Evidence map›Paper›PMID 33706705›Full record

Observational studyBMC cancer2021

Non-maintenance intravesical Bacillus Calmette-Guérin induction therapy with eight doses in patients with high- or highest-risk non-muscle invasive bladder cancer: a retrospective non-randomized comparative study.

Makito Miyake, Kota Iida, Nobutaka Nishimura, Tatsuki Miyamoto, Kiyohide Fujimoto, Ryotaro Tomida, Kazumasa Matsumoto, Kazuyuki Numakura, Junichi Inokuchi, Shuichi Morizane and 16 more

Abstract readComparative StudyMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

23 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  14. Risk stratification and management of non-muscle-invasive bladder cancer: A physician survey in six Asia-Pacific territories.International journal of urology : official journal of the Japanese Urological Association · 2024
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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

26 authors.

Makito MiyakeDepartment of Urology, Nara Medical University, 840 Shijo-cho, Nara, 634-8522, Japan. makitomiyake@yahoo.co.jp.ORCID https://orcid.org/0000-0001-9503-7356
Kota IidaDepartment of Urology, Nara Medical University, 840 Shijo-cho, Nara, 634-8522, Japan.
Nobutaka NishimuraDepartment of Urology, Nara Medical University, 840 Shijo-cho, Nara, 634-8522, Japan.
Tatsuki MiyamotoDepartment of Urology, Nara Medical University, 840 Shijo-cho, Nara, 634-8522, Japan.
Kiyohide FujimotoDepartment of Urology, Nara Medical University, 840 Shijo-cho, Nara, 634-8522, Japan.
Ryotaro TomidaDepartment of Urology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan.
Kazumasa MatsumotoDepartment of Urology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
Kazuyuki NumakuraDepartment of Urology, Akita University Graduate School of Medicine, Akita, Japan.
Junichi InokuchiDepartment of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Shuichi MorizaneDivision of Urology, Department of Surgery, Faculty of Medicine, Tottori University, Tottori, Japan.
Takahiro YoneyamaDepartment of Advanced Transplant and Regenerative Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Aomori, Japan.
Yoshiaki MatsumuraDepartment of Urology, Nara Prefecture General Medical Center, Nara, Japan.
Takashige AbeDepartment of Urology, Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan.
Masaharu InoueDepartment of Urology, National Cancer Center Hospital East, Chiba, Japan.
Takeshi YamadaDepartment of Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Naoki TeradaDepartment of Urology, Miyazaki University, Miyazaki, Japan.
Shuya HiraoDepartment of Urology, Hirao Hospital, Kashihara, Nara, Japan.
Motohide UemuraDepartment of Urology, Osaka University, Graduate School of Medicine, Suita, Osaka, Japan.
Yuto MatsushitaDepartment of Urology, Hamamatsu University School of Medicine, Shizuoka, Japan.
Rikiya TaokaDepartment of Urology, Faculty of Medicine, Kagawa University, Takamatsu, Kagawa, Japan.
Takashi KobayashiDepartment of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Takahiro KojimaDepartment of Urology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Yoshiyuki MatsuiDepartment of Urology, National Cancer Center Hospital, Tokyo, Japan.
Hiroshi KitamuraDepartment of Urology, Faculty of Medicine, University of Toyama, Toyama, Japan.
Hiroyuki NishiyamaDepartment of Urology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Japanese Urological Oncology Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo explore possible solutions to overcome chronic Bacillus Calmette-Guérin (BCG) shortage affecting seriously the management of non-muscle invasive bladder cancer (NMIBC) in Europe and throughout the world, we investigated whether non-maintenance eight-dose induction BCG (iBCG) was comparable to six-dose iBCG plus maintenance BCG (mBCG).

methodsThis observational study evaluated 2669 patients with high- or highest-risk NMIBC who treated with iBCG with or without mBCG during 2000-2019. The patients were classified into five groups according to treatment pattern: 874 (33%) received non-maintenance six-dose iBCG (Group A), 405 (15%) received six-dose iBCG plus mBCG (Group B), 1189 (44%) received non-maintenance seven-/eight-dose iBCG (Group C), 60 (2.2%) received seven-/eight-dose iBCG plus mBCG, and 141 (5.3%) received only ≤5-dose iBCG. Recurrence-free survival (RFS), progression-free survival, and cancer-specific survival were estimated and compared using Kaplan-Meier analysis and the log-rank test, respectively. Propensity score-based one-to-one matching was performed using a multivariable logistic regression model based on covariates to obtain balanced groups. To eliminate possible immortal bias, 6-, 12-, 18-, and 24-month conditional landmark analyses of RFS were performed.

resultsRFS comparison confirmed that mBCG yielded significant benefit following six-dose iBCG (Group B) in recurrence risk reduction compared to iBCG alone (groups A and C) before (P < 0.001 and P = 0.0016, respectively) and after propensity score matching (P = 0.001 and P = 0.0074, respectively). Propensity score-matched sequential landmark analyses revealed no significant differences between groups B and C at 12, 18, and 24 months, whereas landmark analyses at 6 and 12 months showed a benefit of mBCG following six-dose iBCG compared to non-maintenance six-dose iBCG (P = 0.0055 and P = 0.032, respectively). There were no significant differences in the risks of progression and cancer-specific death in all comparisons of the matched cohorts.

conclusionsAlthough non-maintenance eight-dose iBCG was inferior to six-dose iBCG plus mBCG, the former might be an alternative remedy in the BCG shortage era. To overcome this challenge, further investigation is warranted to confirm the real clinical value of non-maintenance eight-dose iBCG.

Indexed as

Adjuvants, ImmunologicAdministration, IntravesicalAgedAged, 80 and overBCG VaccineDisease-Free SurvivalDisease ProgressionDrug Administration ScheduleFemaleFollow-Up StudiesHumansInduction ChemotherapyJapanKaplan-Meier EstimateMaintenance ChemotherapyMaleAdjuvants, ImmunologicBCG VaccineBacillus Calmette-Guérin (BCG)Intravesical therapyLandmark analysisNon-muscle invasive bladder cancerPropensity score matchingUrinary bladder neoplasms

Identifiers

PMID33706705
PMCPMC7948348

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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.