Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research HIV Working Group.

Purpose People with HIV are living longer as a result of effective antiretroviral therapy. Cancer has become a leading cause of morbidity and mortality in this patient population. However, studies of novel cancer therapeutics have historically excluded patients with HIV. Critical review of eligibility criteria related to HIV is required to accelerate development of and access to effective therapeutics for HIV-infected patients with cancer and make studies more generalizable to this patient population. Methods From January through April 2016, the HIV Working Group conducted a series of teleconferences; a review of 46 New Drug Applications from registration studies of unique agents studied in adults with cancer that led to the initial US Food and Drug Administration approval of that agent from 2011 to 2015; and a review of HIV-related eligibility criteria from National Cancer Institute-sponsored studies. Results were discussed and refined at a multistakeholder workshop held May 12, 2016. The HIV Working Group developed recommendations for eligibility criteria that focus on pharmacologic and immunologic considerations in this patient population and that balance patient safety, access to appropriate investigational agents, and study integrity. Results Exclusion of patients with HIV remains common in most studies of novel cancer agents. Models for HIV-related eligibility criteria in National Cancer Institute-sponsored studies are instructive. HIV infection itself should no longer be an exclusion criterion for most studies. Eligibility criteria related to HIV infection that address concurrent antiretroviral therapy and immune status should be designed in a manner that is appropriate for a given cancer. Conclusion Expanding clinical trial eligibility to be more inclusive of patients with HIV is justified in most cases and may accelerate the development of effective therapies in this area of unmet clinical need.

The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of hematologic malignancies: multiple myeloma, lymphoma, and acute leukemia.

Increasing knowledge concerning the biology of hematologic malignancies as well as the role of the immune system in the control of these diseases has led to the development and approval of immunotherapies that are resulting in impressive clinical responses. Therefore, the Society for Immunotherapy of Cancer (SITC) convened a hematologic malignancy Cancer Immunotherapy Guidelines panel consisting of physicians, nurses, patient advocates, and patients to develop consensus recommendations for the clinical application of immunotherapy for patients with multiple myeloma, lymphoma, and acute leukemia. These recommendations were developed following the previously established process based on the Institute of Medicine's clinical practice guidelines. In doing so, a systematic literature search was performed for high-impact studies from 2004 to 2014 and was supplemented with further literature as identified by the panel. The consensus panel met in December of 2014 with the goal to generate consensus recommendations for the clinical use of immunotherapy in patients with hematologic malignancies. During this meeting, consensus panel voting along with discussion were used to rate and review the strength of the supporting evidence from the literature search. These consensus recommendations focus on issues related to patient selection, toxicity management, clinical endpoints, and the sequencing or combination of therapies. Overall, immunotherapy is rapidly emerging as an effective therapeutic strategy for the management of hematologic malignances. Evidence-based consensus recommendations for its clinical application are provided and will be updated as the field evolves.

A retrospective analysis of outcomes using three common methods for immediate breast reconstruction.

BACKGROUND: Breast reconstruction outcome studies typically evaluate satisfaction, complications, or aesthetic results. Some studies report better outcomes with autologous reconstruction, whereas other studies report no difference in outcomes across multiple reconstructive methods. METHODS: The authors retrospectively studied all patients undergoing immediate breast reconstruction over a 5-year period. Questionnaires were sent to all patients to assess satisfaction; preoperative bra size, height, and weight; smoking history; radiation history; length of stay; narcotic use; and recovery time. All charts were reviewed for complications. Four blinded reviewers performed aesthetic evaluations of patient results. RESULTS: One hundred eighty-six consecutive immediate breast reconstruction patients were surveyed. Charts and photographs were reviewed for complication data and aesthetic results. The survey response rate was 42 percent, including 48 of 106 expander/implant patients, 13 of 28 latissimus patients, and 18 of 52 transverse rectus abdominis musculocutaneus (TRAM) flap patients. Patient satisfaction was rated as moderate or better for 93.8 percent of the expander/implant patients, 76.9 percent of the latissimus flap patients, and 83.3 percent of the TRAM flap patients. Expander/implant patients were significantly more satisfied than latissimus flap patients. Complication rates were 21.7 percent for expander/implant patients, 67.9 percent for latissimus flap patients, and 26.9 percent for TRAM flap patients. Reoperation rates were 11.3 percent for expander/implant patients, 10.7 percent for latissimus flap patients, and 5.8 percent for TRAM flap patients. Aesthetic scores were significantly higher for TRAM flap patients compared with expander/implant and latissimus flap patients. CONCLUSION: High satisfaction rates were seen across all three reconstructive groups, with the highest satisfaction levels seen in the expander/implant group, despite higher reoperation rates and lower aesthetic scores for this group.