scholarly journals Prediction of overall survival with 2nd-line (L2OS) chemotherapy (CT) in patients with advanced biliary tract cancer (aBTC): AGEO CT2BIL cohort update and international multicenter external validations

2018 ◽  
Vol 29 ◽  
pp. viii261-viii262
Author(s):  
C. Neuzillet ◽  
A. Casadei Gardini ◽  
B. Brieau ◽  
C. Vivaldi ◽  
C. Smolenschi ◽  
...  
Keyword(s):  
Overall Survival ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Tract Cancer ◽  
International Multicenter

Correlation between overall survival and other efficacy endpoints in advanced biliary tract cancer: Literature-based analysis from 13 randomized trials of first-line chemotherapy.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 352-352
Author(s):  
Toshikazu Moriwaki ◽  
Shinji Endo ◽  
Yoshiyuki Yamamoto ◽  
Takeshi Yamada ◽  
Akinori Sugaya ◽  
...  
Keyword(s):  
Overall Survival ◽  
Correlation Coefficient ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Randomized Trials ◽  
First Line ◽  
Biliary Tract Neoplasms ◽  
Tract Cancer ◽  
The Impact ◽  
Line Chemotherapy

352 Background: Chemotherapy for advanced biliary tract cancer (ABC) has progressed. Now gemcitabine plus cisplatin combination is considered the standard 1st-line treatment based on the results of many randomized studies. However, the impact of various efficacy parameters on overall survival (OS) remains unclear. Methods: We searched PubMed database with the key words of (“biliary tract neoplasms” or “bile duct neoplasms” or “gallbladder neoplasms” or “cholangiocarcinoma” [All fields]) AND (“chemotherapy”[All fields]) AND Clinical trial [ptyp] between Apr 1984 to Jun 2013 and abstracts presented at the meetings of ASCO/Gastrointestinal Cancers Symposium (2004–2013) and ESMO/WCGC (2002–2013). Then we identified randomized trials of 1st-line chemotherapy for ABC, and analyzed the relations between the results of OS and those of progression-free survival (PFS) or time to progression (TTP), response rate (RR), disease control rate (DCR), post-progression survival (PPS = median OS − median PFS/TTP), and the proportion of patients who received 2nd-line chemotherapy (%2nd). Results: Among 329 papers/abstracts retrieved, 13 randomized trials, 26 treatment arms of first-line chemotherapy for ABC were identified. Number of trials with information on median OS, median PFS/TTP, hazard ratio (HR) for OS and PFS/TTP, RR, DCR, and %2nd were 13, 13, 6, 13, 12, and 7, respectively. The analysis of all these trials demonstrated the median values (range) of OS, PFS/TTP, HR of OS, HR of PFS/TTP, RR, DCR, PPS, and %2nd were 9.4 (4.6–13) months, 5.3 (2.7–8.5) months, 0.71 (0.39–0.93), 0.65 (0.44–0.85), 20 (7.1–36) %, 67 (21–87) %, 4.0 (1.0–7.6) months, and 41 (15–79) %, respectively. Spearman rank correlation coefficient of differences (Δ) OS with ΔPFS/TTP, ΔRR, ΔDCR, and ΔPPS were 0.66, − 0.07, 0.66, and 0.34, respectively. The correlation coefficient between HRs for PFS/TTP and OS was 0.60. The correlation coefficient between ΔPPS and Δ%2nd was − 0.15. Conclusions: OS was moderately associated with PFS/TTP and DCR.

Influence of obstructive jaundice on chemotherapy in patients with unresectable biliary tract cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 336-336
Author(s):  
Satoshi Shimizu ◽  
Shuichi Mitsunaga ◽  
Izumi Ohno ◽  
Hideaki Takahashi ◽  
Hiroyuki Okuyama ◽  
...  
Keyword(s):  
Overall Survival ◽  
Obstructive Jaundice ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Biliary Obstruction ◽  
Chief Complaint ◽  
Tract Cancer ◽  
Group 2 ◽  
Line Chemotherapy ◽  
Group 1

336 Background: The aim of this study was to investigate the influences of obstructive jaundice (OJ) in unresectable biliary tract cancer (BTC) patients. Methods: Data of a total of 200 patients who were newly diagnosed as having unresectable BTC and received chemotherapy between July 2006 and December 2012 were retrospectively reviewed. Patients were divided into two groups according to whether or not they presented with OJ as the incipient chief complaint (Group 1, patients with OJ; Group 2, patients without OJ). Results: There were 81 patients in Group 1 and 119 patients in Group 2. In regard to the primary site (Group 1/Group 2), 29 had perihilar (27/2), 7 had distal (7/0), 68 had intrahepatic (15/53), 92 had gallbladder (31/61) and 4 had ampulla of vater (1/3) (p<0.01). The rate of distant metastasis was 60% in Group 1 and 76% in Group 2 (p=0.02). The performance status was good (0 or 1) in 96% of cases of both the groups. There were no significant differences in the median survival time between Group 1 and Group 2 (9.0 months vs. 9.0 months, p=0.42) or in the progression free survival of 1st line chemotherapy between the two groups (4.1 months vs. 3.7 months, p=0.08). The rate of development of biliary obstruction in Group 1 was significantly high during the first line chemotherapy (56% vs. 10%, p<0.01). Discontinuation of 1st line chemotherapy was necessitated due to biliary obstruction in 9 patients (10%) of Group 1 and none of the patients (0%) of Group 2. Multivariate analysis showed that absence of metastasis and use of a doublet chemotherapy regimen were significantly correlated with the overall survival, but not the presence of OJ as the incipient chief complaint (HR, 0.772; 95% CI, 0.532-1.119). Conclusions: Patients with OJ as the incipient chief complaint showed high rate of recurrent biliary obstruction and discontinuation chemotherapy due to biliary obstruction. However, OJ may not disadvantage for overall survival in BTC.

scholarly journals Adjuvant and neoadjuvant therapy for biliary tract cancer: a review of clinical trials

2020 ◽  
Vol 50 (12) ◽  
pp. 1353-1363 ◽  
Author(s):  
Satoshi Nara ◽  
Minoru Esaki ◽  
Daisuke Ban ◽  
Takeshi Takamoto ◽  
Kazuaki Shimada ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Trials ◽  
Bile Duct ◽  
Adjuvant Therapy ◽  
Neoadjuvant Therapy ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Tract Cancer ◽  
Adjuvant And Neoadjuvant Therapy ◽  
Duct Cancer

Abstract Cancer originating in the biliary tract can be classified as bile duct cancer (cholangiocarcinoma), gallbladder cancer, or ampullary cancer. Bile duct cancer is further divided to intrahepatic, perihilar and distal bile duct subtypes according to the anatomical location of the tumor. The biological characteristics of each tumor are heterogeneous. However, because of the rarity of each disease, the efficacy of new drugs has been tested in groups of patients with different biliary tract cancers. In patients with metastatic or recurrent biliary tract cancer, recent randomized clinical trials revealed the non-inferiority of gemcitabine + S-1 and the superiority of gemcitabine + cisplatin + S-1 compared with gemcitabine + cisplatin in terms of overall survival, thereby establishing a new standard treatment. In the field of adjuvant therapy for biliary tract cancer, the British BILCAP (capecitabine compared with observation in resected biliary tract cancer) study revealed longer median overall survival in the capecitabine group than in the observation group in the per-protocol analysis (but not in the intention-to-treat analysis), bringing a shift toward postoperative management. Several other studies of adjuvant therapy are ongoing, and they may lead to reforms in treatment strategy for resectable biliary tract cancer in the future. The use of neoadjuvant therapy for biliary tract cancer is in its infancy, but it is expected to overcome the limitations of adjuvant therapy for this malignancy. In this review, we summarized the evidence available from clinical trials of adjuvant and neoadjuvant therapy for biliary tract cancer and described ongoing clinical trials.

Analysis of 94 patients with advanced biliary tract cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15172-15172
Author(s):  
B. Andritzky ◽  
S. Adler ◽  
I. Burkholder ◽  
I. Thöm ◽  
G. Schuch ◽  
...  
Keyword(s):  
Overall Survival ◽  
Bile Duct ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Primary Tumor ◽  
Median Overall Survival ◽  
Response Rate ◽  
Cytotoxic Agents ◽  
Tract Cancer ◽  
Line Chemotherapy

15172 Background: Cholangiocarcinoma or gallbladder cancer are often diagnosed at an advanced stage with limited treatment options. Methods: Between 1994 and 2004, 94 patients (pts) (47 male, 47 female) with advanced biliary tract cancer were treated at the Department of Oncology and Hematology, University Hospital Hamburg-Eppendorf. Clinical and histopathological characteristics, response to chemotherapy, and survival were investigated in a retrospective analysis. Median age was 59 years (range 30–80) and median Karnofsky performance status was 90%. Predominant histologic type was adenocarcinoma (94.7%). Primary tumor sites were extrahepatic bile duct (29.9%), gallbladder (28.7%), intrahepatic bile duct (10.6%), ampulla of Vater (2.1%), not specified (28.7%). Predominant localizations of metastases were liver (73 pts (77.7%)), lymph nodes (49 pts (52.1%)) and the peritoneum (14 pts (14.9%)). 33 pts (35.1%) underwent surgery of the primary tumor at time of diagnosis. Results: 72 of 94 pts (76.6%) received a first-line chemotherapy, all together 10 different chemotherapy regimens were used. The median number of cycles was 2.5 (range 1 - 12). A single agent chemotherapy with gemcitabine was the most often adminstered regimen (23 pts (31.9%)), followed by carboplatin and etoposide plus whole body hyperthermia (12 pts (16.7%)) and 5- fluorouracil and folic acid (10 pts (13.9%)). The overall response rate was 8.3% (95% CI 3.1 - 17.3) (34.7% SD, 47.2% PD, 9.7% not evaluable). Second-line chemotherapy was given in 27 patients, which induced no tumor response, but a stable disease rate of 22.2%. Median time to follow- up was 44.8 months. Survival was calculated for all 94 pts since time of diagnosis. Median overall survival was 12.2 months and median progression-free survival 9.2 months. The median overall survival time for the 72 pts who were treated with chemotherapy was 14.0 months, and for the 22 pts who did not receive chemotherapy 10.7 months (p=0.2). Conclusions: Our analysis showed a poor prognosis for patients with advanced biliary tract cancer. Response rate to chemotherapy was low. Therefore, well tolerated cytotoxic agents should be used and new treatment strategies (including molecular targeted therapy) should be further investigated. No significant financial relationships to disclose.

scholarly journals The efficacy and safety of apatinib treatment for patients with advanced or recurrent biliary tract cancer: a retrospective study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Caiyun Nie ◽  
Huifang Lv ◽  
Yishu Xing ◽  
Beibei Chen ◽  
Weifeng Xu ◽  
...  
Keyword(s):  
Overall Survival ◽  
Combination Therapy ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Objective Response ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Free Survival ◽  
Tract Cancer ◽  
Systemic Therapies

Abstract Introduction The present study aims to evaluate the efficacy and safety of apatinib monotherapy or combination therapy for patients with advanced or recurrent biliary tract cancer (BTC). Methods Twenty-eight patients with advanced or recurrent BTC who progressed after prior systemic therapies and treated with apatinib from January 2017 to June 2019 were enrolled in this retrospective and observational study. The primary end point was progression free survival (PFS). Secondary end points included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and toxicity. Results A total of 28 patients with advanced or recurrent BTC who progressed after prior systemic therapies received apatinib monotherapy or combination therapy (with capecitabine, S-1, oxaliplatin, irinotecan or PD-1 inhibitor), including 9 cases of gallbladder cancer and 19 cases of cholangiocarcinoma. Six patients achieved PR, 15 patients had SD and 7 patients had PD. Median progression-free survival (PFS) and overall survival (OS) was 4.3 months (95%CI = 1.8–6.8) and 6.2 months (95% CI = 4.6–7.8) respectively. The ORR and DCR were 21.4% (6/28) and 75.0% (21/28), respectively. Most of the adverse events were grade 1–2 in severity, apatinib treatment was well tolerated. Conclusions Apatinib monotherapy or combination therapy can improve PFS in patients with advanced or recurrent BTC who progressed after prior systemic therapies, and adverse reactions can be well tolerated. Our study support apatinib therapy as a feasible therapeutic strategy in advanced or recurrent BTC.

scholarly journals The Efficacy and Safety of Apatinib Treatment for Patients with Advanced or Recurrent Biliary Tract Cancer: A Retrospective Study

2020 ◽  
Author(s):  
Caiyun Nie ◽  
Huifang Lv ◽  
Yishu Xing ◽  
Beibei Chen ◽  
Weifeng Xu ◽  
...  
Keyword(s):  
Overall Survival ◽  
Combination Therapy ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Objective Response ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Free Survival ◽  
Tract Cancer ◽  
Systemic Therapies

Abstract Background The present study aims to evaluate the efficacy and safety of apatinib monotherapy or combination therapy for patients with advanced or recurrent biliary tract cancer(BTC). Methods Twenty-eight patients with advanced or recurrent BTC who progressed after prior systemic therapies and treated with apatinib from January 2017 to June 2019 were enrolled in this retrospective and observational study. The primary end point was progression free survival (PFS). Secondary end points included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and toxicity. Results A total of 28 patients with advanced or recurrent BTC who progressed after prior systemic therapies received apatinib monotherapy or combination therapy, including 9 cases of gallbladder cancer and 19 cases of cholangiocarcinoma. 6 patients achieved PR, 15 patients had SD and 7 patients had PD. Median progression-free survival (PFS) and overall survival (OS) was 4.3 months(95%CI = 1.8–6.8) and 6.2 months(95% CI = 4.6–7.8) respectively. The ORR and DCR were 21.4% (6/28) and 75.0% (21/28), respectively. Most of the adverse events were grade 1–2 in severity, apatinib treatment was well tolerated. Conclusions Apatinib monotherapy or combination therapy can improve PFS in patients with advanced or recurrent BTC who progressed after prior systemic therapies, and adverse reactions can be well tolerated. Our study support apatinib therapy as a feasible therapeutic strategy in advanced or recurrent BTC.

Prognostic factor analysis of second-line chemotherapy in advanced biliary tract cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14688-e14688 ◽  
Author(s):  
Sang-Cheol Lee ◽  
Kyoungha Kim ◽  
Hanjo Kim ◽  
Hyun Jung Kim ◽  
Se Hyung Kim ◽  
...  
Keyword(s):  
Overall Survival ◽  
Prognostic Factors ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Salvage Chemotherapy ◽  
Second Line ◽  
First Line ◽  
Factors Affecting ◽  
Tract Cancer ◽  
Line Chemotherapy

e14688 Background: There is no evidence that second-line chemotherapy in advanced biliary tract cancer (BTC) will result in substantial prolongation of survival. The purpose of this study was to evaluate prognostic factors for the survival of patients with advanced biliary tract cancer who was refractory BTC for first-line chemotherapy. Methods: We reviewed 89 patients retrospecitively with advanced biliary tract cancer who had enrolled in two clinical trials at three branches of Soonchunhyang university hospital. They received palliative chemotherapy with 2 regimens (biweekly GEMOX and modified FOLFOX-6). GEMOX is consist of gemcitabine 1,000 mg/m2 intravenously on day 1 and oxaliplatin 85 mg/m2 intravenously on day 2 every 2 weeks and mFOLFOX-6 is that oxaliplatin 85mg/m2 and folinic acid 400 mg/m2 on day 1 follwed by a 5-FU bolus 400 mg/m2 and 46-h infusion 2400 mg/m2 every 2 weeks. To evaluate the clinicopathologic factors that affected overall survival, univariate and multivariate analyses were performed on the baseline factors. Results: 89 patients were enrolled from Sep 2006 to Aug 2010. Medain age was 62.14 years (range 35-81). Univariate analysis revealed 4 prognostic factors affecting overall survival after first-line chemotherapy. Performance status of 0-1 vs >2 (p=0.014), salvage chemotherapy (p=0.021), locoregional disease vs disseminated disease (p=0.046) and responder of first-line chemotherapy (p=0.025) was revealed. Multivariate analysis found 2 prognostic factors affecting overall survival. They were salvage chemotherapy and initial responder. Conclusions: This results suggest that 2nd-line chemotherapy is needed for patients with good performance and responder of initial chemotherapy.

Neutrophil/lymphocyte ratio (NLR) may predict prognostic factor with gemcitabine, cisplatin (GC) for patients with advanced biliary tract cancer.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 410-410
Author(s):  
Toru Otsuru ◽  
Daisuke Sakai ◽  
Akie Kimura ◽  
Chiaki Inagaki ◽  
Naohiro Nishida ◽  
...  
Keyword(s):  
Overall Survival ◽  
Survival Rate ◽  
Bile Duct ◽  
Prognostic Factor ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Intrahepatic Bile Duct ◽  
Neutrophil Lymphocyte Ratio ◽  
Lymphocyte Ratio ◽  
Tract Cancer

410 Background: There is little information available about prognostic markers of GC (gemcitabine, cisplatin) in patients with advanced biliary tract cancer (BTC). Neutrophil/lymphocyte ratio (NLR) in several cancers was might to be a prognostic factor associated with clinical outcomes, we examine NLR in patient with BTC underwent chemotherapy (GC). Methods: Retrospective chart review for consecutive patients who underwent GC for advanced BTC in our institute were performed. The patients who were enrolled in ongoing clinical trials were excluded. Gemcitabine and cisplatin were administered intravenously at doses of 1,000 or 25 mg/m2, on day one and eight, every three weeks. We divided these patients based on estimated NLR, and evaluated the clinicopathological factors and survival in the two groups (NLR ≥ 3 or < 3). Results: 57 patients from 2013 to 2017 were reviewed. 23 patients were in NLR ≥ 3 group and 34 patients were in NLR < 3 group. Patients characteristics were as follows; median age, 68 years old (range: 38-83) years: male 36 (63%); primary tumor lesion, intrahepatic bile duct 6 (10%)/extrahepatic bile duct 32 (56%)/gallbladder 18 (32%)/ampulla of vater 1 (2%); therapeutic purpose, palliative 50 (88%)/adjuvant 5 (8%)/neoadjuvant 2 (4%); PS, 0/1. Response rate of the patients who had measurable lesion according to RECIST v1.1 was 17% (8/46), and disease control rate was 70% (32/46). The progression-free survival rate between the two groups is not significantly different. Although, the median overall survival (OS) of NLR ≥ 3 group was 11.8 months, while OS of NLR < 3 group was 29.2 months. The overall survival rate in the NLR ≥ 3 group was significantly lower than that in the NLR < 3 group ( P = 0.0339). Conclusions: Our study confirmed that high NLR is associated with worse OS and PFS, and suggested it may be a predictive marker for GC chemotherapy in patients with BTC.

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