In a nutshell
This study investigated the effectiveness and safety of panitumumab (Vectibix) when added to maintenance therapy with fluorouracil (Adrucil) and folinic acid (Leucovirin) (FU/FA) in patients with RAS wild-type metastatic colorectal cancer (mCRC). The data showed that maintenance therapy with FU/FA plus panitumumab was safe and effective for these patients.
Patients who are diagnosed with mCRC have disease that has spread to other areas. Genetic changes in KRAS protein can often occur to promote mCRC growth and spread. mCRC tumors that do not have these genetic changes are known as KRAS wild-type mCRC. The standard treatment for these patients is chemotherapy combined with targeted therapy.
A combination of fluorouracil and folinic acid (FU/FA) plus either oxaliplatin (Eloxatin) (FOLFOX) or irinotecan (Camptosar) (FOLFIRI) chemotherapies are the recommended first-line therapies for advanced CRC. Panitumumab is a type of targeted therapy. It works by targeting certain proteins (EGFR) on the cancer cells and stops them from growing. Chemotherapy with panitumumab has been shown to improve survival in patients with mCRC.
Maintenance treatment is commonly used after first-line treatment to delay relapse or slow down cancer progression. However, the effectiveness and safety of panitumumab when added to maintenance therapy with FU/FA in patients with RAS wild-type mCRC are still unknown.
Methods & findings
This study involved 248 patients with mCRC. Patients were randomly assigned into two groups. Group 1 included 125 patients who received maintenance therapy with FU/FA plus panitumumab. Group 2 included 123 patients who received maintenance therapy with FU/FA alone. The average follow-up time was 35.8 months.
The average survival without cancer progression was significantly longer for group 1 (8.8 months) compared to group 2 (5.7 months). Patients in group 1 were 28% more likely to survive without cancer progression than patients in group 2.
The average overall survival was 28.7 months for group 1 compared to 25.7 months for group 2. Patients in group 1 were 16% more likely to have a better survival than patients in group 2.
The objective response rate (ORR; partial or complete disappearance of cancer) was 40.8% for group 1 compared to 26% for group 2. Patients in group 1 were 1.96 times more likely to respond to treatment better than patients in group 2.
Skin rash was the most common side effect seen in 7.2% of the patients in group 1.
The bottom line
This study concluded that maintenance therapy with FU/FA plus panitumumab was safe and effective for the treatment of patients with RAS wild-type mCRC.
The fine print
This study was funded by Amgen Inc., the manufacturers of panitumumab. There was no standard of care control. This study included some patients who are not ideal for anti-EGFR-based first-line therapy studies.
Published By :
Journal of clinical oncology
Sep 17, 2021
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