Evidence map›Paper›PMID 37325938›Full record

Trial reportCancer medicine2023

Efficacy and safety of irinotecan combined with raltitrexed or irinotecan monotherapy for salvage chemotherapy of esophageal squamous cell cancer: A prospective, open label, randomized phase II study.

Xichao Dai, Leilei Tao, Jinqiu Wang, Wenjuan Wu, Weigang Bian, Xichun Dai, Surong Chen

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 17% of its field
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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
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

7 authors at 2 institutions in 1 country.

Xichao DaiDepartment of Oncology, First people's Hospital of Yancheng, Yancheng, China.
Leilei TaoDepartment of Oncology, First people's Hospital of Yancheng, Yancheng, China.
Jinqiu WangYancheng Dafeng People's Hospital, Yancheng, China.
Wenjuan WuDepartment of Oncology, Northern Jiangsu People's Hospital, Clinical Medical College of Yangzhou University, Yangzhou, China.ORCID 0000-0003-2773-9959
Weigang BianDepartment of Oncology, First people's Hospital of Yancheng, Yancheng, China.
Xichun DaiDepartment of Oncology, Hongze People's Hospital of Huai'an City, China.
Surong ChenDepartment of Oncology, First people's Hospital of Yancheng, Yancheng, China.
Xuzhou Medical College · CNNantong University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEsophageal squamous cell cancer (ESCC) accounts for approximately 90% of esophageal cancer cases in China. There are no standard regimens for second or third-line chemotherapy of metastatic squamous esophageal cancer. The objective of this study was to investigate the security and effectiveness of irinotecan combined with raltitrexed or irinotecan monotherapy for salvage chemotherapy of ESCC.

methodsOne hundred and twenty-eight patients with metastatic ESCC confirmed by histopathology were enrolled into this study. These patients had failure of the first-line chemotherapy combination of fluorouracil or platinum or paclitaxel and had not undergone chemotherapy with irinotecan or raltitrexed previously. Patients were randomly divided into irinotecan combined with raltitrexed group (experiment group) and irinotecan monotherapy group (control group). Overall survival (OS) and progression-free survival (PFS) were the primary endpoint.

resultsIn the control group, the median PFS (mPFS) and median OS (mOS) of patients were 3.37 and 5.3 months. In the experiment group, mPFS and mOS were 3.91 and 7.0 months. There was statistical significance of PFS and OS between two groups (PFS P = 0.002, OS P = 0.01). In subgroup analysis, in the second-line treatment, the mPFS of control and experiment group, was 3.90 and 4.60 months, mOS was 6.95 and 8.5 months, which was statistically significant differences between the two groups. (PFS P = 0.001, OS P = 0.005), In the third-line and beyond treatment, mPFS of control and experiment group was 2.80 and 3.19 months, mOS were 4.5 and 4.8 months. But there was no significant difference of PFS or OS between the two groups (PFS P = 0.19, OS P = 0.31). There was no statistical significance of toxicity side effects between two groups.

conclusionsThe PFS and OS of irinotecan plus raltitrexed may be better than that of irinotecan monotherapy, especially in second line treatment, which should be confirmed with a phase III study including much more patients.

Indexed as

Carcinoma, Squamous CellEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaAntineoplastic Combined Chemotherapy ProtocolsHumansIrinotecanProspective StudiesQuinazolinesThiophenesIrinotecanQuinazolinesraltitrexedThiophenesesophageal squamous cell canceririnotecanraltitrexedsalvage chemotherapy

Identifiers

PMID37325938
PMCPMC10469638
OpenAlexW4380872081

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.