Evidence map›Paper›PMID 29855738›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2019

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.

Atsuo Takashima, Kohei Shitara, Kazumasa Fujitani, Keisuke Koeda, Hiroki Hara, Norisuke Nakayama, Shuichi Hironaka, Kazuhiro Nishikawa, Yutaka Kimura, Kenji Amagai and 16 more

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

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing 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

27 citing papers in PubMed.

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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

26 authors.

Atsuo TakashimaGastrointestinal Medical Oncology Division, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. atakashi@ncc.go.jp.
Kohei ShitaraDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Kazumasa FujitaniDepartment of Surgery, Osaka General Medical Center, Osaka, Japan.
Keisuke KoedaDepartment of Surgery, Iwate Medical University School of Medicine, Morioka, Japan.
Hiroki HaraDepartment of Gastroenterology, Saitama Cancer Center, Ina-machi, Japan.
Norisuke NakayamaDepartment of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan.
Shuichi HironakaClinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.
Kazuhiro NishikawaDepartment of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Yutaka KimuraDepartment of Surgery, Sakai City Medical Center, Sakai, Japan.
Kenji AmagaiDepartment of Gastroenterology, Ibaraki Prefectural Central Hospital, Kasama, Japan.
Hirofumi FujiiDepartment of Clinical Oncology, Jichi Medical University Hospital, Shimotsuke, Japan.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Taito EsakiDepartment of Gastrointestinal and Medical Oncology, National Kyushu Cancer Center, Fukuoka, Japan.
Yasuhiro ChodaDepartment of Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Toshimi TakanoDepartment of Medical Oncology, Toranomon Hospital, Tokyo, Japan.
Keisho ChinDepartment of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Atsushi SatoDepartment of Medical Oncology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Masahiro GotoCancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan.
Norimasa FukushimaDepartment of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan.
Takuo HaraDepartment of Surgery, Kouseiren Takaoka Hospital, Takaoka, Japan.
Nozomu MachidaDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun, Japan.
Manabu OhtaOncology Center, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Narikazu BokuGastrointestinal Medical Oncology Division, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Masashi ShimuraData Science Department, Taiho Pharmaceutical. Co., Ltd., Tokyo, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Wasaburo KoizumiDepartment of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the ABSOLUTE trial, weekly nanoparticle albumin-bound paclitaxel (w-nab-PTX) showed non-inferiority to weekly solvent-based paclitaxel (w-sb-PTX) for overall survival (OS). Thus, w-nab-PTX might be an option for second-line chemotherapy in advanced gastric cancer (AGC). However, predictive factors for efficacies of these agents have not been evaluated.

methodsPatients previously enrolled in the ABSOLUTE trial were divided into apparent peritoneal metastasis group (PM group) and no apparent peritoneal metastasis group (no PM group) based on baseline imaging evaluated by RECIST ver. 1.1 criteria and amount of ascites. OS, progression-free survival, and overall response rate were compared between two arms in each group.

resultsThis study included 240 and 243 patients in the w-nab-PTX and w-sb-PTX arms, respectively. In the PM group, the w-nab-PTX arm (n = 88) had longer OS than the w-sb-PTX arm (n = 103), and median survival time (MST) of 9.9 and 8.7 months [hazard ratio (HR) 0.63; 95% CI 0.45-0.88; P = 0.0060], respectively. In the no PM group, the w-nab-PTX arm (n = 140) had shorter OS than the w-sb-PTX arm (n = 152), and MST of 11.6 and 15.7 months (HR 1.40; 95% CI 1.06-1.86; P = 0.0180), respectively. After adjusting for prognostic factors, the HR for OS in the w-nab-PTX arm versus the w-sb-PTX arm was 0.59 (95% CI 0.42-0.83; P = 0.0023; PM group) and 1.34 (95% CI 1.01-1.78; P = 0.0414; no PM group), with significant interaction between treatment efficacy and presence of peritoneal metastasis (P = 0.0003).

conclusionsThe presence of apparent peritoneal metastasis might be a predictive factor for selecting w-nab-PTX for pretreated AGC patients. TRIAL REGISTRATION NUMBER: JapicCTI-132059.

Indexed as

AdultAgedAlbuminsAntineoplastic AgentsDrug CarriersDrug Delivery SystemsFemaleHumansKaplan-Meier EstimateMaleMiddle AgedNanoparticlesPaclitaxelPeritoneal NeoplasmsProgression-Free SurvivalProportional Hazards Models130-nm albumin-bound paclitaxelAlbuminsAntineoplastic AgentsDrug CarriersPaclitaxelNab-paclitaxelPeritoneal metastasisPredictive factorSecond-line chemotherapySolvent-based paclitaxel

Identifiers

PMID29855738
PMCPMC6315007

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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.