What about adjuvant therapy
What about adjuvant therapy? If you look at … we can talk about staging. Interestingly enough, in the United States in an adjuvant study that I am going to report to you shortly, about 80% of the patients that were referred for adjuvant therapy were node-positive. So they were IIIa or IIIb patients essentially. We know that 80-85% of those patients relapse after surgery. So what about adjuvant chemotherapy, for example? This is really the largest adjuvant chemotherapy study that’s been reported in the United States, a prospectively randomized study of the Southwest Oncology Group. And it used FAM. Started of course, 7804, started in 1978 where FAM was sort of a standard of care and there were 193 patients. If you look here, we presented this at ASCO about four years ago and there’s absolutely no difference for FAM adjuvant therapy. It did not help. This is a relatively small study and one way of looking at relatively small studies in trying to sort out whether there may be benefit buried within them is to do a metaanalysis. And this is a metaanalysis that was published I think in June of 1993 in JCO looking at the papers, the randomized papers, published in the English language literature. Essentially what this shows is that there was a tendency toward some benefit for adjuvant chemotherapy, but when you look at the combined results it was not statistically significant.
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If adjuvant chemotherapy with the combinations we have now is not adequate adjuvant therapy, what might be reasonable adjuvant strategies? One thing that makes a lot of sense when you are dealing with solid tumors, is to understand the pattern of relapse. Because you might be able to design adjuvant therapy using modalities of therapy that are targeted towards that particular pattern of relapse. This just looks at the sites of failure in patients with gastric cancer. Old data from Len Gunderson, who is now at the Mayo Clinic – and this was actually done when he was at the University of Minnesota – and at the University of Minnesota in the 50’s and 60’s they had a re-operation protocol then. You can imagine what your case manager with managed care would think of this. The patient after nine months was taken back to the OR to have another look, another two weeks in the hospital just to see what was going on. I also think that actually Minnesota citizens must be particularly compliant because they basically all agreed to this. So what they did is they looked for evidence of failure. And what they found was that local failure was an important aspect of failure in about 90% of patients. So where the resection is done, the patient is likely to fail. And that’s not surprising because the tumor goes through the wall of the stomach, frequently involves the serosa. That’s a T3 tumor and nodes are involved. So even though you do an en block resection you are very likely to leave microscopic residual disease. So local failure is important. Distant metastases only occur about 25% of the time.
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So with these data in mind, one would say, “What are the local modalities that we have?” and of course one of the major local modalities of therapy available is radiation. So what about the use of radiation as a postoperative therapy in gastric cancer? Well one thing, as a general rule in gastrointestinal cancer – and this is what I call a poor man’s metaanalysis – and what I did was to look at a variety of sites, of reports published over the last 20 years or so in GI cancers and look at whether or not when you use radiation therapy, either in advanced disease or resected disease and when you add 5FU as a radiation sensitizer whether there is benefit for the combined modality therapy. Basically, there is benefit in all the sites that have been looked at. Of course, adjuvant rectal cancer, we know that the combination of 5FU plus radiation is really the heart of the standard of care for postoperative therapy for resected rectal cancer. But there is benefit in these patients by combining radiation and chemotherapy.