1. BILCAP: Phase III Trial of Adjuvant Capecitabine for Biliary Tract Cancer
CCO Independent Conference Highlights* of the 2017 ASCO Annual Meeting; June 2-6, 2017; Chicago, Illinois
*Clinical Care Options (CCO) is an independent medical education organization that provides conference coverage and other unique educational programs for healthcare professionals
This activity is supported by educational grants from AbbVie, Amgen, AstraZeneca, Celgene Corporation, Genentech, Halozyme, Incyte, and Merck & Co., Inc.

2. BILCAP: Background
Biliary tract cancers are uncommon, associated with poor outcomes[1]
1-yr survival: 22%
5-yr survival: 9%
Surgical resection increases 5-yr survival to 15% but possible in < 20% of cases[2]
Current phase III study evaluated benefit of adjuvant PO capecitabine chemotherapy following potentially curative surgery[3]
1. Khan SA, et al. J Hepatol. 2012;56: Office for National Statistics Primrose JN , et al. ASCO Abstract 4006.
Slide credit: clinicaloptions.com

3. Primary analysis after minimum 2-yr follow-up
BILCAP: Study Design
Open-label, randomized, controlled phase III trial
Histologically confirmed biliary tract cancer*; radical and macroscopically complete surgery; ECOG PS ≤ 2; no previous chemotherapy or radiotherapy for biliary tract cancer
(N = 447)
Stratified by surgical center, R0 vs R1 resection, ECOG PS
Capecitabine 1250 mg/m2 BID
Days 1-14 of 21-day cycle for 8 cycles
(n = 223)
Resection
Primary analysis after minimum 2-yr follow-up
Observation
(n = 224)
*Included: intrahepatic CC, hilar CC, muscle-invasive gallbladder cancer, and lower common bile duct CC
Excluded: pancreatic, ampullary, mucosal (T1a) gallbladder cancers; incomplete recovery from prior surgery
CC, cholangiocarcinoma; ECOG, Eastern Cooperative Oncology Group; PS, performance status; QoL, quality of life; RFS, relapse-free survival.
Primary endpoint: OS
Secondary endpoints: RFS, toxicity, QoL, health economics
Slide credit: clinicaloptions.com
Primrose JN , et al. ASCO Abstract 4006.

4. BILCAP: Baseline Characteristics
Capecitabine Arm
(n = 223)
Observation Arm
(n = 224)
Male 50
Median age, yrs (IQR)
62 (55-68)
64 (55-69)
Tumor site
Intrahepatic CC
Hilar CC
Muscle-invasive gall bladder carcinoma
Lower common bile duct CC 19 29 17 34 18 28 36
Resection status, R0/R1
62/38
63/38
ECOG PS, 0/1/2
5/52/3
45/52/3
Tumor size, mm (IQR)
25 (19-45)
25 (20-44)
Lymph node status, N0/N1/not evaluable
45/48/7
48/46/6
CC, cholangiocarcinoma; ECOG, Eastern Cooperative Oncology Group; IQR, interquartile range; PS, performance status.
Slide credit: clinicaloptions.com
Primrose JN , et al. ASCO Abstract 4006.

5. BILCAP: Treatment Compliance
Median capecitabine dose: 1250 mg/m2 BID (IQR: mg/m2) 8
122 (55%) pts in the capecitabine
arm received 8 cycles 6
Cycles of Capecitabine (n) 4
10 (< 5%) pts received 0 cycles 2
IQR, interquartile range. 1 50
100
150
200
223
Pts (n)
Slide credit: clinicaloptions.com
Primrose JN , et al. ASCO Abstract Reproduced with permission.

6. Mos Since Randomization Mos Since Randomization
BILCAP: OS
ITT Population
Per Protocol Population
100
Sensitivity analyses adjusting for further prognostic factors (gender, nodal status, disease grade) HR (95% CI: ; P = .007)
100 75 75
Pts Alive (%) 50
Pts Alive (%) 50 25 25
> 80% pts followed-up for 36 mos 12 24 36 48 60 12 24 36 48 60
Mos Since Randomization
Mos Since Randomization
ITT, intent to treat; NR, not reached.
Treatment
Median OS, Mos
(95% CI)
HR (95% CI)
Capecitabine
51.1 ( )
0.81 ( )
P = .097
Observation
36.4 ( )
Treatment
Median OS, Mos
(95% CI)
HR (95% CI)
Capecitabine
52.7 (40.3-NR)
0.75 ( )
P = .028
Observation
36.1 ( )
Slide credit: clinicaloptions.com
Primrose JN , et al. ASCO Abstract Reproduced with permission.

7. BILCAP: Relapse-Free Survival
ITT Population
Per Protocol Population
100
100 75 75
Pts Recurrence Free (%) 50
Pts Recurrence Free (%) 50 25 25 12 24 36 48 60 12 24 36 48 60
Mos Since Randomization
ITT, intent to treat; RFS, recurrence-free survival.
Mos Since Randomization
Treatment
Median RFS, Mos
(95% CI)
HR (95% CI)
Capecitabine
24.6 ( )
0.76 ( )
P = .039
Observation
17.6 ( )
Treatment
Median RFS, Mos
(95% CI)
HR (95% CI)
Capecitabine
25.9 ( )
0.71 ( )
P = .011
Observation
17.6 ( )
Slide credit: clinicaloptions.com
Primrose JN , et al. ASCO Abstract Reproduced with permission.

8. BILCAP: Safety and QoL
Safety population included 213 patients who received capecitabine
Adverse Event, n (%)
All Grades
Grades 1/2
Grades 3/4
Fatigue
175 (82)
159 (75)
16 (8)
Plantar-palmar erythema
174 (82)
130 (61)
44 (21)
Diarrhea
137 (64)
121 (57)
Nausea
108 (51)
106 (50)
2 (1)
Mucositis/stomatitis
96 (45)
94 (44)
Vomiting
50 (24)
49 (23)
1 (0.5)
Neutropenia
45 (21)
4 (2)
Hyperbilirubinemia
42 (20)
3 (1)
Thrombocytopenia
26 (12)
25 (12)
Alopecia
20 (9)
0 (0)
SAE
n (%)
All
93 (44)
Pts with ≥ 1 SAE
69 (32)
SAEs by treatment arm n
Capecitabine arm
47 (64 events)
30 (33 events)
Observation arm
SAE resulting in death
22 (29 events) 3
QoL, quality of life; SAE, serious adverse event.
QoL was not reduced in capecitabine arm compared with placebo
Slide credit: clinicaloptions.com
Primrose JN , et al. ASCO Abstract 4006.

9. BILCAP: Conclusions
Adjuvant capecitabine associated with improved OS in pts with resected biliary tract cancer
Authors suggest capecitabine should become standard of care in this setting
Capecitabine treatment produced modest toxicity
QoL in capecitabine arm comparable to observation arm
Authors recommend using capecitabine control arm in future adjuvant trials in biliary tract cancer
QoL, quality of life.
Slide credit: clinicaloptions.com
Primrose JN , et al. ASCO Abstract 4006.

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