医療専門家向け Gallbladder Cancer Treatment (PDQ®)

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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.

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).

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General Information About Gallbladder Cancer

Incidence and Mortality

Estimated new cases and deaths from gallbladder (and other biliary) cancer in the United States in 2020:[ 1 ]

Cancer that arises in the gallbladder is uncommon.

Clinical Features

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.[ 2 ] 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.

参考文献

1. American Cancer Society: Cancer Facts and Figures 2020. Atlanta, Ga: American Cancer Society, 2020. Available online. Last accessed May 12, 2020.[PUBMED Abstract]
2. Chao TC, Greager JA: Primary carcinoma of the gallbladder. J Surg Oncol 46 (4): 215-21, 1991.[PUBMED Abstract]
3. Shoup M, Fong Y: Surgical indications and extent of resection in gallbladder cancer. Surg Oncol Clin N Am 11 (4): 985-94, 2002.[PUBMED Abstract]
4. Sasson AR, Hoffman JP, Ross E, et al.: Trimodality therapy for advanced gallbladder cancer. Am Surg 67 (3): 277-83; discussion 284, 2001.[PUBMED Abstract]

Cellular Classification of Gallbladder 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:[ 1 ]

参考文献

1. Gallbladder. In: Amin MB, Edge SB, Greene FL, et al., eds.: AJCC Cancer Staging Manual. 8th ed. New York, NY: Springer, 2017, pp 303–9.[PUBMED Abstract]

Stage Information for Gallbladder Cancer

AJCC Stage Groupings and TNM Definitions

The American Joint Committee on Cancer (AJCC) has designated staging by the TNM classification to define gallbladder cancer.[ 1 ]

Table 1. Definitions of TNM Stage 0^a

Stage	TNM	Description
T = primary tumor; N = regional lymph node; M = distant metastasis.
aReprinted with permission from AJCC: Gallbladder. In: Amin MB, Edge SB, Greene FL, et al., eds.: AJCC Cancer Staging Manual. 8th ed. New York, NY: Springer, 2017, pp 303–9.
0	Tis, N0, M0	Tis = Carcinoma in situ.
		N0 = No regional lymph node metastasis.
		M0 = No distant metastasis.

Table 2. Definitions of TNM Stage I^a

Stage	TNM	Description
T = primary tumor; N = regional lymph node; M = distant metastasis.
aReprinted with permission from AJCC: Gallbladder. In: Amin MB, Edge SB, Greene FL, et al., eds.: AJCC Cancer Staging Manual. 8th ed. New York, NY: Springer, 2017, pp 303–9.
I	T1, N0, M0	T1 = Tumor invades the lamina propria or muscular layer.
		N0 = No regional lymph node metastasis.
		M0 = No distant metastasis.

Table 3. Definitions of TNM Stage IIA^a

Stage	TNM	Description
T = primary tumor; N = regional lymph node; M = distant metastasis.
aReprinted with permission from AJCC: Gallbladder. In: Amin MB, Edge SB, Greene FL, et al., eds.: AJCC Cancer Staging Manual. 8th ed. New York, NY: Springer, 2017, pp 303–9.
IIA	T2a, N0, M0	T2a = Tumor invades the perimuscular connective tissue on the peritoneal side, without involvement of the serosa (visceral peritoneum).
		N0 = No regional lymph node metastasis.
		M0 = No distant metastasis.

Table 4. Definitions of TNM Stage IIB^a

Stage	TNM	Description
T = primary tumor; N = regional lymph node; M = distant metastasis.
aReprinted with permission from AJCC: Gallbladder. In: Amin MB, Edge SB, Greene FL, et al., eds.: AJCC Cancer Staging Manual. 8th ed. New York, NY: Springer, 2017, pp 303–9.
IIB	T2b, N0, M0	T2b = Tumor invades the perimuscular connective tissue on the hepatic side, with no extension into the liver.
		N0 = No regional lymph node metastasis.
		M0 = No distant metastasis.

Table 5. Definitions of TNM Stage IIIA^a

Stage	TNM	Description
T = primary tumor; N = regional lymph node; M = distant metastasis.
aReprinted with permission from AJCC: Gallbladder. In: Amin MB, Edge SB, Greene FL, et al., eds.: AJCC Cancer Staging Manual. 8th ed. New York, NY: Springer, 2017, pp 303–9.
IIIA	T3, N0, M0	T3 = Tumor perforates the serosa (visceral peritoneum) and/or directly invades the liver and/or one other adjacent organ or structure, such as the stomach, duodenum, colon, pancreas, omentum, or extrahepatic bile ducts.
		N0 = No regional lymph node metastasis.
		M0 = No distant metastasis.

Table 6. Definitions of TNM Stage IIIB^a

Stage	TNM	Description
T = primary tumor; N = regional lymph node; M = distant metastasis.
aReprinted with permission from AJCC: Gallbladder. In: Amin MB, Edge SB, Greene FL, et al., eds.: AJCC Cancer Staging Manual. 8th ed. New York, NY: Springer, 2017, pp 303–9.
IIIB	T1–3, N1, M0	T1 = Tumor invades the lamina propria or muscular layer.
		–T1a = Tumor invades the lamina propria.
		–T1b = Tumor invades the muscular layer.
		T2 = Tumor invades the perimuscular connective tissue on the peritoneal side, without involvement of the serosa (visceral peritoneum). Or, tumor invades the perimuscular connective tissue on the hepatic side, with no extension into the liver.
		–T2a = Tumor invades the perimuscular connective tissue on the peritoneal side, without involvement of the serosa (visceral peritoneum).
		–T2b = Tumor invades the perimuscular connective tissue on the hepatic side, with no extension into the liver.
		T3 = Tumor perforates the serosa (visceral peritoneum) and/or directly invades the liver and/or one other adjacent organ or structure, such as the stomach, duodenum, colon, pancreas, omentum, or extrahepatic bile ducts.
		N1 = Metastases to one to three regional lymph nodes.
		M0 = No distant metastasis.

Table 7. Definitions of TNM Stage IVA^a

Stage	TNM	Description
T = primary tumor; N = regional lymph node; M = distant metastasis.
aReprinted with permission from AJCC: Gallbladder. In: Amin MB, Edge SB, Greene FL, et al., eds.: AJCC Cancer Staging Manual. 8th ed. New York, NY: Springer, 2017, pp 303–9.
IVA	T4, N0–1, M0	T4 = Tumor invades the main portal vein or hepatic artery or invades two or more extrahepatic organs or structures.
		N0 = No regional lymph node metastasis.
		N1 = Metastases to one to three regional lymph nodes.
		M0 = No distant metastasis.

Table 8. Definitions of TNM Stage IVB^a

Stage	TNM	Description
T = primary tumor; N = regional lymph node; M = distant metastasis.
aReprinted with permission from AJCC: Gallbladder. In: Amin MB, Edge SB, Greene FL, et al., eds.: AJCC Cancer Staging Manual. 8th ed. New York, NY: Springer, 2017, pp 303–9.
IVB	Any T, N2, M0	TX = Primary tumor cannot be assessed.
		T0 = No evidence of primary tumor.
		Tis = Carcinoma in situ.
		T1 = Tumor invades the lamina propria or muscular layer.
		–T1a = Tumor invades the lamina propria.
		–T1b = Tumor invades the muscular layer.
		T2 = Tumor invades the perimuscular connective tissue on the peritoneal side, without involvement of the serosa (visceral peritoneum). Or, tumor invades the perimuscular connective tissue on the hepatic side, with no extension into the liver.
		–T2a = Tumor invades the perimuscular connective tissue on the peritoneal side, without involvement of the serosa (visceral peritoneum).
		–T2b = Tumor invades the perimuscular connective tissue on the hepatic side, with no extension into the liver.
		T3 = Tumor perforates the serosa (visceral peritoneum) and/or directly invades the liver and/or one other adjacent organ or structure, such as the stomach, duodenum, colon, pancreas, omentum, or extrahepatic bile ducts.
		T4 = Tumor invades the main portal vein or hepatic artery or invades two or more extrahepatic organs or structures.
		N2 = Metastases to four or more regional lymph nodes.
		M0 = No distant metastasis.
	Any T, Any N, M1	TX = Primary tumor cannot be assessed.
		T0 = No evidence of primary tumor.
		Tis = Carcinoma in situ.
		T1 = Tumor invades the lamina propria or muscular layer.
		–T1a = Tumor invades the lamina propria.
		–T1b = Tumor invades the muscular layer.
		T2 = Tumor invades the perimuscular connective tissue on the peritoneal side, without involvement of the serosa (visceral peritoneum). Or, tumor invades the perimuscular connective tissue on the hepatic side, with no extension into the liver.
		–T2a = Tumor invades the perimuscular connective tissue on the peritoneal side, without involvement of the serosa (visceral peritoneum).
		–T2b = Tumor invades the perimuscular connective tissue on the hepatic side, with no extension into the liver.
		T3 = Tumor perforates the serosa (visceral peritoneum) and/or directly invades the liver and/or one other adjacent organ or structure, such as the stomach, duodenum, colon, pancreas, omentum, or extrahepatic bile ducts.
		T4 = Tumor invades the main portal vein or hepatic artery or invades two or more extrahepatic organs or structures.
		NX = Regional lymph nodes cannot be assessed.
		N0 = No regional lymph node metastasis.
		N1 = Metastases to one to three regional lymph nodes.
		N2 = Metastases to four or more regional lymph nodes.
		M1 = Distant metastases.

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%.[ 2 ]

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.

Unresectable

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.

参考文献

1. Gallbladder. In: Amin MB, Edge SB, Greene FL, et al., eds.: AJCC Cancer Staging Manual. 8th ed. New York, NY: Springer, 2017, pp 303–9.[PUBMED Abstract]
2. Shirai Y, Yoshida K, Tsukada K, et al.: Inapparent carcinoma of the gallbladder. An appraisal of a radical second operation after simple cholecystectomy. Ann Surg 215 (4): 326-31, 1992.[PUBMED Abstract]

Localized and Locally Advanced Gallbladder Cancer Treatment

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.[ 1 ][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:

1. Surgery: In previously unsuspected gallbladder cancer that is discovered in the surgical specimen after a routine gallbladder operation and confined to mucosa (T1), the majority of patients are cured.[ 2 ][ 3 ] During laparoscopic removal of an unsuspected cancer, there is potential for implantation of carcinoma at all port sites (including the camera site).[ 4 ] All port sites are typically excised completely, even for stage I cancers.

   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.[ 5 ][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).[ 5 ] 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.

2. External-beam radiation therapy (EBRT): The use of EBRT with or without chemotherapy as a primary treatment has been reported in small groups of patients to produce short-term control. Similar benefits have been reported for radiation therapy with or without chemotherapy administered following resection.[ 9 ][ 10 ]

   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.

参考文献

1. Tsukada K, Kurosaki I, Uchida K, et al.: Lymph node spread from carcinoma of the gallbladder. Cancer 80 (4): 661-7, 1997.[PUBMED Abstract]
2. Fong Y, Brennan MF, Turnbull A, et al.: Gallbladder cancer discovered during laparoscopic surgery. Potential for iatrogenic tumor dissemination. Arch Surg 128 (9): 1054-6, 1993.[PUBMED Abstract]
3. Chijiiwa K, Tanaka M: Carcinoma of the gallbladder: an appraisal of surgical resection. Surgery 115 (6): 751-6, 1994.[PUBMED Abstract]
4. Wibbenmeyer LA, Wade TP, Chen RC, et al.: Laparoscopic cholecystectomy can disseminate in situ carcinoma of the gallbladder. J Am Coll Surg 181 (6): 504-10, 1995.[PUBMED Abstract]
5. Pawlik TM, Gleisner AL, Vigano L, et al.: Incidence of finding residual disease for incidental gallbladder carcinoma: implications for re-resection. J Gastrointest Surg 11 (11): 1478-86; discussion 1486-7, 2007.[PUBMED Abstract]
6. Shirai Y, Yoshida K, Tsukada K, et al.: Inapparent carcinoma of the gallbladder. An appraisal of a radical second operation after simple cholecystectomy. Ann Surg 215 (4): 326-31, 1992.[PUBMED Abstract]
7. Yamaguchi K, Chijiiwa K, Saiki S, et al.: Retrospective analysis of 70 operations for gallbladder carcinoma. Br J Surg 84 (2): 200-4, 1997.[PUBMED Abstract]
8. Downing SR, Cadogan KA, Ortega G, et al.: Early-stage gallbladder cancer in the Surveillance, Epidemiology, and End Results database: effect of extended surgical resection. Arch Surg 146 (6): 734-8, 2011.[PUBMED Abstract]
9. Smoron GL: Radiation therapy of carcinoma of gallbladder and biliary tract. Cancer 40 (4): 1422-4, 1977.[PUBMED Abstract]
10. Hejna M, Pruckmayer M, Raderer M: The role of chemotherapy and radiation in the management of biliary cancer: a review of the literature. Eur J Cancer 34 (7): 977-86, 1998.[PUBMED Abstract]

Unresectable, Metastatic, or Recurrent Gallbladder Cancer Treatment

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:

1. Relief of biliary obstruction is warranted when symptoms such as pruritus and hepatic dysfunction outweigh other symptoms of the cancer. The preferred approach is percutaneous transhepatic drainage or endoscopically placed stents;[ 1 ] surgical bypass may be appropriate when these approaches are infeasible.

   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.

2. Systemic chemotherapy is appropriate for selected patients with adequate performance status and intact organ function. Fluoropyrimidines, gemcitabine, platinum agents, and docetaxel have been reported to produce transient partial remissions in a minority of patients. The incidence of gallbladder cancer is low, and clinical trials often enroll patients with all subsites of biliary tract cancers. Therefore, data must be interpreted with caution when applied specifically to patients with gallbladder cancer. (Refer to the PDQ summary on Bile Duct Cancer [Cholangiocarcinoma] Treatment for more information.)

   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.[ 2 ]

   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.[ 3 ][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).[ 4 ][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.

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.

参考文献

1. Baron TH: Expandable metal stents for the treatment of cancerous obstruction of the gastrointestinal tract. N Engl J Med 344 (22): 1681-7, 2001.[PUBMED Abstract]
2. Valle J, Wasan H, Palmer DH, et al.: Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med 362 (14): 1273-81, 2010.[PUBMED Abstract]
3. Sharma A, Dwary AD, Mohanti BK, et al.: Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol 28 (30): 4581-6, 2010.[PUBMED Abstract]
4. Kim ST, Kang JH, Lee J, et al.: Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol 30 (5): 788-795, 2019.[PUBMED Abstract]
5. Sicklick JK, Kato S, Okamura R, et al.: Molecular profiling of cancer patients enables personalized combination therapy: the I-PREDICT study. Nat Med 25 (5): 744-750, 2019.[PUBMED Abstract]
6. Marabelle A, Le DT, Ascierto PA, et al.: Efficacy of Pembrolizumab in Patients With Noncolorectal High Microsatellite Instability/Mismatch Repair-Deficient Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol 38 (1): 1-10, 2020.[PUBMED Abstract]

Changes to This Summary (03/25/2020)

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.

About This PDQ Summary

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:

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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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