Utilizing Patient-reported Outcomes in Cancer Clinical Trials

Assessing new anticancer therapeutics in clinical trials is a vital step in evaluating the toxicity and efficacy of treatment before its approval for widespread use. Throughout these trials, many patients encounter a variety of side effects, ranging from physical ailments such as nausea or rash to psychological symptoms such as depression or anxiety. While it is standard practice to record clinician-reported outcomes to characterize safety, there is no current standard requirement for the use of patient-reported outcomes (PROs) in cancer clinical trials.

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Broadening Clinical Trial Participation

Patient enrollment in clinical trials has long been on the minds of oncologists and researchers. In 1990, fewer than 3 percent of patients were enrolled in clinical trials—which spurred then president-elect of the American Cancer Society, Walter Lawrence Jr., MD, to write an editorial calling for more concerted efforts. More than 25 years later, clinical trial participation hovers around 5 percent.

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A Targeted Therapy Next in Line for Biomarker-based Cancer Drug Approval?

recent data suggest that there is another potential contender for a biomarker-based FDA approval: a targeted therapeutic called larotrectinib (LOXO-101), which showed promising results in adults and children with a variety of cancer types, all of which had one thing in common – fusions involving the gene TRK.

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AACR Annual Meeting 2017: Most Merkel Cell Carcinoma Responses to the Newly FDA-Approved Avelumab Expected to Last More than a Year

T cells and antibodies

On March 23, the U.S. Food and Drug Administration announced the first-ever approval of a treatment for patients with a rare, aggressive form of skin cancer called Merkel cell carcinoma. The treatment, the immunotherapeutic avelumab (Bavencio), was approved based on data from the JAVELIN Merkel 200 phase II clinical trial.

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AACR Annual Meeting 2017: Immunotherapy Provides Long-lasting Responses to Certain Cancer Types

Now that a plethora of clinical trials have established positive responses from immunotherapies—immune checkpoint inhibitors, in particular—in patients with a variety of cancer types, one of the logical next questions is, are the responses durable?

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SABCS 2016: Co-director Carlos L. Arteaga, MD, Previews Breast Cancer Symposium

SABCS is a comprehensive scientific meeting that provides the latest information on prevention, diagnosis, and treatment of breast cancer and premalignant breast disease to various stakeholders in the field.

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