Evaluation criteria
PD, death, SD, Cancer
DISEASE PROGRESSION, DISEASE, ADVERSE EVENT, CANCER
Positron emission tomography‐computed tomography (PET‐CT) or computed tomography (CT) imaging was performed at baseline, after two cycles, after four cycles, and at the end of the treatment. In addition, CT imaging was repeated every 2 months for 2 years or until the disease had progressed or relapsed. PET‐CT imaging was recommended, but not compulsory.Complete response was defined as no evidence of disease or disease‐related symptoms. Partial response (PR) was defined as a ≥50% decrease in the sum of the product of the diameters of the masses and no new lesions. Stable disease (SD) was defined failure to attain CR or PR, but not fulfilling the criteria for PD. PD was defined as the appearance of new sites or ≥50% increase in the sum of the product of the diameter of previous lesions from the nadir. The ORR was defined as the proportion of CR and PR patients. DDC was defined as the time interval between the first assessment of CR, PR, and SD, and the first assessment of PD or death from any cause. DOR was defined as the interval between the first assessment of CR or PR and PD or death from any cause. PFS was defined as the time from the first day of the regimen to the documentation of disease progression or death. OS was defined as the time interval from the first day of the regimen to death or the final follow‐up. Treatment efficacy was assessed using the revised Cheson Standard Response.All AEs were reported from cycle 1, day 1 until 30 days after the last dose of the study drug, regardless of the relationship to treatment. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0.