Trends and variations in the use of adjuvant immunotherapy for stage III melanoma in the U.S. population.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9077-9077 ◽  
Author(s):  
Teresa J. Nasabzadeh ◽  
Huei-Ting Tsai ◽  
Eshetu Tefera ◽  
Suraj S. Venna ◽  
Arnold L. Potosky ◽  
...  

9077 Background: High dose Interferon alfa-2b (IFN), an adjuvant immunotherapy for patients (pts) with stage III melanoma, was the only approved treatment option in the US from 1995-2011. There is limited information on how high dose IFN has been disseminated to eligible pts in general clinical practice, and whether variations exist in its adoption according to non-clinical factors. Methods: We obtained data on 34,208 pts diagnosed between 1998-2010 with stage III melanoma from the National Cancer Data Base (NCDB). IFN treatment was abstracted as immunotherapy. We investigated the use of immunotherapy according to pt demographic, socioeconomic, and clinical variables. We conducted multiple logistic regression analysis to examine the effect of these variables on the receipt of immunotherapy. Results: 62% of pts in our study population were male, 88% were Caucasian and 31% were over age 65. Overall, 27% of the pts received immunotherapy. There was no significant trend in its adoption between year 1998 and 2010. After adjustment for clinical variables, age at diagnosis, facility type, and geographic region are predictors strongly associated with use of immunotherapy. Only 16% of pts aged 65-74 and 3% over 75 received immunotherapy compared to 42% of those ages less than 45 (adjusted ORs 0.44 [0.32-0.59], 0.05 [0.04-0.14), respectively). Also 24% of pts treated at a comprehensive community cancer program received immunotherapy compared to 30% of those treated at an academic/research program (OR, 0.71 [0.51-0.99]). The frequency of immunotherapy was 25% in the Atlantic region and 17% in the Western region compared to 33% in Northeast (ORs 0.42 [0.18-0.99], 0.31 [0.13-0.74], respectively). Median household income, insurance type and comorbidity were not associated with adoption of immunotherapy after adjustment for all other variables. Conclusions: Less than one-third of all eligible patients received adjuvant immunotherapy in US general practice over the past decade. There is significant variation in its adoption according to non-clinical factors. Further exploration of the reasons for these variations and whether they are linked to important patient outcomes is needed.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19000-e19000
Author(s):  
Arden Fredeking ◽  
Suraj S. Venna ◽  
Sekwon Jang

e19000 Background: The 5-year survival of Stage III melanoma ranges from 30-70%. High dose interferon alfa-2b (IFN) is an adjuvant immunotherapy approved in 1995 for stage III melanoma, however, its use has been limited by its significant toxicity and modest benefit. We hypothesized the utilization of adjuvant immunotherapy is less in older age group compared to younger patients. Methods: Using the National Cancer Data Base (NCDB) aggregate data, demographic, socioeconomic, insurance information, and treatment data were analyzed. Proportions were compared using Pearson Chi squared tests. Results: From 2000-2008, 27,365 cases of stage III melanoma were reported to NCDB. Most patients were male (63%) and Caucasian (94.2%). Twenty-nine percent were over the age of 70. Educational and socioeconomic factors across all age groups were not significantly different. The primary insurer for patients younger than 60 was a managed care plan (54.3%) as compared to Medicare with supplemental insurance for patients older than 60 (47.4%). In terms of systemic therapy, 23% received immunotherapy alone, 6% received chemotherapy alone, 2% received both, and 66% received no therapy. When compared to patients under age 39, older age groups were significantly less likely to receive adjuvant immunotherapy as shown in the table below. Conclusions: There is an inverse relationship between age and the use of adjuvant immunotherapy. Further study is planned to adjust for comorbidity, socioeconomic status using patient-level data. [Table: see text]


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18758-e18758
Author(s):  
Laura D. Leonard ◽  
Robert J. Torphy ◽  
Laurel Beaty ◽  
Thiago B. de Araujo ◽  
Kathryn Colborn ◽  
...  

e18758 Background: There are now numerous effective adjuvant immunotherapy options for surgically resected stage III melanoma including novel checkpoint inhibitors and targeted therapies. Current guidelines recommend that the decision to treat stage III melanoma with adjuvant immunotherapy should be individualized and based upon disease burden, patient goals and anticipated therapy tolerance. We sought to assess the contribution of patient, tumor and facility factors on the implementation of immunotherapy in patients with surgically resected stage III melanoma. Methods: Using the National Cancer Database (NCDB), patients from 2012-2017 that underwent excision and were found to have a positive sentinel node were identified. A multivariable mixed effects logistic regression model with a random intercept for site was used to determine the effect of patient, tumor, and facility variables on the probability of immunotherapy. Reference Effect Measures (REM) were used to estimate the variation in immunotherapy use due to unmeasured facility factors (contextual effects) after adjusting for measured patient, tumor, and facility variables. Results: From 2012 to 2017, the percent of patients with stage III melanoma treated with adjuvant immunotherapy increased from 23.7% to 38.5% (p < 0.05). Overall, younger patients and patients with private insurance were more likely to receive immunotherapy. Tumor factors associated with increased use of adjuvant immunotherapy included increasing depth, mitotic rate ³1, ulceration, lymphovascular invasion (LVI), and undergoing a completion lymph node dissection (CLND). Additionally, treatment at a facility with a surgical volume <190 cases/year was associated with increased immunotherapy use. However, the width of the 90% REM range for unmeasured facility effects exceeded that of the measured facility, tumor, time, and patient demographics suggesting that contextual effects had a higher contribution to the variation in immunotherapy use. Conclusions: Our analysis suggests that uninsured patients and patients with government insurance (Medicaid and Medicare) are not receiving immunotherapy at the same frequency as privately insured patients with the same tumor characteristics treated at the same facility. Lastly, compared to known patient, tumor and facility factors, institutional contextual effects were the major drivers of the implementation of immunotherapy.[Table: see text]


2021 ◽  
Author(s):  
Ann Livingstone ◽  
Kathy Dempsey ◽  
Martin R. Stockler ◽  
Kirsten Howard ◽  
Georgina V. Long ◽  
...  

Abstract BackgroundAdjuvant immunotherapy is revolutionising care for patients with resected stage III and IV melanoma. However, immunotherapy may be associated with toxicity, making treatment decisions complicated. This study aimed to identify factors physicians and nurses considered regarding adjuvant immunotherapy for melanoma.MethodsIn-depth interviews were conducted with physicians (medical oncologists, surgeons and dermatologists) and nurses managing patients with resected stage III melanoma between July 2019 and March 2020. Factors considered regarding adjuvant immunotherapy were explored. Recruitment continued until data saturation and thematic analysis was undertaken. ResultsTwenty-five physicians and nurses, aged 28-68 years, 60% females, including eleven (44%) medical oncologists, eight (32%) surgeons, five (20%) clinical nurse consultants, and one (4%) dermatologist were interviewed. Over half the sample managed five or more new resected stage III patients per month who could be eligible for adjuvant immunotherapy. Three themes about adjuvant immunotherapy recommendations emerged: (1) clinical and patient factors, (2) treatment information provision, and (3) individual physician/nurse factors. Melanoma sub-stage and an individual patient's therapy risk/benefit profile were primary considerations. Secondary factors included uncertainty about adjuvant immunotherapy's effectiveness and their views about treatment burden patients might consider acceptable.ConclusionsPatients' disease sub-stage and their treatment risk versus benefit drove the melanoma health care professionals' adjuvant immunotherapy endorsement. Findings will aid clinical communication with patients and facilitate clinical decision-making about management options for resected stage III melanoma.


2017 ◽  
Vol 35 (7_suppl) ◽  
pp. 159-159 ◽  
Author(s):  
Mridula Krishnan ◽  
Aabra Ahmed ◽  
Nabin Khanal ◽  
Peter T. Silberstein

159 Background: High dose Interferon (IFN) was the standard adjuvant treatment used for stage III melanoma between 2004-2010. To our knowledge, this is the largest study using the NCDB to determine the impact of immunotherapy used prior to 2011 in stage III melanoma. Methods: We identified 19,864 patients with stage III melanoma between 2004-2010. Among these, 5,406 of them received immunotherapy. Chi-square analysis was used to determine demographic differences between those with versus without immunotherapy. Between-therapy survival differences were estimated by the Kaplan-Meier method and associated log-rank tests; Tukey-Kramer adjusted p < 0.05 indicated statistical significance. Results: Patients who received immunotherapy had a mean survival of 89.8 months while those who did not had a mean survival of 71 months. The percentage of patients alive at 5 and 10 years was 62% and 52% (among those who received immunotherapy) compared to 46% and 32% (among those who did not receive immunotherapy) respectively. A much higher percentage of these patients were privately insured (73% vs. 47.1%, p<0.001). Those who received immunotherapy were more likely to be younger, have a higher income (36.2% vs. 34.8%, p<0.001), and a greater percentage of females received immunotherapy compared to males. (See Table 1.) Conclusions: Previously, Kirkwood et al. demonstrated a modest improvement in overall survival with IFN by 12 months (2.8 to 3.8 years). In our study, patients who received immunotherapy had a significant improvement in mean survival by 19 months. It was observed that patients who received immunotherapy were substantially younger, had private insurance and fewer comorbidities. [Table: see text]


Author(s):  
Ragini R. Kudchadkar ◽  
Olivier Michielin ◽  
Alexander C. J. van Akkooi

In this article, we will focus on the practice-changing developments for stage III melanoma, from the use of the sentinel node (SN) biopsy to complete lymph node dissection (CLND) and upcoming adjuvant therapies. MSLT-1 (Multicenter Selective Lymphadenectomy Trial-1) was the first and only prospective randomized controlled trial to examine whether the SN biopsy has any notable melanoma-specific survival benefit (primary endpoint). MSLT-1 randomly assigned 2,001 patients to undergo either wide local excision (WLE) and an SN biopsy or WLE and nodal observation. Two prospective randomized controlled trials have examined the potential benefit for immediate CLND versus delayed CLND after sequential observation. Both the DECOG-SLT and MSLT-2 trials failed to demonstrate a notable benefit for immediate CLND; therefore, sequential follow-up with ultrasonography and a delayed CLND in the case of relapse should be considered the new standard of care. The CheckMate 238 study demonstrated a notable benefit for adjuvant nivolumab in terms of 18-month relapse-free survival (RFS) rates compared with high-dose adjuvant ipilimumab. Single-agent adjuvant BRAF inhibition has been examined and failed to improve RFS. However, the COMBI-AD study did demonstrate a substantial benefit for combination BRAF and MEK inhibition for patients with BRAF-mutated resected stage IIIA to IIIC melanoma.


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