RELUGOLIX COMBINATION THERAPY IMPROVES MULTIPLE DIMENSIONS OF QUALITY OF LIFE IN WOMEN WITH ENDOMETRIOSIS-ASSOCIATED PAIN: RESULTS FROM THE SPIRIT PROGRAM

TPS5608 Background: Pembrolizumab, a selective humanized anti–PD-1 monoclonal antibody, has demonstrated activity in patients with previously treated mismatch repair (MMR) deficient (dMMR; 57.1% ORR as monotherapy and 63.6% ORR as combination therapy with lenvatinib) and MMR proficient (pMMR; 36.2% ORR as combination therapy with lenvatinib) endometrial cancer (EC). ENGOT-en11/GOG-3053/KEYNOTE-B21 is a phase 3, randomized, double-blind study of pembrolizumab or placebo in combination with adjuvant chemotherapy with/without radiotherapy in patients with EC. Methods: Eligible patients are ≥18 years old with newly diagnosed, histologically confirmed high-risk (stage I/II non-endometrioid, stage III/IVa, p53 abnormality) EC (carcinoma or carcinosarcoma) following surgery with curative intent with no evidence of disease post-operatively or on imaging, and without prior systemic therapy/radiotherapy. In total, ̃990 patients are randomized to receive pembrolizumab 200 mg or placebo Q3W for 6 cycles + chemotherapy (carboplatin area under the curve [AUC] 5 or 6 + paclitaxel 175 mg/m2 Q3W or carboplatin AUC 2 or 2.7 + paclitaxel 60 mg/m2 QW) in stage 1. Patients receive pembrolizumab 400 mg or placebo Q6W for 6 cycles in stage 2 per their treatment assignment. At the investigator’s discretion, radiotherapy (external beam radiotherapy [EBRT] and/or brachytherapy) ± radiosensitizing cisplatin 50 mg/m2 (days 1 and 29) may be administered after completion of chemotherapy. Randomization is stratified by MMR status (pMMR vs dMMR) and, within pMMR, by planned radiation therapy (cisplatin-EBRT vs EBRT vs no EBRT), histology (endometrioid vs non-endometrioid), and International Federation of Gynecology and Obstetrics (FIGO) surgical stage (I/II vs III/IVA). Dual primary endpoints are disease-free survival (DFS; per investigator assessment) and overall survival (OS), both estimated by the Kaplan-Meier method, with a stratified log-rank test to assess treatment differences and a Cox proportional hazard model with Efron’s method of tie handling to assess the magnitude of treatment differences. Secondary endpoints include DFS (per blinded independent central review), DFS (per investigator assessment) and OS by biomarker status (PD-L1 and tumor mutational burden), safety (per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0) and quality of life (per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] and Endometrial Cancer Module [EORTC QLQ-EN24]). The study began enrollment in December 2020. Clinical trial information: NCT04634877.

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Impact of stimulating cognitive-motor training on neuropsychological status and quality of life in patients with Parkinson's disease

Neurology neuropsychiatry Psychosomatics ◽

10.14412/2074-2711-2018-4-65-71 ◽

2018 ◽

Vol 10 (4) ◽

pp. 65-71

Author(s):

Yu. N. Bykov ◽

T. B. Bender ◽

Yu. N. Vasiliev ◽

A. N. Kalyagin ◽

Т. М. Maksikova ◽

...

Keyword(s):

Quality Of Life ◽

Parkinson’S Disease ◽

Parkinson's Disease ◽

Combination Therapy ◽

Mobile Devices ◽

Physical Functioning ◽

Motor Training ◽

Neuropsychological Status ◽

Sf 36

Motor and non-motor symptoms are identified in the clinical picture of Parkinson's disease (PD). Among its non-motor manifestations, cognitive impairment (CI) and emotional disorders play a special role in PD. It is important to search for new forms and methods of cognitive therapy in patients with PD.Objective:to analyze neuropsychological status and quality of life (QOL) in PD patients and to evaluate the efficiency of personalized combination therapy with a stimulating cognitive motor training on computer and mobile devices in these patients.Patients and methods. The investigation enrolled 112 patients with PD. A study group included 56 PD patients who received a cycle of combination therapy with cognitive-motor training on PC and mobile devices; a control group consisted of 56 PD patients who had only a drug therapy cycle. To evaluate neuropsychological status and QOL, the investigators used the Montreal Cognitive Assessment (MoCA), the McNair and Kahn memory self-evaluation scale, the Hospital Anxiety and Depression Scale (HADS), and the 36-Item Short Form Health Survey (SF-36) questionnaire.Results and discussion. According to MoCA scores, CI of varying severity was diagnosed in the majority of patients: in 75 and 80.4% in the study and control groups, respectively. Depressive syndrome was detected in 53.6 and 64.3% in these groups, respectively. According to the SF-36, the physical status of patients had the greatest effect in reducing their QOL. There were treatment-induced statistically significant positive changes for the following domains: physical functioning (p<0.01), role-physical functioning (p<0.001), pain intensity (p<0.01), general health (p<0.01), role emotional (p<0.0001), and mental health (p<0.01).Conclusion.The investigation has shown the efficiency of personalized therapy including stimulating cognitive-motor training on computer and mobile devices, which improves neuropsychological status and QOL in patients with PD.

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Quality of Life Is Significantly Impaired in Finnish COPD Patients at Multiple Dimensions of Health.

10.1164/ajrccm-conference.2009.179.1_meetingabstracts.a2929 ◽

2009 ◽

Author(s):

W Mazur ◽

H Kupiainen ◽

U Hodgson ◽

H Stark ◽

A Lindqvist ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Dimensions ◽

Copd Patients

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Validation of a melasma quality of life questionnaire for Brazilian Portuguese language: the MelasQoL-BP study and improvement of QoL of melasma patients after triple combination therapy

British Journal of Dermatology ◽

10.1111/j.1365-2133.2006.07591.x ◽

2006 ◽

Vol 156 ◽

pp. 13-20 ◽

Cited By ~ 50

Author(s):

T.F. Cestari ◽

D. Hexsel ◽

M.L. Viegas ◽

L. Azulay ◽

K. Hassun ◽

...

Keyword(s):

Quality Of Life ◽

Combination Therapy ◽

Brazilian Portuguese ◽

Life Questionnaire ◽

Triple Combination ◽

Triple Combination Therapy ◽

Quality Of Life Questionnaire

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Emerging concepts in combination chemotherapy for metastatic pancreatic cancer: A systematic review of randomized controlled trials.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.4_suppl.228 ◽

2013 ◽

Vol 31 (4_suppl) ◽

pp. 228-228

Author(s):

Basile M. Njei ◽

Ivo C. Ditah ◽

Alexei Shimanovsky ◽

Priscilla Owusu ◽

John W Birk

Keyword(s):

Quality Of Life ◽

Pancreatic Cancer ◽

Overall Survival ◽

Combination Therapy ◽

Adverse Events ◽

Combination Chemotherapy ◽

Metastatic Pancreatic Cancer ◽

Controlled Trials ◽

Randomized Controlled

228 Background: Even though gemcitabine monotherapy is commonly used as first-line treatment for metastatic pancreatic cancer, many novel treatment approaches have focused on combination chemotherapy. FOLFIRINOX, a combination of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin, has recently been shown to improve survival compared to gemcitabine. However, it is unclear whether survival benefits are counterbalanced by a poor quality of life due to the adverse effects. The aim of this study was to review emerging strategies that enhance treatment of patients with metastatic pancreatic cancer. Methods: Two authors independently conducted a comprehensive search of the Cochrane library PUBMED, and published proceedings from major oncologic and gastrointestinal cancer meetings from January 1980 to July 2012. Only published randomized controlled trials were eligible for inclusion. Our primary outcome measures were: progression-free survival (PFS), overall survival (OS) and serious adverse events (grade 3 or 4). Results: Thirty-one studies involving 7,957 patients were included in the analysis. There was an overall statistically significant increase in OS (RR 1.10, 95% CI 1.03-1.30) and PFS (RR 1.27, 95% CI 1.14-1.46) for the gemcitabine-based combination therapy group versus the gemcitabine monotherapy group. Subgroup analysis showed that only patients with fluoropyrimidine and platinum containing regimens showed prolonged survival: RR 1.33, 95% CI 1.04-1.76 and RR 1.38, 95% CI 1.08-1.76, respectively. The most common severe adverse event (neutropenia) was found in 45% of patients treated with FOLFIRINOX. Conclusions: Overall, gemcitabine in combination with fluoropyrimidine or platinum containing regimens can improve overall survival in patients with metastatic pancreatic cancer compared to gemcitabine alone. Even though, FOLFIRINOX therapy is associated with better survival outcomes than gemcitabine, the prolonged survival comes at the cost of poorer quality of life due to a higher incidence of adverse events. More data is needed from studies involving novel combination therapy such as hedgehog pathway inhibitors and radio-immunotherapy.

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A phase Ib/IIa study of combination therapy with gemcitabine and Atu027 in patients with locally advanced or metastatic pancreatic adenocarcinoma.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.4_suppl.385 ◽

2016 ◽

Vol 34 (4_suppl) ◽

pp. 385-385 ◽

Cited By ~ 17

Author(s):

Beate Schultheis ◽

Dirk Strumberg ◽

Jan Kuhlmann ◽

Martin Wolf ◽

Karin Link ◽

...

Keyword(s):

Quality Of Life ◽

Combination Therapy ◽

Statistical Significance ◽

Locally Advanced ◽

Progression Free Survival ◽

Standard Of Care ◽

Small Patient Number ◽

The Difference ◽

Grade 3

385 Background: Atu027 is a liposomally formulated short interfering RNA with anti-metastatic activity, which silences expression of protein kinase N3 (PKN3) in the vascular endothelium. PKN3 acts as a Rho effector downstream of PI3K. This trial was designed to assess safety, pharmacokinetics and efficacy of Atu027 in combination with gemcitabine in advanced pancreatic carcinoma (APC). Methods: 23 patients (pts) with APC stage 3 or 4 were enrolled and randomly assigned to different Atu027 dosing schedules (arm 1: 0.253mg/kg once weekly, n = 11; arm 2: 0.253mg/kg twice-weekly, n = 12) but identical gemcitabine regimen. Response was evaluated according to RECIST 1.1. Quality of life was assessed with EORTC questionnaire QLQ-C30. Results: Combination therapy with Atu027 and gemcitabine was given up to 7.8 months until progression. Grade 3 adverse events (AEs) were reported by 9/11 pts (82%) in arm 1 and 11/12 pts (92%) in arm 2. Grade 4 AEs were reported by two pts in each arm. Interestingly, there was a difference in median progression free survival (mPFS) between the two treatment arms. Arm 1 showed an mPFS of 1.8 [95%CI: 0.4-5.5] months vs. 5.3 [95%CI: 1.5-6.0] months in arm 2, p= 0.399. In a post-hoc analysis of metastatic disease only, the difference in mPFS between the two arms reached statistical significance (1.6 [95%CI:0.4-2.1] vs 2.9 [95%CI:1.0-7.3] months, n = 9 vs 10, p= 0.025). Disease control during treatment was achieved in 4/11 (36%) pts in arm 1 and in 7/12 (58%) pts in arm 2. New lesions occurred in all (6/6) pts in arm 1 who had at least one RECIST re-evaluation but only 5/10 pts (50%) in arm 2. In quality of life analysis, pts in the once-weekly arm showed a stable global health status while pts in the twice-weekly arm reported an improvement (0-100 score change from baseline: -2.3 vs +21.6 after one cycle, N = 7 vs 7). Conclusions: Combination of Atu027 with gemcitabine for the treatment of APC is safe and was well tolerated. Despite the small patient number, there is a clear signal that twice-weekly Atu027 dosing might be superior to the once-weekly regimen. These results suggest efficacy of Atu027 and warrant further investigation with Atu027 added to standard of care in APC. Clinical trial information: NCT01808638.

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