POSA7 Clinical and Health-Related Quality of Life (HRQOL) Outcomes from Interventional Studies in First-Line (1L) Advanced or Metastatic Urothelial Cancer (MUC): A Systematic Literature Review (SLR)

To review the existing evidence on clinical efficacy, safety, and HRQoL outcomes for patients receiving 1L treatment for advanced/mUC. An SLR was performed following a pre-specified framework. Publications were identified within the Embase, Medline (In-Process), Cochrane, and Centre for Reviews and Dissemination databases, as well as from select clinical conferences through 22 May 2020. Results were screened by two independent reviewers. Outcomes of interest were survival, response, safety, and HRQoL. Among 5,158 records screened, 35 randomized controlled trials and 22 non-randomized trials were identified. Median patient age ranged between 56-81 years, and 57%-96% of patients were male across trials. Prior to 1999, MVAC (methotrexate, vinblastine, doxorubicin, cisplatin) was the most frequently reported treatment (n=7 as comparator, n=8 as intervention). Post-1998, commonly evaluated treatments included cisplatin or carboplatin (alone or in combination with gemcitabine; n=17) prior to the introduction of immunotherapies in 2017 (n=15). Complete response rate was the most frequently reported efficacy outcome (n=54; range: 2%-37%), followed by median overall survival (n=52; range: 3.3-20.2 months), overall response rate (n=51; range: 12%-76%), and partial response rate (n=49; range: 8%-53.8%). Nausea (n=31, range: <1%-56%), fatigue (n=13, range: 2%-81.8%), and overall grade ≥3 adverse events (n=12; range: 9%-91%) were the most frequently reported safety outcomes. Two out of three studies reporting HRQoL outcomes saw improved functional and symptom scores (EORTC QLQ-C30) after mUC treatment whereas one study found no difference in HRQoL over time with MVAC or carboplatin+paclitaxel using the Functional Assessment of Cancer Therapy–Bladder. In the identified trials evaluating 1L treatments for patients with advanced/mUC, the most frequently reported efficacy and safety outcomes were for MVAC or platinum-based chemotherapy, with a large range in reported survival and response outcomes. Further research is needed to understand the most suitable options for patients receiving 1L treatment for advanced or mUC.