Efficacy
Fifty-nine patients aged 60 to 75 years were eligible for inclusion in the GHSG studyr; 93% had advanced disease. Patients received PVAG every 22 days for 6 to 8 cycles. Of these, 38 received treatment according to protocol, while five patients were excluded from treatment after 4 or 8 cycles because of insufficient response or progressive disease. At final restaging, 3 months after the end of therapy, a total of 46 responded with a complete response (CR)/complete response unconfirmed (CRu) (78%). The median relative dose intensity was 88% and was at least 80% in 45 of 57 evaluable patients (79%).
In a retrospective analysisr using the same treatment schedule, 26 of 49 patients were in CR (53%), 4 were in partial response (PR) (8%), and 19 patients progressed (39%). 46 patients were evaluated by PET-CT after chemotherapy, the CR and PR rates were 52% and 13%, with 35% of patients with stable or progressive diseases. With a median follow-up of 33.2 months (range, 14.3 -53.7), 26 (53%) patients progressed or relapsed. The median PFS was 21.6 months with a 3-year PFS rate of 48.6% (95% confidence interval (CI), 36,3-65,1). The median OS was 66.5 months with a 3-year OS rate of 73.7% (95%CI, 61.2-88.8).
Table 1: Final responser
© Blood 2011
The 3-year Kaplan-Meier estimates for OS and progression-free survival (PFS) were 66% (95% CI, 50%-78%) and 58% (95% CI, 43%-71%), respectively.
Image 1: Kaplan-Meier plots and 95% CIs for (A) OS, (B) PFS, (C) time to HL-related death, and (D) time to HL-related failure. r
© Blood 2011
A randomised phase II studyr of HL patients with early-stage unfavourable disease randomised 41 patients (median age 38 years, no patients over 60) to receive 8 cycles of PVAG-14 at 2 different doses of doxorubicin, 25 mg/m2 or 35 mg/m2. The CR rate was 98%, 2-year OS was 94.4%, and 2-year PFS was 94.3%.