Sintilimab Plus Modified FOLFIRINOX in Metastatic or Recurrent Pancreatic Cancer : The Randomized Phase II CISPD3 Trial
© 2023. Society of Surgical Oncology..
BACKGROUND: Folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) or modified FOLFIRINOX (mFFX) is the first-line standard of care for metastatic pancreatic adenocarcinoma; effective and safe treatment strategies are needed as survival remains poor. Sintilimab, a human immunoglobulin G4 monoclonal antibody for programmed cell death-1, has shown efficacy in various cancers. We evaluated the efficacy and safety of sintilimab with mFFX for metastatic/recurrent pancreatic ductal adenocarcinoma in China.
PATIENTS AND METHODS: This was a single-center, randomized, controlled, open-label phase II study. Patients were assigned 1:1 to sintilimab + mFFX or mFFX (n = 55, each).
RESULTS: In the intention-to-treat population, median overall survivals (primary endpoint) were similar in the sintilimab + mFFX and mFFX groups: 10.9 and 10.8 months, respectively [hazard ratio (HR) 1.07, 95% confidence interval (CI) 0.69-1.68]. The objective response rate was higher [50.0% (95% CI 34.6-65.4%) versus 23.9% (95% CI 11.1-36.7%)] in the sintilimab + mFFX group (P < 0.05). Median (HR, 95% CI) progression-free survival and disease control rates (95% CI) were also similar at 5.9 and 5.7 months (0.93, 0.62-1.40), and 84.1% (72.8-95.3%) and 71.7%, (58.2-85.3%), respectively. Incidences of grade ≥ 3 treatment-emergent adverse events were 84.9% (45/53) and 74.1% (40/54), and that of grade ≥ 3 immune-related adverse events were 5.7% (3/53) and 0 in each group, respectively.
CONCLUSIONS: The study did not meet its primary endpoint, no clear survival benefit was observed, and the benefit of sintilimab + mFFX for advanced pancreatic cancer was not supported; however, the findings suggest that using this regimen for pancreatic cancer is feasible, has an acceptable safety profile, and leads to an objective response rate of 50%. Trial registration ClinicalTrials.Gov; NCT03977272.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:30 |
|---|---|
| Enthalten in: |
Annals of surgical oncology - 30(2023), 8 vom: 01. Aug., Seite 5071-5080 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Fu, Qihan [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
8FU7FQ8UPK |
|---|
| Anmerkungen: |
Date Completed 07.07.2023 Date Revised 13.12.2023 published: Print-Electronic ClinicalTrials.gov: NCT03977272 Citation Status MEDLINE |
|---|
| doi: |
10.1245/s10434-023-13383-w |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM355571773 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM355571773 | ||
| 003 | DE-627 | ||
| 005 | 20231227131215.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1245/s10434-023-13383-w |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1225.xml |
| 035 | |a (DE-627)NLM355571773 | ||
| 035 | |a (NLM)37052821 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Fu, Qihan |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Sintilimab Plus Modified FOLFIRINOX in Metastatic or Recurrent Pancreatic Cancer |b The Randomized Phase II CISPD3 Trial |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 07.07.2023 | ||
| 500 | |a Date Revised 13.12.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03977272 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. Society of Surgical Oncology. | ||
| 520 | |a BACKGROUND: Folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) or modified FOLFIRINOX (mFFX) is the first-line standard of care for metastatic pancreatic adenocarcinoma; effective and safe treatment strategies are needed as survival remains poor. Sintilimab, a human immunoglobulin G4 monoclonal antibody for programmed cell death-1, has shown efficacy in various cancers. We evaluated the efficacy and safety of sintilimab with mFFX for metastatic/recurrent pancreatic ductal adenocarcinoma in China | ||
| 520 | |a PATIENTS AND METHODS: This was a single-center, randomized, controlled, open-label phase II study. Patients were assigned 1:1 to sintilimab + mFFX or mFFX (n = 55, each) | ||
| 520 | |a RESULTS: In the intention-to-treat population, median overall survivals (primary endpoint) were similar in the sintilimab + mFFX and mFFX groups: 10.9 and 10.8 months, respectively [hazard ratio (HR) 1.07, 95% confidence interval (CI) 0.69-1.68]. The objective response rate was higher [50.0% (95% CI 34.6-65.4%) versus 23.9% (95% CI 11.1-36.7%)] in the sintilimab + mFFX group (P < 0.05). Median (HR, 95% CI) progression-free survival and disease control rates (95% CI) were also similar at 5.9 and 5.7 months (0.93, 0.62-1.40), and 84.1% (72.8-95.3%) and 71.7%, (58.2-85.3%), respectively. Incidences of grade ≥ 3 treatment-emergent adverse events were 84.9% (45/53) and 74.1% (40/54), and that of grade ≥ 3 immune-related adverse events were 5.7% (3/53) and 0 in each group, respectively | ||
| 520 | |a CONCLUSIONS: The study did not meet its primary endpoint, no clear survival benefit was observed, and the benefit of sintilimab + mFFX for advanced pancreatic cancer was not supported; however, the findings suggest that using this regimen for pancreatic cancer is feasible, has an acceptable safety profile, and leads to an objective response rate of 50%. Trial registration ClinicalTrials.Gov; NCT03977272 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 7 | |a folfirinox |2 NLM | |
| 650 | 7 | |a sintilimab |2 NLM | |
| 650 | 7 | |a 8FU7FQ8UPK |2 NLM | |
| 650 | 7 | |a Fluorouracil |2 NLM | |
| 650 | 7 | |a U3P01618RT |2 NLM | |
| 650 | 7 | |a Leucovorin |2 NLM | |
| 650 | 7 | |a Q573I9DVLP |2 NLM | |
| 700 | 1 | |a Chen, Yiwen |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, Dabing |e verfasserin |4 aut | |
| 700 | 1 | |a Guo, Chengxiang |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Xiaochen |e verfasserin |4 aut | |
| 700 | 1 | |a Xiao, Wenbo |e verfasserin |4 aut | |
| 700 | 1 | |a Xue, Xing |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Qi |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Xiang |e verfasserin |4 aut | |
| 700 | 1 | |a Gao, Shunliang |e verfasserin |4 aut | |
| 700 | 1 | |a Que, Risheng |e verfasserin |4 aut | |
| 700 | 1 | |a Shen, Yan |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Jian |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Min |e verfasserin |4 aut | |
| 700 | 1 | |a Bai, Xueli |e verfasserin |4 aut | |
| 700 | 1 | |a Liang, Tingbo |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Annals of surgical oncology |d 1995 |g 30(2023), 8 vom: 01. Aug., Seite 5071-5080 |w (DE-627)NLM074734997 |x 1534-4681 |7 nnns |
| 773 | 1 | 8 | |g volume:30 |g year:2023 |g number:8 |g day:01 |g month:08 |g pages:5071-5080 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1245/s10434-023-13383-w |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 30 |j 2023 |e 8 |b 01 |c 08 |h 5071-5080 | ||