Evidence map›Paper›PMID 35168547›Full record

ArticleBMC cancer2022

Rituximab in combination with gemcitabine plus cisplatin in patients with recurrent and metastatic head and neck squamous cell carcinoma: a phase I trial.

Ching-Yun Hsieh, Ming-Yu Lien, Chen-Yuan Lin, Wen-Jyi Lo, Chung-Hung Hua, Wei-Chao Chang, Chang-Fang Chiu, Ching-Chan Lin

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04361409 (A Phase I Pilot Study of B Cell Depletion With Rituximab Following by Chemotherapy With Cisplatin Plus Gemcitabine for Recurrent Unresectable or Metastatic Head and Neck Cancer Squamous Cell Carcinoma Patients.), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 20% 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.

NCT04361409 phase1completednot on this map

A Phase I Pilot Study of B Cell Depletion With Rituximab Following by Chemotherapy With Cisplatin Plus Gemcitabine for Recurrent Unresectable or Metastatic Head and Neck Cancer Squamous Cell Carcinoma Patients.

TypeinterventionalSponsorChina Medical University HospitalRan2013 to 2017Enrolled10ConditionsHead and Neck Squamous CarcinomaArmsRituximab, Cisplatin, Gemcitabine
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. B cells in tumor metastasis: friend or foe?International journal of biological sciences · 2023
    Review
  6. 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

8 authors at 2 institutions in 1 country.

Ching-Yun HsiehDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, China Medical University, 2 Yude Rd, North District, Taichung, 404, Taiwan.
Ming-Yu LienDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, China Medical University, 2 Yude Rd, North District, Taichung, 404, Taiwan.
Chen-Yuan LinDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, China Medical University, 2 Yude Rd, North District, Taichung, 404, Taiwan.
Wen-Jyi LoDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, China Medical University, 2 Yude Rd, North District, Taichung, 404, Taiwan.
Chung-Hung HuaDepartment of Otorhinolaryngology, China Medical University Hospital, China Medical University, Taichung, 404, Taiwan.
Wei-Chao ChangGraduate Institute of Biomedical Sciences and Center for Molecular Medicine, China Medical University, Taichung, Taiwan.
Chang-Fang ChiuDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, China Medical University, 2 Yude Rd, North District, Taichung, 404, Taiwan.
Ching-Chan LinDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, China Medical University, 2 Yude Rd, North District, Taichung, 404, Taiwan. d13256@mail.cmuh.org.tw.
China Medical University · TWChina Medical University Hospital · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe treatment of recurrent or metastatic head and neck squamous-cell carcinoma (R/M HNSCC) remains challenging. Preclinical studies revealed that B cell depletion could modulate the microenvironment and overcome chemoresistance. We conducted a phase I study to evaluate the feasibility and safety of B cell depletion using the anti-CD20 antibody rituximab to treat HNSCC.

methodsTen patients were enrolled in two protocols. The first four patients treated using protocol 1 received rituximab 1000 mg on days -14 and -7, followed by gemcitabine/cisplatin every 3 weeks, and rituximab was administered every 6 months thereafter. Because of disease hyperprogression, protocol 1 was amended to protocol 2, which consisted of the concomitant administration of rituximab 375 mg/m

resultsThree patients treated using protocol 1 exhibited rapid disease progression, and the remaining patient could not undergo evaluation after rituximab treatment. Conversely, no unpredicted harm was observed in the six patients treated using protocol 2. Among these patients, one achieved complete response, and two had partial responses. The disease-free durations in these patients were 7.0, 6.2, and 7.1 months, respectively. Immune cell analysis revealed a higher ratio of cytotoxic T cells to regulatory T cells in responders than in non-responders.

conclusionsB cell depletion using rituximab alone in patients with HNSCC can cause hyperprogressive disease. Contrarily, the co-administration of rituximab and cisplatin/gemcitabine was feasible and safe.

trial registrationClinicalTrials.gov Identifier: NCT04361409 , 24 April 2020, retrospectively registered.

Indexed as

AdultAntineoplastic Combined Chemotherapy ProtocolsCisplatinDeoxycytidineDisease-Free SurvivalDrug Administration ScheduleFeasibility StudiesGemcitabineHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm Recurrence, LocalPilot ProjectsRituximabSquamous Cell Carcinoma of Head and NeckCisplatinDeoxycytidineGemcitabineRituximabAnti-CD20 antibodyChemotherapyHead and neck squamous-cell carcinomaRituximab

Identifiers

PMID35168547
PMCPMC8845344
OpenAlexW4220727654

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.