Safety of apatinib plus S-1 for advanced solid tumor as palliative treatment

Abstract

The aim of the present study was to explore the safety of apatinib plus S-1 in treating advanced solid tumors after failure of two or more lines of chemotherapy. A total of 33 patients with advanced cancer treated between April 2016 to March 2019 were retrospectively analyzed. Of these, 13 patients had non-small cell lung cancer (NSCLC), 13 patients had SCLC, 4 patients had esophageal cancer and 3 had cervical cancer. All patients were treated with apatinib 250 mg once daily combined with S-1 60 mg/m² twice daily for 14 days, repeated every 3 weeks. Adverse reactions were observed until aggravation of adverse reactions beyond the tolerable range or disease progression, and the survival rate and clinical benefits were calculated. The results suggested that the incidence rate of adverse effects (grade 3-4) was 45.5% (15/33). The top three severe adverse effects were hypertension (15.2%), thrombocytopenia (12.1%) and proteinuria (9.1%). A total of 2 patients with lung squamous-cell carcinomas died of severe pulmonary hemorrhage. Other adverse reactions were tolerated in the cohort. A total of 10 patients achieved partial response and the objective response rate was 30.3%. Furthermore, 13 patients achieved stable disease and 10 patients had progressive disease, and accordingly, the disease control rate was 72.7%. In conclusion, apatinib plus S-1 for advanced solid tumor patients as palliative treatment have a certain efficacy and was relatively safe but should be used with caution in patients with squamous-cell lung carcinoma and the efficacy and safety requires further assessment.

Keywords: advanced solid tumor; adverse reactions; apatinib; safety.

Figure 1

Kaplan-Meier analysis of all 33 patients with advanced solid tumor. (A) PFS (mPFS time, 4.7 months) and (B) OS (mOS time, 10.8 months). mPFS, median progression-free survival; mOS, median overall survival.

Figure 2

Kaplan-Meier analysis of 13 patients with advanced small-cell lung cancer. (A) PFS (mPFS time, 3.3 months) and (B) OS (mOS time, 11.6 months). mPFS, median progression-free survival; mOS, median overall survival.

Figure 3

Kaplan-Meier analysis of 13 patients with advanced non-small-cell lung cancer. (A) PFS (mPFS time, 4.7 months) and (B) OS (mOS time, 9.8 months). mPFS, median progression-free survival; mOS, median overall survival.

Figure 4

Kaplan-Meier analysis of patients with SCLC and NSCLC. There was no significant difference in (A) PFS (P=0.398) and (B) OS (P=0.870) between the two groups. NSCLC, non-small-cell lung cancer; mPFS, median progression-free survival; mOS, median overall survival.

Figure 5

Kaplan-Meier analysis of 4 patients subjected to radiotherapy during medication. (A) PFS (mPFS time, 4.2 months) and (B) OS (mOS time, 8.3 months). mPFS, median progression-free survival; mOS, median overall survival.

Figure 6

Follow-up data of a 60-year-old representative male patient with good efficacy. (A) Tumor markers were detected at the end of 0-6 cycles of treatment. (B) CT images were obtained prior to treatment and after 4 and 6 cycles of treatment (left to right). SCC, squamous cell carcinoma-related antigen; NSE, neurospecific enolase; CA19-9, carbohydrate antigen; CEA, carcinoembryonic antigen; Cyfra21-1, carbohydrate antigen; proGRP, pro-gastrin-releasing peptide.