Dear Editor,
We have read the comments by Dr. Emre Eşkazan on our recent paper [Citation1] reporting the results of a multicenter study from Turkey which evaluated the efficacy and safety of nilotinib 300 mg twice daily among 112 patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP). This study reported the results of frontline nilotinib treatment in patients with CML-CP efficiently and safely.
The author asked for some further points to be clarified which were not mentioned in the paper. These data exists and we would like to counter comment as follows.
All patients were diagnosed within 6 months prior to the study enrolment and no treatments other than anagrelide, hydroxyurea (n = 38, median duration of treatment 22 days), and short-term imatinib (n = 8, median duration of treatment 20.5 days) were given. Patients did not receive therapy with any tyrosine kinase inhibitors before enrolment.
Although Sokal risk scores were identified in our study (), detailed information was not given except a statement in our paper on the higher proportion of patients with low-risk scores. In our study, Sokal risk stratification of patients was mainly distributed to low-risk and medium-risk groups and was similar to Evaluating Nilotinib Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients (ENESTnd) [Citation2] study. Saglio et al. reported with ENESTnd study that the patient group which received 300 mg nilotinib treatment had low Sokal risk (37%), whereas medium- and high-risk groups were identified as 36% and 21%, respectively. Additionally, a beneficial response was observed in patients through all Sokal risk groups.
Table 1. Sokal risk stratification.
On the other hand, in our study, no dose escalations were allowed in patients with treatment failure. Although a treatment modification might prove to be effective, such an option was not defined in our protocol for the sake of clarity and in the light of literature accumulated on Nilotinib treatment in CML-CP patients. However, Hochhaus et al. recently reported that, Nilotinib resulted in rates of BCR-ABL1IS 1% at 3 months as compared to imatinib as a key factor in long-term survival [Citation3]. Our data clearly showed that most of the patients (80%) achieved BCR-ABL1IS ≤10% at 3 months. However, we are still collecting data on complete cytogenetic response (CCyR), major molecular response (MMR), and deep molecular response (DMR) rates in our study group for providing outcomes in patients with BCR-ABL1IS and our results will be available soon.
We believe that our publication which presented the results of a study among Turkish patients with CML-CP receiving frontline nilotinib will provide further information after the completion of long-term evaluation of our patient group’ data and may support a beneficial treatment alternative with an acceptable safety profile.
Declaration of interest
G Saydam has received honoraria from Novartis, Celgene, Bristol-Myers Squibb, and Gilead; served on speakers bureaus for Novartis and Bristol-Myers Squibb, and served as a consultant for Novartis. IC Haznedaroglu has received research funding from, and served on advisory committees for, Novartis. AS Yavuz has served on advisory committees for Novartis. DZ Akkaynak and IM Dag are employees of Novartis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Writing assistance was utilised in the preparation of this manuscript; it was funded by Novartis and carried out by Karen Kaluza, PhD, and Joy Loh, PhD (both of ArticulateScience LLC).
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References
- Saydam G, Haznedaroglu IC, Kaynar L, et al. Outcomes with frontline nilotinib treatment in Turkish patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Expert Opin Pharmacother. 2016;17(14):1851–1858.
- Saglio G, Kim DW, Issaragrisil S, et al. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med. 2010;362(24):2251–2259.
- Hochaus D, Saglo G, Hugher TP, et al. Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial.Leukemia. 2016 May;30(5):1044–1054. Published online 2016 Mar 4. Pre-published online 2016 Feb 3. DOI:10.1038/leu.2016.5.