Evidence map›Paper›PMID 20187101›Full record

Trial reportCancer2010

Pentostatin and rituximab therapy for previously untreated patients with B-cell chronic lymphocytic leukemia.

Neil E Kay, Wenting Wu, Brian Kabat, Betsy LaPlant, Thomas S Lin, John C Byrd, Diane F Jelinek, Michael R Grever, Clive S Zent, Timothy G Call and 1 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIComparative Study
In one paragraph

Trial report in Cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00201721 (Phase II Trial of Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 9% 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.

NCT00201721 phase2completednot on this map

Phase II Trial of Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)

TypeinterventionalSponsorOhio State University Comprehensive Cancer CenterRan2002 to 2006Enrolled28ConditionsB-Chronic Lymphocytic LeukemiaArmsPentostatin, Rituximab, Cyclophosphamide
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Therapeutic advancement of chronic lymphocytic leukemia.Journal of hematology & oncology · 2012
    Review
  5. Choosing first-line therapy for chronic lymphocytic leukemia.Expert review of anticancer therapy · 2011
    Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. 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 2 institutions in 1 country.

Neil E KayDivision of Hematology, Mayo Clinic, Rochester, Minnesota 55905, USA. kay.neil@mayo.edu
Wenting Wu
Brian Kabat
Betsy LaPlant
Thomas S Lin
John C Byrd
Diane F Jelinek
Michael R Grever
Clive S Zent
Timothy G Call
Tait D Shanafelt
Mayo Clinic · USThe Ohio State University · US

Funding

ZESTRIL VS. VERAPAMIL IN THE TREATMENT OF HYPERTENSIONM01RR000585 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 1985 to 2006
$30.4M
Combination Therapy in B-Chronic Lymphocytic LeukemiaR01CA095241 · NCI · MAYO CLINIC ROCHESTER · PI KAY, NEIL E · 2002 to 2012
$5.7M
Role of the BCR in B Cell Chronic Lymphocytic LeukemiaR01CA136591 · NCI · MAYO CLINIC ROCHESTER · PI JELINEK, DIANE F · 2009 to 2013
$1.5M
The Role of Oxidative Stress in CLL B-cell ApoptosisK23CA113408 · NCI · MAYO CLINIC ROCHESTER · PI SHANAFELT, TAIT D · 2006 to 2010
$631k
NCI NIH HHS CA113408NCI NIH HHS CA95241NCI NIH HHS K23 CA113408NCI NIH HHS R01 CA095241NCI NIH HHS R01 CA136591NCRR NIH HHS M01 RR000585
6 · The paper itself

Abstract

backgroundThe combination of pentostatin (P), cyclophosphamide (C), and rituximab (R) achieved an overall response (OR) rate >90%, with >40% complete responses (CRs) in patients with untreated chronic lymphocytic leukemia (CLL).

methodsTo evaluate whether the tolerability of this regimen could be enhanced without sacrificing efficacy, a phase 2 trial was conducted of P and R without C, using a higher P dose (4 mg/m(2)). Among the 33 patients enrolled, 82% were male, the median age was 65 years (9 patients were aged >or=70 years), and 64% were classified as having Rai stage III to IV disease.

resultsThe OR rate was 76%, with 9 CRs (27%), 5 nodular partial responses, and 11 partial responses (PRs) reported. At the time of last follow-up, 29 of 33 patients were still alive at a median follow-up of 14 months (range, 1-34.8 months). Four (12%) patients experienced grade 3 or higher hematologic toxicity, and 5 (15%) experienced grade 3 or higher nonhematologic toxicity. Comparison of this trial with the previous PCR trial demonstrated that patients treated with PCR had a higher OR rate (91% vs 76%) and CR rate (41% vs 27%) compared with patients treated with PR. The median treatment-free survival for all accrued patients was notably longer in patients treated with PCR compared with PR (30 months vs 16 months).

conclusionsThe findings of the current study suggest that increasing the dose of the purine nucleoside analogue does not eliminate the need for cyclophosphamide in chemoimmunotherapy for the treatment of CLL.

Indexed as

AgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsCyclophosphamideFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedPentostatinRituximabTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedCyclophosphamidePentostatinRituximab

Identifiers

PMID20187101
PMCPMC2919331
OpenAlexW2064937871

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.