Evidence map›Paper›PMID 29427038›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2018

Efficacy and tolerability of ramucirumab monotherapy or in combination with paclitaxel in gastric cancer patients from the Expanded Access Program Cohort by the Korean Cancer Study Group (KCSG).

Minkyu Jung, Min-Hee Ryu, Do Youn Oh, Myounghee Kang, Dae Young Zang, In Gyu Hwang, Keun-Wook Lee, Ki Hyang Kim, Byoung Yong Shim, Eun Kee Song and 20 more

Registry-linked trialOpen access · bronzeAbstract readClinical 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, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05640830 (A Phase 1B/2 Study of Trastuzumab, Bevacizumab with Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy), which is not on this map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 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.

NCT05640830 phase1 / phase2recruitingnot on this mapstarted 2023, after this paper: background citation

A Phase 1B/2 Study of Trastuzumab, Bevacizumab with Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy (TREAZURE)

TypeinterventionalSponsorKangbuk Samsung HospitalRan2023 to 2026Enrolled47ConditionsHER2-positive Advanced Gastric CancerArmstrastuzumab, bevacizumab with paclitaxel (triple combination)
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

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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

30 authors at 20 institutions in 1 country.

Minkyu JungDivision of Medical Oncology, Yonsei Cancer Center, Department of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-Ro, Seodaemun-gu, Seoul, South Korea.
Min-Hee RyuDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Do Youn OhDepartment of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
Myounghee KangDivision of Hematology-Oncology, Department of Internal Medicine, Gyeongsang National University Changwon Hospital, Gyeongsang National University College of Medicine, Jinju, South Korea.
Dae Young ZangDivision of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
In Gyu HwangDepartment of Internal Medicine, Chung-Ang University College of Medicine, Seoul, South Korea.
Keun-Wook LeeDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
Ki Hyang KimDivision of Hematology-Oncology, Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, South Korea.
Byoung Yong ShimDepartment of Medical Oncology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, South Korea.
Eun Kee SongDepartment of Internal Medicine, Chonbuk National University Hospital, Chonbuk National University Medical School, Jeonju, South Korea.
Sun Jin SymDepartment of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea.
Hye Sook HanDepartment of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea.
Young Lee ParkCenter for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Gyeonggi, South Korea.
Jin Soo KimDepartment of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, South Korea.
Hyun Woo LeeDepartment of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea.
Moon Hee LeeDivision of Hematology-Oncology, Inha University Hospital and College of Medicine, Incheon, South Korea.
Dong-Hoe KooDepartment of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Hong Suk SongDepartment of Internal Medicine, Dongsan Medical Center, Keimyung University, Daegu, South Korea.
Namsu LeeDepartment of Internal Medicine, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Seoul, South Korea.
Sung Hyun YangDivision of Hematology and Oncology, Department of Internal Medicine, Korea Cancer Center Hospital Korea, Korea Institute of Radiological and Medical Sciences, Seoul, South Korea.
Dae Ro ChoiDepartment of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Chuncheon, South Korea.
Young Seon HongDivision of Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Kyoung Eun LeeDivision of Hematology-Oncology, Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, South Korea.
Chi Hoon MaengDivision of Hematology-Oncology, Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, South Korea.
Jin Ho BaekDepartment of Hematology and Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.
Samyong KimDepartment of Internal Medicine, Chungnam National University College of Medicine, Daejeon, South Korea.
Yeul Hong KimDepartment of Internal Medicine, Anam Hospital, Korea University College of Medicine, Seoul, South Korea.
Sun Young RhaDivision of Medical Oncology, Yonsei Cancer Center, Department of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-Ro, Seodaemun-gu, Seoul, South Korea. rha7655@yuhs.ac.
Jae Yong ChoDivision of Medical Oncology, Gangnam Severance Hospital, Department of Internal Medicine, Yonsei University College of Medicine, 712 Eonjuro, Gangnam-gu, Seoul, 06237, South Korea. chojy@yuhs.ac.
Yoon-Koo KangDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Yonsei University · KRHallym University Medical Center · KRSeoul National University Bundang Hospital · KRUlsan College · KRAjou University · KRAsan Medical Center · KRChung-Ang University · KRChungbuk National University Hospital · KRChungnam National University · KRGachon University Gil Medical Center · KRGyeongsang National University Hospital · KRInha University Hospital · KRInje University Busan Paik Hospital · KRJeonbuk National University Hospital · KRKangbuk Samsung Hospital · KRKeimyung University · KRKorea Institute of Radiological and Medical Sciences · KRKorea University Medical Center · KRKyung Hee University · KRNational Cancer Center · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRamucirumab improves survival in gastric cancer patients. The efficacy and safety of ramucirumab outside of a clinical trial were evaluated using an expanded access program (EAP).

methodsAdvanced gastric cancer patients treated with ramucirumab in combination with paclitaxel or with ramucirumab monotherapy in a Korean EAP were evaluated. Baseline characteristics were assessed for progression-free survival (PFS) and overall survival (OS), and adverse events were evaluated according to the treatment regimen.

resultsOf 265 patients, 228 received ramucirumab plus paclitaxel, and 37 received ramucirumab monotherapy. Grade 3 or 4 neutropenia was more common with ramucirumab plus paclitaxel than with ramucirumab monotherapy (46.7 vs. 8.1%). Gastrointestinal (GI) perforation developed in seven patients (3.1%) in the ramucirumab plus paclitaxel group. The overall response and disease control rates were 16.6 and 66.3% in the ramucirumab plus paclitaxel group, and 5.4 and 37.8% in the ramucirumab monotherapy group, respectively. PFS and OS were 3.8 and 8.6 months in the ramucirumab plus paclitaxel group, and 1.8 and 6.4 months in the ramucirumab monotherapy group, respectively. In multivariate analysis, alkaline phosphatase, albumin, and neutrophil-to-lymphocyte ratio (NLR) were the independent prognostic factors for PFS, while albumin, NLR, number of metastatic sites, and large amount of ascites were independent prognostic factors for OS.

conclusionIn the Korean EAP cohort, ramucirumab showed similar efficacy to the results of the previous trials for gastric cancer. However, the level of GI perforation was slightly increased in the ramucirumab plus paclitaxel group.

Indexed as

AdultAgedAged, 80 and overAlkaline PhosphataseAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAsian PeopleFemaleHumansMaleMiddle AgedPaclitaxelPrognosisRamucirumabStomach NeoplasmsAlkaline PhosphataseAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedPaclitaxelRamucirumabExpanded access programGastric cancerRamucirumabSecond-line chemotherapyVascular endothelial growth factor

Identifiers

PMID29427038
OpenAlexW2791989351

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Registered trials

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.