Evidence map›Paper›PMID 34320929›Full record

ArticleBMC cancer2021

Combination chemoradiotherapy with temozolomide, vincristine, and interferon-β might improve outcomes regardless of O6-methyl-guanine-DNA-methyltransferase (MGMT) promoter methylation status in newly glioblastoma.

Kenichiro Asano, Toshio Fumoto, Masashi Matsuzaka, Seiko Hasegawa, Naoya Suzuki, Kenichi Akasaka, Kosuke Katayama, Akihisa Kamataki, Akira Kurose, Hiroki Ohkuma

Open access · goldAbstract read
In one paragraph

Article in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.5field-weighted citation impact, top 34% 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

5 citing papers in PubMed, 7 citations in OpenAlex.

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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

10 authors at 4 institutions in 1 country.

Kenichiro AsanoDepartment of Neurosurgery, Hirosaki University Graduate School of Medicine, 5 Zaifu-cho, Hirosaki, Aomori, 036-8562, Japan. asanoken@hirosaki-u.ac.jp.ORCID http://orcid.org/0000-0002-4147-4312
Toshio FumotoDepartment of Neurosurgery, Hirosaki University Graduate School of Medicine, 5 Zaifu-cho, Hirosaki, Aomori, 036-8562, Japan.
Masashi MatsuzakaClinical Research Support Center, Hirosaki University Hospital, 53 Hon-cho, Hirosaki, Aomori, 036-8563, Japan.
Seiko HasegawaDepartment of Neurosurgery, Kuroishi General Hospital, 1-70 Kitami-cho, Kuroishi, Aomori, 036-0541, Japan.
Naoya SuzukiDepartment of Neurosurgery, Towada City Hospital, 8-14 Nishi-Jyuniban-cho, Towada, Aomori, 034-0093, Japan.
Kenichi AkasakaDepartment of Neurosurgery, Towada City Hospital, 8-14 Nishi-Jyuniban-cho, Towada, Aomori, 034-0093, Japan.
Kosuke KatayamaDepartment of Neurosurgery, Hirosaki University Graduate School of Medicine, 5 Zaifu-cho, Hirosaki, Aomori, 036-8562, Japan.
Akihisa KamatakiDepartment of Anatomic Pathology, Hirosaki University Graduate School of Medicine, 53 Honcho, Hirosaki, Aomori, 036-8563, Japan.
Akira KuroseDepartment of Anatomic Pathology, Hirosaki University Graduate School of Medicine, 53 Honcho, Hirosaki, Aomori, 036-8563, Japan.
Hiroki OhkumaDepartment of Neurosurgery, Hirosaki University Graduate School of Medicine, 5 Zaifu-cho, Hirosaki, Aomori, 036-8562, Japan.
Hirosaki University · JPTowada City Hospital · JPHirosaki University Hospital · JPKushiro City General Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis investigator-initiated, open-label, single-arm, single-institute study was conducted to investigate the effectiveness of induction combination chemoradiotherapy and long-term maintenance therapy with temozolomide (TMZ) plus interferon (IFN)-β for glioblastoma.

methodsThe initial induction combination chemoradiotherapy comprised radiotherapy plus TMZ plus vincristine plus IFN-β. Maintenance chemotherapy comprised monthly TMZ, continued for 24-50 cycles, plus weekly IFN-β continued for as long as possible. The primary endpoint was 2-year overall survival (2y-OS). The study protocol was to be considered valid if the expected 2y-OS was over 38% and the lower limit of the 95% confidence interval (CI) was no less than 31.7% compared with historical controls, using Kaplan-Meier methods. Secondary endpoints were median progression-free survival (mPFS), median OS (mOS), 5-year OS rate (5y-OS), and mPFS and mOS classified according to MGMT promoter methylation status.

resultsForty-seven patients were analyzed. The 2y-OS was 40.7% (95%CI, 27.5-55.4%). The mPFS and mOS were 11.0 months and 18.0 months, respectively, and 5y-OS was 20.3% (95%CI, 10.9-34.6%). The mPFS in groups with and without MGMT promoter methylation in the tumor was 10.0 months and 11.0 months (p = 0.59), respectively, and mOS was 24.0 months and 18.0 months (p = 0.88), respectively. The frequency of grade 3/4 neutropenia was 19.1%.

conclusionsThe 2y-OS with induction multidrug combination chemoradiotherapy and long-term maintenance therapy comprising TMZ plus IFN-β tended to exceed that of historical controls, but the lower limit of the 95%CI was below 31.7%. Although the number of cases was small, this protocol may rule out MGMT promoter methylation status as a prognostic factor.

trial registrationUniversity Hospital Medical Information Network (number UMIN000040599 ).

Indexed as

ChemoradiotherapyDNA MethylationPromoter Regions, GeneticAdolescentAdultAgedAged, 80 and overCombined Modality TherapyDNA Modification MethylasesDNA Repair EnzymesFemaleGlioblastomaHumansKaplan-Meier EstimateMaleMiddle AgedDNA Modification MethylasesDNA Repair EnzymesMGMT protein, humanTumor Suppressor ProteinsCombination therapyInterferon-βMGMTNewly glioblastomaTemozolomide

Identifiers

PMID34320929
PMCPMC8320052
OpenAlexW3173900028

What OpenQuestion holds

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LicenceCC BY
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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.