När ett av barnen vägrar sova mellan 04 och 06 kan man googla runt lite
Lite jämförande studier med Nucana och även hur senare studier står sig mot ABC-02 studien samt vilken oerhört viktig del Asien är för snabb rekrytering
Nucana vs ABC-02
The ORR (ITT) was 33%, and efficacy evaluable ORR was 44%, compared with 26.1% reported in the ABC‐02 study for the cisplatin/gemcitabine combination [1]. Tumor control and OS in ABC‐08 were 76% and 9.6 months (with an upper 95% CI of 13.1 months), respectively, similar to the cisplatin/gemcitabine combination in ABC‐02: 81.4% and 11.7 months [1]. Despite the potential biological heterogeneity of ABC primary tumor sites [13], responses seen in ABC‐08 were distributed across all five biliary tract cancer subtypes (intrahepatic, hilar, and distal bile duct cholangiocarcinoma, gallbladder cancer, and ampulla of Vater carcinoma).
Nucana 74% Tumor control vs 81% i ABC-02
OS 9,6 vs 11,7.
Translating the ABC-02 trial into daily practice: outcome of palliative treatment in patients with unresectable biliary tract cancer treated with gemcitabine and cisplatin
Studie från 2018 där man ville se om resultaten från ABC-02 är överförbara till vardagen i kliniken.
Methods: Patients diagnosed with unresectable BTC between 2010 and 2015 with an indication for gemcitabine and cisplatin were included. We divided these patients into three groups: (I) patients who received chemotherapy and met the criteria of the ABC-02 trial, (II) patients who received chemotherapy and did not meet these criteria and (III) patients who had an indication for chemotherapy, but received best supportive care without chemotherapy. Primary outcome was overall survival (OS) and secondary outcome was progression-free survival (PFS).
Results: We collected data of 208 patients, of which 138 (66.3%) patients received first line chemotherapy with gemcitabine and cisplatin. Median OS of 69 patients in group I, 63 patients in group II and 65 patients in group III was 9.6 months (95%CI = 6.7-12.5), 9.5 months (95%CI = 7.7-11.3) and 7.6 months (95%CI = 5.0-10.2), respectively. Median PFS was 6.0 months (95%CI = 4.4-7.6) in group I and 5.1 months (95%CI = 3.7-6.5) in group II.
Lägre mOS och mPFS än i referenssrudien ABC-02
Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients
Annan studie från 2017 utförd på ett sjukhus i Sydkorea som också är en av PCIB:s sites i Release studien. 740 patienter inkluderades på 76 månader, 10 patienter per månad på 1 sjukhus!
Nu är inte alla den/de subtyper som PCIB skall ha i sin studie men om man räknar att 30% var extra hepatic så är det fortfarande 3 per månad på 1 site. PCIB har 6 sjukhus i Sydkorea. …
Tror inte vi ska underskatta möjligheten till riktigt hög inklusion hastighet i Asien
Methods
Between April 2010 and June 2016, 740 patients with histologically documented cholangiocarcinoma and gallbladder cancer were treated with first-line GEMCIS in Asan Medical Center, Seoul, Korea.
Results
In 389 patients with measurable disease (53%), the objective response rate was 13% ( n = 50) and there was no significant difference between primary tumor sites ( p = 0.45). With a median follow-up duration of 27.3 months (95% CI 24.2–30.5), the median PFS and OS were 5.2 months (95% CI 4.7–5.6) and 10.4 months (95% CI 9.6–11.2), respectively.
mOS 10,4 vs PCIBs 16,6 (22,2 cohort 4)