Table 1.
Characteristics of the phase I trials
| First author | Patients | Treatment | Design | Primary endpoint | Secondary endpoint |
|---|---|---|---|---|---|
| Ringash [8] | Locally advanced head and neck cancer | Radiotherapy | Fleming multi-step algorithm dose escalation | incidence of radiation-induced acute grade 4 toxicity | |
| Crew [14] | Localized breast cancer | Polyphenon E | Time-to-event continual reassessment method | MTD | Dose-related biologic effects, HRQoL |
| Xiao [15] | Advanced hepatocellular carcinoma | Tyroserleutide | 3 + 3 dose escalation design | MTD, 6-month OS, response, HRQoL | |
| Lin [16] | Advanced breast cancer | Molecular targeted therapy + radiotherapy | 3 + 3 dose escalation design | MTD | ORR, non CNS ORR, PFS, OS, site of first progression, progression free at 6 months, cause of deaths, HRQoL |
| Kanai [17] | Advanced pancreatic and biliary tract cancer | Curcumin | Rolling 6 | MTD, safety, pharmacokinetic, response rate, HRQoL | |
| Tsubata [9] | Advanced non-small cell lung cancer | Chemotherapy | Not clear | MTD | HRQoL, pharmacokinetic |
| Han [18] | Localized colorectal cancer | Calcium-magnesium | Randomized, double-blind, placebo controlled | Pharmacokinetic | EMG, patient-reported neurotoxicity symptoms, study treatment preference for reducing neurotoxicity |
| Rouanne [19] | Advanced cancers | Molecular targeted therapy | NA | HRQoL (ancillary study) | |
| Stephenson [20] | Advanced cancers | Ascorbic acid | 3 + 3 dose escalation design | MTD, pharmacokinetic, HRQoL | |
| Hunn [21] | Glioblastoma | Vaccine | Single cohort | Feasibility, safety | Response rate, 6 month PFS, rate of vaccine-induced immune response, HRQoL |
| Reiss [22] | Advanced cancer with peritoneal carcinomatosis | Molecular targeted therapy + radiotherapy | 3 + 3 dose escalation design | Safety | Response rate, HRQoL |
| Cusi [23] | Advanced cancers | Vaccine | 3 + 3 dose escalation design | MTD, most effective biological dose | Response, PFS, OS, HRQoL |
| McRee [24] | Advanced cancers | Molecular targeted therapy | 3 + 3 dose escalation design | MTD | Safety, response, HRQoL |
| Chin [25] | Localized prostate cancer | Surgery | Single cohort | Safety, feasibility | response, HRQoL |
| Anota [11] | Advanced hepatocellular carcinoma | Chemoembolisation | Continual reassessment method | MTD | HRQoL |
HRQoL Health-related quality of life, MTD maximum tolerated dose, OS overall survival, PFS progression free survival, ORR overall response rate, CNS central nervous system