After Surgery: Follow-Up Guidelines of Melanoma Patients

9576 Background: While management of the nodal basin for melanoma has largely moved to observation for microscopic sentinel lymph node (SLN) metastasis, complete lymph node dissection (CLND) remains the current standard of care for melanoma patients with macroscopic, clinically detectable lymph node metastases (cLN). As CLND is associated with high surgical morbidity, we sought to study whether cLN may be safely managed by excision of only clinically abnormal nodes (precision lymph node dissection, PLND). Currently, a small subset of patients with cLN do not undergo CLND because of frailty or patient preference. We hypothesized that in these selected patients, PLND would provide acceptable regional control rates. Methods: Retrospective chart review was conducted at four academic tertiary care hospitals to identify melanoma patients who underwent PLND for cLN. cLN were defined as palpable or radiographically abnormal nodes. Recurrences were categorized as local/in-transit, same-basin lymph node, or distal lymph node/visceral. The primary outcome was isolated same-basin recurrence after PLND. Results: Twenty-one patients underwent PLND for cLN without synchronous distant metastases (characteristics of primary lesions summarized in Table). Reasons for forgoing CLND included patient preference (n=8), imaging indeterminate for distant metastases (n=2), comorbidities (n=4), loss to follow up (n=1), partial response to checkpoint blockade (n=1), or not reported (n=5). The inguinal node basin was the most common site (n=10), followed by the axillary (n=8) and cervical basins (n=3). A median of 2 nodes were resected at PLND, and 68% of resected nodes were positive for melanoma (median: 1, range: 1-3 nodes). Median follow-up was 23 months from PLND, and recurrence was observed in 28.6% of patients overall. Only 1 patient (4.8%) developed an isolated same-basin recurrence. The 3-year cumulative incidence of isolated same-basin recurrence was 5.3%, while risk of isolated local/in-transit recurrence or distant basin/visceral metastasis were 19.8% and 33.3%, respectively. Complications from PLND were reported in 1 patient (4.8%) and were limited to post-operative seroma and lymphedema. Conclusions: These pilot data suggest that PLND may offer acceptable regional disease control for cLN. Post-operative morbidity from PLND was also low, raising the possibility that PLND may provide adequate regional disease control without the morbidity associated with CLND. These data justify additional, prospective evaluation of PLND in selected patients.[Table: see text]

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Primary analysis and four-year follow-up of the phase III NIBIT-M2 trial in melanoma patients with brain metastases

Clinical Cancer Research ◽

10.1158/1078-0432.ccr-21-1046 ◽

2021 ◽

pp. clincanres.1046.2021

Author(s):

Anna Maria Di Giacomo ◽

Vanna Chiarion-Sileni ◽

Michele Del Vecchio ◽

Pier Francesco Ferrucci ◽

Michele Guida ◽

...

Keyword(s):

Brain Metastases ◽

Phase Iii ◽

Primary Analysis ◽

Melanoma Patients

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The MELFO Study: A Multicenter, Prospective, Randomized Clinical Trial on the Effects of a Reduced Stage-Adjusted Follow-Up Schedule on Cutaneous Melanoma IB–IIC Patients—Results After 3 Years

Annals of Surgical Oncology ◽

10.1245/s10434-019-07825-7 ◽

2019 ◽

Vol 27 (5) ◽

pp. 1407-1417 ◽

Cited By ~ 6

Author(s):

Eric A. Deckers ◽

Josette E. H. M. Hoekstra-Weebers ◽

Samantha Damude ◽

Anne Brecht Francken ◽

Sylvia ter Meulen ◽

...

Keyword(s):

Cutaneous Melanoma ◽

Well Being ◽

Significant Group ◽

Event Scale ◽

Free Survival ◽

Stage Ib ◽

Ajcc Stage ◽

Patient Reported ◽

Melanoma Patients

Abstract Background This study compares well-being, recurrences, and deaths of early-stage cutaneous melanoma patients in follow-up, as recommended in the Dutch guideline, with that of patients in a stage-adjusted reduced follow-up schedule, 3 years after diagnosis, as well as costs. Methods Overall, 180 eligible pathological American Joint Committee on Cancer (AJCC) stage IB–IIC, sentinel node staged, melanoma patients (response rate = 87%, 48% male, median age 57 years), randomized into a conventional (CSG, n = 93) or experimental (ESG, n = 87) follow-up schedule group, completed patient-reported outcome measures (PROMs) at diagnosis (T1): State-Trait Anxiety Inventory–State version (STAI-S), Cancer Worry Scale (CWS), Impact of Event Scale (IES), and RAND-36 (Mental and Physical Component scales [PCS/MCS]). Three years later (T3), 110 patients (CSG, n = 56; ESG, n = 54) completed PROMs, while 42 declined (23%). Results Repeated measures analyses of variance (ANOVAs) showed a significant group effect on the IES (p = 0.001) in favor of the ESG, and on the RAND-36 PCS (p = 0.02) favoring the CSG. Mean IES and CWS scores decreased significantly over time, while those on the RAND-36 MCS and PCS increased. Effect sizes were small. Twenty-five patients developed a recurrence or second primary melanoma, of whom 13 patients died within 3 years. Cox proportional hazards models showed no differences between groups in recurrence-free survival (hazard ratio [HR] 0.71 [0.32–1.58]; p = 0.400) and disease-free survival (HR 1.24 [0.42–3.71]; p = 0.690). Costs per patient after 3 years (computed for 77.3% of patients) were 39% lower in the ESG. Conclusion These results seemingly support the notion that a stage-adjusted reduced follow-up schedule forms an appropriate, safe, and cost-effective alternative for pathological AJCC stage IB–IIC melanoma patients to the follow-up regimen as advised in the current melanoma guideline.

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P865 Safety & efficacy of lifileucel (LN-144) tumor infiltrating lymphocyte therapy in metastatic melanoma patients after progression on multiple therapies – independent review committee data update

Journal for ImmunoTherapy of Cancer ◽

10.1136/lba2019.18 ◽

2020 ◽

Vol 8 (Suppl 1) ◽

pp. A12-A12

Author(s):

Amod Sarnaik ◽

Nikhil Khushalani ◽

Jason Chesney ◽

Harriet Kluger ◽

Brendan Curti ◽

...

Keyword(s):

Metastatic Melanoma ◽

Advanced Melanoma ◽

Review Committee ◽

Safety And Efficacy ◽

Mek Inhibitors ◽

Tumor Infiltrating Lymphocyte ◽

Heavily Pretreated ◽

Independent Review ◽

Melanoma Patients

BackgroundTreatment options are limited for patients with advanced melanoma who have progressed on checkpoint inhibitors and targeted therapies such as BRAF/MEK inhibitors (if BRAF-V600E mutated). Adoptive cell therapy utilizing tumor-infiltrating lymphocytes (TIL) has shown antitumor efficacy with durable responses in heavily pretreated melanoma patients. Safety and efficacy of lifileucel, a centrally manufactured cryopreserved autologous TIL therapy assessed by both investigator and an independent review committee (IRC), are presented.MethodsC-144-01 is a global Phase 2 open-label, multicenter study of the safety and efficacy of lifileucel in patients with unresectable metastatic melanoma. We report on Cohort 2 (N = 66) patients with Stage IIIC/IV unresectable melanoma who received lifileucel. Tumors resected at local institutions were processed in central GMP facilities for TIL production in a 22-day process. Final TIL infusion product was cryopreserved and shipped to sites. Patients received one week of cyclophosphamide/fludarabine preconditioning lymphodepletion, a single lifileucel infusion, followed by up to 6 doses of IL-2. All responses were assessed by RECIST 1.1.Results66 patients had the following baseline characteristics: 3.3 mean prior therapies (anti-PD1 100%; anti-CTLA-4 80%; BRAF/MEK inhibitor 23%), relatively high tumor burden (106 mm mean target lesion sum of diameters), 44% with liver and/or brain lesions, median LDH 244 U/L. Objective Response Rate (ORR) by investigator was 36.4% (2 CR, 22 PR, 1 previously confirmed PR is now changed to SD) and Disease Control Rate (DCR) of 80.3%. At a median follow up of 9.7 months, median Duration of Response (DOR) has not been reached. The adverse event profile was generally consistent with the underlying advanced disease and the profile of the lymphodepletion and IL-2 regimens.The ORR per IRC was 34.8% (2 CR, 21 PR) and DCR was 72.7%. At a median follow up of 6.9 months, the median IRC DOR has not been reached. Overall concordance rate of investigator and IRC read of response was 89.4%. The concordance compares favorably with literature reports in a metastatic disease.1ConclusionsLifileucel treatment resulted in a 36.4% ORR in heavily pretreated metastatic melanoma patients with high baseline disease burden who had received prior anti-PD1 and BRAF/MEK inhibitors, if tumor BRAF mutated. The high concordance of 89.4% between investigator and IRC confirms the original assessment of lifileucel efficacy in metastatic melanoma.2AcknowledgementsThe authors would like to thank the patients and their families for participation in the study.The authors would also like to acknowledge the support and dedication of all investigators and site team members from all participating clinical trial institutions.Trial RegistrationClinicalTrials. gov Identifier: NCT02360579Ethics ApprovalEthics Approval This trial was approved by Western Institutional Review Board - IRB Tracking Number: 20160198.ReferencesGhiorghiu DC, et al. Comparison of central and site review of RECIST data in an open randomised phase II trial in advanced melanoma. 10.1594.ecr 2009/C-075.Sarnaik A, et al. Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients who progressed on multiple prior therapies including anti-PD-1. J Clin Oncol 2019;37:2518–2518.

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The clinical significance of indeterminate pulmonary nodules in melanoma patients at baseline and during follow-up chest CT

European Journal of Radiology Open ◽

10.1016/j.ejro.2019.02.003 ◽

2019 ◽

Vol 6 ◽

pp. 85-90 ◽

Cited By ~ 4

Author(s):

Magdy Soliman ◽

Teresa Petrella ◽

Pascal Tyrrell ◽

Frances Wright ◽

Nicole J. Look Hong ◽

...

Keyword(s):

Clinical Significance ◽

Pulmonary Nodules ◽

Chest Ct ◽

Melanoma Patients

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Prospective evaluation of risk-appropriate management of uveal melanoma patients informed by gene expression profiling

Melanoma Management ◽

10.2217/mmt-2020-0001 ◽

2020 ◽

Vol 7 (1) ◽

pp. 17-25 ◽

Cited By ~ 1

Author(s):

Amy C Schefler ◽

Alison Skalet ◽

Scott C N Oliver ◽

John Mason ◽

Anthony B Daniels ◽

...

Keyword(s):

Gene Expression ◽

Uveal Melanoma ◽

Clinical Utility ◽

Medical Oncology ◽

Treatment Plan ◽

Risk Class ◽

Class 1 ◽

Melanoma Patients ◽

Metastatic Risk

Aim: The Clinical Application of DecisionDx-UM Gene Expression Assay Results study aimed to evaluate the clinical utility of the prognostic 15-gene expression profile (15-GEP) test for uveal melanoma (UM) patients in a large, prospective multicenter cohort. Patients & methods: Nine centers prospectively enrolled 138 UM patients clinically tested with the 15-GEP. Physician-recommended specialty referrals and metastatic surveillance regimens were collected. Results: A total of 93% of high-risk class 2 patients were referred to medical oncology for follow-up, compared with 51% of class 1 patients. A majority (62%) of class 2 patients were recommended overall high-intensity metastatic surveillance, while 85% of class 1 patients were recommended low-intensity metastatic surveillance. Conclusion: Treatment plan recommendations for UM patients are aligned with GEP-informed metastatic risk, consistent with prior studies.

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ASO Author Reflections: Stage-Adjusted Reduced Follow-Up of Melanoma Patients is Justified and Cost Effective, Until Biomarkers to Predict Prognosis Have Been Identified

Annals of Surgical Oncology ◽

10.1245/s10434-019-07611-5 ◽

2019 ◽

Vol 27 (5) ◽

pp. 1418-1419

Author(s):

Anne Brecht Francken ◽

Josette E. H. M. Hoekstra-Weebers ◽

Eric Deckers ◽

Harald J. Hoekstra

Keyword(s):

Cost Effective ◽

Melanoma Patients

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