Evidence map›Paper›PMID 32378071›Full record

Trial reportAdvances in therapy2020

A Phase II Study of Modified FOLFOX6 for Advanced Gastric Cancer Refractory to Standard Therapies.

Seiichiro Mitani, Shigenori Kadowaki, Azusa Komori, Chihiro Kondoh, Isao Oze, Kyoko Kato, Toshiki Masuishi, Kazunori Honda, Yukiya Narita, Hiroya Taniguchi and 4 more

Abstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Advances in therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

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

  1. Health utility book: A systematic review and meta-analysis of health utilities in gastric cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Pooled it
  2. Systematic review of health-related quality of life (HRQoL) issues associated with gastric cancer: capturing cross-cultural differences.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2022
    Pooled it
  3. Article
  4. Observational
  5. Article
  6. Article
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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

14 authors.

Seiichiro MitaniDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Shigenori KadowakiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. skadowaki@aichi-cc.jp.ORCID http://orcid.org/0000-0001-9923-5309
Azusa KomoriDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Chihiro KondohDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Isao OzeDivision of Cancer Epidemiology and Prevention, Aichi Cancer Center, Nagoya, Japan.
Kyoko KatoDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Toshiki MasuishiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Kazunori HondaDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Yukiya NaritaDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Hiroya TaniguchiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Masashi AndoDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Tsutomu TanakaDepartment of Endoscopy, Aichi Cancer Center Hospital, Nagoya, Japan.
Masahiro TajikaDepartment of Endoscopy, Aichi Cancer Center Hospital, Nagoya, Japan.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn patients with advanced gastric cancer refractory to chemotherapy, the treatment options are limited. Via this phase II study, we aimed to assess the efficacy and safety of oxaliplatin in combination with 5-fluorouracil and l-leucovorin (modified FOLFOX6).

methodsPatients who had histologically confirmed metastatic gastric cancer refractory to ≥ two previous chemotherapy regimens were included. The primary endpoint was the overall response rate (ORR) by an independent central review. According to an assumption of a threshold ORR of 10% and expected ORR of 25%, with α = 0.05 and β = 0.20, at least 33 patients were required. The secondary endpoints included overall survival (OS), progression-free survival (PFS), quality of life measured by EQ-5D, and safety.

resultsAmong the 35 enrolled patients, 33 were included in the primary analysis. All patients previously received fluoropyrimidines, cisplatin, and taxanes, and 24 (73%) were pretreated with irinotecan. The confirmed ORR was 27% [95% confidence interval (CI) 13-46]. The median PFS and OS were 2.2 (95% CI 1.2-3.2) and 5.6 (95% CI 4.1-7.0) months, respectively. In the multivariate analyses, immunotherapy within 90 days and a Glasgow Prognostic Score of 0 were associated with better treatment outcomes. The most common grade ≥ 3 adverse event was neutropenia (36%), and no febrile neutropenia was observed. The median EQ-5D scores did not change from baseline at 2, 4, and 8 weeks (p value = 0.38, 0.79, and 0.98, respectively).

conclusionModified FOLFOX6 (mFOLFOX6) showed substantial activity and acceptable toxicity for chemotherapy-refractory advanced gastric cancer.

trial registrationUMIN Clinical Trial Registry (UMIN000016416).

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsFemaleFluorouracilHumansLeucovorinMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinProgression-Free SurvivalStomach NeoplasmsTreatment OutcomeFluorouracilLeucovorinOrganoplatinum CompoundsOxaliplatinChemotherapyFOLFOX regimenGastric cancerPhase II clinical trial

Identifiers

PMID32378071

What OpenQuestion holds

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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.