BMC Cancer. 2019;19(1):10.

Therapeutic outcomes and prognostic factors in unresectable gallbladder cancer treated with gemcitabine plus cisplatin.

, , , , , , ,

제1저자 유민수 · 교신저자 류지곤

PMID 30611225 PMC6321682 DOI 10.1186/s12885-018-5211-y IF 4.1 소화기내과

소속 (2)

Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea.
Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea. jkryu@snu.ac.kr.

Abstract

BACKGROUND Gallbladder cancer (GBC) is likely to be diagnosed at progressive stages and shows a very poor prognosis. Combination therapy with gemcitabine and cisplatin (GEMCIS) has been widely used as first-line palliative chemotherapy for advanced GBC. This study was designed to investigate the efficacy of GEMCIS and identify prognostic factors in patients with unresectable GBC.

METHODS Patients with GBC who were treated with GEMCIS from January 2008 to June 2017 in a single tertiary hospital were included. All cases of GBC were diagnosed by pathologic findings and extent of the tumour was assessed by imaging tests. Combination chemotherapy consisted of cisplatin 25 mg/m² and gemcitabine 1000 mg/m² intravenously on days 1 and 8 every 3 weeks. To determine factors affecting prognosis, Kaplan-Meier survival analysis, log-rank test and the Cox proportional hazard regression linear model were used. All variables with P < 0.1 in univariable analysis were included in the multivariable model.

RESULTS A total of 173 patients received a median of 5.3 ± 4.4 cycles of chemotherapy over 3.8 ± 3.9 months. Most of the patients (94.8%) were stage IVB at the time of diagnosis and the most common site of metastasis was the liver (42.8%). Disease control rate was 59.5%: 2 (1.2%) patients with complete response, 26 (15.0%) patients with partial response and 75 (43.4%) patients with stable disease. Overall survival (OS) and progression-free survival were 8.1 (95% confidence interval [CI], 7.1-10.2) and 5.6 (95% CI 4.5-6.8) months, respectively. Multivariable regression model indicated that metastasis to liver (hazard ratio [HR] = 1.63, 95% CI 1.11-2.40; P = 0.013), neutrophil-to-lymphocyte ratio (NLR) ≥3 (HR 1.65, 95% CI 1.09-2.49; P = 0.017), CEA ≥ 5 ng/mL (HR 1.50, 95% CI 1.02-2.19; P = 0.038), and CA19-9 ≥ 500 U/mL (HR 1.59, 95% CI 1.01-2.50; P = 0.043) were significantly associated with OS.

CONCLUSIONS GEMCIS demonstrated a high disease control rate in patients with unresectable GBC. Factors independently related to OS were metastasis to liver, NLR ≥ 3, CEA ≥ 5 ng/mL and CA19-9 ≥ 500 U/mL.

Keywords

CisplatinGallbladder neoplasmsGemcitabinePrognosisTreatment outcome

Figures

**Fig. 1** Flow chart of patient enrolment between January 2008 and June 2017. GBC, gallbladder cancer; GEMCIS, gemcitabine plus cisplatin

**Fig. 2** Overall survival (OS) and progression-free survival (PFS) of patients treated with gemcitabine plus cisplatin

**Fig. 3** Kaplan–Meier curves of overall survival according to liver metastasis

**Fig. 4** Kaplan–Meier curves of overall survival according to groups based on the results of multivariable analysis and log-rank test. a Classified by NLR ≥3. b Classified by CA19–9 ≥ 500 U/mL and CEA ≥ 5 ng/mL. NLR, neutrophil-to-lymphocyte ratio; CA 19–9, carbohydrate antigen 19–9; CEA, carcinoembryonic antigen

그림 출처: PubMed Central 공개 논문 (PMC6321682)

Conflict of interest statement

ETHICS APPROVAL AND CONSENT TO PARTICIPATE: This study was approved by Institutional Review Board of the Seoul National University Hospital, Seoul, Korea (1703–004-834). Patients were not required to give informed consent to the study because the analysis used anonymous clinical data that were obtained after each patient agreed to treatment by written consent. CONSENT FOR PUBLICATION: Not applicable. COMPETING INTERESTS: The authors declare that they have no competing interests. PUBLISHER’S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

그 밖의 정보