Use of palliative end points to evaluate the effects of mitoxantrone and low-dose prednisone in patients with hormonally resistant prostate cancer.

1994 ◽  
Vol 12 (4) ◽  
pp. 689-694 ◽  
Author(s):  
M J Moore ◽  
D Osoba ◽  
K Murphy ◽  
I F Tannock ◽  
A Armitage ◽  
...  

PURPOSE This phase II study was designed to assess the effects of mitoxantrone with prednisone in patients with metastatic prostate cancer who had progressed on hormonal therapy. The methods of assessment included quality-of-life analyses, pain indices, analgesic scores, and the National Prostatic Cancer Project (NPCP) criteria. PATIENTS AND METHODS Patients received mitoxantrone 12 mg/m2 intravenously every 3 weeks plus prednisone 10 mg orally daily. All had a castrate serum testosterone and Eastern Cooperation Oncology Group (ECOG) performance status < or = 3, and had not received prior chemotherapy. Every 3 weeks, analgesic intake was scored, and a present pain intensity (PPI) record and visual analog scale (VAS) describing pain were collected. Every 6 weeks, the European Organization for Research and Treatment of Cancer (EORTC) core quality-of-life questionnaire plus a prostate-specific module were completed. A palliative response was defined as a decrease in analgesic score by > or = 50% or a decrease in PPI by > or = two integers without any increase in the other. RESULTS Twenty-seven patients were entered onto the study. Nine of 25 (36%) assessable patients achieved a palliative response maintained for > or = two cycles (range, two to eight or more). Improvements in mean PPI and VAS pain scores after each cycle of therapy (P < .05) were seen. Quality-of-life analysis showed improvements in social and emotional functioning, and in pain and anorexia. Using NPCP criteria, one patient achieved a partial response (PR) and 12 had stable disease; one of seven patients with measurable disease had a PR. No serious nonhematologic toxicity was experienced, and there were no episodes of febrile neutropenia. CONCLUSION Mitoxantrone with low-dose prednisone is a well-tolerated treatment regimen that has some beneficial effects on disease-related symptoms and quality of life for patients with advanced prostate cancer.

1989 ◽  
Vol 7 (5) ◽  
pp. 590-597 ◽  
Author(s):  
I Tannock ◽  
M Gospodarowicz ◽  
W Meakin ◽  
T Panzarella ◽  
L Stewart ◽  
...  

Thirty-seven men with symptomatic bone metastases from prostate cancer that had progressed following earlier treatment with estrogens and/or orchidectomy were treated with low-dose prednisone (7.5 to 10 mg daily). The rationale for this treatment was that some patients might still have hormone-sensitive disease that was stimulated by weak androgens of adrenal origin, and that these androgens could be suppressed by prednisone through its negative feedback on secretion of adrenocorticotrophic hormone (ACTH). Response to treatment was assessed by requirement for analgesics, by the McGill-Melzack pain questionnaire, and by a series of 17 linear analog self-assessment (LASA) scales relating to pain and to various aspects of quality of life. Fourteen patients (38%) had improvement in indices used to assess pain at 1 month after starting prednisone, and seven patients (19%) maintained this improvement for 3 to 30 months (median, 4 months). Reduction in pain was associated with improvement in other dimensions of quality of life, and in the scale for overall well-being. Prednisone treatment led to a decrease in the concentration of serum testosterone in seven of nine patients where it was not initially suppressed below 2 nmol/L, and caused a decrease in serum levels of androstenedione and dehydroepiandrosterone sulfate in more than 50% of patients. Symptomatic response was associated with a decrease in serum concentration of adrenal androgens. We conclude that (1) low-dose prednisone may cause useful relief of pain in some patients with advanced prostatic cancer; (2) relief of pain was associated with suppression of adrenal androgens; and (3) measures of pain and quality of life can be used to assess possible benefits of systemic therapy in patients with metastatic prostate cancer.


Medicina ◽  
2013 ◽  
Vol 49 (5) ◽  
pp. 38
Author(s):  
Aušra Mickevičienė ◽  
Giedrius Vanagas ◽  
Mindaugas Jievaltas ◽  
Albertas Ulys

Background. It is licely that illness perceptions can explain variations in quality of life of patients with prostate cancer across different treatment methods and stages. Therefore, the aim of this study was to determine if illness perception can explain variations in quality of life of patients with prostate cancer. Material and Methods. The cross-sectional national-level study was carried out. Quality of life was evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the Visual Analogue Scale. Illness perceptions were measured by the revised Illness Perception Questionnaire. Results. The response rate was 77.1% (N=501). The variation in global quality of life was explained (32.0%) by levels of emotional representation (β=–0.126; P=0.023) and consequences (β=–0.209; P<0.01); physical functioning (27.0%), by consequences (β=–0.203; P<0.01) and chemotherapy (β=–2.911; P=0.007); role functioning (37.0%), by emotional representations (β=–0.198; P<0.01), timeline cyclical (β=–0.209; P=0.014), and stage of the disease (β=–0.779; P=0.007); emotional functioning (43.0%), by emotional representations (β=–0.361; P<0.01) and education level (β=–0.566; P=0.025); cognitive functioning (34.0%), by educational level (β=0.714; P=0.005), emotional representations (β=–0.118; P=0.019), illness coherence (β=–0.167; P=0.030), consequences (β=–0.187; P=0.001), and hormonal therapy (β=–0.778; P=0.049); and social functioning (39.0%), by consequences (β=–0.320; P<0.01) and combined treatment (β=–1.492; P=0.016). Conclusions. Illness perceptions may be important while investigating quality of life in patients with prostate cancer. It may underlie quality-of-life differences in this group of patients and could inform decision makers about the importance of the provision of psychosocial services to patients with prostate cancer.


1999 ◽  
Vol 17 (3) ◽  
pp. 1008-1008 ◽  
Author(s):  
Kristin Bjordal ◽  
Eva Hammerlid ◽  
Marianne Ahlner-Elmqvist ◽  
Alexander de Graeff ◽  
Morten Boysen ◽  
...  

PURPOSE: The aim of this study was to define the scales and test the validity, reliability, and sensitivity of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N35, a questionnaire designed to assess the quality of life of head and neck (H&N) cancer patients in conjunction with the general cancer-specific EORTC QLQ-C30. PATIENTS AND METHODS: Questionnaires were given to 500 H&N cancer patients from Norway, Sweden, and the Netherlands as part of two prospective studies. The patients completed the questionnaires before, during (Norway and Sweden only), and after treatment, yielding a total of 2070 completed questionnaires. RESULTS: The compliance rate was high, and the questionnaires were well accepted by the patients. Seven scales were constructed (pain, swallowing, senses, speech, social eating, social contact, sexuality). Scales and single items were sensitive to differences between patient subgroups with relation to site, stage, or performance status. Most scales and single items were sensitive to changes, with differences of various magnitudes according to the site in question. The internal consistency, as assessed by Cronbach's alpha coefficient, varied according to assessment point and within subsamples of patients. A low overall alpha value was found for the speech and the senses scales, but values were higher in assessments of patients with laryngeal cancer and in patients with nose, sinus, and salivary gland tumors. Scales and single items in the QLQ-H&N35 seem to be more sensitive to differences between groups and changes over time than do the scales and single items in the core questionnaire. CONCLUSION: The QLQ-H&N35, in conjunction with the QLQ-C30, provides a valuable tool for the assessment of health-related quality of life in clinical studies of H&N cancer patients before, during, and after treatment with radiotherapy, surgery, or chemotherapy.


2001 ◽  
Vol 19 (1) ◽  
pp. 62-71 ◽  
Author(s):  
S. D. Fosså ◽  
P. H.Th. Slee ◽  
M. Brausi ◽  
S. Horenblas ◽  
R. R. Hall ◽  
...  

PURPOSE: Time to progression (TTP), overall survival, and quality of life (QL) were compared in patients with hormone-resistant prostate cancer (HRPC) treated with prednisone (5 mg orally, four times a day) or flutamide (250 mg orally, three times a day). PATIENTS AND METHODS: Symptomatic patients were randomized to receive either prednisone (101 patients) or flutamide (100 patients). Subjective response was assessed based on performance status, the use of analgesics, and the need to apply alternative palliative treatment. Prostate-specific antigen (PSA)–based biochemical response (≥ 50% reduction of baseline PSA) was recorded. At baseline and at 6-week intervals during follow-up, patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30. RESULTS: There was no difference between the groups in median TTP (prednisone, 3.4 months; flutamide, 2.3 months) or overall survival (prednisone, 10.6 months; flutamide, 11.2 months). In the prednisone group, 56% of the patients experienced a subjective response, compared with 45% in the flutamide group (P = .18). The median response duration was 4.8 months for prednisone and 4.2 months for flutamide. A biochemical response was observed in 21% and 23% of the prednisone and flutamide groups, respectively. Gastrointestinal toxicity was the reason for trial discontinuation in seven patients receiving flutamide and two patients receiving prednisone. The QL assessment parameters favored the use of prednisone with statistically significant differences in pain, fatigue, role functioning, appetite loss, gastrointestinal distress, and overall QL. CONCLUSION: In symptomatic HRPC, treatment with prednisone or flutamide leads to similar rates of TTP and overall survival and no difference in subjective or biochemical response. The QL results favor the use of low-cost prednisone in patients with HRPC.


2021 ◽  
pp. 1-8
Author(s):  
Helwig Valentin Wundsam ◽  
Christiane Sophie Rösch ◽  
Patrick Kirchweger ◽  
Ines Fischer ◽  
Michael Weitzendorfer ◽  
...  

<b><i>Introduction:</i></b> Intraductal papillary mucinous neoplasms (IPMNs) represent the most common precancerous cystic lesions of the pancreas. The aim of our study was to investigate if resection for non-invasive IPMNs alters quality of life (QoL) in a long-term follow-up. <b><i>Methods:</i></b> Patients (<i>n</i> = 50) included in the analysis were diagnosed and resected from 2010 to 2016. QoL was assessed at a median of 5.5 years after resection. At that point in time, the current QoL as well as the QoL before resection was evaluated retrospectively. The standardised European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Pancreatic Cancer (EORTC QLQ – PAN26) was applied for the QoL assessment. <b><i>Results:</i></b> After a median of 66 months postoperatively, the total QoL score significantly worsened (92.13 vs. 88.04, <i>p</i> = 0.020, maximum achievable score = 100) for patients (median age at surgery 68.0 years), mostly due to digestive symptoms. During the same follow-up period, median Eastern Cooperative Oncology Group (ECOG) performance status did not worsen (<i>p</i> = 0.003). <b><i>Conclusions:</i></b> Long-term QoL statistically significantly worsened after pancreatic resection for IPMN. The extent of worsening, however, was small, and QoL still remained excellent. Therefore, resection in cases of IPMN is appropriate, if indicated carefully.


Author(s):  
Islany Barbosa Soares da Silva ◽  
José de Ribamar Medeiros Lima Júnior ◽  
Joelson Dos Santos Almeida ◽  
Dayara Sthéfane Pereira Cutrim ◽  
Ana Hélia De Lima Sardinha

Introdução: Os cuidados paliativos para pacientes oncológicos tem por finalidade promover a qualidade de vida por meio do controle de sinais e sintomas, melhoria do bem-estar físico, emocional, social e espiritual. Objetivo: Avaliar a qualidade de vida de pacientes oncológicos em cuidados paliativos. Método: Trata-se de uma pesquisa descritiva, transversal, de abordagem quantitativa, realizada com 21 pacientes internados em uma unidade de cuidados paliativos. Foram coletados dados sobre aspectos sociodemográficos e clínicos, e utilizada a escala do European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core15 PAL (EORTC QLQ C-15 PAL) para avaliação da qualidade de vida. Resultados: A media de saúde global foi de 60,32, sendo a qualidade de vida considerada satisfatória. Na escala de sintomas, os domínios mais afetados foram dor (52,38), constipação (46,03) e fadiga (42,86). A função emocional (37,30) mostrou-se pior do que a avaliação da função física (59,79). Houve relação significativa do tempo de diagnostico com a qualidade de vida geral e a dispneia do performance status de Karnofsky (KPS) com o funcionamento físico, bem como da presença de metástase com dispneia. Conclusão: A qualidade de vida deve ser avaliada diariamente, visto que os cuidados paliativos consideram, além dos sintomas, o conforto do próprio paciente durante o estado de doença que ameaça a vida e as intervenções efetivas de cuidados, permitindo assim o direcionamento da atuação da equipe multiprofissional.


2004 ◽  
Vol 22 (19) ◽  
pp. 3877-3885 ◽  
Author(s):  
Laurence Collette ◽  
George van Andel ◽  
Andrew Bottomley ◽  
Gosse O.N. Oosterhof ◽  
Walter Albrecht ◽  
...  

Purpose Patients with symptomatic metastatic hormone-resistant prostate cancer (HRPC) survive a median of 10 months and are often regarded as a homogeneous group. Few prognostic factors have been identified so far. We examined whether baseline health-related quality of life (HRQOL) parameters assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) were independent prognostic factors of survival and whether they bring extra precision to the predictions achievable with models based on clinical and biochemical factors only. Patients and Methods Data of 391 symptomatic (bone) metastatic HRPC patients from three randomized EORTC trials were used in multivariate Cox proportional hazards models. The significance level was set at α = .05. Results Of the 391 patients, 371 died, most of prostate cancer. Bone scan result, performance status, hemoglobin level, and insomnia and appetite loss as measured by the EORTC QLQ-C30 were independent predictors of survival. This model's area under the receiver operating curve was 0.65 compared with 0.63 without the two HRQOL factors. Conclusion Certain HRQOL sores, at baseline, seem to be predictors for duration of survival in HRPC. However, such measurements do not add to the predictive ability of models based only on clinical and biochemical factors.


1996 ◽  
Vol 14 (10) ◽  
pp. 2756-2768 ◽  
Author(s):  
M A Sprangers ◽  
M Groenvold ◽  
J I Arraras ◽  
J Franklin ◽  
A te Velde ◽  
...  

PURPOSE To construct a breast cancer-specific quality-of-life questionnaire (QLQ) module to be used in conjunction with the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and to test its reliability and validity cross-culturally. PATIENTS AND METHODS Module construction took place after the EORTC guidelines for module development. The module--the QLQ-BR23--consists of 23 items covering symptoms and side effects related to different treatment modalities, body image, sexuality, and future perspective. This module was tested in 170 Dutch, 168 Spanish, and 158 American cancer patients at two points in time. The timing for the Dutch and Spanish patients was before and during treatment with radiotherapy or chemotherapy. For the American patients, the questionnaire was administered at admission at the breast clinic and 3 months after the first assessment. RESULTS Multitrait scaling analysis confirmed the hypothesized structure of four of the five scales. Cronbach's alpha coefficients were, in general, lowest in Spain (range; .46 to .94) and highest in the United States (range; .70 to .91). On the basis of known-groups comparisons, selective scales distinguished clearly between patients differing in disease stage, previous surgery, performance status, and treatment modality, according to expectation. Additionally, selective scales detected change over time as a function of changes in performance status and treatment-induced change. CONCLUSION These results lend support to the clinical and cross-cultural validity of the QLQ-BR23 as a supplementary questionnaire for assessing specific quality-of-life issues relevant to patients with breast cancer.


2019 ◽  
Author(s):  
Juan Ignacio Arraras ◽  
Gemma Asin ◽  
José Juan Illarramendi ◽  
Ana Manterola ◽  
Esteban Salgado ◽  
...  

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