Evidence map›Paper›PMID 33185049›Full record

Trial reportJournal of gynecologic oncology2021

Tailored-dose chemotherapy with gemcitabine and irinotecan in patients with platinum-refractory/resistant ovarian or primary peritoneal cancer: a phase II trial.

Shinichi Tate, Kyoko Nishikimi, Ayumu Matsuoka, Satoyo Otsuka, Kazuyoshi Kato, Yutaka Takahashi, Makio Shozu

Open access · diamondAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of gynecologic oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 27% 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

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Investigation of the Possible Protective Effect ofAntioxidants (Basel, Switzerland) · 2022
    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

7 authors at 3 institutions in 1 country.

Shinichi TateDepartment of Gynecology, Chiba University Hospital, Chiba, Japan. state@faculty.chiba-u.jp.ORCID https://orcid.org/0000-0003-4013-5674
Kyoko NishikimiDepartment of Gynecology, Chiba University Hospital, Chiba, Japan.ORCID https://orcid.org/0000-0001-5171-1046
Ayumu MatsuokaDepartment of Gynecology, Chiba University Hospital, Chiba, Japan.ORCID https://orcid.org/0000-0003-3077-5280
Satoyo OtsukaDepartment of Gynecology, Chiba University Hospital, Chiba, Japan.ORCID https://orcid.org/0000-0002-1637-4723
Kazuyoshi KatoDepartment of Obstetrics and Gynecology, Tokyo Medical University, Tokyo, Japan.ORCID https://orcid.org/0000-0001-7622-8253
Yutaka TakahashiDepartment of Clinical Oncology, International University of Health and Welfare (Ichikawa Hospital), Chiba, Japan.ORCID https://orcid.org/0000-0002-2802-5950
Makio ShozuDepartment of Gynecology, Chiba University Hospital, Chiba, Japan.ORCID https://orcid.org/0000-0002-7247-2205
Chiba University Hospital · JPInternational University of Health and Welfare · JPTokyo Medical University · JP

Funding

Japanese Foundation for Multidisciplinary Treatment of Cancer
6 · The paper itself

Abstract

objectiveWe investigated the efficacy and toxicity of tailored-dose chemotherapy with gemcitabine and irinotecan for platinum-refractory/resistant ovarian or primary peritoneal cancer.

methodsWe enrolled patients with ovarian or primary peritoneal cancer who received ≥2 previous chemotherapeutic regimens but developed progressive disease during platinum-based chemotherapy or within 6 months post-treatment. All patients received gemcitabine (500 mg/m²) and irinotecan (50 mg/m²) on days 1 and 8 every 21 days at the starting dose. The dose was increased or decreased by 4 levels in subsequent cycles based on hematological or non-hematological toxicities observed. The primary endpoint was progression-free survival (PFS), and secondary endpoints were disease control rate (DCR), overall survival (OS), and adverse events.

resultsWe investigated 25 patients who received 267 cycles (median 8 cycles/patient) between October 2008 and May 2011. Tailored-dose gemcitabine was administered up to the 5th cycle as follows: 1,000 mg/m² in 1 (4%), 750 mg/m² in 16 (64%), 500 mg/m² in 6 (24%), and 250 mg/m² in 2 patients (8%). The median PFS and OS were 6.2 months (95% confidence interval [CI]=2.7-10.7) and 16.8 months (95% CI=9.4-30.7), respectively. The DCR was 76%, and PFS was >6 months in 12 of 25 patients (48%). Grade 3 hematological toxicities included leukopenia (9.4%), neutropenia (11.2%), anemia (9.8%), and thrombocytopenia (1.1%). Grade 3/4 non-hematological toxicities did not occur except for fatigue in one patient.

conclusionsTailored-dose chemotherapy with gemcitabine and irinotecan was effective and well tolerated in patients with platinum-refractory/resistant ovarian or primary peritoneal cancer.

trial registrationUMIN Clinical Trials Registry Identifier: UMIN000004449.

Indexed as

Ovarian NeoplasmsPlatinumAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineFemaleGemcitabineHumansIrinotecanDeoxycytidineGemcitabineIrinotecanPlatinumChemotherapyDrug ToxicityGemcitabineIrinotecanOvarian CancerRecurrence

Identifiers

PMID33185049
PMCPMC7767653
OpenAlexW3096634786

What OpenQuestion holds

Textmetadata
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.