Godt fundet AntiBody_Man - selv om dataene nok er så kendte,

Gad vide hvor mange af de 4 der stadig er i live, og var det alle sammen dem, der blev dobbelt behandlet.?

Helme5
Siste oppdatering, Q2, opplyste PCIB at tre av pasientene fortsatt var i live.
En av pasientene hadde da fått dobbel behandling der første behandling var på en av de to laveste dosene (mener at det var nest laveste dose), og de to siste pasientene hadde en behandling.
-Wannatri

OS=11,7mnd... Og pcib kan vise til 4 pasienter av 16 som fortsatt er i live mellom 24,3 - 38,8 mnd. Og tre av dem er fra samme doseringsregime. Mtp hvordan denne indikasjonen utvikler seg og hvor dårlig prognose pasientene har, så er resultatene latterlig bra siden vi fortsatt ser på fase I - data.

Veldig bra pcib nå er finansiert (overtegnet selv om alt tydet på at man kunne få det billigere via ob), men veldig irriterende at kursen blir så mishandlet.

ILAV, en presisering:
Per Q2 var antallet som fortsatt var i live, redusert til 3.

Likevel: Veldig gode resultater, og selv om det er få pasienter har PCIB svært gode resultater på tumorresponsnivå, der 17 av 19 viste respons på behandling med over 20% reduksjon, og der 12 av tumorene var ikke-detekterbar etter behandling.
Som kjent er frie galleganger livsnødvendig, og tette galleganger er det som direkte fører til at pasienter dør.
Tumorrespons indikerer derfor overlevelse i neste omgang.
-Wannatri

Hi, below ESMO abstracts for potential competitors although data not directly comparable:

*** NUC 1031, Acelarin (from Nucana) 758P
*** FOLFIRINOX 761P

758P - A new ProTide, NUC-1031, combined with cisplatin for the first-line treatment of advanced biliary tract cancer (ABC-08)

Speakers

Mairead G. McNamara (Manchester, GB)

Abstract

Background

Cisplatin + gemcitabine (cis/gem) is the global standard of care for 1st-line treatment of patients (pts) with locally advanced/metastatic biliary tract cancer (BTC). No agents have regulatory approval for this disease. Cis/gem achieves an objective response rate (ORR) of 26% and median overall survival (OS) of 11.7 months (ABC-02). Inherent/acquired resistance mechanisms limit gemcitabine efficacy. NUC-1031, a phosphoramidate transformation of gemcitabine, is designed to overcome resistance mechanisms associated with poor gemcitabine response.

Methods

Pts with locally advanced/metastatic BTC, ECOG PS of 0-1 and no prior systemic therapy received NUC-1031 (625 or 725 mg/m2) combined with cisplatin (25 mg/m2) on days 1 + 8 every 21 days. Primary endpoints: safety and determination of RP2D. Secondary endpoints: ORR, pharmacokinetics, progression-free and OS.

Results

14 pts (median age 61 yrs, 8 male; 5 hilar, 4 distal bile duct, 2 intrahepatic, 2 ampullary and 1 gallbladder) were enrolled across cohorts 1 (625 mg/m2, n=8) and 2 (725 mg/m2, n=6). 11 pts completed >1 cycle and were efficacy evaluable, receiving a median of 6.5 cycles (range 3.5-12). ORR was 64% (1 CR, 6 PRs) and DCR: 73%. PFS/OS data collection is ongoing. High, durable intracellular levels of the active anti-cancer metabolite dFdCTP were generated in PBMCs (t1/2=22 h). Treatment was well tolerated with no unexpected AEs/DLTs. Grade 3 TEAEs included neutropenia (14%), fatigue (14%), pyrexia (14%), ALT (7%), AST (7%), GGT (7%) and nausea (7%). Based on high response rate and favourable safety profile, 625 mg/m2 was deemed RP2D. An expansion cohort is ongoing (n=6).

Conclusions

NUC-1031 + cisplatin demonstrated a very high ORR, with a favourable safety profile, and may provide an improved treatment option over cis/gem for advanced BTC. Further development of NUC-1031 in BTC is planned.

Clinical trial identification

NCT02351765

************************************
761P - FOLFIRINOX as a first-line chemotherapy for patients (pts) with advanced biliary tract cancer (BTC)

Speakers

Ayhan Ulusakarya (Villejuif, FR)

Abstract 1

Background

FOLFIRINOX is a first-line regimen in the treatment of pancreatic cancer. Historically, BTC and pancreatic cancers were treated similarly with gemcitabine alone or combined with a platinum compound. A growing body of evidence supports the role of fluoropyrimidines in the treatment of BTC.

Methods

We retrospectively analyzed data of all our pts with locally advanced (LA) or metastatic (M) BTC who received FOLFIRINOX as a first-line therapy from 12/2013 to 11/2017 at Paul Brousse university hospital. The main endpoints were OS, TTP, ORR, DC, secondary resection and toxicity.

Results

There were 42 pts: 17 male (40%) and 25 female (60%) pts aged 36 to 84 years (median: 67). Pts had PS of 0 (55%) and 1 (45%). They had intrahepatic cholangiocarcinoma (iCCA) (21 pts, 50%), gallbladder carcinoma (8 pts, 19%), perihilar CCA (7 pts, 17%), distal CCA (4 pts, 10%) and ampulloma (2 pts, 5%). No biopsy could be obtained in 2 pts. BTC was LA or M in 9 (21%) and 33 pts (79%) respectively. Biliary stent was placed in 14 pts (33%). A median (m) of 10 courses was given with m treatment duration of 6 months (mo). At the cutoff on 01/01/2018, regimen was ongoing in 7 pts (18%). Dose intensity (m) was 74, 34 and 1150 mg/m2/w for irinotecan, oxaliplatin and 5FU respectively. The most common nonhematological toxicity was sensory neuropathy: grade 1/2 in 15 pts (36%), no grade 3/4. We observed 15 PR (36%), 16 SD (38%), and 10 PD (24%); 1 pt has not been evaluated for efficacy. Fifteen pts (36%) were alive, 24 pts (57%) died, 3 pts (7%) were lost to follow-up. Four out of 5 pts who underwent resection were alive without disease. At a median follow-up time of 12 mo (1 to 26), mTTP was 9 mo [95%CL, 5 – 12] and mOS was 15 mo [14 – 16]. mTTP was better for LA (not reached) than M-BTC (8 mo), p = 0.05; OS was statistically similar. mTTP was worse in pts with iCCA than other primaries (7 mo [4 – 10] vs 14 mo [9 – 19], p = 0.005); OS was not significantly different. ORR and DC were associated with both better TTP and OS. ORR: mTTP (16 vs 5 mo, p < 0.001), mOS (19 vs 11 mo, p = 0.01); DC: mTTP (10 vs 2 mo, p < 0.001), mOS (18 vs 7 mo, p = 0.002).

Conclusions

First-line FOLFIRINOX offers promising results in patients with LA and M-BTC. It deserves prospective evaluation to further improve outcomes for advanced BTC.

Skulle det vise seg at det dukker opp seriøse konkurrenter på toppen av alt så er det vel ikke lenge før Per W &Co kaster kortene og gjør som de har brukt å gjøre før: - Det har vist seg vanskligere enn vi trodde, så derfor flytter vi over på andre siden av gjerdet. Der er graset mye grønnere ;)

Folifrinox og Nucana sine resultater er drøftet av Snøffelen m.fl og. Resultatene er ikke helt sammenlignbare og de satser nok bredere enn Pcib. Dessuten er de dårligere. Men for noen virker gresset grønnere på den andre siden uansett hvor grønt ens eget gress er.

Og hvorfor skal de kaste kortene når de nettopp er finansiert er klar til å starte opp FS2 og leder kappløpet, som de kanskje blir helt alene om,

Å satse bredere er ikke et minus. Jeg sliter med å se at PciB skal tjene så mye innen sin nisje (CCA) Derfor får de neppe partnere heller