15 juni 2012: voor laatste stand van zaken betreffende immuuntherapie bij longkanker zie deze twee studies: Immuuntherapie bij gevorderde niet-klein-cellige longkanker lijkt een goede aanpak te kunnen worden in de nabije toekomst  en deze: Immuuntherapie bij longkanker: overzicht van stand van zaken aan de hand van studieresultaten van laatste 10 jaar

16 december 2011: ik kreeg een vraag over onderstaande immuuntherapie met Bec2 en BCG, maar het is duidelijk dat deze aanpak weinig kan betekenen voor longkankerpatiënten. Een citaat over deze studie in een review studie naar gerichte aanpak van longkanker uit 2010:

BEC2 (mitumomab, ImClone Systems) is an anti-idiotypic murine IgG2b monoclonal antibody that is known to mimic GD3, a ganglioside found on the cell surface of most SCLC cells. BEC2 monoclonal antibody is used in conjunction with bacille Calmette-Guerin (bCG) vaccine to mount an endogenous immune response to GD3. A large EORTC phase III trial was undertaken to evaluate the use of BEC-2/bCG adjuvant vaccination as a maintenance therapy versus none in patients with LD SCLC who have responded to chemotherapy. The vaccine was well tolerated, but there was no improvement in the PFS or OS in the study arm compared to the control arm. (16.4 months versus 14.3 months, p = 0.28) [Giaccone et al. 2005]. Oftewel: het vaccin werd goed verdragen maar in vergelijking met de controlegroep was er weinig tot geen verbetering van ziektevrije tijd noch van overall overleving.

17 maart 2009:  1: J Clin Oncol. 2005 Oct 1;23(28):6854-64.Click here to read

Vaccinatie met Bec2/bacille Calmette-Guerin bij patienten met niet-klein-cellige longkanker stadium I en II (met beperkte ziekte) geeft geen verschil in ziektevrije tijd of overall overleving in vergelijking met conventionele aanpak van longkanker. De mediane overlevingstijd was in de vaccinatiegreoep zefls nog 2 maanden korter dan in de controlegroep. 14,3 t.o.v. 16,4 maanden Aldus de resultaten uit een fase III studie waaraan ook is meegewerkt door Nederlandse ziekenhuizen onder leiding van dr. Giaccone uit de VU. Toch een zeer gerespecteerd oncoloog in Nederland. Dit is dus een fase III studie met grote aantallen patienten (meer dan 500) die faalt in effectiviteit. Ik ben toch wel benieuwd op welke basis, op welke gegevens uit eerdere fase II studies zo'n dure fase III studie dan wordt opgezet. Vorige maand werd ook al een fase III studie bij darmkanker met Avastin en Erbitux onderbroken omdat de resultaten dramatisch slechter waren in vergelijking met standaard aanpak in controlegroep. Dit lijkt mij weggegooid geld. Hier twee abstracten van dezelfde studie met vaccin bij longkanker uit Pubmed gehaald en gepubliceerd in Clinical Oncology.

 

Phase III study of adjuvant vaccination with Bec2/bacille Calmette-Guerin in responding patients with limited-disease small-cell lung cancer (European Organisation for Research and Treatment of Cancer 08971-08971B; Silva Study).

Division of Medical Oncology, Vrije Universiteit Medical Center, 1117 De Boelelaan, Amsterdam, the Netherlands. g.giaccone@vumc.nl

PURPOSE: Bec2 is an anti-idiotypic antibody that mimics GD3, a ganglioside that is expressed on the surface of tumor cells and is of neuroectodermal origin. We assessed whether Bec2/bacille Calmette-Guerin (BCG) vaccination prolongs survival in patients with limited-disease small-cell lung cancer (SCLC) after a major response to chemotherapy and chest radiation. PATIENTS AND METHODS: Patients were randomly assigned to receive five vaccinations of Bec2 (2.5 mg)/BCG vaccine or follow-up. Vaccination was given over a 10-week period. The sample size was targeted to detect an increase in median survival of 40% after random assignment, and stratification was by performance status, response, and institution. Quality of life was assessed by using the European Organisation for Research and Treatment of Cancer instrument. Humoral response was assessed in patients who received vaccination. RESULTS: A total of 515 patients were randomly assigned. The primary toxicities of vaccination were transient skin ulcerations and mild flu-like symptoms. There was no improvement in survival, progression-free survival, or quality of life in the vaccination arm. Median survival from randomization was 16.4 and 14.3 months in the observation and vaccination arms (P = .28), respectively. Among vaccinated patients, a trend toward prolonged survival was observed in those (one third) who developed a humoral response (P = .085). Multivariate analysis showed a positive impact on survival by prior treatment with concomitant chemoradiotherapy, prophylactic cranial irradiation, female sex, low lactate dehydrogenase, and normal platelets. CONCLUSION: Vaccination with Bec2/BCG has no impact on outcome of patients with limited-disease SCLC responding to combined-modality treatment. Vaccination strategies in SCLC may still be warranted using vaccines that produce a better immunologic response.

PMID: 16192577 [PubMed - indexed for MEDLINE]

 

1: Eur J Cancer. 2008 Oct;44(15):2178-84.Click here to read Links

 

 

Symptom and quality of life results of an international randomised phase III study of adjuvant vaccination with Bec2/BCG in responding patients with limited disease small-cell lung cancer.

Quality of Life Department, European Organisation for Research and Treatment of Cancer, EORTC Headquarters,AISBL-IVZW, Avenue E. Mounierlaan, 83/11, Brussel 1200, Bruxelles, Belgium. andrew.bottomley@eortc.be

AIMS: This study reports the symptom and HRQOL results in which standard treatment was compared to standard therapy plus Bec2, an anti-idiotypic antibody that mimics GD3, a ganglioside antigen. METHODS: Five hundred and fifteen LD SCLC patients were randomised to receive five vaccinations of Bec2 (2.5mg)/BCG vaccine arm (VA) or an observational arm (OA) administered over a 10-week period. Survival was the primary end-point; HRQOL was a secondary end-point, assessed using the EORTC QLQ-C30/LC 13. RESULTS: There was no improvement in survival or progression-free survival in the vaccination arm. At baseline patients in both arms demonstrated significantly impaired scores on the global QOL scale, when compared to a normative population. However, HRQOL and symptom scores between the two treatment arms were not statistically different at any time point. CONCLUSION: We found no benefits to patient HRQOL by additional vaccination with Bec2/BCG to LD SCLC for patients who have been undergoing standard therapy.

PMID: 18676140 [PubMed - indexed for MEDLINE]

 

 


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