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The objective of this study is to evaluate the efficacy and safety profiles of the targeted medications, bevacizumab and cetuximab, in combination with cytostatic drugs in patients with locally advanced or metastatic pancreatic cancer. In this retrospective phase 2 study, a total of 59 patients with pancreatic cancer were recruited and received conventional (gemcitabine, cisplatin, and fluorouracil) or targeted regimen (conventional plus bevacizumab and cetuximab for the first cycle) in 2-week intervals for four cycles. The primary end-point for this study was the overall response rate. Secondary end-points were progression-free survival and the safety profiles of the combined therapy. The median time-to-progression and overall survival were 3 and 7 months, respectively, in the conventional treatment group as well as 11 and 13 months, respectively, in the targeted medications treatment group. The most common adverse events in both treatment groups were nausea and vomiting. Moderate (Grade 2) nausea and vomiting were more common in the conventional group than the targeted group but severe (Grade 3) nausea and vomiting were more common in the targeted group. Bevacizumab and cetuximab in combination with gemcitabine, cisplatin, and fluorouracil may help lengthen overall survival up to six months for patients with pancreatic cancer.

Current chemotherapeutic regimens for nonsmall cell lung cancer (NSCLC) have reached a plateau over the last few years. Targeted therapy makes use of tyrosine kinase inhibitors (TKIs) to suppress a number of signaling pathways including epidermal growth factor receptor and vascular endothelial growth factor which are active in NSCLC biology. In this study, we used sunitinib, a multi-target receptor TKI, combined with chemotherapy for unresectable/metastatic NSCLC. This open label Simon's 2 stage clinical trial enrolled a total of 6 NSCLC patients who received docetaxel (40 mg) and cisplatin (50 mg) on day 1 of each cycle (14 day interval between cycles) and sunitinib (25 mg qd for 10 days between cycles) for a total of 12 cycles (24 weeks), after which patients received maintenance therapy with vinorelbine (30 mg TIW) until disease progression. The sample size was based on a Simon's Optimal Two-Stage Designs for Phase II clinical trials. The expected response rate was set as 35% for P0 and as 60% for P1. The study was designed for a minimum of 6 patients for first stage and 15 patients until second stage with a significance level alpha = 0.10 and power = 70%. Diagnosis of a poor response in the second of 6 patients in Stage I or seventh of the 15 patients in Stage II would lead to early termination of the trial. The overall response rate was 66.7%. Four patients had an overall survival >60 months. The time to PFS ranged from 3 to 42 months. The combination therapy was well-tolerated. Sunitinib combined with chemotherapy shows promise and warrants further investigation.

Supplemental Digital Content is available in the text, The prognostic implication of Barcelona Clinic Liver Cancer (BCLC) substages in Asian patients with hepatocellular carcinoma (HCC) is still obscure. The aim to this study is to compare the prognoses among HCC patients in different substages of the BCLC stage 0 and A. We enrolled 1265 treatment-naive HCC patients with BCLC stage 0 or A from 2007 to 2014. Factors in terms of prognoses were analyzed by multivariate analysis. There were 184, 446, 271, 92, and 272 patients in substage 0, A1, A2, A3, and A4, respectively. After a median follow-up period of 21.0 months, patients in stages 0 and A1 had comparable prognoses (P = 0.136). Both of them had significantly higher overall survival rates than those in stages A2–A4 (all P 20 ng/mL (HR 1.863), tumor size >3 cm (HR 1.542), BCLC stage A2–A4 (HR 1.488), and treatment modality. Surgical resection had the highest overall survival rate followed by radiofrequency ablation (RFA) (HR 1.598), transarterial chemoembolization (HR 2.224), and other treatments (HR 3.707). Verus patients receiving RFA, those who underwent resection had a higher overall survival rate and lower recurrence rate especially in BCLC stages A2–A4. The BCLC-staging system provided good prognostic stratification for early-stage HCC. Patients with a single tumor >2 cm but without portal hypertension or jaundice had similar prognosis to those in BCLC stage 0. Curative therapies—especially hepatic resection—are suggested in early-stage HCC.