Korean Cancer Study Group

Background:The aim of this study was to evaluate the efficacy and safety of gemcitabine plus nab-paclitaxel (GnP) as second-line chemotherapy following first-line FOLFIRINOX treatment failure in advanced pancreatic cancer.Methods:This was a multicenter, single-arm, open-label, phase 2 trial done at three tertiary centers in South Korea from May 2018 to December 2019. Eligible patients were aged 20 years or older, had histologically confirmed advanced pancreatic ductal adenocarcinoma, and disease progression after receiving first-line FOLFIRINOX. Patients received a second-line GnP regimen as intravenous nab-paclitaxel at a dose of 125 mg/m2 and gemcitabine at a dose of 1000 mg/m2, on days 1, 8, and 15 every 4 weeks until disease progression or unacceptable toxicity. The primary outcome was survival rate at 6 months and the secondary outcomes were median progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and adverse events. This study is registered with Clinicaltrials.gov. (NCT03401827)Results:Forty patients were enrolled in the study. The survival rate at 6 months was 72.5% [95% confidence interval (CI), 59.9–87.7], achieving superiority over prespecified assumed 6-month OS rate of 20% for best supportive care only (p < 0.001). The median PFS and OS were 5.8 months (95% CI, 4.3–8.7) and 9.9 months (95% CI, 7.5–12.4), respectively. DCR was 87.5% with six partial responses and 29 stable diseases. Grade 3 or higher treatment-related adverse events occurred in 25 (62.5%) patients with the most common being thrombocytopenia, anemia, neutropenia, peripheral neuropathy, and peripheral edema.Conclusion:GnP demonstrated favorable efficacy with acceptable toxicity in patients with advanced pancreatic ductal adenocarcinoma after FOLFIRINOX failure.

Pembrolizumab, an anti-programmed cell death (PD)-1 monoclonal antibody, is an anticancer agent showing substantial benefit in lung cancer and melanoma treatment. Biliary tract cancer (BTC) has been shown to respond to pembrolizumab; however, no credible data of such treatment outcomes exist. Therefore, we assessed the clinical outcomes and safety of pembrolizumab in patients with gemcitabine/cisplatin-refractory BTC. In this multicenter study, we retrospectively analyzed 51 patients with programmed cell death 1-ligand 1 (PD-L1)-positive gemcitabine/cisplatin-refractory BTC treated with pembrolizumab in four tertiary hospitals in Korea. PD-L1 positivity was defined as the expression of PD-L1 in ≥1% of tumor cells based on immunohistochemical staining (22C3, SP263, and E1L3N assays). The median age of the patients was 66 (range, 43–83) years and 29 (56.9%) were male. Extrahepatic cholangiocarcinoma was the most common cancer type (n = 30, 58.8%). Partial response and stable disease were achieved in 5 (9.8%) and 13 (25.5%) patients, respectively. Median progression-free survival and overall survival were 2.1 (95% CI, 1.7–2.4) and 6.9 (95% CI, 5.4–8.3) months, respectively. Overall, 30 (58.8%) patients experienced treatment-related adverse events (AEs). Only four (7.8%) patients experienced grades 3 and 4 AEs. In PD-L1-positive gemcitabine/cisplatin-refractory BTC, pembrolizumab presented durable efficacy, with a 9.8% response rate and manageable toxicity.

BackgroundWe evaluated the ability of various grading scales including platelet-albumin-bilirubin (PALBI) and albumin-bilirubin (ALBI) grades to predict overall survival (OS) according to treatment modality in patients with hepatocellular carcinoma (HCC).MethodsThe cohort of 6,669 patients with HCC was selected randomly from the 2008–2012 national cohort of the Korean Central Cancer Registry. The OS of 6,507 of these patients was evaluated using the Child-Turcotte-Pugh (CTP) class, Model for End-stage Liver Disease (MELD) score, and ALBI and PALBI grades.ResultsThe patient’s mean age was 59.7 years. The most patients were hepatitis B virus (63.4%) and CTP class A (71.8%). The median OS durations of PALBI grade1 (38.4%), grade2 (33.2%), and grade3 (28.4%) patients were 81, 30, and 5 months, respectively (P<0.001). The PALBI grade had a larger area under the receiver operator characteristic curve (AUC) than did the CTP class, MELD score, and ALBI grade (overall AUC: 0.675 vs. 0.633, 0.645, and 0.642, respectively; P < 0.001). Moreover, the PALBI and ALBI grades enabled sub-classification of CTP A patients (P < 0.001). In a multivariate analysis, the PALBI and ALBI grades were significant risk factors for OS (P < 0.05). According to treatment modality, the PALBI grade was predictive of OS in patients receiving transarterial chemoembolization or supportive care. The ALBI grade was predictive of OS in patients undergoing surgical resection or radiofrequency ablation.ConclusionThe PALBI and ALBI grades are more reliable for accessing liver function and predicting OS in patients with HCC. Moreover, according to treatment modality, appropriate use of the ALBI and PALBI grades will enable accurate determination of the prognosis of patients with HCC.

To determine the national practice processes of care and outcomes of radiotherapy for hepatocellular carcinoma (HCC) in Korea. A national survey of 53 institutions nationwide was conducted by requesting data on their experience of radiotherapy for HCC. Among them, 10 institutions were selected for performing more detailed analysis, based on the radiotherapy experience of at least five HCC patients between 2004 and 2005. This study covered the treatment of 398 HCC patients for 2 years. Most patients (78%) were in stage III or IV. Radiotherapy was chosen after the failure of other treatments, most frequently transarterial chemoembolization. Radiotherapy was performed predominantly using the three-dimensional conformal technique (3D-CRT, 81.9%) mostly with a total dose of >/=45 Gy. In 9.3% of the patients, radiotherapy was performed using radiosurgery. In a biologically effective dose (BED) with 10 Gy of alpha/beta, 4.2-124.3 Gy(10) was delivered. The median survival time was 12 months, and the 2-year overall survival rate was 27.9%. A tumour size <5 cm, a negative lymph node and BED >53.1 Gy(10) were shown by multivariate analysis to be significant factors for a better prognosis. In a subset analysis for the 326 patients treated with 3D-CRT, better liver function with Child-Pugh class A was shown to be an additional factor for a better prognosis. Radiotherapy has been used to treat advanced HCC in various modes, but mostly as a salvage treatment. Although this study was retrospective, it indicates that radiotherapy is a quite effective modality for HCC patients.

Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase II study was designed to evaluate the efficacy and safety of Genexol-PM in patients with histologically confirmed metastatic breast cancer (MBC). Forty-one women received Genexol-PM by intravenous infusion at 300 mg/m2 over 3 h every 3 weeks without premedication until disease progression or intolerability. A total of 331 chemotherapy cycles were administered, with a median of 8 cycles per patient (range, 1-16). Overall response rate was 58.5% (95% CI: 43.5-72.3) with 5 complete responses and 19 partial responses. Thirty-seven patients who received Genexol-PM as a first-line therapy for their metastatic disease showed a response rate of 59.5% (95% CI: 43.5-73.7), and two responses were reported in four patients treated in the second-line setting for their metastatic disease. The median time to progression (TTP) for all patients was 9.0 months (range, 1.0-17.0+ months). Grade 3 non-hematologic toxicities included sensory peripheral neuropathy (51.2%), and myalgia (2.4%). Eight patients (19.5%) experienced hypersensitivity reactions, with grade 3 in two patients. Hematologic toxicities were grade 3 and 4 neutropenia (51.2 and 17.1%, respectively), and grade 1 and 2 thrombocytopenia (22.0%). Notably, no febrile neutropenia was observed. Genexol-PM appears a promising new paclitaxel in view of significant efficacies. Further trials with different dosing schedules, durations of delivery, or in combination with other drugs are warranted.