CML Heads Up!
Anchorage

Tim Hughes, MD (Adelaide, Australia):

"Even under the most favorable conditions, the risk of mortality in the first 12 months after an allograft from a sibling donor for patients with newly diagnosed CML is close to 20%.

Based on the current response data in the IRIS trial, it seems probable that the median survival data in patients treated initially with Imatinib therapy will exceed 10 years. For these reasons, our current policy is to recommend Imatinib as first-line therapy for nearly all patients with de novo CP CML, including those with suitable donors."

He goes on to say that it remains possible that responses may not be durable in the long-term due to the emergence of IM resistance and whether this is the case or not will soon be seen from the patients in the IRIS trial who have been treated 2-3 years and then accordingly the protocol may change.

Michele Baccarani,MD (University of Bologna, Bologna, Italy):

"In my opinion, all patients should be offered IM first, irrespective of the age and the availability of the donor, but NOT irrespective of risk. There is evidence from the IRIS study that high-risk patients respond somewhat less frequently to IM than do lower-risk patients. However, from IFN we have learned that high-risk patients who initially respond to therapy have a relatively short benefit and eventually relapse and progress. This phenomenon has already been seen with IM in accelerated phase CML, a high-risk condition. We do not know if this will occur in imatinib in high-risk chronic phase patients.

Until clear evidence exists, high-risk chronic phase patients should proceed to allo-SCT front-line or as soon as possible. The risk definition that should be used for patient selection should be that of Sokal. A new risk classification for IM-treated patients that incorporates cytogenetic and molecular data is clearly needed."

------
Hope you enjoyed the expert commentary by top CML experts regarding protocol in offering newly diagnosed patients IM or proceeding to a transplant. You will note that high-risk chronic phase patients are recommended by some experts to go for a transplant. Otherwise, IM remains front-line therapy in chronic phase.
                        - Anjana

Back
Back to Goldman's Protocol
Next Commentary on IM Monitoring

CML Prisms - Lit for the Asian CML Support Group Members

CML Expert Commentaries on To Transplant or Not ?  (BMT vs Glivec ?)

Brian Druker, MD (Oregon Health Sciences University):

"Although I generally agree with the proposed algorithm in Table 2, I have tended to use it less and less.

This is due largely to the fact that patient preference is the single most important deciding factor.

Thus, our current approach is to evaluate transplant options for all newly diagnosed CML patients, even if a patient has decided on Imatinib as their initial treatment.

In patients who do not achieve a CHR at 3 months or a MCR at 6 to 12 months, we would readdress transplant options. As the majority of patients achieve CCR, we use a 3-fold increase in the level of BCR-ABL positivity, confirmed on a repeat sample at least 1 month apart, as our trigger to reconsider transplant or change therapies."

BD goes on to point out that curative rate of transplant can range from 50-85% (depending on many factors) and the first-year mortality rate from 10-50% again depending on factors.

For IM, the cure rate is unknown, it never achieves the level of remission of a transplant but the first year survival on IM is in excess of 99% with a progression-free survival of 97.5%. However, the durability of remissions though encouraging in the short-term is unknown in the long-term since IM us a new drug.

Jorge Cortes, MD (MD Anderson Cancer Center):

"Two options are proposed, one is to offer IM to all patients and assess them early for response. The second is to use early stem cell transplant to treat some patients, usually the young and fit.

We favor the first option considering the very good results with IM.

Our approach thus is to offer all patients high dose IM as first line of therapy while still discussing transplant and HLA typing siblings from the onset of therapy.

Patients without a major cytogenetic remission at 1 year and with an expected transplant-related mortality of less than 30% can then be offered allogeneic transplant."

JC goes on to warn about the fact that mortality is not negligible in an SCT and the clear disadvantage of the second option.

Andreas Hochhaus, MD (Mannheim, Germany):

"The ultimate goal of the treatment of advanced disease must be to transplant eligible patients. Considering the high relapse rate, such patients should be transplanted soon after achieving hematological remission regardless of their cytogenetic status."

Francois Guilhot,MD (CHU La-Millerie, Poitiers, France):

"It is important to recognize that the response rate in IM is lower in patients with a high risk score according to the Sokal or Euro scoring system. However, a large percentage (~60%) of high-risk patients attain CCR while on IM therapy, which is higher than the response rates observed with IFN.

In view of this, physicians should seriously consider BMT in these patients, keeping in mind that the medical decision could be difficult."

Search the mariners faq and glossary
database

Join us in an on-line community

Join d discussion forum

Cml ahoy !