Evidence map›Paper›PMID 28111428›Full record

Trial reportCancer research and treatment2017

Randomized Phase II Study of Afatinib Plus Simvastatin Versus Afatinib Alone in Previously Treated Patients with Advanced Nonadenocarcinomatous Non-small Cell Lung Cancer.

Youngjoo Lee, Ki Hyeong Lee, Geon Kook Lee, Soo-Hyun Lee, Kun Young Lim, Jungnam Joo, Yun Jung Go, Jin Soo Lee, Ji-Youn Han

Open access · diamondAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer research and treatment, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 7 pooled it
4.5field-weighted citation impact, top 5% 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

42 citing papers in PubMed, 7 syntheses or guidelines pooled it, 60 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

9 authors at 2 institutions in 1 country.

Youngjoo LeeCenter for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
Ki Hyeong LeeDepartment of Hematology-Oncology, Chungbuk National University Hospital, Cheongju, Korea.
Geon Kook LeeCenter for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
Soo-Hyun LeeCenter for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
Kun Young LimCenter for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
Jungnam JooBiometric Research Branch, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
Yun Jung GoCenter for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
Jin Soo LeeCenter for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
Ji-Youn HanCenter for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea.
National Cancer Center · KRChungbuk National University Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis phase II study examined whether the addition of simvastatin to afatinib provides a clinical benefit compared with afatinib monotherapy in previously treated patients with nonadenocarcinomatous non-small cell lung cancer (NA-NSCLC). MATERIALS AND

methodsPatients with advanced NA-NSCLC who progressed after one or two chemotherapy regimens were randomly assigned to a simvastatin (40 mg/day) plus afatinib (40 mg/day) (AS) arm or to an afatinib (A) arm. The primary endpoint was response rate (RR).

resultsSixty-eight patients were enrolled (36 in the AS arm and 32 in the A arm). The RR was 5.7% (95% confidence interval [CI], 0.7 to 19.2) for AS and 9.4% (95% CI, 2.0 to 25.0) for A (p=0.440). In arms AS and A, the median progression-free survival (PFS) was 1.0 versus 3.6 months (p=0.240) and the overall survival was 10.0 months versus 7.0 months (p=0.930), respectively. Skin rash, stomatitis, and diarrhea were the most common adverse events in both arms. More grade 3 or 4 diarrhea was observed in arm A (18.8% vs. 5.6% in arm AS). In all patients, the median PFS for treatment including afatinib was not correlated with the status of epidermal growth factor receptor (EGFR) mutation (p=0.122), EGFR fluorescence in situ hybridization (p=0.944), or EGFR immunohistochemistry (p=0.976). However, skin rash severity was significantly related to the risk of progression for afatinib (hazard ratio for skin rash grade ≥ 2 vs. grade < 2, 0.44; 95% CI, 0.25 to 0.78; p=0.005).

conclusionThere were no significant differences in the efficacy between AS and A arms in patients with NA-NSCLC.

Indexed as

AdultAfatinibAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Non-Small-Cell LungFemaleHumansLung NeoplasmsMaleMiddle AgedMutationNeoplasm MetastasisNeoplasm StagingQuinazolinesAfatinibBiomarkers, TumorQuinazolinesSimvastatinEGFR mutationEGFR tyrosine kinase inhibitorNon-small-cell lung carcinomaSquamous cell carcinomaStatin

Identifiers

PMID28111428
PMCPMC5654166
OpenAlexW2575804911

What OpenQuestion holds

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LicenceCC BY-NC
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.