Evidence map›Paper›PMID 35182247›Full record

Trial reportInternational journal of clinical oncology2022

First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in advanced non-small cell lung cancer: a subanalysis of Asian patients in CheckMate 9LA.

Thomas John, Hiroshi Sakai, Satoshi Ikeda, Ying Cheng, Kazuo Kasahara, Yuki Sato, Yoshiro Nakahara, Masayuki Takeda, Hiroyasu Kaneda, Helong Zhang and 9 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of clinical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
–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.

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

21 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

19 authors.

Thomas JohnAustin Hospital, 145 Studley Road, Heidelberg, VIC, 3084, Australia. Tom.John@petermac.org.
Hiroshi SakaiSaitama Cancer Center, 780, Komuro, Ina, Kitaadachi District, Saitama, 362-0806, Japan.
Satoshi IkedaKanagawa Cardiovascular and Respiratory Center, 6 Chome-16-1 Tomiokahigashi, Kanazawa Ward, Yokohama, Kanagawa, 236-0051, Japan.
Ying ChengJilin Cancer Hospital, No. 1018 Huguang Road, Changchun, 130012, China.
Kazuo KasaharaKanazawa University Hospital, 13-1 Takaramachi, Kanazawa, Ishikawa, 920-8641, Japan.
Yuki SatoKobe City Medical Center General Hospital, 2-1-1, Minatojima Minamimachi, Chuo Ward, Kobe, Hyogo, 650-0047, Japan.
Yoshiro NakaharaKanagawa Cancer Center, 2 Chome-3-2 Nakao, Asahi Ward, Yokohama, Kanagawa, 241-8515, Japan.
Masayuki TakedaKindai University Hospital, 377-2 Onohigashi, Osakasayama, Osaka, 589-8511, Japan.
Hiroyasu KanedaOsaka City University Hospital, 1 Chome-5-7 Asahimachi, Abeno Ward, Osaka, 545-8586, Japan.
Helong ZhangTangdu Hospital, Xinsi Road, Baqiao District, Xi'an, 710038, Shaanxi, China.
Makoto MaemondoIwate Medical University Hospital, 2-1-1 Idaidori, Yahaba-cho, Shiwa District, Iwate, 028-3695, Japan.
Koichi MinatoGunma Prefectural Cancer Center, 617-1 Takahayashinishi-cho, Ota-shi, Gunma, 373-8550, Japan.
Takeshi HisadaGunma University Hospital, 3 Chome-39-15 Showamachi, Maebashi, Gunma, 371-8511, Japan.
Yuki MisumiYokohama Municipal Citizen's Hospital, 1-1 Mitsuzawa Nishimachi, Kanagawa Ward, Yokohama, Kanagawa, 221-0855, Japan.
Miyako SatouchiHyogo Cancer Center, 13-70 Kita-Oji, Akashi, Hyogo, 673-8558, Japan.
Katsuyuki HottaOkayama University Hospital, 2 Chome-5-1 Shikatacho, Kita Ward, Okayama, 700-0914, Japan.
Ang LiBristol Myers Squibb, 3551 Lawrenceville Road, Princeton, NJ, USA.
Abderrahim OukessouBristol Myers Squibb, 3551 Lawrenceville Road, Princeton, NJ, USA.
Shun LuShanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, 241 West Huaihai Road, Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCheckMate 9LA, a phase 3, randomized, open-label study in first-line advanced non-small cell lung cancer (NSCLC), showed significantly improved overall survival (OS) with nivolumab plus ipilimumab combined with 2 cycles of chemotherapy versus chemotherapy alone (4 cycles). We present results for the Asian subpopulation enrolled in Japan and China.

methodsPatients aged ≥ 18 years with treatment-naive, histologically confirmed stage IV or recurrent NSCLC, Eastern Cooperative Oncology Group performance status 0-1 and no sensitizing EGFR/ALK mutations were randomized 1:1 to nivolumab [360 mg every 3 weeks (Q3W)] plus ipilimumab (1 mg/kg Q6W) combined with chemotherapy (Q3W for 2 cycles), or chemotherapy alone (Q3W for 4 cycles). Primary endpoint was OS; secondary endpoints included progression-free survival (PFS) and objective response rate (ORR).

resultsTwenty-eight patients received nivolumab plus ipilimumab combined with chemotherapy and 30 received chemotherapy. At a minimum follow-up of 12.7 months, median OS was not reached with nivolumab plus ipilimumab combined with chemotherapy versus 13.3 months with chemotherapy [hazard ratio (HR) 0.33; 95% confidence interval (CI) 0.14-0.80]. Median PFS was 8.4 versus 5.4 months (HR 0.47; 95% CI 0.24-0.92) and ORR was 57% versus 23%, respectively. Grade 3-4 treatment-related adverse events were observed in 57% versus 60% of patients, respectively.

conclusionConsistent with results in the all randomized population, nivolumab plus ipilimumab combined with chemotherapy improved efficacy in the Asian subpopulation versus chemotherapy alone and had a manageable safety profile, supporting its use as first-line treatment for advanced NSCLC in Asian patients.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAdolescentAntineoplastic Combined Chemotherapy ProtocolsHumansIpilimumabNeoplasm Recurrence, LocalNivolumabIpilimumabNivolumabAsiaImmunotherapyIpilimumabJapanNivolumabNon-small cell lung cancer

Identifiers

PMID35182247
PMCPMC8956544

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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.