Evidence map›Paper›PMID 24868031›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014

Lenalidomide and rituximab for the initial treatment of patients with chronic lymphocytic leukemia: a multicenter clinical-translational study from the chronic lymphocytic leukemia research consortium.

Danelle F James, Lillian Werner, Jennifer R Brown, William G Wierda, Jacqueline C Barrientos, Januario E Castro, Andrew Greaves, Amy J Johnson, Laura Z Rassenti, Kanti R Rai and 2 more

Open access · greenAbstract readMulticenter Study
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
7.5field-weighted citation impact, top 2% 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

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Immunomodulatory Drugs for the Treatment of B Cell Malignancies.International journal of molecular sciences · 2021
    Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Targeted Therapies in CLL: Monotherapy Versus Combination Approaches.Current hematologic malignancy reports · 2018
    Review
  13. Optimizing frontline therapy of CLL based on clinical and biological factors.Hematology. American Society of Hematology. Education Program · 2017
    Review
  14. Review
  15. Article
  16. Review
  17. Chronic lymphocytic leukaemia.Nature reviews. Disease primers · 2017
    Review
  18. Review
  19. Article
  20. 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

12 authors at 1 institution in 1 country.

Danelle F JamesDanelle F. James, Januario E. Castro, Andrew Greaves, Laura Z. Rassenti, Thomas J. Kipps, Moores Cancer Center, University of California San Diego, La Jolla, CA; Lillian Werner, Jennifer R. Brown, Donna Neuberg, Dana-Farber Cancer Institute, Boston, MA; William G. Wierda, MD Anderson Cancer Center, The University of Texas, Houston, TX; Jacqueline C. Barrientos, Kanti R. Rai, North Shore-Long Island Jewish Health System, New Hyde Park, NY; Amy J. Johnson, The Ohio State University, Columbus, OH.
Lillian WernerDanelle F. James, Januario E. Castro, Andrew Greaves, Laura Z. Rassenti, Thomas J. Kipps, Moores Cancer Center, University of California San Diego, La Jolla, CA; Lillian Werner, Jennifer R. Brown, Donna Neuberg, Dana-Farber Cancer Institute, Boston, MA; William G. Wierda, MD Anderson Cancer Center, The University of Texas, Houston, TX; Jacqueline C. Barrientos, Kanti R. Rai, North Shore-Long Island Jewish Health System, New Hyde Park, NY; Amy J. Johnson, The Ohio State University, Columbus, OH.
Jennifer R BrownDanelle F. James, Januario E. Castro, Andrew Greaves, Laura Z. Rassenti, Thomas J. Kipps, Moores Cancer Center, University of California San Diego, La Jolla, CA; Lillian Werner, Jennifer R. Brown, Donna Neuberg, Dana-Farber Cancer Institute, Boston, MA; William G. Wierda, MD Anderson Cancer Center, The University of Texas, Houston, TX; Jacqueline C. Barrientos, Kanti R. Rai, North Shore-Long Island Jewish Health System, New Hyde Park, NY; Amy J. Johnson, The Ohio State University, Columbus, OH.
William G WierdaDanelle F. James, Januario E. Castro, Andrew Greaves, Laura Z. Rassenti, Thomas J. Kipps, Moores Cancer Center, University of California San Diego, La Jolla, CA; Lillian Werner, Jennifer R. Brown, Donna Neuberg, Dana-Farber Cancer Institute, Boston, MA; William G. Wierda, MD Anderson Cancer Center, The University of Texas, Houston, TX; Jacqueline C. Barrientos, Kanti R. Rai, North Shore-Long Island Jewish Health System, New Hyde Park, NY; Amy J. Johnson, The Ohio State University, Columbus, OH.
Jacqueline C BarrientosDanelle F. James, Januario E. Castro, Andrew Greaves, Laura Z. Rassenti, Thomas J. Kipps, Moores Cancer Center, University of California San Diego, La Jolla, CA; Lillian Werner, Jennifer R. Brown, Donna Neuberg, Dana-Farber Cancer Institute, Boston, MA; William G. Wierda, MD Anderson Cancer Center, The University of Texas, Houston, TX; Jacqueline C. Barrientos, Kanti R. Rai, North Shore-Long Island Jewish Health System, New Hyde Park, NY; Amy J. Johnson, The Ohio State University, Columbus, OH.
Januario E CastroDanelle F. James, Januario E. Castro, Andrew Greaves, Laura Z. Rassenti, Thomas J. Kipps, Moores Cancer Center, University of California San Diego, La Jolla, CA; Lillian Werner, Jennifer R. Brown, Donna Neuberg, Dana-Farber Cancer Institute, Boston, MA; William G. Wierda, MD Anderson Cancer Center, The University of Texas, Houston, TX; Jacqueline C. Barrientos, Kanti R. Rai, North Shore-Long Island Jewish Health System, New Hyde Park, NY; Amy J. Johnson, The Ohio State University, Columbus, OH.
Andrew GreavesDanelle F. James, Januario E. Castro, Andrew Greaves, Laura Z. Rassenti, Thomas J. Kipps, Moores Cancer Center, University of California San Diego, La Jolla, CA; Lillian Werner, Jennifer R. Brown, Donna Neuberg, Dana-Farber Cancer Institute, Boston, MA; William G. Wierda, MD Anderson Cancer Center, The University of Texas, Houston, TX; Jacqueline C. Barrientos, Kanti R. Rai, North Shore-Long Island Jewish Health System, New Hyde Park, NY; Amy J. Johnson, The Ohio State University, Columbus, OH.
Amy J JohnsonDanelle F. James, Januario E. Castro, Andrew Greaves, Laura Z. Rassenti, Thomas J. Kipps, Moores Cancer Center, University of California San Diego, La Jolla, CA; Lillian Werner, Jennifer R. Brown, Donna Neuberg, Dana-Farber Cancer Institute, Boston, MA; William G. Wierda, MD Anderson Cancer Center, The University of Texas, Houston, TX; Jacqueline C. Barrientos, Kanti R. Rai, North Shore-Long Island Jewish Health System, New Hyde Park, NY; Amy J. Johnson, The Ohio State University, Columbus, OH.
Laura Z RassentiDanelle F. James, Januario E. Castro, Andrew Greaves, Laura Z. Rassenti, Thomas J. Kipps, Moores Cancer Center, University of California San Diego, La Jolla, CA; Lillian Werner, Jennifer R. Brown, Donna Neuberg, Dana-Farber Cancer Institute, Boston, MA; William G. Wierda, MD Anderson Cancer Center, The University of Texas, Houston, TX; Jacqueline C. Barrientos, Kanti R. Rai, North Shore-Long Island Jewish Health System, New Hyde Park, NY; Amy J. Johnson, The Ohio State University, Columbus, OH.
Kanti R RaiDanelle F. James, Januario E. Castro, Andrew Greaves, Laura Z. Rassenti, Thomas J. Kipps, Moores Cancer Center, University of California San Diego, La Jolla, CA; Lillian Werner, Jennifer R. Brown, Donna Neuberg, Dana-Farber Cancer Institute, Boston, MA; William G. Wierda, MD Anderson Cancer Center, The University of Texas, Houston, TX; Jacqueline C. Barrientos, Kanti R. Rai, North Shore-Long Island Jewish Health System, New Hyde Park, NY; Amy J. Johnson, The Ohio State University, Columbus, OH.
Donna NeubergDanelle F. James, Januario E. Castro, Andrew Greaves, Laura Z. Rassenti, Thomas J. Kipps, Moores Cancer Center, University of California San Diego, La Jolla, CA; Lillian Werner, Jennifer R. Brown, Donna Neuberg, Dana-Farber Cancer Institute, Boston, MA; William G. Wierda, MD Anderson Cancer Center, The University of Texas, Houston, TX; Jacqueline C. Barrientos, Kanti R. Rai, North Shore-Long Island Jewish Health System, New Hyde Park, NY; Amy J. Johnson, The Ohio State University, Columbus, OH.
Thomas J KippsDanelle F. James, Januario E. Castro, Andrew Greaves, Laura Z. Rassenti, Thomas J. Kipps, Moores Cancer Center, University of California San Diego, La Jolla, CA; Lillian Werner, Jennifer R. Brown, Donna Neuberg, Dana-Farber Cancer Institute, Boston, MA; William G. Wierda, MD Anderson Cancer Center, The University of Texas, Houston, TX; Jacqueline C. Barrientos, Kanti R. Rai, North Shore-Long Island Jewish Health System, New Hyde Park, NY; Amy J. Johnson, The Ohio State University, Columbus, OH. tkipps@ucsd.edu.
Dana-Farber Cancer Institute · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
VIRAL MALIGNANCYP30CA023100 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI DIANE M SIMEONE · 1985 to 2026
$124.9M
Tissue CoreP01CA081534 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI KIPPS, THOMAS J · 2000 to 2016
$59.5M
Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
Genetic Alterations in Families with Multiple LymphomasK23CA115682 · NCI · DANA-FARBER CANCER INSTITUTE · PI BROWN, JENNIFER R · 2005 to 2009
$754k
Lenalidomide Treatment and the Chronic Lymphocytic Leukemia MicroenvironmentR21CA135681 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI KIPPS, THOMAS J · 2009 to 2010
$680k
NCATS NIH HHS UL1 TR000371NCI NIH HHS K23 CA115682NCI NIH HHS P01 CA081534NCI NIH HHS P01-CA081534NCI NIH HHS P30 CA016672NCI NIH HHS P30 CA023100NCI NIH HHS R21 CA135681NCI NIH HHS R21-CA135681
6 · The paper itself

Abstract

purposeLenalidomide is an immunomodulatory agent with therapeutic activity in chronic lymphocytic leukemia (CLL). In preclinical models, lenalidomide acted synergistically with rituximab. The CLL Research Consortium initiated a phase II study to evaluate this combination in treatment-naive patients. PATIENTS AND

methodsLenalidomide was initiated at 2.5 mg/day and was escalated based on treatment tolerability to a maximum of 10 mg/day, for 21 days/cycle, for a maximum of seven cycles. Rituximab was administered at the end of cycle 1 and was continued for seven cycles. Patients received allopurinol and aspirin for prophylaxis.

resultsSixty-nine patients enrolled onto one of two age-specific strata; patients' median age was 56 and 70 years for arms A and B, respectively. Patients in the older-patient stratum more frequently had elevated serum beta-2 microglobulin levels, high-risk Rai stage, and were less likely to complete the maximum planned therapy. Adverse events were similar in the two arms. Nonhematologic toxicity was predominantly at grade 1/2, and neutropenia was the most common hematologic adverse event. The response rate for arm A was 95%, with 20% complete responses (CRs) and 20% nodular partial responses. Of arm B patients, 78% achieved a response, of which 11% were CRs. Median progression-free survival (PFS) was 19 months for the younger cohort and 20 months for the older cohort.

conclusionIntrapatient dose-escalation was safe. The majority of patients reached the maximum lenalidomide dose and experienced a response to a defined seven-cycle course of lenalidomide and rituximab therapy. Despite differences in baseline characteristics and the response rate between the two strata, the PFS did not differ.

Indexed as

AgedAged, 80 and overAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalDrug Administration ScheduleFemaleHumansImmunophenotypingKaplan-Meier EstimateLenalidomideLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedPolymorphism, Single NucleotidePrognosisAntibodies, Monoclonal, Murine-DerivedLenalidomideReceptors, FcRituximabThalidomide

Identifiers

PMID24868031
PMCPMC4067945
OpenAlexW2133111714

What OpenQuestion holds

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Registered trials

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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.