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  • Auteur
  • NVMO-commissie BOM
  • Printdatum
  • 14-9-2012
  • E-pubdatum
  • 14-9-2012

Pemetrexed als onderhoudsbehandeling bij stadium IIIB/IV niet-kleincellig longcarcinoom

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Introductie

1. Kankersoort en lijn van behandeling

2. Vergelijking met de referentiebehandeling in Nederland

3. Methode en kwaliteit van de studies
Switch maintenance

Continuation maintenance

4. Effectiviteit van de behandeling afgezet tegen de bijwerkingen en impact van de behandeling
Switch maintenance

Continuation maintenance

Pallatief, effectiviteit   

Ciuleanu et al [2]

Paz Ares et al [5]    
  • winst progressievrije
    overleving

4,5 vs 2,6 maanden
HR: 0,44 (95% CI: 0,37-
0,60);P < 0,0001  

4,1 vs 2,8 maanden
HR: 0,62 (95% CI: 0,49-
0,79); P < 0,0001

 +   
 
  • winst totale mediane
    overleving 

10,3 vs 15,5 maanden
HR: 0,70 (95% CI: 0,56-
0,88); P < 0,0001  

11,1 vs 13,9 maanden**  
HR: 0,78 (95% CI: 0,64-
0,96); P = 0,0195

 +
 

 

Specifieke bijwerkingen    

  • lethaal < 5%

 0

 0

 +
  • acuut, ernstig < 25%

 0

 < 1%

 +
  • chronisch < 10% 

onbekend

onbekend

 

 

Kwaliteit van leven    

  • geen ernstige deterioratie 

 

   +

 

Impact van behandeling  

  • acceptabele behandellast  
ja

ja

 +

 

Level of evidence 

1 fase III-studie 

1 fase III-studie 

 +

 

Kosten 

€13.862,40 euro voor 4 kuren  

   

Tabel 1. Resultaten studies Ciuleanu et al [2] en Paz Ares et al [5] bij patiënten met niet-planocellulair carcinoom afgezet tegenover de PASKWIL-criteria (**Paz Ares et al [6]).

5. Kosten

Conclusie

Referenties

  1. Soon YY, Stockler ML, Askie LM, et al. Duration of chemotherapy for advanced non-small-cell lung cancer: a systematic review and meta-analysis of randomized trials. J Clin Oncol 2009;27(20):3277-83.
  2. Ciuleanu T, Brodowicz T, Zielinski C, et al. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet 2009;374(9699):1432-40.
  3. Belani CP, Brodowicz T, Ciuleanu TE, et al. Quality of life in patients with advanced non-small-cell lung cancer given maintenance treatment with pemetrexed versus placebo (H3E-MC-JMEN): results from a randomised, double-blind, phase 3 study. Lancet Oncol 2012;13(3):292-9.
  4. Scagliotti GV, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-smallcell lung cancer. J Clin Oncol 2008;26(21):3543-51.
  5. Paz Ares L, de Marinis F, Dediu M, et al. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol 2012;13(3):247-55.
  6. Paz Ares L, de Marinis F, Dediu M, et al. PARAMOUNT: final overall survival (OS) results of the phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo (plb) plus BSC immediately following induction treatment with pem plus cisplatin (cis) for advanced nonsquamous (NS) non-small cell lung cancer (NSCLC). J Clin Oncol 2012;30(18) (suppl; abstr LBA7507).