Evidence map›Paper›PMID 16763786›Full record

Trial reportInvestigational new drugs2006

Phase I dose escalation study of pegylated liposomal doxorubicin (Caelyx) in combination with topotecan in patients with advanced malignancies.

Hervé Ghesquières, Sandrine Faivre, Latifa Djafari, Patricia Pautier, Catherine Lhommé, Stéphanie Lozahic, Kamel Djazouli, Jean-Pierre Armand, Eric Raymond

Abstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2006. 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. Article
  2. Pegylated liposomal doxorubicin in the management of ovarian cancer.Therapeutics and clinical risk management · 2010
    Article
  3. Pegylated liposomal doxorubicin in ovarian cancer.Therapeutics and clinical risk management · 2009
    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

9 authors.

Hervé GhesquièresDepartment of Medicine, Institut Gustave-Roussy, Villejuif.
Sandrine Faivre
Latifa Djafari
Patricia Pautier
Catherine Lhommé
Stéphanie Lozahic
Kamel Djazouli
Jean-Pierre Armand
Eric Raymond

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Aims of this study were to determine the toxicity profile and the recommended dose of pegylated liposomal doxorubicin (Caelyx) in combination with topotecan in patients with advanced malignancies. Caelyx: 35 (DLI) or 40 (DLII) mg/m2/d1 was followed by 0.5 mg/m2/d topotecan daily for 5 days, every 4 weeks. Twenty-three patients received a total of 82 cycles. At DLII, 2/6 patients experienced dose-limiting toxicity consisting of grade 4 neutropenia lasting for more than 7 days and febrile neutropenia. At DLI, 4/18 and 2/18 patients presented febrile neutropenia and grade 4 sustained neutropenia, respectively. Non-hematological toxicities were mild to moderate. One patient with ovarian cancer presented a complete response. The hematological toxicity was a dose limiting factor that led to the recommended dose of 35 mg/m2 Caelyx on day 1 with 0.5 mg/m2/d topotecan on days 1-5. This study results suggest that alternative schedules of this combination are required.

Indexed as

Maximum Tolerated DoseAdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsDoxorubicinFemaleHumansMaleMiddle AgedNeoplasmsNeutropeniaThrombocytopeniaTopotecanAntineoplastic AgentsDoxorubicinTopotecan

Identifiers

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.