Tolerance of Targeted Therapy Used in Metastatic Melanoma in Patients Aged Over 65 and 75-year-old
Condition: Metastatic Melanoma
MeSH terms: Melanoma
Study type: Observational

Summary: 
      Since 2013, therapeutic care of metastatic melanoma (MM) has greatly improved, especially
      thanks to BRAF and MEK targeted therapies. The efficacy of these treatments that are now used
      daily at first line for BRAF mutated MM is widely approved. Their toxicities, in monotherapy
      or in association, are also well-known: fever, arthralgias, digestive disorders, cutaneous
      rash, fatigue, photosensitivity, alopecia, cutaneous hyperkeratosis, squamous cell
      carcinomas, keratoacanthomas, de novo melanomas… However, onco-dermatologists are more and
      more faced with MM of elderly patients. Indeed, life expectancy continues to increase and the
      over-75-year-old age group is becoming larger. These patients are still active but much more
      vulnerable. Nevertheless, there is no data in the literature for this fragile population
      except the MM pivotal studies subgroups of those over 65-year-old. The results vary with
      different regimens. Therefore, there is a wide lack of information that could help make a
      therapeutic decision, inform patients, prevent or treat side effects of BRAF and MEK
      inhibitors in elderly patients
    

Detailed description: 
      Since 2013, therapeutic care of metastatic melanoma (MM) has greatly improved, especially
      thanks to BRAF and MEK targeted therapies. The efficacy of these treatments that are now used
      daily at first line for BRAF mutated MM is widely approved. Their toxicities, in monotherapy
      or in association, are also well-known: fever, arthralgias, digestive disorders, cutaneous
      rash, fatigue, photosensitivity, alopecia, cutaneous hyperkeratosis, squamous cell
      carcinomas, keratoacanthomas, de novo melanomas… However, onco-dermatologists are more and
      more faced with MM of elderly patients. Indeed, life expectancy continues to increase and the
      over-75-year-old age group is becoming larger. These patients are still active but much more
      vulnerable. Nevertheless, there is no data in the literature for this fragile population
      except the MM pivotal studies subgroups of those over 65-year-old. The results vary with
      different regimens. Therefore, there is a wide lack of information that could help make a
      therapeutic decision, inform patients, prevent or treat side effects of BRAF and MEK
      inhibitors in elderly patients. This work aims to study the targeted therapies tolerance in
      over 65 or 75-year-old patients with BRAF mutated MM. The French clinical and biological
      database MELBASE will be analysed to carry out a descriptive retrospective multicentric
      study. This real-life assessment of the adverse effects in older patients will result in more
      adapted therapeutic decisions, better informed patients and improved follow-up care in order
      to increase quality of life and life expectancy.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        More 65 and 75 yo patients, Braf mutated, treated with targeted therapies in mono or
        bitherapy for metastatic melanoma
      
Keywords: melanoma; elderly; tolerance; adverse effects; targeted therapies