Evidence map›Paper›PMID 33026712›Full record

Trial reportThoracic cancer2020

Phase II study of durvalumab and tremelimumab in pulmonary sarcomatoid carcinoma: KCSG-LU16-07.

Miso Kim, Bhumsuk Keam, Chan-Young Ock, Se Hyun Kim, Yu Jung Kim, Sun Min Lim, Jin-Soo Kim, Tae Min Kim, Sook-Hee Hong, Mi Sun Ahn and 8 more

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

Trial report in Thoracic cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 10% 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

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

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  13. Targeted therapy for rare lung cancers: Status, challenges, and prospects.Molecular therapy : the journal of the American Society of Gene Therapy · 2023
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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 9 institutions in 3 countries.

Miso KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Bhumsuk KeamDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0001-8196-4247
Chan-Young OckDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Se Hyun KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.ORCID 0000-0002-2292-906X
Yu Jung KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.
Sun Min LimDepartment of Internal Medicine, CHA Bundang Medical Center, Seongnam, Republic of Korea.
Jin-Soo KimDepartment of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
Tae Min KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Sook-Hee HongDepartment of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Mi Sun AhnDepartment of Hematology-Oncology, Ajou University School of Medicine, Suwon, Republic of Korea.
Seong Hoon ShinDepartment of Internal Medicine, Kosin University Gospel Hospital, Busan, Republic of Korea.
Eun Joo KangDepartment of Internal Medicine, Korea University Medical Center, Korea University College of Medicine, Seoul, Republic of Korea.
Dong-Wan KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0001-5124-7132
Sun-Wha ImGenomic Medicine Institute, Medical Research Center, Seoul National University, Seoul, Republic of Korea.
Jong-Il KimCancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
Jong Seok LeeDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.
Joo-Hang KimDepartment of Internal Medicine, CHA Bundang Medical Center, Seongnam, Republic of Korea.
Dae Seog HeoDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Seoul National University · KRSeoul National University Bundang Hospital · KRSeoul National University of Science and Technology · KRAjou University · KRCHA University Bundang Medical Center · KRKorea University Medical Center · KRKosin University Gospel Hospital · KRSeoul National University Hospital · KRSt. Mary's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPulmonary sarcomatoid carcinoma (PSC) is rare with a poor outcome and is resistant to conventional cytotoxic chemotherapy. The efficacy and safety of durvalumab and tremelimumab for treating recurrent or metastatic PSCs were assessed by a nonrandomized, open-label, phase II study.

methodsA total of 18 patients with recurrent or metastatic PSC received 1500 mg of durvalumab and 75 mg of tremelimumab every four weeks, followed by 750 mg of durvalumab every two weeks until the disease progressed, or an unacceptable toxicity level was reached. The primary endpoint was the objective response rate (ORR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity. Genomic profiling of PSC by next-generation sequencing (NGS) and determination of peripheral blood lymphocyte subsets using flow cytometry were performed for exploratory analysis.

resultsA total of 15 out of 18 patients were evaluated for the analysis of the primary endpoint. At the data cutoff point, the ORR of 26.7% (95% confidence interval [CI]: 7.8-55.1) was achieved with the median follow-up duration of 12.0 months (range, 8.4-16.1). Median PFS and OS were 5.9 months (95% CI: 1.1-11.9) and 15.4 months (95% CI: 11.1-not reached), respectively. Treatment-related adverse events (AEs) of any grade were reported in 16 patients; the most common AEs were pruritus (n = 5), pneumonitis (n = 4), and rash (n = 4). Treatment was discontinued in two patients due to AEs of grade ≥ 3.

conclusionsDurvalumab and tremelimumab demonstrated clinical benefit with a prolonged survival and manageable toxicity profile in patients with recurrent or metastatic PSC.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansImmunotherapyLung NeoplasmsMaleMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizeddurvalumabtremelimumabDurvalumabimmunotherapynon-small cell lung cancerpulmonary sarcomatoid carcinomatremelimumab

Identifiers

PMID33026712
PMCPMC7705626
OpenAlexW3092112918

What OpenQuestion holds

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Registered trials

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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.