The impact of age and comorbidity in advanced or recurrent biliary tract cancer receiving palliative chemotherapy

2020 ◽  
Vol 35 (10) ◽  
pp. 1828-1835
Author(s):  
Naminatsu Takahara ◽  
Yousuke Nakai ◽  
Kei Saito ◽  
Takashi Sasaki ◽  
Yukari Suzuki ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Palliative Chemotherapy ◽  
Tract Cancer ◽  
The Impact

scholarly journals Skeletal muscle depletion predicts survival of patients with advanced biliary tract cancer undergoing palliative chemotherapy

Oncotarget ◽  
2017 ◽  
Vol 8 (45) ◽  
pp. 79441-79452 ◽  
Author(s):  
Kyoung-Min Cho ◽  
Hyunkyung Park ◽  
Do-Youn Oh ◽  
Tae-Yong Kim ◽  
Kyung Hun Lee ◽  
...  
Keyword(s):  
Skeletal Muscle ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Palliative Chemotherapy ◽  
Tract Cancer

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.

scholarly journals Long term responders to palliative chemotherapy for advanced biliary tract cancer

2017 ◽  
Vol 8 (2) ◽  
pp. 352-360 ◽  
Author(s):  
Mark K. Doherty ◽  
Mairéad G. McNamara ◽  
Priya Aneja ◽  
Emma McInerney ◽  
Stephanie Moignard ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Palliative Chemotherapy ◽  
Tract Cancer

The influence of renal function on gemcitabine-based chemotherapy for advanced biliary tract cancer: An exploratory subgroup analysis of JCOG1113.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 368-368
Author(s):  
Makoto Ueno ◽  
Chigusa Morizane ◽  
Takuji Okusaka ◽  
Gakuto Ogawa ◽  
Yuya Sato ◽  
...  
Keyword(s):  
Renal Function ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Cox Regression ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Eligibility Criteria ◽  
Tract Cancer ◽  
Grade 3 ◽  
The Impact

368 Background: JCOG1113 is a randomized phase III trial to evaluate gemcitabine (GEM) plus S-1 (GS) versus GEM plus cisplatin (GC) regarding overall survival (OS) for advanced biliary tract cancer (BTC) (UMIN000001685) and the non-inferiority of GS was demonstrated. It is necessary to consider renal function using cisplatin or S-1 because cisplatin has renal toxicity, and the toxicity of S-1 is affected by renal function. Therefore, we evaluated the influence of renal function on the efficacy and safety of GC and GS in JCOG1113. Methods: All enrolled patients (pts) in JCOG1113 (n = 354) were analyzed. Eligibility criteria included chemotherapy-naïve pts with recurrent or unresectable biliary tract adenocarcinoma, ECOG-PS of 0–1, CCr > 50 ml/min, and adequate organ function. Renal function was classified into two groups by creatinine clearance (CCr) as calculated by the Cockcroft-Gault formula; high CCr (CCr ≥ 80 ml/min) or low CCr (80 > CCr ≥ 50 ml/min). The impact of renal function on OS and progression-free survival (PFS) were compared using the Cox regression model. The adverse events (AEs) were compared using Fisher’s exact test. Results: Eighty-eight pts on GC and 88 pts on GS were included in the high CCr group, and 87 pts on GC and 91 pts on GS were included in the low CCr group. There were no differences between the groups regarding, sex, PS, primary site, biliary drainage, operation, or recurrence, except for age. The hazard ratio (HR) of GS to GC for OS was 1.12 (95% CI 0.81–1.56) in the high CCr group and 0.80 (95% CI 0.58–1.11) in the low CCr group. The HR of GS to GC for PFS was 1.06 (95% CI 0.78–1.44) in the high CCr group and 0.69 (95% CI 0.50–0.94) in the low CCr group. Grade 3-4 AEs of white blood cell count decreased (35.3%/23.6%), anemia (29.4%/7.9%) and platelet count decreased (18.8%/10.1%) were more common in GC than GS in the low CCr group. In contrast, the incidence of all grade 3-4 non-hematological AEs was higher (36.0%/11.8%) in GS than GC in the low CCr group ( p = 0.0002). Conclusions: GS was better in terms of OS, PFS, and hematological toxicities than GC in the low CCr group. GS might be recommended for the population with lower renal function in the treatment for advanced BTC.

Adjuvant Therapy in the Treatment of Biliary Tract Cancer: A Systematic Review and Meta-Analysis

2012 ◽  
Vol 30 (16) ◽  
pp. 1934-1940 ◽  
Author(s):  
Anne M. Horgan ◽  
Eitan Amir ◽  
Thomas Walter ◽  
Jennifer J. Knox
Keyword(s):  
Systematic Review ◽  
Adjuvant Therapy ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Meta Analysis ◽  
Random Effect ◽  
Published Data ◽  
Curative Intent ◽  
Tract Cancer ◽  
The Impact

PurposeThe benefit of adjuvant therapy (AT) for biliary tract cancer (BTC) is unclear, with conflicting results from nonrandomized studies. We report a systematic review and meta-analysis to determine the impact of AT on survival.MethodsStudies published between 1960 and November 2010, which evaluated adjuvant chemotherapy (CT), radiotherapy (RT), or both (CRT) compared with curative-intent surgery alone for resected BTC were included. Only tumors of the gallbladder and bile ducts were assessed. Published data were extracted and computed into odds ratios (ORs) for death at 5 years. Subgroup analyses of benefit based on lymph node (LN) or resection margin positivity (R1) were prespecified. Data were weighted by generic inverse variance and pooled using random-effect modeling.ResultsTwenty studies involving 6,712 patients were analyzed. There was a nonsignificant improvement in overall survival with any AT compared with surgery alone (pooled OR, 0.74; P = .06). There was no difference between gallbladder and bile duct tumors (P = .68). The association was significant when the two registry analyses were excluded. Those receiving CT or CRT derived statistically greater benefit than RT alone (OR, 0.39, 0.61, and 0.98, respectively; P = .02). The greatest benefit for AT was in those with LN-positive disease (OR, 0.49; P = .004) and R1 disease (OR, 0.36; P = .002).ConclusionThis analysis supports AT for BTC. Prospective randomized trials are needed to provide better rationale for this commonly used strategy. On the basis of our data, such trials could involve two active comparators rather than a no-treatment arm among patients with LN-positive or R1 disease.

Patient-Reported Outcomes of Patients With Advanced Biliary Tract Cancers Receiving Gemcitabine Plus Capecitabine: A Multicenter, Phase II Trial of the Swiss Group for Clinical Cancer Research

2008 ◽  
Vol 26 (22) ◽  
pp. 3702-3708 ◽  
Author(s):  
Dieter Koeberle ◽  
Piercarlo Saletti ◽  
Markus Borner ◽  
Daniela Gerber ◽  
Daniel Dietrich ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Patient Reported Outcomes ◽  
Palliative Chemotherapy ◽  
Hematologic Toxicity ◽  
Karnofsky Performance Score ◽  
Pain Intensity Score ◽  
Tract Cancer ◽  
Number Of Patients ◽  
Patient Reported

Purpose To evaluate the effects of palliative chemotherapy with gemcitabine plus capecitabine (GemCap) on patient-reported outcomes measured using clinical benefit response (CBR) and quality-of-life (QOL) measures in patients with advanced biliary tract cancer. Patients and Methods Patients had to manifest symptoms of advanced biliary tract cancer and have at least one of the following: impaired Karnofsky performance score (60 to 80), average analgesic consumption ≥ 10 mg of morphine equivalents per day, and average pain intensity score of ≥ 20 mm out of 100 mm. Treatment consisted of oral capecitabine 650 mg/m2 twice daily on days 1 through 14 plus gemcitabine 1,000 mg/m2 as a 30-minute infusion on days 1 and 8 every 3 weeks until progression. The primary end point was the number of patients categorized as having a CBR or stable CBR (SCBR) during the first three treatment cycles. Results Forty-four patients were enrolled (bile duct cancer, n = 36; gallbladder cancers, n = 8). The main grade 3 or 4 adverse events included hematologic toxicity and fatigue. After three cycles, 36% of patients achieved a CBR, and 34% achieved an SCBR. Over the full course of treatment, 57% of patients achieved a CBR, and 18% achieved an SCBR. Improved QOL was observed in patients with a CBR or SCBR. The objective response rate was 25%. Median time to progression and overall survival times were 7.2 months and 13.2 months, respectively. Conclusion Chemotherapy with GemCap is well tolerated and effective and leads to a high CBR rate. Patient-reported outcomes are useful for evaluating the effects of palliative chemotherapy in patients with biliary tract cancer.

scholarly journals Long-term responders to palliative chemotherapy for advanced biliary tract cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 391-391 ◽  
Author(s):  
Mark Doherty ◽  
Mairead G McNamara ◽  
Priya Aneja ◽  
Anne M. Horgan ◽  
Raymond Woo-Jun Jang ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Palliative Chemotherapy ◽  
Progression Free Survival ◽  
Analysis Data ◽  
First Line ◽  
Tract Cancer ◽  
Tumour Shrinkage ◽  
Third Line

391 Background: Standard palliative chemotherapy (PC) in patients (pts) with Advanced Biliary Tract Cancer (ABTC) since publication of ABC-02 study in 2010 is cisplatin/gemcitabine (cis/gem), with median overall survival (OS) of 11.7 months. Prior to this, institutional standard was gemcitabine/fluoropyrimidine combination. From the ABC-02 study, 8 cycles of PC is standard. Some pts benefit from continuing PC longer than 8 cycles. Methods: Pts treated for ABTC in Princess Margaret Cancer Centre between 06/1987 and 09/2015, receiving > 8 cycles of PC were included for analysis. Data was collected on demographics, clinicopathologic features, PC regimen, toxicities, and survival. Results: Of 553 pts who received PC, 119 pts met inclusion criteria of PC > 8 cycles. Median age was 60 (range 27-80). Site of tumour was ampullary in 11, distal bile duct in 14, gallbladder in 28, intrahepatic in 37, perihilar in 26, and unspecified in 3 pts. 61 (51%) required biliary stenting. 30 (25%) had definitive surgical resection at diagnosis, while 89 (75%) presented with ABTC. First-line PC regimens were cis/gem in 44 and gemcitabine/capecitabine in 62. Other regimens included gemcitabine and 5-fluorouracil alone or combined. Median time on first line PC was 10 months, with median of 12 cycles (range 9-47). 22 pts (19%) had treatment breaks > 8 weeks then restarted same PC. Any tumour shrinkage was seen in 73 pts (61%). The majority of pts discontinued PC due to disease progression (69), however 16 stopped due to toxicity such as thrombocytopenia, neutropenia, fatigue and neuropathy. At time of analysis, 103 pts had progressive disease, with median progression free survival of 11.8 months. 51 and 21 pts received second and third line chemotherapy, respectively. 27 pts are alive; median OS for the whole group was 22 months (95%CI 18.7-27.3 months). Conclusions: A cohort of ABTC pts continued to derive benefit from chemotherapy beyond 8 cycles, with median OS considerably greater than that seen in clinical trials. Toxicities were mostly manageable, with treatment breaks from PC for relief of side-effects observed. Further exploration of factors prognostic and predictive for continued benefit from PC will be explored and updated at presentation.

scholarly journals Outcomes in patients receiving palliative chemotherapy for advanced biliary tract cancer

JHEP Reports ◽  
2021 ◽  
pp. 100417
Author(s):  
Felix Thol ◽  
Simon Johannes Gairing ◽  
Carolin Czauderna ◽  
Thomas Thomaidis ◽  
Thomas Gamstätter ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Palliative Chemotherapy ◽  
Tract Cancer
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