A retrospective comparison of clinical outcomes and quality of life measures between definitive chemoradiation alone and radical surgery for clinical stage II-III esophageal carcinoma

2009 ◽  
Vol 100 (6) ◽  
pp. 435-441 ◽  
Author(s):  
Hideomi Yamashita ◽  
Kae Okuma ◽  
Yasuyuki Seto ◽  
Kazuhiko Mori ◽  
Shino Kobayashi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Esophageal Carcinoma ◽  
Clinical Outcomes ◽  
Radical Surgery ◽  
Clinical Stage ◽  
Stage Ii ◽  
Quality Of Life Measures ◽  
Definitive Chemoradiation ◽  
Retrospective Comparison

PROSPER: A phase III randomized study comparing perioperative nivolumab (nivo) versus observation in patients with localized renal cell carcinoma (RCC) undergoing nephrectomy (ECOG-ACRIN 8143).

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. TPS684-TPS684 ◽  
Author(s):  
Lauren Christine Harshman ◽  
Maneka Puligandla ◽  
Naomi B. Haas ◽  
Mohamad Allaf ◽  
Charles G. Drake ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Overall Survival ◽  
Immune System ◽  
Clinical Outcomes ◽  
Clinical Stage ◽  
Randomized Study ◽  
Phase Iii ◽  
The Impact ◽  
Metastatic Rcc

TPS684 Background: The anti-PD-1 antibody nivo improves overall survival in metastatic RCC and is well tolerated. There is no standard adjuvant systemic therapy that increases overall survival (OS) over surgery alone for non-metastatic RCC. Priming the immune system prior to surgery with anti-PD-1 has shown an OS benefit compared to a pure adjuvant approach in mouse solid tumor models. The PROSPER RCC trial aims to improve clinical outcomes by priming the immune system prior to nephrectomy with neoadjuvant nivo and continued engagement with adjuvant blockade in patients with high risk M0 RCC compared to surgery alone. Methods: This global, unblinded, phase 3 National Clinical Trials Network study is currently accruing patients with clinical stage ≥T2 or node positive M0 RCC of any histology. Tumor biopsy prior to randomization is mandatory to ensure RCC and permits in depth correlative science. The investigational arm will receive two doses of nivo 240mg prior to surgery followed by adjuvant nivo for 9 months (q2 wks x 3 mo followed by 480mg q4 wks x 6 mo). The control arm will undergo standard nephrectomy followed by observation. Randomized patients are stratified by clinical T stage, node positivity, and histology. To enhance accrual and patient quality of life, key upcoming amendments are being instituted. These include biopsy only in the nivo arm, allowance of oligometastatic disease and bilateral renal masses that can be fully resected/ablated, and change of nivo dosing to q4 wks (1 neoadj; 9 adj). With accrual of 766 patients, there is 84.2% power to detect a 14.4% absolute benefit in recurrence-free survival (RFS) at 5 years assuming the ASSURE historical control of ~56% to 70% (HR = 0.70). The study is also powered to evaluate a significant increase in overall survival (HR 0.67). Safety, feasibility, and quality of life endpoints critical to adjuvant therapy considerations are incorporated. PROSPER RCC embeds a wealth of translational work aimed at investigating the impact of the baseline immune milieu, the changes induced by neoadjuvant anti-PD-1 priming, and how both correlate with clinical outcomes. Clinical trial information: NCT03055013.

PROSPER: A phase III randomized study comparing perioperative nivolumab (nivo) versus observation in patients with renal cell carcinoma (RCC) undergoing nephrectomy (ECOG-ACRIN 8143).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS4597-TPS4597 ◽  
Author(s):  
Lauren Christine Harshman ◽  
Maneka Puligandla ◽  
Naomi B. Haas ◽  
Mohamad Allaf ◽  
Charles G. Drake ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Immune System ◽  
Clinical Outcomes ◽  
Clinical Stage ◽  
Randomized Study ◽  
Phase Iii ◽  
Perioperative Therapy ◽  
The Impact ◽  
Metastatic Rcc

TPS4597 Background: The anti-PD-1 antibody nivo improves overall survival (OS) in metastatic RCC and is well tolerated. There is no standard adjuvant (adjuv) systemic therapy that increases OS over surgery alone for non-metastatic RCC. Priming the immune system prior to surgery with anti-PD-1 has shown an OS benefit compared to a pure adjuv approach in mouse solid tumor models. Multiple ph 2 studies in bladder, lung and breast cancers have shown remarkable pathologic responses with neoadjuvant (neoadj) PD-1 blockade. Two ongoing ph 2 studies of perioperative nivo in M0 RCC patients are showing preliminary feasibility and safety with no surgical delays (NCT02575222; NCT02595918). PROSPER RCC (NCT03055013) aims to improve clinical outcomes by priming the immune system prior to nephrectomy with neoadj nivo and continued engagement with adjuv blockade in patients with high risk RCC compared to surgery alone. Methods: This global, unblinded, phase 3 National Clinical Trials Network study is currently accruing patients with clinical stage ≥T2 or TanyN+ RCC of any histology planned for nephrectomy. Oligometastases are permitted if can be rendered NED. We amended the study to enhance accrual and patient quality of life by changing nivo dosing to 480mg q4 wks and requiring baseline tumor biopsy only in the nivo arm. The investigational arm receives 1 dose of nivo prior to surgery followed by 9 adjuv doses. The control arm undergoes standard nephrectomy followed by observation. Randomized patients are stratified by clinical T stage, node positivity, and M stage. Accrual of 805 patients provides 84.2% power to detect a 14.4% absolute benefit in recurrence-free survival (RFS) at 5 years assuming the ASSURE historical control of ~56% to 70% (HR = 0.70). The study is powered to evaluate a significant increase in OS (HR 0.67). Critical perioperative therapy considerations such as safety, feasibility, and quality of life endpoints have been integrated. PROSPER RCC embeds a wealth of translational work aimed at investigating the impact of the baseline immune milieu, the changes induced by neoadjuvant anti-PD-1 priming, and how both may predict clinical outcomes. Clinical trial information: NCT03055013.

Characteristics of patients diagnosed with cervical cancer in Brazil: preliminary results of the prospective cohort EVITA study (EVA001/LACOG 0215)

2021 ◽  
pp. ijgc-2021-002972
Author(s):  
Angélica Nogueira Rodrigues ◽  
Andréia Cristina de Melo ◽  
Aknar Freire de Carvalho Calabrich ◽  
Eduardo Cronenberger ◽  
Kátia Luz Torres ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cervical Cancer ◽  
Prospective Cohort ◽  
Formal Education ◽  
Pap Smear ◽  
Clinical Stage ◽  
Stage Ii ◽  
Stage Iii ◽  
European Organization

ObjectivesCervical cancer is the fourth most common cancer in women worldwide. Epidemiological and quality of life (QoL) data in patients with cervical cancer from low- and middle-income countries are scarce. We aimed to describe sociodemographic and clinicopathological characteristics and quality of life of patients with cervical cancer at diagnosis in Brazil.MethodsEVITA is a prospective cohort study of newly diagnosed patients with cervical cancer from May 2016 to December 2017, stages I–IVB, from 16 Brazilian sites representing the five Brazilian regions. At baseline, medical evaluation was performed and European Organization for Research and Treatment of Cancer (EORTC) QLQ-CX24/C30 questionnaires were administered.ResultsA total of 631 patients were included. Mean±SD age was 49.3±13.9 years; skin color was non-white in 65.3%, and 68.0% had ≤8 years of formal education. In total, 85.1% of patients had a Pap smear. The main reasons reported by patients for not having a Pap smear were: lack of interest (46.9%), shame or embarrassment (19.7%), lack of knowledge (19.7%), and difficulty with access (9.1%). Most patients were diagnosed with locally advanced or metastatic disease (FIGO clinical stage II–IV in 81.8%– stage II in 35.2%, stage III in 36.1%, and stage IV in 10.5%). Patients with clinical stage III–IV had worse physical functioning and role functioning.ConclusionsCervical cancer in Brazil is usually diagnosed at an advanced stage. Most patients have low formal education and are unemployed. Lack of interest was identified as a main reason for not having a screening test, and limited access was reported as a reason by <10% of the patients. Awareness campaigns must be a governmental priority, specially focused on the needy population, along with wide access to treatment.

scholarly journals Relapse in schizophrenia: costs, clinical outcomes and quality of life

2004 ◽  
Vol 184 (4) ◽  
pp. 346-351 ◽  
Author(s):  
Stephen Almond ◽  
Martin Knapp ◽  
Clement Francois ◽  
Mondher Toumi ◽  
Traolach Brugha
Keyword(s):  
Quality Of Life ◽  
Clinical Outcomes ◽  
Multivariate Analyses ◽  
Control Group ◽  
Policy Makers ◽  
Factors Associated ◽  
Suburban Areas ◽  
Quality Of Life Measures ◽  
Relapse Group

BackgroundRelapse is one of the most costly aspects of schizophrenia.AimsTo compare costs, clinical outcomes and quality of life for patients who experienced relapse in schizophrenia with a control group who did not relapse.MethodPatients were randomly selected from current psychiatric case-loads drawn from urban and suburban areas of Leicester. Differences in costs and outcomes by relapse status in the previous 6 months were examined using parametric and non-parametric tests, and multivariate analysis was used to examine factors associated with relapse and costs.ResultsCosts for the patients who relapsed were over four times higher than those for the non-relapse group. There were few statistically significant differences in clinical and quality of life measures by relapse status. Multivariate analyses suggested some significant correlates of relapse and costs.ConclusionsThe higher costs associated with relapse will be of interest to policy-makers who face difficult choices concerning new but more expensive treatments for patients with schizophrenia.

Comorbid PTSD in Bipolar Patients: Clinical Outcomes and Quality of Life

2009 ◽  
Author(s):  
Lucas Quarantini ◽  
Angela Miranda-Scippa ◽  
Monica Nascimento ◽  
Flavio Kapczinski ◽  
Karestan Koenen
Keyword(s):  
Quality Of Life ◽  
Clinical Outcomes ◽  
Bipolar Patients

Efficacy of Apremilast on Quality-of-Life Measures in Patients with Moderate Plaque Psoriasis (UNVEIL Phase IV Study)

2017 ◽  
Vol 1 ◽  
pp. s13
Author(s):  
Jerry Bagel ◽  
Mark Lebwohl ◽  
Linda Stein Gold ◽  
J Mark Jackson ◽  
Joana Goncalves ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Plaque Psoriasis ◽  
Quality Of Life Measures ◽  
Phase Iv

Abstract Not Available Study supported by Celgene.

Sign in / Sign up

Export Citation Format

Share Document