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  • 1
    Online Resource
    Online Resource
    Patients’ perspective on the quality of prostate cancer follow-up care.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 28_suppl ( 2021-10-01), p. 175-175
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 28_suppl ( 2021-10-01), p. 175-175
    Abstract: 175 Background: Information about prostate cancer patients’ perspective on the quality of their follow-up care in the hospital is important to optimize survivorship care. This study assessed the quality of prostate cancer follow-up care as experienced by cancer patients and its association with patients’ sociodemographic and clinical characteristics, and treatment-related symptom burden. Methods: We surveyed 385 (response rate, 100%) patients with localized prostate cancer participating in a randomized controlled trial comparing the (cost)effectiveness of specialist- versus primary care-based prostate cancer follow-up. For this study, we used baseline data that were collected during patients’ first follow-up visit at the hospital (2-34 weeks) after primary treatment (radical prostatectomy or radiotherapy) prior to randomization. We assessed patients’ ratings of the quality of follow-up care using the Assessment of Patient Experiences of Cancer Care survey. This survey consists of thirteen scales: getting needed care, timeliness of care, waiting time in physician’s office, information exchange, physician’s affective behavior, physicians’ knowledge about patients’ life, interaction with nurses, interaction with office staff, symptom management, symptom information provision, health promotion, coordination of care, and overall rating of care. Logistic regression analysis was used to identify factors associated with perceived quality of follow-up care. Results: Patients reported positive experiences with follow-up care for 10 of 13 scales, with mean scores ranging from 72 to 97 (on a 0-100 response scale). The three scales where patients reported suboptimal follow-up care were symptom management (mean score of 43), health promotion (mean score of 45), and physicians’ knowledge about patients’ life (mean score of 66). Overall, patients’ report of suboptimal quality of follow-up care was associated significantly with being more highly educated, not having a partner, being older, having multiple comorbidities, and experiencing symptoms (urinary, bowel, and hormonal symptoms). Conclusions: Prostate cancer patients were generally positive about their initial, hospital-based follow-up care after primary surgery or radiation. However, physicians’ knowledge about patients’ lives, symptom management, and health promotion was rated as suboptimal. The findings point to areas where prostate cancer survivorship care can be improved.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.39.28_suppl.175
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 2
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    Online Resource
    The effect of a reduced dose of enzalutamide on fatigue and cognition.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 5051-5051
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 5051-5051
    Abstract: 5051 Background: Enzalutamide (ENZA) is a highly effective treatment for patients (pts) with metastatic prostate cancer, but central nervous system (CNS)-associated side effects occur frequently and may hamper the quality of life. These side effects are addressed with dose reductions, while they potentially can be prevented by starting at a reduced dose, since androgen receptor saturation is already observed at dose levels above 60 mg once daily (OD) and ENZA plasma concentrations 〉 5 mg/L. We hypothesized that a lower starting dose of ENZA can reduce the risk of CNS side effects in frail pts while preserving efficacy. In this study (NCT03927391) the effect of a reduced dose of ENZA on fatigue and cognitive side effects is determined. Methods: This randomized multi-center trial compared the ENZA standard dose of 160 mg OD to the reduced dose of 120 mg OD in frail prostate cancer pts. At baseline, and 6, 12, and 24 weeks after start of ENZA, fatigue and cognitive side effects were measured by the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) and Functional Assessment of Cancer Therapy-Cognition (FACT-Cog) questionnaires. A change in scores of 3.0 for the FACIT-F and 7.0 for the FACT-Cog was considered clinically relevant. Linear mixed effects models were used to study within and between-group differences in fatigue and cognitive side effects over time. Furthermore, ENZA plasma concentrations were measured after 6, 12, and 24 weeks of treatment and PSA response ( 〉 50% PSA decline) was compared between the two dosing regimens. Results: A total of 51 pts were included (25 reduced dose, 26 standard dose). Completion rates for the questionnaires were high throughout the study ( 〉 90%). Pts treated at the reduced dose showed no significant changes in FACIT-F and FACT-Cog scores over time. Pts treated at the standard dose showed increasingly worse FACIT-F and FACT-Cog scores. This resulted in clinically relevant and statistically significant better FACIT-F and FACT-Cog scores for pts treated at the reduced dose compared to pts treated at the standard dose after 24 weeks (table). All pts had therapeutic ENZA concentrations ( 〉 5 mg/L) throughout the study. PSA response did not differ between both groups (87% for 120mg OD vs 80% for 160mg OD, p=0.796). Conclusions: By starting with a reduced dose of ENZA of 120mg OD CNS side effects can be prevented, which might beneficially affect the quality of life of frail prostate cancer pts, without any indication of interference with efficacy endpoints. Clinical trial information: NCT03927391 . [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.5051
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 3
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    Online Resource
    Safety, tolerability, and preliminary efficacy of TAR-200 in patients with intermediate risk non–muscle-invasive bladder cancer: A phase 1 study.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 6_suppl ( 2023-02-20), p. 505-505
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 6_suppl ( 2023-02-20), p. 505-505
    Abstract: 505 Background: TAR-200 is a novel intravesical drug delivery system designed to provide a continuous, slow release of gemcitabine within the bladder. Prolonged gemcitabine exposure over days, instead of hours, such as with current standard intravesical installations, may achieve more efficient and effective tumor response. We report on the safety and tolerability of TAR-200 in patients with non-muscle–invasive bladder cancer (NMIBC). Methods: In this phase 1b, open-label, prospective study, patients with a papillary recurrence after prior histologically proven, intermediate risk (IR)-NMIBC received two 1-week TAR-200 dosing cycles over a 4- to 6-week period. The study used a marker lesion/ablation design. Cystoscopy was performed to assess for recurrent papillary disease and for complete transurethral resection of the residual bladder tumor. The primary outcome was safety of TAR-200. Secondary outcomes were tolerability, pharmacokinetics, preliminary efficacy, and immunohistochemistry. Results: In total, 12 patients received TAR-200 treatment. Insertion and removal of TAR-200 was uneventful. No TAR-200-related serious adverse events (AEs) occurred. Four patients had no TAR-200-associated AEs; the remainder had varying degrees of AEs (all grade ≤2 [CTCAEv4.0]), mainly consisting of low-grade urinary urgency, urinary frequency, and dysuria, with no delay in the treatment schedule. Two patients refused a second dosing cycle due to urinary urgency and frequency. Plasma gemcitabine concentrations remained below the lower limit of detection. Five of 12 patients (42%) had complete response (CR); of these, 4 had a pathologic CR and 1 had CR based on visual assessment (with no biopsy available for pathologic assessment). Conclusions: In this small, phase 1 series, TAR-200 appears to be safe and well tolerated in patients with IR-NMIBC. Clinical trial information: NCT02720367 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.6_suppl.505
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 4
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    Online Resource
    Value of multimodality MRI and MR-guided biopsy at inclusion in an active surveillance protocol for prostate cancer.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 5_suppl ( 2012-02-10), p. 105-105
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 5_suppl ( 2012-02-10), p. 105-105
    Abstract: 105 Background: To prevent overtreatment of insignificant and/or low-risk prostate carcinoma in the PSA screening era, active surveillance is emerging as a treatment strategy for selected patients. In our series we aim to establish whether MRI could aid in correct risk assessment for these patients within the framework of the Prostate Cancer Research International Active Surveillance (PRIAS) study. Methods: We included patients in our protocol based on contemporary criteria for active surveillance: - Diagnosis of prostate cancer by TRUS-guided biopsy. - PSA ≤10 ng/mL, PSA density 〈 0.2 ng/mL/mL - Clinical stage ≤ T2 - Gleason score (GS) ≤3+3=6 - ≤ 2 biopsy cores with cancer All patients underwent multimodality MRI of the prostate, including T2-weighted, diffusion-weighted and dynamic contrast-enhanced MR sequences. When a tumor-suspicious region (TSR) could be identified a targeted MR-guided biopsy (MRGB) was performed to obtain pathology. Patients were referred for definitive treatment in case of GS 〉 3+3=6 upon MRGB or T3 stage at MRI. Results: In 48 of 49 included patients at least one TSR was identified, with a median of 2 TSRs (range1-4) per patient. MRGB was obtained from every TSR, with a median of 4 MRGBs taken per patient. Five patients had a GS 〉 3+3=6 upon MRGB and were excluded. Three patients were excluded due to suspicion of T3 stage on MRI. Five patient were excluded upon physician’s discretion due to multifocal prostate cancer upon MRGB. Combined multimodality MRI/MRGB in our active surveillance cohort thus excluded 27% (13/49) of patients who were incorrectly stratified as low-risk prostate carcinoma by contemporary criteria. Conclusions: Application of multimodality MRI and MRGB in an active surveillance protocol improves risk stratification, adding onto contemporary PSA and TRUS-guided biopsy criteria for low-risk prostate cancer. This approach might increase safety and reliability of active surveillance for prostate cancer and deserves ongoing prospective evaluation.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.5_suppl.105
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 5
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    Online Resource
    Circulating tumor cell-driven use of neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 4523-4523
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 4523-4523
    Abstract: 4523 Background: International guidelines for the treatment of non-metastatic muscle-invasive bladder cancer (MIBC) recommend neoadjuvant chemotherapy (NAC), which, however, is underutilized in practice. We hypothesized that the absence of circulating tumour cells (CTCs), an established prognostic marker in MIBC, may identify patients with such a favourable prognosis that NAC may be withheld. Methods: The CirGuidance study included adults with clinical stage T2-T4aN0-N1M0 muscle-invasive urothelial carcinoma of the bladder who were fit to undergo radical cystectomy. CTCs were enumerated using the CellSearch system. CTC-negative patients (no CTCs detectable) underwent radical surgery without NAC; CTC-positive patients (≥1 detectable CTCs) were advised to receive NAC followed by radical surgery, but NAC could be withheld at the discretion of the treating physician. The primary endpoint was the two-year overall survival (OS) in the CTC-negative group, analysed in the intention-to-treat population. The prespecified criterion for trial success was a two-year OS of minimally 75% (95% confidence interval (CI) ±5%) in the CTC-negative group. Results: Of 315 patients screened for eligibility, 273 were enrolled in the study. The median age was 69 years; the median follow-up was 36 months. The two-year OS in the CTC-negative group was 69.5% (n = 203; 95% CI 62.6%-75.5%); in the CTC-positive group it was 58.2% (n = 70; 95% CI 45.5%-68.9%). CTC-positive patients had a higher rate of cancer-related mortality (hazard ratio (HR) 1.61, 95% CI 1.05-2.45, p = 0.03) and disease relapse (HR 1.87, 95% CI 1.28-2.73, p = 0.001) than CTC-negative patients. Explorative analyses suggested that CTC-positive patients who had received NAC (n = 22) survived longer than CTC-positive patients who had not (n = 48), with a two-year OS of 74.8% (95%CI 49.5%-88.8%) versus 52.0% (95% CI 37.2%-65.0%), respectively. Conclusions: The two-year OS in the CTC-negative group did not meet the prespecified criterion for trial success. However, given the trial population’s advanced age and high rate of non-cancer related mortality, the benefit of NAC is likely to be limited in CTC-negative MIBC patients. CTC enumeration at the moment of diagnosis could aid in the decision to prescribe neoadjuvant chemotherapy for a muscle-invasive bladder cancer patient as a criterion in addition to clinical characteristics. Clinical trial information: NL3954.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.4523
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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