Evidence map›Paper›PMID 20194867›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010

TI-CE high-dose chemotherapy for patients with previously treated germ cell tumors: results and prognostic factor analysis.

Darren R Feldman, Joel Sheinfeld, Dean F Bajorin, Patricia Fischer, Stefan Turkula, Nicole Ishill, Sujata Patil, Manjit Bains, Lilian M Reich, George J Bosl and 1 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00002558 (PHASE I/II TRIAL OF SEQUENTIAL TAXOL/IFOSFAMIDE AND DOSEINTENSIVE CARBOPLATIN/ETOPOSIDE WITH STEM CELL SUPPORT IN CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH UNFAVORABLE PROGNOSTIC FEATURES), which is not on this map. Cited by 78 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 4 pooled it
10.4field-weighted citation impact, top 1% 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.

NCT00002558 phase1 / phase2completednot on this map

Phase i/ii trial of sequential taxol/ifosfamide and doseintensive carboplatin/etoposide with stem cell support in cisplatin-resistant germ cell tumor patients with unfavorable prognostic features

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan1994 to 2009Enrolled108ConditionsExtragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell TumorArmsfilgrastim, carboplatin, etoposide, ifosfamide, paclitaxel
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 4 syntheses or guidelines pooled it, 233 citations in OpenAlex.

  1. SEOM-GG clinical guidelines for the management of germ-cell testicular cancer (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
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  6. Phase II trial of nivolumab monotherapy and biomarker screening in patients with chemo-refractory germ cell tumors.International journal of urology : official journal of the Japanese Urological Association · 2022
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  20. Malignant germ cells tumor of the ovary.Journal of gynecologic oncology · 2025
    Review

18 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Darren R FeldmanGenitourinary Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10065, USA. feldmand@mskcc.org
Joel Sheinfeld
Dean F Bajorin
Patricia Fischer
Stefan Turkula
Nicole Ishill
Sujata Patil
Manjit Bains
Lilian M Reich
George J Bosl
Robert J Motzer
Memorial Sloan Kettering Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe previously reported a dose-finding and phase II trial of the TI-CE regimen (paclitaxel [T] plus ifosfamide [I] followed by high-dose carboplatin [C] plus etoposide [E] with stem-cell support) in germ cell tumor (GCT) patients predicted to have a poor prognosis with conventional-dose salvage therapy. We now report the efficacy of TI-CE with prognostic factors for disease-free survival (DFS) and overall survival (OS) in our full data set of 107 patients. PATIENTS AND

methodsEligible patients had advanced GCTs with progressive disease following chemotherapy and unfavorable prognostic features (extragonadal primary site, incomplete response [IR] to first-line therapy, or relapse/IR to ifosfamide-cisplatin-based conventional-dose salvage). Univariate and multivariate analyses (MVAs) of prognostic factors were performed. The predictive ability of the Einhorn and Beyer prognostic models was assessed.

resultsMost patients were platinum refractory and had an IR to first-line chemotherapy. There were 54 (5%) complete and eight (8%) partial responses with negative markers; 5-year DFS was 47% and OS was 52% (median follow-up, 61 months). No relapses occurred after 2 years. Five (24%) of 21 primary mediastinal nonseminomatous GCTs are continuously disease free. On MVA, primary mediastinal site (P < .001), two or more lines of prior therapy (P < .001), baseline human chorionic gonadotropin > or = 1,000 U/L (P = .01), and lung metastases (P = .02) significantly predicted adverse DFS. Poor-risk patients did worse than good- or intermediate-risk patients according to both Beyer (P < .002) and Einhorn (P < .05) models.

conclusionTI-CE is effective salvage therapy for GCT patients with poor prognostic features. Mediastinal primary site and two or more lines of prior therapy were most predictive of adverse DFS. Beyer and Einhorn models can assist in predicting outcome.

Indexed as

AdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCombined Modality TherapyDisease-Free SurvivalEtoposideFemaleHematopoietic Stem Cell TransplantationHumansIfosfamideMaleMiddle AgedNeoplasms, Germ Cell and EmbryonalPaclitaxelPrognosisCarboplatinEtoposideIfosfamidePaclitaxel

Identifiers

PMID20194867
PMCPMC3651604
OpenAlexW2163130660

What OpenQuestion holds

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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.