Abstract
BackgroundTo date, chemotherapy remains the only effective treatment of unresectable pancreatic adenocarcinoma. In the past few years, the interest in immunological anticancer therapy rises sharply. AGIG is a novel chemo-immunotherapy regimen that combines nab-paclitaxel + gemcitabine chemotherapy with sequential recombinant interleukin-2 (IL-2) and granulocyte-macrophage colony stimulating factor (GM-CSF) therapy. We conducted a single-arm prospective phase II study to determine the efficacy and safety of the first-line treatment of advanced pancreatic cancer with AGIG regimen.MethodsNab-paclitaxel (125 mg/m2) and gemcitabine (1000 mg/m2) were administered intravenously to all patients on days 1 and 8 triweekly, interleukin-2 (1000000U) and GM-CSF (100 µg) were administered subcutaneously on days 3-5 after chemotherapy. The primary end point was ORR by the Response Evaluation Criteria in Solid Tumors, version 1.1. Secondary end points included safety profile, progression-free survival (PFS), overall survival (OS). Patients’ conditions along with the efficacy and safety were assessed every two cycles.ResultsBetween 11/2018 and 01/2020, sixty-four patients were enrolled. In the sixty-four evaluable patients, the disease control rate (DCR) and overall response rate (ORR) were 76.6% and 43.75%, respectively. The median follow-up time was 12.1 (range 7.1–22.4) months. The median PFS was 5.7 (range 1.63–15.8) months. The median OS was 14.2 (range 2.9–22.0) months. The most common adverse event was fever (75%). The incidence of III/IV grade neutropenia was 4.69%. In subgroup analyses, we found that eosinophil count in the blood elevated three times higher than baseline level predicted a longer survival.ConclusionsThe AGIG chemo-immunotherapy regimen has presented favorable ORR, OS, and manageable toxicities as first-line therapeutic strategy of advanced pancreatic cancer treatment. This regimen may be a novel reliable therapeutic option for patients with preserved performance status. The improvement of treatment efficiency may be related to the activation of non-specific immune response.Clinical Trial Registration https://clinicaltrials.gov/. identifier NCT03768687.
Highlights
Pancreatic cancer is one of the deadliest solid malignancies in the world
51.56% (n = 33) of the tumors were located in the head and neck of the pancreas. 40.63% (n = 26) of the tumors were located in the body or tail of the pancreas. 49 patients were histologically diagnosed as adenocarcinoma including one case of cystadenocarcinoma and one case of mucinous adenocarcinoma. 4 patients were histologically diagnosed as adeno-squamous carcinoma, and none of the patients developed undifferentiated or undifferentiated neuroendocrine carcinoma
We found that eosinophil count in the blood elevated three times higher than baseline level predicted a longer survival (P = 0.016) (Figure 4B)
Summary
Pancreatic cancer is one of the deadliest solid malignancies in the world. Despite decades of efforts, it remains the fourth leading cause of cancer-related death worldwide, with a five-year survival rate of less than 5% [1]. Since 1997, gemcitabine had been the standard treatment for unresectable pancreatic adenocarcinoma [3]. Both FOLFIRINOX (fluorouracil, irinotecan, and oxaliplatin) and nab-paclitaxel with gemcitabine (AG) prolong overall survival (OS) compared with gemcitabine alone [4, 5]. Chemotherapy remains the only effective treatment of unresectable pancreatic adenocarcinoma [6]. Chemotherapy remains the only effective treatment of unresectable pancreatic adenocarcinoma. AGIG is a novel chemoimmunotherapy regimen that combines nab-paclitaxel + gemcitabine chemotherapy with sequential recombinant interleukin-2 (IL-2) and granulocyte-macrophage colony stimulating factor (GM-CSF) therapy. We conducted a single-arm prospective phase II study to determine the efficacy and safety of the first-line treatment of advanced pancreatic cancer with AGIG regimen. Patients’ conditions along with the efficacy and safety were assessed every two cycles
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