Jeg synes også det var spesielt, for selv om PFSen er bedre, så er det jo OS som til syvende og sist teller mest. Avgjørelsen var riktignok marginal; 7 mot 5 stemmer, selv om det ofte ikke er enstemmig.
Nå kunne forklaringen være en vesentlig bedre safety profil, men så vidt jeg kan lese er ikke det forklaringen heller “The safety and tolerability profile of Lynparza in the POLO trial was in line with that observed in prior clinical trials.”
Jeg tror mye av forklaringen er at panceratic cancer er en skikkelig devastating disease hvor det er kommet opp svært lite på 1. linje, så myndighetene er svært medgjørlig for alt som betyr selv bare litt. Og det er jo langt fra alle pancreatic cancer patients denne behandlingen gjelder for: " About 4% to 9% of patients with metastatic pancreatic cancer are thought to carry gBRCAms"
Det som pt brukes generelt for bukspyttkjertelkreft er:“The standard of care for metastatic pancreatic cancer is typically one of two chemotherapy regimens: FOLFIRINOX (5-FU, leucovorin, irinotecan and oxaliplatin) or Gemzar® + ABRAXANE®.”
FOLFIRINOX er en skikkelig tøff behandling, så det vanlige er kanskje Gemzar+Abraxane, og det regimet sammenlignet med gemcitabine (Gemzar) er på en måte for pancreas hva gem-cis er for cholangiocarcinoma (gallegangskreft).
Pancreas cancer, Gemzar+Abraxane (Gemcitabine+ nab Paclitaxel versus gemcitabine
https://www.nejm.org/doi/full/10.1056/NEJMoa1304369
“A total of 861 patients were randomly assigned to nab-paclitaxel plus gemcitabine (431 patients) or gemcitabine (430). The median overall survival was 8.5 months in the nab-paclitaxel–gemcitabine group as compared with 6.7 months in the gemcitabine group (hazard ratio for death, 0.72; 95% confidence interval [CI], 0.62 to 0.83; P<0.001). The survival rate was 35% in the nab-paclitaxel–gemcitabine group versus 22% in the gemcitabine group at 1 year, and 9% versus 4% at 2 years. The median progression-free survival was 5.5 months in the nab-paclitaxel–gemcitabine group, as compared with 3.7 months in the gemcitabine group (hazard ratio for disease progression or death, 0.69; 95% CI, 0.58 to 0.82; P<0.001); the response rate according to independent review was 23% versus 7% in the two groups (P<0.001).”
Cholangiocarcinoma Gemcitabine+cisplatin versus Gemcitabine
https://www.nejm.org/doi/full/10.1056/NEJMoa0908721
“After a median follow-up of 8.2 months and 327 deaths, the median overall survival was 11.7 months among the 204 patients in the cisplatin–gemcitabine group and 8.1 months among the 206 patients in the gemcitabine group (hazard ratio, 0.64; 95% confidence interval, 0.52 to 0.80; P<0.001). The median progression-free survival was 8.0 months in the cisplatin–gemcitabine group and 5.0 months in the gemcitabine-only group (P<0.001).”
Den siste Lynparza-avgjørelsen fra FDA er selvsagt svært interessant for PCI Biotech. Gallegangskreft er ansett å være en like vanskelig krefttype som bukspytkjertelkreft.
Responsrate for Gem-cis i ABC02 var forøvrig 26,1% mot 15,5% for Gemcitabine.
