Evidence map›Paper›PMID 36397238›Full record

Trial reportCancer research and treatment2023

A Phase II Trial of S-1 and Oxaliplatin in Patients with Metastatic Breast Cancer Previously Treated with Anthracycline and Taxane (KCSG-BR07-03).

Dae-Won Lee, Bhumsuk Keam, Keun Seok Lee, Jin-Hee Ahn, Joohyuk Sohn, Jin Seok Ahn, Moon Hee Lee, Jee Hyun Kim, Kyung Eun Lee, Hyo Jung Kim and 10 more

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

Trial report in Cancer research and treatment, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 36% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. 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

20 authors at 9 institutions in 3 countries.

Dae-Won LeeDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Bhumsuk KeamDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Keun Seok LeeCenter for Breast Cancer, National Cancer Center, Goyang, Korea.
Jin-Hee AhnDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Joohyuk SohnDivision of Medical Oncology and Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Jin Seok AhnDivision of Hematology-Oncology, Samsung Medical Center, Seoul, Korea.
Moon Hee LeeDepartment of Internal Medicine, Inha University Hospital, Incheon, Korea.
Jee Hyun KimDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Kyung Eun LeeDepartment of Hematology and Oncology, Ewha Womans University Medical Center, Seoul, Korea.
Hyo Jung KimDivision of Hematology-Oncology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea.
Si-Young KimDepartment of Medical Oncology and Hematology, Kyung Hee University Hospital, Seoul, Korea.
Yeon Hee ParkDivision of Hematology-Oncology, Samsung Medical Center, Seoul, Korea.
Chan-Young OckDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Kyung-Hun LeeDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Sae-Won HanDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Sung-Bae KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Young Hyuck ImDivision of Hematology-Oncology, Samsung Medical Center, Seoul, Korea.
Hyun Cheol ChungDivision of Medical Oncology and Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Do-Youn OhDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Seock-Ah ImDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Seoul National University · KRSamsung Medical Center · KRSeoul National University Hospital · KRYonsei University · KRInha University Hospital · KRKyung Hee University Medical Center · KRNational Cancer Center · KRSacred Heart Hospital · USUlsan College · KR

Funding

Ministry of Health and Welfare 1720150Ministry of Health and Welfare HA17C0055
6 · The paper itself

Abstract

purposeThis single-arm phase II trial investigate the efficacy and safety of S-1 plus oxaliplatin (SOX) in patients with metastatic breast cancer. Materials and Methods: Patients with metastatic breast cancer previously treated with anthracyclines and taxanes were enrolled. Patients received S-1 (40-60 mg depending on patient's body surface area, twice a day, day 1-14) and oxaliplatin (130 mg/m2, day 1) in 3 weeks cycle until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumor 1.1. Secondary endpoints included time-to-progression (TTP), duration-of-response (DoR), overall survival (OS), and adverse events.

resultsA total of 87 patients were enrolled from 11 institutions in Korea. Hormone receptor was positive in 54 (62.1%) patients and six (6.9%) had human epidermal growth factor receptor 2-positive disease. Forty-eight patients (85.1%) had visceral metastasis and 74 (55.2%) had more than three sites of metastases. The ORR of SOX regimen was 38.5% (95% confidence interval [CI], 26.9 to 50.0) with a median TTP of 6.0 months (95% CI, 5.1 to 6.9). Median DoR and OS were 10.3 months (95% CI, 5.5 to 15.1) and 19.4 (95% CI, not estimated) months, respectively. Grade 3 or 4 neutropenia was reported in 28 patients (32.1%) and thrombocytopenia was observed in 23 patients (26.6%).

conclusionThis phase II study showed that SOX regimen is a reasonable option in metastatic breast cancer previously treated with anthracyclines and taxanes.

Indexed as

Breast NeoplasmsNeutropeniaAnthracyclinesAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansNeoplasm MetastasisOxaliplatinTaxoidsAnthracyclinesOxaliplatinTaxoidsBreast neoplasmsDrug therapyOxaliplatinPhase II trialS-1

Identifiers

PMID36397238
PMCPMC10101794
OpenAlexW4308398393

What OpenQuestion holds

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LicenceCC BY-NC
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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.