“Completion dissection” not associated with increased survival in sentinel node metastasis

Sentinel nodes are the first few lymph nodes into which a tumor drains. In melanoma patients with sentinel node metastasis, the results of the phase lll MSLT-ll trial showed that “completion dissection” (the removal of the remaining lymph nodes after sentinel node removal) was not associated with increased melanoma-specific survival, compared to ongoing monitoring.

What Patients Need to Know

The investigators concluded that while immediate completion dissection did not increase survival in melanoma patients with sentinel node metastasis, it did increase the rate of regional disease control (the prevention of the cancer spreading to nearby parts of the body) and provided information about the patient’s prognosis.

Higher-dose adjuvant ipilimumab did not improve recurrence-free survival

A randomized phase lll trial, E1609, compared ipilimumab, a type of immunotherapy, for resected (removed) high-risk melanoma at doses of 3mg/kg and 10mg/kg. The results showed that the higher dose of ipilimumab did not improve recurrence-free survival (RFS). The 3-year RFS rate was 54 percent with the 10mg/kg dose and 56 percent with the 3mg/kg dose.

What Patients Need to Know

Adjuvant (post-resection) ipilimumab administered in the higher dose was associated with higher rates of serious treatment-related adverse events: 57 percent as compared to 36.4 percent in the patients who received the lower dose. Discontinuation of treatment was also higher with the 10mg/kg dose: 53.8 percent compared to 35.2 percent with the 3mg/kg dose.

Study showed that adjuvant nivolumab is superior to the standard of care in a subset of melanoma patients

Results from the randomized, double-blind, phase lll CheckMate 238 trial showed that using nivolumab after resection was better than the standard of care (ipilimumab) in patients with stage III/IV melanoma who are at high risk of relapse. Nivolumab led to better relapse-free survival than did ipilimumab, with fewer side effects.

What Patients Need to Know

Adjuvant therapy is given after initial cancer treatment with the goal of preventing metastases (the spread of the cancer to another part of the body). Both nivolumab and ipilimumab are immunotherapies, and both are approved by the FDA for the treatment of metastatic melanoma.

Targeted therapies had clear advantage over placebo in treatment of BRAF-mutant melanoma

The phase lll trial COMBI-AD compared the combination of targeted therapies dabrafenib and trametinib to a placebo (a look-alike containing no active ingredient) in patients with stage lll BRAF-mutant melanoma who had previously undergone complete resection (removal) of their melanoma. The treatment duration was one year and the primary endpoint was relapse-free survival (RFS).

What Patients Need to Know

The combination of dabrafenib and trametinib had a clear advantage over placebo in RFS and other trial endpoints, such as distant metastases-free survival (surviving without the cancer spreading to other parts of the body) and overall survival.