Evidence map›Paper›PMID 33959770›Full record

Trial reportJapanese journal of clinical oncology2021

Single response assessment of transplant-ineligible multiple myeloma: a supplementary analysis of JCOG1105 (JCOG1105S1).

Nobuhiko Nakamura, Dai Maruyama, Ryunosuke Machida, Tatsuo Ichinohe, Nobuyuki Takayama, Rie Ohba, Ken Ohmachi, Yoshitaka Imaizumi, Masahito Tokunaga, Hiroo Katsuya and 14 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Japanese journal of clinical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

24 authors.

Nobuhiko NakamuraDepartment of Hematology and Infectious Disease, Gifu University Hospital, Gifu, Japan.
Dai MaruyamaDepartment of Hematology Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Ryunosuke MachidaJCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Tatsuo IchinoheDepartment of Hematology and Oncology, Hiroshima University Research Institute for Radiation Biology and Medicine, Hiroshima, Japan.
Nobuyuki TakayamaDepartment of Hematology, Kyorin University School of Medicine, Tokyo, Japan.
Rie OhbaDepartment of Clinical Oncology and Hematology, The Jikei University Daisan Hospital, Tokyo, Japan.
Ken OhmachiDepartment of Hematology/Oncology, Tokai University School of Medicine, Isehara, Japan.
Yoshitaka ImaizumiDepartment of Hematology, Nagasaki University Hospital, Nagasaki, Japan.
Masahito TokunagaDepartment of Hematology, Imamura General Hospital, Kagoshima, Japan.
Hiroo KatsuyaDivision of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.
Isao YoshidaDepartment of Hematologic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Kazutaka SunamiDepartment of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan.
Mitsutoshi KurosawaDepartment of Hematology, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.
Nobuko KubotaDepartment of Hematology, Saitama Cancer Center, Saitama, Japan.
Hiroaki MorimotoDepartment of Hematology, University of Occupational and Environmental Health, Kitakyushu, Japan.
Miki KobayashiDepartment of Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.
Harumi KatoDepartment of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan.
Yoshihiro KameokaDepartment of Hematology, Nephrology and Rheumatology, Akita University School of Medicine, Akita, Japan.
Yoshitoyo KagamiDepartment of Hematology, Toyota Kosei Hospital, Toyota, Japan.
Masahiro KizakiDepartment of Hematology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.
Kazuto TakeuchiFirst Department of Internal Medicine, Ehime University Hospital, Toon, Japan.
Wataru MunakataDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.
Shinsuke IidaDepartment of Hematology and Oncology, Nagoya City University Hospital, Nagoya, Japan.
Hirokazu NagaiDepartment of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.

Funding

Ministry of Health, Labour and Welfare, Japan JP19ck0106348National Cancer Center 2020-J-3
6 · The paper itself

Abstract

backgroundThe International Myeloma Working Group response criteria require two consecutive assessments of paraprotein levels. We conducted an exploratory analysis to evaluate whether a single response assessment could be a substitute for the International Myeloma Working Group criteria using data from JCOG1105, a randomized phase II study on melphalan, prednisolone and bortezomib.

methodsOf 91 patients with transplant-ineligible newly diagnosed multiple myeloma, 79 patients were included. We calculated the kappa coefficient to evaluate the degree of agreement between the International Myeloma Working Group criteria and the single response assessment.

resultsBased on the International Myeloma Working Group criteria, 11 (13.9%), 20 (25.3%), 36 (45.6%) and 12 (15.2%) patients had stringent complete response/complete response, very good partial response, partial response and stable disease, respectively. Based on the single response assessment, 17 (21.5%), 19 (24.1%), 35 (44.3%) and 8 (10.1%) patients had stringent complete response/complete response, very good partial response, partial response and stable disease, respectively. The kappa coefficient was 0.76 (95% confidence interval, 0.65-0.88), demonstrating good agreement. The single response assessment was not inferior to the International Myeloma Working Group criteria in the median progression-free survival (3.8 and 2.9 years) in stringent complete response/complete response patients, suggesting that the single response assessment was not an overestimation.

conclusionsThe single response assessment could be a substitute for the current International Myeloma Working Group criteria for transplant-ineligible newly diagnosed multiple myeloma.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsBortezomibFemaleHumansMaleMelphalanMultiple MyelomaPrednisoloneProgression-Free SurvivalBortezomibMelphalanPrednisolonebortezomibmelphalanmultiple myelomaresponse criteria

Identifiers

PMID33959770
PMCPMC8246272

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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.