Table 2

Dose reductions

Number (%) or time (day)
Treatment permanently interrupted because of toxic effects4/43 (9.3%)
Treatment dose reduced/temporarily interrupted24/43 (55.8%)
Treatment temporarily interrupted6/43 (14.0%)
Treatment dose reduced21/43 (48.8%)
Dose of apatinib +camrelizumab
 500 mg daily +200 mg Q2W initially43/43 (100.0%)
 250 mg daily +200 mg Q2W (−1 dose level)21/43 (48.8%)
 125 mg daily +200 mg Q2W (−2 dose level)1/43 (2.3%)
Days apatinib held for one interruption
 Mean (SD)9.0 (10.2)
 Median (IQR)3.0 (2.0–15.0)
Days apatinib held during trial
 Mean (SD)18.0 (14.2)
 Median (IQR)15.0 (3.0–31.5)
Days camrelizumab held for one interruption
 Mean (SD)12.7 (7.3)
 Median (IQR)11.0 (7.0–17.1)
Days camrelizumab held during trial*
 Mean (SD)12.7 (7.3)
 Median (IQR)11.0 (7.0–17.1)
  • Data are n (%), mean (SD), or median (IQR). Camrelizumab was temporary interrupted mainly because of immune-related toxicities judged by investigators. Temporary interruptions of both drugs were usually for several causes: wound dehiscence, diarrhea, blood bilirubin increased and aminotransferase increased and pneumothorax. Of the 43 patients, 21 patients who had reduced apatinib doses to 250 mg were also treated at a dose level of 200 mg Q2W of camrelizumab (−1 dose level). Thrombocytopenia, hand and foot syndrome, oral mucositis or other skin toxic effects, hypertension, and diarrhea were the most common causes for apatinib dose reductions.

  • *Throughout the trial, camrelizumab had only been held for temporary interruptions for once in all four patients.