Evidence map›Paper›PMID 31667572›Full record

Observational studyJournal of cancer research and clinical oncology2020

A prospective observational study on the optimal maintenance strategy in HER2-positive advanced gastric cancer treated with trastuzumab-based therapy.

Qian Li, Minzhi Lv, Huiqin Jiang, Yan Wang, Shan Yu, Wei Li, Yiyi Yu, Tianshu Liu

Open access · greenAbstract readObservational Study
In one paragraph

Observational study in Journal of cancer research and clinical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 13% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Short-term and long-term survival of patients with gastric cancer.Gastroenterology and hepatology from bed to bench · 2021
    Article
  10. Serum CD4 Is Associated with the Infiltration of CD4Journal of immunology research · 2021
    Observational
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

8 authors at 3 institutions in 1 country.

Qian LiDepartments of Medical Oncology, Zhongshan Hospital, 180 Fenglin Road, Shanghai, 200032, China.
Minzhi LvDepartment of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai, China.
Huiqin JiangDepartments of Laboratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.
Yan WangDepartments of Medical Oncology, Zhongshan Hospital, 180 Fenglin Road, Shanghai, 200032, China.
Shan YuDepartments of Medical Oncology, Zhongshan Hospital, 180 Fenglin Road, Shanghai, 200032, China.
Wei LiDepartments of Medical Oncology, Zhongshan Hospital, 180 Fenglin Road, Shanghai, 200032, China.
Yiyi YuDepartments of Medical Oncology, Zhongshan Hospital, 180 Fenglin Road, Shanghai, 200032, China.
Tianshu LiuDepartments of Medical Oncology, Zhongshan Hospital, 180 Fenglin Road, Shanghai, 200032, China. liu.tianshu@zs-hospital.sh.cn.ORCID http://orcid.org/0000-0002-8604-6311
Zhongshan Hospital · CNSun Yat-sen University · CNFudan University · CN

Funding

Science and Technology Commission of Shanghai Municipality 17411951400
6 · The paper itself

Abstract

purposeTrastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric cancer (AGC). However, the optimal maintenance treatment in patients benefited from the first line therapy remains unclear.

methodsIn this prospective observational study, patients with HER2 positive AGC who received six cycles of trastuzumab-based first line chemotherapy were divided into two arms according to the maintenance strategy: trastuzumab monotherapy (arm A) and trastuzumab plus mono-chemo-agent derived from the initial chemotherapy (arm B). The primary end point was overall survival (OS), the secondary end points were first line progression free survival (PFS), maintenance PFS, cost-effectiveness ratios (CERs), incremental cost-effectiveness ratios (ICERs) and safety.

results30 patients were in arm A received trastuzumab monotherapy and 48 were in arm B. The clinical and pathological characteristics of two arms were well balanced. There was no significant difference of median OS (16.5 vs 20.0 months, HR 0.71 P = 0.169) or PFS (7.9 vs 11.0, HR 1.06, P = 0.892) between two arms, however, adding chemo-agent could lead to a 29% reduction in mortality risk. Adverse effects including cardiac safety were also similar. Subgroup analysis showed chemotherapy additional to trastuzumab benefited on OS in patients who had stable disease (SD) of response (HR: 0.084, P = 0.004), elder than 65 years old (HR: 0.4, P = 0.015), without liver metastasis (HR: 0.271, P = 0.008) or less than two organs of distance metastasis (HR: 0.263, P = 0.005). The average cost per patients in arm A was 153,137 RMB and 165,195 RMB in arm B. While, ICER in arm A was 1.29 times higher than arm B (CERs of two arms were 19,384 vs 15,018 RMB).

conclusionMono-chemo-agent combined with trastuzumab showed an advantage of absolute value and hazard ratio on OS, in addition to ICER of PFS for patients who benefit from the initial six cycles of trastuzumab-based first line therapy, especially in patients with certain clinical or treatment-related characterisitics. A large sample randomized trial is warranted.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsErb-b2 Receptor Tyrosine KinasesFemaleHumansMaleMiddle AgedProspective StudiesStomach NeoplasmsTrastuzumabYoung AdultAntineoplastic Agents, ImmunologicalERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesTrastuzumabCost-effectivenessGastric cancerHER2Maintenance treatment

Identifiers

PMID31667572
PMCPMC11804660
OpenAlexW2982305342

What OpenQuestion holds

Textmetadata
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.