Cancer
Conditions
Keywords
Cancer, Phase I trials, Review
Brief summary
Overview of response rate published in recent oncology phase I trials
Detailed description
Critics have raised a fundamental ethical challenge about phase 1 cancer research. They point to an expected paucity of benefits, since approximately 5% of patients in phase 1 trials are reported to have tumor shrinkage. Objective was to conduct a search of the literature using PubMed to identify articles about phase 1 trials that were published from January 1, 2014, through June 30, 2015. The primary end point was the response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Clinically relevant trials' characteristics were investigated as candidate factors associated with the RR: Funding source (Academic / Industrial), First-in man trial (Yes / No), Expansion cohort (Yes / No), Number of targeted organs (Single / Multiple), Therapy (Single / Combination), Treatment (MAB-Immuno / ITK / Chimioth-HT-other), Biological eligibility criterion (Yes / No), as well as the number of assessable patients, which for ease of clinical interpretation was transformed into a qualitative variable (0-25 / 26 - 50 / 51+). The RR was described according to the individual trials' characteristics. Associations with trials's characteristics were investigated using statistical modeling.
Interventions
OTHERPhase I
Chemotherapy, ITK, Hormotherapy, Immunotherapy
Sponsors
Institut Bergonié
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Trials based on the following eligibility criteria: * cancer phase 1 trials * published from January 1, 2014, through June 30, 2015
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | up to 6 months after treatment initiation | Number of reported responses (complete \[CR\] and partial \[PR\]) divided by the number of reported assessable patients |
Countries
France
Participant flow
Recruitment details
224 trials were analyzed which included 6915 participants
Participants by arm
| Arm | Count |
|---|---|
| Trials Cancer Phase 1 trials | 6,915 |
| Total | 6,915 |
Baseline characteristics
| Characteristic | Trials | — |
|---|---|---|
| Age, Customized trials with participant > 18 years old | 6915 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 3458 Participants | — |
| Sex: Female, Male Male | 3457 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Response Rate
Number of reported responses (complete \[CR\] and partial \[PR\]) divided by the number of reported assessable patients
Time frame: up to 6 months after treatment initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 Oncology Trials | Response Rate | 1371 Participants |