Evidence map›Paper›PMID 38831450›Full record

Trial reportBMC cancer2024

Simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) combined with nimotuzumab for locally advanced esophageal squamous cell carcinoma (ESCC): A phase II clinical trial.

Lan Wang, Lihong Liu, Yu Cao, Xiaoxi Chen, Shutang Liu, Xiaoning Li, Jing Han, Qi Wang, Chun Han

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. 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

9 authors.

Lan Wang *Department of Radiation Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, China.
Lihong Liu *Department of Radiation Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, China.
Yu CaoAnti-Cancer Association of Hebei Province, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Xiaoxi ChenDepartment of Radiation Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, China.
Shutang LiuDepartment of Radiation Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, China.
Xiaoning LiDepartment of Radiation Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, China.
Jing HanDepartment of Medical Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Qi WangDepartment of Radiation Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, China.
Chun HanDepartment of Radiation Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, 050011, China. 46100725@hebmu.edu.cn.

Funding

National emphasis research and development project 2018YFC1313203The "Tumor Targeted Research Special Fund" project of the Institute of Hospital Management of the National Health Commission WJWYGS-201816
6 · The paper itself

Abstract

objectiveTo evaluate the feasibility, safety and efficacy of concurrent simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) combined with nimotuzumab in the treatment of locally advanced esophageal squamous cell cancer (ESCC).

methodsEligible patients were histologically proven to have locally advanced ESCC, and were unable to tolerate or refuse concurrent chemoradiotherapy (CCRT). Enrolled patients underwent concurrent SIB-IMRT in combination with nimotuzumab. SIB-IMRT: For the planning target volume of clinical target volume (PTV

results(1) From December 2018 to August 2021, 35 patients with stage II-IVA ESCC were enrolled and 34 patients completed the full course of radiotherapy and the intravenous infusion of full-dose nimotuzumab. The overall completion rate of the protocol was 97.1%. (2) No grade 4-5 adverse events occurred in the entire group. The most common treatment-related toxicity was acute radiation esophagitis, with a total incidence of 68.6% (24/35). The incidence of grade 2 and 3 acute esophagitis was 25.7% (9/35) and 17.1% (6/35), respectively. The incidence of acute radiation pneumonitis was 8.6% (3/35), including one case each of Grades 1, 2, and 3 pneumonitis. Adverse events in other systems included decreased blood cells, hypoalbuminemia, electrolyte disturbances, and skin rash. Among these patients, five experienced grade 3 electrolyte disturbances during the treatment period (three with grade 3 hyponatremia and two with grade 3 hypokalemia). (3) Efficacy: The overall CR rate was 22.8%, PR rate was 71.4%, ORR rate was 94.2%, and DCR rate was 97.1%.(4) Local control and survival: The 1-, 2-, and 3-year local control (LC) rate, progression-free survival(PFS) rate, and overall survival(OS) rate for the entire group were 85.5%, 75.4%, and 64.9%; 65.7%, 54.1%, and 49.6%; and 77.1%, 62.9%, and 54.5%, respectively.

conclusionsThe combination of SIB-IMRT and nimotuzumab for locally advanced esophageal cancer demonstrated good feasibility, safety and efficacy. It offered potential benefits in local control and survival. Acute radiation esophagitis was the primary treatment-related toxicity, which is clinically manageable. This comprehensive treatment approach is worthy of further clinical exploration (ChiCTR1900027936).

Indexed as

Antibodies, Monoclonal, HumanizedChemoradiotherapyEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaRadiotherapy, Intensity-ModulatedAdultAgedAntineoplastic Agents, ImmunologicalFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalnimotuzumabEfficacyEsophageal squamous cell cancerNimotuzumabSafetySIB-IMRT

Identifiers

PMID38831450
PMCPMC11149230

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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.