Role of chemoradiotherapy in advanced biliary cancers.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14694-e14694
Author(s):  
Asha Nayak ◽  
Sameer Arora ◽  
Edward J. Kruse
Keyword(s):  
Cancer Patients ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Performance Status ◽  
Categorical Variables ◽  
Ecog Performance Status ◽  
Term Survival ◽  
Tract Cancer ◽  
Kaplan Meier ◽  
Radiotherapy Dose

e14694 Background: Patients with metastatic biliary tract cancers have a poor outcome and radiotherapy is administered largely to patients with an intent of palliation. We analyzed our institutional biliary tract cancer database to compare the outcome between chemotherapy alone vs. chemoradiotherapy. Methods: From January 2005 to December 2010, 126 metastatic and inoperable biliary cancer patients were retrospectively analyzed. 59(46.8%) patients received chemoradiotherapy(CRT) and 67(53.1%) patients received chemotherapy alone. Chemotherapy regimens consisted of 5-fluorouracil, gemcitabine, or cisplatin. CRT patients received 3D-CRT with a median dose of 30 Gy (range, 25-35Gy ) at 1.8-2 Gy per fraction per day.Patients were categorized into Gall bladder, extrahepatic or intrahepatic bileduct cancers .The follow-up time was calculated from the time of diagnosis to the date of death or the last contact. Kaplan-Meier analysis was used to calculate the overall survival (OS). Results: Median OS was 6.6 months for all patients. Median OS was 6.9 months (0.8-26.0) for patients treated with chemotherapy alone and 10.2 months (0.8-46.9) for those treated with chemoradiotherapy (p = 0.002). Univariate survival analysis of categorical variables for patients treated with chemoradiotherapy revealed that age, race, gender, location of metastatic site, site of primary tumor ,T stage (T3 v. T4) or nodal stage were not significant. However, ECOG performance status (1 v. 2/3) and the dose of radiation (<30 v. >30 Gy) received were associated with improved survival (p = 0.002, p=0.032). Median OS was 13.2 months for ECOG 1 vs. 4.3 months for ECOG 2/3. Median OS was 12.3 months for patients treated with radiotherapy dose more than 30 Gy vs. 6.4 months for those who received less than 30 Gy. 12/59(20.3%) patients who received chemoradiotherapy lived approximately 2 years longer. Conclusions: Metastatic biliary tract cancer patients with good performance score may benefit from chemoradiotherapy, and this modality did not increase the mortality. Long-term survival was observed in this selected group.

Potential role of chemoradiotherapy for metastatic pancreatic cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 344-344
Author(s):  
D. Y. Lee ◽  
J. M. Robertson ◽  
J. Huang ◽  
J. H. Margolis ◽  
S. Balaraman ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Cancer Patients ◽  
Performance Status ◽  
Metastatic Pancreatic Cancer ◽  
Categorical Variables ◽  
Ecog Performance Status ◽  
Term Survival ◽  
Kaplan Meier ◽  
Radiotherapy Dose

344 Background: Patients with metastatic pancreatic cancer have a poor outcome and the radiotherapy is typically only given to patients requiring palliation. We analyzed our institutional pancreas database to compare the outcome between chemotherapy alone vs. chemoradiotherapy. Methods: From January 2000 to December 2008, 199 metastatic pancreatic cancer patients were retrospectively analyzed. 13 (6.5%) patients received chemoradiotherapy and 186 (93.5%) patients received chemotherapy alone. Chemotherapy regimens consisted of 5-fluorouracil, gemcitabine, erlotinib, or cisplatin. The follow-up time was calculated from the time of diagnosis to the date of death or the last contact. Kaplan-Meier analysis was used to calculate the overall survival (OS). Results: Median OS was 5.3 months for all patients. Median OS was 4.9 months (0.4–27.0) for patients treated with chemotherapy alone and 7.8 months (0.6–44.1) for those treated with chemoradiotherapy (p = 0.013). Univariate survival analysis of categorical variables for patients treated with chemoradiotherapy revealed that age, race, gender, location of metastatic site, T stage (T3 v. T4) or nodal stage were not significant. However, ECOG performance status (1 v. 2/3) and the dose of radiation (<35 v. >35 Gy) received were associated with improved survival (p = 0.013, p=0.049). Median OS was 12.9 months for ECOG 1 vs. 5.6 months for ECOG 2/3. Median OS was 11.1 months for patients treated with radiotherapy dose > 35 Gy vs. 5.9 months for those who received less than 35 Gy. 3/13 (23%) patients who received chemoradiotherapy lived nearly two years or more. Conclusions: Metastatic pancreatic cancer patients with good performance score may benefit from chemoradiotherapy. Long-term survival was observed in this selected group. No significant financial relationships to disclose.

Evaluation of chemotherapy with cisplatin plus gemcitabine after failure of gemcitabine alone for unresectable or recurrent biliary tract cancer.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 377-377
Author(s):  
Ryo Kameda ◽  
Tomoko Ando ◽  
Satoshi Kobayashi ◽  
Makoto Ueno ◽  
Shinichi Ohkawa
Keyword(s):  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Extrahepatic Bile Duct ◽  
Performance Status ◽  
Objective Response ◽  
Locally Advanced ◽  
Tumor Control ◽  
Ecog Performance Status ◽  
Female Ratio ◽  
Tract Cancer

377 Background: As there was no standard chemotherapy for advanced biliary tract cancer before ABC-02, we had treated our patients with gemcitabine alone. However, recently cisplatin plus gemcitabine became standard as first line chemotherapy. We assessed the benefits of chemotherapy with cisplatin plus gemcitabine after failure of gemcitabine alone before ABC-02 era. Methods: We retrospectively examined the patients with advanced biliary tract cancer, who were treated with chemotherapy using cisplatin plus gemcitabine after failure of gemcitabine alone. The eligible patients had unresectable or recurrent biliary tract cancer, objective tumor progression after gemcitabine alone chemotherapy, adequate organ function including renal function and ECOG performance status (PS) 0-1. The treatment consisted of cisplatin (25 mg per square meter of body-surface area) plus gemcitabine (1000 mg per square meter) on days 1 and 8, every 3 weeks. Results: Between December 2010 and July 2011, 10 patients were enrolled. Their median age was 63 years, the male : female ratio was 8:2, intrahepatic bile ducts : gall bladder : extrahepatic bile duct 6:3:1, locally advanced : metastatic disease 1:9, PS0 : PS1 7:3. The objective response rate was 30%, and the tumor control rate was 60%. The median progression-free survival was 4.0 months (95% confidence interval (CI): 1.4-6.9 months) with median overall survival 6.4 months (95% CI: 3.7-7.6 months). Grade 3-4 toxicities were neutropenia (30%) and anemia (30%). Conclusions: Cisplatin plus gemcitabine can be an optional therapy for unresectable or recurrent biliary tract cancer after failure of gemcitabine alone.

Efficacy and safety of cisplatin and gemcitabine (CG) chemotherapy for advanced biliary tract cancer (ABC) in jaundiced patients (pts).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 294-294
Author(s):  
Angela Lamarca ◽  
Sarah Benafif ◽  
John A. Bridgewater ◽  
Paul J. Ross ◽  
Juan W. Valle
Keyword(s):  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Cox Regression ◽  
Performance Status ◽  
Locally Advanced ◽  
Ampullary Cancer ◽  
Rank Test ◽  
Tract Cancer ◽  
Kaplan Meier

294 Background: The ABC-02 study established cisplatin/gemcitabine (CG) as a 1st-line regimen for pts with advanced/metastatic biliary tract cancer (ABC). Biliary tract obstruction (BTO) is common in ABC and pts with bilirubin (bili) ≥1.5xULN were excluded from ABC-02. We assessed retrospectively the safety/efficacy of CG in ABC pts with high bili despite optimal stenting. Methods: Eligible pts had biopsy-proven ABC; received 1st-line CG; baseline bili levels ≥1.5xULN and had follow-up, response and toxicity data available. Survival analysis (Kaplan-Meier), long-rank test, Cox regression and multiple linear regression analyses were performed. Results: Thirty-three pts (of 545 pts screened) met inclusion criteria: median age 58.8 years (range 23-79); male 58%; cholangiocarcinoma 76%; gallbladder 18% or ampullary cancer 6%; locally advanced 42%; metastatic 58% (79% in liver); 68% had a biliary stent; and 97% of pts had good baseline performance status (PS) 0/1/2: 33%/64%/3%. Median baseline bili was 55umol/l (range 32-286); due to BTO in 76% or liver metastases (LM) in 24%. A median of 6 (range 1-8) cycles were given, 70% of pts started full dose CG; 40% completed 8 planned cycles; 40% needed a dose reduction. Early discontinuation (61% of all pts) was due to toxicity (25%), clinical (60%) or radiological progression (15%). Bili normalised in 64% of pts after CG; no unexpected side effects occurred. Most pts achieved stable disease (61%); with one partial response (3%); the median PFS was 6.9 mo (95%-CI: 4.4-9.0) and median OS 9.5 mo (95%-CI: 5.7-12.8). BTO pts had a trend for longer PFS than LM (7.0 vs. 2.6 mo; p=0.1633). Normalisation of bili and completion of CG were associated with longer OS (11.4 vs. 2.9 mo, HR 0.49; p=0.08 and 15.2 vs. 5.4 mo, HR 0.12 p<0.001, respectively). Completion of CG was an independent prognostic factor for OS (multivariate analysis, p=0.001); no difference in OS was shown between the percentiles of baseline bili (p=0.57). Conclusions: For fit ABC patients with high bili, CG can be employed safely with encouraging results. Cause of jaundice (BTO, rather than bilirubin level), completion of chemotherapy and normalisation of bili are associated with improved OS.

scholarly journals CA19-9 or CEA Decline after the First Cycle of Treatment Predicts Survival in Advanced Biliary Tract Cancer Patients Treated with S-1 and Cisplatin Chemotherapy

2017 ◽  
Vol 49 (3) ◽  
pp. 807-815 ◽  
Author(s):  
Dae-Won Lee ◽  
Seock-Ah Im ◽  
Yu Jung Kim ◽  
Yaewon Yang ◽  
Jiyoung Rhee ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Tract Cancer

A phase II trial of oral S-1 combined with gemcitabine in patients with unresectable biliary tract cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15527-e15527 ◽  
Author(s):  
K. Nakamura ◽  
T. Yamaguchi ◽  
K. Sudo ◽  
T. Hara ◽  
T. Denda ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Phase Ii ◽  
Biliary Tract Cancer ◽  
Bile Ducts ◽  
Phase Ii Trial ◽  
Performance Status ◽  
Median Number ◽  
High Response Rate ◽  
Eligibility Criteria ◽  
Tract Cancer

e15527 Background: Optimal chemotherapy for unresectable biliary tract cancer is yet to be defined. We have conducted the phase II trial of Gemcitabine (GEM) with S-1, oral fluorouracil prodrug tegafur combined with two modulators, 5-chloro-2, 4-dihydropridine and potassium oxonate to evaluate the activity and toxicity of such combination in patients with unresectable biliary tract cancer. Methods: Eligibility criteria were pathologically-proven biliary tract cancer, appropriate performance status 0 to 2, age 20 to 79 years, adequate hematological, renal and liver functions, no prior chemotherapy, and written informed consent. S-1 was given orally (30mg/m2) bid for 14 consecutive days and GEM (1000mg/m2) was given on day 8 and 15. Cycle was repeated every 21 days. Results: 30 patients with unresectable biliary tract cancer (Gall-bladder: intrahepatic bile ducts: extrahepatic bile ducts=7:16:7) were enrolled from March 2007 to December 2008. Patients characteristics were: median age; 67 (46–79), male/female; 20/10, PS 0/1/2; 16/13/1. Median number of cycles was 8 (range 1 to 14). Out of total 26 evaluable patients, objective responses were observed in 9 patients (30%); 16 patients achieved stable disease and 1 patients showed disease progression. Median survival was 390 days (95% c.i.: 290 - 490 days). The grade 3–4 toxicities observed were leucopenia (20%), neutropenia (40%), anemia (17%), thrombocytopenia (37%), anorexia (7%), fever (10%), rash (7%) and interstitial pneumonia (7%). Conclusions: The combination chemotherapy with GEM and S-1 was well tolerated and high response rate has been observed. This result is very promising but survival benefit against GEM monotherapy should be demonstrated in future phase 3 studies. No significant financial relationships to disclose.

Preliminary results of a multicenter phase II study of imatinib and fluorourcail/leucovorin (FU/LV) in patients with unresectable or metastatic gallbladder or biliary tract cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15502-e15502
Author(s):  
K. Sprenger ◽  
M. Moehler ◽  
E. Kettner ◽  
S. El-Batran ◽  
S. Hegewisch-Becker ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Phase Ii ◽  
Biliary Tract Cancer ◽  
Phase Ii Study ◽  
Performance Status ◽  
Response Assessment ◽  
Eligibility Criteria ◽  
Tract Cancer ◽  
Multicenter Phase ◽  
Large Patient

e15502 Background: There are no standard chemotherapeutic regimens for incurable biliary adenocarcinomas. Monotherapies with gemcitabine or FU/LV achieve occasional responses and a median overall survival of about 6 months. By blocking PDGFR a decreased intrastromal pressure may increase therapy effects of chemotherapy. The combination of imatinib and FU/LV has been shown to be safe and feasible in a previous Phase I trial. This multicenter phase II trial was designed to investigate the disease control rate (DCR) of FU/LV and imatinib. Methods: Eligibility criteria included unresectable or metastatic measurable biliary tract cancer (BTC)/gallbladder cancer (GBC), performance status < 2, adequate organ function and no clinically significant cardiovascular disease. Enrolment of 44 chemonaive patients (pts.) was planned. Pts. received LV 200 mg/m2 followed by FU 2000 mg/m2 as a 24-hour infusion on days 1 and 2 combined with 600mg imatinib on days -4 to 4 (8 days). Cycles were repeated every 2 weeks up to 12 cycles. Radiological assessments were performed every 4 cycles. Results: 41 pts (19 GBC; 22 BTC) were enrolled in this phase II study since May 2007. Median age was 62 years (range 33–77), male/female=24/17, ECOG 0/1/2=13/23/5. 35 pts. showed metastatic disease at baseline. Treatment was well tolerated. Treatment related grade 3/4 toxicities included (number of pts): diarrhea (2), edema (1), neutropenia (2), nausea (2), transient SGPT elevation (4). The DCR of 26 pts. available for response assessment at time of analysis 1 was 58% (15 pts) (1 CR, 1 PR,13 SD of at least 4 cycles). 11 pts. showed progressive disease (PD) per RECIST criteria. 3 pts. had disease stabilization after 12 cycles and continue on treatment. We present these preliminary data as they represent a large patient number in this entity and response data are promising. Conclusions: This preliminary analysis suggests that the combination of FU/LV and imatinib can be safely administrated in pts. with GBC/BTC. Early evidence of antitumor activity was seen with some pts. achieving long term stabilization of the disease. [Table: see text]

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