Evidence map›Paper›PMID 38048759›Full record

Trial reportOncology2024

Impact of Tumor Shrinkage Pattern with Biweekly Triplet Gemcitabine+Cisplatin+S-1 Regimen for Biliary Tract Cancers: Implications for Neoadjuvant Therapy from the Data of KHBO1401 (KHBO1401-1A Study).

Shogo Kobayashi, Hiroshi Wada, Daisuke Sakai, Hideo Baba, Masashi Kanai, Hirofumi Kamachi, Tadatoshi Takayama, Masaki Ueno, Masahiro Takahashi, Masayuki Sho and 4 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Review
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

14 authors.

Shogo KobayashiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan, s-kobayashi@umin.ac.jp.
Hiroshi WadaDepartment of Gastroenterological Surgery, Osaka International Cancer Institute, Suita, Japan.
Daisuke SakaiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Hideo BabaDepartment of Gastroenterological Surgery, Graduate School of Medical Science, Kumamoto University, Kumamoto, Japan.
Masashi KanaiDepartment of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Hirofumi KamachiDepartment of Gastroenterological Surgery I, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Tadatoshi TakayamaDepartment of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan.
Masaki UenoSecond Department of Surgery, School of Medicine, Wakayama Medical University, Wakayama, Japan.
Masahiro TakahashiDepartment of Medical Oncology, Tohoku University Hospital, Sendai, Japan.
Masayuki ShoDepartment of Surgery, Nara Medical University, Kashihara, Japan.
Kenichi YoshimuraMedical Center for Translational and Clinical Research, Hiroshima University Hospital, Hiroshima, Japan.
Etsuro HatanoDivision of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Hiroaki NaganoDepartment of Gastroenterological, Breast and Endocrine Surgery, Graduate School of Medicine, Yamaguchi University, Yamaguchi, Japan.
Tatsuya IokaDepartment of Oncology Center, Graduate School of Medicine, Yamaguchi University, Yamaguchi, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe multicenter randomized phase III KHBO1401 study (gemcitabine+cisplatin+S-1 [GCS] vs. GC in biliary tract cancers [BTC]) demonstrated that GCS not only prolonged patient survival but also achieved a high response rate and that it should be good for neoadjuvant therapy. Therefore, to explore the possibilities of neoadjuvant therapy, we investigated the tumor shrinkage pattern.

methodsAmong the total of 246 patients enrolled in the KHBO1401, the tumor shrinkage pattern and survival were investigated in patients with measurable BTC (n = 183, 74%; GCS, n = 91; GC, n = 92).

resultsThe tumor shrinkage pattern could be divided into 4 categories based on the response at 100 days after enrollment: categories A (<-30% in size), B (-30-0%), C (0% to +20%), and D (>+20%). The GCS arm included more category A and B cases (61 [67%] vs. 33 [36%], p < 0.0001). Each category predicted the best response and overall survival (p < 0.0001). Category A showed sustained tumor response compared with category B; in GCS, the time to maximum tumor response was 165 ± 76 days in category A and 139 ± 78 in category B. Categories C and D did not achieve tumor shrinkage. The maximum tumor shrinkage size in category A was -53% in the GCS arm and -65% in the GC arm (p = 0.0892). Twenty percent of patients in the GCS showed tumor regrowth 154 ± 143 days later.

conclusionGCS provided faster and greater tumor shrinkage with better survival in comparison to GC, although 20% of patients showed regrowth after 6 cycles.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsCisplatinDeoxycytidineDrug CombinationsGemcitabineNeoadjuvant TherapyOxonic AcidTegafurAdultAgedFemaleHumansMaleMiddle AgedTreatment OutcomeCisplatinDeoxycytidineDrug CombinationsGemcitabineOxonic AcidS 1 (combination)TegafurBiliary tract cancerChemotherapyCisplatinGemcitabineS-1Tumor shrinkage

Identifiers

PMID38048759
PMCPMC11152028

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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.