Randomized phase II clinical trial of chemo-immunotherapy in advanced nonsmall cell lung cancer

Eduardo Lasalvia-Prisco1,4, Emilio Garcia-Giralt2, Jes&uacute;s V&aacute;zquez2,4, Marta Aghazarian4, Eduardo Lasalvia-Galante3,4, Joshemaria Larra&ntilde;aga3,4, Gonzalo Spera31Interdoctors Medical Procedures, North Miami Beach, FL, USA; 2Centre De Canc&eacute;rologi...

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Autores principales:	Eduardo Lasalvia-Prisco, Emilio Garcia-Giralt, Jes&uacute;s V&aacute;zquez, Marta Aghazarian, Eduardo Lasalvia-Galante, et al
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2008
Materias:	Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/eca5ef6a247b466e8d53d912c069ba11
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spelling	oai:doaj.org-article:eca5ef6a247b466e8d53d912c069ba112021-12-02T07:42:52ZRandomized phase II clinical trial of chemo-immunotherapy in advanced nonsmall cell lung cancer1177-54751177-5491https://doaj.org/article/eca5ef6a247b466e8d53d912c069ba112008-09-01T00:00:00Zhttp://www.dovepress.com/randomized-phase-ii-clinical-trial-of-chemo-immunotherapy-in-advanced--a2304https://doaj.org/toc/1177-5475https://doaj.org/toc/1177-5491Eduardo Lasalvia-Prisco1,4, Emilio Garcia-Giralt2, Jes&uacute;s V&aacute;zquez2,4, Marta Aghazarian4, Eduardo Lasalvia-Galante3,4, Joshemaria Larra&ntilde;aga3,4, Gonzalo Spera31Interdoctors Medical Procedures, North Miami Beach, FL, USA; 2Centre De Canc&eacute;rologie Hartmann, Neuilly Sur Seine, France; 3Interdoctors Medical Procedures, Montevideo, Uruguay; 4National Institute of Oncology, Montevideo, Uruguay (initial data)Abstract: The purpose of this study was to compare chemotherapy-naive patients with stage IV nonsmall cell lung cancer patients treated with chemotherapy or chemoimmunotherapy. We tested doxetacel plus cisplatinum as chemotherapy protocol. An immunomodulatory adjuvant system was added as chemoimmunotherapy to the previously mentioned protocol. This system contains three well-known and complementary conditioners of protective immune-responses: cyclophosphamide low-dose, granulocyte macrophage-colony stimulant factor and magnesium silicate granuloma. Eighty-eight patients were randomly assigned to receive every 3-weeks one of the treatments under comparison. Patients received four cycles of treatment unless disease progression or unacceptable toxicity was documented. The maximum follow-up was one year. In each arm, tumor response (rate, duration), median survival time, 1-year overall survival, safety, and immunity modifications were assessed. Immunity was evaluated by submitting peripheral blood mononuclear cells to laboratory tests for nonspecific immunity: a) phytohemaglutinin-induced lymphocyte proliferation, b) prevalence of T-Regulatory (CD4+CD25+) cells and for specific immunity: a) lymphocyte proliferation induced by tumor-associated antigens (TAA) contained in a previously described autologous thermostable hemoderivative. The difference (chemotherapy vs. chemoimmunotherapy) in response rate induced by the two treatments (39.0% and 35.0%) was not statistically significant. However, the response duration (22 and 31 weeks), the median survival time (32 and 44 weeks) and 1-year survival (33.3% and 39.1%) were statistically higher with chemoimmunotherapy. No difference in toxicity between both arms was demonstrated. A switch in the laboratory immunity profile, nonspecific and specific, was associated with the chemoimmunotherapy treatment: increase of proliferative lymphocyte response, decrease of tolerogenic T-regulatory cells and eliciting TAA-sensitization.Keywords: lung cancer chemotherapy, lung cancer chemoimmunotherapy, cancer vaccine, immunomodulatory cancer treatment, immunotherapy adjuvants, cancer therapy Eduardo Lasalvia-PriscoEmilio Garcia-GiraltJes&uacute;s V&aacute;zquezMarta AghazarianEduardo Lasalvia-Galanteet alDove Medical PressarticleMedicine (General)R5-920ENBiologics: Targets & Therapy, Vol 2008, Iss Issue 3, Pp 555-561 (2008)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine (General) R5-920
spellingShingle	Medicine (General) R5-920 Eduardo Lasalvia-Prisco Emilio Garcia-Giralt Jes&uacute;s V&aacute;zquez Marta Aghazarian Eduardo Lasalvia-Galante et al Randomized phase II clinical trial of chemo-immunotherapy in advanced nonsmall cell lung cancer
description	Eduardo Lasalvia-Prisco1,4, Emilio Garcia-Giralt2, Jes&uacute;s V&aacute;zquez2,4, Marta Aghazarian4, Eduardo Lasalvia-Galante3,4, Joshemaria Larra&ntilde;aga3,4, Gonzalo Spera31Interdoctors Medical Procedures, North Miami Beach, FL, USA; 2Centre De Canc&eacute;rologie Hartmann, Neuilly Sur Seine, France; 3Interdoctors Medical Procedures, Montevideo, Uruguay; 4National Institute of Oncology, Montevideo, Uruguay (initial data)Abstract: The purpose of this study was to compare chemotherapy-naive patients with stage IV nonsmall cell lung cancer patients treated with chemotherapy or chemoimmunotherapy. We tested doxetacel plus cisplatinum as chemotherapy protocol. An immunomodulatory adjuvant system was added as chemoimmunotherapy to the previously mentioned protocol. This system contains three well-known and complementary conditioners of protective immune-responses: cyclophosphamide low-dose, granulocyte macrophage-colony stimulant factor and magnesium silicate granuloma. Eighty-eight patients were randomly assigned to receive every 3-weeks one of the treatments under comparison. Patients received four cycles of treatment unless disease progression or unacceptable toxicity was documented. The maximum follow-up was one year. In each arm, tumor response (rate, duration), median survival time, 1-year overall survival, safety, and immunity modifications were assessed. Immunity was evaluated by submitting peripheral blood mononuclear cells to laboratory tests for nonspecific immunity: a) phytohemaglutinin-induced lymphocyte proliferation, b) prevalence of T-Regulatory (CD4+CD25+) cells and for specific immunity: a) lymphocyte proliferation induced by tumor-associated antigens (TAA) contained in a previously described autologous thermostable hemoderivative. The difference (chemotherapy vs. chemoimmunotherapy) in response rate induced by the two treatments (39.0% and 35.0%) was not statistically significant. However, the response duration (22 and 31 weeks), the median survival time (32 and 44 weeks) and 1-year survival (33.3% and 39.1%) were statistically higher with chemoimmunotherapy. No difference in toxicity between both arms was demonstrated. A switch in the laboratory immunity profile, nonspecific and specific, was associated with the chemoimmunotherapy treatment: increase of proliferative lymphocyte response, decrease of tolerogenic T-regulatory cells and eliciting TAA-sensitization.Keywords: lung cancer chemotherapy, lung cancer chemoimmunotherapy, cancer vaccine, immunomodulatory cancer treatment, immunotherapy adjuvants, cancer therapy
format	article
author	Eduardo Lasalvia-Prisco Emilio Garcia-Giralt Jes&uacute;s V&aacute;zquez Marta Aghazarian Eduardo Lasalvia-Galante et al
author_facet	Eduardo Lasalvia-Prisco Emilio Garcia-Giralt Jes&uacute;s V&aacute;zquez Marta Aghazarian Eduardo Lasalvia-Galante et al
author_sort	Eduardo Lasalvia-Prisco
title	Randomized phase II clinical trial of chemo-immunotherapy in advanced nonsmall cell lung cancer
title_short	Randomized phase II clinical trial of chemo-immunotherapy in advanced nonsmall cell lung cancer
title_full	Randomized phase II clinical trial of chemo-immunotherapy in advanced nonsmall cell lung cancer
title_fullStr	Randomized phase II clinical trial of chemo-immunotherapy in advanced nonsmall cell lung cancer
title_full_unstemmed	Randomized phase II clinical trial of chemo-immunotherapy in advanced nonsmall cell lung cancer
title_sort	randomized phase ii clinical trial of chemo-immunotherapy in advanced nonsmall cell lung cancer
publisher	Dove Medical Press
publishDate	2008
url	https://doaj.org/article/eca5ef6a247b466e8d53d912c069ba11
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Randomized phase II clinical trial of chemo-immunotherapy in advanced nonsmall cell lung cancer

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