Analysis of patient screening in the phase III, international, randomized, open-label APACT trial

Abstract

Introduction: Pancreatic cancer (PC) is associated with a poor prognosis and has the lowest survival rates among all cancers. The 5‐year survival rate is<10% for all stages of PC combined, which reflects the frequently advanced disease stage at diagnosis. In fact,< 20% of patients are candidates for resection at diagnosis. The phase III, international, open‐label, APACT trial assessed the efficacy and safety of nab‐paclitaxel plus gemcitabine vs gemcitabine alone in treatment‐naive patients with surgically resected PC. Given the low prevalence of resectable cases at diagnosis among patients with PC, we report the process for patient identification and reasons for exclusion in APACT. Methods: Patients aged ≥18 years with histologically confirmed pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) were eligible. Key inclusion criteria were an Eastern Cooperative Oncology Group performance status of 0 or 1, acceptable blood chemistry levels (absolute neutrophil count ≥1500/mm3, platelet count ≥100,000/mm 3 , hemoglobin ≥ 9 g/dL, total bilirubin ≤ upper limit of normal), PC surgical staging (T1‐3, N0‐1, M0), and a CA19‐9 level < 100 U/mL within 14 days of randomization. Patients with presence of or a history of metastatic or locally recurrent PC or those who previously received systemic treatment (including neoadjuvant) for PC were excluded. During the screening period, patients were assessed by computed tomography scan performed within 14 days before randomization. Treatment was to be started within 12 weeks following surgery. Results: Overall, 1226 patients were screened for eligibility; of these, 360 (29%) were excluded during screening. Patients may have had ≥1 reason for exclusion. Themost common reasons for exclusion were CA19‐9> 100U/mL (10%), metastatic disease (7%), unacceptable blood chemistry levels (4%), PC surgical staging of> T3 orM1(3%), and unwillingness or inability to comply with study protocol (2%). In addition, some patients (≈1% in each of the following scenarios) were excluded due to inability to adhere to study schedule and requirements, ineligible histology, significantmedical condition, unacceptable hematology parameters, another malignancy within 5 years of randomization, serious medical risk factors, or inability to start treatment within 12 weeks after surgery. Conclusion: Among patients with surgically resected PC, 29% of those screened were deemed ineligible for inclusion in the APACT trial. The screening process may have helped to identify patients who were most likely to be able to complete 6 cycles of adjuvant chemotherapy.