DR. GOLDSTONE: At M.D. Anderson, what determines -- the subtle selection bias comparing these things, if you are between ages 13 and 16, what determined whether you went to an adult doctor or a pediatric doctor in Houston?

DR. JEHA: It is the personal referral. As you notice, the age of 16 is usually the more black and white sort of thing, but usually it depends on the referrals. Between the ages of 13 and 19, it depends what doctor you are referred to, or where the patient wants to go. So, the patient is given the choice.

DR. TALLMAN: Sima, there are some studies suggesting that women in general may fare less well than men with leukemia. Have you looked at gender, to see if there may be some hormonal issue?

DR. JEHA: Actually, in pediatrics, it is the opposite. The girls do better than the boys. This is why we give the boys three years of maintenance compared to the girls, where we give two years of maintenance.

I looked at Anderson in adults, and there is no difference in genders. It is seen in our pediatric populations, but in adults there was no difference at all. This is just Anderson. I am not sure about the national data, but we see a lot of adult ALL at Anderson. So, I think it was representative.

DR. KANTARJIAN: Any comments on future cooperative group studies? I think this is an important issue that a lot of us are struggling with. So, any ideas about how we are going to go about that?

DR. SCHIFFER: Another issue with the adult cooperative groups is where the patients are treated. At least in our city, and I am sure all over the country, a substantial fraction are treated by people who really do breast cancer, lung cancer and colon cancer for a living. Sometimes they refer the patient, particularly if they don't have insurance, and sometimes they don't.

It is obvious that you need a pretty rigorous team approach to treat ALL effectively, to get your drugs in on time, etc..

Part of the information, I think, that should be collected on all collaborative trials between adults and children is who is treating the patients, in particular, the percent drug delivery on time.

I don't know how to get around that issue with adult cooperative groups where, a) we get a small fraction of the patients referred, b) it is probably selective and, c) even the patients who do, in fact, get treated on trials are usually -- I don't whether usually -- but a substantial fraction are not treated at leukemia centers.

DR. GOLDSTONE: Some of the lessons to be learned are very simple. Probably they should no longer be separate children and adult leukemia study groups.

Certainly, for this key age group, for the adolescents, however it is to be defined, the patient should be in exactly the same study on exactly the same protocol and randomized appropriately, so that they are distributed among the child treaters and the adult treaters in an absolutely non-biased way.

I think there is so much that we need to learn from the children's groups that actually, as far as the adults are concerned, that the separateness of the two types of groups should be terminated.

DR. KANTARJIAN: I think sometimes we try to learn from them and by the time we adopt the learning curve, they have backed away from it.

For example, three years ago, Dr. Nachman came to M.D. Anderson and he convinced us that the DCTER regimen was adopted, and that the DCTER was superior.

So, we did an analysis, taking the same adult patients that would have been on the DCTER regimen, and when we analyzed the data, the augmented DCTER looked much better than the standard DCTER, which looked the same as the adult ALL.

So, we adopted the intensive doctor for the past three years. Today I learned from Dr. Nachman that they are not using it any more. They went back to MRC12.

I think what my concern is that we could take a false step that could invest a lot of resources in a study that they may not be believing in any more.

DR. LINKER: How did patients do at M.D. Anderson on the augmented DCTER?

DR. KANTARJIAN: They did poorly and they had a lot of GI toxicity. Today, Dr. Nachman told me that, yes, pediatrics do very poor in terms of GI toxicity, but I didn't learn it then. I learned it now.

PARTICIPANT: They learned what we learned, not to listen to Nachman. [Laughter]

DR. KANTARJIAN: I think Dr. Nachman is always on the point with those issues, and I would like to learn more. What my concern is today is, many of the adult groups are looking at the two comparative studies and they feel, appropriately so, that the pediatric studies are giving better results in adolescents than adults.

So, we would like to do like we did with the doctor, take all patients age zero to 50 and treat them on the same protocol, but we want to make sure which is the best protocol so that, if we adopt it today, we don't end up with an outdated protocol three years down the road for both.

DR. JEHA: Ten to 50.

PARTICIPANT: [Comments off microphone]

DR. KANTARJIAN: When Dr. Hoelzer presents the BFM data in adults that is similar to the childhood BFM, he doesn't get the same childhood BFM results. That is an important question for the simultaneous session. Any other comments?

DR. LOOK: Maybe in T cell ALL it would be a good one to think about combining trials. At least molecularly, there seem to be the same five groups.

The distribution changes. So, with HOX11, actually a better risk group is more common in adults. If one accounted for sort of the molecular type, it might make sense to treat those cases similarly.

DR. CARROLL: The only other comments, I think some of this is beginning to take place in our own cancer centers. I think that, as we develop more biology and research, we should have a single leukemia service in the context of the cancer center, with the pediatricians and the adults.

As we begin to merge away from departments of pediatrics to departments of medicine in the cancer center, I think this is fertile ground to begin to teach each other about some of these issues.

DR. KANTARJIAN: Okay, so we are going to try to take the lunch break until 12:30. Then, there will be the simultaneous sessions, parallel and back to back and then we will reconvene. Thank you.

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