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Learning Objectives After completing this course, the reader will be able to: Describe the benefits of adjuvant high-dose interferon-α therapy to melanoma patients.List the toxicities most commonly associated with adjuvant high-dose interferon-α therapy in melanoma patients.Assist patients with melanoma to decide whether to choose adjuvant high-dose interferon-α therapy. Access and take the CME test online and receive 1 hour of AMA PRA category 1 credit at CME.TheOncologist.com High-dose interferon-α2b is a U.S. Food and Drug Administration–approved adjuvant treatment for stage III melanoma, and yet, because of its limited efficacy and well-known toxicity, it is not universally accepted by patients and oncologists. In this paper, we evaluate the benefits and risks of adjuvant high-dose interferon-α2b and try to provide a framework to help oncologists guide patients trying to decide whether to undergo adjuvant high-dose interferon therapy.

Evaluation of: Moreau S, Saiag P, Aegerter P et al. Prognostic value of BRAF (V600) mutations in melanoma patients after resection of metastatic lymph nodes. Ann. Surg. Oncol. 19(13), 4314–4321 (2012).Recently introduced systemic agents have shown promising results in melanoma patients with distant metastases. However, the durability of the effect of these agents is still disappointing. In melanoma patients with palpable regional lymph node metastases, these new systemic drugs might induce longer efficacy as tumor load is low compared to patients with distant metastases. However, before administering these potentially toxic and still very expensive systemic drugs the selection of patients who will most probably benefit from them is important. In this key paper evaluation, the use of BRAF mutation status as a prognostic marker in stage III melanoma is discussed.

Immunotherapy for melanoma patients is a promising treatment option, as clinical evidence of the use of systemic CTLA4- and PD1-antibodies has demonstrated. With the exception of unresectable melanoma patients, there is a great need for an adequate therapeutic option for patients with locally advanced melanoma (stage III). In this issue of the European Journal of Dermatology, Seledtsova et al.[1] report their investigations on the treatment of stage III melanoma patients with a xenogeneic cell-based [...]

9586 Background: The combination of IPI+NIVO induces high response rates and improved overall survival in late stage melanoma. T cell checkpoint inhibition is of greatest value at the moment of TCR triggering and therefore dependent on the amount of antigen present, indicating that adjuvant immunotherapy may work most efficiently, when initiated prior to surgery. Methods: Two-arm Phase 1b feasibility trial of 20 high risk AJCC stage IIIB and IIIC melanoma patients with palpable nodal disease receiving the combination of IPI 3mg/kg and NIVO 1mg/kg, either adjuvant four courses after surgery, or split two courses neo-adjuvant and two courses adjuvant. Results: In this update all 20 patients are evaluable. Neo-adjuvant application of IPI+NIVO was feasible and no surgery-associated adverse events were attributed to (neo-)adjuvant therapy. 18/20 patients had to stop early due to grade 3/4 toxicities. Neo-adjuvant IPI+NIVO reduced tumor load in 8/10 patients (3 pCR, 4 near-pCRs [minimal remaining micrometastases], 1 pPR [75% reduction], 1 SD and 1 PD). To date, after a median follow-up of 45 weeks (range 13-74), none of the responders in the neoadjuvant arm has relapsed. Relapse was observed for both non-responders within the neo-adjuvant arm and for 3 patients within the adjuvant arm. TCR sequencing and MHC tetramer-based analysis to compare the induction and expansion of tumor (neo-)antigen-specific T cell responses between both treatment arms are underway and will be presented. Conclusions: The combination of IPI+NIVO in the (neo-)adjuvant treatment setting for high risk stage III melanoma patients is feasible and induces very frequent responses. At the same time, severe grade 3/4 toxicity is more frequent than expected from stage IV melanoma patient study data. These results indicate that IPI+NIVO is a promising combination for neo-adjuvant treatment in stage III melanoma. Adjusted combination schemes are currently tested in the phase 2 OpACIN-neo trial, with the aim of reducing toxicity while preserving efficacy. Clinical trial information: NCT02437279.

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

visits for patients treated for localized primary cutaneous melanoma. J Clin Oncol 29:4641-4646, 2011 4. Siegel R, Ward E, Brawley O, et al: Cancer statistics, 2011: The impact of eliminating socioeconomic and racial disparities on premature cancer deaths. CA Cancer J Clin 61:212-236, 2011 5. Romano E, Scordo M, Dusza SW, et al: Site and timing of first relapse in stage III melanoma patients: Implications for follow-up guidelines. J Clin Oncol 28:3042-3047, 2010

The NCCN Guidelines for Melanoma provide multidisciplinary recommendations for the management of patients with melanoma. These NCCN Guidelines Insights highlight notable recent updates. Dabrafenib and trametinib, either as monotherapy (category 1) or combination therapy, have been added as systemic options for patients with unresectable metastatic melanoma harboring BRAF V600 mutations. Controversy continues regarding the value of adjuvant radiation for patients at high risk of nodal relapse. This is reflected in the category 2B designation to consider adjuvant radiation following lymphadenectomy for stage III melanoma with clinically positive nodes or recurrent disease.

Purpose New primary melanomas (NPMs) have developed in some patients with metastatic melanoma treated with BRAF inhibitors. We sought to determine the background incidence of spontaneous NPMs after a diagnosis of American Joint Committee on Cancer/International Union Against Cancer stage III or IV melanoma in patients not treated with a BRAF inhibitor. Patients and Methods Patients diagnosed with stage III or IV melanoma at Melanoma Institute Australia between 1983 and 2008 were analyzed, and those who received a BRAF inhibitor were excluded. Results Two hundred twenty-nine (5%) of 4,215 patients with stage III melanoma and 43 (1%) of 3,563 patients with stage IV melanoma had at least one NPM after diagnosis of stage III or IV disease. The 6-month, 1-year, and 10-year cumulative incidence rates of developing an NPM after stage III melanoma were 1.2% (95% CI, 0.86% to 1.51%), 1.8% (95% CI, 1.44% to 2.26%), and 5.9% (95% CI, 5.08% to 6.74%), respectively. The 3-month, 6-month, and 1-year cumulative incidence rates of NPM after diagnosis of stage IV melanoma were 0.2% (95% CI, 0.07% to 0.36%), 0.3% (95% CI, 0.15% to 0.51%), and 0.4% (95% CI, 0.25% to 0.7%), respectively. In both patients with stage III and stage IV melanoma, male patients and patients with a prior history of multiple primaries had a higher incidence of NPM. Conclusion Patients with stage III and stage IV melanoma remain at risk for development of further primary melanomas, particularly if they have a history of multiple primary melanomas before stage III or IV disease. The incidence rates are lower than those reported in patients receiving BRAF inhibitors. However, the results must be compared with caution because dermatologic assessment is more frequent in BRAF inhibitor trials.

Inthisissue,Mianetal 1 usehigh-resolutionmassspectrometry (MS) to define the serum peptidome of patients with melanoma. They trained machine learning algorithms to recognize serum peptidomic patterns that clustered with specific disease states. This strategy enabled them to discriminatestageImelanomapatientsfromstageIVpatients. Furthermore,thepeptidomicpatternswereabletodiscriminate stage III melanoma patients who developed tumor recurrences within the first year after diagnosis from stage III patients who remained disease free. An artificial neural network analysis of the peptide patterns was able to correctly identify 80% of patients who eventually experienced recurrence,comparedwitha21%predictionratewhentheseinves

Development of a melanoma-specific vaccine is of clinical necessity. Therefore, a phase III, randomized, double-blind trial was performed (June 1988–June 1991) to assess the clinical effectiveness of our vaccinia melanoma oncolysate (VMO) vaccine in stage III melanoma patients. Patient data were collected from 11 institutions, as well as from the Social Security Death Index and were analyzed from April through August 2008 for disease-free interval (DFI) and overall survival (OS). The median OS for patients who were administered the VMO vaccine was 7.71 years, compared to 7.95 years for patients administered the vaccinia virus vaccine (V) (p=0.70). The median DFI for the VMO group was six years, while the median DFI for the V group has not yet been reached. This analysis demonstrated a statistically significant difference in OS in females in both groups (VMO, 79%; V, 92%), as compared to males (VMO, 57%; V, 68%) (p=0.0473). This follow-up analysis demonstrated that females had a survival advantage over males, thus warranting further investigation. This significant observation may facilitate the recruitment of patients for future clinical trials, as well as determine which patients are more likely to benefit from receiving the VMO vaccine.

Purpose To describe the anatomic distribution of regionally recurrent disease in patients with stage III melanoma in the axilla after curative-intent surgery with and without adjuvant radiation therapy. Methods and Materials A single-institution, retrospective analysis of a prospective database of 277 patients undergoing curative-intent treatment for stage III melanoma in the axilla between 1992 and 2012 was completed. For patients who received radiation therapy and those who did not, patterns of regional recurrence were analyzed, and univariate analyses were performed to assess for potential factors associated with location of recurrence. Results There were 121 patients who received adjuvant radiation therapy because their clinicopathologic features conferred a greater risk of regional recurrence. There were 156 patients who received no radiation therapy. The overall axillary control rate was 87%. There were 37 patients with regional recurrence; 17 patients had received adjuvant radiation therapy (14%), and 20 patients (13%) had not. The likelihood of in-field nodal recurrence was significantly less in the adjuvant radiation therapy group ( P =.01) and significantly greater in sites adjacent to the axilla ( P =.02). Patients with high-risk clinicopathologic features who did not receive adjuvant radiation therapy also tended to experience in-field failure rather than adjacent-field failure. Conclusions Patients who received adjuvant radiation therapy were more likely to experience recurrence in the adjacent-field regions rather than in the in-field regions. This may not simply reflect higher-risk pathology. Using this data, it may be possible to improve outcomes by reducing the number of adjacent-field recurrences after adjuvant radiation therapy.

3084Background: Cancer-testis antigen NY-ESO-1 is a highly immunogenic melanoma antigen which has been adopted for adjuvant vaccine trials. Three such trials (NCT00124124, NCT00821652, NCT01079741)...

9555Background: Circulating tumor cells have been postulated as indicators of the metastatic spread of cancer via the lymphatic and circulatory systems. We have developed a photoacoustic flow cytom...

e21063Background: Current AJCC staging criteria provide limited prognostic value for stage III melanoma patients, who have a 50% chance of recurrence. Complete loss of PTEN expression is known to b...

Melanoma patients in stage III have a considerable recurrence rate. The 10-year survival in this stage depends on the number and size of affected nodes. Currently, there is no optimal serum marker for early detection of relapse available. The goal of the study was to assess the utility of melanoma inhibitory activity (MIA) serum marker in the follow up and primary diagnosis of stage III melanoma patients. One hundred and thirty-eight melanoma patients in stage III at time of primary diagnosis were analyzed at time of primary diagnosis and during periodical routine follow up both for serum MIA using an enzyme-linked immunosorbent assay and for serum lactate dehydrogenase (LDH). Results were correlated with the positivity of the sentinel lymph node (SLN) and the number of lymph node metastases in the completion lymph node dissection at time of primary diagnosis. During follow up, the overall survival time was assessed using the Kaplan-Meier method in terms of elevated MIA (>12 ng/mL) values. Regarding SLN status, significant differences of MIA values (P = 0.024) and LDH (P = 0.007) were found, both within the normal cut-off. Having lymph node metastases in the completion lymph node dissection, significantly higher MIA values (12.55 ng/mL [±0.48], P < 0.0001) were found. In patients with three or more tumor-positive nodes, MIA values were significantly higher when compared to patients with one or two affected nodes (P = 0.024). In the routine follow-up, stage III patients with an MIA value of more than 12 ng/mL had a five times higher risk for developing recurrences (P < 0.0001). Patients with relapsing disease had a significantly (P < 0.0001) higher mean MIA value (13.76 ng/mL) compared to patients without relapse (7.52 ng/mL). The MIA serum marker can be helpful in patients undergoing lymph node dissection. Furthermore, during follow up, patients showing relapsing diseases can have an elevated MIA value.

Several hypotheses proposed to explain the worse prognosis for older melanoma patients include different tumor biology and diminished host response. If the latter were true, then biologic frailty, and not age, should be an independent prognostic factor in melanoma.Our prospective institutional review board (IRB)-approved database was queried for stage III patients with computed tomography (CT) scans at time of lymph node dissection (LND). Psoas area (PA) and density (PD) were determined in semi-automated fashion. Kaplan-Meier (K-M) survival estimates and Cox proportional-hazard models were used to determine PA and PD impact on survival and surgical complications.Among 101 stage III patients, PD was significantly associated with both disease-free survival (DFS) (P = 0.04) and distant disease-free survival (DDFS) (P = 0.0002). Cox multivariate modeling incorporating thickness, age, ulceration, and N stage showed highly significant association with PD and both DFS and DDFS. DDFS was significantly associated with Breslow thickness (P = 0.04), number of positive nodes (P = 0.001), ulceration (P = 0.04), and decreasing muscle density (P = 0.01), with hazard ratio of 0.55 [95% confidence interval (CI) 0.35-0.87]. PD also correlated with surgical complications, with odds ratio (OR) of 1.081 [95% CI 1.016-1.150, P = 0.01].Decreased psoas muscle density on CT, an objective measure of frailty, was as important a predictor of outcome as tumor factors in a cohort of stage III melanoma patients. On multivariate analysis, frailty, not age, was associated with decreased disease-free survival and distant disease-free survival, and higher rate of surgical complications.

BACKGROUND Prognostic factors for patients with stage III melanoma are still controversial. METHODS Two hundred eighty-six patients with solitary cutaneous malignant melanoma of the skin in Stage III (International Union Against Cancer [UICC]) were followed up for as long as 11 years. RESULTS Patients in risk group pT 4a, pN O (primary tumor thickness of more than 4 mm or invasion of subcutis and absence of regional lymph node metastasis in elective lymph node specimen) have a 5-year survival rate of 72.8%. If regional metastases are excluded clinically (pT 4a, NO), the 5-year survival rate is 62.8%. Patients with regional lymph node metastases have an average 5-year survival rate of 39%, depending mainly on the number of involved lymph nodes and the depth infiltration of the primary tumor. The number of involved lymph nodes reflects the grade of dissemination. It shows a stronger correlation with the prognosis than does the size of metastases. CONCLUSIONS The authors recommend that revisions of the UICC classification should distinguish Stage IIIA and IIIB based on the presence or absence of regional metastases and that a clearer distinction should be made between regional cutaneous or subcutaneous metastases and regional lymph node metastases.

Background Elevation of the tumor marker S-100B in melanoma patients is a highly specific indicator of recurrence. Materials and methods The role of S-100B in disease-free survival (DFS) was evaluated in stage III melanoma patients (staged with fluorodeoxyglucose positron emission tomography [FDG-PET] and computed tomography [CT]) with palpable lymph node metastases who underwent therapeutic lymph node dissection. S-100B and LDH were measured on the day before surgery (d = −1) and on days 1, 2, and 7 postoperatively. Multivariate logistic regression was used to study factors associated with preoperative elevation of S-100B. Univariate (log-rank test) and multivariate (Cox regression) survival analyses were performed to identify factors associated with DFS. Results Between 2004 and 2008, 56 patients (median age 57, range 24–93) years, 27 males (48%) and 29 females (52%) entered the study. Preoperative S-100B elevation was found in 27 patients (48%) and elevated LDH in 20 patients (36%). No association was found between these two markers at any time. Multivariate analysis showed that elevated S-100B preoperatively (hazard ratio [HR] 2.7, P = .03) was associated with DFS. S-100B elevation was associated with increased tumor size (odds ratio [OR] 3.40; P = .03). Conclusion Elevated S-100B preoperatively in patients with optimally staged clinical stage III melanoma is associated with decreased disease-free survival. S100-B could be used as a prognostic marker in the stratification of new adjuvant trials to select stage III melanoma patients for adjuvant systematic treatment.

9016 Background: There is a need for more sensitive and specific prognostic markers for advanced stage melanoma patients to help improve the risk-benefit ratio of systemic adjuvant therapies. While...

e20097 Background: Significant advances have been made in the treatment of stage IV melanoma through the use of targeted therapies in patients (pts) with BRAF V600 mutations. However, there is a cr...

Aims To analyse disease-free and overall survival in 67 melanoma patients who underwent dissection for clinically apparent regional lymph node metastases, taking into account the total number of excised lymph nodes. Methods After a median follow-up time of 16 months, 47 recurrences were observed and 43 patients died. The median disease-free and overall survival intervals were 14 and 24 months respectively. Results Multivariate analyses revealed that the number of excised lymph nodes had a significant impact on overall survival (P = 0.036) but not on disease-free survival (P = 0.97). Extranodal growth was the only statistically significant prognostic factor both for disease-free (P = 0.005) and overall (P = 0.038) survival. Age, nodal basin, primary tumor ulceration, tumor thickness and number of positive lymph nodes were not significant prognostic factors. Conclusions Our results suggest that the total number of lymph nodes excised in the dissection has impact on overall survival of stage III melanoma patients and should be considered in clinical assays.

Aim: Ipi, a fully human monoclonal antibody that blocks cytotoxic T-lymphocyte antigen-4 to augment antitumor immune responses, is an approved treatment for advanced melanoma. We report primary efficacy data and ongoing analyses from a phase III trial to evaluate Ipi as an adjuvant therapy for resected stage III melanoma at high risk of recurrence. Methods: In this randomized, double-blind trial, eligible patients (pts) included those ≥18 yrs of age who underwent complete resection of stage III cutaneous melanoma (excluding lymph node metastasis ≤1 mm or in-transit metastasis). 951 pts were randomized (stratified by stage and region) 1:1 to Ipi 10 mg/kg (n = 475) or placebo (Pbo, n = 476) q3w for 4 doses, then every 3 mos for up to 3 yrs until completion, disease recurrence, or unacceptable toxicity. The primary endpoint was recurrence-free survival (RFS). Secondary endpoints included safety and health-related QoL. Results: Overall, 20%/44%/36% of pts had stage IIIA/IIIB/IIIC, 42% ulcerated primary, and 58% macroscopic lymph node involvement. At a median follow-up of 2.7 yrs, Ipi significantly improved RFS vs Pbo (234/475 vs 294/476 events): median RFS 26.1 mos for Ipi vs 17.1 mos for Pbo (HR 0.75, 0.64–0.90; log-rank P = 0.0013). 3-yr RFS rates were 46.5% and 34.8%, respectively. RFS benefit was consistent across subgroups (e.g., stage IIIB or IIIC, ulcerated primary). Most common grade 3/4 immune-related adverse events (irAEs) in the Ipi and Pbo arms were gastrointestinal (15.9% vs 0.8%), hepatic (10.6% vs 0.2%), and endocrine (8.5% vs 0%). Most irAEs were managed and resolved using established algorithms. Of 471 pts who started Ipi, 245 (52%) discontinued treatment due to AEs (182 [38.6%] within 12 weeks); 5 (1.1%) died due to drug-related AEs. RFS analyses adjusted for prognostic factors and key HRQoL data will be presented. Conclusions: In this phase III trial, Ipi as adjuvant therapy provided a clinically and statistically significant improvement in RFS vs Pbo for pts with stage III melanoma at high risk of recurrence. AE profile was generally consistent with that observed in advanced melanoma, although with a higher incidence of endocrinopathies. Disclosure: A.M.M. Eggermont: Financial interest: Advisory boards for Amgen, Bristol-Myers Squibb, GlaxoSmithKline, MedImmune, and MSD; V. Chiarion-Sileni: Advisory board participation: Bristol-Myers Squibb, GlaxoSmithKline, and Roche; J.-. Grob: Consultant or advisory role: Bristol-Myers Squibb, Roche, GlaxoSmithKline, Merck; honoraria: Bristol-Myers Squibb, Roche, GlaxoSmithKline, Merck; R. Dummer: Consultant or advisory role, honoraria, and research funding: AstraZeneca, Novartis, Cephalon, MSD, Bristol-Myers Squibb, GlaxoSmithKline, Roche, Amgen, Bayer; J.D. Wolchok: Grants and personal fees: Bristol-Myers Squibb, during conduct of the study; grants and personal fees from Medimmune, Glaxo SmithKline; personal fees: Merck Sharpe and Dohme, EMDSerono, Johnson and Johnson; H. Schmidt: Advisory board: Roche; speakers' bureau: Bristol-Myers Squibb; O. Hamid: Consultant or advisory role: Bristol-Myers Squibb; speakers' bureau: Bristol-Myers Squibb; research funding from Bristol-Myers Squibb to The Angeles Clinic; C. Robert: Consultant or advisory role: Bristol-Myers Squibb, GlaxoSmithKline, Roche, MSD; honoraria: Bristol-Myers Squibb, GlaxoSmithKline, Roche; P.A. Ascierto: Consultant or advisory role: Bristol-Myers Squibb, Roche-Genentech, MSD, GlaxoSmithKline, Novartis, Ventana; honoraria: Bristol-Myers Squibb, Roche-Genentech, GlaxoSmithKline; research funding: Bristol-Myers Squibb, Ventana; J.M. Richards: Stock ownership: Bristol-Myers Squibb; C. Lebbe: Advisory boards: Bristol-Myers Squibb, Roche, Novartis, GlaxoSmithKline, Amgen.; M. Smylie: Consultant or advisory role: Bristol-Myers Squibb; honoraria: Bristol-Myers Squibb; J.S. Weber: Advisory boards: Bristol-Myers Squibb (less than 10,000 USD annually for advisory boards); grants from Bristol-Myers Squibb to Moffitt for the conduct of the trial in question; M. Maio: Consultant or advisory role: Bristol-Myers Squibb; honoraria: Bristol-Myers Squibb; research funding: Bristol-Myers Squibb; C. Konto: Employee of Bristol-Myers Squibb; V. De Pril: Employee of Bristol-Myers Squibb; stock ownership: Bristol-Myers Squibb; A. Testori: Consultant or advisory role: Bristol-Myers Squibb, Roche, GlaxoSmithKline, Amgen, Celgene; honoraria: Bristol-Myers Squibb. All other authors have declared no conflicts of interest.

9064 Background: The extent of regional lymphadenectomy in stage III melanoma is still controversial because most recommendations are not based on statistical analysis of the minimum number of excised nodes necessary to minimize regional recurrence. Methods: We used our center’s melanoma database to identify all patients diagnosed with stage III neck, axillary or inguinal regional metastasis of cutaneous melanoma between 1971 and 2010. We then excluded cases with multiple tumor-involved nodal basins, multiple primaries

Metastatic disease is detected infrequently by computed tomography (CT) in early stage melanoma. The diagnostic yield of routine CT for stage III melanoma is less established, despite extensive use in clinical practice.Charts from 347 asymptomatic patients with stage III melanoma were reviewed. Findings suggestive of metastatic melanoma identified by head or body CT, chest radiography, bone scan, or liver function studies were confirmed histologically or by progression of disease.Individual CT scans identified 33/788 (4.2%) instances of metastatic melanoma, with 66/788 (8.4%) false positive studies. No metastases were identified among 104 head CT scans. Chest CT had the highest yield in patients with cervical adenopathy (7/35, 20%), and the lowest yield with groin adenopathy (1/50, 2%). Pelvic CT diagnosed metastases in 7/94 (7.4%) patients with groin adenopathy, but no patients with palpable axillary (n = 76) or cervical (n = 21) nodes. Metastatic melanoma was diagnosed in 11/136 (8.1%) patients having complete body CT imaging (chest, abdomen, and pelvis), including six patients (4.4%) identified by CT alone.Routine CT in patients with clinical stage III melanoma infrequently identifies metastatic disease. Head CT in the asymptomatic patient, chest CT in patients with groin adenopathy, and pelvic CT in the presence of axillary or cervical adenopathy are not indicated. Selective use of chest CT in patients with cervical adenopathy or pelvic CT in the presence of groin disease may be useful.

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.

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]