Evidence map›Paper›PMID 26386560›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2016

Randomized phase II study of second-line chemotherapy with the best available 5-fluorouracil regimen versus weekly administration of paclitaxel in far advanced gastric cancer with severe peritoneal metastases refractory to 5-fluorouracil-containing regimens (JCOG0407).

Tomohiro Nishina, Narikazu Boku, Masahiro Gotoh, Yasuhiro Shimada, Yasuo Hamamoto, Hirofumi Yasui, Kensei Yamaguchi, Hiroki Kawai, Norisuke Nakayama, Kenji Amagai and 5 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 9 pooled it
3.1field-weighted citation impact, top 8% 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

33 citing papers in PubMed, 9 syntheses or guidelines pooled it, 47 citations in OpenAlex.

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  8. Japanese gastric cancer treatment guidelines 2014 (ver. 4).Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2017
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  12. Peritoneal metastasis as a predictive factor for nab-paclitaxel in patients with pretreated advanced gastric cancer: an exploratory analysis of the phase III ABSOLUTE trial.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2019
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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

15 authors at 10 institutions in 1 country.

Tomohiro NishinaDepartment of Gastrointestinal Medical Oncology, Shikoku Cancer Center, 160 Minami-Umenomoto Kou, Matsuyama, Ehime, 791-0280, Japan. tnishina@shikoku-cc.go.jp.
Narikazu BokuDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Masahiro GotohCancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan.
Yasuhiro ShimadaDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Yasuo HamamotoDepartment of Medical Oncology, Tochigi Cancer Center, Utsunomiya, Japan.
Hirofumi YasuiDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun, Japan.
Kensei YamaguchiDivision of Gastroenterology, Saitama Cancer Center, Kita-adachi-gun, Japan.
Hiroki KawaiDepartment of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.
Norisuke NakayamaDepartment of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan.
Kenji AmagaiDepartment of Gastroenterology, Ibaraki Prefectural Central Hospital, Kasama, Japan.
Junki MizusawaJCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo, Japan.
Kenichi NakamuraJCOG Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo, Japan.
Kuniaki ShiraoDepartment of Medical Oncology and Hematology, Faculty of Medicine, Oita University, Yufu, Japan.
Atsushi OhtsuExploratory Oncology Research and Clinical Trial Center, National Cancer Center, Kashiwa, Japan.
Gastrointestinal Oncology Study Group of the Japan Clinical Oncology Group
National Cancer Center Hospital East · JPAichi Cancer Center · JPIbaraki Prefectural Central Hospital · JPKanagawa Cancer CenterOita University · JPOsaka Medical and Pharmaceutical University · JPSaitama Cancer Center · JPShikoku Cancer Center · JPShizuoka Cancer Center · JPTochigi Cancer Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis randomized phase II study compared weekly administration of paclitaxel (wPTX) with the best available 5-fluorouracil (5-FU) regimen as second-line treatment for advanced gastric cancer patients with severe peritoneal metastasis refractory to fluoropyrimidine.

methodsIn the best available 5-FU arm, continuous infusion of 5-FU (800 mg/m(2)/day, days 1-5, every 4 weeks) was given to patients with prior chemotherapy including bolus 5-FU, and methotrexate and 5-FU sequential bolus injection (methotrexate at 100 mg/m(2) followed by bolus 5-FU at 600 mg/m(2) with leucovorin, weekly) was given to those who had previously received continuous infusion of 5-FU or oral administration of fluoropyrimidine. In the wPTX arm, paclitaxel (80 mg/m(2)) was administered on days 1, 8, and 15, every 4 weeks. This study adopted a screening design (one-sided α = 30 %) with the primary end point of overall survival.

resultsOne hundred patients were randomized to the 5-FU arm (n = 49) or the wPTX arm (n = 51). Although the median survival time was 7.7 months in both arms, the 2-year survival rates were 2.9 % in the 5-FU arm and 9.1 % in the wPTX arm [hazard ratio 0.89 (95 % confidence interval 0.57-1.38), one-sided p = 0.298}. The median progression-free survival was longer with wPTX than with 5-FU [3.7 months vs 2.4 months; hazard ratio 0.58 (95 % confidence interval 0.38-0.88), one-sided p = 0.005]. The incidences of grade 4 neutropenia, grade 3/4 febrile neutropenia, diarrhea, and treatment-related death were 6 %, 4 %, 10 %, and 2 %, respectively, in the 5-FU arm and 2 %, 0 %, 0 %, and 0 %, respectively, in the wPTX arm.

conclusionsAs second-line chemotherapy, wPTX appears feasible and promising. This regimen can be included in a test arm in future phase III trials for treatment of advanced gastric cancer with severe peritoneal metastasis.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCapecitabineDrug CombinationsFemaleFluorouracilFollow-Up StudiesHumansIrinotecanLeucovorinMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingCamptothecinCapecitabineDrug CombinationsFluorouracilIrinotecanLeucovorinOxonic AcidPaclitaxelS 1 (combination)Tegafur5-FluorouracilGastric cancerPaclitaxelPeritoneal metastasisPhase II study

Identifiers

PMID26386560
OpenAlexW2191185651

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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.