19 april 2008: Bron: 1: Cancer Immunol Immunother. 2008 Apr 8 [Epub ahead of print]Click here to read Links

Een vaccin met Her2-Neu peptides zorgt voor significant minder recidieven van borstkanker. En een verschil in overlijden van 12,5% tot 41,78 % in de niet vaccinatiegroep. Deze cijfers werden vastgesteld in een kleinschalige maar wel gerandomiseerde studie en gepresenteerd op ASCO 2008.

RESULTATEN: De recidieven in de controlegroep 14.8 % en 8.3% in de vaccinatie groep (P = 0.17). Vergeleken met de  8 gevaccineerde recidieven (V-R) met de 88 gevaccineerde niet-recidieven (V-NR), had de V-R groep een hoger lymfklierstadium (>/=N2: 75 vs. 5%, P = 0.0001) en een hoger stadiumgraad van tumoren (%grade 3: 88 vs. 31%, P = 0.003). .... Vergeleken met de patienten met een recidief uit de controlegroep (C-R), V-R patienten neigden naar  hogere-graad tumoren en hormoon-receptor negatief. C-R patienten hadden 50% alleen bot recidieven, vergeleken met V-R patienten met geen alleen bot recidieven. (P = 0.05). Tenslotte, V-R overlijdingscijfer was 12.5% vergeleken met 41.7% voor de C-R group (P = 0.3).

 Hier de meest recente studie daaronder een eerder uitgevoerde studie met vergelijkbare resultaten.
 
Assessment of immunologic response and recurrence patterns among patients with clinical recurrence after vaccination with a preventive HER2/neu peptide vaccine: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02.

Department of Surgery, General Surgery Service, Walter Reed Army Medical Center, Washington, DC, USA.

BACKGROUND: E75, a HER2/neu immunogenic peptide, is expressed in breast cancer (BCa). We have performed clinical trials of E75 + GM-CSF vaccine in disease-free, node-positive and node-negative BCa patients at high recurrence risk and recurrences were noted in both control and vaccine groups.

METHODS: Among the 186 BCa patients enrolled, 177 completed the study. Patients were HLA typed; the HLA-A2(+)/A3(+) patients were vaccinated; HLA-A2(-)/A3(-) patients were followed as controls. Standard clinicopathological factors, immunologic response to the vaccine, and recurrences were collected and assessed.

RESULTS: The control group recurrence rate was 14.8 and 8.3% in the vaccinated group (P = 0.17). Comparing the 8 vaccinated recurrences (V-R) to the 88 vaccinated nonrecurrent patients (V-NR), the V-R group had higher nodal stage (>/=N2: 75 vs. 5%, P = 0.0001) and higher grade tumors (%grade 3: 88 vs. 31%, P = 0.003). The V-R group did not fail to respond immunologically as noted by equivalent dimer responses and post-DTH responses. Compared to control recurrent patients (C-R), V-R patients trended toward higher-grade tumors and hormone-receptor negativity. C-R patients had 50% bone-only recurrences, compared to V-R patients with no bone-only recurrences (P = 0.05). Lastly, V-R mortality rate was 12.5% compared with 41.7% for the C-R group (P = 0.3).

CONCLUSIONS: The vaccinated patients who recurred had more aggressive disease compared to V-NR patients. V-R patients had no difference in immune response to the vaccine either in vitro or in vivo. V-R patients, when compared to C-R patients, trended towards more aggressive disease, decreased recurrence rates, decreased mortality, and no bone-only recurrences.

PMID: 18392824 [PubMed - as supplied by publisher]

 

1: Clin Cancer Res. 2008 Feb 1;14(3):797-803.Click here to read Links

 

Combined clinical trial results of a HER2/neu (E75) vaccine for the prevention of recurrence in high-risk breast cancer patients: U.S. Military Cancer Institute Clinical Trials Group Study I-01 and I-02.

Department of Surgery, General Surgery Service, Brooke Army Medical Center, Fort Sam Houston, San Antonio, Texas 78234, USA. george.peoples@amedd.army.mil

PURPOSE: E75 is an immunogenic peptide from the HER2/neu protein, which is overexpressed in many breast cancer patients. We have conducted two overlapping E75 vaccine trials to prevent recurrence in node-positive (NP) and node-negative (NN) breast cancer patients.

EXPERIMENTAL DESIGN: E75 (HER2/neu 369-377) + granulocyte macrophage colony-stimulating factor was given intradermally to previously treated, disease-free NP breast cancer patients in a dose escalation safety trial and to NN breast cancer patients in a dose optimization study. Local and systemic toxicity was monitored. Immunologic responses were assessed using in vitro assays and in vivo delayed-type hypersensitivity responses. Clinical recurrences were documented.

RESULTS: One hundred and eighty-six patients were enrolled in the two studies (NP, 95; NN, 91). Human leucocyte antigen A2 (HLA-A2) and HLA-A3 patients were vaccinated (n = 101), whereas all others (n = 85) were followed prospectively as controls. Toxicities were minimal, and a dose-dependent immunologic response to the vaccine was shown. Planned primary analysis revealed a recurrence rate of 5.6% in vaccinated patients compared with 14.2% in the controls (P = 0.04) at a median of 20 months follow-up. As vaccine-specific immunity waned over time, the difference in recurrence lost significance at 26 months median follow-up (8.3% versus 14.8%); however, a significant difference in the pattern of recurrence persisted.

CONCLUSIONS: E75 is safe and effective in raising a dose-dependent HER2/neu immunity in HLA-A2 and HLA-A3 NP and NN breast cancer patients. More importantly, E75 may reduce recurrences in disease-free, conventionally treated, high-risk breast cancer patients. These findings warrant a prospective, randomized phase III trial of the E75 vaccine with periodic booster to prevent breast cancer recurrences.

PMID: 18245541 [PubMed - in process]

 

 


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