Dataset Information

Gemcitabine and capecitabine for advanced biliary cancer.

ABSTRACT: BACKGROUND:Gemcitabine with capecitabine (gem-cap) is an established regimen for advanced biliary cancer (ABC) supported by our previously reported phase II trial. Here, we provide our updated experience. METHODS:Single institution, retrospective study from 2005 to 2015 of ABC treated with gem-cap. RESULTS:A total of 372 patients with ABC were identified, of whom 227 (61.0%) were treated with chemotherapy. 153 patients (67.4%) received gem-cap, of which 129 (56.8%) received it in the first line. Thirty two point six percent (42/129) were locally advanced, 67.4% (87/129) had metastatic disease, and 18.6% (24/129) received it as adjuvant therapy. Disease sites included 48.8% [63] intrahepatic cholangiocarcinoma (IHCC), 24.0% [31] extrahepatic cholangiocarcinoma (EHCC) and 27.1% [35] gallbladder carcinoma (GBC). Median follow-up was 49.7 months (mo). The median PFS and OS were 8.0 mo [95% confidence intervals (CI): 6.0-9.3] and 13.0 mo (95% CI: 10.7-17.4), respectively. Overall, 53.5% (69/129) experienced a grade 3/4 toxicity. The most common (35.7%) was a hematologic toxicity (neutropenia or thrombocytopenia) followed by infection (25.6%). CONCLUSIONS:Gem-cap provides similar survival outcomes to gemcitabine/cisplatin based on historical comparison to the ABC-2 trial (median PFS =8.0 mo and OS =11.7 mo). Gem-cap may offer the advantage of fewer adverse events compared to the levels reported in ABC-2 (grade 3/4 events 70.7%).

SUBMITTER: Gabriel E

PROVIDER: S-EPMC5582046 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Gemcitabine and capecitabine for advanced biliary cancer.

Gabriel Emmanuel E Gandhi Shipra S Attwood Kristopher K Kuvshinoff Boris B Hochwald Steven S Iyer Renuka R

Journal of gastrointestinal oncology 20170801 4

<h4>Background</h4>Gemcitabine with capecitabine (gem-cap) is an established regimen for advanced biliary cancer (ABC) supported by our previously reported phase II trial. Here, we provide our updated experience.<h4>Methods</h4>Single institution, retrospective study from 2005 to 2015 of ABC treated with gem-cap.<h4>Results</h4>A total of 372 patients with ABC were identified, of whom 227 (61.0%) were treated with chemotherapy. 153 patients (67.4%) received gem-cap, of which 129 (56.8%) received ...[more]

PMID: 28890824

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Project description:BackgroundPatients with advanced biliary tract cancer who progress on first-line therapy have limited treatment options. The TreeTopp study assessed varlitinib, a reversible small molecule pan-human epidermal growth factor receptor inhibitor, plus capecitabine in previously treated advanced biliary tract cancer.Patients and methodsThis global, double-blind, randomized, placebo-controlled phase II study enrolled patients with confirmed unresectable or metastatic biliary tract cancer and disease progression after one prior line of gemcitabine-containing chemotherapy. Patients received oral varlitinib 300 mg or placebo twice daily (b.i.d.) for 21 days, plus oral capecitabine 1000 mg/m2 b.i.d. on days 1-14, in 21-day treatment cycles. Co-primary endpoints were objective response rate and progression-free survival (PFS) according to RECIST v1.1 by Independent Central Review.ResultsIn total, 127 patients received varlitinib plus capecitabine (n = 64) or placebo plus capecitabine (n = 63). The objective response rate was 9.4% with varlitinib plus capecitabine versus 4.8% with capecitabine alone (odds ratio 2.28; P = 0.42). Median PFS was 2.83 versus 2.79 months [hazard ratio (HR), 0.90; 95% confidence interval (CI), 0.60-1.37; P = 0.63] and overall survival was 7.8 versus 7.5 months (HR, 1.11; 95% CI, 0.69-1.79; P = 0.66), respectively. In a subgroup analysis, the addition of varlitinib appeared to provide a PFS benefit in female patients (median, 4.1 versus 2.8 months; HR, 0.59; 95% CI, 0.28-1.23) and those with gallbladder cancer (median, 2.9 versus 1.6 months; HR, 0.55; 95% CI, 0.26-1.19). Grade ≥3 treatment-emergent adverse events were reported in 65.6% of patients receiving varlitinib plus capecitabine versus 58.7% of those receiving capecitabine alone.ConclusionsIn patients with advanced biliary tract cancer, second-line treatment with varlitinib plus capecitabine was well tolerated but did not improve efficacy versus capecitabine alone. A PFS benefit was suggested in female patients and those with gallbladder cancer.

Project description:BackgroundIn the UK, chemotherapy is the standard treatment for inoperable, locally advanced, non-metastatic pancreatic cancer. Chemoradiotherapy is also an acceptable treatment option, for which gemcitabine, fluorouracil, or capecitabine can be used as concurrent chemotherapy agents. We aimed to assess the activity, safety, and feasibility of both gemcitabine-based and capecitabine-based chemoradiotherapy after induction chemotherapy for patients with locally advanced pancreatic cancer.MethodsIn this open-label, randomised, two-arm, phase 2 trial, patients aged 18 years or older with histologically proven, locally advanced pancreatic cancer (with a tumour diameter of 7 cm or less) were recruited from 28 UK centres between Dec 24, 2009 and Oct 25, 2011. After 12 weeks of induction gemcitabine and capecitabine chemotherapy (three cycles of gemcitabine [1000 mg/m(2) on days 1, 8, 15 of a 28-day cycle] and capecitabine [830 mg/m(2) twice daily on days 1-21 of a 28-day cycle]), patients with stable or responding disease, tumour diameter of 6 cm or less, and WHO performance status 0-1 were randomly assigned to receive a further cycle of gemcitabine and capecitabine chemotherapy followed by either gemcitabine (300 mg/m(2) once per week) or capecitabine (830 mg/m(2) twice daily, Monday to Friday only), both in combination with radiation (50·4 Gy in 28 fractions). Randomisation (1:1) was done via a central computerised system and used stratified minimisation. The primary endpoint was 9-month progression-free survival, analysed by intention to treat including only those patients with valid CT assessments. This trial is registered with ISRCTN, number 96169987.Findings114 patients were registered and 74 were randomly allocated (38 to the gemcitabine group and 36 to the capecitabine group). After 9 months, 22 of 35 assessable patients (62·9%, 80% CI 50·6-73·9) in the capecitabine group and 18 of 35 assessable patients (51·4%, 39·4-63·4) in the gemcitabine group had not progressed. Median overall survival was 15·2 months (95% CI 13·9-19·2) in the capecitabine group and 13·4 months (95% CI 11·0-15·7) in the gemcitabine group (adjusted hazard ratio [HR] 0·39, 95% CI 0·18-0·81; p=0·012). 12-month overall survival was 79·2% (95% CI 61·1-89·5) in the capecitabine group and 64·2 (95% CI 46·4-77·5) in the gemcitabine group. Median progression-free survival was 12·0 months (95% CI 10·2-14·6) in the capecitabine group and 10·4 months (95% CI 8·9-12·5) in the gemcitabine group (adjusted HR 0·60, 95% CI 0·32-1·12; p=0·11). Eight patients in the capecitabine group had an objective response at 26 weeks, as did seven in the gemcitabine group. More patients in the gemcitabine group than in the capecitabine group had grade 3-4 haematological toxic effects (seven [18%] vs none, p=0·008) and non-haematological toxic effects (ten [26%] vs four [12%], p=0·12) during chemoradiation treatment; the most frequent events were leucopenia, neutropenia, and fatigue. Two patients in the capecitabine group progressed during the fourth cycle of induction chemotherapy. Of the 34 patients in the capecitabine group who received chemoradiotherapy, 25 (74%) received the full protocol dose of radiotherapy, compared with 26 (68%) of 38 patients in the gemcitabine group. Quality-of-life scores were not significantly different between the treatment groups.InterpretationOur results suggest that a capecitabine-based regimen might be preferable to a gemcitabine-based regimen in the context of consolidation chemoradiotherapy after a course of induction chemotherapy for locally advanced pancreatic cancer. However, these findings should be interpreted with caution because the difference in the primary endpoint was non-significant and the number of patients in the trial was small.FundingCancer Research UK.

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Gemcitabine and capecitabine for advanced biliary cancer.

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Gemcitabine and capecitabine for advanced biliary cancer.

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