Martin Sebastian1, Anna Rydén2, Andrew Walding3, Vassiliki Papadimitrakopoulou4. 1. Department of Medicine, Hematology and Oncology, University of Frankfurt, Theodor-Stern-Kai 7, 60595, Frankfurt, Germany. Electronic address: martin.sebastian@kgu.de. 2. AstraZeneca Gothenburg, Pepparedsleden 1, 431 50, Mölndal, Sweden. 3. AstraZeneca R&D, 132 Hills Rd, Cambridge CB2 1 PG, UK. 4. Department of Thoracic, Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, 1400 Holcombe, Boulevard, Houston, TX 77030-4009, USA.
Abstract
OBJECTIVES: In the AURA3 trial, individuals received osimertinib 80 mg once daily or chemotherapy for advanced non-small cell lung cancer. Here, we explore patient-reported symptoms possibly related to treatment. MATERIALS AND METHODS: AURA3 was an open-label, randomized phase III trial involving 419 patients. As part of the trial's exploratory objectives, individuals were asked to complete the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) electronically, first weekly for 18 weeks and then every 3 weeks for up to 57 weeks, subject to the availability of validated local-language versions (English, German, Japanese and Spanish versions were available). RESULTS: In total, 161 patients (38%; 102 receiving osimertinib, 59 receiving chemotherapy) provided data for PRO-CTCAE analyses (mean age: 64 years; 63% women). Diarrhea was reported more commonly with osimertinib than with chemotherapy, and was mostly graded as occurring rarely or occasionally. Decreased appetite was reported less commonly with osimertinib than with chemotherapy. The proportion of patients reporting nausea changed little from baseline with osimertinib and increased with chemotherapy. Few patients reported vomiting. Both nausea and vomiting were generally graded as mild in severity. Fatigue was reported less commonly with osimertinib than with chemotherapy, and was mostly graded as mild or moderate. Of patients reporting fatigue, the proportion grading it as interfering at least 'somewhat' with their usual or daily activities was lower with osimertinib than with chemotherapy. CONCLUSION: Symptoms were generally mild and not frequent, with some differences in symptom patterns between the two treatment groups. The results support and complement the AURA3 trial data and give insight into patients' experience with treatment.
OBJECTIVES: In the AURA3 trial, individuals received osimertinib 80 mg once daily or chemotherapy for advanced non-small cell lung cancer. Here, we explore patient-reported symptoms possibly related to treatment. MATERIALS AND METHODS: AURA3 was an open-label, randomized phase III trial involving 419 patients. As part of the trial's exploratory objectives, individuals were asked to complete the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) electronically, first weekly for 18 weeks and then every 3 weeks for up to 57 weeks, subject to the availability of validated local-language versions (English, German, Japanese and Spanish versions were available). RESULTS: In total, 161 patients (38%; 102 receiving osimertinib, 59 receiving chemotherapy) provided data for PRO-CTCAE analyses (mean age: 64 years; 63% women). Diarrhea was reported more commonly with osimertinib than with chemotherapy, and was mostly graded as occurring rarely or occasionally. Decreased appetite was reported less commonly with osimertinib than with chemotherapy. The proportion of patients reporting nausea changed little from baseline with osimertinib and increased with chemotherapy. Few patients reported vomiting. Both nausea and vomiting were generally graded as mild in severity. Fatigue was reported less commonly with osimertinib than with chemotherapy, and was mostly graded as mild or moderate. Of patients reporting fatigue, the proportion grading it as interfering at least 'somewhat' with their usual or daily activities was lower with osimertinib than with chemotherapy. CONCLUSION: Symptoms were generally mild and not frequent, with some differences in symptom patterns between the two treatment groups. The results support and complement the AURA3 trial data and give insight into patients' experience with treatment.
Authors: Jody Underwood; Ann Raldow; Amar Kishan; Chad Zalkin; Lisa Scott Holt; Andrew Webb; Kathleen A Lynch; Thomas M Atkinson; Susan McCloskey; Daniel Navarro Journal: JMIR Form Res Date: 2022-04-12
Authors: Suriya Ye Yessentayeva; Valeriy A Makarov; Zhanna A Kalmatayeva; Zhanar K Zhakenova; Dauranbek T Arybzhanov Journal: Med J Islam Repub Iran Date: 2021-10-12