Evidence map›Paper›PMID 31138332›Full record

Trial reportCancer communications (London, England)2019

Quality of life outcomes including neuropathy-associated scale from a phase II, multicenter, randomized trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine as first-line chemotherapy for HER2-negative metastatic breast cancer: Korean Cancer Study Group Trial (KCSG BR13-11).

Ji-Yeon Kim, Seri Park, Seock-Ah Im, Sung-Bae Kim, Joohyuk Sohn, Keun Seok Lee, Yee Soo Chae, Ki Hyeong Lee, Jee Hyun Kim, Young-Hyuck Im and 11 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer communications (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. 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

21 authors.

Ji-Yeon KimDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, South Korea.
Seri ParkDepartment of Health Sciences and Technology, Samsung Advanced Institute for Health Sciences and Technology, Sungkyunkwan University, Seoul, 06351, South Korea.
Seock-Ah ImDepartment of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, College of Medicine, Seoul National University, Seoul, 03080, South Korea.
Sung-Bae KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, 05505, South Korea.
Joohyuk SohnDivision of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 03722, South Korea.
Keun Seok LeeCenter for Breast Cancer, National Cancer Center, Goyang, 10408, South Korea.
Yee Soo ChaeDepartment of Internal Medicine, Kyungpook National University Hospital, Daegu, 41944, South Korea.
Ki Hyeong LeeDeparment of Internal Medicine, Chungbuk National University Hospital, Cheongju, 28644, South Korea.
Jee Hyun KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, 13620, South Korea.
Young-Hyuck ImDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, South Korea.
Tae-Yong KimDepartment of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, College of Medicine, Seoul National University, Seoul, 03080, South Korea.
Kyung-Hun LeeDepartment of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, College of Medicine, Seoul National University, Seoul, 03080, South Korea.
Jin-Hee AhnDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, 05505, South Korea.
Gun Min KimDivision of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 03722, South Korea.
In Hae ParkCenter for Breast Cancer, National Cancer Center, Goyang, 10408, South Korea.
Soo Jung LeeDepartment of Internal Medicine, Kyungpook National University Hospital, Daegu, 41944, South Korea.
Hye Sook HanDeparment of Internal Medicine, Chungbuk National University Hospital, Cheongju, 28644, South Korea.
Se Hyun KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, 13620, South Korea.
Kyung Hae JungDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, 05505, South Korea. khjung@amc.seoul.kr.
Yeon Hee ParkDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, South Korea. yhparkhmo@skku.edu.
Korean Cancer Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA phase II clinical trial of the comparison between eribulin plus gemcitabine (EG) and paclitaxel plus gemcitabine (PG) as first-line chemotherapy for patients with metastatic breast cancer (MBC) found that the EG regimen was less neurotoxic, but was similar in efficacy to the PG regimen. In the present study, we analyzed functional assessment of cancer therapy-taxane (FACT-Taxane) questionnaires from patients in this clinical trial to determine their quality of life (QoL).

methodsQoL was assessed using the Korean version of the FACT-Taxane questionnaires. After baseline assessment, QoL was assessed every 2 cycles for 12 cycles and every 3 cycles thereafter. The linear mixed model was used to evaluate the difference in QoL between the EG and PG arms.

resultsOf the 118 enrolled patients, 117 responded to the FACT-Taxane questionnaires at baseline, 1 in the PG arm did not. Baseline QoL scores were not different between the EG and PG arms. During treatment, taxane subscale scores were significantly higher in the PG arm than in the EG arm after 2-13 cycles of chemotherapy (all P < 0.05), except for the 11th cycle. Neuropathy-specific analysis showed that patients in the PG arm had earlier and more severe neuropathic symptoms than those in the EG arm (P < 0.001).

conclusionsIn our QoL analysis, the EG regimen delayed and decreased neuropathy as compared with the PG regimen. Therefore, eribulin would be a reasonable substitute for paclitaxel as first-line chemotherapy for MBC.

Indexed as

Quality of LifeAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDeoxycytidineErb-b2 Receptor Tyrosine KinasesFemaleFuransGemcitabineHumansKetonesPaclitaxelPeripheral Nervous System DiseasesPolyether PolyketidesRepublic of KoreaSurveys and QuestionnairesDeoxycytidineERBB2 protein, humanErb-b2 Receptor Tyrosine KinaseseribulinFuransGemcitabineKetonesPaclitaxelPolyether PolyketidesEribulinFunctional assessment of cancer therapy-taxane questionnairesMetastatic breast cancerNeuropathyPaclitaxelQuality of life

Identifiers

PMID31138332
PMCPMC6540535

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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.