Evidence map›Paper›PMID 19594547›Full record

Trial reportCancer science2009

Phase II study of oral fludarabine in combination with rituximab for relapsed indolent B-cell non-Hodgkin lymphoma.

Kensei Tobinai, Ken-ichi Ishizawa, Michinori Ogura, Kuniaki Itoh, Yasuo Morishima, Kiyoshi Ando, Masafumi Taniwaki, Takashi Watanabe, Joji Yamamoto, Toshiki Uchida and 6 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer science, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 31% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. 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

16 authors at 11 institutions in 4 countries.

Kensei TobinaiHematology and Stem Cell Transplantation Division, National Cancer Center Hospital, Tokyo, Japan. ktobinai@ncc.go.jp
Ken-ichi Ishizawa
Michinori Ogura
Kuniaki Itoh
Yasuo Morishima
Kiyoshi Ando
Masafumi Taniwaki
Takashi Watanabe
Joji Yamamoto
Toshiki Uchida
Masanobu Nakata
Takashi Terauchi
Shigeru Nawano
Masaki Matsusako
Masaki Hayashi
Tomomitsu Hotta
National Cancer Center · USPalmetto Hematology Oncology · USRed Cross Hospital · GRTohoku University Hospital · JPAichi Cancer Center · JPBayer (United States) · USKyoto Prefectural University of Medicine · JPNagoya Medical Center · JPNational Cancer Center Hospital East · JPSt. Luke's International Hospital · JPTokai University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Oral fludarabine is more convenient than intravenous fludarabine in an outpatient setting. To assess the efficacy and toxicity of oral fludarabine in combination with rituximab in patients with relapsed indolent B-cell non-Hodgkin lymphoma (B-NHL), we conducted a multicenter phase II study. Patients with relapsed indolent B-NHL with two or fewer prior regimens and up to 16 doses of rituximab were eligible. Patients received 375 mg/m(2) rituximab on day 1, and 40 mg/m(2) oral fludarabine once daily on days 1 through 5 every 28 days for up to six cycles. The primary endpoint was the overall response rate. Forty-one patients were enrolled, including 38 (93%) with follicular lymphoma. Thirty-four patients (83%) had received rituximab as prior therapy. Twenty-seven patients (66%) completed the planned six cycles. Dose reduction of oral fludarabine was required in 17 patients (41%). The overall response rate was 76% (31 of 41 patients; 95% confidence interval, 60-88%) with a complete response rate of 68% (28 of 41 patients; 95% confidence interval, 52-82%). Median progression-free survival for the 41 patients was 19.7 months (95% confidence interval, 12.3-26.5 months). Hematological toxicities, including grade 4 neutropenia (68%), were the most frequent toxicities. Non-hematological toxicities were mild, except for one patient who died of Pneumocystis jiroveci pneumonia 4 months after the protocol treatment. In conclusion, oral fludarabine in combination with rituximab is a highly effective and convenient therapy for patients with relapsed indolent B-NHL who have mostly been pretreated with rituximab.

Indexed as

Administration, OralAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateLymphoma, B-CellMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingRituximabAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedfludarabineRituximabVidarabine

Identifiers

PMID19594547
PMCPMC11159842
OpenAlexW1968509228

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.