Evidence map›Paper›PMID 37489066›Full record

ArticleCancer medicine2023

Safety and tolerability of first-line durvalumab with tremelimumab and chemotherapy in esophageal squamous cell carcinoma.

Dae Ho Lee, Hye Ryun Kim, Bhumsuk Keam, Ken Kato, Yasutoshi Kuboki, Haiyan Gao, Alejandro Yovine, Scott H Robbins, Myung-Ju Ahn

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article 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 NCT02658214 (A Phase Ib Study to Evaluate the Safety and Tolerability of Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Patients With Advanced Solid Tumors.), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 14% 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.

NCT02658214 phase1completednot on this map

A Phase Ib Study to Evaluate the Safety and Tolerability of Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Patients With Advanced Solid Tumors.

TypeinterventionalSponsorAstraZenecaRan2016 to 2019Enrolled32ConditionsSmall Cell Lung Carcinoma, Carcinoma, Squamous Cell of Head and Neck, Stomach Neoplasms, Triple Negative Breast NeoplasmsArmspaclitaxel + carboplatin, carboplatin + etoposide, gemcitabine + carboplatin, nab-paclitaxel (paclitaxel-albumin) + carboplatin, oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Immunotherapy in Gastrointestinal Cancers: Current Insights.Clinical pharmacology : advances and applications · 2025
    Review
  4. Review
  5. Article
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

9 authors at 8 institutions in 4 countries.

Dae Ho LeeDepartment of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Hye Ryun KimDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Bhumsuk KeamDepartment of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.ORCID 0000-0001-8196-4247
Ken KatoDepartment of Head and Neck, Esophageal Oncology, National Cancer Center Hospital, Tokyo, Japan.
Yasutoshi KubokiGastrointestinal Oncology Division, National Cancer Center Hospital, East Kashiwa, Japan.
Haiyan GaoAstraZeneca, Cambridge, UK.
Alejandro YovineAstraZeneca, Cambridge, UK.
Scott H RobbinsAstraZeneca, Gaithersburg, Maryland, USA.
Myung-Ju AhnDivision of Hematology-Oncology, Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea.ORCID 0000-0002-5740-9654
AstraZeneca (United Kingdom) · GBAstraZeneca (United States) · USNational Cancer Center · USNational Cancer Center Hospital East · JPSamsung Medical Center · KRSeoul National University Hospital · KRUlsan College · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdvanced or metastatic esophageal squamous cell carcinoma (ESCC) is associated with poor prognosis; new first-line systemic treatment options are needed. Combining immuno-oncology therapies with standard chemotherapy may represent a promising approach for the treatment of solid tumors. Results from a Phase Ib study evaluating durvalumab with tremelimumab and chemotherapy in patients with advanced or metastatic ESCC are reported.

methodsAdults with advanced or metastatic ESCC who were candidates for first-line platinum-based chemotherapy received durvalumab 1500 mg (Day 1), tremelimumab 75 mg (Day 1), cisplatin 80 mg/m

resultsSixteen patients were enrolled, 6 in Part A and 10 in Part B, and received a median of 4.0 treatment cycles. All patients were Asian; median age was 65.0 years. All patients experienced adverse events (AEs) related to cisplatin and 5-FU, and 8 (50.0%) patients experienced AEs related to durvalumab and tremelimumab. Grade ≥3 treatment-related AEs occurred in 7 (43.8%) patients. There were no deaths associated with AEs. Six (37.5%) patients achieved an objective response. Median progression-free survival was 3.75 months, and median overall survival was 9.69 months.

conclusionsDurvalumab with tremelimumab and chemotherapy demonstrated manageable safety and antitumor activity in patients with advanced or metastatic ESCC, warranting further investigation in randomized trials. Registered with ClinicalTrials.gov: NCT02658214.

Indexed as

Esophageal NeoplasmsEsophageal Squamous Cell CarcinomaAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCisplatinFluorouracilHumansAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCisplatindurvalumabFluorouraciltremelimumabchemotherapyclinical trialsesophageal squamous cellimmunology

Identifiers

PMID37489066
PMCPMC10469840
OpenAlexW4385230742

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.