Evidence map›Paper›PMID 19767314›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2010

Dose-dense temozolomide regimen for the treatment of brain metastases from melanoma, breast cancer, or lung cancer not amenable to surgery or radiosurgery: a multicenter phase II study.

S Siena, L Crinò, M Danova, S Del Prete, S Cascinu, S Salvagni, I Schiavetto, M Vitali, E Bajetta

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00831545 (Multicenter Phase 2 Evaluation of Temozolomide for Treatment of Brain Metastases of Either Malignant Melanoma, Breast and Non-small Cell Lung Cancer.), which is not on this map. Cited by 37 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 3 pooled it
7.4field-weighted citation impact, top 2% 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.

NCT00831545 phase2completednot on this map

Multicenter Phase 2 Evaluation of Temozolomide for Treatment of Brain Metastases of Either Malignant Melanoma, Breast and Non-small Cell Lung Cancer.

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2000 to 2006Enrolled162ConditionsMetastases of Central Nervous System, Melanoma, Breast Neoplasm, Carcinoma, Non-Small-Cell LungArmsTemozolomide
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 3 syntheses or guidelines pooled it, 99 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Chinese Society of Clinical Oncology breast cancer expert consensus on the diagnosis and treatment of breast cancer brain metastasis (2025).Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026
    Review
  7. Central Nervous System Metastases in Breast Cancer.Current treatment options in oncology · 2025
    Review
  8. CSCO expert consensus on the diagnosis and treatment of breast cancer brain metastasis.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2022
    Review
  9. Review
  10. Leptomeningeal Metastases.Current treatment options in oncology · 2018
    Review
  11. Review
  12. Review
  13. Article
  14. Cancer and the metastatic substrate.Ecancermedicalscience · 2016
    Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Profound prevention of experimental brain metastases of breast cancer by temozolomide in an MGMT-dependent manner.Clinical cancer research : an official journal of the American Association for Cancer Research · 2014
    Article
  20. 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

9 authors at 5 institutions in 1 country.

S SienaDivisione Oncologia Falck, Ospedale Niguarda Ca'Granda, Milan. Electronic address: salvatore.siena@ospedaleniguarda.it.
L CrinòDivisione Oncologia Medica, Policlinico Regionale Silvestrini, Perugia.
M DanovaDivisione Oncologia Medica, Istituto Ricerca e Cura a Carattere Scientifico Policlinico San Matteo, Pavia.
S Del PreteDivisione Oncologia Medica, Ospedale San Giovanni di Dio, Frattamaggiore (Naples).
S CascinuClinica Oncologica Medica, Ospedali Riuniti Umberto I-Salesi, Torrette (Ancona).
S SalvagniDipartimento Oncologia Medica, Ospedale di Parma, Parma.
I SchiavettoDivisione Oncologia Falck, Ospedale Niguarda Ca'Granda, Milan.
M VitaliDivisione Oncologia Medica B, Istituto Nazionale Tumori, Fondazione Istituto Ricerca e Cura a Carattere Scientifico, Milan, Italy.
E BajettaDivisione Oncologia Medica B, Istituto Nazionale Tumori, Fondazione Istituto Ricerca e Cura a Carattere Scientifico, Milan, Italy.
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITNuovo Ospedale San Giovanni di Dio · ITOspedale di Parma · ITOspedali Riuniti Umberto I · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBrain metastases reduce survival because therapeutic options are limited. This phase II study evaluated the efficacy of single-agent therapy with alternating weekly, dose-dense temozolomide in pretreated patients with brain metastases prospectively stratified by primary tumor type.

methodsEligible patients had bidimensionally measurable brain metastases from histologically/cytologically confirmed melanoma, breast cancer (BC), or non-small-cell lung cancer (NSCLC). Prior chemotherapy, radiotherapy, and whole-brain radiotherapy (WBRT) were allowed. Patients received temozolomide 150 mg/m(2)/day (days 1-7 and 15-21 every 28- or 35-day cycle).

resultsIn the intent-to-treat population (N = 157; 53 melanoma, 51 BC, and 53 NSCLC), one patient had complete response, nine (6%) had partial responses, and 31 (20%) had stable disease in the brain. Median progression-free survival was 56, 58, and 66 days for melanoma, BC, and NSCLC, respectively. Median overall survival was 100 days for melanoma, 172 days for NSCLC, and not evaluable in the BC group. Thrombocytopenia was the most common adverse event causing dose modification or treatment discontinuation. Grade 4 toxic effects were rare.

conclusionsThis alternating weekly, dose-dense temozolomide regimen was well tolerated and clinically active in heavily pretreated patients with brain metastases, particularly in patients with melanoma. Combining temozolomide with WBRT or other agents may improve clinical outcomes.

Indexed as

Antineoplastic Agents, AlkylatingBrain NeoplasmsBreast NeoplasmsCarcinoma, Non-Small-Cell LungDacarbazineDrug Resistance, NeoplasmFemaleHumansLung NeoplasmsMaleMaximum Tolerated DoseMelanomaMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPalliative CareAntineoplastic Agents, AlkylatingDacarbazineTemozolomide

Identifiers

PMID19767314
PMCPMC2826096
OpenAlexW2102513746

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.