Dataset Information

Nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule (S-1) as first-line treatment for advanced biliary tract adenocarcinoma: a phase 2 clinical trial.

ABSTRACT:

Background

This study aimed to evaluate the efficacy and safety of a new combination of nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule (S-1) for patients with advanced biliary tract carcinoma (BTC).

Methods

Patients were treated with nab-paclitaxel at a dose of 125 mg/m² on day 1 and 8, and S-1, 80 to 120 mg/day on days 1-14 of a 21-day cycle. Treatments were repeated until disease progression or unacceptable toxicity occurred. The primary endpoint was objective response rate (ORR). The secondary endpoints were median progression-free survival (PFS), overall survival (OS), and adverse events (AEs).

Results

The number of patients enrolled were 54, and 51 patients were evaluated for efficacy. A total of 14 patients achieved partial response (PR) with an ORR of 27.5%. The ORR varied by sites, with 53.8% (7/13) for gallbladder carcinoma, 18.4% (7/38) for cholangiocarcinoma. The most common grade 3 or 4 toxicities were neutropenia and stomatitis. The median PFS and OS were 6.0 and 13.2 months, respectively.

Conclusions

The combination of nab-paclitaxel with S-1 showed explicit antitumor activities and favorable safety profile in advanced BTC and could serve as a potential non-platinum and -gemcitabine-based regimen.

SUBMITTER: Zhang W

PROVIDER: S-EPMC9944545 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule (S-1) as first-line treatment for advanced biliary tract adenocarcinoma: a phase 2 clinical trial.

Zhang Wen W Sun Yongkun Y Jiang Zhichao Z Qu Wang W Gong Caifeng C Zhou Aiping A

Hepatobiliary surgery and nutrition 20211018 1

<h4>Background</h4>This study aimed to evaluate the efficacy and safety of a new combination of nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule (S-1) for patients with advanced biliary tract carcinoma (BTC).<h4>Methods</h4>Patients were treated with nab-paclitaxel at a dose of 125 mg/m<sup>2</sup> on day 1 and 8, and S-1, 80 to 120 mg/day on days 1-14 of a 21-day cycle. Treatments were repeated until disease progression or unacceptable toxicity occurred. The primary endpoint was ...[more]

PMID: 36860259

Similar Datasets

Project description:The current study aimed to evaluate the efficacy and safety of neoadjuvant apatinib plus tegafur/gimeracil/oteracil potassium (S-1) plus oxaliplatin (SOX) chemotherapy in patients with locally advanced gastric carcinoma (LAGC). Therefore, patients with LAGC treated with neoadjuvant apatinib plus SOX chemotherapy (apatinib + SOX group; n=25) or SOX chemotherapy (SOX group; n=35) were enrolled in the present study. Subsequently, the objective response (ORR) and disease control rates (DCR), pathological response, disease-free survival (DFS), overall survival (OS) and adverse events were recorded. The results showed that patients in the apatinib + SOX group exhibited a higher ORR (64.0 vs. 37.1%; P=0.040), but a similar DCR (96.0 vs. 88.6%; P=0.580), compared with those in the SOX group. The pathological response rates in patients with grade 0, 1, 2 and 3 LAGC were 0.0, 20.8, 62.5 and 16.7%, respectively, in the apatinib + SOX group, while in those treated with SOX alone they were 9.1, 39.4, 42.4 and 9.1%, respectively. By contrast, the pathological response was elevated in the apatinib + SOX group compared with the SOX group (P=0.030). During a median follow-up period of 21.0 months (range, 6.4-38.1 months), median DFS and OS were not reached. More specifically, the 1-, 2- and 3-year DFS rates were 91.7, 75.2 and 75.2% in the apatinib + SOX group and 71.8, 59.6 and 44.7% in the SOX group, respectively. In addition, the 1-, 2- and 3-year OS rates were 100.0, 89.6 and 78.4% in the apatinib + SOX group, while those in the SOX group were 90.3, 69.2 and 55.4%, respectively. However, no differences in DFS (P=0.094) or OS (P=0.155) were observed between the two groups. Additionally, the most common adverse events in the SOX group were mild leukopenia (42.9%) and fatigue (34.3%), while those in the apatinib + SOX group were tolerable leukopenia (44.0%) and hypertension (44.0%). In conclusion, the present study suggested that neoadjuvant apatinib plus SOX chemotherapy could be more effective and tolerable compared with SOX chemotherapy alone in patients with LAGC.

Project description:BackgroundA recent phase II trial reported prolonged survival in patients with advanced biliary tract cancer (BTC) following treatment with nab-paclitaxel plus gemcitabine-cisplatin (Gem/Cis/nab-P). We aimed to evaluate the clinical outcomes of Gem/Cis/nab-P in Asian patients with advanced BTC in a real-world setting.MethodsWe reviewed the data of patients who received Gem/Cis/nab-P for the management of advanced BTC between September 2019 and April 2021 at four institutes in Korea. Patients were classified into the Gem/Cis/nab-P and nab-P addition groups depending on the starting point of nab-P administration.ResultsA total of 178 patients treated with Gem/Cis/nab-P were included in the study. Of these, 43.8% had intrahepatic cholangiocarcinoma (CCA), 34.8% had extrahepatic CCA, and 21.3% had gall bladder cancer. A total of 117 (65.7%) patients received Gem/Cis/nab-P as the first-line treatment, while 61 (34.3%) were treated with gemcitabine-cisplatin-based chemotherapy followed by nab-P addition. The objective response rate (ORR) and disease control rate in all patients were 42.1% and 84.8%, respectively. The ORR in the Gem/Cis/nab-P group was 47.9%, while that in the nab-P addition group was 31.1%. The median progression-free survival and overall survival were 8.5 months [95% confidence interval (CI), 6.9-10.1] and 14.6 months (95% CI, 10.2-19.0), respectively. In patients who received Gem/Cis/nab-P as initial treatment, the median PFS was 9.4 months (95% CI, 7.9-10.9) and the median OS was not-reached (95% CI, not available). Anemia (n = 42, 23.6%), neutropenia (n = 40, 22.5%), and thrombocytopenia (n = 16, 9.0%) were the most common grade 3-4 toxicities. A total of 20 patients (11.2%) had conversions from unresectable to resectable disease and underwent surgery with curative intent.ConclusionGem/Cis/nab-P showed favorable real-life efficacy and safety outcomes in Korean patients with advanced BTC, which was consistent with the phase II trial outcomes.

Project description:ImportanceAdministration of gemcitabine-cisplatin, the current standard therapy for advanced biliary tract cancers, results in median progression-free survival and overall survival of 8.0 and 11.7 months, respectively. New treatments offering improved survival outcomes are therefore needed.ObjectiveTo evaluate the association between progression-free survival and the addition of nanoparticle albumin-bound (nab)-paclitaxel to gemcitabine-cisplatin for the treatment of patients with advanced biliary tract cancer.Design, setting, and participantsThis open-label, single-arm, phase 2 clinical trial conducted at the University of Texas MD Anderson Cancer Center and the Mayo Clinic in Phoenix, Arizona, enrolled 62 patients with advanced biliary tract cancers between April 14, 2015, and April 24, 2017.InterventionsPatients initially received gemcitabine, 1000 mg/m2, cisplatin, 25 mg/m2, and nab-paclitaxel, 125 mg/m2, on days 1 and 8 of 21-day cycles. Owing to hematologic adverse events among the first 32 patients enrolled, these starting doses were reduced to 800, 25, and 100 mg/m2, respectively, for the remaining 28 patients.Main outcomes and measuresThe primary trial end point was investigator-assessed progression-free survival in the intention-to-treat population.ResultsOf 60 patients who started treatment, the mean (SD) age was 58.4 (11.0) years, 38 (63%) had intrahepatic cholangiocarcinoma, 9 (15%) had extrahepatic cholangiocarcinoma, 13 (22%) had gallbladder cancer, 47 (78%) had metastatic disease, and 13 (22%) had locally advanced disease. Median follow-up was 12.2 (95% CI, 9.4-19.4) months, and median progression-free survival was 11.8 (95% CI, 6.0 to 15.6) months. The partial response rate was 45%, and the disease control rate was 84%. Median overall survival was 19.2 months (95% CI, 13.2 months to not estimable). Patients in the safety population (n = 57) received a median of 6 (interquartile range, 3-11) cycles of treatment; 26 patients (46%) remained on their starting dose throughout the trial. Grade 3 or higher adverse events occurred in 58% of patients, and 9 patients (16%) withdrew owing to adverse events. Neutropenia was the most common grade 3 or higher adverse event, occurring in 19 patients (33%) overall. Post hoc analyses showed that treatment efficacy was not significantly associated with starting dose, tumor type, or disease status and that tolerability was improved with reduced- vs high-dose treatment.Conclusions and relevanceTreatment with nab-paclitaxel plus gemcitabine-cisplatin prolonged median progression-free survival and overall survival vs those reported for historical controls treated with gemcitabine-cisplatin alone. These findings will be tested in a phase 3 randomized clinical trial.Trial registrationClinicalTrials.gov identifier: NCT02392637.

Dataset Information

Nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule (S-1) as first-line treatment for advanced biliary tract adenocarcinoma: a phase 2 clinical trial.

Background

Methods

Results

Conclusions

Publications

Nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule (S-1) as first-line treatment for advanced biliary tract adenocarcinoma: a phase 2 clinical trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets