Page 54 - Demo

Chapter 352 OS, PFS and%u00a0responseThe median OS from diagnosis until death was 23.4 months (95%CI, 21.0 to 25.8), 15.7 months (95%CI, 13.4 to 18.0) and 11.5 months (95%CI, 10.0 to 13.1) for patients who were treated with FOLFIRINOX reintroduction, gemcitabine + nab-paclitaxel and gemcitabine monotherapy in second line respectively fig 1a, p<0.01). Patients who presented with or without metastatic disease had a similar median OS from diagnosis until death after FOLFIRINOX reintroduction (22.7 months (95%CI, 19 to 26.4) versus 24.4 months (95%CI, 21.7 to 27.1)(p=1.0)). The median OS from start of FOLFIRINOX reintroduction until death was 8.3 months (95%CI, 6.8 to 9.7)(fig 1b) while the median OS from stop of FOLFIRINOX reintroduction until death was 4.4 months (95% CI, 3.2 to 5.6). Median PFS after start of FOLFIRINOX reintroduction (n=119) was 6.8 months (95% CI, 6.1 to 7.5) (fig 1c). In sensitivity analysis, with death within 30 days after the stop date of last FOLFIRINOX treatment as a progression event, a shorter PFS of 5.4%u00a0 months%u00a0 (95%%u00a0 CI,%u00a0 3.7-7.0)%u00a0 was%u00a0 found.All patients (response unknown in 12/119) who received FOLFIRINOX reintroduction experienced clinical benefit during first line FOLFIRINOX as best response compared to 51,6% and 53,7% of patients who received second line gemcitabine + nab-paclitaxel and gemcitabine monotherapy (response unknown in 33/155 and 14/67 patients). More than half of the patients (n=70, 58.8%) experienced clinical benefit as best response during FOLFIRINOX reintroduction (table 3, response unknown in 20%). To identify patients without benefit of FOLFIRINOX reintroduction we analyzed which patients died or stopped shortly after start of FOLFIRINOX reintroduction. Twenty-four of 119 patients (20.2%) deceased (n=4) or stopped FOLFIRINOX (n=20) within 30 days after start of FOLFIRINOX reintroduction. The median therapy-free interval from first line FOLFIRINOX until first FOLFIRINOX reintroduction was 5.4 months (range 3.1 -35.7 months; < 6 months in n=13/24, 54.2%) compared to 7.1 months (range 3.1 -31.7 months; < 6 months in n=32/95, 33.7%) for patients who did%u00a0or%u00a0did%u00a0not%u00a0die%u00a0or%u00a0stop%u00a0within%u00a030%u00a0days%u00a0after%u00a0FOLFIRINOX%u00a0reintroduction.A small group of patients (n=15, 53% metastatic disease) was even treated with a second reintroduction of FOLFIRINOX without any other systemic therapy in between and had a median OS of 31 months from diagnosis and 17.4 months from start of first reintroduction.