Dermatology-related quality of life outcomes in patients with <i>RAS</i> wild-type (wt) metastatic colorectal cancer (mCRC) treated with fluorouracil and folinic acid with or without panitumumab (Pmab) maintenance after FOLFOX + Pmab induction: A prespecified secondary analysis of the phase 2 randomized PanaMa (AIO KRK 0212) trial.
Authors: Alexej Ballhausen, Meinolf Karthaus, Stefan Fruehauf, Ullrich Graeven, Lothar Müller, Alexander Koenig, Ludwig Fischer Von Weikersthal, Greta Sommerhäuser, Ivan Jelas, Annabel Helga Sophie Alig, Annika Kurreck, Arndt Stahler, Eray Goekkurt, Swantje Held, Stefan Kasper, Kathrin Heinrich, Volker Heinemann, Sebastian Stintzing, Tanja Trarbach, Dominik Paul Modest
Journal: Journal of Clinical Oncology (2024)

e15539 Background: The addition of anti-EGFR antibodies (i.e. Pmab) to maintenance therapy has demonstrated improved progression-free survival (PFS) in patients with RAS wt mCRC, with no impact on health related quality of life (HRQOL) measured by EORTC-QLQ-C30. Here, we report the specifically assessed dermatology-related quality of life (DRQOL) from the PanaMa trial (AIO KRK0212). Methods: DRQOL outcomes were assessed using the Functional Assessment of Cancer Therapy- Epidermal Growth Factor Receptor Inhibitor (FACT-EGFRI), Dermatology Life Quality Index (DLQI), and Skindex-16 questionnaires at every cycle of therapy until disease progression/death. DRQOL outcomes were mean changes in DRQOL scores from baseline (prior to cycle 1 of therapy) to every second cycle of treatment (both induction and maintenance therapy). Multiple linear regression analyses was used to test for impact of baseline characteristics and toxicity endpoints on DRQOL outcomes. Results: At least one DRQOL questionnaire was completed by a total of 310/377 (82%) patients who received induction therapy, and by 216/248 (87%) patients who were randomized and received maintenance therapy. During induction therapy, significant deterioration was observed in all DRQOL measures, most prominently for mean Skindex-16 scores (mean deterioration 26.78; 95% CI 23.24—30.32; P &lt; 0.001). Between cycles 1 and 6 of maintenance therapy, patients receiving FU/FA had significant recovery in all DRQOL measures (i.e. Skindex-16, mean difference -23.26; 95% CI -29.37—17.15; P &lt; 0.001), while those receiving additional Pmab did not. At cycle 6 of maintenance, patients who received FU/FA + Pmab maintenance had significantly worse mean DRQOL scores, compared to those who received FU/FA alone (Skindex-16, mean difference -16.53; 95% CI -22.68—10.38; P &lt; 0.001). Multiple linear regression including baseline characteristics and toxicity endpoints significantly predicted all DRQOL measures, i.e. Skindex-16 scores at cycle 6 of maintenance (F [18, 105] = 3.23, R 2 = 0.36, P &lt; 0.001). Strongest individual predictors for favorable Skindex-16 outcomes were FU/FA arm (t = -5.49, P &lt; 0.001) and ECOG 0 (t = -3.08, P = 0.003). Conclusions: Patients randomized to maintenance treatment with FU/FA + Pmab reported a significant disadvantage in terms of DRQOL outcomes according to multiple validated measures as compared to patients receiving FU/FA alone. These results suggest that patient reported outcomes by FACT-EGFRI, DLQI, and Skindex-16 reflect toxicity as recorded by classic toxicity scores which are not covered by global HRQOL assessment. These data, together with HRQOL may support clinical decision-making of maintenance therapy. Clinical trial information: NCT01991873 .