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Gemcitabine Plus Cisplatin for Advanced Biliary Tract Cancer: A Systematic Review.

Park JO, Oh DY, Hsu C, Chen JS, Chen LT, Orlando M, Kim JS, Lim HY - Cancer Res Treat (2015)

Bottom Line: Evidence suggests that combined gemcitabine-cisplatin chemotherapy extends survival in patients with advanced biliary tract cancer (BTC).Heterogeneity in study designs and data collected prevented formal meta-analysis, however exploratory assessments suggested that efficacy did not vary with primary tumor site (gallbladder vs. others), disease stage (metastatic vs. locally advanced), or geographic origin (Asia vs. other).Despite individual variation in study designs, the evidence presented suggests that gemcitabine-cisplatin is effective in patients from a diverse range of countries and with heterogeneous disease characteristics.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

ABSTRACT
Evidence suggests that combined gemcitabine-cisplatin chemotherapy extends survival in patients with advanced biliary tract cancer (BTC). We conducted a systematic review in order to collate this evidence and assess whether gemcitabine-cisplatin efficacy is influenced by primary tumor site, disease stage, or geographic region, and whether associated toxicities are related to regimen. MEDLINE (1946-search date), EMBASE (1966-search date), ClinicalTrials. gov (2008-search date), and abstracts from major oncology conferences (2009- search date) were searched (5 Dec 2013) using terms for BTC, gemcitabine, and cisplatin. All study types reporting efficacy (survival, response rates) or safety (toxicities) outcomes of gemcitabine-cisplatin in BTC were eligible for inclusion; efficacy data were extracted from prospective studies only. Evidence retrieved from one meta-analysis (abstract), four randomized controlled trials, 12 nonrandomized prospective studies, and three retrospective studies supported the efficacy and safety of gemcitabine-cisplatin for BTC. Median overall survival ranged from 4.6 to 11.7 months, and response rate ranged from 17.1% to 36.6%. Toxicities were generally acceptable and manageable. Heterogeneity in study designs and data collected prevented formal meta-analysis, however exploratory assessments suggested that efficacy did not vary with primary tumor site (gallbladder vs. others), disease stage (metastatic vs. locally advanced), or geographic origin (Asia vs. other). Incidence of grade 3/4 toxicities was not related to gemcitabine dose or cisplatin frequency. Despite individual variation in study designs, the evidence presented suggests that gemcitabine-cisplatin is effective in patients from a diverse range of countries and with heterogeneous disease characteristics. No substantial differences in toxicity were observed among the different dosing schedules of gemcitabine and cisplatin.

No MeSH data available.


Related in: MedlinePlus

Forest plots of median overall survival and response rate plotted against the percentage of participants with gallbladder cancer (A) and metastatic disease (B) reported in individual publications of prospective studies. Error bars represent 95% confidence intervals (CI; where reported).
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f3-crt-2014-308: Forest plots of median overall survival and response rate plotted against the percentage of participants with gallbladder cancer (A) and metastatic disease (B) reported in individual publications of prospective studies. Error bars represent 95% confidence intervals (CI; where reported).

Mentions: The percentage of participants with gallbladder cancer varied from 0% [29] to 100% [23], although in most studies, the percentage was between 30% and 50% (Table 1, Fig. 3A). Subgroup analyses of efficacy based on primary tumor site were performed in three studies; however, no statistical comparison between tumor site groups was performed. In the ABC-02 trial [17], there was no difference in treatment effect relative to gemcitabine monotherapy on OS between participants with gallbladder, intrahepatic, extrahepatic, hilar, or ampulla tumors. However, the response rate of participants with gallbladder cancer (37.7%; 23 of 61) was numerically higher than for those with other primary tumor sites (19.0%; 19 of 100). In the BT-22 trial [32], the median OS was numerically lower (9.1 months) in participants with gallbladder cancer compared to those with other primary tumor sites (13.0 months). In a non-randomized trial [30], participants with gallbladder cancer showed a numerically higher response rate (28.6%; 4 of 14) than those with other primary tumor sites (9.5%; 2 of 21). Among all of the studies, there was no apparent relationship between the percentage of participants with gallbladder cancer and OS (Fig. 3A), response rate (Fig. 3A), or disease control rate.


Gemcitabine Plus Cisplatin for Advanced Biliary Tract Cancer: A Systematic Review.

Park JO, Oh DY, Hsu C, Chen JS, Chen LT, Orlando M, Kim JS, Lim HY - Cancer Res Treat (2015)

Forest plots of median overall survival and response rate plotted against the percentage of participants with gallbladder cancer (A) and metastatic disease (B) reported in individual publications of prospective studies. Error bars represent 95% confidence intervals (CI; where reported).
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4509359&req=5

f3-crt-2014-308: Forest plots of median overall survival and response rate plotted against the percentage of participants with gallbladder cancer (A) and metastatic disease (B) reported in individual publications of prospective studies. Error bars represent 95% confidence intervals (CI; where reported).
Mentions: The percentage of participants with gallbladder cancer varied from 0% [29] to 100% [23], although in most studies, the percentage was between 30% and 50% (Table 1, Fig. 3A). Subgroup analyses of efficacy based on primary tumor site were performed in three studies; however, no statistical comparison between tumor site groups was performed. In the ABC-02 trial [17], there was no difference in treatment effect relative to gemcitabine monotherapy on OS between participants with gallbladder, intrahepatic, extrahepatic, hilar, or ampulla tumors. However, the response rate of participants with gallbladder cancer (37.7%; 23 of 61) was numerically higher than for those with other primary tumor sites (19.0%; 19 of 100). In the BT-22 trial [32], the median OS was numerically lower (9.1 months) in participants with gallbladder cancer compared to those with other primary tumor sites (13.0 months). In a non-randomized trial [30], participants with gallbladder cancer showed a numerically higher response rate (28.6%; 4 of 14) than those with other primary tumor sites (9.5%; 2 of 21). Among all of the studies, there was no apparent relationship between the percentage of participants with gallbladder cancer and OS (Fig. 3A), response rate (Fig. 3A), or disease control rate.

Bottom Line: Evidence suggests that combined gemcitabine-cisplatin chemotherapy extends survival in patients with advanced biliary tract cancer (BTC).Heterogeneity in study designs and data collected prevented formal meta-analysis, however exploratory assessments suggested that efficacy did not vary with primary tumor site (gallbladder vs. others), disease stage (metastatic vs. locally advanced), or geographic origin (Asia vs. other).Despite individual variation in study designs, the evidence presented suggests that gemcitabine-cisplatin is effective in patients from a diverse range of countries and with heterogeneous disease characteristics.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

ABSTRACT
Evidence suggests that combined gemcitabine-cisplatin chemotherapy extends survival in patients with advanced biliary tract cancer (BTC). We conducted a systematic review in order to collate this evidence and assess whether gemcitabine-cisplatin efficacy is influenced by primary tumor site, disease stage, or geographic region, and whether associated toxicities are related to regimen. MEDLINE (1946-search date), EMBASE (1966-search date), ClinicalTrials. gov (2008-search date), and abstracts from major oncology conferences (2009- search date) were searched (5 Dec 2013) using terms for BTC, gemcitabine, and cisplatin. All study types reporting efficacy (survival, response rates) or safety (toxicities) outcomes of gemcitabine-cisplatin in BTC were eligible for inclusion; efficacy data were extracted from prospective studies only. Evidence retrieved from one meta-analysis (abstract), four randomized controlled trials, 12 nonrandomized prospective studies, and three retrospective studies supported the efficacy and safety of gemcitabine-cisplatin for BTC. Median overall survival ranged from 4.6 to 11.7 months, and response rate ranged from 17.1% to 36.6%. Toxicities were generally acceptable and manageable. Heterogeneity in study designs and data collected prevented formal meta-analysis, however exploratory assessments suggested that efficacy did not vary with primary tumor site (gallbladder vs. others), disease stage (metastatic vs. locally advanced), or geographic origin (Asia vs. other). Incidence of grade 3/4 toxicities was not related to gemcitabine dose or cisplatin frequency. Despite individual variation in study designs, the evidence presented suggests that gemcitabine-cisplatin is effective in patients from a diverse range of countries and with heterogeneous disease characteristics. No substantial differences in toxicity were observed among the different dosing schedules of gemcitabine and cisplatin.

No MeSH data available.


Related in: MedlinePlus