Evidence mapPaperPMID 35904643Full record

Trial reportEsophagus : official journal of the Japan Esophageal Society2022

Phase II study of BKM120 in patients with advanced esophageal squamous cell carcinoma (EPOC1303).

Takashi Kojima, Ken Kato, Hiroki Hara, Shunji Takahashi, Kei Muro, Tomohiro Nishina, Masashi Wakabayashi, Shogo Nomura, Akihiro Sato, Atsushi Ohtsu and 1 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Esophagus : official journal of the Japan Esophageal Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.9field-weighted citation impact, top 8% 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

19 citing papers in PubMed, 22 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. International journal of molecular sciences · 2025
    Review
  6. Review
  7. Review
  8. Article
  9. Tumor biomarkers for diagnosis, prognosis and targeted therapy.Signal transduction and targeted therapy · 2024
    Review
  10. Regulation of PI3K signaling in cancer metabolism and PI3K-targeting therapy.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2024
    Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Review
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 5 institutions in 1 country.

Takashi KojimaDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Ken KatoDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
Hiroki HaraSaitama Cancer Center Hospital, Saitama, Japan.
Shunji TakahashiCancer Chemotherapy Center, Cancer Institute Hospital, Tokyo, Japan.
Kei MuroAichi Cancer Center Hospital, Nagoya, Japan.
Tomohiro NishinaShikoku Cancer Center, Matsuyama, Japan.
Masashi WakabayashiClinical Research Support Office, National Cancer Center Hospital East, Kashiwa, Japan.
Shogo NomuraClinical Research Support Office, National Cancer Center Hospital East, Kashiwa, Japan.
Akihiro SatoClinical Research Support Office, National Cancer Center Hospital East, Kashiwa, Japan.
Atsushi OhtsuDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Toshihiko DoiDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. tdoi@east.ncc.go.jp.
National Cancer Center Hospital East · JPAichi Cancer Center · JPSaitama Cancer Center · JPShikoku Cancer Center · JPThe Cancer Institute Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPI3K/AKT/mTOR pathway is frequently overactive in esophageal squamous cell carcinoma (ESCC), making it an attractive treatment target. BKM120 is an oral pan-class I PI3K inhibitor with promising activity in several cancers. We prospectively investigated efficacy, safety, and biomarkers of BKM120 in advanced ESCC. We conducted a multicenter phase II study of BKM120 monotherapy in patients with pretreated advanced ESCC.

methodsBKM120 (100 mg/day) was administered orally in a 28-day cycle. The primary end point was disease control rate (DCR). Tumor samples for all patients were collected for gene alteration analysis in a comprehensive genomic profiling assay.

resultsOf 42 patients enrolled, 20 had stable disease and two had confirmed partial response. One ineligible patient was excluded from the primary analysis, which met the primary end point (DCR 51.2%; 95% confidence interval [CI], 35.1-67.1). In the 42 patients, median progression-free survival and overall survival were 2.3 (95% CI 1.8-3.2) and 9.0 (95% CI 6.5-11.4) months, respectively. Common grade 3 or 4 adverse events were rash, anorexia, hyponatremia, and abnormal hepatic function; profiles of these events in this study were similar to those in previous studies of BKM120 monotherapy. No treatment-related deaths occurred. PI3K pathway activation was observed in patients with good clinical response.

conclusionsBKM120 monotherapy showed promising efficacy and a manageable toxicity profile even in patients with pretreated advanced ESCC. This study showed the potential target PI3K for ESCC, and further confirmatory trial will be necessary to confirm it. Unique ID issued by UMIN: UMIN 000011217.

Indexed as

Esophageal NeoplasmsEsophageal Squamous Cell CarcinomaAminopyridinesHumansMorpholinesPhosphatidylinositol 3-KinasesAminopyridinesMorpholinesNVP-BKM120Phosphatidylinositol 3-KinasesEsophageal NeoplasmsNVP-BKM120Phosphatidylinositol 3-Kinases

Identifiers

PMID35904643
PMCPMC9436835
OpenAlexW4288489123

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.