Table 3.

Observational Studies of IFN- Combined With Other Drugs in the Treatment of CML

Authors, Year No.PatientsPopulation Description rIFN-α Dose (MU/M2/d) Other Agent3-150Med f-u (mo)Outcomes
Hematologic Response3-151Cytogenetic Response3-152Survival
CHR % PHR % CCyR % PCyR % 5-yr % Med (mo)
rIFN- + HU and/or BUS 
Kantarjian et al,15 1995  274 CP-Ph+, med age = 41, <12 mo (med) from dx, 64% symptomatic, 54% with prior treatment, 36% with splenomegaly   5
HU rIFN-γ  		52  80  7  26  12  63  89  
Alimena et al,20 1990  114  CP 92%, Ph+, mo from dx NR, 67% with prior treatment   2-5 HU  32  54  45 Median of Ph+
 cells = 65%
 		NR  NR 
Freund et al,40 1993  46  CP-Ph+, med age = 45, mo from dx and other clinical characteristics NR, none with prior treatment    3 BUS induct  20  59  30  13 4  NR  NR 
rIFN- + Cytarabine (Ara-C)  
Henic et al,31 1996  64  Newly diagnosed Ph+; otherwise clinical presentation, med age, prior treatment NR   5 with or without  Ara-C  NR NR  NR  13  NR  NR  NR 
Freund et al,40 1993  48  76% Ph+, CP, med age = 45, mo from dx and other clinical characteristics NR, 31% with prior treatment   3 Ara-C  8  50  31  0  8 NR  NR  
Kantarjian et al,39 1992  40  CP (>1 yr), Ph+, 40% over age 50, 28% with splenomegaly, some with prior treatment   5 Ara-C  Up to 60  55  3 0  5  75% at 3 yr  
Guilhot et al,52 1990  24  CP 96%, Ph+, med age = 45, mo from dx NR 50% with prior treatment   5 HU, Ara-C  40 NR  NR  42  NR 70% at 40 mo  
Hochhaus et al,301996  106  CP, Ph+/bcr/abl+, med age = 45, mo from dx NS, at least 9% with prior treatment   IFN3-153 HU BUS, Ara-C, other  26  NR  NR  23% 20%  NR  NR  
Kantarjian et al,28 1991 32  CP-Ph+, med age = 36, mo from dx NR, 28% with prior treatment   3-5 Ind:dauno, Ara-C,  vincr, pred  67 100  NR  41  19  58% at 6 yr  
Nagler et al,53 1994  10  CP 70%, Ph+, med age = 37, 36 mo (med) from dx, no matched donor for BMT, no other chemotherapy within 6 wk of study, 100% with prior treatment  3 HU, interleukin  16  60  30  10 NR  NR  NR  
Arlin et al,54 1990  15 CP, CML definition NS, med age = 34, 4 mo (med) from dx, prior treatment NR   3 HU, Ara-C, dauno  NR NR  NR  20% with up to
 “one third
 reduction of
 pretreatment
 value”
 		NR  NR 
Authors, Year No.PatientsPopulation Description rIFN-α Dose (MU/M2/d) Other Agent3-150Med f-u (mo)Outcomes
Hematologic Response3-151Cytogenetic Response3-152Survival
CHR % PHR % CCyR % PCyR % 5-yr % Med (mo)
rIFN- + HU and/or BUS 
Kantarjian et al,15 1995  274 CP-Ph+, med age = 41, <12 mo (med) from dx, 64% symptomatic, 54% with prior treatment, 36% with splenomegaly   5
HU rIFN-γ  		52  80  7  26  12  63  89  
Alimena et al,20 1990  114  CP 92%, Ph+, mo from dx NR, 67% with prior treatment   2-5 HU  32  54  45 Median of Ph+
 cells = 65%
 		NR  NR 
Freund et al,40 1993  46  CP-Ph+, med age = 45, mo from dx and other clinical characteristics NR, none with prior treatment    3 BUS induct  20  59  30  13 4  NR  NR 
rIFN- + Cytarabine (Ara-C)  
Henic et al,31 1996  64  Newly diagnosed Ph+; otherwise clinical presentation, med age, prior treatment NR   5 with or without  Ara-C  NR NR  NR  13  NR  NR  NR 
Freund et al,40 1993  48  76% Ph+, CP, med age = 45, mo from dx and other clinical characteristics NR, 31% with prior treatment   3 Ara-C  8  50  31  0  8 NR  NR  
Kantarjian et al,39 1992  40  CP (>1 yr), Ph+, 40% over age 50, 28% with splenomegaly, some with prior treatment   5 Ara-C  Up to 60  55  3 0  5  75% at 3 yr  
Guilhot et al,52 1990  24  CP 96%, Ph+, med age = 45, mo from dx NR 50% with prior treatment   5 HU, Ara-C  40 NR  NR  42  NR 70% at 40 mo  
Hochhaus et al,301996  106  CP, Ph+/bcr/abl+, med age = 45, mo from dx NS, at least 9% with prior treatment   IFN3-153 HU BUS, Ara-C, other  26  NR  NR  23% 20%  NR  NR  
Kantarjian et al,28 1991 32  CP-Ph+, med age = 36, mo from dx NR, 28% with prior treatment   3-5 Ind:dauno, Ara-C,  vincr, pred  67 100  NR  41  19  58% at 6 yr  
Nagler et al,53 1994  10  CP 70%, Ph+, med age = 37, 36 mo (med) from dx, no matched donor for BMT, no other chemotherapy within 6 wk of study, 100% with prior treatment  3 HU, interleukin  16  60  30  10 NR  NR  NR  
Arlin et al,54 1990  15 CP, CML definition NS, med age = 34, 4 mo (med) from dx, prior treatment NR   3 HU, Ara-C, dauno  NR NR  NR  20% with up to
 “one third
 reduction of
 pretreatment
 value”
 		NR  NR 

Abbreviations: Ara-C, cytarabine; CHR, complete hematologic response; PHR, partial hematologic response; CCyR, complete cytogenetic response; PCyR, partial cyogenetic response; CP, chronic phase; MU, mega units; NR, not reported; dauno, daunomycin; ds, disease; dx, diagnosis; f-u, follow-up period (mo); induct, induction; med, median; med age, in years; pred, prednisone; vincr, vincristine.

F3-150

Protocols for rIFN-α and combination agent highly variable across studies. Dosage generally increased to highest tolerable dose or specified ceiling (eg, 5, 7, or 10 MU/d), continued for varying periods (1-24 mo, depending on study), and reduced or discontinued for remission, no response, disease progression, toxicity, or crossover to BMT.

F3-151

Generally based on M.D. Anderson criteria, but details vary across studies. M.D. Anderson criteria: CHR = normal WBC count, platelet count, and differential all normal and disappearance of symptoms/signs; PHR = decrease in WBC count to <50% of pretreatment level and <20,000/μL or normalization of WBC count with persistent splenomegaly or immature cells in the peripheral blood.

F3-152

With exception of Henic et al, defined on the basis of M.D. Anderson criteria and percentage of Ph+ metaphases on most favorable karyotype. M.D. Anderson criteria: CCyR = 0% Ph+ metaphases; PCyR = 5% to 34% Ph+; denominator used for calculating response rate is original sample size.

F3-153

IFN: rIFN-α2a, b, or c, or lymphoblastoid IFN-αn1. Dose is NR.

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