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Preface Led by Chinese scholar Professor Deng Yanhong from the Sixth Affiliated Hospital of Sun Yat-sen University, "Toripalimab (PD-1 inhibitor) combined with or without celecoxib (COX-2 inhibitor) neoadjuvant therapy mismatch repair.
The short-term efficacy results of a single-center, parallel, non-controlled, randomized, phase II clinical trial (PICC) in locally advanced colorectal cancer (CRC) with protein deficiency (dMMR) or microsatellite high instability (MSI-H) are in The Lancet.
Gastroenterology & hepatology (2020 IF: 18.
486) is published online
.
Background Colorectal cancer is the second most common cancer in the world, with more than 1.
9 million new cases and 935,000 deaths in 2020
.
Previous studies have demonstrated the efficacy of PD-1 inhibitors in dMMR/MSI-H metastatic CRC, but the role of PD-1 inhibitors in neoadjuvant therapy in patients with resectable dMMR/MSI-H CRC is unclear
.
The aim of this study was to evaluate the efficacy and safety of the PD-1 inhibitor toripalimab with or without the COX-2 inhibitor celecoxib as neoadjuvant therapy in patients with dMMR/MSI-H locally advanced CRC
.
Research Methods The PICC study is a single-center, open-label, parallel-group, non-comparative, randomized phase II clinical trial
.
Enrolled patients were 18-75 years old, ECOG score 0/1, clinical stage T3-T4 or any T stage with positive lymph node, and histopathologically confirmed dMMR/MSI-H CRC patients
.
The enrolled patients were randomly (1:1) divided into toripalimab + celecoxib group (T+A) group (T, 3 mg/kg, D1, q2w; C, 200 mg, bid, q2w) or special treatment group.
Ripilimumab (T) group (T, 3mg/kg, D1, q2w)
.
The primary endpoint of the study was pathological complete response rate (pCR)
.
Study Design Study Results From May 1, 2019 to April 1, 2021, a total of 53 patients were screened, of whom 34 were randomly assigned to T+A (n=17) or T (n=17)
.
The median age was 49 years (IQR 41-58 years), 11 women (32%) and 23 men (68%) were Asian
.
Of the 34 patients, 28 (82%) had colon cancer, 4 (12%) rectal cancer, and 2 (6%) both colon and rectal primary cancers
.
Nine (26%) patients had previously received neoadjuvant chemotherapy, of which one (11%) patient discontinued chemotherapy due to intolerable toxicity, two (22%) patients refused to continue chemotherapy, and six (67%) patients had disease progress
.
All 34 (100%) patients underwent R0 resection (ie, the resection margin was >1 mm)
.
Fifteen patients (88%; 95% CI 64%-99%) in the T+A arm achieved pCR and 16 (94%; 95% CI 71%-100%) patients in the T arm achieved pCR
.
The median follow-up time was 14.
9 months (IQR 8.
8-17.
0), and all patients were alive and relapse-free, i.
e.
1-year event-free survival (EFS), disease-free survival (DFS) and overall survival (OS) were all in both groups.
is 100% (95% CI 81-100)
.
During the study period, 26 of 34 patients (76%) experienced at least one treatment-related adverse event (TRAE)
.
During the neoadjuvant phase, 10 (59%) patients in the T+A arm and 10 (59%) in the T arm experienced at least grade 1-2 TRAEs
.
In the adjuvant phase, 7 (41%) patients in the T+A arm and 6 (35%) in the T arm experienced grade 1-2 TRAEs
.
Summary This study is the first in the world to report the prospective use of anti-PD-1 monoclonal antibody-based, monoclonal or combined COX-2 inhibitor, preoperative neoadjuvant immunotherapy in patients with locally advanced CRC with dMMR/MSI-H.
clinical trials
.
The results of the study showed that the pCR rate of patients in the toripalimab plus celecoxib group was as high as 88%, and the pCR rate of the toripalimab monotherapy group was 65%
.
This breakthrough achievement fills the gap in the field of neoadjuvant anti-PD-1 single-agent immunotherapy for dMMR/MSI-H locally advanced CRC, and was invited to fast track publication
.
References: Hu, H.
, Kang, L.
, Zhang, J.
, Wu, Z.
, Wang, H.
, Huang, M.
, Lan, P.
, Wu, X.
, Wang, C.
, Cao, W.
, Hu, J.
, Huang, Y.
, Huang, L.
, Wang, H.
, Shi, L.
, Cai, Y.
, Shen, C.
, Ling, J.
, Xie, X.
, Cai, Y.
, … Deng, Y.
(2022).
Neoadjuvant PD-1 blockade with toripalimab, with or without celecoxib, in mismatch repair-deficient or microsatellite instability-high, locally advanced, colorectal cancer (PICC): a single-centre, parallel-group, non-comparative, randomised, phase 2 trial.
The lancet.
Gastroenterology & hepatology, 7(1), 38–48.
https://doi.
org/10.
1016/S2468-1253(21)00348-4
The short-term efficacy results of a single-center, parallel, non-controlled, randomized, phase II clinical trial (PICC) in locally advanced colorectal cancer (CRC) with protein deficiency (dMMR) or microsatellite high instability (MSI-H) are in The Lancet.
Gastroenterology & hepatology (2020 IF: 18.
486) is published online
.
Background Colorectal cancer is the second most common cancer in the world, with more than 1.
9 million new cases and 935,000 deaths in 2020
.
Previous studies have demonstrated the efficacy of PD-1 inhibitors in dMMR/MSI-H metastatic CRC, but the role of PD-1 inhibitors in neoadjuvant therapy in patients with resectable dMMR/MSI-H CRC is unclear
.
The aim of this study was to evaluate the efficacy and safety of the PD-1 inhibitor toripalimab with or without the COX-2 inhibitor celecoxib as neoadjuvant therapy in patients with dMMR/MSI-H locally advanced CRC
.
Research Methods The PICC study is a single-center, open-label, parallel-group, non-comparative, randomized phase II clinical trial
.
Enrolled patients were 18-75 years old, ECOG score 0/1, clinical stage T3-T4 or any T stage with positive lymph node, and histopathologically confirmed dMMR/MSI-H CRC patients
.
The enrolled patients were randomly (1:1) divided into toripalimab + celecoxib group (T+A) group (T, 3 mg/kg, D1, q2w; C, 200 mg, bid, q2w) or special treatment group.
Ripilimumab (T) group (T, 3mg/kg, D1, q2w)
.
The primary endpoint of the study was pathological complete response rate (pCR)
.
Study Design Study Results From May 1, 2019 to April 1, 2021, a total of 53 patients were screened, of whom 34 were randomly assigned to T+A (n=17) or T (n=17)
.
The median age was 49 years (IQR 41-58 years), 11 women (32%) and 23 men (68%) were Asian
.
Of the 34 patients, 28 (82%) had colon cancer, 4 (12%) rectal cancer, and 2 (6%) both colon and rectal primary cancers
.
Nine (26%) patients had previously received neoadjuvant chemotherapy, of which one (11%) patient discontinued chemotherapy due to intolerable toxicity, two (22%) patients refused to continue chemotherapy, and six (67%) patients had disease progress
.
All 34 (100%) patients underwent R0 resection (ie, the resection margin was >1 mm)
.
Fifteen patients (88%; 95% CI 64%-99%) in the T+A arm achieved pCR and 16 (94%; 95% CI 71%-100%) patients in the T arm achieved pCR
.
The median follow-up time was 14.
9 months (IQR 8.
8-17.
0), and all patients were alive and relapse-free, i.
e.
1-year event-free survival (EFS), disease-free survival (DFS) and overall survival (OS) were all in both groups.
is 100% (95% CI 81-100)
.
During the study period, 26 of 34 patients (76%) experienced at least one treatment-related adverse event (TRAE)
.
During the neoadjuvant phase, 10 (59%) patients in the T+A arm and 10 (59%) in the T arm experienced at least grade 1-2 TRAEs
.
In the adjuvant phase, 7 (41%) patients in the T+A arm and 6 (35%) in the T arm experienced grade 1-2 TRAEs
.
Summary This study is the first in the world to report the prospective use of anti-PD-1 monoclonal antibody-based, monoclonal or combined COX-2 inhibitor, preoperative neoadjuvant immunotherapy in patients with locally advanced CRC with dMMR/MSI-H.
clinical trials
.
The results of the study showed that the pCR rate of patients in the toripalimab plus celecoxib group was as high as 88%, and the pCR rate of the toripalimab monotherapy group was 65%
.
This breakthrough achievement fills the gap in the field of neoadjuvant anti-PD-1 single-agent immunotherapy for dMMR/MSI-H locally advanced CRC, and was invited to fast track publication
.
References: Hu, H.
, Kang, L.
, Zhang, J.
, Wu, Z.
, Wang, H.
, Huang, M.
, Lan, P.
, Wu, X.
, Wang, C.
, Cao, W.
, Hu, J.
, Huang, Y.
, Huang, L.
, Wang, H.
, Shi, L.
, Cai, Y.
, Shen, C.
, Ling, J.
, Xie, X.
, Cai, Y.
, … Deng, Y.
(2022).
Neoadjuvant PD-1 blockade with toripalimab, with or without celecoxib, in mismatch repair-deficient or microsatellite instability-high, locally advanced, colorectal cancer (PICC): a single-centre, parallel-group, non-comparative, randomised, phase 2 trial.
The lancet.
Gastroenterology & hepatology, 7(1), 38–48.
https://doi.
org/10.
1016/S2468-1253(21)00348-4
