Evidence map›Paper›PMID 32535711›Full record

Trial reportInternational journal of clinical oncology2020

Phase II clinical trial of gemcitabine plus oxaliplatin in patients with metastatic pancreatic adenocarcinoma with a family history of pancreatic/breast/ovarian/prostate cancer or personal history of breast/ovarian/prostate cancer (FABRIC study).

Naohiro Okano, Chigusa Morizane, Shogo Nomura, Hideaki Takahashi, Hidetaka Tsumura, Hironaga Satake, Nobumasa Mizuno, Kunihiro Tsuji, Kazuhiko Shioji, Akinori Asagi and 14 more

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

Trial report in International journal of clinical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
0.5field-weighted citation impact, top 33% 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

10 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Hereditary pancreatic cancer.International journal of clinical oncology · 2021
    Review
  9. Review
  10. 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

24 authors at 19 institutions in 1 country.

Naohiro OkanoDepartment of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan. naohiro-okano@ks.kyorin-u.ac.jp.ORCID http://orcid.org/0000-0002-4098-5217
Chigusa MorizaneDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Shogo NomuraBiostatistics Division, Center for Research Administration and Support, National Cancer Center, Kashiwa, Japan.
Hideaki TakahashiDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Hidetaka TsumuraDepartment of Gastroenterology, Hyogo Cancer Center, Hyogo, Japan.
Hironaga SatakeDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.
Nobumasa MizunoDepartment of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.
Kunihiro TsujiDepartment of Gastroenterology, Ishikawa Prefectural Central Hospital, Ishikawa, Japan.
Kazuhiko ShiojiDepartment of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.
Akinori AsagiDepartment of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Kohichiroh YasuiDepartment of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Sho KitagawaDepartment of Gastroenterology, Sapporo Kosei General Hospital, Sapporo, Japan.
Tomomi KashiwadaDivision of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.
Atsushi IshiguroDepartment of Medical Oncology, Teine Keijinkai Hospital, Sapporo, Japan.
Masashi KanaiDepartment of Medical Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Makoto UenoDepartment of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, Yokohama, Japan.
Takashi OguraDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.
Satoshi ShimizuDepartment of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
Kazutoshi TobimatsuDivision of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.
Masayo MotoyaDepartment of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Koji NakashimaDepartment of Clinical Oncology, University of Miyazaki Hospital, Miyazaki, Japan.
Masafumi IkedaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Takuji OkusakaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Junji FuruseDepartment of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan.
National Cancer Center Hospital East · JPKyorin University · JPAichi Cancer Center · JPHyogo Prefectural Cancer Center · JPIshikawa Prefectural Central Hospital · JPKanagawa Prefectural Hospital Organization · JPKobe City Medical Center General Hospital · JPKobe University · JPKyoto Prefectural University of Medicine · JPKyoto University · JPNiigata Cancer Center Hospital · JPSaga University · JPSaitama Cancer Center · JPSapporo Kosei General Hospital · JPSapporo Medical University · JPShikoku Cancer Center · JPSt. Marianna University School of Medicine · JPTeine Keijinkai Hospital · JPUniversity of Miyazaki Hospital · JP

Funding

Japan Agency for Medical Research and Development 16ck0106084h0003
6 · The paper itself

Abstract

backgroundA family/personal history of breast, ovarian, or pancreatic cancer is a useful predictive marker for response to platinum-based chemotherapy in treating patients with pancreatic cancer. These cancers, and prostate cancer, are known as BRCA-related malignancies. We evaluated the efficacy of gemcitabine plus oxaliplatin (GEMOX) in patients with metastatic pancreatic cancer with a family/personal history of these cancers.

methodsChemotherapy-naïve patients with metastatic pancreatic cancer with a family history of pancreatic/breast/ovarian/prostate cancer or a personal history of breast/ovarian/prostate cancer were included. Patients received fixed dose-rate gemcitabine (1000 mg/m

resultsAmong the first 43 enrolled patients, the 1-year survival rate was 27.9% [90% confidence interval (CI) 17.0-41.3], which did not meet the primary endpoint. Median overall survival, progression-free survival, and response rates were 7.6 months (95% CI 6.0-10.7), 4.0 months (95% CI 2.0-4.6), and 26.7% (95% CI 14.6-41.9), respectively, in all registered patients. The GEMOX regimen was generally tolerated; the most common grade three or higher adverse events were hematological toxicities.

conclusionGEMOX did not show the expected efficacy in patients with metastatic pancreatic cancer with a family or personal history of pancreatic/breast/ovarian/prostate cancer. Selection of GEMOX based on family/personal history is not recommended. TRIAL REGISTRATION NUMBER: UMIN000017894.

Indexed as

AdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDeoxycytidineFemaleHumansMaleMedical History TakingMiddle AgedOrganoplatinum CompoundsOvarian NeoplasmsPancreatic NeoplasmsProgression-Free SurvivalProstatic NeoplasmsDeoxycytidineOrganoplatinum CompoundsBRCAGemcitabineOxaliplatinPancreatic cancerPlatinum compounds

Identifiers

PMID32535711
OpenAlexW3034197259

What OpenQuestion holds

Textmetadata
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Registered trials

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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.