Evidence map›Paper›PMID 35303078›Full record

Trial reportThe oncologist2022

Phase II Study of Continued Trastuzumab Plus Irinotecan in Patients with HER2-positive Gastric Cancer Previously Treated with Trastuzumab (HGCSG 1201).

Yasuyuki Kawamoto, Satoshi Yuki, Takashi Meguro, Kazuteru Hatanaka, Minoru Uebayashi, Michio Nakamura, Hiroyuki Okuda, Ichiro Iwanaga, Takashi Kato, Shintaro Nakano and 6 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.1field-weighted citation impact, top 24% 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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
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

16 authors at 11 institutions in 1 country.

Yasuyuki KawamotoDivision of Cancer Center, Hokkaido University Hospital, Sapporo, Japan.ORCID 0000-0002-7706-0015
Satoshi YukiDepartment of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan.
Takashi MeguroDepartment of Internal Medicine, Hokkaido Gastroenterology Hospital, Sapporo, Japan.
Kazuteru HatanakaDepartment of Gastroenterology, Hakodate Municipal Hospital, Hakodate, Japan.
Minoru UebayashiDepartment of Gastroenterology, Japanese Red Cross Kitami Hospital, Kitami, Japan.
Michio NakamuraDepartment of Gastroenterology, Sapporo City General Hospital, Sapporo, Japan.
Hiroyuki OkudaDepartment of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, Japan.
Ichiro IwanagaDepartment of Medical Oncology, Sapporo-Kosei General Hospital, Sapporo, Japan.
Takashi KatoDepartment of Gastroenterology, Tomakomai City Hospital, Tomakomai, Japan.
Shintaro NakanoDepartment of Gastroenterology, Iwamizawa Municipal General Hospital, Iwamizawa, Japan.
Atsushi SatoDepartment of Medical Oncology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Kazuaki HaradaDepartment of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan.
Koji ObaDepartment of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Yuh SakataDepartment of Internal Medicine, Misawa City Hospital, Misawa, Japan.
Naoya SakamotoDepartment of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan.
Yoshito KomatsuDivision of Cancer Center, Hokkaido University Hospital, Sapporo, Japan.
Hokkaido University Hospital · JPHakodate National Hospital · JPHirosaki University · JPHokkaido hospital · JPKeiyukai Sapporo Hospital · JPMisawa City Hospital · JPMiwa Hospital · JPNational Institute of Technology, Tomakomai College · JPSapporo City General Hospital · JPSapporo Kosei General Hospital · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy of irinotecan plus continuous trastuzumab beyond progression in patients with gastric cancer previously treated with trastuzumab plus standard first-line chemotherapy has not been reported.

methodsPatients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer who were previously treated with trastuzumab received trastuzumab every 3 weeks and irinotecan every 2 weeks. The primary endpoint was the overall response rate (ORR), and the secondary endpoints included progression-free survival (PFS), 6-month survival rates, safety, and subgroup analysis by HER2 status.

resultsSixteen patients were enrolled in a 3-year pre-planned registration period. This study was prematurely closed due to poor patient accrual. The ORR and disease control rate were 6.7% (95% CI, 0.2-32.0) and 53.3% (95% CI, 26.6-78.7). The median PFS and overall survival (OS) were 2.4 months (95% CI, 0.0-5.2) and 9.7 months (95% CI, 8.2-11.2), respectively. The most frequently reported grades 3-4 adverse events were neutropenia (40%), anemia (27%), anorexia (33%), and fatigue (33%).

conclusionWith only 16 patients enrolled, the present study has very low power to detect any clinical benefit of trastuzumab plus irinotecan beyond disease progression in patients with HER2-positive advanced gastric cancer who previously received trastuzumab.Trial Identifier: UMIN000007636.

Indexed as

Stomach NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsErb-b2 Receptor Tyrosine KinasesFemaleHumansIrinotecanSurvival RateTrastuzumabErb-b2 Receptor Tyrosine KinasesIrinotecanTrastuzumabgastric cancerHER2irinotecansecond-line treatmenttrastuzumab

Identifiers

PMID35303078
PMCPMC9075004
OpenAlexW4205619361

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.