Skip to main content
Erschienen in: Cancer Chemotherapy and Pharmacology 1/2017

08.06.2017 | Original Article

Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients

verfasst von: Bum Jun Kim, Jaewon Hyung, Changhoon Yoo, Kyu-pyo Kim, Seong-Joon Park, Sang Soo Lee, Do Hyun Park, Tae Jun Song, Dong Wan Seo, Sung Koo Lee, Myung-Hwan Kim, Jin-hong Park, Hyungwoo Cho, Baek-Yeol Ryoo, Heung-Moon Chang

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 1/2017

Einloggen, um Zugang zu erhalten

Abstract

Purpose

Biliary tract cancer (BTC) is a heterogeneous group of diseases comprising intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer. Although gemcitabine plus cisplatin (GEMCIS) was established as the standard first-line chemotherapy based on the ABC-02 trial, more data are needed to define the clinical course of BTC and its prognostic factors with the standard GEMCIS treatment.

Methods

Between April 2010 and June 2016, 740 patients with histologically documented cholangiocarcinoma and gallbladder cancer were treated with first-line GEMCIS in Asan Medical Center, Seoul, Korea.

Results

In 389 patients with measurable disease (53%), the objective response rate was 13% (n = 50) and there was no significant difference between primary tumor sites (p = 0.45). With a median follow-up duration of 27.3 months (95% CI 24.2–30.5), the median PFS and OS were 5.2 months (95% CI 4.7–5.6) and 10.4 months (95% CI 9.6–11.2), respectively. In multivariate analysis, male gender (female versus male, hazard ratio [HR] 0.83), baseline CA 19-9 level (elevated versus normal, HR 1.31), initially metastatic disease (versus locally advanced disease, HR 1.92), poor performance status (2 versus 0–1, HR 1.45), and measurable disease by RECIST criteria (versus non-measurable, HR 1.40) were significantly associated with a poorer OS (all p < 0.05).

Conclusions

Our retrospective analysis of a large number of patients in a real-world setting found comparable efficacy outcomes to the ABC-02 trial. The prognostic factors identified here may help to predict clinical outcomes and design future clinical trials for advanced BTC.
Literatur
1.
2.
Zurück zum Zitat Edge SB, Compton CC (2010) The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNM. Ann Surg Oncol 17:1471–1474CrossRefPubMed Edge SB, Compton CC (2010) The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNM. Ann Surg Oncol 17:1471–1474CrossRefPubMed
3.
Zurück zum Zitat Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J (2010) ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med 362:1273–1281CrossRefPubMed Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J (2010) ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med 362:1273–1281CrossRefPubMed
4.
Zurück zum Zitat Okusaka T, Nakachi K, Fukutomi A, Mizuno N, Ohkawa S, Funakoshi A, Nagino M, Kondo S, Nagaoka S, Funai J, Koshiji M, Nambu Y, Furuse J, Miyazaki M, Nimura Y (2010) Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan. Br J Cancer 103:469–474CrossRefPubMedPubMedCentral Okusaka T, Nakachi K, Fukutomi A, Mizuno N, Ohkawa S, Funakoshi A, Nagino M, Kondo S, Nagaoka S, Funai J, Koshiji M, Nambu Y, Furuse J, Miyazaki M, Nimura Y (2010) Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan. Br J Cancer 103:469–474CrossRefPubMedPubMedCentral
5.
Zurück zum Zitat Valle JW, Furuse J, Jitlal M, Beare S, Mizuno N, Wasan H, Bridgewater J, Okusaka T (2014) Cisplatin and gemcitabine for advanced biliary tract cancer: a meta-analysis of two randomised trials. Ann Oncol 25:391–398CrossRefPubMed Valle JW, Furuse J, Jitlal M, Beare S, Mizuno N, Wasan H, Bridgewater J, Okusaka T (2014) Cisplatin and gemcitabine for advanced biliary tract cancer: a meta-analysis of two randomised trials. Ann Oncol 25:391–398CrossRefPubMed
6.
Zurück zum Zitat Park JO, Oh DY, Hsu C, Chen JS, Chen LT, Orlando M, Kim JS, Lim HY (2015) Gemcitabine plus cisplatin for advanced biliary tract cancer: a systematic review. Cancer Res Treat 47:343–361CrossRefPubMedPubMedCentral Park JO, Oh DY, Hsu C, Chen JS, Chen LT, Orlando M, Kim JS, Lim HY (2015) Gemcitabine plus cisplatin for advanced biliary tract cancer: a systematic review. Cancer Res Treat 47:343–361CrossRefPubMedPubMedCentral
7.
Zurück zum Zitat Park I, Lee JL, Ryu MH, Kim TW, Sook Lee S, Hyun Park D, Soo Lee S, Wan Seo D, Koo Lee S, Kim MH (2009) Prognostic factors and predictive model in patients with advanced biliary tract adenocarcinoma receiving first-line palliative chemotherapy. Cancer 115:4148–4155CrossRefPubMed Park I, Lee JL, Ryu MH, Kim TW, Sook Lee S, Hyun Park D, Soo Lee S, Wan Seo D, Koo Lee S, Kim MH (2009) Prognostic factors and predictive model in patients with advanced biliary tract adenocarcinoma receiving first-line palliative chemotherapy. Cancer 115:4148–4155CrossRefPubMed
8.
Zurück zum Zitat Peixoto RD, Renouf D, Lim H (2014) A population based analysis of prognostic factors in advanced biliary tract cancer. J Gastrointest Oncol 5:428–432PubMedPubMedCentral Peixoto RD, Renouf D, Lim H (2014) A population based analysis of prognostic factors in advanced biliary tract cancer. J Gastrointest Oncol 5:428–432PubMedPubMedCentral
9.
Zurück zum Zitat Bridgewater J, Lopes A, Wasan H, Malka D, Jensen L, Okusaka T, Knox J, Wagner D, Cunningham D, Shannon J, Goldstein D, Moehler M, Bekaii-Saab T, McNamara MG, Valle JW (2016) Prognostic factors for progression-free and overall survival in advanced biliary tract cancer. Ann Oncol 27:134–140CrossRefPubMed Bridgewater J, Lopes A, Wasan H, Malka D, Jensen L, Okusaka T, Knox J, Wagner D, Cunningham D, Shannon J, Goldstein D, Moehler M, Bekaii-Saab T, McNamara MG, Valle JW (2016) Prognostic factors for progression-free and overall survival in advanced biliary tract cancer. Ann Oncol 27:134–140CrossRefPubMed
10.
Zurück zum Zitat Nakamura H, Arai Y, Totoki Y, Shirota T, Elzawahry A, Kato M, Hama N, Hosoda F, Urushidate T, Ohashi S, Hiraoka N, Ojima H, Shimada K, Okusaka T, Kosuge T, Miyagawa S, Shibata T (2015) Genomic spectra of biliary tract cancer. Nat Genet 47:1003–1010CrossRefPubMed Nakamura H, Arai Y, Totoki Y, Shirota T, Elzawahry A, Kato M, Hama N, Hosoda F, Urushidate T, Ohashi S, Hiraoka N, Ojima H, Shimada K, Okusaka T, Kosuge T, Miyagawa S, Shibata T (2015) Genomic spectra of biliary tract cancer. Nat Genet 47:1003–1010CrossRefPubMed
11.
Zurück zum Zitat Javle M, Bekaii-Saab T, Jain A, Wang Y, Kelley RK, Wang K, Kang HC, Catenacci D, Ali S, Krishnan S, Ahn D, Bocobo AG, Zuo M, Kaseb A, Miller V, Stephens PJ, Meric-Bernstam F, Shroff R, Ross J (2016) Biliary cancer: utility of next-generation sequencing for clinical management. Cancer 122:3838–3847CrossRefPubMed Javle M, Bekaii-Saab T, Jain A, Wang Y, Kelley RK, Wang K, Kang HC, Catenacci D, Ali S, Krishnan S, Ahn D, Bocobo AG, Zuo M, Kaseb A, Miller V, Stephens PJ, Meric-Bernstam F, Shroff R, Ross J (2016) Biliary cancer: utility of next-generation sequencing for clinical management. Cancer 122:3838–3847CrossRefPubMed
12.
Zurück zum Zitat Bridgewater J, Palmer D, Cunningham D, Iveson T, Gillmore R, Waters J, Harrison M, Wasan H, Corrie P, Valle J (2013) Outcome of second-line chemotherapy for biliary tract cancer. Eur J Cancer 49:1511CrossRefPubMed Bridgewater J, Palmer D, Cunningham D, Iveson T, Gillmore R, Waters J, Harrison M, Wasan H, Corrie P, Valle J (2013) Outcome of second-line chemotherapy for biliary tract cancer. Eur J Cancer 49:1511CrossRefPubMed
13.
Zurück zum Zitat Lamarca A, Hubner RA, Ryder WD, Valle JW (2014) Second-line chemotherapy in advanced biliary cancer: a systematic review. Ann Oncol 25:2328–2338CrossRefPubMed Lamarca A, Hubner RA, Ryder WD, Valle JW (2014) Second-line chemotherapy in advanced biliary cancer: a systematic review. Ann Oncol 25:2328–2338CrossRefPubMed
14.
Zurück zum Zitat Brieau B, Dahan L, De Rycke Y, Boussaha T, Vasseur P, Tougeron D, Lecomte T, Coriat R, Bachet J-B, Claudez P, Zaanan A, Soibinet P, Desrame J, Thirot-Bidault A, Trouilloud I, Mary F, Marthey L, Taieb J, Cacheux W, Lièvre A (2015) Second-line chemotherapy for advanced biliary tract cancer after failure of the gemcitabine-platinum combination: a large multicenter study by the Association des Gastro-Entérologues Oncologues. Cancer 121:3290–3297CrossRefPubMed Brieau B, Dahan L, De Rycke Y, Boussaha T, Vasseur P, Tougeron D, Lecomte T, Coriat R, Bachet J-B, Claudez P, Zaanan A, Soibinet P, Desrame J, Thirot-Bidault A, Trouilloud I, Mary F, Marthey L, Taieb J, Cacheux W, Lièvre A (2015) Second-line chemotherapy for advanced biliary tract cancer after failure of the gemcitabine-platinum combination: a large multicenter study by the Association des Gastro-Entérologues Oncologues. Cancer 121:3290–3297CrossRefPubMed
15.
Zurück zum Zitat Walter T, Horgan AM, McNamara M, McKeever L, Min T, Hedley D, Serra S, Krzyzanowska MK, Chen E, Mackay H, Feld R, Moore M, Knox JJ (2013) Feasibility and benefits of second-line chemotherapy in advanced biliary tract cancer: a large retrospective study. Eur J Cancer 49:329–335CrossRefPubMed Walter T, Horgan AM, McNamara M, McKeever L, Min T, Hedley D, Serra S, Krzyzanowska MK, Chen E, Mackay H, Feld R, Moore M, Knox JJ (2013) Feasibility and benefits of second-line chemotherapy in advanced biliary tract cancer: a large retrospective study. Eur J Cancer 49:329–335CrossRefPubMed
16.
Zurück zum Zitat Kim BJ, Yoo C, Kim KP, Hyung J, Park SJ, Ryoo BY, Chang HM (2017) Efficacy of fluoropyrimidine-based chemotherapy in patients with advanced biliary tract cancer after failure of gemcitabine plus cisplatin: retrospective analysis of 321 patients. Br J Cancer 116:561–567CrossRefPubMed Kim BJ, Yoo C, Kim KP, Hyung J, Park SJ, Ryoo BY, Chang HM (2017) Efficacy of fluoropyrimidine-based chemotherapy in patients with advanced biliary tract cancer after failure of gemcitabine plus cisplatin: retrospective analysis of 321 patients. Br J Cancer 116:561–567CrossRefPubMed
17.
Zurück zum Zitat Valle JW, Borbath I, Khan SA, Huguet F, Gruenberger T, Arnold D (2016) ESMO Guidelines Committee. Biliary cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 27:v28–v37CrossRefPubMed Valle JW, Borbath I, Khan SA, Huguet F, Gruenberger T, Arnold D (2016) ESMO Guidelines Committee. Biliary cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 27:v28–v37CrossRefPubMed
Metadaten
Titel
Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients
verfasst von
Bum Jun Kim
Jaewon Hyung
Changhoon Yoo
Kyu-pyo Kim
Seong-Joon Park
Sang Soo Lee
Do Hyun Park
Tae Jun Song
Dong Wan Seo
Sung Koo Lee
Myung-Hwan Kim
Jin-hong Park
Hyungwoo Cho
Baek-Yeol Ryoo
Heung-Moon Chang
Publikationsdatum
08.06.2017
Verlag
Springer Berlin Heidelberg
Erschienen in
Cancer Chemotherapy and Pharmacology / Ausgabe 1/2017
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-017-3353-2

Weitere Artikel der Ausgabe 1/2017

Cancer Chemotherapy and Pharmacology 1/2017 Zur Ausgabe

Update Onkologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.