Prognostic factors in advanced biliary tract cancer treated with first-line chemotherapy with cisplatin and gemcitabine.

350 Background: Data regarding prognostic factors in advanced biliary tract cancer (ABTC) remains scarce. The aim of this study was to review our experience in ABTC as well as to evaluate potential prognostic factors for overall survival (OS) as defined in the ABC-02 trial. Methods: 106 consecutive patients with ABTC who initiated palliative chemotherapy with Cisplatin and Gemcitabine from 2009 to 2012 at the BC Cancer Agency were identified using our pharmacy database. Clinicopathologic variables and treatment outcome were retrospectively collected. Potential prognostic factors were assessed by univariate (Kaplan-Meier curves and log-rank test) and multivariate analyses (Cox proportional hazards model). Results: 106 patients (46 males) with a median age of 64 years (range 43 – 88) were included. Median progression free-survival (PFS) was 6.2 months (95%CI: 5.4-7.0). Median OS from diagnosis of advanced disease to death was 12.9 months (95%CI: 10.0-15.7), while median OS from initiation of chemotherapy to death was 10.0 months (95%CI: 7.3-12.6). 34.9% of the patients received 2nd line chemotherapy, with single-agent 5-fluorouracil being the most used drug. On univariate analysis, ECOG performance status (PS) at diagnosis, primary tumor location (gallbladder, intra-hepatic cholangiocarcinoma, extra-hepatic cholangiocarcinoma, ampulla of Vater, unkown), and sites of advanced disease (unresectable locally advanced, regional lymph nodes, liver-limited metastases, extra-hepatic metastases) were significantly associated with worse OS (p < 0.001, 0.003 and 0.009, respectively). Age, gender, CA19-9, CEA, hemoglobin, neutrophil count, prior stent and prior surgery were not significantly associated with OS. On multivariate analysis, predictors of poorer OS were ECOG PS (p<0.001), primary location (p=0.009), site of advanced disease (p=0.006) and CEA (p=0.002). Conclusions: In this population based analysis, outcomes for patients with ABTC were comparable to those noted in the ABC-02 trial. ECOG PS, primary tumor location, site of advanced disease and CEA were all found to be significantly prognostic.

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Outcomes of continuously infused 5-fluorouracil, doxorubicin, and mitomycin-C (iFAM) as salvage regimen in patients with biliary tract cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.4_suppl.282 ◽

2011 ◽

Vol 29 (4_suppl) ◽

pp. 282-282 ◽

Cited By ~ 1

Author(s):

K. Lim ◽

S. Han ◽

D. Oh ◽

S. Im ◽

T. Kim ◽

...

Keyword(s):

Prognostic Factors ◽

Mitomycin C ◽

Biliary Tract ◽

Biliary Tract Cancer ◽

Salvage Chemotherapy ◽

First Line ◽

Salvage Regimen ◽

Tract Cancer ◽

Ecog Ps ◽

Line Chemotherapy

282 Background: In advanced biliary tract cancer, after failure of first-line chemotherapy, salvage chemotherapy has not yet been established and the prognostic factors in salvage setting have not been widely known. The purpose of this study was to evaluate the efficacy and safety of iFAM as salvage chemotherapy in biliary tract cancer and to reveal the prognostic factors. Methods: Eligibility included: 1) age 18-75, 2) histologically confirmed biliary tract cancer, 3) previously treated with palliative first-line chemotherapy, 4) ECOG PS 0-2, 5) adequate organ function. iFAM consisted of 5-FU 800 mg/m2 over 12 hour on days 1-5, doxorubicin 30 mg/m2 on day 1, and mitomycin-C 8 mg/m2 on day 1, every 4 weeks. Results: Between February 2003 and August 2009, 50 patients (pts) were enrolled. The median age was 57.3 yrs (range: 26.0-71.5 yrs), and there were 33 men (66%). 32 pts (64%) had ECOG PS 0-1 and 18 pts (36%) had PS 2. Biliary tract cancers were extrahepatic cholangiocarcinoma (30%), intrahepatic cholangiocarcinoma (30%) and gallbladder cancer (40%). Previous chemotherapy mainly consisted of gemcitabine-based and 5-FU-based regimens. Median cycles of iFAM were 2 (range: 1-6). Best responses to iFAM were PR in 2 (4%) pts and SD in 9 (18%), that is response rate was 4% and disease control rate was 22% (95% CI: 7.35-28.65). The median PFS and OS were 2.2 (95% CI: 2.0–2.4) months and 5.0 (95% CI: 3.3–6.7) months, respectively. Grade 3/4 hematologic toxicities were neutropenia (10%), anemia (2%), and thrombocytopenia (8%). Frequent nonhematologic toxicities were alopecia (34%), stomatitis (28%), vomiting (24%), and diarrhea (12%), which were grade 1/2. ECOG PS (0-1 vs 2) was significant prognostic factor for both PFS (p=0.029) and OS (p=0.025). Poor response to previous chemotherapy (p=0.031) were poor prognostic factors for OS. Conclusions: iFAM is an effective and safe treatment option in refractory biliary tract cancer and can be considered as salvage regimen, especially for patients with good PS and good response to previous chemotherapy. No significant financial relationships to disclose.

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Analysis of 94 patients with advanced biliary tract cancer

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.15172 ◽

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.

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Retrospective analysis of the difference of prognosis between unresectable and recurrent biliary tract cancer: Kansai Hepatobiliary Oncology Group (KHBO) 1001.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e14518 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e14518-e14518

Author(s):

Masashi Kanai ◽

Kenji Ikezawa ◽

Tetsuo Ajiki ◽

Tadashi Tsukamoto ◽

Hideyoshi Toyokawa ◽

...

Keyword(s):

Prognostic Factors ◽

Survival Rate ◽

Biliary Tract ◽

Biliary Tract Cancer ◽

Patient Characteristics ◽

Lymph Node Involvement ◽

Tract Cancer ◽

The Status ◽

The Difference ◽

Ecog Ps

e14518 Background: The difference of prognosis between patients (pts) with unresectable and recurrent biliary tract cancer (BTC) receiving chemotherapy has not been clarified although some studies reported prognostic factors of BTC. In this study, we aimed to compare the prognosis of unresectable BTC with that of recurrent BTC. We also evaluated other prognostic factors of BTC. Methods: This study retrospectively reviewed the data of 403 consecutive pts with pathologically proven unresectable or recurrent BTC who received palliative chemotherapy from 18 hospitals in Japan between April 2006 and March 2009. The 1-year survival rate and overall survival (OS) and patient characteristics were compared between unresectable and recurrent cases. Univariate and multivariate analyses were performed to identify prognostic factors. Results: 380 pts (94.3%) received chemotherapy using gemcitabine and/or S-1. The 1-year survival rate and OS were significantly better in 192 pts with recurrent BTC than 211 pts with unresectable BTC (1-year survival 57.3% vs. 43.1%, p=0.005; OS 398 days [95% confidence interval (CI) 365-430] vs. 323 days [95% CI 282-364], p=0.004). In baseline characteristics, the proportion of pts who had distant metastasis was significantly greater in recurrent BTC than unresectable BTC (77.1% vs. 66.8%, p<0.001). In contrast, lymph node involvement, biliary intervention and elevated tumor marker levels (CEA and CA19-9) were more common in pts with unresectable BTC (p<0.001). After the multivariate analysis, unresectable BTC group still demonstrated a significantly worse survival than recurrent BTC group (hazard ratio [HR] 1.44, 95% CI 1.15-1.80, p=0.002). Other statistically significant prognostic factors were ECOG PS (HR 1.49, 95% CI 1.18-1.87, p<0.001), metastatic disease (HR 1.53, 95% CI 1.20-1.97, p<0.001) and higher CEA (≥5 ng/ml) (HR 1.71, 95% CI 1.36-2.15, p<0.001). Conclusions: The status of unresectable/recurrent disease is identified as one of the prognostic factors for pts with BTC receiving chemotherapy and recommended to be used as a stratification factor in the clinical trials.

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Prognostic Factors for the Selection of Patients Eligible for Second-Line Chemotherapy in Advanced Biliary Tract Cancer

Chemotherapy ◽

10.1159/000370193 ◽

2014 ◽

Vol 60 (2) ◽

pp. 91-98 ◽

Cited By ~ 5

Author(s):

Eun Joo Kang ◽

Yoon Ji Choi ◽

Jung Sun Kim ◽

Kyong Hwa Park ◽

Sang Chul Oh ◽

...

Keyword(s):

Prognostic Factors ◽

Biliary Tract ◽

Biliary Tract Cancer ◽

Second Line ◽

Second Line Chemotherapy ◽

Tract Cancer ◽

Selection Of Patients ◽

Line Chemotherapy ◽

Selection Of

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

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e14688 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e14688-e14688 ◽

Cited By ~ 4

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.

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