A pathological complete response after combined chemotherapy of gemcitabine and S-1 in advanced biliary tract cancer with para-aortic lymph nodes metastasis: a case report

535 Background: This study aimed to evaluate the efficacy and safety of SHR-1210 (a humanized anti-programmed cell death receptor 1 antibody) plus gemcitabine and oxaliplatin (GEMOX) as first line treatment in patients (pts) with biliary tract cancer (BTC). Methods: This was a single-arm, single-center, exploratory trial, which included advanced BTC pts. Pts received SHR-1210 (3mg/kg, total dose ≤200mg, ivd, D1/2W) combined with gemcitabine (800 mg/m2, ivd, D1/2W) and oxaliplatin (85mg/m2, ivd, D2/2W). Combined chemotherapy lasted for no more than 12 cycles. Once chemotherapy intolerance occurred or at end of 12-cycle combined chemotherapy, pts with stable disease or objective response would continue to take SHR-1210 as single agent until disease progression or intolerable toxicity. The primary endpoint was the 6-month progression free survival (PFS) rate. Results: From February 2018 to April 2019, 37 eligible pts were enrolled. The median age was 64 (range 41-74) years, male/female was 70.3/29.7%, and bile duct cancer/gallbladder cancer was 59.5/40.5%. All 37 pts were included in the safety analysis. The overall AE incidence rate was 97.3%. The incidence of grade ≥3 AEs was 73.0%, which mainly included increased GGT (gammaglutamyltransferase, 18.9%), hypokalemia (18.9%), and fatigue (16.2%). Particularly, the incidence of fever is 73.0%, in which 2 pts experienced grade 3/4 fever. Among 36 evaluable pts, 19 pts got partial response (PR, 52.8%), 14 pts stable disease (SD, 38.9%), and 3 pts progressive disease (PD, 8.3%) at best. The primary endpoint 6-month PFS rate was 50.0% (95% CI 32.4-65.4), which indicated that the primary endpoint of the study was reached, and mPFS was 6.2 months (95% CI 4.2-7.1). The 12-month overall survival (OS) rate was 50.5% (95% CI 30.6-67.4), and mOS was 12.1 months (95% CI 8.0-NA). Conclusions: This study has reached the pre-defined primary endpoint with a high response rate. Predictive biomarker analysis was reported in another abstract. Further study is needed to validate the efficacy of this combination. Clinical trial information: NCT03486678.

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Efficacy and Safety of Pembrolizumab in Patients with Refractory Advanced Biliary Tract Cancer: Tumor Proportion Score as a Potential Biomarker for Response

Cancer Research and Treatment ◽

10.4143/crt.2019.493 ◽

2020 ◽

Vol 52 (2) ◽

pp. 594-603 ◽

Cited By ~ 2

Author(s):

Junho Kang ◽

Jae Ho Jeong ◽

Hee-Sang Hwang ◽

Sang Soo Lee ◽

Do Hyun Park ◽

...

Keyword(s):

Biliary Tract ◽

Biliary Tract Cancer ◽

Objective Response ◽

Evaluation Criteria ◽

Progression Free Survival ◽

Complete Response ◽

Current Standard ◽

Durable Response ◽

Tract Cancer ◽

Potential Biomarker

Purpose The current standard chemotherapy for advanced biliary tract cancer (BTC) has limited benefit, and novel therapies need to be investigated. Materials and MethodsIn this prospective cohort study, programmed death ligand-1 (PD-L1)–positive BTC patients who progressed on first-line gemcitabine plus cisplatin were enrolled. Pembrolizumab 200 mg was administered intravenously every 3 weeks. ResultsBetween May 2018 and February 2019, 40 patients were enrolled. Pembrolizumab was given as second-line (47.5%) or ≥ third-line therapy (52.5%). The objective response rate was 10% and 12.5% by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 and immune- modified RECIST (imRECIST) and median duration of response was 6.3 months. Among patients with progressive disease as best response, one patient (1/20, 5.0%) achieved complete response subsequently. The median progression-free survival (PFS) and overall survival (OS) were 1.5 months (95% confidence interval [CI], 0.0 to 3.0) and 4.3 months (95% CI, 3.5 to 5.1), respectively, and objective response per imRECIST was significantly associated with PFS (p < 0.001) and OS (p=0.001). Tumor proportion score ≥ 50% was significantly associated with higher response rates including the response after pseudoprogression (vs. < 50%; 37.5% vs. 6.5%; p=0.049). Conclusion Pembrolizumab showed modest anti-tumor activity in heavily pretreated PD-L1–positive BTC patients. In patients who showed objective response, durable response could be achieved.

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Clinicopathological features of long-term survivors for advanced biliary tract cancer and impact of the number of lymph nodes involved

International Journal of Surgery ◽

10.1016/j.ijsu.2012.12.006 ◽

2013 ◽

Vol 11 (2) ◽

pp. 145-151 ◽

Cited By ~ 7

Author(s):

Shogo Kobayashi ◽

Hiroaki Nagano ◽

Shigeru Marubashi ◽

Koichi Kawamoto ◽

Hiroshi Wada ◽

...

Keyword(s):

Lymph Nodes ◽

Biliary Tract ◽

Biliary Tract Cancer ◽

Clinicopathological Features ◽

Tract Cancer ◽

Long Term Survivors

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Endoscopic ultrasonography confirmed recurrence of gallbladder cancer: a case report (with a video).

10.22541/au.161278707.73249219/v1 ◽

2021 ◽

Author(s):

Lifen Xu ◽

Duanmin Hu

Keyword(s):

Case Report ◽

Gallbladder Cancer ◽

Biliary Tract ◽

Malignant Tumor ◽

Biliary Tract Cancer ◽

Radical Resection ◽

Late Recurrence ◽

High Grade ◽

Recurrent Cancer ◽

Tract Cancer

Biliary tract cancer is the most common biliary malignant tumor, which is considered to be a high-grade malignant tumor because of its frequent recurrence / metastasis[1]. Late recurrence of gallbladder cancer after operation is rare. We presented a case of recurrent cancer after radical resection of gallbladder cancer.

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Cisplatin plus irinotecan versus cisplatin plus gemcitabine in the treatment of advanced or metastatic gallbladder or biliary tract cancer: Results of a randomized phase II trial (NCT01859728)– the Gambit trial.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.4_suppl.529 ◽

2020 ◽

Vol 38 (4_suppl) ◽

pp. 529-529

Author(s):

Lucas Vieira dos Santos ◽

Gustavo Sanches Faria Pinto ◽

Mauricio Wagner Souto Ferraz ◽

Arinilda Bragagnoli ◽

Florinda Santos ◽

...

Keyword(s):

Adverse Events ◽

Biliary Tract ◽

Biliary Tract Cancer ◽

Progression Free Survival ◽

Standard Of Care ◽

Distant Metastases ◽

Complete Response ◽

Current Standard ◽

Tract Cancer ◽

To Receive

529 Background: The combination of gemcitabine-cisplatin (GC) is the current standard of care chemotherapy for metastatic/unresectable biliary tract cancer (BTC). However, the prognosis remains poor. This randomized trial aimed to evaluate the efficacy and safety of irinotecan plus cisplatin (IP) versus GC in advanced or metastatic BTC. Methods: Patients with biopsy-proven, chemo-naïve, unresectable or metastatic BTC, ECOG 0-2, measurable disease per RECIST 1.1, adequate organ function and written informed consent were stratified by ECOG (0 or 1 vs 2) and distant metastases and randomized to receive irinotecan 65 mg/m² IV D1 and D8 plus cisplatin 60 mg/m² D1 repeated every 3 weeks (IP) or gemcitabine 1000 mg/m² IV D1 and D8 plus cisplatin 25 mg/m² IV D1 and D8 repeated every 3 weeks, until disease progression or unacceptable toxicity. The primary endpoint was overall response rate (ORR). Results: Between January 2013 and April 2018, 47 pts were randomized (1:1) to receive IP (N = 24) or GC (N = 23). Overall, groups were well balanced according to prognostic factors. The ORR was 35% (complete response 5%, partial response 30%) and 31.8% in IP and GC arms, respectively. Median progression-free survival were 5.3 vs 7.8 months (HR = 1.165, 95%CI 0.628-2.161, p = 0.628) and median overall survival were 11.9 and 9.8 months (HR = 0.859, 95%CI 0.431 – 1.710, p = 0.665) for IP and GC, respectively. Adverse events were not statistically different between arms, and results were consistent with previous experiences with these regimens. No therapy-related death were reported. Conclusions: Irinotecan-cisplatin combination is active in BTC, with similar ORR, PFS and OS when compared to gemcitabine-cisplatin. Irinotecan-cisplatin were well tolerated, and adverse events were manageable. Irinotecan-cisplatin could be considered as an alternative to gemcitabine-cisplatin. Clinical trial information: NCT01859728.

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Success rate of microsatellite instability examination and complete response with pembrolizumab in biliary tract cancer

JGH Open ◽

10.1002/jgh3.12576 ◽

2021 ◽

Author(s):

Yugo Kai ◽

Kenji Ikezawa ◽

Ryoji Takada ◽

Kazuma Daiku ◽

Shingo Maeda ◽

...

Keyword(s):

Microsatellite Instability ◽

Success Rate ◽

Biliary Tract ◽

Biliary Tract Cancer ◽

Complete Response ◽

Tract Cancer

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Efficacy and safety of nivolumab in first-line or further treatment of advanced metastatic biliary tract cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.4_suppl.315 ◽

2019 ◽

Vol 37 (4_suppl) ◽

pp. 315-315

Author(s):

Miaomiao Gou ◽

Yong Zhang ◽

Haiyan Si ◽

Guanghai Dai

Keyword(s):

Biliary Tract ◽

Biliary Tract Cancer ◽

Univariate Analysis ◽

Objective Response ◽

Progression Free Survival ◽

Complete Response ◽

Hematologic Toxicity ◽

Efficacy And Safety ◽

Peripheral Neurotoxicity ◽

Tract Cancer

315 Background: PD-1 inhibitors have improved efficacy in many cancers. There are few report of nivolumab for metastatic biliary tract cancer (MBTC). This study reviewed the efficacy and safety of nivolumab for MBTC to improve efficacy and survival. Methods: Thirty patients with MBTC were voluntarily treated with non-clinical nivolumab at the PLA General Hospital. Nivolumab 200 mg or 180 mg was administered according to patient tolerance. Progression free survival (PFS), overall survival (OS) was evaluated by kaplan-meier and univariate analysis were carried out among clinical characteristics. Objective response rates (ORR), disease control rates (DCR), and treatment-related adverse events (AEs) were also evaluated. Results: The median treatment cycle is 4 cycles. One case was complete response (CR), 5 cases partial response (PR), 12 cases stable (SD). ORR was 20%, DCR was 60%. PFS was 3.1m (95% CI: 2.13~4.06 months). The AEs of nivolumab monothrapy were fatigue (3 cases), fever (2 cases), hypothyroidism (1 case), skin reaction (1 case). Nivolumab combined with chemotherapy related 1-2 hematologic toxicity were leukopenia (5 cases), thrombocytopenia (2 cases), and grade 3-4 were leukopenia (3 cases). Non-hematologic toxicity grade 1-2 were nausea and vomiting (4 cases), fatigue (4 cases), fever (3 cases), peripheral neurotoxicity (3 cases), and hypothyroidism (1 case). Univariate analysis showed that PFS was 4.20m in patients older than 53 years, slightly higher than those younger than 53 years (3.0 m, P = 0.047). PFS of nivolumab combined with chemotherapy was statistically significant compared with nivolumab monothrapy (4.1 m vs 2.3 m, p = 0.031). Patients with metastatic number > 2 had a shorter PFS than those < 2 (1.4 m vs 4.1 m, P = 0.05). PD-L1 expression positive have no better PFS compared with PD-L1 negative (3.6 m vs 3.1 m , p = 0.801). Multivariate analysis show nivolumab combined with chemotherapy was only independent factor for longer PFS (HR: 0.432, P < 0.05). Conclusions: the safety of nivolumab in MBTC is controllable. Subgroup analysis suggests that further selection of superior populations is needed and sample size need to be expanded to improve the efficacy of nivolumab in MBTC.

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