Evidence map›Paper›PMID 38755585›Full record

Trial reportBMC medicine2024

Exploratory biomarker analysis in the phase III L-MOCA study of olaparib maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer.

Huayi Li, Zikun Peng, Jianqing Zhu, Weidong Zhao, Yi Huang, Ruifang An, Hong Zheng, Pengpeng Qu, Li Wang, Qi Zhou and 23 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in BMC medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03534453 (An Open Label, Single Arm, Multicentre Study to Assess the Clinical Efficacy and Safety of Lynparza), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT03534453 phase3completednot on this map

An Open Label, Single Arm, Multicentre Study to Assess the Clinical Efficacy and Safety of Lynparza (Olaparib) Tablets Maintenance Monotherapy in Platinum Sensitive Relapsed Ovarian Cancer Patients Who Are in Complete or Partial Response Following Platinum Based Chemotherapy (L-MOCA)

TypeinterventionalSponsorAstraZenecaRan2018 to 2025Enrolled229ConditionsRelapsed Ovarian Cancer, Following Complete or Partial Response to Platinum Based Chemotherapy, Platinum SensitiveArmsOlaparib 300mg tablets
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

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

33 authors.

Huayi Li *Department of Obstetrics and Gynaecology, National Clinical Research Centre for Obstetrics and Gynaecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Hankou, Wuhan, 430030, China.
Zikun Peng *Department of Obstetrics and Gynaecology, National Clinical Research Centre for Obstetrics and Gynaecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Hankou, Wuhan, 430030, China.
Jianqing Zhu *Department of Gynaecologic Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.
Weidong Zhao *Department of Gynaecologic Oncology, Anhui Provincial Cancer Hospital, Hefei, China.
Yi HuangDepartment of Gynaecologic Oncology, Hubei Cancer Hospital, Wuhan, China.
Ruifang AnDepartment of Obstetrics and Gynaecology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Hong ZhengDepartment of Gynaecology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Beijing Cancer Hospital, Beijing, China.
Pengpeng QuDepartment of Gynaecology Oncology, Tianjin Central Hospital of Gynaecology Obstetrics, Tianjin, China.
Li WangDepartment of Gynaecologic Oncology, Affiliated Cancer Hospital of Zhengzhou University, (Henan Cancer Hospital), Zhengzhou, China.
Qi ZhouDepartment of Gynaecologic Oncology, Chongqing University Cancer Hospital, Chongqing, China.
Danbo WangDepartment of Gynaecologic Oncology, Liaoning Cancer Hospital, Shenyang, China.
Ge LouDepartment of Gynaecologic Oncology, Harbin Medical University Cancer Hospital, Harbin, China.
Jing WangDepartment of Gynaecologic Oncology, Hunan Cancer Hospital, Changsha, China.
Ke WangDepartment of Gynaecologic Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Beihua KongDepartment of Obstetrics and Gynaecology, Qilu Hospital of Shandong University, Jinan, China.
Xing XieDepartment of Gynaecologic Oncology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Rutie YinDepartment of Obstetrics and Gynaecology, West China Second University Hospital, Chengdu, China.
John LowCancer Centre @ PHKL, Pantai Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.
Abdul Malik RozitaClinical Oncology Unit, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Lim Chun SenOncology Department, Hospital Sultan Ismail, Johor Bahru, Malaysia.
Yong Chee MengGynaeoncology, Hospital Ampang, Ampang, Malaysia.
Kho Swee KiongOncology, Hospital Umum Sarawak, Kuching, Sarawak, Malaysia.
Jihong LiuDepartment of Gynaecologic Oncology, Sun Yat-sen University Cancer Centre, Guangzhou, China.
Zhiqing LiangDepartment of Gynaecologic Oncology, Southwest Hospital, Third Military Medical University, Chongqing, China.
Weiguo LvDepartment of Gynaecologic Oncology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Yaping ZhuDepartment of Gynaecology, Shanghai General Hospital, Shanghai, China.
Weiguo HuFudan University Shanghai Cancer Centre and Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai, China.
Wei SunDepartment of Gynaecologic Oncology, Anhui Provincial Cancer Hospital, Hefei, China.
Jingya SuDepartment of Medical Affairs, AstraZeneca, Shanghai, China.
Qiqi WangDepartment of Medical Affairs, AstraZeneca, Shanghai, China.
Rongyu ZangDepartment of Gynaecologic Oncology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China. ryzang@yahoo.com.
Ding MaDepartment of Obstetrics and Gynaecology, National Clinical Research Centre for Obstetrics and Gynaecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Hankou, Wuhan, 430030, China. dingma424@126.com.
Qinglei GaoDepartment of Obstetrics and Gynaecology, National Clinical Research Centre for Obstetrics and Gynaecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Hankou, Wuhan, 430030, China. qingleigao@hotmail.com.ORCID 0000-0002-9448-3423

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe prospective phase III multi-centre L-MOCA trial (NCT03534453) has demonstrated the encouraging efficacy and manageable safety profile of olaparib maintenance therapy in the Asian (mainly Chinese) patients with platinum-sensitive relapsed ovarian cancer (PSROC). In this study, we report the preplanned exploratory biomarker analysis of the L-MOCA trial, which investigated the effects of homologous recombination deficiency (HRD) and programmed cell death ligand 1 (PD-L1) expression on olaparib efficacy.

methodsHRD status was determined using the ACTHRD assay, an enrichment-based targeted next-generation sequencing assay. PD-L1 expression was assessed by SP263 immunohistochemistry assay. PD-L1 expression positivity was defined by the PD-L1 expression on ≥ 1% of immune cells. Kaplan-Meier method was utilised to analyse progression-free survival (PFS).

resultsThis exploratory biomarker analysis included 225 patients and tested HRD status [N = 190; positive, N = 125 (65.8%)], PD-L1 expression [N = 196; positive, N = 56 (28.6%)], and BRCA1/2 mutation status (N = 219). The HRD-positive patients displayed greater median PFS than the HRD-negative patients [17.9 months (95% CI: 14.5-22.1) versus 9.2 months (95% CI: 7.5-13.8)]. PD-L1 was predominantly expressed on immune cells. Positive PD-L1 expression on immune cells was associated with shortened median PFS in the patients with germline BRCA1/2 mutations [14.5 months (95% CI: 7.4-18.2) versus 22.2 months (95% CI: 18.3-NA)]. Conversely, positive PD-L1 expression on immune cells was associated with prolonged median PFS in the patients with wild-type BRCA1/2 [20.9 months (95% CI: 13.9-NA) versus 8.3 months (95% CI: 6.7-13.8)].

conclusionsHRD remained an effective biomarker for enhanced olaparib efficacy in the Asian patients with PSROC. Positive PD-L1 expression was associated with decreased olaparib efficacy in the patients with germline BRCA1/2 mutations but associated with improved olaparib efficacy in the patients with wild-type BRCA1/2.

trial registrationNCT03534453. Registered at May 23, 2018.

Indexed as

B7-H1 AntigenBiomarkers, TumorMaintenance ChemotherapyOvarian NeoplasmsPhthalazinesPiperazinesAdultAgedAntineoplastic AgentsBRCA1 ProteinBRCA2 ProteinFemaleHomologous RecombinationHumansMiddle AgedNeoplasm Recurrence, LocalAntineoplastic AgentsB7-H1 AntigenBiomarkers, TumorBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanCD274 protein, humanolaparibPhthalazinesPiperazinesBiomarkerBRCA1/2Homologous recombination deficiencyL-MOCA trialOlaparibPARP inhibitorsPD-L1 expressionPlatinum-sensitive relapsed ovarian cancer

Identifiers

PMID38755585
PMCPMC11100112

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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.