Evidence map›Paper›PMID 37260158›Full record

Trial reportCancer medicine2023

Efficacy and safety of maintenance therapy with pamiparib versus placebo for advanced gastric cancer responding to first-line platinum-based chemotherapy: Phase 2 study results.

Fortunato Ciardiello, Yung-Jue Bang, Andrés Cervantes, Mikhail Dvorkin, Charles D Lopez, Jean-Philippe Metges, Antonio Sánchez Ruiz, Mariona Calvo, Andrew H Strickland, George Kannourakis and 8 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03427814 (A Phase 2, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 9% 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.

NCT03427814 phase2completednot on this map

A Phase 2, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy

TypeinterventionalSponsorBeiGeneRan2018 to 2023Enrolled136ConditionsAdvanced or Inoperable Gastric CancerArmsPamiparib, Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 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

18 authors at 16 institutions in 10 countries.

Fortunato CiardielloDipartimento di Medicina di Precisione, Università degli Studi della Campania Luigi Vanvitelli, Caserta, Italy.
Yung-Jue BangDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.
Andrés CervantesDepartment of Medical Oncology, Biomedical Research Institute INCLIVA, CiberOnc, University of Valencia, Valencia, Spain.
Mikhail DvorkinAlgorithmic Biology Laboratory, St. Petersburg Academic University, Russian Academy of Sciences, St. Petersburg, Russia.
Charles D LopezDepartment of Medicine, Knight Cancer Institute/Oregon Health and Science University, Portland, Oregon, USA.
Jean-Philippe MetgesInstitute of Oncology and Haematology, CHU Morvan, Arpego Network, Brest, France.
Antonio Sánchez RuizHospital Puerta de Hierro Majadohonda, Madrid, Spain.
Mariona CalvoDepartment of Medical Oncology, ONCOBELL Program (IDIBELL), Institut Català d'Oncologia-L'Hospitalet, Barcelona, Spain.
Andrew H StricklandDepartment of Medical Oncology, Monash Health, Monash University, Melbourne, Victoria, Australia.
George KannourakisBallarat Oncology & Haematology Services, Wendouree, Victoria, Australia.ORCID 0000-0001-6880-9795
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.ORCID 0000-0002-5572-743X
Hisato KawakamiDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.ORCID 0000-0002-3280-4850
Jia WeiThe Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University & Clinical Cancer Institute of Nanjing University, Nanjing, China.
Christophe BorgUniversity Hospital of Besançon, Medical Oncology Department, CIC-BT1431, Besançon, France.
Zhaoyin ZhuClinical Development, BeiGene Ltd, Cambridge, Massachusetts, USA.
Neal GuptaClinical Development, BeiGene Ltd, Cambridge, Massachusetts, USA.
Robert J PelhamClinical Development, BeiGene Ltd, Cambridge, Massachusetts, USA.
Lin ShenDepartment of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, China.ORCID 0000-0002-8798-4756
Biogen (United States) · USAichi Cancer Center · JPBallarat Health Services · AUCentre Hospitalier Régional Universitaire de Brest · FRHospital Universitario Puerta de Hierro Majadahonda · ESInserm · FRInstitut d'Investigació Biomédica de Bellvitge · ESKindai University · JPMonash Medical Centre · AUNanjing Drum Tower Hospital · CNOregon Health & Science University · USPeking University · CNSaint Petersburg Academic University · RUSeoul National University · KRUniversitat de València · ESUniversity of Campania "Luigi Vanvitelli" · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPoly (ADP-ribose) polymerase (PARP) inhibitors (PARPi) are approved for the treatment of various solid tumors. In gastric cancer, genes commonly harbor mutations in the homologous recombination DNA repair pathway, potentially increasing sensitivity to PARPi. Pamiparib (BGB-290) is a small molecule inhibitor of PARP1 and PARP2.

methodsThe PARALLEL-303 study (NCT03427814) investigated the efficacy and safety of pamiparib 60 mg orally (PO) twice daily (BID) versus placebo PO BID as maintenance therapy in patients with inoperable locally advanced or metastatic gastric cancer that responded to platinum-based first-line chemotherapy. The primary endpoint of this double-blind, randomized, global phase 2 study was progression-free survival (PFS) (RECIST version 1.1; per investigator assessment). Secondary endpoints included overall survival (OS) and safety.

resultsIn total, 136 patients were randomized 1:1 to receive pamiparib (n = 71) or placebo (n = 65). Median PFS was numerically longer with pamiparib versus placebo but did not reach statistical significance (3.7 months [95% confidence interval (CI): 1.9, 5.3] vs. 2.1 months [95% CI: 1.9, 3.8]; hazard ratio 0.8 [95% CI: 0.5, 1.2]; p = 0.1428). Median OS was 10.2 months (95% CI: 8.7, 16.3) in the pamiparib arm versus 12.0 months (95% CI: 8.2, not estimable) in the placebo arm. Overall, 8 patients (11.3%) in the pamiparib arm and 2 patients (3.1%) in the placebo arm experienced ≥1 TEAE leading to treatment discontinuation.

conclusionsMaintenance pamiparib did not meet statistical significance for superiority versus placebo for PFS, but was well tolerated with few treatment discontinuations; no unexpected safety signals were identified.

Indexed as

Stomach NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsDouble-Blind MethodFluorenesHumansPlatinumProgression-Free SurvivalFluorenespamiparibPlatinumclinical trialgastric cancermaintenancephase 2poly(ADP-ribose) polymerase inhibitors

Identifiers

PMID37260158
PMCPMC10315793
OpenAlexW4378953444

What OpenQuestion holds

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LicenceCC BY
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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.