Evidence map›Paper›PMID 35192397›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Efficacy and Safety of Sintilimab Plus Anlotinib for PD-L1-Positive Recurrent or Metastatic Cervical Cancer: A Multicenter, Single-Arm, Prospective Phase II Trial.

Qin Xu, Junjie Wang, Yang Sun, Yibin Lin, Jing Liu, Yanhong Zhuo, Zhangzhou Huang, Songhua Huang, Ying Chen, Li Chen and 7 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 106 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
106citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

106 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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46 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Qin XuDepartments of Gynecology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Jinan District, Fuzhou, Fujian Province, China.
Junjie WangDepartment of Radiation, Peking University Third Hospital, Haidian District, Beijing, China.
Yang SunDepartments of Gynecology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Jinan District, Fuzhou, Fujian Province, China.
Yibin LinDepartments of Gynecology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Jinan District, Fuzhou, Fujian Province, China.
Jing LiuDepartments of Gynecology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Jinan District, Fuzhou, Fujian Province, China.
Yanhong ZhuoDepartment of Radiation Oncology, Zhangzhou Hospital, Teaching Hospital of Fujian Medical University, Zhangzhou, Fujian Province, China.
Zhangzhou HuangDepartments of Physicians, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Jinan District, Fuzhou, Fujian Province, China.
Songhua HuangDepartment of Oncology, Sanming Second Hospital, Yongan, Fujian Province, China.
Ying ChenDepartments of Gynecology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Jinan District, Fuzhou, Fujian Province, China.
Li ChenDepartments of Gynecology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Jinan District, Fuzhou, Fujian Province, China.
Meifang KeDepartments of Gynecology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Jinan District, Fuzhou, Fujian Province, China.
Li LiDepartments of Gynecology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Jinan District, Fuzhou, Fujian Province, China.
Zirong LiDeparment of Radiation Oncology, Longyan First Hospital, Affiliated to Fujian Medical University, Longyan, Fujian Province, China.
Junping PanDepartments of Gynecology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Jinan District, Fuzhou, Fujian Province, China.
Yanwen SongDepartments of Gynecology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Jinan District, Fuzhou, Fujian Province, China.
Rongqiang LiuDepartment of Radiation, Nanping First Hospital, Yanping District, Nanping, Fujian Province, China.
Chuanben ChenDepartment of Radiation Oncology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Jinan District, Fuzhou, Fujian Province, China.ORCID 0000-0002-9890-255X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeNo combined immunotherapy and antiangiogenic therapy have been investigated in exclusively programmed death-ligand 1 (PD-L1)-positive advanced cervical cancer (CA). We investigated the efficacy and safety of sintilimab plus anlotinib as second-line or later therapy for PD-L1-positive recurrent or metastatic (R/M) CA. PATIENTS AND

methodsPatients with PD-L1-positive (Combined Positive Score ≥ 1) R/M CA who progressed after at least one prior systemic chemotherapeutic regimen or could not tolerate chemotherapy were eligible for the phase II trial. The patients received 200 mg sintilimab once on day 1 and 10 mg anlotinib once daily on days 1-14 every 3 weeks. The primary end point was investigator-confirmed objective response rate (ORR) per RECIST v1.1. Secondary end points included progression-free survival (PFS), overall survival, and disease control rate. Biomarkers were explored.

resultsForty-two patients were enrolled. The ORR was 54.8% (95% CI, 38.7 to 70.2). In 39 efficacy-evaluable patients, the ORR was 59.0% (95% CI, 42.1 to 74.4); the disease control rate was 94.9% (95% CI, 82.7 to 99.4). The median PFS was 9.4 months (95% CI, 8.0 to 14.6). The median overall survival was not reached. Furthermore, 85.8% of the patients experienced treatment-related adverse events. The most frequent treatment-related adverse events were hypothyroidism (33.3%), elevated aspartate aminotransferase levels (21.4%), and hypertension (19.0%). Patients with altered

conclusionSintilimab plus anlotinib as second-line or later therapy is efficacious and safe for patients with advanced CA who have failed prior chemotherapy.

Indexed as

B7-H1 AntigenUterine Cervical NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansIndolesNeoplasm Recurrence, LocalPhosphatidylinositol 3-KinasesProspective StudiesQuinolinesanlotinibAntibodies, Monoclonal, HumanizedB7-H1 AntigenCD274 protein, humanIndolesPhosphatidylinositol 3-KinasesQuinolinessintilimab

Identifiers

PMID35192397
PMCPMC9148684

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.