Real-World Study Demonstrates Benefits with Adjuvant Nivolumab in Resected Stage IIIA Melanoma

A significant proportion of patients with resected stage IIIA melanoma are alive and well after treatment with adjuvant nivolumab (Opdivo) at a median follow-up of more than 20 months, according to a real-world analysis presented at the society’s 19th International Congress. It was free of repetition. For Melanoma Research.1

Patients treated with adjunctive nivolumab (n = 171) had a 12-month recurrence-free rate of 97.1% (95% CI, 93.1%-98.8%) compared with 81.6% (95% CI, 65.2%-90%). Achieved survival (RFS) rate. %) for patients who were observed (n = 38). RFS rates at 18 months were 91.4% (95% CI, 85.6%-94.9%) vs 78.6% (95% CI, 61.6%-88.7%), respectively. Median RFS was not reached in either arm.

Additionally, treatment with neoadjuvant nivolumab improved 12- and 18-month overall survival (OS) rates. 94.7% (95% CI, 80.6%-98.7%) and 91.8% (95% CI, 76.6%-97.3%) in the observation group, respectively. Median OS was 34.6 months and not reached, respectively.

“In the 2 real-world studies that have been published, nivolumab was shown to have a benefit, but the numbers were small,” Anna C. Pavlik, BSN, MSc, DO, MBA, New York A medical oncologist at Weill Cornell Medicine, New York, said in a presentation of the data. “So, we’re presenting a real-world cardinal health database. [for patients] with resected stage IIIA melanoma treated with nivolumab or observation; It is the largest real-world database offered to date.

The real-world study collected data from Cardinal Health’s extended network of oncology providers. Data from the phase 3 CHECKMATE 238 trial (NCT02388906) led to the approval of nivolumab monotherapy for adjuvant treatment in patients with resected stage III/IV melanoma. 2017.3 However, according to the AJCC-7 staging criteria, patients with stage IIIA melanoma were excluded and a minimal number of patients per AJCC-8 was enrolled.

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The adjuvant nivolumab cohort (n = 171) and an observational cohort included patients aged 18 years and older with AJCC-8 stage IIIA melanoma and complete surgical resection between January 1, 2018 and December 31, 2019. was2

The mean age of patients was 57.4 years in the adjunctive nivolumab group and 68.1 years in the observation group. Both groups were dominated by white males. Year of resection was 30% in 2018 and 70% in 2019 versus 47% in 2018 and 53% in 2019, respectively.

Most patients in both cohorts had 1 lymph node involvement, but 33% of patients in the nivolumab arm had 2 or 3 nodes involved versus 26% in the observation arm. Only 1 patient had 4 or more and was in the nivolumab arm.1

In patients with known or available data, most sentinel lymph node tumor burdens in both arms ranged from 1 mm to 4 mm. Primary lesion sites were similar between groups: trunk, (25% vs 24%), extremities (55% vs 53%), head/neck (20% vs 21%), and external genitalia (1% vs 3%). , in the nivolumab and observation groups, respectively. Although ulcers were mostly absent, ulcers were present in 22% of patients in the nivolumab arm and 18% of patients in the observation arm. Median Breslow thickness of tumors at resection was 1.80 vs 1.90, respectively. ECOG performance status ranges from 0 to 3 with most patients scoring 0.

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The median duration of treatment with nivolumab was 12.0 months (95% CI, 11.8-12.0). Three patients continued treatment and 91% of patients completed the prescribed duration of nivolumab therapy, with the most common reasons for discontinuation being patient preference, toxicity, and disease progression.

Additional study data showed that distant metastasis–free survival was also evaluated and was 98.2% and 91.3% versus 94.7% and 88.8%, respectively.

The median time to first recurrence was 18.9 (range, 3.9-29.1) months in the neovolumab arm and 9.4 months (range, 2.6-30.6) in the observation arm, with the most frequent sites being the lungs and lymph nodes. Any first recurrence occurred in 11% versus 26% of patients, respectively. There were 11 deaths (6%) in the nivolumab group and 6 deaths (16%) in the observation group, and the most common cause was disease progression. Cardiovascular disease, infectious disease, and unspecified were also classified as fatal events.1

Regarding safety, endocrine, dermatologic, gastrointestinal, and hepatic treatment-related adverse events (TRAEs) of any grade occurred at rates of 13%, 11%, 8%, and 5%, respectively, in the nivolumab group. Grade 3 or 4 events were observed in 1% and 2% of patients in the endocrine and gastrointestinal categories, respectively, and 2% of patients discontinued treatment due to TRAEs. The investigators noted that the data were collected from patient charts and may be underreported because the data are real-world.

Although this study used a nationwide database to assess real-world data from this subgroup of patients that may be able to date more accurately than data from a randomized controlled trial population, the analysis The former was Further limitations include the short follow-up of survival outcome data, as patients with stage IIIA melanoma have a relatively good prognosis, errors that could have occurred in data entry, and differences in baseline characteristics of the cohort.

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Lack of adjustment for differences between the 2 groups was a challenge when reporting Kaplan–Meier curves, the study authors wrote.

When asked if removing patients with less than 1 mm of IIIA would result in curves as high as one would expect, Pavlik explained, “There are very few patients who have been measured. who had a quantitative measurement in their sentinel lymph node. [and because] It was mostly reported as positive or negative which would be difficult to do.”

references

  1. Pavlik AC, Amin A, Moser JC, et al. Outcomes in patients with resected stage IIIA melanoma treated with adjuvant nivolumab or monitored with observation: a real-world study. Presented at: 19th International Congress of the Society for Melanoma Research. 17-20 October 2022. Edinburgh, Scotland.
  2. Pavlik AC, Amin A, Moser JC, et al. Outcomes in patients with resected stage IIIA melanoma treated with adjuvant nivolumab or monitored with observation: a real-world study. J Clin Oncol. 2022; 40 (suppl 16): e21534. doi:10.1200/JCO.2022.40.16_suppl.e21534
  3. The FDA formally approves nivolumab for the adjuvant treatment of melanoma. FDA December 20, 2017. Accessed November 7, 2022. bit.ly/3WYnDe6

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