Table 2.
Patients’ Characteristics and BV Efficacy Measures | UK-Wide [68] | Italian [69] | USA [70] | German [71] | Greek [58] | Italian [57] |
---|---|---|---|---|---|---|
Patients (#) | 99 | 30 | 15 | 9 | 20 | 71 |
Age (median (range)) | 32 (13–70) | 27 (NR) | 31 (16–64) | 36 (24–71) | 27 | 24% > 60 y |
ECOG PS ≥ 2 | 5% | NR | NR | 44% | NR | 0% |
Previous lines of Tx (median(range)) | 2 (2–4) | 2 (2–4) | 2 (2–4) | 3 (2–6) | 3 (2–11) | NR |
Salvage regimen | P/G | P/G/B | P | NR | NR | NR |
Response to salvage regimen | ||||||
Refractory (SD + PD) | 52% (15 + 37) | PET + in all pts | 73% (60 + 13) | 89% | 75% | NR |
PR | 38% | PET + in all pts | 27% | 11% | 20% | NR |
CR | 10% | 0% | 5% | NR | ||
Time from last treatment to BV (months; median (range)) | 2.5 (0.7–34.8) | NR | NR | 2 (1–22) | NR | NR |
Response to BV | ||||||
ORR | 56% | 40% | NR | 55% | NR | 51% |
CR | 29% | 30% | 53% | 33% | NR | 25% |
Subsequent autoSCT (or allo) | ||||||
Proceeded directly | 34% * | 47% † | 80% § | 44% | 40% ¶ | NR |
Proceeded after further Tx | 27% | 13% | 20% | 0% | 0% | NR |
No SCT | 39% ** | 40% | 0% | 55% | 60% ¶ | NR |
PS = performance status; Tx = treatment; SD = stable disease; PD = progressive disease; PR = partial remission; CR = complete response; ORR = overall response rate; SCT = alloSCT = allogeneic stem cell transplantation; NR = not reported; P =platinum-based; G = Gemcitabine-based; B = BEACOPP. * Almost all had responded to BV; 2/3 had CR after BV; ** typically refractory to BV and subsequent therapy, if given; 26% achieved short-lived PRs of 3.6 months median duration; † including 14 patients; nine in CR and five refractory to BV, § including 12 patients; eight in CR and four refractory to BV; ¶ Among 8/20 patients who proceeded to autoSCT only three responded (all PR); among 12/20 who did not undergo SCT, two responded (CR and PR) but refused further therapy.