PURPOSE To provide guidance to clinicians regarding the use of systemic therapy for melanoma. METHODS ASCO convened an Expert Panel and conducted a systematic review of the literature. RESULTS A systematic review, one meta-analysis, and 34 additional randomized trials were identified. The published studies included a wide range of systemic therapies in cutaneous and noncutaneous melanoma. RECOMMENDATIONS In the adjuvant setting, nivolumab or pembrolizumab should be offered to patients with resected stage IIIA/B/C/D BRAF wild-type cutaneous melanoma, while either of those two agents or the combination of dabrafenib and trametinib should be offered in BRAF-mutant disease. No recommendation could be made for or against the use of neoadjuvant therapy in cutaneous melanoma. In the unresectable/metastatic setting, ipilimumab plus nivolumab, nivolumab alone, or pembrolizumab alone should be offered to patients with BRAF wild-type cutaneous melanoma, while those three regimens or combination BRAF/MEK inhibitor therapy with dabrafenib/trametinib, encorafenib/binimetinib, or vemurafenib/cobimetinib should be offered in BRAF-mutant disease. Patients with mucosal melanoma may be offered the same therapies recommended for cutaneous melanoma. No recommendation could be made for or against specific therapy for uveal melanoma. Additional information is available at www.asco.org/melanoma-guidelines .

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OBJECTIVE The purpose of this study was to establish the prognostic utility in human papillomavirus (HPV)–positive stage III and IV oropharyngeal squamous cell carcinoma (SCC) of the 18F-FDG parameters maximal, mean, and peak standardized uptake value (SUVmax, SUVmean, and SUVpeak, respectively); metabolic tumor volume (MTV); and total lesion glycolysis (TLG). MATERIALS AND METHODS We included 70 patients in the present study who had a biopsy-proven HPV-positive (by in situ hybridization) stage III and IV oropharyngeal SCC and had a baseline PET/CT examination at our institution. Outcome endpoint was event-free survival (EFS), which included recurrence-free and overall survival. Cox proportional hazards multivariate regression analyses were performed. Survival analysis was performed using Kaplan-Meier survival curves. RESULTS In Cox regression proportional hazard univariate analysis, total MTV (hazard ratio [HR], 1.02; p = 0.008), primary-tumor MTV (HR, 1.02; p = 0.024), neck nodal MTV (HR, 1.03; p = 0.006), neck nodal TLG (HR, 1.01; p = 0.006), and neck node status (HR, 4.45; p = 0.03) showed a statistically significant association with EFS. There was no statistically significant association of EFS with SUVmax, SUVmean, SUVpeak, and primary-tumor or overall TLG. In Cox regression proportional hazard multivariate model I, total MTV remained an independent prognostic marker for EFS when adjusted for every other variable individually in the model; in model II, primary-tumor MTV, neck node status, and SUVpeak are independent prognostic markers for EFS. The Kaplan-Meier survival curves using optimum cut point of 41 mL of total MTV were not significant (p = 0.09). CONCLUSION Total MTV and primary-tumor MTV are associated with survival outcomes in patients with HPV-positive stage III and IV oropharyngeal SCC.

These results can be used to identify patients at increased risk for CRE colonization and to help target active surveillance programs in healthcare settings.

Age, SUVmax, peak SUV, and total lesion glycolysis (i.e., tumor glycolytic activity) of the primary tumor are associated with PFS, and tumor glycolytic activity is associated with OS in patients with pancreatic adenocarcinoma.

Objective To assess differences in morphological and glycolytic characteristics of primary tumors and locoregional nodal disease between HPV-positive and HPV-negative oropharygeal head and neck squamous cell carcinoma (HNSCC). Methods A retrospective analysis of 123 baseline FDG PET/CT scans from patients (age: 57.0 ± 10.6 yrs), newly diagnosed with oropharyngeal SCC between January 2003 and June 2012. There were 98 HPV positive and 25 HPV negative patients. SUVmax, SUVpeak, and SUVmean based on lean body mass, as well as RECIST dimensions, metabolic tumor volume (MTV) (gradient and threshold segmentation methods) and total lesion glycolysis (TLG) were determined for primary and locoregional nodal disease. Results HPV negative primary tumors were significantly larger in size as measured by RECIST longest diameter (p=0.002), slightly more heterogenous as meassured by the heterogenity index (HI) (p=0.07), higher SUVmax (p<0.01), SUVpeak (p=0.01), SUVmean (p=0.01), MTV (p=0.002), and TLG (p=0.001), for both segmentation methods. Index parameters of HPV positive nodal disease tends to be larger, but some with no statistical significance (p>0.05). There was no significant difference in the metabolic parameters of primary tumor or nodal metastases for HPV positive patients with and without smoking history. Conclusion Index morphologic and glycolytic parameters as measured in FDG PET/CT are significantly larger in HPV negative as compared to HPV positive primary oropharyngeal carcinoma. In contrast, the same parameters trended to be larger in HPV positive regional nodal disease.

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18 F-FDG PET/CT is used in the follow-up of patients with head and neck squamous cell cancer (HNSCC). However, its impact on clinical decision making and patient outcome is not fully established. The objective of this study was to determine the prognostic value of 18 F-FDG PET/CT for overall survival (OS) of HNSCC patients when performed in addition to clinical assessment between 4 and 24 mo after treatment. Methods: This was a retrospective study at a single tertiary center. The institutional review board approved this study, and the requirement to obtain informed consent was waived. The study included 134 biopsy-proven HNSCC patients with 227 followup PET/CT scans. The primary outcome measure was OS. Median follow-up was 40 mo (range, 7-145 mo). Survival is presented as Kaplan-Meier plots with Mantel-Cox log-rank test. The multivariate Cox model included clinical covariates. Results: Of the 227 PET/CT scans, 41 (18%) were positive for tumor and 186 (82%) were negative for tumor. PET/CT identified recurrence in 5% (9/194) of scans performed without prior clinical concern and ruled out tumor in 51.5% (17/33) of scans performed to evaluate clinical suspicion or uncertainty of recurrence. The median survival of PET-positive and -negative groups from the date of the scan was 20 and 30.5 mo, respectively (P , 0.0001). There was a significant difference in OS from the scan date between patients who had a positive PET/CT result for tumor and those who had a negative result (log-rank, P , 0.0001), with a hazard ratio of 29.74. Human papillomavirus status (P 5 0.001) and PET/CT result (P 5 0.04) were the only factors significantly associated with OS, adjusted for all other covariates. Conclusion: 18 F-FDG PET/CT performed between 4 and 24 mo after treatment adds value to clinical assessment at the time of the study, especially when there is clinical suspicion or uncertainty, and can serve as a prognostic marker of OS in HNSCC.