Evidence map›Paper›PMID 31127479›Full record

Trial reportInternational journal of clinical oncology2019

A phase II randomized controlled study of pegylated liposomal doxorubicin and carboplatin vs. gemcitabine and carboplatin for platinum-sensitive recurrent ovarian cancer (GOTIC003/intergroup study).

Hiroyuki Fujiwara, Kimio Ushijima, Shoji Nagao, Yuji Takei, Muneaki Shimada, Masashi Takano, Kiyoshi Yoshino, Yoshiaki Kawano, Yasuyuki Hirashima, Satoru Nagase and 10 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer.The Cochrane database of systematic reviews · 2023
    Review
  4. Article
  5. Article
  6. Article
  7. 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

20 authors.

Hiroyuki FujiwaraDepartment of Obstetrics and Gynecology, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, 329-0498, Tochigi, Japan. fujiwara@jichi.ac.jp.ORCID http://orcid.org/0000-0002-8888-9937
Kimio UshijimaDepartment of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan.
Shoji NagaoDepartment of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Yuji TakeiDepartment of Obstetrics and Gynecology, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, 329-0498, Tochigi, Japan.
Muneaki ShimadaDepartment of Obstetrics and Gynecology, Tottori University School of Medicine, Tottori, Japan.
Masashi TakanoDepartment of Obstetrics and Gynecology, National Defense Medical College Hospital, Saitama, Japan.
Kiyoshi YoshinoDepartment of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, Osaka, Japan.
Yoshiaki KawanoDepartment of Obstetrics and Gynecology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Yasuyuki HirashimaDepartment of Gynecology, Shizuoka Cancer Center Hospital, Shizuoka, Japan.
Satoru NagaseDepartment of Obstetrics and Gynecology, Yamagata University School of Medicine, Yamagata, Japan.
Shin NishioDepartment of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan.
Tadaaki NishikawaDepartment of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Kimihiko ItoDepartment of Obstetrics and Gynecology, Kansai Rosai Hospital, Hyogo, Japan.
Tadahiro ShojiDepartment of Obstetrics and Gynecology, Iwate Medical University, Iwate, Japan.
Eizo KimuraDepartment of Obstetrics and Gynecology, Kosei Hospital, Tokyo, Japan.
Tadao TakanoDepartment of Obstetrics and Gynecology, Tohoku University School of Medicine, Miyagi, Japan.
Toru SugiyamaDepartment of Obstetrics and Gynecology, Iwate Medical University, Iwate, Japan.
Junzo KigawaDepartment of Obstetrics and Gynecology, Tottori University School of Medicine, Tottori, Japan.
Keiichi FujiwaraDepartment of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Mitsuaki SuzukiDepartment of Obstetrics and Gynecology, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, 329-0498, Tochigi, Japan.

Funding

Japan Society of Clinical Oncology Clinical Research Program Grant
6 · The paper itself

Abstract

purposeTo compare the efficacy, safety, and tolerability profiles of pegylated liposomal doxorubicin and carboplatin (PLDC) with those of gemcitabine and carboplatin (GC) for the treatment of patients with platinum-sensitive recurrent ovarian cancer.

methodsOvarian cancer patients with recurrence > 6 months after first-line platinum and taxane-based therapies were randomly assigned to PLDC [pegylated liposomal doxorubicin 30 mg/m

resultsOne-hundred patients (49 PLDC; 51 GC) were randomly assigned. Over a median follow-up of 24 months, the median progression-free survival was 12.0 months (95% CI 9.2-15.0) for PLDC and 9.8 months (8.9-12.3) for GC [HR 0.69 (0.455-1.047)] with a difference of 2.2 months. The response rate was 57.1% (41.0-72.3) for PLDC and 56.4% (39.6-72.2) for GC. No obvious differences in toxicity (G3/4) were noted between arms. The median relative dose intensity of planned dose per week was 88.9% for pegylated liposomal doxorubicin and 53.1% for gemcitabine (p < 0.0001).

conclusionsPLDC and GC are both good treatment candidates for platinum-sensitive recurrent ovarian cancer patients; however, the dose intensity was lower for GC than for PLDC. PLDC had a more favorable risk-benefit profile than that of GC for patients.

Indexed as

Adenocarcinoma, Clear CellAdenocarcinoma, MucinousAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarboplatinDeoxycytidineDoxorubicinFemaleGemcitabineHumansMiddle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsPolyethylene GlycolsCarboplatinDeoxycytidineDoxorubicinGemcitabineliposomal doxorubicinPolyethylene GlycolsGemcitabinePegylated liposomal doxorubicinPlatinum-sensitive recurrent ovarian cancerRandomized clinical trial

Identifiers

What OpenQuestion holds

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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.