Addition of camrelizumab to docetaxel, cisplatin, and radiation therapy in patients with locally advanced esophageal squamous cell carcinoma: a phase 1b study

Figures & data

Table 1. Baseline patient characteristics

Characteristic	Data (n = 20)
Age, median (range), y	64 (56–74)
Sex
Male	18 (90)
Female	2 (10)
ECOG performance status score
0	16 (80)
1	4 (20)
Smoking status
Never	7 (35)
Former or current	13 (65)
Drinking status
Never	6 (30)
Former or current	14 (56)
Location
Cervical segment	2 (10)
Upper thoracic segment	7 (35)
Middle thoracic segment	8 (40)
Inferior thoracic segment	3 (15)
AJCC8^a disease stage
I	1 (5)
III	6 (30)
IV	13 (65)
AJCC6^b disease stage
IIb	2 (10)
III	13 (65)
IVa	5 (25)

Data are n (%), unless otherwise specified. ^a8^th (2017) version of the AJCC Staging Manual. ^b6^th (2002) version of the AJCC Staging Manual. AJCC = American Joint Committee on Cancer. ECOG = Eastern Cooperative Oncology Group.

Table 2. Treatment-related adverse events

Treatment-related adverse events	All	Grade 1	Grade 2	Grade 3	Grade 4
Any treatment-related adverse event	20 (100)	2 (10)	9 (45)	9 (45)	0
Pain	19 (95)	10 (50)	7 (35)	2 (10)	0
Decreased albumin	18 (90)	13 (65)	5 (25)	0	0
WBC count decreased	18 (90)	7 (35)	9 (45)	2 (10)	0
Radiation esophagitis	17 (85)	4 (20)	9 (45)	4 (20)	0
Anemia	15 (75)	13 (65)	2 (10)	0	0
Decreased appetite	15 (75)	11 (55)	4 (20)	0	0
Reactive capillary hemangiomas	10 (50)	10 (50)	0	0	0
Weight loss	10 (50)	10 (50)	0	0	0
Fatigue	10 (50)	8 (40)	1 (5)	1 (5)	0
Neutrophilic granulopenia	9 (45)	4 (20)	5 (25)	0	0
Increased bilirubin	7 (35)	7 (35)	0	0	0
Thrombocytopenia	7 (35)	6 (30)	1 (5)	0	0
Cough	7 (35)	2 (10)	4 (20)	1 (5)	0
Fever	5 (25)	4 (20)	1 (5)	0	0
Nausea	4 (20)	4 (20)	0	0	0
BUN abnormal	4 (20)	4 (20)	0	0	0
Increased ALT	3 (15)	3 (15)	0	0	0
Hypothyroidism	3 (15)	3 (15)	0	0	0
Radiation dermatitis	3 (15)	2 (10)	1 (5)	0	0
Radiation pneumonia	3 (15)	1 (5)	2 (10)	0	0
CRE abnormal	2 (10)	2 (10)	0	0	0
Febrile neutropenia	2 (10)	2 (10)	0	0	0
Hypertension	2 (10)	2 (10)	0	0	0
Lung infection	2 (10)	0	2 (10)	0	0
Esophageal fistula	2 (10)	0	0	2 (10)	0
Allergy	1 (5)	1 (5)	0	0	0

Data are n (%), unless otherwise specified. ALT = alanine aminotransferase. BUN = blood urea nitrogen. CRE = creatinine. WBC = white blood cell.

Figure 1. Duration of response and survival

(A) Duration of response. (B) Kaplan–Meier plot of overall survival. (C) Kaplan–Meier plot of progression-free survival. PD-L1 = programmed cell-death protein 1. CR = complete response. PR = partial response. SD = stable disease. Pt = patient.

Figure 2. Changes from baseline in EORTC QLQ-C30 and QLQ-OES18

(A) Changes from baseline in QLQ-C30 global health status/quality of life; QLQ-C30 functioning scales (B), QLQ-C30 symptom scales (C), and QLQ-OES18 functioning and symptom scales (D) at weeks 7 and 19. EORTC = European Organization for Research and Treatment of Cancer. Mean change from baseline in Quality of Life Questionnaire-Core 30 (QLQ-C30) global health status (GHS) by visit. Data are shown as mean score changes (95%CIs). A higher score in the functional domains and global health status means better functional status and better QoL. A higher score in the symptom domains indicates more severe symptoms or problems (worse QoL). QLQ-C30 = Quality of Life Questionnaire Core 30. QLQ-OES18 = Quality of Life Questionnaire Module 18 in Esophageal Cancer. GHS = global health status. QoL = quality of life.

Figure 3. Tumor biomarkers associated with survival

(A) Results of hematoxylin and eosin staining (left), and multi-color immunofluorescence (middle and right) of serial tissue section from patient 19.(B) Changes of tumor immune microenvironment after 40 Gy radiation. Kaplan–Meier plot of overall survival in patients with (C) a baseline PD-L1 ≥ 7.613%; (D) baseline tumor-infiltrated CD11⁺ dendritic cells ≥2.987%. PD-L1 = programmed cell-death protein 1.

Figure 4. Gene amplification and peripheral cytokines associated with survival

Kaplan-Meier plot of overall survival in patients with a baseline IL-27 ≥ 919.090 pg/mL (A), an on-treatment IL-27 ≥ 1037.75 pg/mL (B), a baseline IL-15 ≥ 2.87 pg/mL (C), a baseline Eotaxin-3 ≥ 22.55 pg/mL (D), an on-treatment IL-22 ≥ 1.015 pg/mL in peripheral blood (E), and CCND1/FGF19/FGF4 gene amplification in tumor tissues (F).