Updated efficacy and safety data from a phase II, single-arm, open-label study of durvalumab plus gemcitabine, cisplatin, and nab-paclitaxel (DurGAP) in resectable biliary tract cancer
Background: Our previous research (2024 ASCO Abstract: e16260) highlighted the efficacy and safety data of DurGAP in resectable biliary tract cancer (BTC). This study aims to provide an updated analysis of the safety and efficacy of neoadjuvant DurGAP for resectable BTC in our latest cohort of 30 pa...
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Elsevier
2025-02-01
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| Series: | The Lancet Regional Health. Western Pacific |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S266660652400347X |
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| author | Huikai Li Yang Liu Xihao Zhang |
| author_facet | Huikai Li Yang Liu Xihao Zhang |
| author_sort | Huikai Li |
| collection | DOAJ |
| description | Background: Our previous research (2024 ASCO Abstract: e16260) highlighted the efficacy and safety data of DurGAP in resectable biliary tract cancer (BTC). This study aims to provide an updated analysis of the safety and efficacy of neoadjuvant DurGAP for resectable BTC in our latest cohort of 30 patients. The current results demonstrate consistent outcomes. Detailed data are presented herein. Methods: Resectable, treatment-naïve BTC pts were enrolled and administered 3 cycles of neoadjuvant durvalumab (1000 mg, iv, d1, q3w) + GAP (gemcitabine 1000 mg/m2, cisplatin 25 mg/m2, Nab-paclitaxel 100 mg/m2, d1, d8, 21d cycle). Primary endpoints included assessing Adverse Events (AEs), Objective Response Rate (ORR) and Disease Control Rate (DCR). Secondary endpoints comprised R0 resection rate, Recurrence-Free Survival (RFS), Overall Survival (OS). Findings: Between Feb, 2023 to Aug, 2024, a total of 30 patients were enrolled, 13 (43.3%) were male, all with ECOG 0 and 24 (80.0%) presenting with N1 status. Median age: 65.3 years. Primary sites: intrahepatic (40.0%), extrahepatic (26.7%), gallbladder (33.3%). Median follow-up: 9.45 months; all pts received ≥2 neoadjuvant cycles. The ORR was 60%, with 18 pts demonstrating partial responses (PR). The DCR was 86.7% with 18 PR and 8 stable disease (SD) responses. The most common treatment-related adverse events (TRAEs) were increased ALT/AST (26.7%), anemia (23.3%), hypoalbuminemia (16.7%). Grade ≥3 TRAEs occurred in 2 (6.7%) pts. 16 pts underwent resection, comprising 12 PR, 2 SD, and 2 pts deemed eligible for surgery post-assessment despite a PD response, achieving R0 resection in 15 (93.8%) of cases. 14 pts did not undergo resection, with reasons including patient refusal (4 PR, 1 SD), not meeting resection criteria (2 PD), lost to follow-up (1 PR, 1 SD), and still under active follow-up (1 PR, 4 SD). Interpretation: Neoadjuvant DurGAP demonstrated a consistent and promising ORR and DCR, with a tolerable safety profile, warranting further investigations in a larger cohort. Clinical trial information: NCT05640791. Research Sponsor: None. |
| format | Article |
| id | doaj-art-d8d773fa2c274cf0b26a6c7ccdef20f2 |
| institution | DOAJ |
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| publishDate | 2025-02-01 |
| publisher | Elsevier |
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| series | The Lancet Regional Health. Western Pacific |
| spelling | doaj-art-d8d773fa2c274cf0b26a6c7ccdef20f22025-08-20T03:12:53ZengElsevierThe Lancet Regional Health. Western Pacific2666-60652025-02-015510135310.1016/j.lanwpc.2024.101353Updated efficacy and safety data from a phase II, single-arm, open-label study of durvalumab plus gemcitabine, cisplatin, and nab-paclitaxel (DurGAP) in resectable biliary tract cancerHuikai Li0Yang Liu1Xihao Zhang2Department of Hepatobiliary and Pancreatic Oncology, Tianjin Cancer Hospital airport Hospital, ChinaDepartment of Hepatobiliary and Pancreatic Oncology, Tianjin Cancer Hospital airport Hospital, ChinaDepartment of Hepatobiliary and Pancreatic Oncology, Tianjin Cancer Hospital airport Hospital, ChinaBackground: Our previous research (2024 ASCO Abstract: e16260) highlighted the efficacy and safety data of DurGAP in resectable biliary tract cancer (BTC). This study aims to provide an updated analysis of the safety and efficacy of neoadjuvant DurGAP for resectable BTC in our latest cohort of 30 patients. The current results demonstrate consistent outcomes. Detailed data are presented herein. Methods: Resectable, treatment-naïve BTC pts were enrolled and administered 3 cycles of neoadjuvant durvalumab (1000 mg, iv, d1, q3w) + GAP (gemcitabine 1000 mg/m2, cisplatin 25 mg/m2, Nab-paclitaxel 100 mg/m2, d1, d8, 21d cycle). Primary endpoints included assessing Adverse Events (AEs), Objective Response Rate (ORR) and Disease Control Rate (DCR). Secondary endpoints comprised R0 resection rate, Recurrence-Free Survival (RFS), Overall Survival (OS). Findings: Between Feb, 2023 to Aug, 2024, a total of 30 patients were enrolled, 13 (43.3%) were male, all with ECOG 0 and 24 (80.0%) presenting with N1 status. Median age: 65.3 years. Primary sites: intrahepatic (40.0%), extrahepatic (26.7%), gallbladder (33.3%). Median follow-up: 9.45 months; all pts received ≥2 neoadjuvant cycles. The ORR was 60%, with 18 pts demonstrating partial responses (PR). The DCR was 86.7% with 18 PR and 8 stable disease (SD) responses. The most common treatment-related adverse events (TRAEs) were increased ALT/AST (26.7%), anemia (23.3%), hypoalbuminemia (16.7%). Grade ≥3 TRAEs occurred in 2 (6.7%) pts. 16 pts underwent resection, comprising 12 PR, 2 SD, and 2 pts deemed eligible for surgery post-assessment despite a PD response, achieving R0 resection in 15 (93.8%) of cases. 14 pts did not undergo resection, with reasons including patient refusal (4 PR, 1 SD), not meeting resection criteria (2 PD), lost to follow-up (1 PR, 1 SD), and still under active follow-up (1 PR, 4 SD). Interpretation: Neoadjuvant DurGAP demonstrated a consistent and promising ORR and DCR, with a tolerable safety profile, warranting further investigations in a larger cohort. Clinical trial information: NCT05640791. Research Sponsor: None.http://www.sciencedirect.com/science/article/pii/S266660652400347X |
| spellingShingle | Huikai Li Yang Liu Xihao Zhang Updated efficacy and safety data from a phase II, single-arm, open-label study of durvalumab plus gemcitabine, cisplatin, and nab-paclitaxel (DurGAP) in resectable biliary tract cancer The Lancet Regional Health. Western Pacific |
| title | Updated efficacy and safety data from a phase II, single-arm, open-label study of durvalumab plus gemcitabine, cisplatin, and nab-paclitaxel (DurGAP) in resectable biliary tract cancer |
| title_full | Updated efficacy and safety data from a phase II, single-arm, open-label study of durvalumab plus gemcitabine, cisplatin, and nab-paclitaxel (DurGAP) in resectable biliary tract cancer |
| title_fullStr | Updated efficacy and safety data from a phase II, single-arm, open-label study of durvalumab plus gemcitabine, cisplatin, and nab-paclitaxel (DurGAP) in resectable biliary tract cancer |
| title_full_unstemmed | Updated efficacy and safety data from a phase II, single-arm, open-label study of durvalumab plus gemcitabine, cisplatin, and nab-paclitaxel (DurGAP) in resectable biliary tract cancer |
| title_short | Updated efficacy and safety data from a phase II, single-arm, open-label study of durvalumab plus gemcitabine, cisplatin, and nab-paclitaxel (DurGAP) in resectable biliary tract cancer |
| title_sort | updated efficacy and safety data from a phase ii single arm open label study of durvalumab plus gemcitabine cisplatin and nab paclitaxel durgap in resectable biliary tract cancer |
| url | http://www.sciencedirect.com/science/article/pii/S266660652400347X |
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