Evidence map›Paper›PMID 32567012›Full record

Trial reportInternational journal of clinical oncology2020

Phase II multi-institutional prospective trial of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer refractory to fluoropyrimidine with modified dose reduction criteria (CCOG1303).

Daisuke Kobayashi, Yoshinari Mochizuki, Koji Torii, Shin Takeda, Yoshihisa Kawase, Kiyoshi Ishigure, Hitoshi Teramoto, Masahiko Ando, Yasuhiro Kodera

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2020. 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
0.3field-weighted citation impact, top 40% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  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

9 authors at 8 institutions in 1 country.

Daisuke KobayashiDepartment of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan. kobadai@med.nagoya-u.ac.jp.ORCID http://orcid.org/0000-0002-6965-2707
Yoshinari MochizukiDepartment of Surgery, Komaki City Hospital, Komaki, Japan.
Koji ToriiDepartment of Surgery, Meitetsu Hospital, Nagoya, Japan.
Shin TakedaDepartment of Surgery, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Yoshihisa KawaseDepartment of Surgery, Tosei General Hospital, Seto, Japan.
Kiyoshi IshigureDepartment of Surgery, Konan Kosei Hospital, Konan, Japan.
Hitoshi TeramotoDepartment of Surgery, Yokkaichi Municipal Hospital, Yokkaichi, Japan.
Masahiko AndoCenter for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.
Yasuhiro KoderaDepartment of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.
Nagoya University · JPKomaki City Hospital · JPKonan Kosei Hospital · JPMeitetsu Hospital · JPNagoya University Hospital · JPNational Hospital Organization · JPTosei General Hospital · JPYokkaichi Municipal Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of this study was to explore the efficacy and safety of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer with modified dose reduction criteria by which the doses were manipulated earlier.

methodsGastric cancer patients who developed progression during the fluoropyrimidine-containing first-line chemotherapy were assigned to receive nab-paclitaxel (260 mg/m

resultsA total of 50 patients were enrolled, 47 of whom were eligible for efficacy analyses. The median number of treatment cycles and relative dose intensity given per patient was four (range 1-25), and 90% (range 60-100). Of total administration throughout the trial of 280 cycles, dose reduction was required in 50 cycles. The median progression-free survival was 3.5 months (95% confidence interval 2.5-4.4) that met the primary endpoint. The median overall survival was 9.0 months (95% confidence interval 6.8-11.8), overall response rate was 16% (95% confidence interval 2-30), and disease control rate was 72% (95% confidence interval 54-90). The median time to treatment failure was 3.5 months (95% confidence interval 2.5-4.4). Adverse events of grade 3 or worse included neutropenia in 49%, and peripheral sensory neuropathy in 11%. Febrile neutropenia occurred only in one patient (2%).

conclusionThe modified dose reduction criteria for triweekly administration of nab-paclitaxel resulted in decreased incidence of severe peripheral sensory neuropathy without decline in efficacy.

Indexed as

AdultAgedAged, 80 and overAlbuminsAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedNeutropeniaPaclitaxelProspective StudiesStomach NeoplasmsTreatment Failure130-nm albumin-bound paclitaxelAlbuminsPaclitaxelGastric cancerNab-paclitaxelPeripheral sensory neuropathy

Identifiers

PMID32567012
OpenAlexW3036388479

What OpenQuestion holds

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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.