Evidence map›Paper›PMID 34081738›Full record

Trial reportPloS one2021

Phase II trial of cisplatin, gemcitabine and pembrolizumab for platinum-resistant ovarian cancer.

Christine S Walsh, Mitchell Kamrava, Andre Rogatko, Sungjin Kim, Andrew Li, Ilana Cass, Beth Karlan, Bobbie J Rimel

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

Trial report in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
3.3field-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.

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

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 22 citations in OpenAlex.

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  11. Cabozantinib inhibits tumor growth in mice with ovarian cancer.American journal of cancer research · 2024
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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

8 authors at 1 institution in 1 country.

Christine S WalshDepartment of Obstetrics and Gynecology, Division of Gynecologic Oncology, Cedars-Sinai Medical Center, Los Angeles, California, United States of America.ORCID 0000-0002-0903-3971
Mitchell KamravaCedars-Sinai Cancer, Cedars-Sinai Medical Center, Los Angeles, California, United States of America.
Andre RogatkoCedars-Sinai Cancer, Cedars-Sinai Medical Center, Los Angeles, California, United States of America.ORCID 0000-0001-8935-8890
Sungjin KimCedars-Sinai Cancer, Cedars-Sinai Medical Center, Los Angeles, California, United States of America.
Andrew LiDepartment of Obstetrics and Gynecology, Division of Gynecologic Oncology, Cedars-Sinai Medical Center, Los Angeles, California, United States of America.
Ilana CassDepartment of Obstetrics and Gynecology, Division of Gynecologic Oncology, Cedars-Sinai Medical Center, Los Angeles, California, United States of America.ORCID 0000-0001-9236-1281
Beth KarlanDepartment of Obstetrics and Gynecology, Division of Gynecologic Oncology, Cedars-Sinai Medical Center, Los Angeles, California, United States of America.
Bobbie J RimelDepartment of Obstetrics and Gynecology, Division of Gynecologic Oncology, Cedars-Sinai Medical Center, Los Angeles, California, United States of America.
Cedars-Sinai Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the combination of pembrolizumab, cisplatin and gemcitabine in recurrent platinum-resistant ovarian cancer.

methodsPatients received six cycles of chemotherapy with gemcitabine and cisplatin on day 1 and day 8 of a 21-day treatment cycle. Pembrolizumab was administered on day 1 of cycles 3-6 and as maintenance monotherapy in cycles 7-34. Palliative radiation to a non-target symptomatic lesion was allowed. The primary objective was overall response rate by RECIST 1.1 criteria. Secondary objectives included safety, progression-free survival, time to progression, duration of response and overall survival.

resultsAn interim analysis for futility was performed at 18 evaluable patients. Overall response rate was 60%, duration of response was 4.9 months and time to progression was 5.2 months. Progression-free survival at 6 and 12 months was 43% and 5%. Median progression-free survival was 6.2 months and median overall survival was 11.3 months. In all patients, CA125 levels reflected response and progression. There were no pseudoprogression events. After receiving palliative radiation during pembrolizumab maintenance, a patient with recurrent ovarian clear cell carcinoma had an exceptional and durable response that is ongoing for greater than 2 years. After consultation with the sponsor, based on the modest duration of response observed at the interim analysis for futility, the decision was made to close the trial to further accrual.

conclusionsThe addition of pembrolizumab to cisplatin and gemcitabine did not appear to provide benefit beyond chemotherapy alone in patients with recurrent platinum-resistant ovarian cancer.

Indexed as

AgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenCA-125 AntigenCisplatinDeoxycytidineDrug Administration ScheduleDrug Resistance, NeoplasmFemaleGemcitabineHumansMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingOvarian NeoplasmsAntibodies, Monoclonal, HumanizedB7-H1 AntigenCA-125 AntigenCD274 protein, humanCisplatinDeoxycytidineGemcitabinepembrolizumabPlatinum

Identifiers

PMID34081738
PMCPMC8174738
OpenAlexW3165566354

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.