NCCN Guidelines® Insights: Melanoma: Cutaneous, Version 2.2021

Swetter, Susan M.; Thompson, John A.; Albertini, Mark R.; Barker, Christopher A.; Baumgartner, Joel M.; Boland, Genevieve M.; Chmielowski, Bartosz; DiMaio, Dominick J.; Durham, Alison B.; Fields, Ryan C.; Fleming, Martin D.; Galan, Anjela; Gastman, Brian; Grossmann, Kenneth F.; Guild, Samantha; Holder, Ashley M.; Johnson, Douglas B.; Joseph, Richard W.; Karakousis, Giorgos C.; Kendra, Kari; Lange, Julie R.; Lanning, Ryan M.; Margolin, Kim; Olszanski, Anthony J.; Ott, Patrick A.; Ross, Merrick I.; Salama, April K.S.; Sharma, Rohit; Skitzki, Joseph J.; Sosman, Jeffrey A.; Wuthrick, Evan; McMillian, Nicole R.; Engh, Anita M.

doi:10.6004/jnccn.2021.0018

Cited by 196 publications

(185 citation statements)

References 151 publications

(180 reference statements)

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“…Data of a randomized controlled trial assessing nivolumab or pembrolizumab EI dosing in locally advanced or metastatic cancers is expected in 2025 (ClinicalTrials.gov NCT04295863). EI dosing for nivolumab in metastatic melanoma, on the contrary, is common practice [5] .…”

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Extended Interval Dosing for Immune Checkpoint Inhibitors in Non–Small Cell Lung Cancer During the COVID-19 Pandemic

Hijmering-Kappelle¹,

Hiltermann²,

Bensch³

2022

Clinical Lung Cancer

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Introduction Extended interval (EI) dosing for immune checkpoint inhibitor (ICI) mono- or consolidation therapy initiated due to the COVID-19 pandemic led to a significant reduction in ICI-related site visits for patients with stage III and IV non-small cell lung cancer (NSCLC). Here we report the safety and efficacy compared to standard dose (SD) schedules. Method In this retrospective analysis patients who received ICI mono- or consolidation therapy, or adjuvant ICI therapy were assessed. Safety and efficacy of EI dosing with data of SD schedules were compared. Results One hundred seventeen patients received EI dosing for ICI and 88 patients SD. Patient characteristics were comparable. We observed 237 adverse events in the EI dosing cohort versus 118 in the SD group ( p = 0.02). Overall, there was no difference in the occurrence of grade ≥3 adverse events (EI dosing: 21/237 [8.9%]; SD group: 20/118 [17.0%], p = 0.42), except for the pembrolizumab EI dosing cohort. Of all patients who received an EI dosing schedule, however, only 8 (6.8%) were reduced to SD because of toxicity. In 5 (4.3%) patients ICI was permanently stopped because of severe toxicity compared to 11 (12.5%) discontinuations in the SD group. Short-term treatment interruption occurred with similar frequencies in both groups. PFS and OS were comparable in patients receiving pembrolizumab and in those receiving adjuvant durvalumab. Progression-free survival and OS were better in the EI dosing cohort of nivolumab. Conclusion EI dosing for ICI did not lead to an increase of clinically relevant toxicities resulting in dose reduction and/or treatment discontinuation. Efficacy of EI dosing of pembrolizumab and durvalumab were comparable to SD. Based on our safety and efficacy data EI dosing for ICI seems a safe and effective strategy. Micro abstract Aim Retrospective analysis of the safety and efficacy of extended interval dosing (EI) ICI compared to standard dose (SD) schedules. Results 117 patients received EI dosing and 88 SD. In the EI dosing cohort was no increase in toxicity leading to dose reduction and/or discontinuation of treatment. Furthermore, efficacy of EI dosing of pembrolizumab and durvalumab were comparable to SD. Based on our safety and efficacy data EI dosing for ICI seem a safe and effective strategy and should be continued also beyond the COVID-19 pandemic.

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Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Extended Interval Dosing for Immune Checkpoint Inhibitors in Non–Small Cell Lung Cancer During the COVID-19 Pandemic

Hijmering-Kappelle¹,

Hiltermann²,

Bensch³

2022

Clinical Lung Cancer

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“…Our analysis of SLN-positive and -negative patients show worse survival rates than in similar studies [29,30], probably because of differences in patient selection criteria. These differences in survival could justify the use of new adjuvant therapies and should be discussed with patients [5].…”

Section: Discussionmentioning

confidence: 99%

“…This is important, particularly in our setting, where tumors with a Breslow thickness < 1 mm are the most common diagnosed melanomas [3]. In addition, SLNB is recommended for patients with stage T1b melanoma and stage T1a melanoma if there are other highrisk factors, such as a mitotic rate > 2 mitoses/mm 2 [4], lymphovascular invasion, and young age [5].…”

Section: Introductionmentioning

confidence: 99%

Sentinel Lymph Node Biopsy vs. Observation in Thin Melanoma: A Multicenter Propensity Score Matching Study

Tejera‐Vaquerizo¹,

Boada

Ribero

et al. 2021

JCM

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The therapeutic value of sentinel lymph node biopsy (SLNB) in thin melanoma remains controversial. The aim of this study is to determine the role of SLNB in the survival of thin melanomas (≤1 mm). A multicenter retrospective observational study was designed. A propensity score matching was performed to compare patients who underwent SLNB vs. observation. A multivariate Cox regression was used. A total of 1438 patients were matched by propensity score. There were no significant differences in melanoma-specific survival (MSS) between the SLNB and observation groups. Predictors of MSS in the multivariate model were age, tumor thickness, ulceration, and interferon treatment. Results were similar for disease-free survival and overall survival. The 5- and 10-year MSS rates for SLN-negative and -positive patients were 98.5% vs. 77.3% (p < 0.001) and 97.3% vs. 68.7% (p < 0.001), respectively. SLNB does not improve MSS in patients with thin melanoma. It also had no impact on DSF or OS. However, a considerable difference in MSS, DFS, and OS between SLN-positive and -negative patients exists, confirming its value as a prognostic procedure and therefore we recommend discussing the option of SLNB with patients.

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“…As a result, MAPK TT are now standard of care treatments for patients with BRAF V600 mutant melanoma, lung cancer, and colorectal cancer [12][13][14].…”

Section: Introductionmentioning

confidence: 99%

Clinical activity of MAPK targeted therapies in patients with non-V600 BRAF mutant tumors

Dankner

Wang

Fazelzad

et al. 2022

Preprint

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Purpose: Non-V600 mutations comprise approximately 35% of all BRAF mutations in cancer. Many of these mutations have been identified as oncogenic drivers in a wide array of cancer types and can be classified into three Classes according to molecular characteristics. Consensus treatment strategies for Class 2 and 3 BRAF mutations have not yet been established. Methods: We performed a systematic review and meta-analysis of individual patient data to assess treatment outcomes with FDA-approved mitogen activated protein kinase pathway (MAPK) targeted therapy according to BRAF Class, cancer type and MAPK targeted therapy type. A search was conducted on literature from 2010-2021. Individual patient data was collected and analyzed from published reports of patients with cancer harboring Class 2 or 3 BRAF mutations and who received MAPK targeted therapy with available treatment response data. Co-primary outcomes were response rate (RR) and progression-free survival (PFS). Results: 18167 studies were screened, identifying 80 studies with 238 patients that met inclusion criteria. This included 167 patients with Class 2 and 71 patients with Class 3 BRAF mutations. Overall, 77 patients achieved a treatment response. In both univariate and multivariable analyses, RR and PFS were higher among patients with Class 2 compared to Class 3 mutations, findings that remain when analyses are restricted to patients with melanoma or lung primary cancers. MEK +/- BRAF inhibitors demonstrated greater clinical activity in Class 2 compared to Class 3 BRAF mutant tumors than BRAF or EGFR inhibitors. Conclusions: This meta-analysis suggests that MAPK targeted therapies have clinical activity in some Class 2 and 3 BRAF mutant cancers. BRAF Class may dictate responsiveness to current and emerging treatment strategies, particularly in metastatic melanoma and lung cancers. Together, this analysis provides clinical validation of predictions made based on a mutation classification system established in the preclinical literature. Further evaluation with prospective clinical trials is needed for this population.

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NCCN Guidelines® Insights: Melanoma: Cutaneous, Version 2.2021

Cited by 196 publications

References 151 publications

Safety and Efficacy of Extended Interval Dosing for Immune Checkpoint Inhibitors in Non–Small Cell Lung Cancer During the COVID-19 Pandemic

Safety and Efficacy of Extended Interval Dosing for Immune Checkpoint Inhibitors in Non–Small Cell Lung Cancer During the COVID-19 Pandemic

Sentinel Lymph Node Biopsy vs. Observation in Thin Melanoma: A Multicenter Propensity Score Matching Study

Clinical activity of MAPK targeted therapies in patients with non-V600 BRAF mutant tumors

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