Table 1.
1 |
When a patient of yours receives a preliminary diagnosis of CML, where do you typically obtain confirmatory testing by cytogenetics and/or FISH? |
At your institution/hospital; Nearby institution/hospital lab in your country; Institution/hospital in another country; Commercial laboratory; Other |
2 |
When a new patient of yours receives a preliminary diagnosis of CML, where do you typically obtain confirmatory testing by qRT-PCR and / or BCR-ABL kinase domain mutation ? |
At your institution/hospital; Nearby institution/hospital lab in your country; Institution/hospital in another country; Commercial laboratory; Other |
3 |
When evaluating a patient with a white cell count (eg. 65,000) and a morphologic picture compatible with CML, which of the following initial diagnostic tests would you typically perform? Please choose all that apply. |
Bone marrow aspiration; Biopsy; Cytogenetics; FISH; Quantitative PCR; BCR-ABL mutation analysis; Other |
4 |
In addition to peripheral blood counts, which of the following do you routinely use in monitoring response to Imatinib therapy? Please choose all that apply. |
Cytogenetics; FISH; Quantitative PCR; BCR-ABL kinase domain mutation analysis; Other |
5 |
How frequently do you typically repeat cytogenetic analysis studies for monitoring response to Imatinib therapy? |
Every 3 months; Every 6 months; Every 12 months; Not routinely repeated; Other |
6 | How frequently do you typically repeat qRT-PCR for BCR-ABL for monitoring response to Imatinib therapy? | Every 3 months; Every 6 months; Yearly; Don’t utilize qRT-PCR |
7 |
How frequently do you typically repeat BCR-ABL kinase domain mutation studies for monitoring response to Imatinib therapy? |
When patients fail to achieve or lose their CyR; When patients fail to achieve or lose their hematologic response; When there is a 2-fold rise in BCR-ABL transcript levels; Never ordered the test; Unavailable; Not familiar with this test |
8 |
In a newly diagnosed 20-year old patient with chronic phase CML who has a matched related sibling, which of the following would you typically recommend? |
Imatinib 400 mg/day: Imatinib 600–800 mg/day; Allogeneic SCT; Interferon alpha; Other |
9 |
In a newly diagnosed 20-year old patient with chronic phase CML who has an unrelated matched donor, which of the following would you typically recommend? |
Imatinib 400 mg/day; Imatinib 600–800 mg/day; Allogeneic SCT; Interferon alpha; Other |
10 |
In a newly diagnosed 80-year old patient with chronic phase CML who has an unrelated matched donor, which of the following, would you typically recommend? |
Imatinib 400 mg/day; Imatinib 600–800 mg/day; Allogeneic SCT; Interferon alpha Hydroxyurea; Other |
11 |
In a patient with diagnosis of CML in chronic phase with a WBC of 225 × 109/L, how do you typically initiate therapy? |
Hydroxyurea until the WBC decreases significantly, then start imatinib; Start Imatini; Start Imatinib and hydroxyurea at the same time; Leukapheresis before imatinib; Leukapheresis and start imatinib; Other |
12 |
On a patient with CML in chronic phase in whom you started therapy with Imatinib but who has not achieved a complete hematologic response, at what point do you typically consider changing therapy? |
One Month; 2 months; 3 months; 6 months; 12 months; 18 months; Other |
13 |
On a patient with CML in chronic phase in whom you started therapy with Imatinib but who has not achieved any cytogenetic response (ie, still 100% Ph positive) at what point do you typically consider changing therapy? |
One Month; 2 months; 3 months; 6 months; 12 months; 18 months; Other |
14 |
On a patient with CML in chronic phase in whom you started therapy with Imatinib but who has not achieved a major cytogenetic response (ie, still >35% Ph positive), at what point do you typically consider changing therapy? |
One Month; 2 months; 3 months; 6 months; 12 months; 18 months; Other |
15 |
In a 70-year old patient with Philadelphia chromosome-positive CML in chronic phase on Imatinib 400 mg orally daily, which of the following strategies would you use routinely for monitoring response to Imatinib treatment? Please choose all that apply |
Blood counts; Cytogenetics; FISH; Quantitative PCR; Mutation analysis; Other |
16 |
In a 50-year old patient with Philadelphia chromosome-positive CML in chronic phase with a matched related sibling donor currently on Imatinib 400 mg daily, which of the following monitoring strategies would you use? Please choose all that apply. |
Blood counts; Cytogenetics; FISH; Quantitative PCR; Mutation analysis; Other |
17 |
In a patient with CML receiving therapy with Imatinib, which of the following would cause you to decide that the patient had experienced failure to therapy and should receive an alternative treatment? Please choose all that apply. |
At 3 months, no CHR; At 3 months, no CyR (ie, Ph+ 100%); At 6 months, no cytogenetic response (ie, Ph+ 100%); At 6 months, no major CyR (ie, Ph+ >35%); At 6 months, no CCyR (ie, Ph+ >0%); At 12 months, no CyR (ie. Ph+ 100%); At 12 months, no MCyR (ie, Ph+ >35%); At 12 months, no CCyR (ie, Ph+ >0%); At 12 months, no MMR (ie, <3-log reduction in BCR-ABL transcript levels); At 18 months, no CR (ie, Ph+ 100%); At 18 months, no MCyR (ie, Ph+ >35%); At 18 months, no CCyR (ie, Ph+ >0%); At 18 months, no MMR (ie, <3-log reduction in BCR-ABL transcript levels); At 18 months, no MMR (ie, <3-log reduction in BCR-ABL transcript levels); 2-fold rise in QPCR while in CCyR; ≥1 log rise in QPCR while in CCyR; Loss of CHR; Loss of CCyR; Loss of MCyR; None of the above |
18 |
Do you make a distinction between patients with failure to Imatinib and patients with suboptimal response to Imatinib? |
Yes, suboptimal response is a distinct entity; No, suboptimal response is the same as failure; No, patients are either failing or not |
19 |
If you do recognize suboptimal response as a separate entity, which of the following do you consider criteria for suboptimal response? Please choose all that apply. |
At 3 months, no CHR; At 3 months, no CyR (ie, Ph+ 100%); At 6 months, no cytogenetic response (ie, Ph+ 100%); At 6 months, no major CyR (ie, Ph+ >35%); At 6 months, no CCyR (ie, Ph+ >0%); At 12 months, no CyR (ie, Ph+ 100%); At 12 months, no MCyR (ie, Ph+ >35%); At 12 months, no CCyR (ie, Ph+ >0%); At 12 months, no MMR (ie, <3-log reduction in BCR-ABL transcript levels); At 18 months, no CR (ie, Ph+ 100%); At 18 months, no MCyR (ie, Ph+ >35%); At 18 months, no CCyR (ie, Ph+ >0%); At 18 months, no MMR (ie. <3-log reduction in BCR- ABL transcript levels); 2-fold rise in QPCR while in CCyR; ≥1 log rise in QPCR while in CCyR; Loss of CHR; Loss of CCyR; Loss of MCyR; None of the above |
20 |
On a 50-year old patient with a matched sibling donor who in your opinion has experienced failure to Imatinib 400 mg daily, what is your preferred course of action: |
Increase the dose of Imatinib to 600mg; to 800mg; Change therapy to Dasatinib to Nilotinib; Stem cell transplantation; Other clinical trials; Other |
21 |
On a 50-year old patient with a matched sibling donor who in your opinion has experienced suboptimal response to Imatinib 400 mg daily, what is your preferred course of action: |
Increase the dose of Imatinib to 600mg; to 800mg; Change therapy to Dasatinib; to Nilotinib; Stem cell transplantation; Other clinical trials; Other |
22 |
If you decide to increase the dose of Imatinib, how long do you try this approach before considering a change in therapy if not responding: |
3 months; 6 months; 12 months; 18 months; 24 months; Other |
23 |
For patients with suboptimal response to Imatinib do you typically assess for BCR-ABL kinase domain mutations? |
Yes; No |
24 |
For a 60-year old patient with CML who has failed Imatinib (using your standard criteria), and who has a matched related sibling. which of the following treatment options would you typically choose next? |
Allogeneic SCT; Dasatinib; Nilotinib; Low dose IFN, AraC, hydroxyurea, or combination of these; Other investigational strategy |
25 |
For a 60-year old patient with CML who has failed Imatinib (using your standard criteria), who has a matched unrelated donor, which of the following treatment options would you choose next? |
Allogeneic SCT; Dasatinib; Nilotinib; Low dose IFN, AraC, hydroxyurea, or combination of these; Other investigational strategy |
26 |
For a 35-year old with a matched sibling who is receiving Imatinib 400mg daily for CML in CP who is in complete cytogenetic remission and had achieved a major molecular response and now has a 5-fold increase in transcript levels and has lost major molecular response (but still in complete cytogenetic remission) your preferred course of action would be: |
Continue therapy unchanged; Increase the dose of Imatinib to 600mg daily; to 800 mg daily; Change therapy to Dasatinib; to Nilotinib; to stem cell transplant |
27 | In the case of this 35-year old patient, would you assess for mutations: | Yes; Would like to, but not available; No, only if the patient has lost cytogenetic or hematologic response ; Not in any instance |
28 | How would you use the information obtained from assessing mutations? Please choose all that apply. | Keep as background information only; Change therapy to a new TKI only if mutation is present; Select new TKI based on mutation detected; Transplant the patient if T315I found; Transplant the patent if P-loop found; Increase the dose only if not mutation identified; Other |
29 | How do you usually assess Imatinib-associated toxicity in your patients? | Frequent physician visits; Frequent nurse visits; Toxicity questionnaire completed by patients; Telephone query performed by nurse; Other |
30 |
Which, of the following Imatinib toxicities have you encountered in your patients with CML? Please check all toxicities as either “Ever encountered” or “Never encountered” |
CML indicates chronic myeloid leukemia; SCT, stem cell transplantation; FISH, fluorescence in situ hybridization; IFN, interferon; PCR, polymerase chain reaction; QPCR, Quantitative PCR; CHR, complete hematologic response; CyR, cytogenetic response; MCyR, major CyR; CCyR; CCyR, complete CyR; Ph, Philadelphia chromosome