> Biliary Tract Cancer

Adjuvant Therapy for Resected Biliary Tract Cancer

Based on guidelines from the American Society of Clinical Oncology.

Treatment

Adjuvant Capecitabine Chemotherapy

Patients with resected biliary tract cancer should be offered adjuvant capecitabine chemotherapy for a duration of 6 months.

Moderate recommendation

Intermediate quality evidence

In the BILCAP (Adjuvant Capecitabine for Biliary Tract Cancer) phase III randomized controlled trial, capecitabine was delivered at a dose of 1,250 mg/m² twice a day on treatment days 1 to 14 of a 3-week cycle for 24 weeks (eight cycles) [Qualifying statement].

N/A

The Expert Panel agrees that the recommended dose of capecitabine may be determined by institutional and regional practices [Qualifying statement].

N/A

Chemoradiotherapy

Patients with extrahepatic cholangiocarcinoma or gallbladder cancer and a microscopically positive surgical margin resection (R1 resection) may be offered chemoradiotherapy.

Moderate recommendation

Low quality evidence

A shared decision-making approach is recommended, considering the risk of potential harm and potential for benefit associated with radiation therapy for patients with extrahepatic cholangiocarcinoma or gallbladder cancer [Qualifying statement].

N/A

The Expert Panel notes that in the SWOG0809 prospective single-arm trial of chemoradiotherapy, radiation was delivered at a dose of 45 Gy to regional lymphatics and 54 to 59.4 Gy to the tumor bed. However, at this time, the evidence base is not sufficiently well developed to make a recommendation for optimal dosing of radiation therapy in the context of chemoradiation therapy [Qualifying statement].

N/A

What do the icons mean?

How strong is the ASCO's recommendation?

Strong recommendation

High confidence that recommendation reflects best practice, based on (1) strong evidence for true net effect (benefits > harms); (2) consistent results, with no or minor exceptions; (3) minor or no concerns about study quality; and/or (4) extent of panelists’ agreement.

Moderate recommendation

Moderate confidence that recommendation reflects best practice, based on (1) good evidence for true net effect (benefits > harms); (2) consistent results, with minor and/or few exceptions; (3) minor and/or few concerns about study quality; and/or (4) extent of panelists’ agreement.

Some confidence that recommendation offers the best current guidance for practice, based on (1) limited evidence for true net effect (benefits > harms); (2) consistent results, but with important exceptions; (3) concerns about study quality; and/or (4) extent of panelists’ agreement.

N/A

No recommendation was assigned.

High quality evidence

High confidence that available evidence reflects true magnitude and direction of net effect (i.e., balance of benefits vs harms) and that further research is very unlikely to change either magnitude or direction of this net effect.

Intermediate quality evidence

Moderate confidence that available evidence reflects true magnitude and direction of net effect. Further research is unlikely to alter the direction of the net effect; however, it might alter the magnitude of the net effect.

Low quality evidence

Low confidence that available evidence reflects true magnitude and direction of the net effect. Further research may change either the magnitude and/or direction of this net effect.

Insufficient evidence

Evidence is insufficient to discern true magnitude and direction of net effect. Further research may better inform the topic. The use of the consensus opinion of experts is reasonable to inform outcomes related to the topic.

N/A

No evidence was assigned.

Literature

Original/Primary Reference

Shroff RT, Kennedy EB, Bachini M, et al. Adjuvant Therapy for Resected Biliary Tract Cancer: ASCO Clinical Practice Guideline. J Clin Oncol. 2019;37(12):1015-1027.

Calc Function

Treatment