Phase II Study of Hepatic Arterial Infusion Chemotherapy with Oxaliplatin and 5-Fluorouracil for Advanced Perihilar Cholangiocarcinoma

Abstract

Purpose To evaluate the efficacy and safety of hepatic arterial infusion (HAI) of oxaliplatin and 5-fluorouracil for advanced perihilar cholangiocarcinoma (PCC) in this prospective phase II study. Materials and Methods The protocol was approved by the local ethics committee, and all patients gave informed consent. Patients with nonresectable PCC were included in a prospective, open phase II study investigating HAI through interventionally implanted port catheters. HAI consisted of infusions of oxaliplatin 40 mg/m for 2 hours, followed by 5-fluorouracil 800 mg/m for 22 hours on days 1-3 every 3-4 weeks. A maximum of six cycles of HAI were applied for tumor control patients followed by maintenance with oral capecitabine until tumor progression. The primary end points were tumor response and progression-free survival (PFS). The secondary end points were local PFS, overall survival, and adverse events. Kaplan-Meier methodology and Cox regression analysis were used to evaluate the risk factors for survival. Results Between 2012 and 2015, 37 patients were enrolled. The overall response rate was 67.6% (25 of 37), and the disease control rate was 89.2% (33 of 37). Median PFS, local PFS, and overall survival were 12.2, 25.0, and 20.5 months, respectively. All three survival lengths in patients with periductal infiltrating pattern were found to be significantly longer than those in patients with mass-forming pattern (P < .001, hazard ratio < 0.2). Macroscopic growth patterns (P = .018) and number of HAI cycles (P < .001) were independent risk factors of survival. The most frequent adverse events were grades 1 and 2 gastrointestinal side effects and sensory neuropathy in 31 (83.8%) and 28 (75.7%) patients, respectively. Conclusion HAI with oxaliplatin and 5-fluorouracil may be an encouraging treatment choice for advanced PCC due to its high tumor control, survival benefit, and low toxicity, especially in patients with periductal infiltrating pattern. RSNA, 2016.

Effects of Preoperative Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios on Survival in Patients with Extrahepatic Cholangiocarcinoma

“…Moreover, our study showed that patients with high PLR had more frequent liver recurrences and recurrences within 1 year of surgery than did patients with low PLR. These results suggest that surgeons might want to administer adjuvant chemotherapy or hepatic arterial infusion chemotherapy to patients with high PLR values (34,35).…”

Prognostic nomogram to predict overall survival for patients with perihilar cholangiocarcinoma: A population-based study of SEER database

“…Furthermore, some important clinicopathological parameters and widely used tumor biomarkers for pCCA, such as surgical margin status, the information of serum carbohydrate antigen 19 − 9 (CA199), carcinoembryonic antigen (CEA) and vascular encasement were unavailable in SEER database. In addition, many promising options like interventional therapy [49], immunotherapy [50] and targeted treatment [51] are enjoying increasing popularities among pCCA patients, but it is a pity that they have been inaccessible in SEER program until now. As a user-friendly method for prognosis prediction and decision-making, there is di culty in providing everlastingly excellent prognosis prediction in clinical practice, because not all signi cant prognostic factors were embodied in this tool.…”

Medical treatment for cholangiocarcinoma

“…Selected studies of the 3 strategies are summarized in Table 3, focusing on prospective or comparative studies when available. [103][104][105][106][107][108][109][110][111][112][113][114][115][116][117][118][119] The analysis is a difficult one because very few studies are prospective or comparative, while most have a low number of patients and describe single-centre experience. Moreover, there is a high heterogeneity in terms of patient population within and across studies that limits the interpretability of data.…”