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Title: | Allogeneic cells vaccine increases disease-free survival in stage III melanoma patients. A non randomized phase II study | Authors: | Mordoh, Jose Kairiyama, Claudia Bover, Laura Solarolo, Elsa |
Keywords: | Melanoma;Vacunas contra el Cáncer;Ganglios Linfáticos;Células Alogénicas;Argentina | Issue Date: | 1997 | Project: | datasets | Journal: | Medicina (Buenos Aires) | Abstract: | The incidence of melanoma is increasing rapidly, and in many cases the primary tumor is excised after metastatic spreading. In 80% of the cases, the first metastatic site is in regional lymph nodes (AJCC Stage III). After excision of these nodes, the patient is clinically disease-free, but the chances of recurrency vary between 40-80%. Thirty patients with stage III melanoma were treated in a non-randomized Phase II adjuvant trial with a vaccine consisting of a mixture of three allogeneic cell lines: IIB-MEL-J, IIB-MEL-LES and IIB-MEL-IAN (5 x 10(6) cells each). The cells were irradiated (5,000 cGy) and BCG was used as nonspecific stimulant. Before each vaccination (72 hr) the patients received cyclophosphamide (300 mg/sqm). The untreated control group was composed of 24 Stage III melanoma patients. Vaccination started within 60 days after surgery, and patients received 4 vaccinations, one every 21 days and then 1 every two months during the 1st year; 1 every three months during the 2nd year, and 1 every 6 months during the 3rd, 4th and 5th years. The treated group was composed by 19 men (63.3%) and 11 women (36.7%); average age: 47.6 +/- 14.1 years (range: 16-70 yr). The control group was composed by 18 men (75%) and 6 women (25%); average age 49.8 +/- 14.2 yr (range: 26-73 yr). The median disease free survival (DFS) calculated according to Kaplan-Meier was 7.0 months in the control group vs 20.0 months in the treated group (p < 0.001). The results of this clinical trial suggest that treatment with allogeneic cell vaccines increases DFS in stage III melanoma patients. |
Description: | Fil: Solarolo, Elsa. ANLIS Dr.C.G.Malbrán. Instituto Nacional de Microbiología; Argentina. Fil: Mordoh, Jose. Instituto de Investigaciones Bioquímicas. Fundación Campomar; Argentina Fil: Kairiyama, Claudia. Instituto de Investigaciones Bioquímicas. Fundación Campomar; Argentina Fil: Bover, Laura. Instituto de Investigaciones Bioquímicas. Fundación Campomar; Argentina |
URI: | http://sgc.anlis.gob.ar/handle/123456789/35 http://books.google.com.ar/books?id=9WnXip7NmMQC&pg=PA421&lpg=PA421&dq=Allogeneic+cells+vaccine+increases+disease-free+survival+in+stage+III+melanoma+patients:+a+non+randomized+phase+II+study&source=bl&ots=j_vwN9CtFg&sig=xNiKSFhLqtAaxKRJUIzM4U02q4g&hl=es#v=onepage&q=Allogeneic%20cells%20vaccine%20increases%20disease-free%20survival%20in%20stage%20III%20melanoma%20patients%3A%20a%20non%20randomized%20phase%20II%20study&f=false |
ISSN: | 0025-7680 | Rights: | info:eu-repo/semantics/openAccess Open Access |
Appears in Collections: | snrd Publicaciones INPB |
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File | Description | Size | Format | |
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Medicina (Buenos Aires) vol57,n4,1997 421-27.pdf | 2.89 MB | Adobe PDF | View/Open |
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