Abstract
90 Background: MCC is a rare, aggressive skin cancer with a poor prognosis. Avelumab is the only anti–PD-L1 monoclonal antibody approved for treatment of mMCC. This qualitative research embedded in a clinical trial aimed to explore pt experiences on treatment with avelumab. Methods: All treatment-naive pts with mMCC entering the registrational, open-label, multicenter trial to investigate the clinical activity and safety of avelumab were invited to participate in optional, semistructured, 30-min phone interviews at baseline (prior to study drug administration) and at weeks 13 and 25. Interviews were conducted by trained professionals, audio-recorded, transcribed, and analyzed using a qualitative software package, ATLAS.ti V7. Key concepts identified from the baseline interview for each pt were assessed during follow-up interviews. Results: A total of 29 pts (mean age, 71 y; 76% male) completed the baseline interview; 19 pts (6 in USA, 4 in France, 5 in Italy, 3 in Germany, 1 in Australia) had ≥1 follow-up interview. The baseline interviews revealed the negative psychological burden on pts living with a symptomless disease and the hope for avelumab to be a successful therapy. Over the course of the trial, most pts reported an increased or continued sense of hope and willingness to fight MCC. Pts who self-reported their disease to be improved (n=12) also reported being stable or experiencing improvements in their ability to do their daily activities and in their physical well-being and having more energy than before starting avelumab. They also reported worrying less and being optimistic. Six pts among the 7 who reported their condition as stable (n=4) or worsened (n=3) reported a worsening of their physical well-being. Nine pts reported fatigue/tiredness on the day of and the day after receiving the avelumab infusion. The reported baseline and longitudinal experiences were similar across pts from all countries. Conclusions: This qualitative study alongside a registrational trial showed that pts experienced perceptible benefits in their physical and psychological well-being following treatment success with avelumab in mMCC. Clinical trial information: NCT02155647 part B.
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