Outcome measure | Evidence | Implications |
---|---|---|
Disease-oriented evidence | ||
Phase I–II studies | Panitumumab was well tolerated, and no human anti-human antibody formation or infusion-related reactions were observed. Moreover, the use of panitumumab increased overall response rate and seemed to improve PFS and OS. |
Panitumumab was evaluated in phase III trials in patients with relapsed or refractory metastatic CRC. |
Phase III | Panitumumab significantly improved overall response rate, PFR and OS in mCRC pretreated patients. | Panitumumab monotherapy received FDA approval for the treatment of metastatic colorectal cancer with disease progression while receiving or after receiving fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens. |
K-RAS | Clinical efficacy of panitumumab therapy is restricted to patients with wild-type K-RAS tumors. There was no evidence of benefit in patients with mutated K-RAS tumors. | K-RAS genotyping of tumors should be strongly considered to select patients being treated with panitumumab. |
Skin Toxicity | The development of skin toxicity during panitumumab monotherapy has been significantly linked with higher response rate and longer survival. | Skin toxicity cannot be used to select patients and it could be useful in the clinical practice to identify patients who may derive greater benefit from panitumumab treatment. |
Economic evidence | ||
Role of K-RAS testing in clinical practice. | Screening could cost several thousand dollars per patient and still result in a lower overall cost of care, based on very conservative estimates of the cost reduction associated with treatment avoidance in patients with K-RAS mutations. | Implementing routine K-RAS screening and limiting the use of EGFR inhibitors to patients with wild-type K-RAS actually appears the better strategy for selecting only the patients who could benefit from the therapy with panitumumab and also may have the potential for cost savings. |