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Home > Living Well > Health Library > Gallbladder Cancer Treatment (PDQ®): Treatment - Health Professional Information [NCI]
This information is produced and provided by the National Cancer Institute (NCI). The information in this topic may have changed since it was written. For the most current information, contact the National Cancer Institute via the Internet web site at http://cancer.gov or call 1-800-4-CANCER.
Incidence and Mortality
Estimated new cases and deaths from gallbladder (and other biliary) cancer in the United States in 2020:
Cancer that arises in the gallbladder is uncommon.
The most common symptoms caused by gallbladder cancer are jaundice, pain, and fever.
Histopathology and Diagnostics
In patients whose superficial cancer (T1 or confined to the mucosa) is discovered on pathological examination of tissue after gallbladder removal for other reasons, the disease is often cured without further therapy. In patients who present with symptoms, the tumor is rarely diagnosed preoperatively. In such cases, the tumor often cannot be removed completely by surgery and the patient cannot be cured, although palliative measures may be beneficial. For patients with T2 or greater disease, extended resection with partial hepatectomy and portal lymph node dissection may be an option.[3,4]
Other Prognostic Factors
Cholelithiasis is an associated finding in the majority of cases, but less than 1% of patients with cholelithiasis develop this cancer.
Some histologic types of gallbladder cancer have a better prognosis than others; papillary carcinomas have the best prognosis. The histologic types of gallbladder cancer include the following:
AJCC Stage Groupings and TNM Definitions
The American Joint Committee on Cancer (AJCC) has designated staging by the TNM classification to define gallbladder cancer.
Localized and Locally Advanced
Patients with stage I disease have cancer confined to the gallbladder wall that can be completely resected. Stage I tumors that are discovered incidentally and resected during routine cholecystectomy have 5-year survival rates of nearly 100%.
Patients with stage II or III disease have tumors with direct extension into the muscular layer, serosa, or adjacent organs, with or without involvement of locoregional lymph nodes.
Patients with disease that has spread beyond the locoregional lymph nodes or to distant organs have unresectable tumors, and standard therapy is directed at palliation. Patients with earlier-stage disease with poor performance status and/or significant comorbidities may also be deemed to be poor surgical candidates.
When gallbladder cancer is previously unsuspected and is incidentally discovered in the mucosa of the gallbladder at pathologic examination, it is curable in more than 80% of cases. Gallbladder cancer suspected before surgery because of symptoms, however, usually penetrates the muscularis and serosa and is curable in fewer than 5% of patients.
One study reported on patterns of lymph node spread from gallbladder cancer and outcomes of patients with metastases to lymph nodes in 111 consecutive surgical patients in a single institution from 1981 to 1995.[Level of evidence: 3iiiA] The standard surgical procedure was removal of the gallbladder, a wedge resection of the liver, resection of the extrahepatic bile duct, and resection of the regional (N1 and N2) lymph nodes. Kaplan-Meier estimates of the 5-year survival for node-negative tumors pathologically staged as T2 to T4 were 42.5% ± 6.5% and for similar node-positive tumors, 31% ± 6.2%.
Standard treatment options for localized and locally advanced gallbladder cancer
Standard treatment options for localized and locally advanced gallbladder cancer include the following:
The need for re-exploration for more extended resection in incidentally discovered T1b disease is controversial. A multicenter retrospective review identified lymph node metastases in 12% of patients who underwent re-resection after cholecystectomy, but there are no prospective data regarding relative outcome with a second surgery in these patients.[Level of evidence: 3iiiD]
Patients with T2 or T3 disease have higher rates of unsuspected invasive disease at the time of diagnosis. A multicenter retrospective review was performed on patients who underwent re-resection after carcinoma was discovered incidentally. Residual disease was present in 57% of patients with T2 disease (including 31% with lymph node involvement and 10% with liver involvement) and in 77% of patients with T3 disease (including 46% with lymph node metastases and 36% with liver involvement). On the basis of these observations, eligible patients may undergo re-exploration to resect liver tissue near the gallbladder bed, portal lymph nodes, and lymphatic tissue in the hepatoduodenal ligament. Retrospective analyses suggest delayed recurrences and potentially improved survival with extended re-resection.[6,7,8][Level of evidence: 3iiiD]
For patients with locoregional lymph node involvement (at the cystic duct, common bile duct, hepatic artery, and portal vein), long-term disease-free survival can occasionally be achieved with radical resection. In jaundiced patients (stage III or stage IV), there should be consideration of preoperative percutaneous transhepatic biliary drainage for relief of biliary obstruction.
Surgery with curative intent is not considered possible in patients with metastatic spread beyond the locoregional lymph nodes or to distant organs.
There are no phase III studies to support the use of adjuvant radiation therapy, even for patients with high-risk localized disease.
Treatment options under clinical evaluation for localized and locally advanced gallbladder cancer
Treatment options under clinical evaluation for localized and locally advanced gallbladder cancer include the following:
Current Clinical Trials
Use our advanced clinical trial search to find NCI-supported cancer clinical trials that are now enrolling patients. The search can be narrowed by location of the trial, type of treatment, name of the drug, and other criteria. General information about clinical trials is also available.
Unresectable, metastatic, and recurrent gallbladder cancer are not curable. Significant symptomatic benefit can often be achieved with relief of biliary obstruction. A few patients have very slow-growing tumors and may live several years. Patients with unresectable, metastatic, or recurrent gallbladder cancer should be considered for inclusion in clinical trials whenever possible. Information about ongoing clinical trials is available from the NCI website.
Treatment options for unresectable, metastatic, or recurrent gallbladder cancer
Treatment options for unresectable, metastatic, or recurrent gallbladder cancer include the following:
Palliative radiation therapy after biliary drainage may be beneficial, and patients may be candidates for inclusion in clinical trials that explore ways to improve the effects of radiation therapy with various radiation sensitizers such as hyperthermia, radiosensitizer drugs, or cytotoxic chemotherapeutic agents.
In a phase III study, 410 patients with unresectable, metastatic, or recurrent biliary tract cancer were randomly assigned to receive of up to 6 months of gemcitabine versus gemcitabine and cisplatin.
A three-arm randomized phase III study of patients with unresectable gallbladder cancer compared best supportive care (n = 27), fluorouracil plus folinic acid (FUFA) weekly for 30 weeks (n = 28), and modified gemcitabine plus oxaliplatin (mGEMOX) for up to six 21-day cycles.[Level of evidence: 1iiA]
A phase III noninferiority study (NCT01470443) enrolled 114 patients with metastatic biliary tract cancers, including 30 (26%) with primary gallbladder cancer. Patients were randomly assigned to receive capecitabine plus oxaliplatin (XELOX) or gemcitabine plus oxaliplatin (GEMOX).[Level of evidence: 1iiD]
Pending further clinical trials, cisplatin plus gemcitabine is considered the reference standard for patients with unresectable, metastatic, or recurrent gallbladder cancer. Potential alternatives include gemcitabine plus capecitabine, GEMOX, and XELOX. Clinical trials should be considered for all patients.
All patients with unresectable, metastatic, or recurrent disease should have molecular testing for deficient mismatch repair (dMMR) or microsatellite instability (MSI-H). Extrapolating from a subgroup of patients with gastrointestinal and hepatopancreatobiliary tumors in the I-PREDICT (NCT02534675) and KEYNOTE-158 (NCT02628067) studies, patients with either dMMR or MSI-H tumors can be considered for treatment with pembrolizumab.[5,6][Level of evidence: 3iiiDiv]
Additional testing for isocitrate dehydrogenase 1 (IDH1) mutation, and fibroblast growth factor receptor 2 (FGFR2) fusion may provide potential targets in clinical trials.
The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.
This summary was comprehensively reviewed and extensively revised.
This summary is written and maintained by the PDQ Adult Treatment Editorial Board, which is editorially independent of NCI. The summary reflects an independent review of the literature and does not represent a policy statement of NCI or NIH. More information about summary policies and the role of the PDQ Editorial Boards in maintaining the PDQ summaries can be found on the About This PDQ Summary and PDQ® - NCI's Comprehensive Cancer Database pages.
Purpose of This Summary
This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the treatment of gallbladder cancer. It is intended as a resource to inform and assist clinicians who care for cancer patients. It does not provide formal guidelines or recommendations for making health care decisions.
Reviewers and Updates
This summary is reviewed regularly and updated as necessary by the PDQ Adult Treatment Editorial Board, which is editorially independent of the National Cancer Institute (NCI). The summary reflects an independent review of the literature and does not represent a policy statement of NCI or the National Institutes of Health (NIH).
Board members review recently published articles each month to determine whether an article should:
Changes to the summaries are made through a consensus process in which Board members evaluate the strength of the evidence in the published articles and determine how the article should be included in the summary.
The lead reviewers for Gallbladder Cancer Treatment are:
Any comments or questions about the summary content should be submitted to Cancer.gov through the NCI website's Email Us. Do not contact the individual Board Members with questions or comments about the summaries. Board members will not respond to individual inquiries.
Levels of Evidence
Some of the reference citations in this summary are accompanied by a level-of-evidence designation. These designations are intended to help readers assess the strength of the evidence supporting the use of specific interventions or approaches. The PDQ Adult Treatment Editorial Board uses a formal evidence ranking system in developing its level-of-evidence designations.
Permission to Use This Summary
PDQ is a registered trademark. Although the content of PDQ documents can be used freely as text, it cannot be identified as an NCI PDQ cancer information summary unless it is presented in its entirety and is regularly updated. However, an author would be permitted to write a sentence such as "NCI's PDQ cancer information summary about breast cancer prevention states the risks succinctly: [include excerpt from the summary]."
The preferred citation for this PDQ summary is:
PDQ® Adult Treatment Editorial Board. PDQ Gallbladder Cancer Treatment. Bethesda, MD: National Cancer Institute. Updated <MM/DD/YYYY>. Available at: https://www.cancer.gov/types/gallbladder/hp/gallbladder-treatment-pdq. Accessed <MM/DD/YYYY>. [PMID: 26389371]
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Last Revised: 2020-03-25
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