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SWOG S1203: A Randomized Phase III Study of Standard Cytarabine Plus Daunorubicin (7+3) Therapy Versus Idarubicin with High Dose Cytarabine
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A majority of younger pts with AML receive initial therapy with a 7+3 scheme. Escalated doses of daunorubicin (dauno) in combination with standard doses of ara-C may lead to improved outcomes (Fernandez; NEJM 2009). A phase II trial of idarubicin and high-dose ara-C (IA) in combination with the histone deacetylase inhibitor vorinostat (IA+V) resulted in historically high response rates compared to IA or 7+3 (Garcia-Manero; JCO 2011). SWOG 1203 tested whether a high-dose ara-C induction with or without vorinostat could result in improved outcomes for younger AML pts compared to 7+3.

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Hello. I'm Guillermo Garcia-Manero. I'm from the M.D. Anderson Cancer Center in Houston, Texas. I'm a professor in the department of leukemia. I'm going to present to you a summary of a study known as SWOG 12O3.

SWOG 1203 is a very large randomized clinical trial for younger patients with Acute Myeloid Leukemia. The study was designed a few years ago, to compare the standard of care that is known as 7+3 with a high dose Ara-C type of induction that we call IA, that has been the standard at M.D. Anderson for many years, versus a third arm where we added a histone deacetylase inhibitor, known as vorinostat, to this IA from M.D. Anderson.

The rationale for this triple combination were studies from my lab and a phase to study that was conducted after, but we show a very high response rate with this triple combination of idarubicin high dose Ara-C on vorinostat induction. The SWOG group and the NCI Leukemia Steering Committee looked at this data and they decided to perform this very large clinical trial, probably one of the largest, ever performed.

As you see in this slide, the study actually involves 738 patients randomized into three arms: conventional 7+3, IA, and IA vorinostat. Arms were very well balanced in terms of cytogenetics and molecular alterations. The goal of the study, actually, was to prove that IA-vorinostat was superior, at least in terms of event free survival, compared to 7+3 or IA.

There was a second end to the study that was actually to prove that we could transplant over 60% of patients with high risk cytogenetic alterations in first completed remission. We were also interested on comparing high dose Ara-C induction type of approach, versus conventional 7+3 therapy.

The results are shown in this slide that I have right now, where we actually see that there was no benefit with the IA or the IA-vorinostat compared to 7+3, so the results were basically identical. The complete remission rate without count recovery were similar in both strategies, which in a way, was very disappointing to us, because we were expecting that the high dose Ara-C, partly with the addition of the vorinostat, was going to be superior to standard 7+3 therapy.

The response, as I said, were similar toxicities probably a little in favor 7+3 because of the addition of vorinostat that we know was going to be a little bit more toxic. The final question is whether this has translated into better or worse survival, and as you can see on this slide, actually the survival was identical for the three arms.

The conclusion of the studies, that use of high dose Ara-C with or without vorinostat, the induction programming younger patients with AML did not result at an increased response rate better event free survival or overall survival.

We need to keep working on better combinations for frontline patients, younger with Acute Myeloid Leukemia. With that, I want to finish and thank you for listening to this. Thank you.