Shengbai oral solution for chemotherapy-induced neutropenia and symptom management in non-small cell lung cancer: A multicenter, randomized, open-label trial.

BACKGROUND

Interventions for chemotherapy-induced neutropenia are often limited by their adverse effects and significant costs.

PURPOSE: To evaluate the efficacy and safety of Shengbai Oral Solution (SBOS) in reducing neutropenia and alleviating the moderate-to-severe symptom burden in patients with non-small cell lung cancer (NSCLC) undergoing platinum-based chemotherapy.

STUDY

DESIGN

Multicenter, open-label, randomized clinical trial.

METHODS

This study included 215 patients with NSCLC from 17 hospitals in China. Eligible patients scheduled for platinum-based chemotherapy were randomly assigned to receive SBOS with chemotherapy (CT+SBOS group) or chemotherapy alone (CT alone group). Primary outcomes included the incidence of neutropenia during chemotherapy. Secondary outcomes included the patient-reported symptom burden, use of granulocyte colony-stimulating factor (G-CSF), and adverse events (AEs) per CTCAE v4.0.

RESULTS

The CT+SBOS group had a significantly lower incidence of neutropenia over the 42-day trial (estimated effect: -0.048, 95 % CI [-0.078, -0.018], p = 0.002) and required fewer G-CSF treatments. The incidence of moderate-to-severe scores on any of the top five symptoms (fatigue, pain, cough, disturbed sleep, and shortness of breath) significantly decreased over time in the CT+SBOS group (estimated effect: -0.025, 95 % CI [-0.044, -0.007], p = 0.007). Fewer patients in the CT+SBOS group used analgesics for pain (6.25 % vs. 16.50 %, p = 0.017). No significant differences in AEs were observed (p = 0.631).

CONCLUSION

SBOS, in combination with platinum-based chemotherapy, demonstrated safety and significantly reduced the incidence of neutropenia. Furthermore, it reduced moderate-to-severe symptoms during chemotherapy. Therefore, SBOS could be an effective option for neutropenia and reducing symptom burden in patients with NSCLC undergoing chemotherapy.

TRIAL REGISTRATION: ChiCTR1800014538, Chinese Clinical Trial Registry.