Added Prince et al. as reference 57 and Pro et al. as reference 58. Added text to state that in a phase II study, 66% of 58 patients attained a complete response with brentuximab vedotiin, and at a median follow-up of 58 months, the 5-year progression-free survival (PFS) was 57%, and the 5-year overall survival (OS) was 79% with 42% of these patients undergoing autologous stem cell transplantation (ASCT) (added level of evidence 3iiiDiv).
Revised text to state that the increased risk of central nervous system involvement and of local recurrence has led to recommendations for radiation therapy locally, concurrently, before the start of chemotherapy or between cycle two and three of chemotherapy, and for intrathecal prophylaxis and/or prophylactic cranial radiation therapy (cited Vargo et al. as reference 73). Revised text to state that low-risk patients fared best with radiation therapy alone, while high-risk patients fared best with a strategy of radiation therapy concurrent with chemotherapy, following cycle two of chemotherapy or followed by chemotherapy. Also added that higher doses of radiation therapy administered at more than 50 Gy are associated with improved outcomes according to anecdotal reports.
Added text to state that a randomized trial that compared bendamustine plus rituximab (BR) with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone failed to show any benefit for rituximab maintenance after BR.
Added text to state that in a prospective trial of 299 patients who were previously untreated for mantle cell lymphoma, 257 responders received four courses of rituximab, dexamethasone, cytarabine, and cisplatin and ASCT. The patients were randomly assigned to rituximab maintenance therapy for 3 years versus no maintenance therapy. After randomization, a median follow-up at 50.2 months showed the rate of PFS at 4-years favored the rituximab-maintenance group at 83% versus the no-maintenance group at 64%. The 4-year OS rate also favored the rituximab-maintenance group at 89% versus the no-maintenance group at 80% (cited Le Gouill as reference 188 and level of evidence 1iiA).
Added text to state that in one anecdotal case, a newborn exposed to a rituximab-containing regimen in utero was born with no circulating B lymphocytes. Added that the newborn was otherwise normal and recovered the circulating B lymphocytes by age 6 months with no unusual or persisting intercurrent infections (cited Mandal et al. as reference 11).
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weblog.maimonides.edu/farmacia/archives/UM_Informe_Autoevaluacion_FyB.pdf - //
weblog.maimonides.edu/farmacia/archives/0216_Admin_FarmEcon.pdf - //
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