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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 2013:
Cancer that arises in the gallbladder is uncommon. The most common symptoms caused by gallbladder cancer are jaundice, pain, and fever.
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, though palliative measures may be beneficial. For patients with T2 or greater disease, extended resection with partial hepatectomy and portal node dissection may be an option.[3,4]
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:
*Grade 4 by definition.
Definitions of TNM
The American Joint Committee on Cancer has designated staging by the TNM classification to define gallbladder cancer.
Localized (Stage I)
These types of patients have cancer confined to the gallbladder wall that can be completely resected. They represent a minority of cases of gallbladder cancer. Patients with cancers confined to the mucosa have 5-year survival rates of nearly 100%. Patients with muscular invasion or beyond have a survival of less than 15%. Regional lymphatics and lymph nodes should be removed along with the gallbladder in such patients.
Unresectable (Stage II–IV)
With the exception of some patients with focal stage IIA disease, these types of patients have cancer that cannot be completely resected. They represent the majority of cases of gallbladder cancer. Often the cancer invades directly into adjacent liver or biliary lymph nodes or has disseminated throughout the peritoneal cavity. Spread to distant parts of the body is not uncommon. At this stage, standard therapy is directed at palliation. Because of its rarity, no specific clinical trials exist; however, such patients can be included in trials aimed at improving local control by combining radiation therapy with radiosensitizer drugs.
When gallbladder cancer is previously unsuspected and is 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:
Implantation of the carcinoma at all port sites (including the camera site) after laparoscopic removal of an unsuspected cancer is a problem. Even for stage I cancers, the port sites must be excised completely.
Treatment options under clinical evaluation:
Current Clinical Trials
Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with localized gallbladder cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.
General information about clinical trials is also available from the NCI Web site.
These patients 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, recurrent, or metastatic gallbladder cancer should be considered for inclusion in clinical trials whenever possible. Information about ongoing clinical trials is available from the NCI Web site.
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.
A randomized, phase III study of up to 6 months of gemcitabine versus gemcitabine and cisplatin in 410 patients with unresectable, recurrent, or metastatic gallbladder cancer demonstrated an improvement in median overall survival (OS) among patients treated with combination therapy (11.7 months vs. 8.1 months; HR, 0.64; [95% confidence interval, 0.52–0.80], P < .001).[Level of evidence: 1iiA] A similar median OS benefit was demonstrated in all subgroups, including 149 patients with gallbladder cancer. Grade 3 and 4 toxicities occurred with similar frequency in both study arms, with the exception of increased hematologic toxic effects in patients randomly assigned to gemcitabine-cisplatin and increased hepatotoxicity in patients randomly assigned to single-agent gemcitabine.
A multi-institutional, randomized, phase III study (NCT01149122) of advanced biliary cancers evaluating the benefit of chemotherapy (gemcitabine and oxaliplatin) with or without erlotinib failed to meet its endpoint of improvement in OS and progression-free survival.[Level of evidence: 1iiD]
Other drugs and drug combinations await evaluation in randomized trials.
Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with unresectable gallbladder cancer, recurrent gallbladder cancer and metastatic gallbladder cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.
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.
Unresectable, Recurrent, or Metastatic Gallbladder Cancer
Added text to state that a multi-institutional, randomized, phase III study (NCT01149122) of advanced biliary cancers evaluating the benefit of chemotherapy (gemcitabine and oxaliplatin) with or without erlotinib failed to meet its endpoint of improvement in overall survival and progression-free survival (cited Lee et al. as reference 3 and level of evidence 1iiD).
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 Web site's Contact Form. 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:
National Cancer Institute: PDQ® Gallbladder Cancer Treatment. Bethesda, MD: National Cancer Institute. Date last modified <MM/DD/YYYY>. Available at: http://cancer.gov/cancertopics/pdq/treatment/gallbladder/HealthProfessional. Accessed <MM/DD/YYYY>.
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Last Revised: 2013-05-24
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