Development and Multicentre Validation of the Modena Score to Predict Survival in Advanced Biliary Cancers Undergoing Second-Line Chemotherapy

Figures & data

Table 1 Baseline Patients’ Characteristics in the Training Cohort (n = 98)

Variable	N (%)
Age, years median	63 (29–82)
Gender
Female	52 (53)
Male	46 (47)
ECOG PS
0	62 (63)
1–2	36 (37)
Primary tumor site
Intrahepatic cholangiocarcinoma	61 (62)
Perihilar cholangiocarcinoma	14 (14)
Distal cholangiocarcinoma	8 (8)
Gallbladder carcinoma	15 (16)
Previous surgery on the primary tumor
Yes	19 (19)
No	79 (81)
Liver metastases
Yes	85 (87)
No	13 (13)
Distant node metastases
Yes	43 (44)
No	55 (56)
Lung metastases
Yes	28 (29)
No	70 (71)
Peritoneum metastases
Yes	26 (27)
No	72 (73)
Bone metastases
Yes	9 (9)
No	89 (91)
First-line chemotherapy
Gemcitabine/platinum	71 (72)
Gemcitabine monotherapy	15 (15)
Fluoropyrimidine-based doublet	12 (12)
Best response to 1st-line
Complete response	1 (1)
Partial response	30 (31)
Stable disease	36 (37)
Progressive disease	31 (31)
2nd-line chemotherapy
FOLFIRI	25 (26)
FOLFOX	20 (20)
Gemcitabine/platinum	18 (18)
Fluoropyrimidine monotherapy	19 (19)
Other	16 (16)

Table 2 Multiple Cox Proportional Hazard Regression in the Training Cohort (n = 98)

Factor	HR (95% CI)	p-value
ECOG PS >0	2.33 (1.38–3.95)	0.002
Peritoneal involvement	2.93 (1.70–5.07)	<0.001
LDH >430 UI/L	3.30 (1.92–5.67)	<0.001
Albumin <3.5 g/dL	3.14 (1.55–6.24)	0.001
Gamma-GT >100 UI/L	2.44 (1.47–4.07)	0.001
PFS to 1st line <6 months	1.75 (1.07–2.85)	0.025
Na+ <140 mEq/L	2.93 (1.29–6.63)	0.010
ALC < 1000 /uL	1.94 (1.07–3.53)	0.030

Table 3 Risk-Group Assignment Based on the Prognostic Score in the Training Cohort (n = 98)

Risk Group	N (%)	1-Year OS% (95% CI)	HR (95% CI)	p-value	Median OS (Months)
Low (0/2)	27 (27)	69 (48–83)	1.00		18.0 (14.7–21.2)
Intermediate (3–4)	35 (36)	26 (13–41)	3.78 (2.09–6.84)	<0.001	9.4 (7.9–11.0)
High (5/8)	36 (37)	NA	32.2 (27.0–38.1)	<0.001	2.9 (2.4–3.5)
		High vs Intermediate	16.5 (7.55–25.9)	<0.001

Notes: Score: PS, peritoneum, LDH, albumin, ALC, Na+, g-GT, time to 1st progression with weight = 1. Score from 0 to 8, stratified in three groups of risk.

Figure 1 Overall survival by risk groups in the training cohort (n=98). Kaplan–Meier curves of overall survival (OS) according to the Modena score in the training cohort. The prognostic score assigned patients to three risk groups with statistically different OS: low-risk (n=27; mOS 18 months), intermediate-risk (n=35; mOS 9.4 months) and high-risk (n=27; mOS 2.9 months) (p<0.001).

Figure 2 Nomogram for overall survival of biliary cancers treated with second-line chemotherapy. Using and interpreting the nomogram. Each variable incorporated in the Modena score has been listed separately together with the corresponding number of points reflecting its magnitude. For each variable, draw an upward vertical line to the “Points” bar to calculate points, then sum the points for each variable and locate this sum on the “Total Points” axis. Draw a downward vertical line from the “Total Points” line to calculate 6-month and 12-month overall survival probability.

Figure 3 Overall survival by risk groups in the validation cohort (n=120). Kaplan–Meier curves of overall survival (OS) according to the Modena score in the validation cohort. The prognostic score assigned patients to three risk groups with statistically different OS: low-risk (n=22; mOS 12.8 months), intermediate-risk (n=43; mOS 6.4 months) and high-risk (n=55; mOS 2.5 months) (p<0.001).