Hand-foot syndrome (HFS) related to new targeted therapies is a common cutaneous toxicity, with potentially serious impacts on the patient QoL. Previous reports indicate that the incidence of HFS was about 30% in apatinib monotherapy for NSCLC. HFS was also reported to be associated with immunotherapy. We conducted a phase II clinical trial on apatinib combined with anti-PD-1 antibody SHR-1210 for advanced NSCLC (No. CTR20170090). Whether the combined therapy leads to a dramatic increase in the incidence of HFS remains uncertain. There are a variety of scales to evaluate the patients’ QoL, but the specific scale for patients with HFS needs further verification.
Multiply questionnaires including the HFS-specific QoL questionnaire (HFS-14), Dermatology Life Quality Index (DLQI), Skindex-16 and short-form 12 health-related questionnaire (SF-12) were developed to measure the effect of HFS on daily activities. The HFS clinical grade was based on NCI-CTCAE, v3.0.
The validation study included 26 patients, of 21 (80%) developed HFS of varying grades, with 8 (31%) of grade 1, 7 (27%) of grade 2 and 6 (23%) of grade 3. 52% of patients declared involving one limb, and the rest patients developed HFS in both the hands and feet. The mean time to occurring HFS was 30 ± 64 days. In patients with various grades of HFS, the mean HFS-14 and DLQI scores were significantly higher with higher HFS grades, whereas the Skindex-16 and SF-12 scores did not differ. Four kinds of scales analysis also showed significant differences according to the degree of limb involvement, where the scores were significantly higher in patients having both hands and feet severely involved than in those having severe involvement of either only the hands or feet. When in patients with grade 2 HFS, the HFS-14 score was significantly higher in patients involving both the hands and the feet than in patients having only the hands or the feet severely affected; while Skindex-16, DLQI and SF-12 scores have no difference between these two groups.
The incidence of HFS induced by the treatment of anti-PD-1 antibody SHR-1210 combined with apatinib is extremely high. HFS-14 may serve as a more sensitive and valuable tool for early measuring HFS-related QoL impairment.
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All authors have declared no conflicts of interest.