Evidence map›Paper›PMID 19575146›Full record

Trial reportInvestigational new drugs2010

Phase II study of gemcitabine in combination with vinorelbine versus gemcitabine followed by vinorelbine for metastatic breast cancer.

In Hae Park, Jungsil Ro, Keun Seok Lee, Shi Nae Kim, Young Ho Yun, Byung Ho Nam

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

Trial report in Investigational new drugs, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 35% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. 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

6 authors at 2 institutions in 2 countries.

In Hae ParkCenter for Breast Cancer, National Cancer Center, 111 Jungbalsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, 410-769, Korea. parkih@ncc.re.kr
Jungsil Ro
Keun Seok Lee
Shi Nae Kim
Young Ho Yun
Byung Ho Nam
National Cancer Center · KRBreast Cancer Research Foundation · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNo clear data are available concerning the superiority of combination chemotherapy to sequential therapy using agents beyond 1st or 2nd line chemotherapy for treating patients with metastatic breast cancer.

methodsPatients were randomized to receive a combination of gemcitabine and vinorelbine or gemcitabine until disease progression followed by vinorelbine monotherapy. Quality of life was assessed using EORTC QLQ-C30 questionnaires.

resultsForty-two patients were randomized to the combination arm and 40 were randomized to the sequential arm. Baseline characteristics were well balanced between the arms. The median number of chemotherapy cycles was 4 (range, 1-23) for the combination arm and 6 (range, 1-25) for the sequential arm. Patients receiving combination therapy had a higher composite response rate (26.8% vs. 12.5%; P = 0.106) but a shorter median time to treatment failure (3.6 vs. 4.4 months, P = 0.252) as compared to patients receiving sequential monotherapy. Median overall survival for the combination and sequential arms was 10.6 months and 8.9 months, respectively (P = 0.436). Toxicities were manageable and similar in both arms. Quality of life measurements in global health, role, and social function were superior in the combination arm (P < 0.05).

conclusionsCombined gemcitabine and vinorelbine therapy appears comparable to sequential monotherapy for heavily pretreated patients with metastatic breast cancer as demonstrated by improved quality of life outcomes with similar therapeutic efficacies and incidences of adverse events.

Indexed as

AdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDeoxycytidineFemaleGemcitabineHumansMiddle AgedNeoplasm MetastasisQuality of LifeSurvival AnalysisTime FactorsTreatment FailureVinblastineAntineoplastic AgentsDeoxycytidineGemcitabineVinblastineVinorelbine

Identifiers

PMID19575146
OpenAlexW2032162539

What OpenQuestion holds

Textmetadata
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.