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Advanced/Metastatic PDAC Phase III Trials Summary

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Update: My blog posting has an updated results table here.

Metastatic pancreatic adenocarcinoma patients (PDAC) don't have a lot of good options. Here, I summarize the completed phase III trials for metastatic patients, outlining the basic survival statistics. The trial name is a link to the full-text trial results, except the NAPOLI-1 trial that hasn't fully published yet.

The blog hosting software for this site is limiting me to 10K characters, so I am posting a full version on my personal blog posting.

In almost all cases, both arms of the phase III trials are presented on consecutive rows below. The trial name is identical for treatments from the same trial.

Note that apples-to-apples comparisons between the trials are not really possible. In all cases, the patient selection criteria are different, which is why we have a randomized trial process in the first place. Some trials include patients with prior treatment, and others don't. Some trials include non-metastatic patients while others don't. These factors confound a direct comparison between trials, but hopefully you get an idea of effectiveness.

While median OS (OS1/2) is easy for researchers to compare between trials, I think patients might find the 1-yr survival rate (OS1y) more useful. I've gathered the 6, 12, and 18 month OS rates, and the 6, 12, and 18 month Progression-Free Survival (PFS) rates in a longer version of this table.

Year Treatment N Stage Prior Treat OS1/2 OS1y ORR PFS1/2 Trial Name
1997 Gemcitabine 63 ? None 5.7m 18% 24% N/A Burris HA, et al.
1997 5-FU 63 ? None 4.4m 2% 5% N/A Burris HA, et al.
1999 Gemcitabine* 3023 II-IV chemo 4.8m 15% 12% 2.7m Storniolo AM, et al.
2002 Gem/5-FU 160 II-IV chemo, rad 6.7m ~21% 7% 3.4m Berlin, et al.
2002 Gemcitabine 162 II-IV chemo, rad 5.4m ~18% 6% 2.2m Berlin, et al.
2002 Gem/Cis 53 II-IV None 6.9m N/A 26% 4.6m Colucci G, et al.
2002 Gemcitabine 54 II-IV None 4.6m N/A 9% 1.8m Colucci G, et al.
2004 Gem/Irinotecan 173 III-IV chemorad 6.3m 21% 16% 3.5m Rocha-Lima CM, et al.
2004 Gemcitabine 169 III-IV chemorad 6.6m 22% 4% 3.0m Rocha-Lima CM, et al.
2005 Gem/Oxaliplatin 157 III-IV none 9.0m 35% 27% 5.8m Louvet C, et al.
2005 Gemcitabine 156 III-IV none 7.1m 28% 17% 3.7m Louvet C, et al.
2007 Gem/Erlotinib 282 III-IV chemorad 6.2m 23% 9% 3.8m PA.3
2007 Gemcitabine 280 III-IV chemorad 5.9m 17% 8% 3.6m PA.3
2011 FOLFIRINOX 171 IV none 11.1m 48% 32% 6.4m PRODIGE 4/ACCORD 11
2011 Gemcitabine 171 IV none 6.8m 21% 9% 3.3m PRODIGE 4/ACCORD 11
2013 Gem/Ax 431 IV none 8.5m 35% 23% 5.5m IMPACT
2013 Gemcitabine 430 IV none 6.7m 22% 7% 3.7m IMPACT
2014 MM-398/5-FU/LV 117 III-IV Gem 6.1m NAPOLI-1
2014 5-FU/LV 119 III-IV Gem 4.2m NAPOLI-1
* - This is a large retrospective study of Gemcitabine given as compassionate use (before approval) and is here to provide reference statistics for the Gemcitabine monotherapy.

Key to the columns above:
N # patients on this treatment
Stage Staging at the start of treatment
Prior Treat Treatments patients may have had before enrolling in this study. Chemo=previous chemotherapy; rad=previous radiation; chemorad=previous radiation w/chemo sensitising agent
OS1/2 Median Overall Survival of patients taking this treatment. 1/2 of patients survived longer, 1/2 did not.
OS1y % of patients taking this treatment that survived >1 year
ORR Overall Response Rate: % of patients taking this treatment that had a measureable decrease in tumor size.
PFS1/2 Median Progression-Free Survival of patients taking this treatment. This many months after treatment started, 1/2 of patients had their tumors grow larger.

Updated 07-03-2015 at 04:33 PM by ddessert

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Clinical Trials