Patient-reported outcome measures compared to clinician reported outcomes regarding incontinence and erectile dysfunction in localized prostate carcinoma after robot assisted radical prostatectomy: Impact on management.

PURPOSE/ BACKGROUND: Patient-reported outcome measures (PROMs) are widely used after robot assisted radical prostatectomy (RARP) in order to evaluate the impact/burden of the treatment. The most bothersome side effects of RARP are urine incontinence (UI) and erectile dysfunction (ED). During the follow up consultations, clinicians report these side effects in interviewing patients. Our study examined the discrepancy between the PROMs and clinician report outcomes (CROs) and hypothesized that the disagreement could have an impact on the management of UI and ED. METHODS: Up to 1 year after RARP, UI and ED recovery of 312 men with localized and locally advanced prostate cancer were assessed using the International Consultation Incontinence Questionnaire Short-Form (ICIQ-SF) and the International Index of Erectile Function (IIEF-EF) and CROs by interview. Discrepancies between PROs and CROs were studied in light of treatment offered and management. RESULTS: The ICIQ-SF Score matched with CROs in all sum score categories except in ICIQ sum score 6 to 12; here the UI was underreported by clinicians in 58% and 59% of patients at 8 and 12 months (P < 0.001). Furthermore, at 8 and 12 months postoperatively, clinicians underreported UI in 29% and 23% of patients with ICIQ score 13-18 (P < 0.001). The clinician significantly over-reported the recovery of erectile function ("normal erection") (P < 0.001), especially in men with IIEF-EF sum score 6 to 16. Independently of ICIQ-SF/IIEF-EF scores, discrepancy between PROs and CROs did not affect rate of health care offered to patients. CONCLUSIONS: This is to our knowledge the first study that compared the PROs with clinician reported functional outcomes and the impact of discrepancies on the management of side effects of RARP in prostate cancer. Observed discrepancies between the PROs and CROs did not affect offered management and counseling of UI and ED.

Functional outcomes rather than complications predict poor health-related quality of life at 6 months after robot-assisted radical prostatectomy.

The objective is to evaluate the effect of robot-assisted radical prostatectomy (RARP)-related postoperative complications on the 6-month postoperative health-related quality of life (HRQoL). A total of 1008 patients underwent a RARP with or without pelvic lymph node dissection (PLND) between 2012 and 2020 and were invited to complete questionnaires about HRQoL and functional outcomes (urinary incontinence (UI), erectile dysfunction (ED) and urinary complaints (UC)) before and 6 months after RARP. Patient characteristics and postoperative complications up to 90 days after surgery were prospectively recorded. Associations between complications and HRQoL/functional outcomes were assessed by multivariate linear regression analyses. In total, 528 patients (52.4%) were included in the analyses. Complications occurred in 165/528 (31.3%) patients, of which 30/165 (18.2%) had a Clavien-Dindo ≥ III complication. In multivariate regression analyses, postoperative complications were not significantly associated with postoperative HRQoL, UI and ED (p = 0.73, p = 0.72 and p = 0.95, respectively), but were significantly associated with a minor increase in UC (ß = 1.7, p < 0.001). More specifically, infectious and urological complications were significantly associated with an increase in UC (ß = 1.9, p < 0.001 and ß = 0.9, p = 0.004, respectively). The presence of UTI, in particular, was significantly associated with this minor increase (ß = 1.5, p = 0.002). Functional outcomes were all significantly associated with the HRQoL at 6 months postoperatively. No significant associations were found between postoperative complications and HRQoL at 6 months after RARP. However, worse functional outcomes were associated with a worse HRQoL at 6 months postoperatively. In addition, postoperative infectious and urological complications were significantly associated with a minor increase in UC.

Symptoms from treatment with sunitinib or sorafenib: a multicenter explorative cohort study to explore the influence of patient-reported outcomes on therapy decisions.

PURPOSE: Optimal long-lasting treatment with sunitinib and sorafenib is limited by dose modifications (DMs) due to adverse events (AEs). These AEs may be underrecognized and their influence on health-related quality of life (HRQL) underestimated. Improved insight into the relationship between AEs and therapy decisions is needed. To improve decision making around managing symptoms and reduce DMs, this study was set up to explore the influence of patient-reported symptoms on therapy decisions. METHODS: In this multicenter cohort study, patient characteristics, reasons for and different forms of used dose modifications, and AEs were prospectively obtained from cancer patients on sunitinib/sorafenib treatment. Used instruments to get insight into AEs were the patient-scored Utrecht Symptom Diary (USD) and the professional-scored Common Terminology Criteria for AEs version 3.0. RESULTS: Median total treatment duration in 42 patients was 16 weeks. Median time till dose modification was 10 weeks. DMs occurred mostly due to multiple mild AEs. By using the USD, a higher prevalence of most AEs was found compared to the literature. Sixty percent of the patients experienced a decreased HRQL due to multiple AEs. CONCLUSIONS: Because severe AEs due to sunitinib/sorafenib treatment seldom occur, it is more important to focus on treating and preventing multiple mild AEs with higher impact on HRQL, when trying to avoid dose modifications. Using patient self-reported measurement methods helps to early recognize symptoms and to differentiate among symptom intensities. This systematic approach might help to achieve the optimal dosing, which might improve PFS and OS.

Predictive factors for severe toxicity of sunitinib in unselected patients with advanced renal cell cancer.

Sunitinib has been registered for the treatment of advanced renal cell cancer (RCC). As patient inclusion was highly selective in previous studies, experience with sunitinib in general oncological practice remains to be reported. We determined the efficacy and safety of sunitinib in patients with advanced RCC included in an expanded access programme. ECOG performance status >1, histology other than clear cell and presence of brain metastases were no exclusion criteria. Eighty-two patients were treated: 23% reached a partial response, 50% had stable disease, 20% progressed and six patients were not evaluable. Median progression-free survival (PFS) was 9 months and median overall survival (OS) was 15 months. Importantly, 47 patients (57%) needed a dose reduction, 35 (43%) because of treatment-related adverse events, 10 (12%) because of continuous dosing, and two because of both. Stomatitis, fatigue, hand-foot syndrome and a combination of grade 1-2 adverse events were the most frequent reasons for dose reduction. In 40 patients (49%), there was severe toxicity, defined as dose reduction or permanent discontinuation, which was highly correlated with low body surface area, high age and female gender. On the basis of age and gender, a model was developed that could predict the probability of severe toxicity.