The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors.
The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient.
| Study | Description | Average follow-up (interval) (months) |
|---|---|---|
| Van Cutsem et al77. Van Cutsem E, Peeters M, Siena S, Humblet Y, Hendlisz A, Neyns B, et al. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 2007;25:1658-64. | PAN + BSC vs BSC main study | 8,8 (3,8-19) |
| Siena et al88. Siena S, Peeters M, Van C, Humblet Y, Conte P, Bajetta E, et al. Association of progressionfree survival with patient-reported outcomes and survival: results from a randomised phase 3 trial of panitumumab. Br J Cancer 2007;97:1469-74. | Analysis of PFS association with symptoms of colorectal cancer, HRQoL and OS | 18 (13-28.3) |
| Van Cutsem et al99. Van Cutsem E, Siena S, Humblet Y, Canon JL, Maurel J, Bajetta E, et al. An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy. Ann Oncol 2008;19:92-8. | Crossover Extension Study | 15.3 (4.5-25,8) |
| Amado et al1010. Amado RG, Wolf M, Peeters M, Van Cutsem E, Siena S, Freeman D, et al. Wild-Type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 2008;26:1626-34. | Retrospective analysis of the main study for KRAS | 14,1 (for 36 patients remaining at the time of analysis) |
| Peeters et al1111. Peeters M, Siena S, Van Cutsem E, Sobrero A, Hendlisz A, Cascinu S, et al. Association of progression-free survival, overall survival, and patient-reported outcomes by skin toxicity and KRAS status in patients receiving panitumumab monotherapy. Cancer 2009;115:1544-54. | Analysis of the association of skin toxicity severity with PAN efficacy | 18 (13-28,3) |
| Peeters et al1212. Peeters M, Oliner KS, Parker A, Siena S, Van Cutsem E, Huang J et al. Massively parallel tumour multigene sequencing to evaluate response to panitumumab in a randomized phase III study of metastatic colorectal cancer. Clin Cancer Res 2013 1; 19(7):1902-12. | Retrospective analysis of the main study for various genes | — |
| P | Patients with metastatic colorectal cancer |
| I | Chemotherapy with panitumumab |
| C | Chemotherapy without panitumumab or placebo or supportive care |
| O | Survival and adverse events (efficacy and safety) |
|
Study date Reference, Study design, JADAD, evidence strength |
Sample calculation Estimated differences, power, significance level, total patients |
|
Patient selection Inclusion and exclusion criteria |
Patients Recruited, randomized, prognostic differences |
|
Randomization Description and blind allocation |
Patients follow-up Time, losses, migration |
|
Treatment protocol Intervention, control and blinding |
Analysis Treatment intention, analysed, intervention and control |
|
Considered outcomes Main, secondary, measurement instrument of the outcome of interest |
Result Benefit or harm in absolute data, average benefit or harm |
| Representativeness of exposed and selection of non-exposed (max. 2 points) | Definition of exposure (max. 1 point) | Demonstration that the outcome of interest was not present at the beginning of the study (max. 1 point) | Comparability on the basis of design or analysis (max. 2 points) | Evaluation of outcome (max. 1 point) | Follow-up appropriate time (max. 2 points) | Evidence level score |
| Evidence included |
| Study design |
| Population selected |
| Follow-up time |
| Outcomes considered |
| Expression of results: percentage, risk, odds, hazard ratio, average |
