Vinflunine/gemcitabine versus carboplatin/gemcitabine as first-line treatment in cisplatin-ineligible patients with advanced urothelial carcinoma: A randomised phase II trial (VINGEM)

Holmsten, Karin; Jensen, Niels Viggo; Mouritsen, Lene Sonne; Jonsson, Erland; Mellnert, Camilla; Agerbæk, Mads; Nilsson, Cecilia; Moe, Mette; Carus, Andreas; Öfverholm, Elisabeth; Lahdenperä, Outi; Brandberg, Yvonne; Johansson, Hemming; Hellström, Mats; Maase, Hans von der; Pappot, Helle; Ullén, Anders

doi:10.1016/j.ejca.2019.08.033

Cited by 19 publications

(9 citation statements)

References 23 publications

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“…In this study, a high percentage of patients experienced hospitalization and a low percentage of patients completed treatment. Previous studies report similar discontinuation rates and median number of cycles to that presented in this study [ 6 , 38 , 39 ]. Recent data indicate that UCC patients not receiving optimal neoadjuvant chemotherapy are at higher risk of recurrence and death [ 40 ].…”

Section: Discussionsupporting

confidence: 85%

Patient-Reported Outcomes, Health-Related Quality of Life, and Clinical Outcomes for Urothelial Cancer Patients Receiving Chemo- or Immunotherapy: A Real-Life Experience

Taarnhøj

Lindberg

Johansen

et al. 2021

JCM

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Patients with urothelial cell carcinoma (UCC) often have comorbidities, which cause trouble for the completion of oncological treatment, and little is known about their quality of life (QoL). The aim of the present study was to obtain and describe patient-reported outcomes (PRO) and QoL data from UCC patients in the treatment for locally advanced muscle-invasive or metastatic UCC. A total of 79 patients with UCC completed four questionnaires (EORTC QLQ-C30, QLQ-BLM30, HADS, and select PRO-CTCAE™ questions) once weekly during their treatment. From those, 26 patients (33%) underwent neoadjuvant treatment for local disease while 53 patients (67%) were treated for metastatic disease. Of all patients, 54% did not complete the planned treatment due to progression, nephrotoxicity, death, or intolerable symptoms during treatment. The five most prevalent PRO-CTCAE grade ≥ 2 symptoms were frequent urination (37%), fatigue (35%), pain (31%), dry mouth (23%), and swelling of the arms or legs (23%). The baseline mean overall QoL was 61 (±SD 24) for all patients (neoadjuvant (73, ±SD 19) and metastatic (54, ±SD 24)) and remained stable over the course of treatment for both groups. A stable overall QoL was observed for the patients in this study. More than half of the patients did not, however, complete the planned treatment. Further supportive care is warranted for bladder cancer patients.

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Section: Discussionsupporting

confidence: 85%

Patient-Reported Outcomes, Health-Related Quality of Life, and Clinical Outcomes for Urothelial Cancer Patients Receiving Chemo- or Immunotherapy: A Real-Life Experience

Taarnhøj

Lindberg

Johansen

et al. 2021

JCM

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“…The primary endpoint of improvement in PFS was not met; however, compared with GCa, VG had a higher CR rate (22% vs 3%) 119 . Conversely, patients who received VG had higher rates of grade 3 and 4 neutropenia (VG vs GCa, 62% vs 43%) and febrile neutropenia (VG vs GCa, 31% vs 7%) 119 . Currently, GCa remains the preferred cytotoxic chemotherapy regimen for first‐line treatment of cisplatin‐ineligible patients with mUC.…”

Section: Advanced Urothelial Carcinomamentioning

confidence: 95%

“…Most recently, the VINGEM study (A Trial With Vinflunine in Patients With Metastatic Bladder Cancer and Impaired Renal Function; ClinicalTrials.gov identifier NCT02665039) investigated VG compared with GCa in 59 patients who had a CrCl of 30 to 60 mL per minute and a performance status ≤1. The primary endpoint of improvement in PFS was not met; however, compared with GCa, VG had a higher CR rate (22% vs 3%) 119 . Conversely, patients who received VG had higher rates of grade 3 and 4 neutropenia (VG vs GCa, 62% vs 43%) and febrile neutropenia (VG vs GCa, 31% vs 7%) 119 .…”

Section: Advanced Urothelial Carcinomamentioning

confidence: 96%

Treatment of muscle‐invasive and advanced bladder cancer in 2020

Patel

Galsky

2020

CA A Cancer J Clinicians

699

520

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Bladder cancer accounts for nearly 170,000 deaths worldwide annually. For over 4 decades, the systemic management of muscle-invasive and advanced bladder cancer has primarily consisted of platinum-based chemotherapy. Over the past 10 years, innovations in sequencing technologies have led to rapid genomic characterization of bladder cancer, deepening our understanding of bladder cancer pathogenesis and exposing potential therapeutic vulnerabilities. On the basis of its high mutational burden, immune checkpoint inhibitors were investigated in advanced bladder cancer, revealing durable responses in a subset of patients. These agents are now approved for several indications and highlight the changing treatment landscape of advanced bladder cancer. In addition, commonly expressed molecular targets were leveraged to develop targeted therapies, such as fibroblast growth factor receptor inhibitors and antibody-drug conjugates. The molecular characterization of bladder cancer and the development of novel therapies also have stimulated investigations into optimizing treatment approaches for muscle-invasive bladder cancer. Herein, the authors review the history of muscle-invasive and advanced bladder cancer management, highlight the important molecular characteristics of bladder cancer, describe the major advances in treatment, and offer future directions for therapeutic development.

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“…In previous studies we have seen that bladder cancer patients have very poor clinical outcomes with 66% of the patients experiencing hospitalisation during oncological treatment and only 45-50% of patients completing the planned treatment, whether as neoadjuvant treatment or treatment for metastatic disease [1][2][3]. One of the explanations for this could be that many of these patients deal with comorbidities troubling completion of treatment [4].…”

Section: Introductionmentioning

confidence: 99%

Electronic reporting of patient-reported outcomes in a fragile and comorbid population during cancer therapy – a feasibility study

Taarnhøj

Lindberg

Dohn

et al. 2020

Health Qual Life Outcomes

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Background: Electronic collection of patient-reported outcomes (ePROs) is becoming widespread in health care, but the implementation into routine cancer care during therapy remains to be seen. Especially, little is known of the use and success of electronic reporting during active cancer treatment in fragile and comorbid patients. The aim of this study was to test the feasibility of ePRO and its incorporation into routine cancer care, measured by physician compliance, for a fragile and comorbid bladder cancer (BC) population receiving chemo-or immunotherapy. Methods: All BC patients initiating treatment for locally advanced or metastatic bladder cancer at Rigshospitalet or Herlev Hospital, Denmark, were approached during an 8 month period. Exclusion criteria were patients not speaking Danish or not being signed up for electronic communication with health authorities. Enrolled patients were prompted to complete weekly ePROs from home. Patients completed the European Organisation for Research and Treatment of Cancer's general quality of life questionnaire, QLQ-C30, and the module for muscle-invasive bladder cancer QLQ-BLM30, the Hospital Anxiety and Depression Scale, HADS, and selected items from the Patient Reported-Outcomes version of the Common Terminology Criteria of Adverse Events (PRO-CTCAE), in total 158 questions weekly. If failing to report when prompted, patients were sent two e-mail reminders. Patients were informed that the physician would have an overview of the reported ePROs at their following clinical visits. Physicians were at all clinical visits informed to look at the ePROs in a software solution separate from the medical records. Physicians were logged to check their compliance to the task. No continuous surveillance of ePROs was established. Results: Of 91 patients screened for enrolment, 19 patients (21%) were not found eligible for standard treatment, eight patients (9%) were not signed up for electronic communication with the health authorities and nine patients (10%) declined participation. Another six patients did not meet other inclusion criteria. In total 49 BC patients were enrolled, 29 initiating chemotherapy and 20 initiating immunotherapy. A total of

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Vinflunine/gemcitabine versus carboplatin/gemcitabine as first-line treatment in cisplatin-ineligible patients with advanced urothelial carcinoma: A randomised phase II trial (VINGEM)

Cited by 19 publications

References 23 publications

Patient-Reported Outcomes, Health-Related Quality of Life, and Clinical Outcomes for Urothelial Cancer Patients Receiving Chemo- or Immunotherapy: A Real-Life Experience

Patient-Reported Outcomes, Health-Related Quality of Life, and Clinical Outcomes for Urothelial Cancer Patients Receiving Chemo- or Immunotherapy: A Real-Life Experience

Treatment of muscle‐invasive and advanced bladder cancer in 2020

Electronic reporting of patient-reported outcomes in a fragile and comorbid population during cancer therapy – a feasibility study

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