New RWE publication Prognostic significance of patient-reported outcomes in cancer
New RWE publication First-line immune checkpoint inhibitor use in cisplatin-eligible patients with advanced urothelial carcinoma: a secular trend analysis
New white paper Adding real-world evidence to a totality of evidence approach for evaluating marketed product effectiveness
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Published in JCO Oncology Practice
Prognostic significance of patient-reported outcomes in cancer
Performance status (PS), while often used as a prognostic surrogate of cancer survival, may be prone to bias due to its reliance on a physician’s subjective interpretation of a patient’s status. The National Cancer Institute (NCI) Patient-Reported Outcomes Measurement Information System–Cancer (PROMIS-Ca) Bank, on the other hand, relies on patient-reported outcomes (PROs) to monitor patient status, eliminating the potential biases from physician interpretation.
In collaboration with Huntsman Cancer Institute, we looked at whether PROMIS-Ca can also be used as a prognostic indicator for overall survival and hospitalization-free survival (HFS).
First-line immune checkpoint inhibitor use in cisplatin-eligible patients with advanced urothelial carcinoma: a secular trend analysis
Standard first-line treatment of advanced urothelial cell carcinoma involves cisplatin-based chemotherapy, with carboplatin or immune checkpoint inhibitor therapy (ICI) reserved for cisplatin-ineligible individuals. However, due to the general tolerability of ICI and its lack of the traditional toxicities of chemotherapy, oncologists and cisplatin-eligible patients may opt to bypass cisplatin-based chemotherapy in favor of ICI in first-line settings.
In partnership with researchers from the University of Pennsylvania and Tisch Cancer Institute, we examined trends in the utilization of first-line systemic therapies in cisplatin-eligible patients.
New white paper: Adding Real-World Evidence to a Totality of Evidence Approach for Evaluating Marketed Product Effectiveness
The Duke-Margolis Center for Health Policy released a new white paper last month. In it, they describe a framework for how RWE may contribute to regulatory decisions about the effectiveness of drugs as part of the “totality of evidence” submitted to FDA.