Technology Assessment: Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy, Part 3. Imatinib for Chronic Myeloid Leukemia (CML). Table 15

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Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy

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Table 15. Characteristics Predictive of Disease Response or Survival: Group 4—Other Factors

Prognostic factor	Studies indicating an association and quality	Strength of association with tumor response
Bone marrow cellularity	Frater, 2003¹⁰⁹ (Quality = 1/5) CP-IFN-r	BM cellularity 100% N =13 with decrease when responds to I
Myelosuppression	Sneed, 2003¹¹⁰ (Quality 5/6) CP-IFN-r	Any myelosuppression >Grade 3: Yes (N=76) MCR 62% CCR 45% No (N=67) MCR 78% CCR 64% p=0.01 Any myelosuppression >Grade 3 for > 2wk duration: Yes (N=50) MCR 58% CCR 36% No (N=93) MCR 75% CCR 63% p=0.001
Persistent BCR-ABL in CD34+ cells after CCR with I	Bhatia, et al., 2003²⁷ (Quality = 2/5) CP & AP	100% (N=15) had persistent evidence of BCR-ABL by FISH or RT-PCR up to 61 months (range 1-61) after starting I
Evidence of BCR-ABL in CCR	Paschka, 2003¹⁰ (Quality = 4/6) CP, AP & BC	21/68 (31%) samples derived from pts in CCR by conventional cytogenetics have evidence of residual disease by HM-FISH All (N=234) samples of CCR patients had evidence of BCR-ABL by RT-PCR
Abnormal cytogenetics in Ph- cells	O'Dwyer, 2003³⁵ (Quality 2/5) CP-IFN-r	Clones with abnormal cytogenetics could be identified in the Ph- cells of 7 patients in MCR; link to disease outcome not presented

Abbreviations: AP = Accelerated Phase; BC = Blast crisis; CP = Chronic Phase; CCR = complete cytogenetic response; I = Imatinib; MCR = Major cytogenetic response, Ph- = Philadelphia chromosome negative; pt(s) = patient(s)

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