It was the intention to analyse all endpoints from mCRC and SCCHN patients separately; however, the low number of patients in each subgroup and the high number of skin care medications given precluding meaningful interpretation of data in the subgroups. the Netherlands. The occurrence of skin reactions and the care and management options taken were documented for 16 weeks, starting from the first administration of cetuximab. Results A total of Ravuconazole 103 patients were included in 7 hospitals. 38 patients (37%) developed a grade 2 skin reaction. Eighty-six patients could be analysed for the primary endpoint (73.3% males, mean age 62.4 years, = 44 LA SCCHN, = 16 R/M SCCHN, = 26 mCRC). The most frequently used skin products at some point during the observation period were moisturizing products (70%), systemic antibiotics (64%), topical antibiotics (58%), lipid-regenerating (28%) and other topical products (28%). The overall use of products gradually increased from baseline to week 6C10, reducing by week 16. Hospital protocols were the primary reason ( 50%) for choice of the skincare products and medications. Conclusion A variety of skin care products and antibiotics were commonly used. Only few patients developed severe cutaneous reactions. For patients, the occurrence of skin reactions did not influence their willingness to continue cetuximab therapy. = 4); no documented cetuximab treatment (= 14) and insufficient data regarding the primary endpoint at baseline (= 1). For some subjects, Ravuconazole there was more than one reason for exclusion. Patients demographic characteristics from the FAS are summarized in Table ?Table1.1. Most patients were male (73%) with a median age of 62 years (range 31C80). Cetuximab was administered in the majority of patients for locally advanced SCCHN (= 44, 51%) as primary treatment, with a planned treatment period of 8 weeks. 26 patients were treated for mCRC (30%) and 16 patients received cetuximab for R/M SCCHN (19%). Open in a separate window Fig. 1 Consort flow diagram Table 1 Demographic Ravuconazole characteristics and baseline data = 86)(%)??Male63 (73.3)??Female23 (26.7)Age (years)??(%)86 (100)??Mean SD62.4 10.02??Min; max31; 80Body surface area (m2)??(%)86 (100)??Mean SD1.92 0.24??Min; max1.43; 2.73Diagnosis, (%)??mCRC26 (30.2%)??R/M SCCHN16 (18.6%)??LA SCCHN44 (51.2%)ECOG performance score, (%)??030 (34.9%)??149 (57.0%)??27 (8.1%)Previous anticancer treatment, (%)??Surgery22 (25.6)??Chemotherapy29 (33.7)??Radiation therapy17 (19.8)??Biological4 (4.7)??Other treatment5 (5.8)??No previous anticancer treatment44 (51.2)Planned treatment duration, (%)??Until progression/death27 (31.4)??Fixed number of cycles55 (64.0)??Missing4 (4.7)Planned treatment duration (weeks)= 51??Mean SD7.7 3.0??Min; max1; 24Line of treatment, (%)??Primary44 (51.1)??1st line15 (17.4)??2nd line14 (16.3)??3rd line11 (12.8)??Later1 (1.2)??Missing1 (1.2) Open in a separate window = 102) (%)(%)(%)(%)(%)(%)= 86)= 86)= 82)= 78)= 56)= 29)(%)5 (5.8)24 (27.9)39 (47.6)40 (51.3)25 (44.6)9 (31.0)??95% CI1.9C13.018.8C38.636.4C58.939.7C62.831.3C58.515.3C50.8Systemic antibiotics??(%)17 (19.8)28 (32.6)39 (47.6)35 (44.9)26 (46.4)8 (27.6)??95% CI12.0C29.822.8C43.536.4C58.933.6C56.633.0C60.312.7C47.2Moisturizing product??(%)33 (38.4)36 (41.9)41 (50.0)40 (51.3)25 (44.6)10 (34.5)??95% CI28.1C49.531.3C53.038.7C61.339.7C62.831.3C58.517.9C54.3Lipid-regenerating product??(%)10 (11.6)10 (11.6)18 (22.0)20 (25.6)6 (10.7)1 (3.4)??95% CI5.7C20.35.7C20.313.6C32.516.4C36.84.0C21.90.1C17.8Vitamin K1 cream??(%)8 (9.3)12 (14.0)11 (13.4)9 (11.5)8 Ravuconazole (14.3)5 (17.2)??95% CI4.1C17.57.4C23.16.9C22.75.4C20.86.4C26.25.8C35.8Other topical treatments??(%)07 (8.1)14 (17.1)16 (20.5)13 (23.2)3 (10.3)??95% CI3.3C16.19.7C27.012.2C31.213.0C36.42.2C27.4 Open in a separate window em CI /em Ravuconazole , confidence interval Reasons for the choice of the applied skin care products The hospital protocol was the primary reason for choice of the skin care products at baseline (58%) and during treatment (up to 71%). Remaining reasons were investigator choice, previous experience, advice by a dermatologist or other reasons ( 20% each). Percentage of days under skin care products The proportion of days on skin treatment during the observation period (from the day of the first cetuximab treatment until 2C4 weeks after the last administration of cetuximab) was in a similar range for the specific type of treatments (about 50 Cav2 to 70%). Health-related quality of life A continuous decrease in HRQoL, as measured by the FACT-EGFRI-18, was seen during the observation period, with the strongest deterioration at week 10 followed by a slight improvement at week 16. Both the total and all domain scores of the FACT-EGFRI-18 decreased over time, indicating that the treatment that patients received in this study, consisting of cetuximab monotherapy, or combined with radiation therapy or chemotherapy, had effect on physical functioning and overall well-being. Perceived effectiveness of applied skin products For almost all products effectiveness ratings varied across patients and HCPs from no effect, weak and moderate/strong, while very strong was rarely mentioned. During the observation period for all products, an increase in the percentage of patients.
It was the intention to analyse all endpoints from mCRC and SCCHN patients separately; however, the low number of patients in each subgroup and the high number of skin care medications given precluding meaningful interpretation of data in the subgroups