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- Kellokumpu-Lehtinen, P-L, et al.
(författare)
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Toxicity in patients receiving adjuvant docetaxel plus hormonal treatment after radical radiotherapy for intermediate or high-risk prostate cancer : a preplanned safety report of the SPCG-13 trial
- 2012
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Ingår i: Prostate Cancer and Prostatic Diseases. - : Springer Science and Business Media LLC. - 1365-7852 .- 1476-5608. ; 15:3, s. 303-307
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Radical radiotherapy (RD combined with androgen deprivation therapy is currently the standard treatment for elderly patients with localized intermediate- or high-risk prostate cancer (PC). To increase the recurrence-free and overall survival, we conducted an adjuvant, randomized trial using docetaxel (T) in PC patients (Scandinavian Prostate Cancer Group trial 13). METHODS: The inclusion criteria are the following: men > 18 and <= 75 years of age, WHO/ECOG performance status 0-1, histologically proven PC within 12 months before randomization and one of the following: T2, Gleason 7 (4 + 3), PSA > 10; T2, Gleason 8-10, any PSA; or any T3 tumors. Neoadjuvant/adjuvant hormone therapy is mandatory for all patients. The patients were randomized to receive six cycles of T (75 mg m(-2) d 1. cycle 21 d) or no docetaxel after radical RI (with a minimum tumor dose of 74 Gy). This study identifier number is NTC 006653848 (http://www.clinicaltrials.org). RESULTS: In this preplanned safety analysis of 100 patients, T treatment induced grade (G) 3 adverse events (AEs) in 15 patients (30%) and G4 AEs in 30 patients (60%), mainly due to bone marrow toxicity. Neutropenia G3-4 was observed in 72% of the patients, febrile neutropenia was found in 24% of patients, neutropenic infection in 10% of patients and G3 infection without neutropenia in 4% of patients. Nonhematological G3 AEs were rare: anorexia, diarrhea, mucositis, nausea, pain (1 patient each) and fatigue (5). Other severe serious AEs related to T were pulmonary embolism and renal failure. However, only three patients discontinued T before completing the planned six cycles. No deaths had occurred. No patients in the control arm experienced G3-4 toxicities at 12 weeks after the randomization. CONCLUSIONS: Adjuvant docetaxel chemotherapy after radiotherapy has a higher frequency of neutropenia than previous studies on patients with metastatic disease. Otherwise, the treatment was quite well tolerated.
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| 2. |
- Alverbratt, Charlotte, et al.
(författare)
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Time difference in retrieving clinical information in Patient-overview Prostate Cancer compared to electronic health records
- 2022
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Ingår i: Scandinavian Journal of Urology. - : Medical Journals Sweden AB. - 2168-1805 .- 2168-1813. ; 56:2, s. 95-101
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Tidskriftsartikel (refereegranskat)abstract
- Background: Patients with advanced prostate cancer (PCa) typically undergo numerous lines of treatment leading to large amounts of information in Electronic Health Records (EHRs). The Patient-overview Prostate Cancer (PPC) presents clinical information in a graphical overview. The aim of this study was to measure time spent on retrieving clinical information in PPC compared to EHRs, to assess if retrieved data was correct and to explore usability of PPC. Material and methods: Oncologists, urologists and nurses in three hospitals in Sweden were timed when filling out questionnaires about patients using PPC and two different EHRs; Melior and COSMIC. Time and number of errors were analysed using linear mixed models (LMMs). Usability of PPC was measured with the System Usability Scale. Results: The LMM showed a significantly shorter time to retrieve information in PPC compared to EHRs. The estimated time to complete one questionnaire was 8 minutes (95% CI = 6–10, p < 0.001) in PPC compared to 25 minutes in Melior and 21 minutes in COSMIC. Compared to PPC, the estimated time difference was 17 minutes longer in Melior (95% CI = 14–20, p < 0.001) and 13 minutes longer in COSMIC (95% CI = 10–17, p < 0.001). The LMM showed significantly fewer errors in PPC compared to Melior. No significant difference in the number of errors was found between PPC and COSMIC. The usability of PPC was rated as excellent by oncologists, urologists and nurses. Conclusion: A graphical overview of a patient’s medical history, as in PPC, gives health staff rapid access to relevant information with a high degree of usability.
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