The impact of peritoneal lavage cytology in biliary tract cancer ( KHBO1701 ): Kansai Hepato‐Biliary Oncology Group

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.

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Randomized Phase II Trial of Gemcitabine Plus S-1 Combination Therapy Versus S-1 in Advanced Biliary Tract Cancer: Results of the Japan Clinical Oncology Group Study (JCOG0805)

Annals of Oncology ◽

10.1093/annonc/mds548 ◽

2012 ◽

Vol 23 ◽

pp. xi15

Author(s):

M. Ikeda ◽

T. Okusaka ◽

J. Mizusawa ◽

A. Takashima ◽

C. Morizane ◽

...

Keyword(s):

Combination Therapy ◽

Clinical Oncology ◽

Biliary Tract ◽

Biliary Tract Cancer ◽

Phase Ii Trial ◽

Oncology Group ◽

Japan Clinical Oncology Group ◽

Oncology Group Study ◽

Tract Cancer ◽

Randomized Phase Ii

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AB061. P-32. Multicenter, randomized phase II trial of S-1, leucovorin, oxaliplatin and gemcitabine (SLOG) in chemo-naïve advanced biliary tract cancer: a Taiwan Cooperative Oncology Group study

HepatoBiliary Surgery and Nutrition ◽

10.21037/hbsn.2019.ab061 ◽

2019 ◽

Vol 8 (S1) ◽

pp. AB061-AB061

Author(s):

Jen-Shi Chen ◽

Li-Yuan Bai ◽

Ming-Huang Chen ◽

Nai-Jung Chiang ◽

Chiun Hsu ◽

...

Keyword(s):

Biliary Tract ◽

Phase Ii ◽

Biliary Tract Cancer ◽

Phase Ii Trial ◽

Oncology Group ◽

Oncology Group Study ◽

Tract Cancer ◽

Randomized Phase Ii

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

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.4_suppl.368 ◽

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.

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

Journal of Clinical Oncology ◽

10.1200/jco.2011.40.5381 ◽

2012 ◽

Vol 30 (16) ◽

pp. 1934-1940 ◽

Cited By ~ 351

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.

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