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Local peripheral therapies improve efficacy of ipilimumab for melanoma
The addition of ipilimumab to local peripheral treatments significantly extended OS in patients with melanoma, according to the results of a retrospective clinical study.
The combination treatment approach did not significantly raise immune-related adverse event rates, results showed.
Sebastian Theurich
“Our results are concordant with those previously reported for 29 patients treated in the United States with ipilimumab [Yervoy, Bristol-Myers Squibb] and local radiotherapy,” Sebastian Theurich, MD, lecturer and physician–scientist at University Hospital of Cologne’s Center for Integrated Oncology in Germany, said in a press release. “Having data from different parts of the world improves the validity of the results, especially if you deal with retrospective analyses.”
Theurich and colleagues performed a retrospective review of 127 patients (mean age, 61.7 years; range, 23-89; 54.3% men) with stage IIIC or stage IV melanoma, treated at four hospitals in Germany and Switzerland.
The majority of patients (n = 82) received 3 mg/kg IV ipilimumab alone. The remaining patients (n = 45) were treated with ipilimumab and local peripheral treatments, which included radiotherapy (n = 40), electrochemotherapy (n = 4) or selective internal radiotherapy (n = 1). Patients received local peripheral treatments during (n = 19), after (n = 17) or before (n = 9) ipilimumab.
Ninety-five patients received at least three cycles of ipilimumab.
Median potential follow-up was 39 weeks for patients treated with ipilimumab alone and 87 weeks for patients treated with ipilimumab and local peripheral treatments.
Forty-two patients (51.2%) treated with ipilimumab alone died, compared with 19 patients (42.2%) who received ipilimumab and local peripheral treatments.
A significantly greater proportion of patients who received local peripheral treatments in addition to ipilimumab achieved clinical benefit (57.8% vs. 38.8%; P = .05). Those who received the combination also demonstrated significantly longer median OS (93 weeks vs. 42 weeks; HR = 0.46; 95% CI, 0.27-0.73).
The association between local peripheral treatments and prolonged OS remained significant when the researchers excluded patients with central nervous system metastases from the analysis (median, 117 weeks vs. 46 weeks; HR = 0.41; 95% CI, 0.17-0.78).
Time of local peripheral treatment receipt did not significantly affect OS, although patients who received these therapies during or prior to ipilimumab treatment had slightly prolonged median OS than patients who received them before (117 weeks vs. 96 weeks vs. 86 weeks).
A multivariate analysis showed that OS remained improved with the addition of local peripheral treatments after controlling for BRAF mutation status, tumor stage, tumor burden and CNS metastases (adjusted HR = 0.56; 95% CI, 0.31-1.01).
The researchers reported no increase in severe immune-related adverse events among patients who received both therapies, indicating that local peripheral treatments were well tolerated.
The use of retrospective data may be a study limitation, but prospective clinical trials are underway, Theurich said.
“This survival advantage seemed to overcome even traditional risk factors of poor outcomes,” Theurich said. “This suggests that this combination could be an option for all patients with malignant melanoma, and this is being tested in ongoing prospective clinical trials.” – by Cameron Kelsall
Disclosure: Theurich reports no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.