The Efficacy and Safety of the Shouzu Ning Decoction Treatment for Multi-Kinase Inhibitors-Associated Severe Hand–Foot Skin Reaction

Abstract

Background: Multi-kinase inhibitors (MKIs) treatment plays an important role in cancer therapy, but still suffers from a high incidence of hand-foot skin reaction (HFSR), leading to MKIs dose modification or termination. Thus, there is a high need for therapeutic strategy for HFSR. Patients and Methods: This prospective analysis included twenty patients, who were continuously administered with MKIs treatment and presented with a grade 3 HFSR during January 2018 to December 2019. All the patients were treated with the Shouzu Ning Decoction (SND) twice a day, in addition to the MKIs treatment. Grading of HFSR was assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Pain intensity was evaluated using the numerical rating scale (NRS). Quality of life was assessed using the Hand-Foot Quality of Life Scale (HF-QoLS). Results: The median time from MKIs initiation to onset of grade 3 HFSR was 26.2 days. Following the SND treatment, seventeen (17/20) patients displayed grade 2 HFSR with a median time of 5.1 days. Among whom, seven (7/17) finally transformed to grade 1 with a median time of 9.9 days. While all of the grade 1 patients (7/7) had local recurrence, and retreatment of the SND was effective. In addition, after the SND treatment, the score of NRS and HF-QoLS decreased to 1.60 ± 1.14 (P < 0.01) and 26.75 ± 11.76 (P < 0.01), respectively. Conclusion:The SND treatment could alleviate symptoms, relieve pain and improve quality of life in HFSR patients. The SND treatment was proved to be an effective and welltolerated treatment for MKIs-associated grade 3 HFSR patients for the first time. Indeed, further randomized controlled trails with large-scale, multi-center are require to fully determine the clinical application of the SND in MKIs-associated HFSR.

Leveraging molecular targeted drugs and immune checkpoint inhibitors treat advanced thyroid carcinoma to achieve thyroid carcinoma redifferentiation

“…The median PFS achieved with these drugs ranged from 5.4 to 11.7 months, suggesting their potential in managing RAI-RDTC [79][80][81][82][83][84]. Overall, these findings highlight the remarkable progress of TKItargeted therapy in patients with dedifferenti-Am J Cancer Res 2024;14(2):407-428 found to relieve symptoms of HFSR according to a study [95]. However, it is important to note that the prevention and treatment of adverse events using TCM require more stringent trials and accurate evaluation criteria to verify their efficacy.…”

The Efficacy and Safety of the Shouzu Ning Decoction Treatment Versus Halometasone Plus Celecoxib Treatment in Patients With Grade 2 HFSR: A Randomized Clinical Trial

“…The present study indicated that topical SND treatment for 4 weeks revealed a remission rate of 56.52%, which was significantly superior to that achieved by Halometasone plus Celecoxib treatment. 23 Furthermore, patients with SND treatment had better-alleviated symptoms of HFSR and better-improved quality of life compared to that in the Hal/Cxb group. In addition, the time to HFSR degradation was similar in both groups (10.46 days vs 13.17 days), indicating that a 2-week treatment is likely needed to be efficacious.…”

“…And the detailed fabrication process of the SND was shown in our previous study. 23 Halometasone cream and Celecoxib capsules were purchased from Bright Future Pharmaceuticals Factory (Hongkong, China, LOT:6201340) and Pfizer Pharmaceuticals LLC (Puerto Rico, America, LOT:DX7406), respectively. The main ingredient of halometasone cream is halometasone-hydrate, and its specification is 1 g: 0.5 mg.…”

“…In a previous study, we prospectively demonstrated that the SND treatment could alleviate symptoms, relieve pain and improve the quality of life in patients with grade 3 HFSR. 23 HPLC approach was also applied for the quality consistency assessment of SND. Despite its robust efficacy, only 35% of the patients recovered to grade 1.…”

“…Despite its robust efficacy, only 35% of the patients recovered to grade 1. 23 Generally, grade ≤1 HFSR is considered a safe stage for tolerating adequate dosage.…”