Efficacyr
After a median follow-up of 56 months (IQR 31–77) in the doxorubicin only group and 59 months (IQR 36–72) in the combination group, no significant difference in overall survival (OS) was seen between the treatment arms.
Median OS was 14.3 months with doxorubicin/ifosfamide and 12.8 months with doxorubicin (HR 0.83; 95% CI: 0.67-1.03, p=0.076). Overall survival at 1 year was 51% (95·5% CI 44–58) in the doxorubicin alone group versus 60% (53–66) in the doxorubicin and ifosfamide group, whereas at 2 years it was 28% (22–34) and 31% (25–38), respectively. No significant difference was noted between the groups in the per-protocol analysis (p=0·057)
However, doxorubicin/ifosfamide was associated with a longer progression-free survival (median: 7.4 months versus 4.6 months; HR 0.74; 95% CI: 0.60-0.90, p=0.003) and higher overall response rate (26.5% versus 13.6%) compared with doxorubicin alone, but this was at the cost of increased toxicity.
Kaplan-Meier curves for overall survival (A) and progression-free survival (B)
HR=hazard ratio
© Lancet Oncol 2014
Best overall response:r
Best overall response to treatment differed significantly between the two groups in favour of doxorubicin and ifosfamide (31 [14%] of patients in the doxorubicin group and 60 [26%] in the doxorubicin and ifosfamide group had an overall response; p=0·0006).
|
Doxorubicin
(n=228)
|
Doxorubicin/Ifosfamide
(n=227)
|
Complete response |
1 (<1%) |
4 (2%) |
Partial response |
30 (13%) |
56 (25%) |
ORR |
14 % |
26% |
Stable disease |
105 (46%) |
114 (50%) |
Progressive disease |
74 (32%) |
30 (13%) |
Early death (progression) |
4 (2%) |
5 (2%) |
Early death (other cause) |
3 (1%) |
2 (1%) |
Not evaluable |
11 (5%) |
16 (7%) |