Table 1.
Clinical trials (randomized phase II and phase III trials) in metastatic PDAC.
| Drug tested | Setting | Population | n | Outcomes | |
|---|---|---|---|---|---|
| Conroy et al. 6 | FOLFIRINOX versus gemcitabine | First-line | Metastatic PDAC | 342 | mOS 11.1 versus 6.9 months (HR 0.57; 95% CI [0.45–0.73]; p < 0.001) |
| mPFS 6.4 versus 3.3 months (HR 0.47; 95% CI [0.37–0.59; p < 0.001) | |||||
| Von Hoff et al. 7 | Gemcitabine-nab paclitaxel versus gemcitabine | First-line | Metastatic PDAC | 861 | mOS 8.5 versus 6.7 months (HR 0.72; 95% CI [0.62–0.83]; p < 0.001) |
| mPFS 5.5 versus 3.7 months (HR 0.69; 95% CI [0.58–0.82]; p < 0.001) | |||||
| Moore et al. 9 | Gemcitabine-erlotinib versus gemcitabine | First-line | Metastatic PDAC | 569 | mOS 6.24 versus 5.91 months (HR 0.82; 95% CI [0.69–0.89]; p = 0.038) |
| mPFS 3.75 versus 3.55 months (HR 0.77; 95% CI [0.64–0.92]; p = 0.004) | |||||
| Pelzer et al. 10 | OFF versus best supportive care | Second-line | Metastatic PDAC progressing on gemcitabine | 46 | mOS 9.09 versus 7.90 months (HR 0.50, 95% CI [0.27–0.95], p = 0.031) |
| Oettle et al. 11 | OFF versus 5-FU | Second-line | Metastatic PDAC progressing on gemcitabine | 168 | mOS 5.9 versus 3.3 months (HR 0.66; 95% CI [0.48–0.91]; p < 0.01) |
| Gill et al. 12 | mFOLFOX6 versus LV5FU2 | Second-line | Metastatic PDAC progressing on gemcitabine | 108 | mOS 6.1 versus 9.9 months(HR 1.78; 95% CI [1.08–2.93]; p = 0.024) |
| Yoo et al. 13 | mFOLFIRI-3 versus mFOLFOX | Second-line | Metastatic PDAC progressing on gemcitabine | 61 | 6-months survival rate 27% [95% CI (13–46)] versus 30% [95% CI (15–49)] |
| Wang-Gillam et al. 14 | Nal-IRI plus LV5FU2 versus LV5FU2 | Second-line | Metastatic PDAC progressing on gemcitabine | 417 | mOS 6.2 versus 4.2 months [HR 0.67; 95% CI (0.49–0.92); p = 0.012] |
| Dahan et al. 15 | FOLFIRINOX (arm A) versus FOLFIRINOX 4 months then LV5FU2 (arm B) versus gemcitabine and FOLFIRI.3 alternating every 2 months (arm C) | Maintenance | Metastatic PDAC | 273 |
mOS 10.1 months (arm A) 11.2 months (arm B) |
| 7.3 months (arm C) | |||||
| Reni, 201332 | Sunitinib versus observation | Maintenance | Metastatic PDAC without progression after 6 months of first-line chemotherapy | 56 | mPFS 3.2 versus 2 months [HR 0.51; 95% CI (0.29–0.89); p < 0.01] |
| mOS 10.6 versus 9.2 months [HR 0.71; 95% CI (0.40–1.26); p = 0.11] | |||||
| Golan et al. 16 | Olaparib versus placebo | Maintenance | Metastatic PDAC without progression after first-line platinum-based chemotherapy and BRCA1 or BRCA2 germline mutation | 154 | mPFS 7.4 versus 3.8 months [HR 0.53; 95% CI (0.35–0.82); p = 0.004] |
| mOS 18.9 versus 18.1 months [HR 0.91; 95% CI (0.56–1.46); p = 0.68] |
5-FU, 5-fluorouracil; BRCA1/2, breast cancer gene 1/2; CI, confidence interval; FOLFIRI-3, irinotecan 90 mg/m2 at days 1 and 3, 5-FU 2000 mg/m2 over 46 hours; FOLFIRINOX, 5-fluoruouracil, irinotecan and oxaliplatin; HR, hazard ratio; n, number of patients randomized; LV5FU2, 5-FU bolus 400 mg/m2 and 5-FU 2400 mg/m2 over 48 hours; mFOLFIRI-3, irinotecan 70 mg/m2 at days 1 and 3, 5-FU 2000 mg/m2 over 46 hours; mFOLFOX6, oxaliplatin 85 mg/m2, 5-FU bolus 400 mg/m2 and 5-FU 2400 mg/m2 over 48 hours; mOS, median overall survival; mPFS, median progression free survival; Nal-IRI, liposomal irinotecan, 5-FU; OFF, oxaliplatin, folinic acid and 5-FU; PDAC, pancreatic ductal adenocarcinoma