Dear Allyson, Just to make you smile, here is what Dr. Talpaz said about Interferon.(he invented the drug)
http://www.healthtalk.com/otherconditions/programs/14_458/page01.cfm "My claim to fame, or rather infamy, is the introduction of alpha interferon in 1980. This is not a drug. This is a natural substance, a cytokine [a substance that helps regulate immunity in the cells], but it was terribly toxic. And as much as it had an impact on survival - the median survival was prolonged to about seven-and-a-half years, that's an addition of two years - regretfully, some of the patients couldn't pay attention to it because we made them walking zombies." He has a great sense of humor and did so much for CML by giving hope in a small subset of patients, 10-15%, who achieved remission using Interferon as monotherapy. This was a stepping stone to Gleevec that gives 87% rate of remission and Dr. Talpaz, himself, advocates Gleevec as first-line therapy and also ran the first trials on Dasatinib which is saving lives of Gleevec-resistant patients. Interferon can be associated with severe memory problems, people who took Interferon referred to this as "Interferon fog." GI upsets may, though, be due to 800mg Gleevec. Dr. Druker's nurse, Carolyn Blasdel gave an excellent webcast on remedies of Gleevec side-effects and you can also ask your nurse if she can suggest something. Below find the combo results of Gleevec/Interferon. You are very right in interpreting your doctor's observation, the most severe side-effect was hematologic toxicity, in other words, low counts. And the combo only used 400mg Gleevec. The results compared side-effects of Gleevec monotherapies at 400mg and 600mg with Interferon and Ara-C combos and more patients of the Interferon/Gleevec combo discontinued due to side-effects. One thing your doctors may be considering is that since your PCR has become stable and not going down any further with the combo, why continue with added toxicity. That is why they are reducing the Interferon or taking it off. I know quite a few patients who went on Gleevec/IFN/GCSF combos and they are all only on Gleevec, now. There are a few patients in Germany, however, who were on IFN/Gleevec and became PCRU on the therapy and after remaining PCRU for sometime, a few are now only on Interferon, having taken off Gleevec. So, watch the results of this trial with interest. Whether PCRU can be maintained with Interferon and then later on, if one can go off meds and still maintain remission. A few Interferon monotherapy patients in the past could remain in remission off Interferon and it will be really interesting to see if this holds with Gleevec/Interferon combo patients. Some doctors think, maybe not, since Gleevec can suppress the immune system and may neutralize IFN's efforts to stimulate it and that is the rationale behind combo patients going on IFN monotherapy after PCRU without the Gleevec to see if the immune response is stimulated allowing them to go off meds. Best Wishes, Anjana caregiver to Roy RANDOMIZED COMPARISON OF IMATINIB WITH IMATINIB COMBINATION THERAPIES IN NEWLY DIAGNOSED CHRONIC MYELOGENOUS LEUKEMIA PATIENTS: DESIGN AND FIRST INTERIM ANALYSIS OF A PHASE III TRIAL 1026 FG Guilhot, P Rousselot, P Cony-Makhoul, JJ Sotto, B Rio, H Guy, H Tilly, M Schoenwald, JJ Kiladjian, E Jourdan, CE Bulabois, B Christian, P Rousselot (Poitiers, France) Background: Imatinib (IM) at 400 mg daily has emerged as the preferred therapy for newly diagnosed CML pts. Despite impressive results, only a minority of pts treated with IM achieved a molecular remission. To improve upon these results, the CML French Group designed a phase III, multicentre, open-label, prospective randomized trial. Methods: The experimental arms are IM 400 mg daily in combination with Peg-IFNa 2a, 90 µg weekly or IM 400mg daily in combination with Ara-C, (20 mg/m2/day, days 15-28 of 28-day cycles ) or IM 600mg daily. The reference arm is IM 400mg daily. All pts (over 18 years of age with Bcr-Abl positive CML in chronic phase within 3 months of diagnosis) receive IM 400 mg/day as monotherapy days 1-14 and then start the assigned randomized regimen. Treatment continues at least 12 months or until treatment failure or major toxicity. The primary endpoint will be the overall survival. Other endpoints will be: rate and duration of hematologic and cytogenetic responses, major (MCyR) and complete (CCyR), molecular response and the tolerability. Using treatment allocation ratio 1.1.1.1, randomization is stratified according to Sokal risk groups. An interim analysis of the first 636 patients (a=0.85%, ß=10%) at 1 year from randomization will allow evaluation of molecular response rates, one of the experimental arm being selected for further comparison with IM 400. The increased dose of IM or a combination regimen would be considered as promising if it increased the 4 log reduction response rate by at least 20 percentage points, e.g. from 15% to 35%, with an acceptable tolerability. Evaluation of molecular response up to 12 months is centralized and blinded. Results: This evaluation is based on a cohort of 315 pts with a median time of observation of 12 months, [median age 53 yrs (18-78), 60% of pts were male; Sokal risk distribution: 39% of pts low risk, 38% intermediate risk, and 23% high risk]. At 3 months 82% of pts achieved complete hematologic response. Cytogenetic data are available from 154 pts. At 6 months, 135 pts (87%) achieved a MCyR, being complete in 105 pts (68%). Grade 3/4 neutropenia and thrombocytopenia occurred in 5% and 0% of IM400 pts , in 5% and 1% of IM600 pts, in 30% and 4% of IM+IFN pts and in 24% and 13% of IM+Ara-c pts respectively. Dose of Peg IFN was reduced in 16% of pts, 45 µg per week being well tolerated. Grade 3/4 non hematological toxicity occurred in 6% of IM400 pts (mainly skin rash and muscle cramps), in 10% of IM600 pts, in 5% of IM+IFN pts (maily skin rash) and in 13% of IM+Ara-c pts ( mainly diarrhea). Discontinuation of experimental treatment occurred in 15% of IM600 pts, 28% of IM+IFN pts and in 13% of IM+Ara-c pts. Conclusions: This first analysis has proven feasibility of IM combinations in addition to high response rates. However a substantial hematological toxicity was recorded with IFN or Ara-c combination, which requires a careful assessment during the first 6 months of treatment. --~--~---------~--~----~------------~-------~--~----~ [CMLHope] A support group of http://cmlhope.com ------------------------------------------------- You received this message because you are subscribed to the Google Groups "CMLHope" group. 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