Table 2.
Neoadjuvant treatment in resectable PDAC.
| References | Type of study | Treatment | No. of patients | Resection rate (%) | R0 (%) | mOS (mo) |
|---|---|---|---|---|---|---|
| RESULTS OF NEOADJUVANT THERAPY FOR RESECTABLE PDAC | ||||||
| Neoadjuvant chemotherapy alone | ||||||
| Heinrich et al. (87) | Phase II | Gem/Cis | 28 | 89 | 80 | 27 |
| Tajima et al. (89) | Retrospcective | Gem/S1 | 34 | 100 | 85 | 56% 2-year OS |
| O'Reilly et al. (91) | Phase II | GemOx | 38 | 71 | 74 | 27 |
| Unno et al. (94) | Phase II/III | Gem/S1 | 362 | 37 | ||
| Neoadjuvant chemoradiotherapy | ||||||
| Talamonti et al. (85) | Phase II | Gem + CRTx | 22 | 85 | 80 | 26 (resected) |
| Evans et al. (86) | Phase II | Gem + CRTx | 86 | 74 | 86 | 22 |
| Turrini et al. (88) | Retrospective | 5-FU/Cis + CRTx | 102 | 61 | 92 | 17 |
| Takahashi et al. (90) | Phase II | Gem + CRTx | 188 | 97 | 99 | 57% 5-year OS (resected) |
| Golcher et al. (13) | Phase II | Gem/Cis + CRTx | 29 | 66 | 52 | 17 |
| Okano et al. (93) | Phase II | S1 + CRTx | 33 | 97 | 98 | 83% 2-year OS |
| Grose et al. (92) | Retrospective | FOLFIRINOX or Gem + Cape | 45 | 40 | 71 | 22 |
| Neoadjuvant chemotherapy + adjuvant chemoradiation | ||||||
| Varadhachary et al. (95) | Phase II | Gem/Cis –> Gem + RTx | 90 | 58 | 96 | 19 |
| References | Study phase | Treatment | Number planned | Resectability | Primary outcome measures | ClinicalTrials.gov indentifier |
| ONGOING NEOADJUVANT TRIALS FOR RESECTABLE PDAC | ||||||
| Hozaeel et al. (96) | Phase II/III | FOLFIRINOX vs. Upfront surgery | 126 | R/BR | Median overall survival | NCT02172976 |
| Labori et al. (97) | Phase III | FOLFIRINOX vs. Upfront surgery | 90 | R | Overall mortality | NCT02919787 |
| Heinrich et al. (98) | Phase III | GemOx vs. Upfront surgery | 155 | R | Progression free survival | NCT01314027 |
| Sohal et al. (99) | Phase II | FOLFIRINOX vs. GnP | 118 | R | 2-year overall survival | NCT02562716 |
mOS (mo), median overall survival (months); Gem, gemcitabine; Cis, cisplatin; GnP, Gemcitabine + nab-paclitaxel; GemOx, gemcitabine + oxaliplatin; CRTx, chemoradiotherapy; Cape, capecitabine; OS, overall survival; R, resectable; BR, borderline resectable.