Adjuvant immunotherapy extends OS for certain patients with stage III melanoma
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Adjuvant immunotherapy conferred a significant OS benefit among patients with resected stage IIIC melanoma, according to study results presented at American Association for Cancer Research Virtual Annual Meeting II.
Researchers noted that sociodemographic factors appeared associated with receipt of adjuvant immunotherapy.
“Immune checkpoint inhibitors have significantly improved outcomes in clinical trials in melanoma. Following the improvement in RFS with adjuvant ipilimumab [Yervoy, Bristol-Myers Squibb] after surgical resection, the FDA approved adjuvant ipilimumab in this setting is 2015,” Justin T. Moyers, MD, fellow at Loma Linda University in California, said during a press briefing in advance of the meeting. “Subsequently, CheckMate 238 showed superior RFS with nivolumab [Opdivo, Bristol-Myers Squibb] vs. ipilimumab in the adjuvant setting and was approved by the FDA in 2017.”
Moyers and colleagues pooled data from the National Cancer Database to assess the OS benefit of immunotherapy after surgery among 8,160 patients (median age, 60.3 years) diagnosed with stage III melanoma between 2015 and 2016. Among 4,093 patients who met criteria for survival analysis, researchers compared outcomes of those who received adjuvant immunotherapy (n = 1,014; median age, 54.8 years) with those who did not (n = 3,079; median age, 62.4 years).
Between 2015 and 2016, researchers observed an increase in the use of immunotherapy, from 24.8% to 30.6%. Patients appeared less likely to receive immunotherapy if they had a higher Charlson-Deyo comorbidity score and had Medicare as their primary payer. Researchers also reported a trend toward decreased immunotherapy receipt and lower income and lower high school graduation rate, although these did not reach statistical significance, according to Moyers.
Although median OS had not been reached, those who received adjuvant immunotherapy had a similar 2-year survival rate (83%) compared with those who did not (80%).
However, when researchers separated patients by disease stage, they observed significant differences between patients with stage IIIA and stage IIIC disease. Two-year OS rates among those who received vs. did not receive immunotherapy were 94% vs. 91% among those with stage IIIA disease and 70% vs. 59% among those with stage IIIC disease.
Results showed a significant OS benefit with adjuvant immunotherapy for patients with stage IIC melanoma (32 months vs. 28 months; P < .01).
“The National Cancer Database is a retrospective cohort database, and as such, has limitations. The specific agents used cannot be assessed and we cannot differentiate between those who received immunotherapy as adjuvant treatment compared with those who had early progression after surgery,” Moyers said. “Nonetheless, a survival benefit was seen in those with stage IIIC disease who received adjuvant immunotherapy compared with those who did not. Further research should be conducted to demonstrate real-world benefit of adjuvant immunotherapy in this setting.”
Advances in melanoma treatment have been remarkable in the last decade in both the metastatic and advanced disease setting. The CTLA-4 inhibitor ipilimumab, which improves both RFS and OS in stage III melanoma, was approved in 2015. However, its use has been supplanted by the PD-1 inhibitors nivolumab, approved in 2017, and pembrolizumab (Keytruda, Merck), approved in 2019, as they have demonstrated convincing RFS benefits with less toxicity. At ASCO20 Virtual Scientific Program, 3-year follow up of adjuvant pembrolizumab vs. placebo revealed an absolute 20% difference in RFS among patients with high-risk, resected stage III melanoma (64% vs. 44%).
In the current retrospective study, Moyers and colleagues evaluated patients with surgically resected stage III melanoma between 2015 and 2016. Of 8,160 patients, 28% received therapy after surgery, and there was a trend toward longer survival. This is consistent with the previously mentioned ipilimumab data, which proved an OS benefit in a clinical trial population and assures us that the clinical trial findings can be translated to the treatment of a broader population.
With the majority of patients now receiving PD-1 inhibitors after surgery, we can wait in hopeful anticipation that these newer immune therapies will likewise confer a survival advantage, which is our expectation. Ongoing research is unmistakably leading the way in providing better, more effective treatment options to patients with melanoma.
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Antoni Ribas, MD, PhD, FAACR
Moyers and colleagues analyzed real-world data from the National Cancer Database to study the use of adjuvant immunotherapy among patients with resected melanoma at high risk for relapse. Of note, patients with lower income and lower education levels were less likely to receive adjuvant immunotherapy. These data highlight the negative impact of sociodemographic background on access to proven therapy that benefits patients in clinical trials and in real-world data.
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Anthony J. Olszanski, MD, RPh
Advances in melanoma treatment have been remarkable in the last decade in both the metastatic and advanced disease setting. The CTLA-4 inhibitor ipilimumab, which improves both RFS and OS in stage III melanoma, was approved in 2015. However, its use has been supplanted by the PD-1 inhibitors nivolumab, approved in 2017, and pembrolizumab (Keytruda, Merck), approved in 2019, as they have demonstrated convincing RFS benefits with less toxicity.
At ASCO20 Virtual Scientific Program, 3-year follow up of adjuvant pembrolizumab vs. placebo revealed an absolute 20% difference in RFS among patients with high-risk, resected stage III melanoma (64% vs. 44%).
In the current retrospective study, Moyers and colleagues evaluated patients with surgically resected stage III melanoma between 2015 and 2016. Of 8,160 patients, 28% received therapy after surgery, and there was a trend toward longer survival. This is consistent with the previously mentioned ipilimumab data, which proved an OS benefit in a clinical trial population and assures us that the clinical trial findings can be translated to the treatment of a broader population.
With the majority of patients now receiving PD-1 inhibitors after surgery, we can wait in hopeful anticipation that these newer immune therapies will likewise confer a survival advantage, which is our expectation. Ongoing research is unmistakably leading the way in providing better, more effective treatment options to patients with melanoma.'
Reference:
Eggermont AMM, et al. Abstract 10000. Presented at: ASCO20 Virtual Scientific Program; May 29-31, 2020.
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Moyers JT, et al. Abstract 4338. Presented at: American Association for Cancer Research Virtual Annual Meeting II; June 22-24, 2020.
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