Is weight-based IV dosing of trastuzumab preferable to SC fixed-dose in some patients? A systematic scoping review.

Trastuzumab, a key treatment for HER2-positive breast cancer, is available in weight-based IV and fixed-dose (600 mg) SC formulations. While the Phase 3 HannaH trial indicated non-inferiority of the SC formulation, there is some concern that the target plasma concentration may not be reached in overweight/obese patients whereas low-body-weight patients may be at risk of toxicity. This scoping review evaluated whether overweight/obese patients are at risk of below-target exposure with fixed-dose SC trastuzumab, whether low-body-weight patients are at risk of increased toxicity, especially cardiotoxicity, and whether IV and SC trastuzumab are equivalent in terms of treatment-emergent adverse events (TEAEs) (e.

The clinical and cost-effectiveness of supplemental parenteral nutrition in oncology.

Background: Clinical guidelines recommend that parenteral nutrition (PN) is added to enteral nutrition (EN; supplemental parenteral nutrition (SPN)) in order to meet energy and protein needs in patients with cancer when EN alone is insufficient. However, although cancer-related malnutrition is common, there is poor awareness of the value of nutritional care, resulting in SPN being chronically underused.

Methods: We performed a targeted literature review and exploratory cost-utility analysis to gather evidence on the clinical effectiveness of SPN, and to estimate the potential cost-effectiveness of SPN versus EN alone in an example cancer setting.

Review and comparison of clinical evidence submitted to support European Medicines Agency market authorization of orphan-designated oncological treatments.

Background: Clinical trials for treatments indicated for orphan diseases may be limited due to the low prevalence of such diseases; this can result in implications for both regulatory and health economic perspectives. This study assessed the pivotal clinical evidence packages submitted to support applications for European Medicines Agency (EMA) marketing authorizations for treatments for orphan conditions, in relation to the size of the eligible patient population.

Methods: Approved treatments for EMA-designated orphan conditions (defined as life-threatening or chronically debilitating conditions that affect ≤5/10,000 people) were identified from the EMA web site.