Evidence map›Paper›PMID 33826027›Full record

ArticleInternational journal of clinical oncology2021

First-line durvalumab plus platinum-etoposide in extensive-stage small-cell lung cancer: CASPIAN Japan subgroup analysis.

Katsuyuki Hotta, Makoto Nishio, Haruhiro Saito, Isamu Okamoto, Yasuharu Nakahara, Hidetoshi Hayashi, Manabu Hayama, Peter Laud, Haiyi Jiang, Luis Paz-Ares and 1 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in International journal of clinical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03043872 (A Phase III, Randomized, Multicenter,Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients With Extensive Disease Small-Cell Lung Cancer), 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
1.2field-weighted citation impact, top 19% 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.

NCT03043872 phase3active not recruitingnot on this map

A Phase III, Randomized, Multicenter,Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients With Extensive Disease Small-Cell Lung Cancer (SCLC) (CASPIAN)

TypeinterventionalSponsorAstraZenecaRan2017 to 2026Enrolled987ConditionsSmall Cell Lung Carcinoma Extensive DiseaseArmsDurvalumab, Tremelimumab, Carboplatin, Cisplatin, Etoposide
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 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

11 authors at 11 institutions in 4 countries.

Katsuyuki HottaDepartment of Respiratory Medicine, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700 8558, Japan. khotta@okayama-u.ac.jp.
Makoto NishioDepartment of Thoracic Medical Oncology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Haruhiro SaitoDepartment of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.
Isamu OkamotoResearch Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Yasuharu NakaharaDepartment of Respiratory Medicine, Himeji Medical Center, Himeji, Japan.
Hidetoshi HayashiDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.
Manabu HayamaAstraZeneca K.K, Tokyo, Japan.
Peter LaudStatistical Services Unit, University of Sheffield, Sheffield, UK.
Haiyi JiangAstraZeneca, Gaithersburg, MD, USA.
Luis Paz-AresDepartment of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.
Koichi AzumaDepartment of Internal Medicine, Kurume University School of Medicine, Kurume, Japan.
AstraZeneca (Japan) · JPAstraZeneca (United States) · USHimeji Medical Center · JPHospital Universitario 12 De Octubre · ESJapanese Foundation For Cancer Research · JPKanagawa Cancer CenterKindai University · JPKurume University · JPKyushu University · JPOkayama University Hospital · JPUniversity of Sheffield · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the phase 3 CASPIAN study (NCT03043872), first-line durvalumab plus etoposide and cisplatin or carboplatin (EP) significantly improved OS versus EP alone in patients with extensive-stage (ES)-SCLC (HR 0.73 [95% CI 0.59-0.91; p = 0.0047]). Here we report results for a preplanned subgroup analysis of patients recruited in Japan.

methodsTreatment-naïve patients with ES-SCLC received either 4 cycles of durvalumab 1500 mg plus EP q3w followed by maintenance durvalumab 1500 mg q4w until disease progression or up to 6 cycles of EP q3w. The primary endpoint was OS. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), safety, and tolerability.

resultsIn the Japan subgroup, 18 patients were randomized to durvalumab plus EP and 16 patients to EP. At the interim analysis with a median follow-up of 12.5 months in the subgroup, OS numerically favored durvalumab plus EP versus EP (HR 0.77 [95% CI 0.26‒2.26]; median not reached vs 15.2 months). PFS was similar for durvalumab plus EP versus EP (HR 0.90 [95% CI 0.43‒1.89]). Confirmed ORR was 89% with durvalumab plus EP versus 69% with EP. Adverse events (AEs) of CTCAE grade 3 or 4 were reported in 78% versus 94% of patients in the durvalumab plus EP versus EP arms. There were no AEs leading to treatment discontinuation or death in the Japan subgroup.

conclusionFirst-line durvalumab plus EP was effective and well tolerated in Japanese patients with ES-SCLC. Despite the small size of the Japan subgroup, results were generally consistent with the global study population.

Indexed as

CASPIANDurvalumabJapanese patientsSmall-cell lung cancerSubgroup analysis

Identifiers

PMID33826027
PMCPMC8134304
OpenAlexW3145483179

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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.