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Adoptive cellular therapy (ACT) for patients with advanced melanoma involves nonmyeloablative (NMA) chemotherapy followed by ex vivo expanded tumor-infiltrating lymphocytes (TILs) and high-dose interleukin-2. To evaluate the potential benefit of adding myeloablative total body irradiation (TBI) to ACT to enhance lymphodepletion, investigators conducted a prospective, randomized trial involving 101 patients with metastatic melanoma. Patients received NMA chemotherapy with or without TBI (12 Gy) before transfer of TILs.
Adding TBI to ACT failed to improve overall response, complete response, progression-free survival, or overall survival. All patients receiving TBI required peripheral blood stem cell infusions, and more than 25% developed micr…