BiovaxID, een vaccin, geeft significant langere ziektevrije tijd bij lymfklierkanker (non-Hodgkin) blijkt uit fase III studie.

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11 januari 2012:
Interessant is aanvullend op onderstaande informatie te vermelden een overzichts artikel van de aanpak met radiotherapie - bestraling in combinatie met vormen van chemo en immuuntherapeutische middelen waaronder ook Zevalin en Bexxar en Yttrium-90: Radioimmunotherapy of Non-Hodgkin’s Lymphoma: From the ‘Magic Bullets’ to ‘Radioactive Magic Bullets’
In het abstract staat dit, maar klikt u op deze link voor het volledige studierapport.

Onderaan staat informatie over immuuntherapie met BiovaxID®. Als u hier klikt kunt u lezen en zien hoe u als patiënt BiovaxID® wellicht kunt verkrijgen:

Source: Radioimmunotherapy (RIT) of lymphoma with Zevalin and Bexxar was approved by FDA in 2002 and 2003, respectively, for the treatment of relapsed or refractory CD20+ follicular B-cell non-Hodgkin´s lymphoma. In 2009, Zevalin was also approved for consolidation therapy in patients with follicular non-Hodgkin’s lymphoma that achieve a partial or complete response to first-line chemotherapy. For follicular lymphoma patients, the overall response and progression-free survival rates have significantly improved since the implementation of RIT. The predominant complication of RIT is hematological toxicity that is usually manageable. There are ongoing trials to further define the expanding role of RIT as first line or concomitant therapy in the treatment of lymphoma as well as for certain antibiotic resistant infections and aggressive malignancies. There is also growing interest in the development of newer protocols for increased and more uniform dose delivery resulting in better outcomes and improved patient survival. This review will primarily focus on the role of RIT in treatment of non-Hodgkin’s lymphoma, which is of established clinical utility and FDA approved. The mechanism of RIT, available radionuclides and pharmacokinetics, therapy administration, clinical utility and toxicities, and future directions would be discussed.

17 januari 2010: bron: Abramson Cancer Center of the University of Pennsylvania

Een vaccin genaamd BiovaxID dat wordt gemaakt van het tumorweefsel van de patient zelf geeft significant langere ziektevrije tijd bij lymfklierkanker - non-Hodgkin van het type Folliculair lymfoom (FL) bij patienten die met chemo al 6 maanden ziektevrije tijd hadden bereikt.

117 deelnemers kregen het vaccin samen met een immuunstimulator GM-csf (76 deelnemers) of placebo (41 deelnemers). Ze hadden allemaal stadium II tot IV en hadden ten minste 6 maanden remissie bereikt met hulp van chemotherapie (PACE regiem). De studie loopt nog steeds maar in een tussenevaluatie zijn deze resultaten er uitgekomen. De mediane follow-up tijd bij deze tussenevaluatie was 56,6 maanden. De mediane tijd tot een recidief was 44,2 maanden voor de vaccingroep tegenover 30,6 maanden voor de placebgroep. Dit is statistisch significant (p = 0,045). De totale overleving is nog niet bereikt met meer dan 95% van de vaccingroep en 91% van de placebogroep leven nog steeds op moment van deze tussenevaluatie. Geen ernstige bijwerkingen werden toegeschreven aan het vaccin en de bijwerkingen waren vergelijkbaar in beide groepen. aanvankelijk hadden 234 deelnemers ingeschreven maar 25% viel daarvan af omdat zij niet de 6 maanden ziektevrije tijd bereikten. De onderzoekers pleiten nu voor studies met Rituxan en zonder chemo of vooraf aan chemo. Toch wel een mooi resultaat bij een immuuntherapie die veel lijkt op dendritische celtherapie als er vers tumorweefsel voorhanden is.

Origineel abstract:

Title: Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first complete remission: Phase III clinical trial results
Presenter: S. J. Schuster, MD
Affiliation: University of Pennsylvania

Non-Hodgkin's Lymphoma (NHL) is the 6th most common type of cancer in the US. There will be approximately 65,980 news cases diagnosed in the US in 2009.

Follicular Lymphoma (FL) is the 2nd most common type of NHL and accounts for 25% of all NHL. It is a B-cell derived neoplasm, which expresses a specific idiotype marker on the surface of tumor cells. Despite effective chemotherapy regimens, this type of lymphoma typically recurs and becomes resistant to therapy. This study evaluated the use of a vaccine created from the patient's tumor cells.

Participants had been in remission for at least 6 months after standard chemotherapy (though not Rituxan, as this was not yet standard when the study started). A “personalized” vaccine was made for each patient using tissue from lymph node biopsies. Unique markers were identified for each person's lymphoma and, from this, a vaccine that targets this marker was created. The vaccine was then given in conjunction with an immune stimulating agent called GM-CSF, which helps to stimulate an immune response. Normal cells are spared any damage because they do not have the target marker.

One-hundred and seventeen participants received either vaccine (76 patients) or placebo (41 pts). They had stage IIx-IV FL and had achieved at least a 6 month remission after chemotherapy (regimen used was PACE). Participants are still being monitored, but as is common in trials, an interim analysis was done. The median follow up time at this analysis was 56.6 months. The median time to relapse was 44.2 months (vaccine) versus 30.6 (placebo), which was statistically significant (p=0.045). The overall survival has not yet been reached with over 95% of the vaccine and 91% of the placebo arms alive at this follow up. No serious side effects were attributed to the vaccine and the side effects were similar in both groups.

Although similar types of vaccines have been tested previously, this is the first trial to show a statistically significant improvement in progression-free survival in follicular lymphoma patients treated with the vaccine. Previous trials included patients who had partial or complete responses, whereas this trial only vaccinated patients who had no detectable tumor remaining after chemotherapy. Under these conditions, the investigators hypothesized that the vaccine could hold minimal residual disease in check. It is also important to point out that the trial had originally enrolled 234 participants, but 25% did not achieve the 6 month remission. Those patients require further therapy options.

The study is exciting for the field of vaccines, but some new questions arise, including: how does the now standard Rituxan fit into this regimen and is there a better time point to give a vaccine (pre-chemo, in conjunction with chemo).

immuuntherapie, lymfklierkanker, zevalin, vaccin, BiovaxID