Quality of life and pain relief in men with metastatic castration-resistant prostate cancer on cabazitaxel: the non-interventional 'QoLiTime' study.

OBJECTIVE: To examine health-related quality of life (QoL) in men with metastatic castration-resistant prostate cancer (mCRPC) on cabazitaxel. PATIENTS AND METHODS: Men with mCRPC receiving cabazitaxel (25 mg/m², every 3 weeks) and 10 mg/day oral prednis(ol)one were enrolled (2011-2014) in the non-interventional prospective 'QoLiTime' study. Primary outcome was change in QoL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item) with respect to prostate-specific antigen (PSA) response after four cycles of cabazitaxel. Secondary outcomes included occurrence of adverse events (AEs). RESULTS: Of 527 men, 348 received four cycles of cabazitaxel and 266 had the necessary PSA level measurements. After four cycles, 92 (34.6%) men had a PSA level decrease ≥50% (responders). QoL remained stable throughout the study (P = 0.62). Change in QoL did not differ between responders and non-responders (P = 0.69). Change in PSA level and global health status between baseline and four cycles showed an inversely proportional relationship (correlation coefficient -0.14; 95% confidence interval -0.26 to -0.01; P = 0.03), with increasing PSA level corresponding to lower health status. Responders showed no change in physical functioning vs baseline (-1.75, P = 0.12); non-responders showed a reduction vs baseline (-7.00, P < 0.001) and responders (P = 0.05). Responders showed an improvement in pain vs baseline (-7.61, P = 0.05) and vs non-responders (P = 0.01). AEs occurred in 292 patients (55.4%), most commonly anaemia (16.5%), fatigue (12.3%) and diarrhoea (11.8%). Neutropenia and febrile neutropenia were reported in 3.8% and 3.6% of patients, respectively. CONCLUSION: Prostate-specific antigen level response was associated with stable physical functioning and improvement in pain. Symptom increases were seen in areas typical of chemotoxicity, but QoL was maintained.

[Investigations about kind and frequency of mechanical dystocia in ewes with special regard to the vaginal prolapse ante partum]. / Erhebungen zur Art und Häufigkeit mechanischer Geburtsstörungen beim Schaf unter besonderer Berücksichtigung des Prolapsus vaginae ante partum.

The incidence of dystocia from ewes in nine lambing periods (1992-2000) was recorded at an obstetrical clinic. First we analysed parturition difficulties in normal pregnant sheep (group 1, n = 229). In the second group parturitions of ewes with vaginal prolapse ante partum were investigated (n = 129). In group 1 maternal causes of dystocia occurred more often than fetal ones (50% maternal, 45% fetal). In maternal parturition difficulties ringwomb was the dominating reason (64%), while abnormal presentations, position and/or posture of the lambs occurred most frequently in fetal dystocia (67%). But there was no statistical influence of age and number of parturitions in both groups. The average of the first notice of prolapsed vaginal tissue was 11 days before lambing. There was a predominance in the affection of sheep at first and second pregnancy (52%). Only 26% of the group 2 sheep had a spontaneous delivery. In 58% of the cases a dystocia was diagnosed. A preterm caesarean section had carried out in 12%, five ewes died before parturition because of septicemia (4%). Sheep suffering from vaginal prolapse ante partum showed maternal caused dystocia significant more frequently than members of group 1 (p < 0.001), with ringwomb as dominating reason (70%). The number of born lambs was significant higher in group 2 than in group 1 (p = 0.019).