Evidence map›Paper›PMID 29533000›Full record

Trial reportCancer medicine2018

Ibrutinib versus rituximab in relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma: a randomized, open-label phase 3 study.

Xiaojun Huang, Lugui Qiu, Jie Jin, Daobin Zhou, Xiequn Chen, Ming Hou, Jianda Hu, Yu Hu, Xiaoyan Ke, Junmin Li and 13 more

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 7 pooled it
3.5field-weighted citation impact, top 7% 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

29 citing papers in PubMed, 7 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. 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

23 authors at 16 institutions in 4 countries.

Xiaojun HuangPeking University People's Hospital, Beijing, China.ORCID 0000-0003-1906-5819
Lugui QiuInstitute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.
Jie JinThe First Affiliated Hospital, Zhejiang University College of Medicine, Zhejiang, China.
Daobin ZhouPeking Union Medical College Hospital, Beijing, China.
Xiequn ChenXijing Hospital, Shanxi, China.
Ming HouQilu Hospital of Shandong University, Jinan, China.
Jianda HuFujian Medical University Union Hospital, Fuzhou, China.
Yu HuWuhan Union Hospital, Wuhan, China.ORCID 0000-0002-2815-4568
Xiaoyan KePeking University Third Hospital, Beijing, China.
Junmin LiRuijin Hospital, Shanghai, China.
Yingmin LiangTangdu Hospital, Shanxi, China.
Ting LiuWest China Hospital, Chengdu, China.
Yue LvSun Yat-Sen University Cancer Center, Guangzhou, China.
Hanyun RenPeking Union Medical College Hospital, Beijing, China.
Aining SunThe First Affiliated Hospital of Soochow University, Suzhou, China.
Jianmin WangChanghai Hospital, The Second Military Medical University, Shanghai, China.
Chunting ZhaoThe Affiliated Hospital of Qingdao University Medical College, Qingdao, China.
Mariya SalmanJanssen Research & Development, Raritan, New Jersey.
Steven SunJanssen Research & Development, Raritan, New Jersey.
Angela HowesJanssen Research & Development, High Wycombe, UK.
Jingzhao WangJanssen China Research & Development Center, Beijing, China.
Peng WuJanssen China Research & Development Center, Beijing, China.
Jianyong LiJiangsu Province Hospital, Nanjing, China.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNJanssen (Belgium) · BEJanssen (United States) · USPeking University · CNRuijin Hospital · CNFirst Affiliated Hospital Zhejiang University · CNFujian Medical University · CNJanssen (United Kingdom) · GBQilu Hospital of Shandong University · CNQingdao University · CNSichuan University · CNSoochow University · CNSun Yat-sen University · CNTang Du Hospital · CNWuhan Union Hospital · CNXijing Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the Asia-Pacific region, treatment options are limited for patients with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Rituximab is widely used in this setting when purine analog-based therapies are not appropriate. We evaluated the efficacy and safety of ibrutinib compared with rituximab in a randomized, open-label phase 3 study in predominantly Asian patients with relapsed/refractory CLL/SLL. Patients (N = 160) were randomly assigned 2:1 to receive 420 mg ibrutinib (n = 106) until disease progression (PD) or unacceptable toxicity or up to six cycles of rituximab (n = 54). The primary endpoint was investigator-assessed progression-free survival (PFS); key secondary endpoints were overall response rate (ORR), overall survival (OS), and safety. Rituximab-treated patients could crossover to receive ibrutinib after confirmed PD. At data cutoff, median treatment duration was 16.4 months for ibrutinib and 4.6 months for rituximab. Ibrutinib significantly improved PFS (hazard ratio [HR] = 0.180, 95% confidence interval [CI]: 0.105-0.308). ORR was significantly higher (P < 0.0001) with ibrutinib (53.8%) than with rituximab (7.4%). At a median follow-up of 17.8 months, ibrutinib improved OS compared with rituximab (HR = 0.446; 95% CI: 0.221-0.900; P = 0.0206). Overall incidence of adverse events (AEs) was similar between treatments and was not exposure-adjusted. With ibrutinib, most common AEs were diarrhea and platelet count decreased; with rituximab, most common AEs were neutrophil count decreased and platelet count decreased. Grade ≥3 AEs were reported in 82.7% of ibrutinib-treated patients and 59.6% of rituximab-treated patients. Ibrutinib improved PFS, ORR, and OS compared with rituximab and displayed a manageable safety profile in Asian patients with relapsed/refractory CLL/SLL.

Indexed as

AdenineAntineoplastic Combined Chemotherapy ProtocolsDrug Resistance, NeoplasmFemaleHumansKaplan-Meier EstimateLeukemia, Lymphocytic, Chronic, B-CellMalePiperidinesProportional Hazards ModelsPyrazolesPyrimidinesRecurrenceRetreatmentRituximabTreatment OutcomeAdenineibrutinibPiperidinesPyrazolesPyrimidinesRituximabAsia-Pacificchronic lymphocytic leukemiaibrutinibrituximabsmall lymphocytic lymphoma

Identifiers

PMID29533000
PMCPMC5911578
OpenAlexW2789826025

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.