First Quarter 2008 - Issues in Hematology - ION Solutions

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drug updateoncologistics volume 7, issue 1 - spring 2008 32PROLONGED SURVIVAL IN HIGHER-RISK MDSFrom Abstract #817 in Blood, Volume 110, Issue 11,November 16, 2007A previous Cancer and Leukemia Group B (CALGB) trial,CALGB 9221, showed a positive overall survival (OS)trend with Vidaza versus best supportive care (BSC)in MDS patients. With this in mind, a new Phase III,international, multicenter, randomized, prospective trialwas initiated to demonstrate the superiority of Vidazaplus BSC over conventional care regimens (CCR) plusBSC for prolonging OS. In this study, only higher-riskMDS patients—those presenting with a FAB defi ned asRAEB, RAEB-T, or CMML (10-29% marrow blasts) withan IPSS of Int-2 or High by central pathology/cytogeneticreview—were eligible.Before randomization, trial participants chose amongone of three conventional care regimens: BSC only,low-dose ara-C (LDAC, 20 mg/m 2 /d x 14d, q 28d), orstandard chemotherapy. Patients were then stratifi ed byFAB/IPSS and randomized to Vidaza (75 mg/m 2 /d x 7d,q 28d) or CCR. During the trial, Vidaza was administeredfor a median of nine cycles and the median follow-upfor OS analysis was 21.1 months. Results showed thatVidaza demonstrated statistically superior OS versusCCR, with a median OS (Kaplan-Meier ) of 24.4 monthsversus 15 months, respectively (p=0.0001). The hazardratio was 0.58 for a 74% OS improvement. There wasa two-fold increase in the percent surviving at 2 yearsfor the Vidaza group, 50.8% compared to 26% for thosein the CCR group.In the trial, Vidaza was well tolerated, and the safety datawas consistent with previous reports. This trial involvingVidaza was the fi rst MDS clinical study demonstratinga signifi cant OS advantage that altered natural diseasecourse, and supports the notion that Vidaza should beconsidered fi rst-line therapy for higher-risk MDS patients.ALTERNATE DOSING IN MDSFrom Abstract #819 in Blood, Volume 110, Issue 11,November 16, 2007At a dosing schedule of 75 mg/m 2 /day subcutaneousfor 7 days every 4 weeks, Vidaza has proven to be aneffective treatment for patients with MDS. However, manypatients, as well as clinicians, would benefi t from theconvenience of a dosing schedule that does not includeweekend administration. The initial phase of an ongoingstudy evaluating three alternative dosing schedules wasrecently completed.In this Phase II multicenter, open-label trial, MDS patientswere randomized to one of three regimens administeredevery 4 weeks for 6 cycles: Vidaza 5-2-2 (75 mg/m 2 /dayx 5 days, followed by 2 days without treatment, followedby 75 mg/m 2 /day x 2 days); Vidaza 5-2-5 (50 mg/m 2 /dayx 5 days, followed by 2 days no treatment, followed by50 mg/m 2 /day x 5 days); or Vidaza 5 (75 mg/m 2 /dayx 5 days). Hematologic improvements were assessedby International Working Group (IWG) criteria andparticipants with >56 treatment days were evaluablefor response. To determine whether or not the desiredresponse was maintained after 6 cycles of therapy,a 12-month maintenance phase using the Vidaza5 regimen administered every 4 or 6 weeks wassubsequently added. Patients who presented with atleast stable disease were eligible to participate in thisphase of the study.A total of 151 patients were randomized to treatmentwith Vidaza 5-2-2 (n=50), Vidaza 5-2-5 (n=51), or Vidaza5 (n=50). Of the 139 patients (92%) who received>56 days of treatment and were evaluable for response:74 (49%) completed >6 treatment cycles. Of IWGevaluablepatients, 71 (51%) experienced hematologicimprovements. The proportions of red blood cell (RBC)transfusion-dependent patients who achieved transfusionindependence were Vidaza 5-2-2: 55%, Vidaza 5-2-5:60%, and Vidaza 5: 67%. In FAB low-risk (RA/RARS)transfusion-dependent patients at baseline, RBCtransfusion independence was reached by 60%, 56%,and 61%, respectively. No treatment-related mortalityhad been reported at the time of the study’s release.Most grades 3 and 4 treatment-related adverse eventswere hematological.Independent of the alternative dosing regimen, theresults of the initial 6-cycle treatment phase demonstratea consistent response for hematologic improvements,
oncologistics drug updateRBC transfusion independence, and safety profi le acrossa broad range of MDS patients, including FAB low-riskpatients. The majority of patients treated in this studyto date are lower-risk patients (RA and RARS) and thusthe alternative dosing schedules produce hematologicimprovements and transfusion independence. The impactof these alternative regimens on survival of higher-riskpatients is unknown and thus these alternative doseregimens cannot be recommended as equivalentsubstitutes for the standard 7 consecutive day regimen.AZACITIDINE (VIDAZA) AND AMLFrom Abstract #1849 in Blood, Volume 110, Issue 11,November 16, 2007Approved for MDS by the FDA, Vidaza is also currentlybeing investigated in AML. ATUs are patient-namedprograms launched by French health authorities forpromising drugs that have yet to be approved. A programis currently ongoing for Vidaza in MDS and AML. FromSeptember 2004 through June 2007, 108 AML patientswho had completed one or more courses of Vidazaparticipated in the program. The participants receivedVidaza 75 mg/m 2 /d (d 1-7) subcutaneous every 4 weeksfor a minimum of 4 courses.Median age in the study was 75 years, with a male tofemale ratio of 66/42. Fifty-one patients had AML withoutand 57 patients with preceding MDS, p-AML and s-AML,respectively. Patients received a median of 4 cyclesof therapy [range 2-16], and response was assessedonly after these 4 cycles, with patients who progressedbefore the exception. As such, 15 patients were not yetevaluable, and of the remaining 93 patients, 12 achievedcomplete response, 34 achieved partial response (PR)(OR=49%) and 43 (46%) were considered failure.Four patients died before end of cycle 2, withoutevidence of progression. Thirty-fi ve of the 46 respondersreceived maintenance therapy after response wasachieved. Myelosuppression led to dose reductionin 16% of patients and the hospitalization of 17% ofpatients, but no toxic deaths were seen. Other sideeffects included local reactions (reversible with localNSAID) (19%), and grade I-II gastrointestinal disorders(52%). OR was 34% (11% CR+23% PR) in p-AML and60% in s-AML patients (12% CR+48% PR) (p1 relapse/refractory (p
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First Quarter 2008 - Issues in Hematology - ION Solutions

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