Table 2.
Overall survival (OS) with first-line nab-P/Gem in studies of ≥45 patients with metastatic pancreatic cancer
First author, year | Type of study | Agent(s)a | n | Age, median, years | PS | Median OS (95% CI), months | P value |
---|---|---|---|---|---|---|---|
Von Hoff, 201110 | Ph I/II | nab-Pb/Gem | 67 | 61c | ECOG 0–1 | 12.2c | NR |
Cartwright, 201411 | Retro | nab-Pd/Gem | 189 | Gem-based regimens: 70 | Gem-based regimens: | 10.2 | NR |
Gem + other chemo | 1,567 | KPS <70, 7% | 7.0 | ||||
FOLFIRINOX | 666 | 60 | KPS <70, 1% | 11.2 | |||
Santoni, 201412 | Retro | nab-Pd/Gem | 41 | 66 | NR | 11.6 | NR |
Gem | 159 | 5.5 | |||||
Gem + cisplatin/oxaliplatin | 234 | 7.5 | |||||
Gem + capecitabine | 43 | 9.1 | |||||
FOLFIRINOX | 101 | 13.0 | |||||
Krishna, 201513 | Retro | nab-P/Geme | 49 | 65 | ECOG 0–1 | 11.1 (5.3–not reached) | NA |
MPACT | Ph III | nab-P/Gem | 431 | 62 | KPS <80, ≈7% | 8.7 (7.9–9.7) | <0.001 |
Goldstein, 20155 | Gem | 430 | 63 | KPS <80, 8% | 6.6 (6.0–7.2) | ||
Giordano, 201550 | Retro | nab-Pf/Gem | 208 | 67 | ECOG PS 2, 17.8% | 11 (8.8–13.2) | NA |
Shen, 201617 | Ph II | nab-P/Gem | 83 | 57 | KPS 70–80, 30% | 9.2 (5.29–7.16) | NA |
Hammel, 201615 | Ph II | nab-P/Gem | 39 | 65.3 | ECOG 2, 15.4% | 9.2 (6.0–13.6) | NR |
nab-P + sLV5FU2 | 75 | 66.2 | ECOG 2, 16.0% | 11.4 (8.8–16.6) |
Notes:
nab-P at 125 mg/m2 the first 3 of 4 weeks (qw 3/4) unless otherwise indicated.
nab-P at 100, 125, or 150 mg/m2 qw 3/4.
For nab-P 125 mg/m2 qw 3/4 (n=44).
Dose and schedule of nab-P not reported.
nab-P at 125 mg/m2 and Gem at 1,000 mg/m2 both given q2w. Supportive care also included dexamethasone 12 mg 30 min prior to chemotherapy administration.
nab-P at 100 or 125 mg/m2 qw 3/4.
Abbreviations: chemo, chemotherapy; CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; FOLFIRINOX, folinic acid, 5-fluorouracil, irinotecan, and oxaliplatin; Gem, gemcitabine; KPS, Karnofsky performance status; NA, not applicable; NR, not reported; nab-P, nanoparticle albumin-bound paclitaxel; Ph, phase; PS, performance status; Retro, retrospective; sLV5FU2, simplified leucovorin and 5-fluorouracil regimen.