SNFGE SNFGE
 
Thématique :
- Foie
Originalité :
Réexamen
Solidité :
A confirmer
Doit faire évoluer notre pratique :
Pas encore
 
 
Nom du veilleur :
Professeur Christine SILVAIN
Coup de coeur :
 
 
Hepatology
  2015/11  
 
  2015 Nov;62(5):1456-65  
  doi: 10.1002/hep.27905  
 
  Temoporfin improves efficacy of photodynamic therapy in advanced biliary tract carcinoma: A multicenter prospective phase II study  
 
  Wagner A, Denzer UW, Neureiter D, Kiesslich T, Puespoeck A, Rauws EA, Emmanuel K, Degenhardt N, Frick U, Beuers U, Lohse AW, Berr F, Wolkersdörfer GW  
  http://www.ncbi.nlm.nih.gov/pubmed/?term=Temoporfin+improves+efficacy+of+photodynamic+therapy+in+advanced+biliary+tract+carcinoma%3A+A+multicenter+prospective+phase+II+study.  
 
 

Photodynamic therapy using porfimer (P-PDT) improves palliation and survival in nonresectable hilar bile duct cancer. Tumoricidal penetration depth of temoporfin-PDT (T-PDT) is twice that of P-PDT. In a single-arm phase II study we investigated the safety, efficacy, survival time, and adverse events of T-PDT compared with previous data on P-PDT. Twenty-nine patients (median 71 [range 47-88] years) with nonresectable hilar bile duct cancer were treated with T-PDT (median 1 [range 1-4] sessions) plus stenting and followed up every 3 months. The PDT was well tolerated. In patients with occluded segments at baseline (n = 28) a reopening of a median of 3 (range 1-7) segments could be achieved: n = 16 local response and n = 11 stable local disease, one progressive disease. Cholestasis and performance significantly improved when impaired at baseline. Time to local tumor progression was a median of 6.5 (2.7-41.0) months. Overall survival time was a median of 15.4 (range 4.4-62.4) months. Patients died from tumor progression (55%), cholangitis (18%), pneumonia (7%), hemobilia (7%), esophagus variceal hemorrhage (3%), and vascular diseases (10%). Adverse events were cholangitis (n = 4), liver abscess (n = 2), cholecystitis (n = 2), phototoxic skin (n = 5), and injection site reactions (n = 7). Compared to previous P-PDT, T-PDT shows prolonged time to local tumor progression (median 6.5 versus 4.3 months, P < 0.01), fewer PDT treatments needed (median 1 versus 3, P < 0.01), a higher 6-month survival rate (83% versus 70%, P < 0.01), and a trend for longer overall median survival (15.4 versus 9.3 months, P = 0.72) yet not significantly different. The risk of adverse events is not increased except for (avoidable) subcutaneous phototoxicity at the injection site.

CONCLUSION:

Temoporfin-PDT can safely be delivered to hilar bile duct cancer patients and results in prolonged patency of hilar bile ducts, a trend for longer survival time, and similar palliation as with P-PDT. (Hepatology 2015;62:1456-1465).

 
Question posée
 
Etude de phase I2 : traitement photodynamique PDT (temporfin-PDT) des cholangiocarcinomes non résécables du hile associés à la prothèse : sécurité, survie, effets indésirables ?
 
Question posée
 
Bonne tolérance avec désobstruction d’au moins 3 segments chez plus de la moitié des malades et stabilité de l’atteinte locale dans un tiers des cas. Le temps de progression local médian est de 6,5 mois et la survie globale médiane est de15 mois. Comparé à la P (porfimer)-PDT, la T-PDT parait mieux tolérée est plus efficace mais de façon non significative.
 
Commentaires

Faible effectif mais intéressant … en attente de phase 3.

 
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