PURPOSE: Patients with metastatic or relapsed pediatric sarcomas receive cytotoxic regimens that induce high remission rates associated with profound lymphocyte depletion, but ultimately few survive long-term. We administered adjuvant immunotherapy to patients with metastatic and recurrent pediatric sarcomas in an effort to improve outcomes. EXPERIMENTAL DESIGN: Mononuclear cells were collected via apheresis and tumor lysate was acquired via percutaneous biopsy at enrollment. Participants received standard anti-neoplastic therapy, followed by autologous lymphocytes, tumor lysate/KLH pulsed dendritic cell vaccinations ± recombinant human interleukin-7. Primary outcomes were toxicity and vaccine responses. Secondary outcomes were immune reconstitution, EFS and OS. RESULTS: Forty-three patients enrolled and 29 received immunotherapy. The regimen was well tolerated. Intent-to-treat analysis demonstrated 5-yr OS of 51% with significant differences based upon histologic group (63% vs 0% for Ewing/rhabdomyosarcoma vs other sarcomas) and response to standard therapy (74% no residual disease vs 0% residual disease). 5-yr intent-to-treat OS of patients with newly diagnosed metastatic Ewing/rhabdomyosarcoma was 77%, higher than previously reported in this population and higher than observed in a similar group treated with an earlier adjuvant immunotherapy regimen (25% 5-yr OS). T cell responses to autologous tumor lysate were identified in 62% of immunotherapy recipients and survival was higher in those patients (73% 5-yr OS with vs 37% without immune response, p=.017). Immune reconstitution, measured by CD4 count recovery, was significantly enhanced in subjects treated with recombinant human interleukin-7. CONCLUSION: Adjuvant immunotherapy may improve survival in patients with metastatic pediatric sarcoma.
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