- Ovarian cancer has a high mortality to case ratio. To improve the initial response to therapy, trials of biologic agents in combination with primary chemotherapy and as maintenance after completing chemotherapy are being conducted. Multiple trials are ongoing and this strategy has great promise. However, the changing landscape of primary treatment will make designing future trials in ovarian cancer difficult as there may not be a consensus on the optimal primary therapy.
- The success of targeted and immune therapies in other malignancies has led to an exponential increase in the number of active and pending clinical trials using these therapeutic approaches in patients with gynecologic cancers. These novel investigational agents are associated with unique and potentially life-threatening toxicities and many require special multidisciplinary logistical considerations. The objective of this review is to describe a practical approach for the safe implementation of targeted and immune therapies in academic gynecologic oncology practices based on our experience at M.D.
- The goal of clinical trial design is to efficiently and accurately determine the efficacy of an intervention in a specific patient population. While 35% of cancer deaths arise from the rarest 20% of cancers, unique challenges exist in the clinical trial design and study of rare tumors . Due to the uncommon nature of these diseases, they are distributed across a wide geographic area, often with limited access to experienced oncologists. The natural history of many of these cancers is often poorly defined, and the “lumping together” of similar tumors yields phenotypic heterogeneity, such that histologic subtypes that are clinically distinct are studied together to meet accrual goals.