Table 2.
Summary of Selected Clinical Trials of Systemic Therapy for Pancreatic Cancer
| Trial | Setting of therapy | Study regimen | Comparator regimen | Randomized patients, No. | Primary end point | Median survival, mo | Common serious adverse eventsa reported in study group (% of patients) |
|---|---|---|---|---|---|---|---|
| CONKO-00165 (2007) | Adjuvant | Gemcitabine | Observation | 368 | Disease-free survival | 13.4 vs 6.7 | Leukopenia (2), anemia (1), thrombocytopenia (1), nausea/vomiting (1), hepatic dysfunction (1), diarrhea (1) |
| ESPAC-466 (2017) | Adjuvant | Gemcitabine and capecitabine | Gemcitabine | 730 | Overall survival | 28.0 vs 25.5 | Neutropenia (38), leukopenia (10), hand-foot syndrome (7), fatigue (6), diarrhea (5) |
| PRODIGE-245 (2018) | Adjuvant | mFOLFIRINOX | Gemcitabine | 493 | Overall survival | 54.4 vs 35 | Neutropenia (28), diarrhea (19), paresthesia (13), fatigue (11), sensory peripheral neuropathy (9), nausea (6), hepatic dysfunction (<5) |
| PRODIGE3 (2011) | First-line for metastatic disease | FOLFIRINOX | Gemcitabine | 342 | Overall survival | 11.1 vs 6.8 | Neutropenia (46), fatigue (24), vomiting (15), diarrhea (13), thrombocytopenia (9), sensory neuropathy(9), hepatic dysfunction (7), thromboembolism (7), anemia (8) |
| MPACT4 (2013) | First-line for metastatic disease | Gemcitabine and albumin-bound paclitaxel | Gemcitabine | 861 | Overall survival | 8.5 vs 6.7 | Neutropenia (38), leukopenia (31), thrombocytopenia (13), anemia (13), fatigue (17), peripheral neuropathy (17), diarrhea (6) |
| NAPOLI-167 (2015) | For metastatic disease after progression on gemcitabine therapy | 5-FU/LV and nanoliposomal irinotecan | 5-FU/LV | 417 | Overall survival | 6.2 vs 4.2 | Neutropenia (27), fatigue (14), diarrhea (13), vomiting (11), anemia (9) |
| POLO8 (2019) | Maintenance following ≥4 mo of platinum-based therapy (germline BRCA1/2) | Olaparib | Placebo | 154 | Progression-free survival | 7.4 vs 3.8 | Anemia (11), fatigue (5), decreased appetite (3), abdominal pain (2), vomiting (1), arthralgia (1) |
Abbreviations: 5-FU/LV, fluorouracil, leucovorin; mFOLFIRINOX, modified FOLFIRINOX (fluorouracil, leucovorin, irinotecan, oxaliplatin).
a
Grade 3 or higher.