolved significantly in recent years, notably with the approval of 2 immuno-oncology agents (IO), pembrolizumab (second-line [2L] approval, 2016; first-line [1L] approval, 2019) and nivolumab (2L approval, 2016). Review of the literature suggests there is limited real-world (rw) data on clinical outcomes and safety associated with chemotherapy (chemo) and IO in R/M HNSCC. These analyses present a review of patient charts to assess rw clinical outcomes and safety in R/M HNSCC, stratified by patient factors. Methods: Data were derived via structured data extraction and manual review of electronic health records (EHRs; January 1, 2016–December 31, 2019) for patients with R/M HNSCC and who initiated systemic treatment at a community oncology practice in The US Oncology Network. Time-to-event endpoints were assessed by unadjusted Kaplan–Meier analyses and included death (rw overall survival [OS]), provider-assessed progression (rw progression-free survival [PFS]), rw duration of response (DoR), and treatment discontinuation (rw time-to-discontinuation [TTD]). Treatment sequences were evaluated following R/M HNSCC diagnosis. Provider-assessed response rates and adverse events (AEs) as captured in the EHRs were reported. Results: Overall, 257 patients who received 1L treatment were included in these analyses; median age was 64 years (range: 21, 90+); the majority of patients were male (77.4%) and white (74.7%), and 17.5% had evaluable PD-L1 status. The most common 1L treatment regimens were nivolumab (18.3%), carboplatin + paclitaxel (16.0%), and pembrolizumab (14.8%). Median follow-up time from treatment initiation was 7.9 months (range: 0.2, 45.9). Of the 174 patients with evaluable response to 1L treatment, overall response rate was 48.5% (95% CI: 38.3, 58.8) for chemo and 40.0% (95% CI: 28.9, 52.0) for IO. Median rwDoR was 7.6 months (95% CI: 5.8, 11.2). Median rwOS was 12.1 months (95% CI: 10.5, 16.6), and median rwPFS was 5.9 months (95% CI: 4.7, 6.8). Median rwTTD was 2.3 months (95% CI: 2.0, 3.2). The top reason for treatment discontinuation was treatment completion (38.5%) for chemo and progression (46.6.%) for IO. The most commonly reported AEs were rash (17.5%), fatigue (14.4%), and nausea (14.4%) for chemo and fatigue (12.4%), rash (7.2%), and anemia (5.2%) for IO. The percentage of AEs that did not require any intervention was 34.4% for chemo and 20.6% for IO. Conclusions: These analyses present rw clinical outcomes for patients with R/M HNSCC in community oncology practices. The proven role of IO continues to evolve, and continued work is needed to best demarcate the use of these agents, in addition to exploration of additional therapeutics for use in R/M HNSCC. Study funding: GlaxoSmithKline (GSK Study 207139).

scholarly journals A Smartphone App to Monitor Mood Symptoms in Bipolar Disorder: Development and Usability Study

10.2196/19476 ◽  
2020 ◽  
Vol 7 (9) ◽  
pp. e19476
Author(s):  
Kelly Ann Ryan ◽  
Pallavi Babu ◽  
Rebecca Easter ◽  
Erika Saunders ◽  
Andy Jinseok Lee ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Treatment Options ◽  
Treatment Decision ◽  
Clinical Information ◽  
Standard Of Care ◽  
Text Messages ◽  
Adherence Rate ◽  
Mixed Effect ◽  
Psychomotor Activity ◽  
Measurement Based Care

Background There is considerable scientific interest in finding new and innovative ways to capture rapid fluctuations in functioning within individuals with bipolar disorder (BD), a severe, recurrent mental disorder associated with frequent shifts in symptoms and functioning. The use of smartphones can provide valid and real-world tools for use in measurement-based care and could be used to inform more personalized treatment options for this group, which can improve standard of care. Objective We examined the feasibility and usability of a smartphone to capture daily fluctuations in mood within BD and to relate daily self-rated mood to smartphone use behaviors indicative of psychomotor activity or symptoms of the illness. Methods Participants were 26 individuals with BD and 12 healthy control individuals who were recruited from the Prechter Longitudinal Study of BD. All were given a smartphone with a custom-built app and prompted twice a day to complete questions of mood for 28 days. The app automatically and unobtrusively collected phone usage data. A poststudy satisfaction survey was also completed. Results Our sample showed a very high adherence rate to the daily momentary assessments (91% of the 58 prompts completed). Multivariate mixed effect models showed that an increase in rapid thoughts over time was associated with a decrease in outgoing text messages (β=–.02; P=.04), and an increase in impulsivity self-ratings was related to a decrease in total call duration (β=–.29; P=.02). Participants generally reported positive experiences using the smartphone and completing daily prompts. Conclusions Use of mobile technology shows promise as a way to collect important clinical information that can be used to inform treatment decision making and monitor outcomes in a manner that is not overly burdensome to the patient or providers, highlighting its potential use in measurement-based care.

scholarly journals Stereotactic Ablative Radiotherapy for the Treatment of Oligometastatic Cancer: A Clinical Review as Part of a Health Technology Assessment

2021 ◽  
Vol 1 (3) ◽  
Author(s):  
Chantelle C. Lachance ◽  
Khai Tran ◽  
Elizabeth Carson ◽  
Joanne Kim ◽  
David Palma ◽  
...  
Keyword(s):  
Clinical Review ◽  
Treatment Options ◽  
Progression Free Survival ◽  
Clinical Effectiveness ◽  
Standard Of Care ◽  
The Body ◽  
Stereotactic Ablative Radiotherapy ◽  
High Dose ◽  
Normal Tissues ◽  
Oligometastatic Cancer

Oligometastatic cancer (cancer with a limited number of metastases) represents an intermediate state between cancer confined to a single location in the body and cancer that has metastasized — or spread — widely. One treatment option, for which there is growing interest, is stereotactic ablative radiotherapy, also known as SABR. SABR precisely delivers a high dose of radiation to ablate tumours at specific sites while minimizing the radiation dose to surrounding normal tissues. SABR may be used independently or alongside other treatment options in the management of oligometastatic cancer. This CADTH clinical review evaluated the evidence regarding the clinical effectiveness and safety of SABR with or without standard of care (SOC) for people with oligometastatic cancer and found the following: SABR in addition to SOC may offer a benefit in terms of overall survival (OS) and progression-free survival (PFS). The findings for the effectiveness of SABR alone compared with SOC were mixed and deemed inconclusive. There are insufficient data related to adverse events (AEs) at the present time to draw conclusions regarding the safety of SABR relative to SOC alternatives. Note that the CADTH Clinical Review Report will be updated every 3 months to ensure the findings remain up-to-date as new evidence emerges.

INNV-22. FACTORS GUIDING THE INITIATION OF TUMOR TREATING FIELDS (TTFIELDS; 200 KHZ) THERAPY FOR GLIOBLASTOMA: SELF-REPORTED PATIENT AND ONCOLOGIST PERSPECTIVES

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi109-vi110
Author(s):  
Peggy Frongillo ◽  
P Gage Gwyn ◽  
Connie Wagenknecht ◽  
Nichelle Renae Adams
Keyword(s):  
Support Groups ◽  
Treatment Options ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Tumor Location ◽  
Survey Study ◽  
Patient Treatment ◽  
Survey Analysis ◽  
Tumor Treating Fields ◽  
Post Surgery

Abstract BACKGROUND The standard-of-care for newly-diagnosed glioblastoma (ndGBM) has been the standard Stupp protocol. In ndGBM, approved TTFields (200 KHz) concomitant with maintenance temozolomide significantly improved progression-free survival and overall survival. TTFields-therapy selectively disrupts cancer cell division, requiring array-application to the shaved-scalp to non-invasively deliver TTFields to tumor location and confer clinical benefit. This survey-study assessed factors impacting decision of oncologist/patient/caregiver to initiate TTFields-therapy. METHODS A clinical-market research group administered double-blinded, online-questionnaires (30-min) to oncologists/ndGBM-patients/caregivers. Survey questions, an amalgamate of closed-/open-ended questions, were designed to track awareness, perceptions, and acceptance of ndGBM treatments in a representative United States (US) oncologist and adult patient/caregiver population (semi-annually; 2018-2020). The present survey-analysis focuses on results related to initiation of TTFields-therapy for ndGBM. RESULTS Four separate patient/caregiver surveys (Q1/2018-Q3/2020; (n=50-51/wave) and 4 separate oncologist surveys (Q2/2019-Q4/2020; n=130/wave) were conducted. Results suggest majority of patients with ndGBM research treatment options, including TTFields-therapy, immediately after surgery and before radiation/initial temozolomide; and initiate TTFields-therapy after radiation/initial temozolomide (ie, before maintenance temozolomide). Patients-reported initially learning about TTFields post-surgery via oncologists, nurses, support groups, social-media, and TTFields web-based resources. Among 97% of current/previous TTFields-users, the key patient-driver for selecting TTFields, mirroring oncologist-driver to recommend, was efficacy/survival benefit. Other highly-rated selection-drivers were anti-mitotic mechanism (93%), improved long-term 5-year survival (87%), sustained quality-of-life (87%), and no travel requirement to start (87%). In latest study wave, reported patient usage-barrier was the inability to subsequently enroll in clinical trials (64%), while the top-reported oncologist prescribing-barrier was concern with patient treatment usage (60%). Also, survey suggests oncologists discuss TTFields with most patients with ndGBM, citing efficacy and National Comprehensive Cancer Network® inclusion as key treatment-initiation drivers. CONCLUSIONS Overall, survey data suggests awareness (100%, aided; 61%-68%, unaided) by US oncologists/patients/caregivers of TTFields (200 kHz) as a viable treatment option for adults with ndGBM.

Prospective phase II study of sunitinib rechallenge in metastatic renal cell carcinoma (mRCC): A G.I.O.N. trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16081-e16081 ◽  
Author(s):  
Camillo Porta ◽  
Vittorio D. Ferrari ◽  
Paolo Andrea Zucali ◽  
Giuseppe Fornarini ◽  
Antonio Bernardo ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Treatment Options ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Cross Resistance ◽  
Stage Design ◽  
Free Survival ◽  
Prospective Phase ◽  
Grade 3

e16081 Background: Sunitinib is a 1st-line standard of care in mRCC. Lack of cross-resistance to sequential VEGF-targeting drugs and the possibility of a successful rechallenge with Sunitinib have been postulated. Whether mRCC patients (pts) could benefit from rechallenge with Sunitinib after progressing on 1st-line Sunitinib and 2nd-line Everolimus was the aim of this phase II study Methods: 39 mRCCpts were prospectively treated with Sunitinib (50 mg/daily, 4:2); main inclusion criteria were: histologically proven RCC with clear cell component, previous 1st-line Sunitinib with a Disease Control Rate lasting at least 10 months, 2nd-line Everolimus, and written informed consent. The primary end-point of this study was 6-months progression-free survival (PFS). A Simon’s 2-stage design was used; after testing Sunitinib on 12 pts in the first stage, the trial would have been terminated if 5 or fewer had a PFS of less than 6 months. Otherwise, the trial would have proceeded to the second stage, enrolling a total of 38 pts. If the total number of pts free of progression at 6 months would have been less than or equal to 18, Sunitinib would have been rejected Results: As a whole, 39 pts (30 males, 9 females) were enrolled. The study quickly moved from the first stage to its completion and ultimately succeeded; indeed, 6-months PFS was 60%, median PFS being 8.6 months (average: 9.59, range: 0.7-24.6 months). In terms of safety no unexpected toxicities were observed. Tx-related grade 3-4 AEs observed in ≥5% of the pts were: hand-foot skin reaction, fatigue, nausea, hypertriglyceridemia, hypophosphatemia, hypocalcemia, hyperglycemia, and neutropenia. One case each of myocardial infarction, atrial flutter and spontaneous pneumothorax were also reported, but resolved Conclusions: Despite an ineluctable time-lead-bias, median PFS on Sunitinib rechallenge was high (8.6 months), clearly showing that many pts may become sensitive again to VEGFRs-inhibition. Although many agents are presently available from 2nd-line on, in countries where treatment options are still limited, Sunitinib rechallenge could still represent a reasonable treatment option. EudraCT number: 2012-000473-23. Clinical trial information: 2012-000473-23.

scholarly journals Predictive factors of response to mTOR inhibitors in neuroendocrine tumours

2015 ◽  
Vol 23 (3) ◽  
pp. R173-R183 ◽  
Author(s):  
Maria Chiara Zatelli ◽  
Giuseppe Fanciulli ◽  
Pasqualino Malandrino ◽  
Valeria Ramundo ◽  
Antongiulio Faggiano ◽  
...  
Keyword(s):  
Kinase Inhibitors ◽  
Neuroendocrine Tumours ◽  
Somatostatin Analogs ◽  
Progression Free Survival ◽  
Mtor Inhibitors ◽  
Free Survival ◽  
Development Of Resistance ◽  
Imaging Markers ◽  
Intensive Investigation ◽  
Recent Demonstration

Medical treatment of neuroendocrine tumours (NETs) has drawn a lot of attention due to the recent demonstration of efficacy of several drugs on progression-free survival, including somatostatin analogs, small tyrosine kinase inhibitors and mTOR inhibitors (or rapalogs). The latter are approved as therapeutic agents in advanced pancreatic NETs and have been demonstrated to be effective in different types of NETs, with variable efficacy due to the development of resistance to treatment. Early detection of patients that may benefit from rapalogs treatment is of paramount importance in order to select the better treatment and avoid ineffective and expensive treatments. Predictive markers for therapeutic response are under intensive investigation, aiming at a tailored patient management and more appropriate resource utilization. This review summarizes the available data on the tissue, circulating and imaging markers that are potentially predictive of rapalog efficacy in NETs.

scholarly journals A Smartphone App to Monitor Mood Symptoms in Bipolar Disorder: Development and Usability Study (Preprint)

2020 ◽  
Author(s):  
Kelly Ann Ryan ◽  
Pallavi Babu ◽  
Rebecca Easter ◽  
Erika Saunders ◽  
Andy Jinseok Lee ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Treatment Options ◽  
Treatment Decision ◽  
Clinical Information ◽  
Standard Of Care ◽  
Text Messages ◽  
Adherence Rate ◽  
Mixed Effect ◽  
Psychomotor Activity ◽  
Measurement Based Care

BACKGROUND There is considerable scientific interest in finding new and innovative ways to capture rapid fluctuations in functioning within individuals with bipolar disorder (BD), a severe, recurrent mental disorder associated with frequent shifts in symptoms and functioning. The use of smartphones can provide valid and real-world tools for use in measurement-based care and could be used to inform more personalized treatment options for this group, which can improve standard of care. OBJECTIVE We examined the feasibility and usability of a smartphone to capture daily fluctuations in mood within BD and to relate daily self-rated mood to smartphone use behaviors indicative of psychomotor activity or symptoms of the illness. METHODS Participants were 26 individuals with BD and 12 healthy control individuals who were recruited from the Prechter Longitudinal Study of BD. All were given a smartphone with a custom-built app and prompted twice a day to complete questions of mood for 28 days. The app automatically and unobtrusively collected phone usage data. A poststudy satisfaction survey was also completed. RESULTS Our sample showed a very high adherence rate to the daily momentary assessments (91% of the 58 prompts completed). Multivariate mixed effect models showed that an increase in rapid thoughts over time was associated with a decrease in outgoing text messages (β=–.02; <i>P</i>=.04), and an increase in impulsivity self-ratings was related to a decrease in total call duration (β=–.29; <i>P</i>=.02). Participants generally reported positive experiences using the smartphone and completing daily prompts. CONCLUSIONS Use of mobile technology shows promise as a way to collect important clinical information that can be used to inform treatment decision making and monitor outcomes in a manner that is not overly burdensome to the patient or providers, highlighting its potential use in measurement-based care.

Chemo-immunotherapy combination after PD-1 inhibitor failure improves clinical outcomes in metastatic melanoma patients.

2019 ◽  
Vol 37 (8_suppl) ◽  
pp. 138-138
Author(s):  
Jesus Vera Aguilera ◽  
Jonas Paludo ◽  
Jarrett Failing ◽  
Robert R. McWilliams ◽  
Lisa A. Kottschade ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Clinical Outcomes ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Treatment Options ◽  
Standard Of Care ◽  
Efficacy And Safety ◽  
Wild Type ◽  
Lung Cancer Patients ◽  
Melanoma Patients

138 Background: Clinical management of metastatic melanoma (MM) after PD-1 blockade failure remains challenging and lacks a standard of care. Chemo-immunotherapy (CIT) combinations have demonstrated favorable efficacy and safety profiles in lung cancer patients. In this study, we compared the clinical outcomes of CIT with immunotherapy or chemotherapy alone after PD-1 blockade failure. Methods: We reviewed MM patients seen at Mayo Clinic between Jan, 2012 and Jun, 2018 who failed anti-PD1 therapy and received subsequent CIT, or immune checkpoint inhibitors (ICI) or chemotherapy alone. A total of 60 patients were analyzed, the CIT cohort [n=33 (55%)] treatment consisted of carboplatin/paclitaxel (n=29), nab-paclitaxel (n=2), paclitaxel (n=1), and temozolomide (n=1). In the ICI (n=9) or chemotherapy alone cohort (n=18) [n=27 (45%)], treatment consisted of carboplatin/paclitaxel (n=11), temozolomide (n=4), nab-paclitaxel (n=3), ipilimumab/nivolumab (n=4), pembrolizumab (n=4), or nivolumab (n=1). Results: Patients in the CIT cohort had a median OS of 3.5 years (95% CI: 1.7-NR) compared to 1.8 years (95% CI: 0.9-2) in the ICI or chemotherapy alone cohort, p=0.02. The median EFS following CIT was 7.6 months (95% CI: 6-10) compared to 3.4 months (95% CI: 2.8-4.1) following either ICI or chemotherapy alone, p=0.0005. A trend towards longer median EFS with use of CIT was seen in patients with BRAF wild-type [median 9 months (95% CI: 6-12)] compared to those harboring a BRAF mutation [median 6.5 months (95% CI: 1.8-9.1), p=0.29]. Side effects were similar among both groups. Conclusions: In MM patients who have failed anti-PD-1 therapy, the CIT combination showed favorable clinical outcomes and acceptable safety profile. This regimen should be considered for MM pts in this setting who have limited treatment options. [Table: see text]

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