Assessment of Quality of Life in Cancer Patients: Complexity, Criticism, Challenges

Grumann, M.; Schlag, Peter M.

doi:10.1159/000050275

Cited by 23 publications

(19 citation statements)

References 34 publications

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“…PSA measurements as well as immunohistochemistry evaluation of prostatic biopsies were performed in the same hospital's central laboratory where was carried out the clinical trial (Modena University Hospital, Italy). Possible changes in LUTS, using the International Prostate Symptom Score (IPSS), and QoL were evaluated as described (15,16).…”

Section: Study Proceduresmentioning

confidence: 99%

Effect of green tea catechins in patients with high-grade prostatic intraepithelial neoplasia: Results of a short-term double-blind placebo controlled phase II clinical trial

Micali

Territo

Pirola

et al. 2017

Arch Ital Urol Androl

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Background and study objective: Several studies suggest a protective role of green tea catechins against prostate cancer (PCa). In order to evaluate the efficacy of green tea catechins for chemoprevention of PCa in patients with high-grade prostate intraepithelial neoplasia (HG-PIN) we performed a phase II clinical trial. Methods: Sixty volunteers with HG-PIN were enrolled to carry out a double-blind randomized placebo-controlled phase II clinical trial. Treated group took daily 600 mg of green tea catechins (Categ Plus ® ) for 1 year. Patients were screened at 6 and 12 months through prostatic biopsy and measurements of prostate-specific antigen (PSA). Results: Despite the statistically significant reduction of PSA observed in subjects who received green tea catechins for 6 and 12 months, we did not find any statistical difference in PCa incidence between the experimental groups neither after 6 nor after 12 months. However, throughout the one-year follow-up we observed very limited adverse effects induced by green tea catechins and a not significant improvement in lower urinary tract symptoms and quality of life. Conclusions: Although the small number of patients enrolled in our study and the relatively short duration of intervention, our findings seems to deny the efficacy of green tea catechins. However, results of our clinical study, mainly for its low statistical strength, suggest that the effectiveness of green tea catechins should be evaluated in both a larger cohort of men and longer trial.

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Section: Study Proceduresmentioning

confidence: 99%

Effect of green tea catechins in patients with high-grade prostatic intraepithelial neoplasia: Results of a short-term double-blind placebo controlled phase II clinical trial

Micali

Territo

Pirola

et al. 2017

Arch Ital Urol Androl

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“…24) and quality of life score (QoL; ref. 25) in men with coexistent benign prostate hyperplasia (BPH) were also pursued as secondary observations.…”

Section: Cancer Researchmentioning

confidence: 99%

Chemoprevention of Human Prostate Cancer by Oral Administration of Green Tea Catechins in Volunteers with High-Grade Prostate Intraepithelial Neoplasia: A Preliminary Report from a One-Year Proof-of-Principle Study

et al. 2006

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Green tea catechins (GTCs) proved to be effective in inhibiting cancer growth in several experimental models. Recent studies showed that 30% of men with high-grade prostate intraepithelial neoplasia (HG-PIN) would develop prostate cancer (CaP) within 1 year after repeated biopsy. This prompted us to do a proof-of-principle clinical trial to assess the safety and efficacy of GTCs for the chemoprevention of CaP in HG-PIN volunteers. The purity and content of GTCs preparations were assessed by high-performance liquid chromatography [(À)-epigallocathechin, 5.5%; (À)-epicatechin, 12.24%; (À)-epigallocatechin-3-gallate, 51.88%; (À)-epicatechin-3-gallate, 6.12%; total GTCs, 75.7%; caffeine, <1%]. Sixty volunteers with HG-PIN, who were made aware of the study details, agreed to sign an informed consent form and were enrolled in this double-blind, placebo-controlled study. Daily treatment consisted of three GTCs capsules, 200 mg each (total 600 mg/d). After 1 year, only one tumor was diagnosed among the 30 GTCs-treated men (incidence, f3%), whereas nine cancers were found among the 30 placebo-treated men (incidence, 30%). Total prostate-specific antigen did not change significantly between the two arms, but GTCs-treated men showed values constantly lower with respect to placebotreated ones. International Prostate Symptom Score and quality of life scores of GTCs-treated men with coexistent benign prostate hyperplasia improved, reaching statistical significance in the case of International Prostate Symptom Scores. No significant side effects or adverse effects were documented. To our knowledge, this is the first study showing that GTCs are safe and very effective for treating premalignant lesions before CaP develops. As a secondary observation, administration of GTCs also reduced lower urinary tract symptoms, suggesting that these compounds might also be of help for treating the symptoms of benign prostate hyperplasia.

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“…Remarkably, assessment of QoL parameters has not been performed in any of these trials. With a median survival time of about half a year, however, treatment should only be justified either if QoL remains unchanged or improves [10,11]. In contrast to the prior phase II trials, QoL assessment was performed in the current trial.…”

Section: Gemcitabine Monotherapy As Second-line Treatment In Cisplatimentioning

confidence: 99%

Gemcitabine Monotherapy as Second-Line Treatment in Cisplatin-Refractory Transitional Cell Carcinoma – Prognostic Factors for Response and Improvement of Quality of Life

et al. 2002

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Objectives: i) To evaluate objective response, toxicity, and quality of life (QoL) of gemcitabine monotherapy as second-line treatment in patients with cisplatin-refractory, metastatic transitional cell carcinoma (TCC). ii) To assess prognostic parameters for response to treatment and for improvement of QoL parameters. Patients and Methods: 30 patients were prospectively enrolled in this open-label, nonrandomized multicenter phase II trial. Patients received up to 6 courses of gemcitabine monotherapy (1,250 mg/m² on day 1 and 8 of a 21-day course). 28 of 30 patients were available for response evaluation. Results: Objective response (OR) was seen in 3/28 (11%) of patients (2 complete remissions, 1 partial remission). The mean time to progression (TTP) was 4.9 ± 3.5 months and mean disease-specific survival time was 8.7 ± 4.7 months. 13 of 28 patients did not progress (OR + 10 stable diseases), and TTP (8.0 ± 2.7 months, p < 0.001) as well as survival time (10.2 ± 3.8 months, p < 0.05) differed significantly from those who showed progressive disease within 18 weeks of treatment. Pain values significantly improved in the group of responders from 4.3 ± 1.9 to 5.8 ± 1.3 points (p < 0.05). Response to cisplatin pretreatment was the best prognosticator for the response to gemcitabine. Conclusions: Gemcitabine monotherapy as second-line treatment is justified in patients with metastatic TCC who are refractory to cisplatin treatment. Patients with initially OR to cisplatin benefit most from second-line treatment. QoL remains stable during treatment, and pain improves especially in patients with bone metastases.

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Assessment of Quality of Life in Cancer Patients: Complexity, Criticism, Challenges

Cited by 23 publications

References 34 publications

Effect of green tea catechins in patients with high-grade prostatic intraepithelial neoplasia: Results of a short-term double-blind placebo controlled phase II clinical trial

Effect of green tea catechins in patients with high-grade prostatic intraepithelial neoplasia: Results of a short-term double-blind placebo controlled phase II clinical trial

Chemoprevention of Human Prostate Cancer by Oral Administration of Green Tea Catechins in Volunteers with High-Grade Prostate Intraepithelial Neoplasia: A Preliminary Report from a One-Year Proof-of-Principle Study

Gemcitabine Monotherapy as Second-Line Treatment in Cisplatin-Refractory Transitional Cell Carcinoma – Prognostic Factors for Response and Improvement of Quality of Life

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