Evidence map›Paper›PMID 26038198›Full record

Trial reportDrugs & aging2015

Phase II Study of a Platinum-Based Adapted Chemotherapy Regimen Combined with Radiotherapy in Patients 75 Years and Older with Esophageal Cancer.

Stéphanie Servagi-Vernat, Gilles Créhange, Bernard Roullet, Valentine Guimas, Philippe Maingon, Marc Puyraveau, Jean François Bosset

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Drugs & aging, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02879227 (Phase II of Radiochemotherapy in Elderly Patients With Oesophagus Cancer), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

NCT02879227 phase2completednot on this map

Phase II of Radiochemotherapy in Elderly Patients With Oesophagus Cancer

TypeinterventionalSponsorCentre Hospitalier Universitaire de BesanconRan2010 to 2014Enrolled23ConditionsEsophagus CancerArmsCisplatin, Oxaliplatin
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

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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.

Stéphanie Servagi-VernatDepartment of Radiation Oncology, Besançon University Hospital, Besançon, France, stephanie.servagi@gmail.com.
Gilles Créhange
Bernard Roullet
Valentine Guimas
Philippe Maingon
Marc Puyraveau
Jean François Bosset

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe management of elderly patients with cancer is a therapeutic challenge and a public health problem. The aim of this phase II single-arm study was to evaluate the acute toxicities and efficacy of chemoradiotherapy (CRT) comprising a single platinum-based agent combined with radiotherapy in elderly patients with esophageal cancer.

methodsBetween March 2000 and October 2011, patients aged 75 years and older were prospectively treated with external beam radiotherapy combined with cisplatin or oxaliplatin. Other selection criteria included Eastern Cooperative Oncology Group status 0-2, disease stage II-III, squamous cell carcinoma or adenocarcinoma, and an adequate biological profile. The radiotherapy dose was 50 Gy administered over 5 weeks to the primary tumor and involved lymph nodes. Cisplatin was planned at a dose of 75 mg/m(2) on days 1 and 21 and oxaliplatin at 85 mg/m(2) on days 1, 15, and 29. Treatment was delivered an outpatient setting.

resultsThirty patients with a mean age of 85.2 (range 79.4-92.0) years were included; 28 completed the treatment. Dysphagia was the only grade 4 toxicity to occur during the study; no grade 5 toxicities were observed. Six weeks after the completion of treatment, 16 patients (53.3%) were in complete response. Two patients in complete response died from pneumonitis 5 and 7 months after CRT. With a 36-month median follow-up, 18 patients died from cancer (nine from local failure, nine from metastasis). Seven patients died from other causes and two patients were alive 40.3 and 56 months after the end of their treatment. Three-year overall survival was 22.2%.

conclusionsSelected elderly patients with esophageal cancer and adequate functional status should not be excluded from CRT and may be able to tolerate the treatment with acceptable acute toxicities. However, mid-term efficacy is mediocre. Our data also suggest that the therapeutic ratio or locoregional control might be improved by increasing the radiotherapy dose or by testing new radiosensitizer agents since half of the failures were within the treated volume.

trial registrationEudraCT no. 2009-010113-76.

Indexed as

AgedAged, 80 and overAge FactorsAntineoplastic AgentsChemoradiotherapyCisplatinEsophageal NeoplasmsFemaleHumansMaleNeoplasm StagingOrganoplatinum CompoundsOxaliplatinProspective StudiesRemission InductionAntineoplastic AgentsCisplatinOrganoplatinum CompoundsOxaliplatin

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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.