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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 12. Tumor Characteristics Predictive of Disease Response or Survival: Group 1B—DNA Factors Evaluated During Imatinib Therapy

Prognostic factor Studies indicating an association and quality Strength of association with tumor response Strength of association with survival
Cytogenetic response to imatinib Marin, Marktel, Szydlo, et al., 200368
(Quality 5/5)
CP-IFN-r
Achieved at least a minor CR with I:
RR for PFS = 0.09 (CI 0.03-0.25, p<0.0001)

No cytogenetic response with I:
RR for OS = 1.94 (CI 1.22-3.01, p=0.0053)
Achieved at least a minor CR with I:
RR for OS = 0.13 (CI 0.05-0.39, p=0.0002)

No cytogenetic response with I:
RR for OS = 1.69 (CI 1.09-2.64, p=0.02)

Adjusted probabilities of OS at 8 years were 78% (CI 51-93%) for responders, 23% (CI 18-29%) for IFN refractory historical controls not getting I, and 6% (CI 2-17%) for non-responders
O'Dwyer, 200496
(Quality 2/5)
CP-IFN-r
Relationship of MCR to hemotologic relapse:
No MCR: N= 77 26%
   p=0.0339
MCR: N = 64 3%
HR 0.193 (CI 0.042-0.883)
 
Rosti, 20048
(Quality 4/5)
CP
  Achieved at least a MCR with I:
OS estimated from KM at 26 mo median f/u
No MCR = 92%
   p=0.037
MCR = 97%
Silver, 200483
(Quality*)
CP, AP, BP
  AP: Relationship between MCR at 3 mo and 3-yr survival:
MCR at 3 mo - 85% 3-yr OS
No MCR - 52% 3-yr OS
   p<0.001

CP: Relationship between at least a MinorCR at 6 mos and 3-yr survival:
MinorCR at 6 mo - 96% 3-yr OS
No MinorCR at 6 mo - 86% 3-yr OS
   p<0.001
Karntarjian, Cortes, et al., 200472
(Quality 5/6)
CP-IFN-r
Relationship between Major or Minor CR and 4-yr PFS:
CR = 93%
No CR = 55%
   p<0.0001

Relationship between Major CR at 6 mo and 4-yr PFS:
CR = 94%
No CR = 51%
   p<0.0001
Relationship between MCR or MinorCR and 4-yr OS:
CR = 95%
No CR = 72%
   p<0.0001

Relationship between MCR or MinorCR at 6 mo and 4-yr OS:
CR = 96%
No CR = 70%
   p<0.0001

In multivariate analysis, MinorCR or MCR at 3 and 6 mo predict survival (p=0.03 and 0.01, respectively).
*Guilhot, 200462
(Quality*)
CP-new diagnosis
Relationship between MCR at 6 mo and 30-mo PFS:
MCR at 6 mo (n=407) - 97%
No MCR at 6 mo (n=124) - 89%
   p<0.001
Relationship between MCR at 6 mo and 30-mo OS:
MCR at 6 mo (n=407) - 97%
No MCR at 6 mo (n=124) - 92%
   p=0.0162
Marin, Marktel, Bua, et al., 200375
(Quality 2/5)
CP
Relationship to PFS (described in terms of % of Ph+ metaphases at 3 months):
Ph+ 0-65% (Minor CR + MCR): N= 52 83%
   p=<0.0001
Ph+ > 65% (No CR): N = 88 32%
Relationship to OS:
Ph+ 0-65%: N= 52 96%
   p=<0.0001
Ph+ >65%: N = 88 52%
Change in CD34+ cells in the bone marrow *Marin, 2004100
(Quality*)
CP
Degree of reduction of CD34+ cells—RR for PFS = 0.88
(CI 0.53-0.93)
   p=0.006
 

Abbreviations: * = abstract; AP = Accelerated phase; BP = Blastic phase; CI = 95% confidence interval; CP = Chronic phase; f/u = followup; HR = Hazard Ratio; I = Imatinib; IFN = Interferon; IFN-r = IFN refractory; K-M = Kaplan-Meier; OS = overall survival; EFS = event-free survival; M = Male; MCR = major molecular response; minorCR = minor molecular response; OS= Overall Survival; PFS = progression-free survival; pt(s) = patient(s); RR = relative risk

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