Table 1.
Randomized controlled trials evaluating second-line chemotherapy in gemcitabine-refractory advanced pancreatic cancer
| Study | Treatment | No of patients | Median age | ECOG 0–1 (%)/KPS 90–100 (%) | Metastatic disease (%) | Response rate | Median response duration | Median PFS | Median OS |
|---|---|---|---|---|---|---|---|---|---|
| Ioka et al47 | S-1 + irinotecan S-1 |
60 67 |
62 65 |
100 100 |
100 100 |
ORR 18.3% ORR 6.0% |
TTF 2.1 months TTF 1.8 months |
3.5 months 1.9 months |
6.8 months 5.8 months |
| Ueno et al45 | SL S-1 |
69 71 |
65 64 |
100 100 |
NR NR |
ORR 27.5% ORR 19.7% |
TTF 3.7 months TTF 2.4 months |
3.8 months 2.7 months |
6.3 months 6.1 months |
| Gill et al12 | mFOLFOX6 FU/LV |
54 54 |
65 67 |
88.9 94.4 |
92.6 94.4 |
CR 0%; PR 13.2%; SD 44.7% CR 0%; PR 8.5%; SD 55.3% |
TTP 2.2 months TTP 3.8 months |
3.1 months 2.9 months |
6.1 months 9.9 months |
| Wang-Gillam et al11 | Nanoliposomal irinotecan plus FU/LV Nanoliposomal irinotecan FF |
117 151 149 |
63 65 63 |
59 57 51 |
100 100 100 |
ORR 16% ORR 6% ORR 1% |
TTF 2.3 months TTF 1.7 months TTF 1.4 months |
3.1 months 2.7 months 1.6 months |
6.1 months 4.9 months 4.2 months |
| Ohkawa et al46 | S-1 + oxaliplatin S-1 |
136 132 |
65 63.5 |
100 100 |
100 100 |
ORR 20.9% ORR 11.5% |
NR NR |
3.0 months 2.8 months |
7.4 months 6.9 months |
| Oettle et al10 | OFF FF |
76 84 |
62 61 |
53.9 47.6 |
88.2 88.1 |
CR 1.3% CR 1.2% |
TTP 2.9 months TTP 2.0 months |
2.9 months 2.0 months |
5.9 months 3.3 months |
| Ge et al44 | SL S-1 |
45 47 |
NR NR |
NR NR |
100 100 |
NR NR |
NR NR |
3.0 months 1.9 months |
6.3 months 5.5 months |
| Pelzer et al13 (terminated) | OFF BSC |
23 23 |
60 61 |
47.8 52.2 |
73.9 69.6 |
CR 0%; PR 0% CR 0%; PR 0% |
NR NR |
NR NR |
4.82 months 2.30 months |
| Ciuleanu et al14 | Glufosfamide BSC |
148 155 |
58 57 |
40 44 |
100 100 |
CR 0%; PR 2.1%; SD 31% CR 0%; PR 0.7%; SD 19% |
NR NR |
46 days 43 days |
105 days 84 days |
| Yoo et al27 | mFOLFIRI.3 mFOLFOX |
31 30 |
55 55 |
100 97 |
NR NR |
PR 0%; SD 23%; PD 68% PR 7%; SD 10%; PD 70% |
NR NR |
8.3 weeks 6.0 weeks |
16.6 weeks 14.9 weeks |
| Ulrich-Pur et al35 | Raltitrexed plus irinotecan Raltitrexed |
19 19 |
63 60 |
21 21 |
100 100 |
PR 16%; SD 32% PR 0%; SD 37% |
RD 14 weeks RD 11 weeks |
4.0 months 2.5 months |
6.5 months 4.3 months |
Notes: FU/LV = leucovorin 400 mg/m2 on Day 1, fluorouracil 400 mg/m2 bolus on Day 1, followed by fluorouracil 2,400 mg/m2 continuous infusion for 46 hours every 14 days. mFOLFOX6 = FU/LV plus oxaliplatin 85 mg/m2 on Day 1 every 14 days. FF = intravenous folinic acid 200 mg/m2 and continuous infusion of fluorouracil 2,000 mg/m2 over 24 hours on days 1, 8, 15, and 22 of a 6-week cycle. OFF = FF plus oxaliplatin 85 mg/m2 on days 8 and 22. mFOLFIRI.3 = irinotecan 70 mg/m2 on Day 1, leucovorin 400 mg/m2 on Day 1, fluorouracil 2,000 mg/m2 over 46 hours from Day 1, followed by irinotecan 70 mg/m2 every 2 weeks. mFOLFOX = oxaliplatin 85 mg/m2 on Day 1, leucovorin 400 mg/m2 on Day 1, followed by fluorouracil 2,000 mg/m2 over 46 hours every 2 weeks.
Abbreviations: BSC, best supportive care; CR, complete response; ECOG, Eastern Oncology Cooperative Group; KPS, Karnofsky performance status; NR, not reported; ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease; S-1, tegafur/gimeracil/oteracil; SL, S-1 plus leucovorin; TTF, time to treatment failure; TTP, time to progression.