Evidence map›Paper›PMID 15150623›Full record

Trial reportBritish journal of cancer2004

Randomised controlled trial comparing single agent paclitaxel vs epidoxorubicin plus paclitaxel in patients with advanced ovarian cancer in early progression after platinum-based chemotherapy: an Italian Collaborative Study from the Mario Negri Institute, Milan, G.O.N.O. (Gruppo Oncologico Nord Ovest) group and I.O.R. (Istituto Oncologico Romagnolo) group.

A Buda, I Floriani, R Rossi, N Colombo, V Torri, P F Conte, R Fossati, A Ravaioli, C Mangioni

Registry-linked trialOpen access · hybridAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04421547 (Phase III Randomized Control Case Study of Letrozole in Women With Heavily Pretreated Ovarian Cancer), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
4.5field-weighted citation impact, top 6% 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.

NCT04421547 phase3terminatednot on this mapstarted 2020, after this paper: background citation

Phase III Randomized Control Case Study of Letrozole in Women With Heavily Pretreated Ovarian Cancer (MITO32)

TypeinterventionalSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCSRan2020 to 2024Enrolled86ConditionsEpithelial Ovarian CancerArmsLetrozole 2.5mg, Standard single agent chemotherapy
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 80 citations in OpenAlex.

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  19. Overview of a chemoresponse assay in ovarian cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2014
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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

9 authors at 5 institutions in 1 country.

A BudaLaboratory of Clinical Research in Oncology, Mario Negri Institute of Pharmacological Research, Via Eritrea 62, 20157 Milan, Italy. buda@marionegri.it
I Floriani
R Rossi
N Colombo
V Torri
P F Conte
R Fossati
A Ravaioli
C Mangioni
Mario Negri Institute for Pharmacological Research · ITAzienda Ospedaliera San Gerardo · ITEuropean Institute of Oncology · ITOspedale degli Infermi · ITOspedale Santa Chiara · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of the study was to evaluate the role of epidoxorubicin plus paclitaxel combination (ET) vs single agent paclitaxel (T), as second-line chemotherapy treatment in advanced ovarian cancer patients in early progression within 12 months after platinum-based chemotherapy. From October 1994 up to June 1999, 234 patients from 34 Italian hospitals were randomised to receive: (A) epidoxorubicin (E) 80 mg m(-2) + paclitaxel (T) 175 mg m(-2) (3 h infusion), every 21 days for 4-6 cycles. (B) Paclitaxel 175 mg m(-2) (3 h infusion) every 21 days for 4-6 cycles. Evaluable for survival analysis were 106 and 106 patients in ET and T arm, respectively. Platinum-based monochemotherapy was the first-line treatment in 43% patients, while polichemotherapy containing anthracyclines was the preferred first-line therapy in 22% patients. The median time from the end of first-line therapy to randomisation was 3 months. Treatment was completed in 87 and 85% of T and ET arm, respectively. Haematological toxicity was significantly more common in ET group (ECOG grade 3-4 neutropenia: 37.4% in ET vs 18.2% in T arm). Neuropathies were similar in both arms (sensory: ECOG grade 2-3: 12.1% in ET vs 14.7% in T arm, motor: 6.1% in ET vs 5.3% in T arm). Objective response was achieved in 37.4% of patients in ET group and in 46.9% of patients in T arm. At a median follow-up of time of 48 months, a total of 180 patients progressed and 163 patients died. Survival analysis showed no difference between ET and T (median time to progression: 6 months for both regimens, median survival: 12 and 14 months for ET and T, respectively; hazard ratio for mortality of ET vs T: 1.17 (95% CI 0.86-1.59; P=0.33). The ET regimen does not seem to be more effective than T in refractory advanced ovarian cancer patients in early progression after platinum-based chemotherapy. Despite an acceptable response rate, the control of disease progression remains poor.

Indexed as

AdultAgedAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsCarcinomaDisease ProgressionEpirubicinFemaleHumansInfusions, IntravenousMiddle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsPaclitaxelSurvival AnalysisTreatment OutcomeAntineoplastic Agents, PhytogenicEpirubicinPaclitaxel

Identifiers

PMID15150623
PMCPMC2409494
OpenAlexW2084233475

What OpenQuestion holds

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LicenceCC BY
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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.