Hypofractionated radiotherapy for complicated bone metastases in patients with poor performance status: a phase II international trial

2018 ◽  
Vol 105 (2) ◽  
pp. 181-187 ◽  
Author(s):  
Mauricio F. Silva ◽  
Gustavo N. Marta ◽  
Felipe P.C. Lisboa ◽  
Guilherme Watte ◽  
Fabio Trippa ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Bone Metastases ◽  
Phase Ii ◽  
Weight Bearing ◽  
Performance Status ◽  
Poor Performance ◽  
Hypofractionated Radiotherapy ◽  
Poor Performance Status ◽  
Life Questionnaire

Purpose: To evaluate the efficacy and safety of hypofractionated radiotherapy (16 Gy in 2 fractions, 1 week apart) in patients with complicated bone metastases and poor performance status. Methods: A prospective single-arm phase II clinical trial was conducted from July 2014 to May 2016. The primary endpoint was pain response as defined in the International Consensus on Palliative Radiotherapy Endpoints. Secondary endpoints included quality of life as measured by quality of life questionnaire (QLQ) PAL-15 and QLQ-BM22 European Organisation for Research and Treatment of Cancer guidelines, pain flare, adverse events, re-irradiation, and skeletal complications. Results: Fifty patients were enrolled. There were 23 men with a median age of 58 years (range 26-86). Of the 50 patients, 38 had an extraosseous soft tissue component, 18 needed postsurgical radiation, 3 had neuropathic pain, and 3 had an impending fracture in a weight-bearing bone. At 2 months, 33 patients were alive (66%). Four (12.5%) had a complete response and 12 (37.5%) had a partial response. A statistically significant improvement was seen in the functional interference (p = 0.01) and psychosocial aspects (p = 0.03) of the BM22. No patient had spinal cord compression. One patient required surgery for pathologic fracture, and another re-irradiation. Conclusions: Hypofractionated radiotherapy (16 Gy in 2 fractions of 8 Gy 1 week apart) achieved satisfactory pain relief and safety results in patients with complicated bone metastases and poor performance status.

scholarly journals Self-directed home-based neuromuscular electrical stimulation (NMES) in patients with advanced cancer and poor performance status: a feasibility study

2020 ◽  
Vol 28 (11) ◽  
pp. 5529-5536 ◽  
Author(s):  
Dominic O’Connor ◽  
Olive Lennon ◽  
Sarah Wright ◽  
Brian Caulfield
Keyword(s):  
Quality Of Life ◽  
Electrical Stimulation ◽  
Advanced Cancer ◽  
Performance Status ◽  
Neuromuscular Electrical Stimulation ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Walk Test ◽  
Timed Up And Go

Abstract Purpose Concurrent neuromuscular electrical stimulation (NMES) involving sub-tetanic low frequency and tetanic high frequency which targets aerobic and muscular fitness is a potential alternative to conventional exercise in cancer rehabilitation. However, its safety and feasibility in patients with advanced cancer are unknown. The aim of this feasibility study was to determine safety and feasibility and evaluate changes in functional and health-related quality of life (HR-QoL) outcomes in individuals with advanced cancer and poor performance status after concurrent NMES. These results should help inform the design of future studies. Methods Participants with advanced cancer and poor performance status (Eastern Cooperative Oncology Group scale ≥ 2) (n = 18) were recruited. The intervention included a novel NMES intervention implemented over a 4-week period. Functional exercise capacity, lower limb muscle endurance and HR-QoL were measured by 6-min walk test (6MWT), 30-s sit-to-stand (30STS) and European Organization for Research and Treatment quality of life questionnaire core-30 (EORTC QLQ C30) pre and post-intervention. Participants unable to complete the 6-min walk test completed the timed up and go test. Participant experience and the impact of the intervention on daily life were investigated through semi-structured interviews. Results Ten of 18 participants completed the intervention. No adverse events were reported. Seven of 8 participants improved 6MWT performance (2 of 2 improved timed up and go), 8 of 10 participants improved 30STS and 8 of 10 participants improved Global quality of life. Perceived benefits included improved mobility and muscle strength. Conclusions Neuromuscular electrical stimulation appears safe and feasible in advanced cancer and may improve physical and HR-QoL outcomes. Future prospective trials are warranted to confirm these findings prior to clinical implementation in an advanced cancer setting.

scholarly journals ASSESSMENT AND COMPARISON OF QUALITY OF LIFE AND SYMPTOM RELIEF IN PATIENT OF INOPERABLE NON-METASTATIC NON SMALL CELL LUNG CANCER UNDERGOING DIFFERENT PALLIATIVE RADIATION THERAPY.

2020 ◽  
pp. 62-64
Author(s):  
Shampa Maity ◽  
Apurba Bikash Pramanik ◽  
Partha Dasgupta ◽  
Pulakesh Sinha ◽  
Debarshi Jana
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Survival Time ◽  
Performance Status ◽  
Symptom Relief ◽  
Locally Advanced ◽  
Poor Performance Status ◽  
Life Questionnaire ◽  
Health Related

Lung cancer incidence in Indian men is 54000, with mortality at 49000 and in females at much less 17000 with mortality at 15,000. The aim of our study is Health related QoL changes: By using EORTC Quality of Life Questionnaire (QLQ)-C30 and QLQ-LC13. All histology proven patients of locally advanced NSCLC attending Department of Radiotherapy, R.G.Kar Medical College & Hospital during study period from January, 2017 to July 2018. Patient with poor performance status and inoperable NSCLC causing pulmonary symptoms, hypofractionated, involved field radiotherapy 8.5 Gy in two fractions offer acceptable palliation with minimal toxicity. A clear advantage of the very short hypofractionated regimen is that it enable patients with a short expected survival time to spend more of their remaining time away from their hospital. Palliative radiotherapy plays an important role of palliation of symptomatic intrathoracic disease and in preservation of health related quality of life (HRQOL) in patients who have limited expected survival time and/or intolerance to combined chemotherapy and radical radiotherapy regimen.

Psychosocial functioning and quality of life in patients with primary brain tumors

1996 ◽  
Vol 84 (1) ◽  
pp. 29-34 ◽  
Author(s):  
Michael A. Weitzner ◽  
Christina A. Meyers ◽  
Kevin Byrne
Keyword(s):  
Quality Of Life ◽  
Brain Tumors ◽  
Psychosocial Functioning ◽  
Research Question ◽  
Performance Status ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Content Type ◽  
Primary Brain Tumors

✓ Perceived quality of life (QOL) was evaluated in a group of 50 patients with primary brain tumors. Participants completed two QOL measures and a demographic profile. Age was found not to be an important factor in differentiating QOL in these patients. All areas of QOL were found to be affected adversely by one or more of five factors: being female, being divorced, having bilateral tumor involvement, having received chemotherapy, and having a poor performance status. Pearson product-moment correlations conducted on the subscale and total scores of the two QOL instruments revealed that the two scales measure different QOL aspects and overlap in only a few areas. This may be related to the different measurement paradigms that these two instruments represent. This study is one of the first to evaluate the multidimensional aspects of QOL in patients with primary brain tumors, an understudied group. A prospective study of QOL in this group, already underway at the authors' institution, is needed to evaluate comprehensively the effect of different treatments and interventions on the QOL functioning of primary brain tumor patients. Additionally, this study shows that the choice of QOL instruments is very important and needs to be driven by the research question.

Reliability and Validity of the Functional Assessment of Cancer Therapy–Ovarian

2001 ◽  
Vol 19 (6) ◽  
pp. 1809-1817 ◽  
Author(s):  
Karen Basen-Engquist ◽  
Diane Bodurka-Bevers ◽  
Mary A. Fitzgerald ◽  
Kimberly Webster ◽  
David Cella ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ovarian Cancer ◽  
Functional Assessment ◽  
Performance Status ◽  
Reliability And Validity ◽  
Poor Performance ◽  
Well Being ◽  
Poor Performance Status ◽  
Test Retest Reliability

PURPOSE: To report the reliability and validity of the Functional Assessment of Cancer Therapy–Ovarian (FACT-O) in a consecutive series of outpatients with epithelial ovarian cancer. PATIENTS AND METHODS: Two hundred thirty-two ovarian cancer patients attending an outpatient gynecologic oncology clinic completed questionnaires at baseline. The patients’ FACT-O scores were compared with their performance status, disease stage, treatment status, and other factors hypothesized to be related to quality of life. Patients received a second questionnaire either one week after baseline to assess the instrument’s test-retest reliability and/or two months after baseline to evaluate its sensitivity to change in performance status. RESULTS: Internal consistency and test-retest reliability of the FACT-O were adequate. Overall, the scales correlated with other measures as expected; all correlations were in the hypothesized direction. Patients with advanced disease, poor performance status, and who were receiving active treatment had lower scores on physical, functional, and ovarian cancer-specific scales. The total FACT-O and emotional well-being scores were lower for patients with poor performance status and patients in active treatment. The FACT-O total and all subscale scores except emotional well-being were sensitive to decreases in performance status. CONCLUSION: Overall, the FACT-O provides a reliable and valid assessment of the quality of life of women with ovarian cancer, and is appropriate as a brief quality of life assessment in clinical trials and descriptive studies.

Temozolomide in Elderly Patients With Newly Diagnosed Glioblastoma and Poor Performance Status: An ANOCEF Phase II Trial

2011 ◽  
Vol 29 (22) ◽  
pp. 3050-3055 ◽  
Author(s):  
Jaime Gállego Pérez-Larraya ◽  
François Ducray ◽  
Olivier Chinot ◽  
Isabelle Catry-Thomas ◽  
Luc Taillandier ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Elderly Patients ◽  
Disease Progression ◽  
Phase Ii Trial ◽  
Performance Status ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Newly Diagnosed ◽  
Mgmt Promoter

Purpose The management of glioblastoma multiforme (GBM) in elderly patients with poor performance status is not well established. A trial evaluating the efficacy and safety of temozolomide alone in this population was undertaken. Patients and Methods Patients age 70 years or older with newly diagnosed GBM and postoperative Karnofsky performance score (KPS) less than 70 were eligible for this nonrandomized phase II trial. Treatment consisted of 150 to 200 mg/m2/d temozolomide for 5 days every 4 weeks until disease progression. Radiotherapy was not administered. The primary end point was overall survival (OS); secondary end points included progression-free survival (PFS), safety, quality of life, and cognition. Results Seventy patients (median age, 77 years; median KPS, 60) were enrolled between July 2007 and February 2009. Grade 3 to 4 neutropenia and thrombocytopenia occurred in 13% and 14% of patients, respectively. Median PFS was 16 weeks (95% CI, 10 to 20 weeks), and median OS was 25 weeks (95% CI, 19 to 28 weeks), comparing favorably with a 12- to 16-week OS expected from a purely supportive approach. Twenty-three patients (33%) improved their KPS by 10 or more points, and 18 (26%) became capable of self-care (KPS ≥ 70). Overall quality of life and cognition improved over time before disease progression. In the 31 tumors evaluated for O6-methylguanine–DNA methyltransferase (MGMT) promoter methylation, a methylated status indicated longer PFS (26 v 11 weeks; P = .03) and OS (31 v 19 weeks; P = .03). Conclusion Temozolomide has an acceptable tolerance in elderly patients with GBM and KPS less than 70. It is associated with improvement of functional status in 33% of patients and appears to increase survival compared with supportive care alone, especially in patients with methylated MGMT promoter.

scholarly journals A Review of Docetaxel: Its Use in the Treatment of Gastric Cancer

2010 ◽  
Vol 2 ◽  
pp. CMT.S5191
Author(s):  
Alessandro Inno ◽  
Michele Basso ◽  
Alessandra Cassano ◽  
Carlo Barone
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Performance Status ◽  
Single Agent ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Phase Iii ◽  
Poor Performance Status ◽  
Phase Ii Studies ◽  
Combination Regimens

Docetaxel, a member of the taxane family, promotes cell death by binding β-tubulin and has demonstrated activity against several human malignancies, both as a single agent and in combination therapy. It has been approved in Europe and the US as front-line treatment for advanced gastric cancer in combination with cisplatin and fluorouracil (DCF regimen). This approval was based on the results of a pivotal study (V325) which demonstrated that the addition of docetaxel to the reference regimen of cisplatin and fluorouracil improves overall survival and progression-free survival with a better quality of life despite increased toxicity (mainly haematological). Modifications of DCF regimen have been successfully investigated as a means of making the treatment more tolerable and suitable also for elderly patients or patients with poor performance status. Emerging data from several phase II studies suggest that other docetaxel-based combination regimens with anthracyclines or irinotecan have interesting activity with acceptable toxicity profiles, but the true efficacy of these regimens needs to be assessed in large randomized phase III studies. Thus, the best docetaxel-containing regimen has yet to be identified. Docetaxel also represents a good candidate for combination with novel molecular target agents. In light of the high response rates observed in phase II-III studies, a docetaxel-based chemotherapy regimen might also be considered a treatment option as perioperative or adjuvant therapy in potentially curable gastric cancer and further studies with or without biological agents are eagerly awaited in this setting.

Phase II clinical trial of nab-paclitaxel plus gemcitabine in elderly patients with previously untreated locally advanced or metastatic pancreatic adenocarcinoma: BIBABRAX study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4615-4615 ◽  
Author(s):  
Jaime Feliu Batlle ◽  
Monica Jorge Fernandez ◽  
Teresa Macarulla ◽  
Bartomeu Massuti ◽  
Ana Albero ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Elderly Patients ◽  
Phase Ii ◽  
Clinical Benefit ◽  
Performance Status ◽  
Locally Advanced ◽  
Standards Of Care ◽  
Ecog Ps

4615 Background: FOLFIRINOX and nab-paclitaxel plus gemcitabine (nab-P+G) are the standard of care in the first-line treatment of mPC patients (pt) with good performance status. However, no standards of care exist for elderly ( > 70 years) pt as they are usually excluded in clinical trials. This study aimed to evaluate whether the clinical benefit of nab-P+G could be extended to elderly pt with mPC. Methods: This was an open-label, single-arm, multicenter, phase II trial, to assess the efficacy and safety of Nab-P+G in elderly pt (≥ 70 years) with ECOG PS 0–1 and untreated unresectable locally advanced or metastatic PC. Pt received four-week cycles of intravenous (i.v.) nab-paclitaxel 125 mg/m2, followed by i.v. gemcitabine 1,000 mg/m2, on days 1, 8 and 15, until disease progression. Efficacy was evaluated according RECIST v 1.1 criteria and safety according NCI-CTCAE v 4.0 criteria. Results: Eighty pt were enrolled in the study. Median age was 74.6 years (range 70-87.9), 57.5% were men, 71% had ECOG PS 1 and 86% metastatic disease. 16.3% of patients had a history of prior tumor surgical resection, 12.5% received chemotherapy and 3.8% radiotherapy. Primary tumor was located in head (32.5%), tail (25.0%) and body (22.5%). Nab-P and G was reduced in 49% and 41% of pt respectively. 15 pt definitely interrupt study treatment due to toxicity: neurotoxicity (7), asthenia (5), neutropenia (1), leukocytosis (1) and hepatotoxicity (1). Time until definite deterioration (reduction ≥10 points as compared to baseline in EORTC-QLQ C30) was 1.6 months and deterioration-free rate at 3 months was 54.3%. Overall response rate was 13.8%, clinical benefit rate 67.5%, median PFS 7.2 months and median OS 9.2 months. The most common treatment-related adverse events were asthenia (60.0%), diarrhea (40.0%), neutropenia (33.8%), hair loss (28.8%), thrombocytopenia (26.3%), and nausea (23.8%). Only asthenia and neutropenia presented a relatively high incidence of grade 3 and 4 toxicities (21.3%). At least 1 SAE was reported in 55% of pt. Conclusions: BIBABRAX study confirms the clinical benefit of nab-P+G in an elderly population with mPC, in terms of survival, clinical response and tolerance, therefore it could be considered a treatment option for elderly patients. However, it was unable to demonstrate the preplanned benefit on the quality of life. Further research is needed on treatment strategies that could reduce deterioration of the quality of life in these pt. Clinical trial information: NCT02391662 .

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