Evidence map›Paper›PMID 35418080›Full record

Trial reportBMC cancer2022

Four cycles of R-CHOP followed by two applications of rituximab based on negative interim PET/CT: an analysis of a prospective trial.

Jia Jin, Dongmei Ji, Zuguang Xia, Kai Xue, Qunling Zhang, Yizhen Liu, Junning Cao, Xiaonan Hong, Juan J Gu, Ye Guo and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report 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 NCT01804127 (Interim PET/CT Guided Cycle Numbers of R-CHOP in Patients With Diffuse Large B-cell Lymphoma), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 46% 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.

NCT01804127 phase2unknown statusnot on this map

Interim PET/CT Guided Cycle Numbers of R-CHOP in Patients With Diffuse Large B-cell Lymphoma: a Exploratory Phase II Study Study

TypeinterventionalSponsorFudan UniversityRan2013 to 2017Enrolled196ConditionsDiffuse Large B-cell LymphomaArmsR-CHOP
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  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

11 authors at 4 institutions in 2 countries.

Jia JinDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Shanghai, 200032, China.
Dongmei JiDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Shanghai, 200032, China.
Zuguang XiaDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Shanghai, 200032, China.
Kai XueDepartment of Hematology, Shanghai Jiao Tong University School of Medicine, Affiliated Ruijin Hospital, Shanghai, 200025, China.
Qunling ZhangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Shanghai, 200032, China.
Yizhen LiuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Shanghai, 200032, China.
Junning CaoDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Shanghai, 200032, China.
Xiaonan HongDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Shanghai, 200032, China.
Juan J GuOncology Department, Northern Jiangsu People;s Hospital; Cancer Institute affiliated to Northern Jiangsu People's Hospital; Medical College, Yangzhou University, Yangzhou, 255000, Jiangsu Province, China.
Ye GuoDepartment of Oncology, Shanghai East Hospital, Tongji University, Shanghai, 200120, China. pattrickguo@gmail.com.
Fangfang LvDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong'an Road, Shanghai, 200032, China. lvff80@163.com.ORCID http://orcid.org/0000-0001-6636-3056
Shanghai Medical College of Fudan University · CNCancer Institute (WIA) · INShanghai East Hospital · CNShanghai Jiao Tong University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundR-CHOP with or without radiotherapy is the standard treatment for limited-stage diffuse large B-cell lymphoma (DLBCL). To prevent overtreatment, we assessed whether four cycles of CHOP plus six applications of rituximab was adequate with negative interim PET/CT and the role of consolidation radiotherapy specifically for patients with Waldeyer's ring DLBCL. One hundred and twenty-nine patients with limited-stage DLBCL were enrolled in this open-label, nonrandomized, single-arm, phase 2 clinical trial (NCT01804127).

methodsAll patients were initially treated with 4 cycles of R-CHOP and underwent interim PET/CT. Patients with negative PET/CT (Deauville scores 1-2) received 2 additional cycles of rituximab monotherapy, unless they had any risk factors (primary mediastinal large B-cell lymphoma, extranodal primary or bulky disease). Otherwise, patients received another 2 cycles of R-CHOP. Patients with partial response on interim PET/CT received another 4 cycles of R-CHOP. No radiotherapy was conducted in Waldeyer's ring DLBCL patients with negative PET/CT. The primary endpoint was 3-year progression-free survival (PFS). Overall survival (OS) in this study was compared with those from a historical study (NCT 00854568159).

resultsOne hundred fifteen interim PET/CT scans (89.1%) were negative after 4 cycles of R-CHOP. An elevated lactate dehydrogenase level was significantly associated with positive interim PET/CT (P < 0.05). A trend of inferior outcome was observed in patients with positive interim PET/CT in terms of 3-year PFS (78.6% vs. 91.9%, P = 0.24) and 3-year OS (85.7% vs. 95.6%, P = 0.16). There were no PFS or OS differences found between patients treated with 4R-CHOP+2R and those treated with 6R-CHOP from a historical control study. Patients with Waldeyer's ring DLBCL and negative interim PET/CT achieved a 3-year PFS of 87.2% and a 3-year OS of 89.7%.

conclusionsOur results suggested that for interim PET/CT-negative patients without risk factors, the extra 2 cycles of CHOP might be omitted, and radiotherapy might also be omitted in patients with Waldeyer's ring DLBCL without compromising the efficacy. These results need to be confirmed in a randomized study.

trial registrationclinicaltrials.gov ,  NCT01804127 . Date of first registration: 05/03/2013.

Indexed as

Lymphoma, Large B-Cell, DiffusePositron Emission Tomography Computed TomographyAntineoplastic Combined Chemotherapy ProtocolsCyclophosphamideDoxorubicinFluorodeoxyglucose F18HumansPrednisoneProspective StudiesRituximabVincristineCyclophosphamideDoxorubicinFluorodeoxyglucose F18PrednisoneRituximabVincristineDiffuse large B-cell lymphomaLimited stagePositron emission tomographyPrognosis

Identifiers

PMID35418080
PMCPMC9006508
OpenAlexW4223550018

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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.