Abstract
BackgroundGallbladder 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.MethodsPatients 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.ResultsA 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.ConclusionsGEMCIS 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.
Highlights
Gallbladder cancer (GBC) is likely to be diagnosed at progressive stages and shows a very poor prognosis
Gemcitabine plus cisplatin (GEMCIS) is widely used as first-line chemotherapy for unresectable GBC based on a recent clinical trial showing favourable outcomes of the combination chemotherapy in patients with biliary tract cancer (BTC) [4]
ECOG Eastern Cooperative Oncology Group, BMI body mass index, WBC white blood cell, CRP C-reactive protein, eGFR estimated glomerluar filtration rate, AST aspartate aminotransferase, ALT alanine aminotransferase, ALP alkaline phosphatase, CEA carcinoembryonic antigen, CA 19–9 carbohydrate antigen 19–9, NLR neutrophil-to-lymphocyte ratio, PLR platelet-to-lymphocyte ratio was 10.0 months
Summary
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. Gemcitabine plus cisplatin (GEMCIS) is widely used as first-line chemotherapy for unresectable GBC based on a recent clinical trial showing favourable outcomes of the combination chemotherapy in patients with biliary tract cancer (BTC) [4]. (OS) and progression-free survival (PFS) were 11.7 and 8.0 months, respectively, in patients with BTC treated with GEMCIS [4]. In a more recent phase II clinical study that included only patients with unresectable GBC, median OS and PFS were 6.2 and 3.1 months, respectively [5]. Even though prognosis and response to chemotherapy in patients with GBC are different from those in patients with other subtypes of BTC, there is a lack of studies evaluating the efficacy of GEMCIS only in patients with GBC
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