دورية أكاديمية
Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer: a multicenter, randomized, phase II study.
| العنوان: | Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer: a multicenter, randomized, phase II study. |
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| المؤلفون: | Jin M; Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China.; Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, 430022, People's Republic of China.; Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China., Liu HL; Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China.; Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, 430022, People's Republic of China.; Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China., Xue J; Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China.; Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, 430022, People's Republic of China.; Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China., Ma H; Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China.; Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, 430022, People's Republic of China.; Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China., Liu JL; Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China.; Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, 430022, People's Republic of China.; Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China., Lin ZY; Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China.; Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, 430022, People's Republic of China.; Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China., Wang J; Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China.; Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, 430022, People's Republic of China.; Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China., Bao LQ; Department of Hepatobiliary and Pancreatic Surgery, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China., Luo ZG; Department of Clinical Oncology, Taihe Hospital, Hubei University of Medicine, Shiyan, 442000, People's Republic of China., Yu XJ; Department of Oncology, Shiyan People's Hospital, Shiyan, 442000, People's Republic of China., Li S; Department of Oncology, First Affiliated Hospital of Yangtze University, Jingzhou, 434000, People's Republic of China., Hu JL; Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China.; Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, 430022, People's Republic of China.; Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China., Zhang T; Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China.; Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, 430022, People's Republic of China.; Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China. |
| المصدر: | The oncologist [Oncologist] 2024 Jul 11. Date of Electronic Publication: 2024 Jul 11. |
| Publication Model: | Ahead of Print |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: England NLM ID: 9607837 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1549-490X (Electronic) Linking ISSN: 10837159 NLM ISO Abbreviation: Oncologist Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2022- : Oxford : Oxford University Press Original Publication: Dayton, Ohio : AlphaMed Press, c1996- |
| مستخلص: | Background: Encouraging antitumor activity of nab-paclitaxel plus S-1 (AS) has been shown in several small-scale studies. This study compared the efficacy and safety of AS versus standard-of-care nab-paclitaxel plus gemcitabine (AG) as a first-line treatment for advanced pancreatic cancer (PC). Methods: In this multicenter, randomized, phase II trial, eligible patients with unresectable, locally advanced, or metastatic PC were recruited and randomly assigned (1:1) to receive AS (nab-paclitaxel 125 mg/m2 on days 1 and 8; S-1 twice daily on days 1 through 14) or AG (nab-paclitaxel 125 mg/m2 on days 1 and 8; gemcitabine 1000 mg/m2 on days 1 and 8) for 6 cycles. The primary endpoint was progression-free survival (PFS). Results: Between July 16, 2019, and September 9, 2022, 62 patients (AS, n = 32; AG, n = 30) were treated and evaluated. With a median follow-up of 8.36 months at preplanned interim analysis (data cutoff, March 24, 2023), the median PFS (8.48 vs 4.47 months; hazard ratio [HR], 0.402; P = .002) and overall survival (OS; 13.73 vs 9.59 months; HR, 0.226; P < .001) in the AS group were significantly longer compared to the AG group. More patients had objective response in the AS group than AG group (37.50% vs 6.67%; P = .005). The most common grade 3-4 adverse events were neutropenia and leucopenia in both groups, and gamma glutamyl transferase increase was observed only in the AG group. Conclusion: The first-line AS regimen significantly extended both PFS and OS of Chinese patients with advanced PC when compared with the AG regimen, with a comparable safety profile. (ClinicalTrials.gov Identifier: NCT03636308). (© The Author(s) 2024. Published by Oxford University Press.) |
| معلومات مُعتمدة: | Union Hospital; Tongji Medical College; Huazhong University of Science and Technology |
| فهرسة مساهمة: | Keywords: S-1; first-line treatment; gemcitabine; nab-paclitaxel; pancreatic cancer |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03636308 |
| تواريخ الأحداث: | Date Created: 20240711 Latest Revision: 20240711 |
| رمز التحديث: | 20240711 |
| DOI: | 10.1093/oncolo/oyae171 |
| PMID: | 38990195 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1549-490X |
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| DOI: | 10.1093/oncolo/oyae171 |