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P.A. Carpenter et al.
data were necessary to enable meaningful analysis. Near real-time monitoring (8-10 weeks after diagnosis) was invoked later by the BMT CTN in an effort to improve the quality of clinically annotated data in a more recent prospective correlative study of serum biomarkers, GvHD and other clinical outcomes.28 These experiences from the 0801 CTN trial also directly informed simplifications implemented in the 2014 revision of the NIH diagnostic and response criteria.29.30
Regardless of treatment arm, success rates at 6 months were only modest; approximately half of all subjects failed to achieve a complete or partial response and remain alive without relapse or receipt of secondary immunosuppres- sive therapy. There were fewer relapses in the two-drug arm, which contained more patients with early stage dis- ease, more with acute leukemia (likely in first remission), and more recipients of myeloablative conditioning. Conceivably these chance imbalances might have resulted
Figure 4. Quality of life. Unadjusted graphs are shown for SF-36 quality of life scores:23 (left) Physical Component Summary scores; (right) Physical Functioning subscale scores.
AB
Figure 5. Six-month landmark analysis. (A) Overall survival after the 6-month landmark with a median follow up for survivors of 30 months. The mortality rates after the 6-month landmark were similar in the complete or partial response group and stable or progressive disease group (hazard ratio, 0.71; 95% confidence interval: 0.17-2.96; P=0.63) or secondary treatment groups (hazard ratio, 0.54; 95% confidence interval: 0.13-2.26; P=0.39), respectively. (B) Cumulative incidence of dis- continuation of immunosuppressive therapy after the 6-month landmark. Patients who died or were lost to follow up or experienced relapse before the landmark were excluded (n=19) and no patients ended immunosuppressive therapy before the landmark. CR/PR: patients with complete or partial response without relapse and without secondary therapy at the time of assessment (n=68). SD/PD/Rx: patients not in complete or partial response and alive without relapse and without sec- ondary therapy at the time of assessment (n=31), and patients who had secondary therapy without relapse regardless of response before the landmark (n=16); IST: immunosuppressive therapy.
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haematologica | 2018; 103(11)