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Randomized, Prospective Evaluation Comparing Intensity of Lymphodepletion Before Adoptive Transfer of Tumor-Infiltrating Lymphocytes for Patients With Metastatic Melanoma

Goff, Stephanie L ; Dudley, Mark E ; Citrin, Deborah E ; Somerville, Robert P ; Wunderlich, John R ; Danforth, David N ; Zlott, Daniel A ; Yang, James C ; Sherry, Richard M ; Kammula, Udai S ; Klebanoff, Christopher A ; Hughes, Marybeth S ; Restifo, Nicholas P ; Langhan, Michelle M ; Shelton, Thomas E ; Lu, Lily ; Kwong, Mei Li M ; Ilyas, Sadia ; Klemen, Nicholas D ; Payabyab, Eden C ; Morton, Kathleen E ; Toomey, Mary Ann ; Steinberg, Seth M ; White, Donald E ; Rosenberg, Steven A

Journal of clinical oncology, 2016-07, Vol.34 (20), p.2389-2397 [Periódico revisado por pares]

United States: American Society of Clinical Oncology

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Título:
Randomized, Prospective Evaluation Comparing Intensity of Lymphodepletion Before Adoptive Transfer of Tumor-Infiltrating Lymphocytes for Patients With Metastatic Melanoma
Autor: Goff, Stephanie L ; Dudley, Mark E ; Citrin, Deborah E ; Somerville, Robert P ; Wunderlich, John R ; Danforth, David N ; Zlott, Daniel A ; Yang, James C ; Sherry, Richard M ; Kammula, Udai S ; Klebanoff, Christopher A ; Hughes, Marybeth S ; Restifo, Nicholas P ; Langhan, Michelle M ; Shelton, Thomas E ; Lu, Lily ; Kwong, Mei Li M ; Ilyas, Sadia ; Klemen, Nicholas D ; Payabyab, Eden C ; Morton, Kathleen E ; Toomey, Mary Ann ; Steinberg, Seth M ; White, Donald E ; Rosenberg, Steven A
Assuntos: Adolescent ; Adult ; Aged ; Female ; Humans ; Immunotherapy, Adoptive ; Lymphocyte Depletion ; Lymphocytes, Tumor-Infiltrating - immunology ; Male ; Melanoma - immunology ; Melanoma - mortality ; Melanoma - therapy ; Middle Aged ; Neoplasm Metastasis ; Original Reports ; Prospective Studies ; Whole-Body Irradiation
É parte de: Journal of clinical oncology, 2016-07, Vol.34 (20), p.2389-2397
Notas: ObjectType-Article-2
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ObjectType-News-1
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Descrição: Adoptive cell transfer, the infusion of large numbers of activated autologous lymphocytes, can mediate objective tumor regression in a majority of patients with metastatic melanoma (52 of 93; 56%). Addition and intensification of total body irradiation (TBI) to the preparative lymphodepleting chemotherapy regimen in sequential trials improved objective partial and complete response (CR) rates. Here, we evaluated the importance of adding TBI to the adoptive transfer of tumor-infiltrating lymphocytes (TIL) in a randomized fashion. A total of 101 patients with metastatic melanoma, including 76 patients with M1c disease, were randomly assigned to receive nonmyeloablative chemotherapy with or without 1,200 cGy TBI before transfer of tumor-infiltrating lymphcytes. Primary end points were CR rate (as defined by Response Evaluation Criteria in Solid Tumors v1.0) and overall survival (OS). Clinical and laboratory data were analyzed for correlates of response. CR rates were 24% in both groups (12 of 50 v 12 of 51), and OS was also similar (median OS, 38.2 v 36.6 months; hazard ratio, 1.11; 95% CI, 0.65 to 1.91; P = .71). Thrombotic microangiopathy was an adverse event unique to the TBI arm and occurred in 13 of 48 treated patients. With a median potential follow-up of 40.9 months, only one of 24 patients who achieved a CR recurred. Adoptive cell transfer can mediate durable complete regressions in 24% of patients with metastatic melanoma, with median survival > 3 years. Results were similar using chemotherapy preparative regimens with or without addition of TBI.
Editor: United States: American Society of Clinical Oncology
Idioma: Inglês

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Randomized, Prospective Evaluation Comparing Intensity of Lymphodepletion Before Adoptive Transfer of Tumor-Infiltrating Lymphocytes for Patients With Metastatic Melanoma

United States: American Society of Clinical Oncology

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