Table 1.
Eight randomized, controlled trials of systemic anticancer therapy with or without statin in human cancer.
| First Author, (Year) [Ref.] | Cancer Type | Phase | Setting | Treatment Arm | No. of Patients | Primary Endpoint | ORR | Any Gr 3–5AEs | mPFS (Month) | mOS(Month) | Jadad Score |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Kawata (2001) [30] | HCC | II | 1st | TAE + oral 5-FU + pravastatin 40 mg | 41 | OS | NA | NA | NA | 18 | 3 |
| TAE + oral 5-FU | 42 | NA | NA | NA | 9 | ||||||
| Konings (2010) [31] | GC | II | 1st | Epirubicin/cisplatin/capecitabine + pravastatin 40 mg | 15 | PFS | 33.3% | 8 (53.3%) * | 6 | 8 | 2 |
| Epirubicin/cisplatin/capecitabine | 15 | 46.7% | 7 (46.7%) * | 5 | 6 | ||||||
| Han (2011) [32] | NSCLC | III | 2nd or 3rd | Gefitinib 250 mg + simvastain 40 mg | 52 | ORR | 38.5% | 2 (4%) | 3.3 | 13.6 | 3 |
| Gefitinib 250 mg | 54 | 31.5% | 1 (2%) | 1.9 | 12 | ||||||
| Kim (2014) [33] | GC | III | 1st | Capecitabine/cisplatin + simvastatin 40 mg | 120 | PFS | 27.5% | 63 (52.5%) | 5.2 | 11.6 | 5 |
| Capecitabine/cisplatin + placebo | 124 | 29.0% | 70 (56.4%) | 4.6 | 11.5 | ||||||
| Hong (2014) [34] | PC | II | 1st | Gemcitabine + simvastatin 40 mg | 58 | PFS | 6.9% | 11 (18.9%) | 2.4 | 6.3 | 5 |
| Gemcitabine + placebo | 56 | 14.3% | 5 (9%) | 3.6 | 8.7 | ||||||
| Lim (2015) [35] | CRC | III | 2nd | XELIRI or FOLFIRI + simvastatin 40mg | 134 | PFS | 11.9% | 65 (48.5%) | 5.9 | 15.3 | 5 |
| XELIRI or FOLFIRI + placebo | 135 | 11.8% | 62 (45.9%) | 7.0 | 19.2 | ||||||
| Seckl (2017) [36] | SCLC | III | 1st | Etoposide/platinum +/− RT + pravastatin 40 mg | 422 | OS | 69.0% | 333 (81.2%) | 7.7 | 10.7 | 5 |
| Etoposide/platinum +/− RT + placebo | 424 | 69.1% | 333 (81.4%) | 7.3 | 10.6 | ||||||
| Lee (2017) [37] | Non-ADC NSCLC | II | 2nd or 3rd | Afatinib + simvastatin 40 mg | 36 | ORR | 5.7% | 2 (5.6%) ‡ | 1.0 | 10 | 3 |
| Afatinib | 32 | 9.4% | 6 (16.8%) ‡ | 3.6 | 7 |
HCC, hepatocellular carcinoma; GC, gastric cancer; NSCLC, non-small-cell lung cancer; PC, pancreatic cancer; CRC, colorectal cancer; SCLC, small-cell lung cancer, non-ADC, non-adenocarcinoma; TAE, transcatheter arterial embolization; 5-FU, 5-fluorouracil; XELIRI, capecitabine + irinotecan; FOLFIRI, 5-FU + leucovorin + irinotecan; RT, radiotherapy; AEs, adverse events; ORR, overall response rate; mOS, median overall survival; mPFS, median progression-free survival; OR, odds ratio; HR, hazard ratio; NA, not available. CI, confidence interval; * neutropenia, ‡ diarrhea.