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Tumor-Infiltrating Lymphocyte Therapy or Ipilimumab in Advanced Melanoma.
Rohaan, Maartje W; Borch, Troels H; van den Berg, Joost H; Met, Özcan; Kessels, Rob; Geukes Foppen, Marnix H; Stoltenborg Granhøj, Joachim; Nuijen, Bastiaan; Nijenhuis, Cynthia; Jedema, Inge; van Zon, Maaike; Scheij, Saskia; Beijnen, Jos H; Hansen, Marten; Voermans, Carlijn; Noringriis, Inge M; Monberg, Tine J; Holmstroem, Rikke B; Wever, Lidwina D V; van Dijk, Marloes; Grijpink-Ongering, Lindsay G; Valkenet, Ludy H M; Torres Acosta, Alejandro; Karger, Matthias; Borgers, Jessica S W; Ten Ham, Renske M T; Retèl, Valesca P; van Harten, Wim H; Lalezari, Ferry; van Tinteren, Harm; van der Veldt, Astrid A M; Hospers, Geke A P; Stevense-den Boer, Marion A M; Suijkerbuijk, Karijn P M; Aarts, Maureen J B; Piersma, Djura; van den Eertwegh, Alfons J M; de Groot, Jan-Willem B; Vreugdenhil, Gerard; Kapiteijn, Ellen; Boers-Sonderen, Marye J; Fiets, W Edward; van den Berkmortel, Franchette W P J; Ellebaek, Eva; Hölmich, Lisbet R; van Akkooi, Alexander C J; van Houdt, Winan J; Wouters, Michel W J M; van Thienen, Johannes V; Blank, Christian U.
Afiliação
  • Rohaan MW; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Borch TH; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • van den Berg JH; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Met Ö; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Kessels R; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Geukes Foppen MH; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Stoltenborg Granhøj J; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Nuijen B; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Nijenhuis C; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Jedema I; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • van Zon M; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Scheij S; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Beijnen JH; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Hansen M; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Voermans C; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Noringriis IM; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Monberg TJ; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Holmstroem RB; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Wever LDV; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • van Dijk M; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Grijpink-Ongering LG; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Valkenet LHM; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Torres Acosta A; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Karger M; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Borgers JSW; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Ten Ham RMT; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Retèl VP; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • van Harten WH; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Lalezari F; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • van Tinteren H; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • van der Veldt AAM; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Hospers GAP; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Stevense-den Boer MAM; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Suijkerbuijk KPM; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Aarts MJB; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Piersma D; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • van den Eertwegh AJM; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • de Groot JB; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Vreugdenhil G; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Kapiteijn E; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Boers-Sonderen MJ; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Fiets WE; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • van den Berkmortel FWPJ; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Ellebaek E; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Hölmich LR; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • van Akkooi ACJ; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • van Houdt WJ; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Wouters MWJM; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • van Thienen JV; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
  • Blank CU; From the Division of Medical Oncology (M.W.R., M.H.G.F., M.K., J.S.W.B., J.V.T., C.U.B., A.M.-E., S.K., S.W., J.B.A.G.H.), the BioTherapeutics Unit, Hospital Pharmacy (J.H. van den Berg, C.N., M.Z., S.S.), the Divisions of Pharmacy and Pharmacology (B.N., J.H. Beijnen), Molecular Oncology and Immuno
N Engl J Med ; 387(23): 2113-2125, 2022 12 08.
Article em En | MEDLINE | ID: mdl-36477031
ABSTRACT

BACKGROUND:

Immune checkpoint inhibitors and targeted therapies have dramatically improved outcomes in patients with advanced melanoma, but approximately half these patients will not have a durable benefit. Phase 1-2 trials of adoptive cell therapy with tumor-infiltrating lymphocytes (TILs) have shown promising responses, but data from phase 3 trials are lacking to determine the role of TILs in treating advanced melanoma.

METHODS:

In this phase 3, multicenter, open-label trial, we randomly assigned patients with unresectable stage IIIC or IV melanoma in a 11 ratio to receive TIL or anti-cytotoxic T-lymphocyte antigen 4 therapy (ipilimumab at 3 mg per kilogram of body weight). Infusion of at least 5×109 TILs was preceded by nonmyeloablative, lymphodepleting chemotherapy (cyclophosphamide plus fludarabine) and followed by high-dose interleukin-2. The primary end point was progression-free survival.

RESULTS:

A total of 168 patients (86% with disease refractory to anti-programmed death 1 treatment) were assigned to receive TILs (84 patients) or ipilimumab (84 patients). In the intention-to-treat population, median progression-free survival was 7.2 months (95% confidence interval [CI], 4.2 to 13.1) in the TIL group and 3.1 months (95% CI, 3.0 to 4.3) in the ipilimumab group (hazard ratio for progression or death, 0.50; 95% CI, 0.35 to 0.72; P<0.001); 49% (95% CI, 38 to 60) and 21% (95% CI, 13 to 32) of the patients, respectively, had an objective response. Median overall survival was 25.8 months (95% CI, 18.2 to not reached) in the TIL group and 18.9 months (95% CI, 13.8 to 32.6) in the ipilimumab group. Treatment-related adverse events of grade 3 or higher occurred in all patients who received TILs and in 57% of those who received ipilimumab; in the TIL group, these events were mainly chemotherapy-related myelosuppression.

CONCLUSIONS:

In patients with advanced melanoma, progression-free survival was significantly longer among those who received TIL therapy than among those who received ipilimumab. (Funded by the Dutch Cancer Society and others; ClinicalTrials.gov number, NCT02278887.).
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Imunoterapia Adotiva / Linfócitos do Interstício Tumoral / Melanoma Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Revista: N Engl J Med Ano de publicação: 2022 Tipo de documento: Article
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Imunoterapia Adotiva / Linfócitos do Interstício Tumoral / Melanoma Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Revista: N Engl J Med Ano de publicação: 2022 Tipo de documento: Article