PMID- 38106561
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231219
IS  - 2589-5370 (Electronic)
IS  - 2589-5370 (Linking)
VI  - 65
DP  - 2023 Nov
TI  - Efficacy and safety of sintilimab plus albumin-bound-paclitaxel in recurrent or 
      metastatic cervical cancer: a multicenter, open-label, single-arm, phase II 
      trial.
PG  - 102274
LID - 10.1016/j.eclinm.2023.102274 [doi]
LID - 102274
AB  - BACKGROUND: Sintilimab is an antibody against programmed cell death protein 1. We 
      assessed the efficacy and safety of sintilimab plus albumin-bound 
      (nab)-paclitaxel for the treatment of recurrent or metastatic cervical cancer. 
      METHODS: This multicenter, open-label, single-arm, phase II study 
      (ClinicalTrials.gov identifier NCT04341883) enrolled patients with recurrent or 
      metastatic cervical cancer who progressed after at least one line of systemic 
      therapy. The patients received sintilimab 200 mg and nab-paclitaxel 260 mg/m(2) 
      body surface area every 3 weeks. The primary endpoint was objective response rate 
      (ORR) assessed by investigators per Response Evaluation Criteria in Solid Tumors 
      version 1.1. Key secondary endpoints were progression-free survival (PFS), 
      overall survival (OS), duration of response (DoR), and safety. FINDINGS: From 
      January 13, 2020 to February 21, 2022, 27 patients were enrolled and received 
      treatment. Median patient age was 50 years (range, 34-68 years). By data cut-off 
      (May 22, 2022), in intention-to-treat population, ORR was 44.4% (95% CI, 
      24.4%-64.5%). The disease control rate was 88.9% (95% CI, 70.8%-97.6%). Median 
      PFS was 5.2 months (95% CI, 2.7-7.7 months). Median DoR was 3.8 months (95% CI, 
      0.7-6.9 months), and median OS was 13.1 months (95% CI, 5.8-20.4 months). 
      Treatment-related grade 3 or 4 adverse events (AEs) occurred in 44.4% of the 
      patients, and the most common AEs were decreased neutrophil count (22.2%), 
      decreased white blood cell count (14.8%), and anemia (7.4%). The most common 
      potential immune-related AEs were grade 1-2 hypothyroidism (18.5%), neutropenia 
      (11.1%), and rash (7.4%). INTERPRETATION: Sintilimab plus nab-paclitaxel 
      treatment shows promising antitumor activity and manageable toxicity in patients 
      with advanced cervical cancer. Larger randomized controlled trials are required 
      for validation. FUNDING: Innovent Biologics Co., Ltd.; Csps Holdings Co., Ltd.
CI  - (c) 2023 The Author(s).
FAU - Wang, Yin
AU  - Wang Y
AD  - Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State 
      Key Laboratory of Oncology in South China, Collaborative Innovation Center for 
      Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, China.
FAU - Zhao, Jing
AU  - Zhao J
AD  - Department of Medical Imaging, Sun Yat-sen University Cancer Center, State Key 
      Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer 
      Medicine, 651 Dongfeng Road East, Guangzhou 510060, China.
FAU - Liang, Haixi
AU  - Liang H
AD  - Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State 
      Key Laboratory of Oncology in South China, Collaborative Innovation Center for 
      Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, China.
FAU - Liu, Junxiu
AU  - Liu J
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital, Sun Yat-sen 
      University, 58 Zhongshaner Road, Guangzhou 510080, China.
FAU - Huang, Shenjiao
AU  - Huang S
AD  - Department of Obstetrics and Gynecology, Guangzhou Women and Children's Medical 
      Center, Guangzhou Medical University, 9 Jinsui Road, Guangzhou 556599, China.
FAU - Zou, Guorong
AU  - Zou G
AD  - Department of Radiotherapy, Panyu Central Hospital, Cancer Institute of Panyu, 8 
      Fuyu East Road, Guangzhou 511400, China.
FAU - Huang, Xin
AU  - Huang X
AD  - Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State 
      Key Laboratory of Oncology in South China, Collaborative Innovation Center for 
      Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, China.
FAU - Lan, Chunyan
AU  - Lan C
AD  - Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State 
      Key Laboratory of Oncology in South China, Collaborative Innovation Center for 
      Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT04341883
PT  - Journal Article
DEP - 20231024
PL  - England
TA  - EClinicalMedicine
JT  - EClinicalMedicine
JID - 101733727
PMC - PMC10725023
OTO - NOTNLM
OT  - Albumin-bound-paclitaxel
OT  - Cervical cancer
OT  - Immunotherapy
OT  - Sintilimab
COIS- All authors declare no competing interests.
EDAT- 2023/12/18 06:41
MHDA- 2023/12/18 06:42
PMCR- 2023/10/24
CRDT- 2023/12/18 04:42
PHST- 2023/06/21 00:00 [received]
PHST- 2023/09/25 00:00 [revised]
PHST- 2023/09/28 00:00 [accepted]
PHST- 2023/12/18 06:42 [medline]
PHST- 2023/12/18 06:41 [pubmed]
PHST- 2023/12/18 04:42 [entrez]
PHST- 2023/10/24 00:00 [pmc-release]
AID - S2589-5370(23)00451-0 [pii]
AID - 102274 [pii]
AID - 10.1016/j.eclinm.2023.102274 [doi]
PST - epublish
SO  - EClinicalMedicine. 2023 Oct 24;65:102274. doi: 10.1016/j.eclinm.2023.102274. 
      eCollection 2023 Nov.