Pancreatic Cancer. Markers for pancreatic cancer
Markers for pancreatic cancer: CEA is frequently elevated in pancreatic cancer, but the marker which is most useful negative will not make CA19-9, but without exception CA19-9 usually reaches very high levels, in the thousands false positives and biliary disease. Patients with infectious cholangitis have very high levels, sometimes in cirrhosis and if you. Before going to chemotherapy for pancreatic cancer, I want to insert a couple of caveats. And these are that you have to be very careful when you interpret. In the old trials, the response rate in pancreatic cancer to chemotherapy is almost invariably grossly overstated. And the reason is because of non-uniform response criteria. The benefits that patients feel from chemotherapy in pancreatic cancer is much more frequent. There is a lot of wishful thinking. Those are largely the trials in which single agents were evaluated. They are what we have, but there are a lot of scar tissue in them and they are very slow to resolve. Even if the chemotherapy is working. So there is a negative bias in looking at objective response rate. Overall the objective response rate is low and is slow to occur. Palliative responses are more common and any trial in pancreatic cancer nowadays should have some and to know what you are dealing with. Because these numbers are much bigger than these numbers and you have to compare one with the same parameter. There are basically two that are well documented: infusional 5FU and gemcitabine and then there are all the rest, some of which may be promising but don’t have much data yet. Here are the data for 5FU. Probably the response rate for bolus schedules of 5FU is less than 10%. With leucovorin involving the GI tumor study group schedule, the Mayo schedule and yet another. You put them all together and only 3% responses. It’s only when you get into the infusional schedules that response rates. Protracted infusion or the 24 hour weekly high dose schedule with leucovorin, popularized by Arnold high dose infusion.
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Here are the single agent data for gemcitabine. Objective response rates ranging between 5-10%. Clinical benefit response rates ranging between 20-30%. Survival quite uniform even though the clinical benefit response was good. This is the phase III trial, Burrus et all, that resulted in gemcitabine being approved. It was a randomized trial between gemcitabine in their right mind would use that schedule. It was a stroke of genius to get the FDA to accept it as a control arm. There were no objective responders in the 5FU arm, and only 5% clinical benefit responses. This is a excellent objective responders in the gemcitabine trial and 24% CBR’s. There’s also a small difference in survival, which was statistically significant. Other drugs, various other drugs. Most of these older single agent numbers are quite suspect. They are purported to be objective response rates, but in the old days FAM or SMF were used widely for pancreatic cancer because of some promise. Both ended up in cooperative group trials and large cooperative group trials, and they’ve largely been abandoned when it was seen that out of five arms involving these trials. On the other hand, regimens based on protracted infusional 5FU do have reproducible objective response rates, running up in the response rates in the 40-50% range. Even protracted 5FU by itself is not bad. There are two trials with protracted 5FU plus gemcitabine which was published this year in JCO by Hildago and group. That’s the regimen that we are currently using off protocol.
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