Background: Many cytotoxic and biological drugs are cause of severe dermatological side effects, such as hand-foot syndrome (HFS) and hand-foot skin reaction (HFSR). Oncologic patients with HFS or HFSR presents relevant symptoms that interferes with daily activities and with adherence to anticancer treatment. The HFRS control and treatment are important goals to enhance the quality of life of oncologic patients. The aim of this study was to assess the efficacy and tolerability of a b.i.d. (bis in die) topical administration of an anhydric ointment based on topical non-occlusive polymers (TNOP) in patients with HFS on current anticancer drug regiments.
Methods: A prospective, open, multicenter clinical study was conducted in oncologic patients with HFS attended two hospital-based Italian dermatological unit. A global-non-instrumental evaluation, based on different standardized tools (i.e., Sum Score System Index [SRRC] Score, Dermatology Life Qualiy Index [DLQI] and global efficacy) was conducted using measurements at baseline, at 4 and 8 weeks. Non-parametric test for two correlate samples, was used to assess changes in means of the different scores. The protocol was approved by ethical committee of both dermatology service pariticipating to the study.
Results: Twenty-one oncologic patients were enrolled. Thirteen (61.9%) of participants were female. The median age was 63 years (range: 37-73). Seventeen (80.9%) patients presenting a HFS associated to capecitabine, and four patients (19.1%) associated to docetaxel. At the enrollment, 33.3% (7/21) of patients showed at level of the hands a HFS of grade 2 and 9.5% (2/21) of grade 3. At level of the feet, 28.6% (6/21) showed a HFS of grade 2, and 17.4% (4/21) of grade 3. The SRRC scores were significantly decreased after 8 weeks of treatment compared to baseline, for both sites. In particular, SRRC score decreased from 4.38 to 1.67 (Z=-3.60, P=0.00) and from 4.48 to 1.43 (Z=-3.87, P=0.00) for hands and feet, respectively. A consistent significant improvement in the perceived QoL of patients was also observed. From baseline to visit 3, the total mean score of DLQI decreased from 10.62 to 4.57 (Δ=-57%, Z=-4.020, P=0.000).
Conclusions: In a sample of oncologic patients with HFS, the b.i.d. administration of TNOP for eight weeks, induced a progressive and significant decrease of the SRRC Score and a relevant improvement in the perceived quality of life.