Cancer-related fatigue in patients before and after radical prostatectomy. Results of a prospective multi-centre study.

PURPOSE: A multi-centre, longitudinal study was conducted to assess the prevalence of fatigue amongst men with localized prostate cancer, to describe several dimensions of fatigue and to explore the predictability of fatigue by psychological distress and physical function. METHODS: The prevalence of fatigue was evaluated using the Multidimensional Fatigue Inventory in 329 prostate cancer patients before, 3, 6 and 12 months after surgery. Psychological distress was assessed using the Hospital Anxiety and Depression Scale. Physical function was measured using the EORTC QLQ-C30. RESULTS: After surgery, about 14 % of the patients were screened with chronic fatigue. For all dimensions of fatigue, only small longitudinal changes could be observed. Psychological distress could be identified as a good predictor of fatigue after but not before surgery. CONCLUSIONS: Radical prostatectomy has no or little impact on the prevalence of fatigue. However, about 14 % of patients with chronic fatigue could possibly benefit from psychosomatic interventions. Interventions should consider the simultaneous appearance of fatigue and psychological distress and a reduced physical function.

[The assessment of therapy success after radical prostatectomy]. / Die Beurteilung des Behandlungserfolges nach Radikaler Prostatektomie.

OBJECTIVES: Patient satisfaction plays an important role in the outcome quality of treatment for localized prostate carcinoma. This paper identifies factors that impact patients' assessment of therapy success one year after surgery. METHODS: Patient assessment of therapy success was measured with the Hamburger Fragebogen zum Krankenhausaufenthalt (Lecher et al. 2002). Also, several sociodemographic, clinical and quality-of-life factors were tested for their impact on the patient assessment of therapy success. RESULTS: 25 % of patients gave a negative assessment of therapy success. Factors with the strongest impact were urinary incontinence, sexual impotence, younger age and higher risk of recidive. CONCLUSIONS: Especially the prevention of urinary continence and sexual dysfunction may lead to a better assessment of therapy. Moreover, the patients' expectations have a great impact on the assessment of therapy success.

Cabazitaxel plus prednisone for metastatic castration-resistant prostate cancer progressing after docetaxel: results from the German compassionate-use programme.

BACKGROUND: Cabazitaxel (Cbz) is an approved second-line treatment in metastatic castration-resistant prostate cancer (mCRPC) following docetaxel therapy with a significant survival benefit compared with mitoxantrone. However, grade 3/4 toxicities were reported in 82% of patients. OBJECTIVE: To report on the safety results of mCRPC patients treated within a compassionate-use programme in Germany. DESIGN, SETTING, AND PARTICIPANTS: A total of 111 patients with a mean age of 67.9 yr (range: 49-81 yr) and progressive mCRPC were included. Patients had received a mean number of 12.7 ± 10.8 cycles (range: 6-69 cycles) of docetaxel with a mean cumulative dose of 970.9 mg/m(2); mean time from last docetaxel application to progression was 6.95 mo (range: 2-54 mo). Of the patients, 31.5% progressed by prostate-specific antigen (PSA) increase only; the remainder had a combination of PSA increase and clinical progression. INTERVENTION: Cbz at a dosage of 25mg/m(2) intravenously every 3 wk combined with 5mg of oral prednisone twice a day. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Treatment-associated toxicity was the primary study end point; progression-free and overall survival were secondary end points. A descriptive statistical analysis was performed. RESULTS AND LIMITATIONS: Patients received a mean number of 6.5 ± 2.2 cycles of Cbz and a mean cumulative dose of 160.3 ± 51.5mg/m(2). Grade 3 and 4 treatment-emergent adverse events were recorded in 34 patients (30.6%) and 18 patients (16.2%), respectively. Grade 3/4 anaemia, neutropenia, and thrombocytopenia were reported in 4.5%, 7.2%, and 0.9% of the patients, respectively. Neutropenic fever was reported in 1.8% of the patients. Grade 3/4 gastrointestinal toxicity was identified in 4.5% of the patients. Three patients died because of Cbz-related toxicity. Granulocyte colony-stimulating growth factors were used in 17.1% of patients. The limitations are due to the nonrandomised nature of the trial. CONCLUSIONS: Treatment with Cbz is tolerable and is associated with a low incidence of serious adverse events in a real-world patient population with CRPC. The outcome of serious adverse events can be minimised with proactive treatment management and conscientious monitoring.

Organ-sparing treatment of advanced bladder cancer: paclitaxel as a radiosensitizer.

BACKGROUND AND PURPOSE: Transurethral resection of bladder tumor (TUR-BT) and radiochemotherapy with cisplatin achieve high rates of bladder preservation and survival figures identical to radical cystectomy in muscle-invasive bladder cancers. The authors have investigated the potential use of paclitaxel in a radiochemotherapy protocol for patients with inoperable bladder carcinomas and mainly contraindications to cisplatin. PATIENTS AND METHODS: Between October 1997 to August 2004, 42 patients (median age 71 years) suffering from muscle-invasive (n=32) or recurrent (n=10) bladder cancers were treated with a paclitaxel-containing radiochemotherapy (paclitaxel 25-35 mg/m(2) twice weekly) after TUR-BT (R0/1/2/x in n=18/4/14/3) or cystectomy with residual tumor (n=3). Five patients received additional cisplatin. Radiation treatment was administered to a total dose of 45-60 Gy. RESULTS: 76.2% completed the planned regimen. Adaptations of treatment were mainly required due to diarrhea. Grade 3/4 toxicities occurred in 15/1 patients. Severe renal toxicities did not occur. 28 patients underwent restaging TUR-BT 6 weeks after radiochemotherapy (complete remission/partial remission/progressive disease: n=24/3/1). Three patients developed a local recurrence and four distant metastases. Seven patients died from tumor, six of other reasons. CONCLUSION: Radiochemotherapy with paclitaxel was feasible and this bladder approach needs further investigation to evaluate whether paclitaxel could become a substitute for cisplatin.

Organ-sparing treatment in muscle-invasive bladder cancer.

BACKGROUND AND PURPOSE: Organ-sparing treatment of bladder cancer by a trimodality approach is feasible and effective. In this study, the results of a series of patients are reported, who were, in the majority, not suitable for major surgery. PATIENTS AND METHODS: In the period from June 1995 through December 2003, 68 patients (64 males, four females) with urothelial bladder cancer were treated with curative intent. The median age was 68 years (range 42-82 years). Clinical T-category was 32x T2, 20x T3, and 16x T4. Transurethral resection was performed in all cases, and a complete TUR-BT (transurethral resection of bladder tumor) was attempted, if possible. Radiotherapy was administered in conventional fractionation (five fractions of 1.8 Gy per week) up to 50.4 Gy to bladder, and regional nodes and the whole bladder received a boost up to 54-59.4 Gy. 34 patients received concurrent cisplatin-based chemotherapy (25 mg/m(2) on days 1-5 and 29-33), and patients with impaired renal function were either treated with irradiation alone (n = 7) or received paclitaxel as alternative to cisplatin in a phase II protocol or on an individual decision (n = 27). The median follow-up was 34 months (range 2-104 months). RESULTS: A histologically confirmed complete remission (CR) on restaging cystoscopy was observed in 40/46 patients (87%) who underwent restaging cystoscopy. CR rates were not significantly correlated to T-category (CR: 24/32 T2, 9/19 T3, and 9/16 T4 tumors) or clinical nodal status. Patients with non-radical resection and macroscopic residual tumor (R2 resection) achieved a CR in only 39% (12/31); this figure was significantly lower as compared to patients with radical R0 TUR-BT (CR: 15/16, 94%, p = 0.013) Furthermore, age and preexisting anemia had no impact on response. The overall survival of the whole group was 45% after 5 years, and survival according to clinical T-category was 62% for T2, 43% for T3, and 19% for T4 (p = 0.015). In eleven patients, local disease progression or relapse was observed. So far, only one salvage cystectomy has been performed, due to contraindications to surgery in the majority of patients. CONCLUSION: The data obtained in this study confirm the high efficacy of TUR and radiochemotherapy for locally advanced bladder cancer.