TABLE 6.2 Outcome of some of the Phase III clinical trials with ABC transporter inhibitors.Year
Trialgroup
Number of
patients
Cancer type
Modulator Anticancer drugs
Outcome
Reference
1995 MRC
235
Relapsed andrefractory AML
Cyclosporin Daunorubicin
CytarabineEtoposide
No benefit
Yin et al. (2001)
1998 SWOG
226
Poor-risk AML,
RAEB-t
Cyclosporin Daunorubicin
Cytarabine
Improved OS in
P-gp positive
patients
List et al. (2001)
1996 Novartis
256
AML
PSC833
DaunorubicinCytarabineEtoposide
No benefit
Sonneveld et al. (2001)
2000 CALGB
410
Untreated AML
PSC-833 Daunorubicin
EtoposideCytarabine
No OS advantage forthose
>
45 years; OS
benefit for those
<
45 years
Baer et al. (2002)
1996
315
Poor-risk acute
leukemia
Quinine
Mitoxantrone
Cytarabine
No benefit
Solary et al. (1996)
1996 GFM
131
High risk MDS
Quinine
Mitoxantrone
Cytarabine
Improved OS in
P-gp positive patients
Wattel et al. (1999)
1999 GEO-
LAMS
425
De novo
AML
Quinine
IdarubicineCytarabineMitoxantrone
Significant improvementin the CR rate in P-gp
positive patients.No OS advantage
Solary et al. (2003)
AML, acute myelogenous leukemia; CR, complete response; MDS, myelodysplastic syndrome; OS, overall survival; RAEB-t, refractory anemia with exce
ss of
blasts in transformation; RR, response rate.
156