Evidence map›Paper›PMID 33591324›Full record

Trial reportBlood advances2021

A randomized phase 2/3 study of R-CHOP vs CHOP combined with dose-dense rituximab for DLBCL: the JCOG0601 trial.

Ken Ohmachi, Tomohiro Kinoshita, Kensei Tobinai, Gakuto Ogawa, Tomonori Mizutani, Nobuhiko Yamauchi, Noriko Fukuhara, Toshiki Uchida, Kazuhito Yamamoto, Kana Miyazaki and 24 more

Open access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood advances, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 5% 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

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Review
  14. DA-R-EPOCH vs R-CHOP in DLBCL: How do we choose?Clinical advances in hematology & oncology : H&O · 2021
    Review
  15. Article
  16. Review
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

34 authors at 20 institutions in 1 country.

Ken OhmachiDepartment of Hematology and Oncology, Tokai University School of Medicine, Kanagawa, Japan.
Tomohiro KinoshitaDepartment of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Aichi, Japan.
Kensei TobinaiDepartment of Hematology and.
Gakuto OgawaJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Tomonori MizutaniJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Nobuhiko YamauchiDepartment of Hematology, National Cancer Center Hospital East, Chiba, Japan.
Noriko FukuharaDepartment of Hematology, Tohoku University Hospital, Miyagi, Japan.
Toshiki UchidaDepartment of Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Aichi, Japan.
Kazuhito YamamotoDepartment of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Aichi, Japan.
Kana MiyazakiDepartment of Hematology and Oncology, Mie University Graduate School of Medicine, Mie, Japan.
Norifumi TsukamotoDepartment of Hematology, Gunma University Hospital, Gunma, Japan.
Shinsuke IidaDepartment of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan.
Takahiko UtsumiDepartment of Hematology, Shiga General Hospital, Shiga, Japan.
Isao YoshidaDepartment of Hematologic Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.
Yoshitaka ImaizumiDepartment of Hematology, Nagasaki University Hospital, Nagasaki, Japan.
Takashi TokunagaDepartment of Hematology, National Hospital Organization Nagoya Medical Center, Aichi, Japan.
Shinichiro YoshidaDepartment of Hematology, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan.
Yasufumi MasakiDepartment of Hematology and Immunology, Medicine, Kanazawa Medical University, Ishikawa, Japan.
Tohru MurayamaDepartment of Hematology, Hyogo Cancer Center, Hyogo, Japan.
Yoshihiro YakushijinFirst Department of Internal Medicine, Ehime University Graduate School of Medicine, Ehime, Japan.
Youko SuehiroDepartment of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Kisato NosakaDepartment of Hematology, Kumamoto University Hospital, Kumamoto, Japan.
Nobuaki DobashiDepartment of Clinical Oncology and Hematology, The Jikei University Daisan Hospital, Tokyo, Japan.
Junya KurodaDivision of Hematology and Oncology, Department of Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Yasushi TakamatsuDepartment of Medical Oncology, Hematology and Infectious Diseases, Fukuoka University Hospital, Fukuoka, Japan; and.
Dai MaruyamaDepartment of Hematology and.
Kiyoshi AndoDepartment of Hematology and Oncology, Tokai University School of Medicine, Kanagawa, Japan.
Kenichi IshizawaDepartment of Hematology, Tohoku University Hospital, Miyagi, Japan.
Michinori OguraDepartment of Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Aichi, Japan.
Tadashi YoshinoDepartment of Pathology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Tomomitsu HottaDepartment of Hematology, National Hospital Organization Nagoya Medical Center, Aichi, Japan.
Kunihiro TsukasakiDepartment of Hematology, National Cancer Center Hospital East, Chiba, Japan.
Hirokazu NagaiDepartment of Hematology, National Hospital Organization Nagoya Medical Center, Aichi, Japan.
Japan Clinical Oncology Group
National Hospital Organization · JPAichi Cancer Center · JPJapan Clinical Cancer Research Organization · JPJapanese Red Cross Nagoya Daini Hospital · JPNational Cancer Center Hospital East · JPTohoku University Hospital · JPTokai University · JPEhime University · JPFukuoka University Hospital · JPGunma University Hospital · JPHyogo Prefectural Cancer Center · JPKanazawa Medical University · JPKumamoto University Hospital · JPKyoto Prefectural University of Medicine · JPMie University · JPNagasaki Medical Center · JPNagasaki University Hospital · JPNagoya City University · JPNational Hospital Organization Kyushu Cancer Center · JPOkayama University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Rituximab plus cyclophosphamide-doxorubicin-vincristine-prednisone (R-CHOP) is the standard of care for untreated diffuse large B-cell lymphoma (DLBCL). However, the schedule for rituximab administration has not been optimized. To compare standard R-CHOP with CHOP plus dose-dense weekly rituximab (RW-CHOP) in patients with untreated DLBCL, we conducted a phase 2/3 study (JCOG0601, jRCTs031180139). Patients were randomly assigned to R-CHOP (CHOP-21 with 8 doses of rituximab once every 3 weeks [375 mg/m2]) or RW-CHOP (CHOP-21 with 8 doses of weekly rituximab [375 mg/m2]) groups. The primary end point of the phase 2 component was percent complete response (%CR) of the RW-CHOP arm, whereas that of the phase 3 component was progression-free survival (PFS). Between December 2007 and December 2014, 421 untreated patients were randomly assigned to R-CHOP (213 patients) or RW-CHOP (208 patients). The %CR in the RW-CHOP arm was 85.3% and therefore met the prespecified decision criteria for the phase 2 component. With a median follow-up of 63.4 months, the 3-year PFS and overall survival were 79.2% and 88.7% in the R-CHOP arm and 80.3% and 90.4% in the RW-CHOP arm, respectively. There was no significant difference in PFS (hazard ratio, 0.95; 90.6% confidence interval, 0.68-1.31). Although the safety profile and efficacy of RW-CHOP was comparable with R-CHOP and its tolerability was acceptable, weekly rituximab in combination with CHOP during the early treatment period did not improve PFS in untreated patients with DLBCL. This trial was registered at jrct.niph.go.jp as #jRCTs031180139.

Indexed as

Lymphoma, Large B-Cell, DiffuseAntineoplastic Combined Chemotherapy ProtocolsCyclophosphamideDoxorubicinHumansPrednisoneRituximabVincristineCyclophosphamideDoxorubicinPrednisoneRituximabVincristine

Identifiers

PMID33591324
PMCPMC7903239
OpenAlexW3130564240

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.