Evidence map›Paper›PMID 19294501›Full record

ArticleBreast cancer research and treatment2009

Tolerability of and adherence to combination oral therapy with gefitinib and capecitabine in metastatic breast cancer.

E L Mayer, A H Partridge, L N Harris, R S Gelman, S T Schumer, H J Burstein, E P Winer

Abstract readClinical Trial, Phase I
In one paragraph

Article in Breast cancer research and treatment, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 pooled it
2.1field-weighted citation impact, top 13% 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

24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Effectiveness of mHealth apps on adherence and symptoms to oral anticancer medications: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
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  7. Implications for medication safety and adherence in dermato-oncology: The AMBORA care program for oral antitumor therapeutics.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2025
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  14. Oral antineoplastic agents: how do we care about adherence?British journal of clinical pharmacology · 2015
    Review
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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.

E L MayerDana-Farber Cancer Institute, Harvard Medical School, 44 Binney Street, Mayer 224, Boston, MA 02115, USA. emayer@partners.org
A H Partridge
L N Harris
R S Gelman
S T Schumer
H J Burstein
E P Winer
Harvard University · USDana-Farber Cancer Institute · USYale University · US

Funding

Physician Scientist Training in Cancer ResearchT32CA009172 · NCI · DANA-FARBER CANCER INSTITUTE · PI Jennifer R Brown, James A. DeCaprio · 1985 to 2026
$17.1M
NCI NIH HHS T32 CA009172
6 · The paper itself

Abstract

purposeThis phase I study explored gefitinib (G) and capecitabine (C) in metastatic breast cancer (MBC).

methodsSequential cohorts (n = 3) received G and escalating C on a 14 day on/7 day off schedule, with a validation cohort (n = 10) at the maximum tolerated dose (MTD). Dose limiting toxicity (DLT) was defined in cycle 1. The primary endpoint was safety; secondary endpoints included response and adherence.

resultsAbout 19 patients were treated for a median of 5 cycles. No patients in sequential cohorts experienced DLT; C MTD was 2,000 mg/m(2)/day when paired with daily G 250 mg. In the validation cohort, four experienced serious toxicities, including diarrhea, mucositis, and palmarplantar dysesthesia. At the MTD, 6 (46%) required a C dose reduction, and 3 (23%) came off study for toxicity. One partial response was observed (8%, 95% CI 0.2-38.5%); five had stable disease >24 weeks (26, 95% CI 9-51%). Patients missed few drug doses, with the suggestion of overadherence to therapy.

conclusionsIn this phase I study of G and C in MBC, a C MTD was identified, and significant toxicity was observed. About 8% demonstrated a response, with 26% maintaining stable disease. The possibility of overadherence, as suggested in this study, may have implications for other trials of oral antineoplastic therapy.

Indexed as

Medication AdherenceAdministration, OralAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineDeoxycytidineDose-Response Relationship, DrugErbB ReceptorsFemaleFluorouracilGefitinibHumansMaximum Tolerated DoseMiddle AgedQuinazolinesCapecitabineDeoxycytidineErbB ReceptorsFluorouracilGefitinibQuinazolines

Identifiers

PMID19294501
PMCPMC4578795
OpenAlexW2061855310

What OpenQuestion holds

Textmetadata
LicenceTDM
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.