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ESMO management and treatment adapted recommendations in the COVID-19 era: Melanoma

The tiered approach of ESMO in delivering a guidance for cancer patients during the COVID-19 pandemic is designed across three levels of priorities, namely: tier 1 (high priority intervention), 2 (medium priority) and 3 (low priority) – defined according to the criteria of the Cancer Care Ontario, Huntsman Cancer Institute and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS), incorporating the information on the value-based prioritisation and clinical cogency of the interventions

  • High priority: Patient's condition is immediately life threatening, clinically unstable, and/or the magnitude of benefit qualifies the intervention as high priority (e.g. significant overall survival [OS] gain and/or substantial improvement in quality of life [QoL]);
  • Medium priority: Patient's situation is non-critical but delay beyond 6 weeks could potentially impact overall outcome and/or the magnitude of benefit qualifies for intermediate priority;
  • Low priority: Patient's condition is stable enough that services can be delayed for the duration of the COVID-19 pandemic and/or the intervention is non-priority based on the magnitude of benefit (e.g. no survival gain with no change nor reduced QoL).

 

Priorities for Melanoma patients

Outpatient visit priorities

High Priority

  • New diagnosis of invasive primary melanoma, unless tumour is Tis or T1a and wide excision has been performed
  • Post-operative patients with complications

High/Medium Priority

  • Established patients with new problems or symptoms from treatment (depending on severity of symptoms, burden of progression, etc.) - convert as many visits as possible to telemedicine visits
  • Triggers for high-priority visits include:
    • For patients on IO: shortness of breath, grade 2 or higher diarrhoea or new neurological symptoms.  COVID-19 testing as appropriate
    • For patients on BRAFi/MEKi: fever that does not resolve with treatment interruption prompts for COVID-19 testing

Medium Priority 

  • Visits between two treatments for patients on immunotherapies: refer to telemedicine
  • Post-operative patients with no complications

 Low Priority

  • Patients in follow-up with no active treatment or melanoma survivors: refer to telemedicine
  • Patients with dysplastic naevi syndrome or other increased risk conditions
  • Psychological support visits (convert to telemedicine)

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  • For patients on PD-1 blockade, we recommend double dosing with double interval to reduce visits: pembrolizumab 400 mg q6w and nivolumab 480 mg q4w with one inter-cure visit in telemedicine with blood exams performed in a laboratory close to the patient if a suitable COVID-19-protected facility is available, otherwise at the centre under current precautions
  • For patients on TKIs, refer follow-up visits (e.g. monthly or q2m) to telemedicine with blood exams performed in a laboratory close to the patient if a suitable COVID-19-protected facility is available, otherwise at the centre under current precautions

Priorities for Surgery in Primary Melanoma

High Priority

  • Any curative resection for stage III melanoma
  • Surgical management of complications from surgical procedures
  • Surgery planned for patients in neo-adjuvant trials

High/Medium Priority 

  • Wide excision and sentinel lymph node biopsy for new diagnosis of invasive primary melanoma T1b or higher. High priority can be given to T3 and T4 and medium to T1 and T2. Depending on the local COVID-19 situation, delaying surgery is acceptable as this was not shown to influence survival [1,2]
  • For T1a or lower, wide excision alone with medium priority
  • Resection of oligo-metastatic disease

 Low Priority

-

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  • Inclusions in adjuvant and neo-adjuvant trials should be discouraged as these will result in additional visits to the centre and expose the patient

Priorities for Adjuvant Systemic Therapies for Stage III Melanoma

High Priority

  • Continuation of treatment in the context of a clinical trial, provided patient benefits outweigh risks, with possible adaptation of procedures without affecting patient safety and study conduct

High/Medium Priority

  • Adjuvant targeted or immunotherapies for patients with high-risk stage III disease (sentinel lymph node deposit of more than 1 mm and AJCC 8th Edition stage > IIIA)

 Low Priority

  • Any adjuvant treatment for sentinel lymph node deposit of less than 1 mm or stage AJCC 8th Edition IIIA

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  • Depending on the local hospital situation, adjuvant treatments can be delayed up to the 12 weeks allowed in the adjuvant clinical trials
  • Depending on the local hospital situation, adjuvant BRAFi/MEKi (as this oral strategy is more amenable to telemedicine) could be initiated and a later switch to adjuvant IO could be discussed
  • Inclusions in adjuvant and neo-adjuvant trials should be discouraged as these will result in additional visits to the centre and expose the patient
  • For patients on PD-1 blockade, we recommend double dosing with double interval to reduce visits: pembrolizumab 400 mg q6w and nivolumab 480 mg q4w with one inter-cure visit in telemedicine with blood exams performed in a laboratory close to the patient if a suitable COVID-19-protected facility is available, otherwise at the centre under current precautions

Priorities for Systemic Therapies for Non-Operable Stage III/IV Melanoma

High Priority

  • Targeted therapies or immunotherapies for non-operable stage III or IV melanoma
  • Continuation of treatment in the context of a clinical trial, provided patient benefits outweigh risks, with possible adaptation of procedures without affecting patient safety and study conduct

Medium Priority 

-

 Low Priority

-

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  • For IO, the small numerical benefit of IPI/NIVO compared with PD-1 single agent has to be weighed against increased grade III/IV irAEs and the risk associated with steroid usage. The CheckMate 511 regimen (IPI 1 mg/kg and NIVO 3 mg/kg) can be discussed on a case-by-case basis
  • For patients on PD-1 blockade, prefer double dosing with double interval to reduce visits: pembrolizumab 400 mg q6w and nivolumab 480 mg q4w with one inter-cure visit in telemedicine with blood exams performed in a laboratory close to the patient if a suitable COVID-19-protected facility is available, otherwise at the centre under current precautions
  • Patients on IO showing signs of pneumonitis on CT scans should be tested for COVID-19 before administrating steroids
  • For patients on TKIs, refer follow-up visits to telemedicine with blood exams performed in a laboratory close to the patient if a suitable COVID-19-protected facility is available, otherwise at the centre under current precautions

Priorities for Radiotherapy for Non-Operable Stage III/IV Melanoma

High Priority

  • Stereotactic radiosurgery for brain metastases
  • Threatening lesion, e.g. risk of fracture or bleeding
  • Acute spinal cord compression

High/Medium Priority 

  • Irradiation of symptomatic metastases (depending on symptoms and availability of radiotherapy resources)

 Low Priority

  • Adjuvant radiotherapy post-radical lymphadenectomy to improve local control
  • Irradiation of asymptomatic and not threatening metastases

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  • Steroids should be avoided as much as possible or administrated as conservatively as possible

  

 

List of abbreviations: AJCC, American Joint Committee on Cancer; BRAFi, BRAF inhibitor; CT, computed tomography; IO, immuno-oncology; IPI, ipilimumab; irAE, immune-related adverse event; MEKi, MEK inhibitor; NIVO, nivolumab; PD-1, programmed cell death protein 1; qXm, every X months; qXw, every X weeks; TKI, tyrosine kinase inhibitor.

 

Specific bibliography

  1. Oude Ophuis CM, Verhoef C, Rutkowski P, et al. The interval between primary melanoma excision and sentinel node biopsy is not associated with survival in sentinel node positive patients - An EORTC Melanoma Group study. Eur J Surg Oncol 2016;42(12):1906-1913. 
  2. Oude Ophuis CM, van Akkooi AC, Rutkowski P, et al. Effects of time interval between primary melanoma excision and sentinel node biopsy on positivity rate and survival. Eur J Cancer 2016;67:164-173. 

 

Essential bibliography

World Health Organization. COVID-19: Operational guidance for maintaining essential health services during an outbreak. Available at: https://www.who.int/publications-detail/covid-19-operational-guidance-for-maintaining-essential-health-services-during-an-outbreak (1st April 2020, date last accessed). 

ESMO Clinical Practice Guidelines: Melanoma. Available at: https://www.esmo.org/guidelines/melanoma (20 April 2020, date last accessed).

American College of Surgeons. COVID-19 Guidelines for Triage Cancer Patients. Available at: https://www.facs.org/covid-19/clinical-guidance/elective-case/cancer-surgery (1st April 2020, date last accessed).

American Society for Radiation Oncology (ASTRO). COVID-19 Recommendations to Radiation Oncology Practices. Available at: https://www.astro.org/Daily-Practice/COVID-19-Recommendations-and-Information (1st April 2020, date last accessed). 

National Comprehensive Cancer Network. Coronavirus Disease 2019 (COVID-19) Resources for the Cancer Care Community. Available at: https://www.nccn.org/covid-19/ (1st April 2020, date last accessed). 

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