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15 juni 2012: Bron: PLoS One. 2012; 7(3): e32695. Published online 2012 March 5. doi:  10.1371/journal.pone.0032695

Immuuntherapie bij gevorderde niet-klein-cellige longkanker lijkt een goede aanpak te kunnen zijn en worden. Dit blijkt uit een meta analyse van 12 gerandomiseerde fase II en III studies uitgevoerd door Chinese onderzoekers. We hebben het abstract zo goed als mogelijk letterlijk vertaald in het Nederlands met hulp van google translation. Onderaan staat een deeplink naar het volledige studierapport en een referentielijst.

Abstract:

Achtergrond:
Longkanker is wereldwijd een van de belangrijkste oorzaken van overlijden door kanker. Niet-kleincellige longkanker (NSCLC) is ongeveer 85% van alle voorkomende vormen van longkanker. Immuuntherapie heeft tot op vandaag geen consistent voordeel opgeleverd voor deze patiënten. Het beoordelen van de objectieve werkzaamheid en veiligheid van immuuntherapie voor gevorderde niet-kleincellige longkanker patiënten zal helpen om de toekomstige ontwikkeling van immuuntherapeutische medicijnen te verbeteren.

Methoden en voornaamste resultaten:
We deden een meta-analyse van 12 gerandomiseerde gecontroleerde studies met 3134 patiënten (1570 patiënten in de immuuntherapeutische groep en 1564 patiënten in de controlegroep) met een histologisch bevestigde fase IIIA, IIIB of IV niet-kleincellig longcarcinoom. De analyse werd uitgevoerd met de einddoelen met betrekking tot de totale overleving (OS), progressie-vrije overleving (PFS), complete respons (CR), partiële respons (PR), en de totale effectiviteit

Resultaten:
de totale overleving (OS), progressie-vrije overleving (PFS) en de totale effectiviteit  bleken significant verbeterd bij de patiënten met vergevorderd NSCLC in de immuuntherapeutische groep (P = 0,0007, 0,0004, 0,002, 0,003, respectievelijk), terwijl de complete respons (CR) niet beter was (P = 0,97). Een subgroep analyse toonde aan dat de monoklonale antistof (mAb) bij patiënten met gevorderde niet-klein-cellige longkanker uit de immuuntherapeutische groep significant de progressie vrije overleving (PFS), de partiële respons (PR) en de totale effectiviteit verbeterde en laat een trend zien naar het verbeteren van de totale overleving (OS) in vergelijking met de controlegroep. Wel was er een dominant verschil in negatieve bijwerkingen. Vergeleken met de controlegroep en de vaccin subgroep werd geen significant verschil met betrekking tot ernstige bijwerkingen gevonden, terwijl de cytokine immuuntherapie significant drie soorten van ernstige bijwerkingen veroorzaakte. (Diarree, leukopenie en trombocytopenia)

Conclusies:
Immuuntherapie werkt efficiënt bij patiënten met niet-klein-cellige longkanker  (NSCLC).  mAb immuuntherapie kan een potentiële immuuntherapie voor gevorderde niet-kleincellige longkanker patiënten een standaard aanvullende therapeutische aanpak worden in de toekomst als met betrekking tot toxiciteit en de allergene werking van mAb's afdoende antwoorden zijn gevonden..

Op de website van PLOIS One kunt u het volledige studierapport gratis inzien. Hier het abstract van deze studie.

Strengths and Weaknesses of Immunotherapy for Advanced Non-Small-Cell Lung Cancer: A Meta-Analysis of 12 Randomized Controlled Trials

PLoS One. 2012; 7(3): e32695.
Published online 2012 March 5. doi:  10.1371/journal.pone.0032695
PMCID: PMC3293858

Strengths and Weaknesses of Immunotherapy for Advanced Non-Small-Cell Lung Cancer: A Meta-Analysis of 12 Randomized Controlled Trials

Abstract

Background

Lung cancer is one of the leading causes of cancer death worldwide. Non-small-cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers. Immunotherapy has yielded no consistent benefit to date for those patients. Assessing the objective efficacy and safety of immunotherapy for advanced NSCLC patients will help to instruct the future development of immunotherapeutic drugs.

Methodology and Principal Findings

We performed a meta-analysis of 12 randomized controlled trials including 3134 patients (1570 patients in the immunotherapy group and 1564 patients in the control group) with histologically confirmed stage IIIA, IIIB, or IV NSCLC. The analysis was executed with efficacy end points regarding overall survival (OS), progression-free survival (PFS), complete response (CR), partial response (PR), and total effective rate. Overall unstratified OS, PFS, PR, and total effective rate were significantly improved in advanced NSCLC patients in the immunotherapy group (P = 0.0007, 0.0004, 0.002, 0.003, respectively), whereas CR was not improved (P = 0.97). Subgroup analysis showed that monoclonal antibody (mAb) immunotherapy significantly improved the PFS, PR, and total effective rate and showed a trend of improving OS of advanced NSCLC patients compared with the control group, with one kind of adverse event being significantly dominant. Compared with the control group, the vaccine subgroup showed no significant difference with regard to serious adverse events, whereas cytokine immunotherapy significantly induced three kinds of serious adverse events.

Conclusions

Immunotherapy works efficiently on advanced NSCLC patients. Of several immunotherapies, mAb therapy may be a potential immunotherapy for advanced NSCLC patients, and become a standard complementary therapeutic approach in the future if the issues concerning toxicity and allergenicity of mAbs have been overcome.

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