Chronic Myelogenous Leukemia (CML) Support Group

There are trials being done of stopping Gleevec in patients who have been negative by PCR at least 2 years. The results are given in the newsreport below after the last American Society of Hematology 2008 meeting. More than half of the patients relapsed when Gleevec was taken off and they had been PCR negative for 2 years.

While a small subset of patients may remain in remission off Gleevec, most doctors, like my husband's doctor feel results of large scale trials should be looked at before taking a patient off Gleevec. I know several patients who went off Gleevec and all relapsed and one never regained her PCR negative status. So, there is an element of risk here, why not wait to see more large scale trial results.

My husband has recently tested PCR negative but our doctor and we do not plan for him to go off Gleevec until further results are in.

Some doctors have found out that those who had taken Interferon before Gleevec have a better chance of remaining in remission off Gleevec. But again, only some and not all.

I would feel very worried if my husband went off Gleevec. What if the disease came back and he never went to low levels again? What if Gleevec resistance developed? So many unknowns at this point. So, we will wait to see how the going off Gleevec trials do.

See below the results of one of the first such trials.

Best Wishes,
Anjana
wife of Royston
d/x Jan 2002
400mg Gleevec
PCRU

ASH 2008: Imatinib Can Be Discontinued in Some Patients With CML

Roxanne Nelson

December 8, 2008 (San Francisco, California) - For some patients with chronic myeloid leukemia (CML), it might be possible to discontinue imatinib mesylate (Gleevec) after they have achieved a complete molecular remission. Research presented here at the American Society of Hematology (ASH) 50th Annual Meeting and Exposition confirmed the results of a pilot study that demonstrated that remission can be sustained after imatinib is discontinued, particularly in patients who have been pretreated with interferon.

The discontinuation of imatinib is feasible and does not automatically lead to relapse, reported lead author, François-Xavier Mahon, MD, from Hématopoïèse leucémique, Université Victor Segalen CHU de Bordeaux, in France.

"Imatinib has greatly improved survival in CML," said Dr. Mahon, "but patients must continue on the treatment for an unknown period of time."

Imatinib, a BCR-ABL tyrosine kinase inhibitor, is able to induce a complete cytogenetic response in more than 85% of patients with CML. However, the researchers note that patients with a complete cytogenic response tend to relapse when imatinib is discontinued, and less than 10% of patients achieve a molecular remission, defined by an undetectable residual disease using real-time quantitative-polymerase chain reaction.

Previously, Dr. Mahon and colleagues conducted a pilot study and explored the feasibility of discontinuing imatinib in CML patients who had experienced a complete molecular response. Of the 15 patients included in the cohort, 7 relapsed within 6 months, but they were able to reattain a complete molecular response after imatinib was restarted. The other 8 patients remain in remission after the discontinuation of imatinib (median follow-up is 37 months).

The patients who did not relapse were all pretreated with interferon, Dr. Mahon pointed out.

The current trial looked at 69 patients from 22 centers in France and, of this group, 60 patients had follow-up for more than 1 month. They had a median age of 62 years (range, 32-81 years). Thirty one had been previously treated with interferon, and 29 were de novo. To meet the criteria for inclusion, the patients had to be receiving imatinib treatment and to have had a complete molecular response and undetectable BCR-ABL transcript for at least 2 years.

Currently, 27 patients have relapsed since the discontinuation of their imatinib, and most of the relapses were observed during the first 6 months of discontinuation. Of this group, 13 patients had received interferon and 14 had only received imatinib.

"At 9 months, 46% of patients are still in remission," said Dr. Mahon. "Fifty-three percent were pretreated with interferon and 39% are de novo patients."

Dr. Mahon also emphasized that all of the patients who relapsed were sensitive to imatinib after it was restarted. Some of the relapsed patients went back into remission very quickly, but for others, it is a slower process.

Although the follow-up in this study is short, patients in the pilot study have now been followed for several years. The results from both of these trials confirm that complete molecular response can be sustained after imatinib is discontinued. This is particularly true for patients who have been pretreated with interferon, said Dr. Mahon.

But among the patients who were not pretreated with interferon, over half have not relapsed, and 20% have reached a follow-up of 6 months or more without relapse. Dr. Mahon concluded that it is possible to stop imatinib treatment in patients who have a sustained complete molecular response, even in those who received single-agent treatment with imatinib.

American Society of Hematology (ASH) 50th Annual Meeting and Exposition: Abstract 187. Presented December 8, 2008.

Thank you very much for reply and very useful information, now the other alternative is to continue using Gleevec, but, instead of the 400 mg. go down to the 100 mg. mainly because the 100 is supposed to be cheaper than the 400.
If you or anybody had this type of experience or information about it, I will greatly appreciated.