Evidence map›Paper›PMID 28864978›Full record

Trial reportInvestigational new drugs2017

Phase II basket trial of perifosine monotherapy for recurrent gynecologic cancer with or without PIK3CA mutations.

Kosei Hasegawa, Masahiro Kagabu, Mika Mizuno, Katsutoshi Oda, Daisuke Aoki, Seiji Mabuchi, Shoji Kamiura, Satoshi Yamaguchi, Yoichi Aoki, Toshiaki Saito and 5 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 7% 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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Review
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  4. Article
  5. Review
  6. Review
  7. Drug repositioningFrontiers in oncology · 2023
    Article
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  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Article
  15. Review
  16. Article
  17. Article
  18. Basket Trials for Intractable Cancer.Frontiers in oncology · 2019
    Review
  19. Article
  20. 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

15 authors at 12 institutions in 1 country.

Kosei HasegawaDepartment of Gynecologic Oncology, Saitama Medical University International Medical Center, 1397-1, Yamane, Hidaka, Saitama, 350-1298, Japan. koseih@saitama-med.ac.jp.ORCID 0000-0002-1903-7001
Masahiro KagabuDepartment of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 19-1, Uchimaru, Morioka, Iwate, 020-8505, Japan.
Mika MizunoDepartment of Gynecology, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.
Katsutoshi OdaDepartment of Obstetrics and Gynecology, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Daisuke AokiDepartment of Obstetrics and Gynecology, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Seiji MabuchiDepartment of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
Shoji KamiuraDepartment of Obstetrics and Gynecology, Osaka International Cancer Center, 1-69, 3-Chome Otemae, Chuo-ku, Osaka-shi, Osaka, 541-8567, Japan.
Satoshi YamaguchiDepartment of Obstetrics and Gynecology, Hyogo Cancer Center, 13-70, Kitaoji, Akashi, Hyogo, 673-8558, Japan.
Yoichi AokiDepartment of Obstetrics and Gynecology, University of the Ryukyus Hospital, 207, Uehara, Nishihara, nakagami-gun, Okinawa, 903-0215, Japan.
Toshiaki SaitoGynecology Service, National Kyushu Cancer Center, 3-1-1, Notame, minami-ku, Fukuoka, 811-1395, Japan.
Mayu YunokawaDivision of Breast and Medical Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Kazuhiro TakeharaDepartment of Gynecologic Oncology, Shikoku Cancer Center, 160, Minamiumemoto-machi-kou, Matsuyama, Ehime, 791-0280, Japan.
Aikou OkamotoDepartment of Obstetrics and Gynecology, The Jikei University School of Medicine, 3-25-8, Nishi-shinbashi, Minato-ku, Tokyo, 105-8461, Japan.
Kazunori OchiaiDepartment of Obstetrics and Gynecology, The Jikei University School of Medicine, 3-25-8, Nishi-shinbashi, Minato-ku, Tokyo, 105-8461, Japan.
Tadashi KimuraDepartment of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
Jikei University School of Medicine · JPThe University of Osaka · JPAichi Cancer Center · JPHyogo Prefectural Cancer Center · JPIwate Medical University · JPKeio University · JPNational Hospital Organization Kyushu Cancer Center · JPOsaka International Cancer Institute · JPSaitama Medical University · JPShikoku Cancer Center · JPThe University of Tokyo · JPUniversity of the Ryukyus · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective Perifosine exhibits anti-tumor activity by inhibiting AKT phosphorylation. The purpose of this phase II basket trial was to evaluate the efficacy and safety of perifosine monotherapy for ovarian, endometrial, and cervical cancers. Methods Recurrent or persistent ovarian, endometrial, or cervical cancer patients were assigned to PIK3CA wild-type or mutant groups. Each patient received 600 mg oral perifosine on day 1 followed by a maintenance dose of 100 mg daily. The primary endpoint was disease control rate; secondary endpoints included response rate, progression-free survival, overall survival, and safety. Immunohistochemical staining and targeted sequencing were used to explore new biomarkers in such patients. Results Sixteen and 5 ovarian, 17 and 7 endometrial, and 18 and 8 cervical cancer patients with PIK3CA wild-type and mutant, respectively, were enrolled. Disease control rates (wild-type/mutant) were 12.5/40.0%, 47.1/14.3%, and 11.1/25.0% in ovarian, endometrial, and cervical cancer, respectively. The most common grade 3/4 toxicities were anemia (22.5%) and anorexia (11.3%). Immunohistochemical staining revealed that the disease control rate in patients with negative phosphatase and tensin homolog (PTEN) expression was 50.0%, and the odds ratio of positive to negative patients was 0.24 in all patients. Conclusions Perifosine monotherapy showed good tolerability but expected efficacy was not achieved. Modest efficacy was demonstrated in ovarian cancer patients with PIK3CA mutations and endometrial cancer patients with PIK3CA wild-type; no difference was observed between PIK3CA wild-type and mutant in cervical cancer. Absence of PTEN expression may be predictive of clinical efficacy with perifosine monotherapy.

Indexed as

MutationAdultAgedClass I Phosphatidylinositol 3-KinasesCohort StudiesFemaleFollow-Up StudiesGenital Neoplasms, FemaleHumansMiddle AgedNeoplasm Recurrence, LocalPhosphorylcholinePrognosisClass I Phosphatidylinositol 3-KinasesperifosinePhosphorylcholinePIK3CA protein, humanCervical cancerEndometrial cancerOvarian cancerPerifosinePIK3CA

Identifiers

PMID28864978
OpenAlexW2752346196

What OpenQuestion holds

Textmetadata
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.