PEI REGIMEN: A Therapeutic Option in Small Cell Lung Cancer? A Monoinstitutional Experience of 46 Consecutive Cases

June 6, 2025 updated by: Azienda USL Reggio Emilia - IRCCS

PEI REGIMEN: A THERAPEUTIC OPTION IN SMALL CELL LUNG CANCER? A MONOINSTITUTIONAL EXPERIENCE OF 46 CONSECUTIVE CASES

ABSTRACT Objectives Combination chemotherapy is very active in small cell lung cancer (SCLC), although no improvement in overall survival (OS) has been done in the last 25 years , with Cisplatin-Etoposide (PE) still considered the world-wide standard, with an average median survival of about 7-8 months in patients with extended disease (ED).

In 1995, a randomized trial of the Hoosier Group in 171 ED patients showed a significant advantage in overall survival in patients treated with PEI (Cisplatin, Etoposide and Ifosfamide), compared to PE. Despite that, PEI regimen has not become a commonly used regimen in SCLC.

Materials and Methods Here we present a series of 46 consecutive patients (30 males and 16 females) with SCLC that were treated at our Institution with PEI regimen: Cisplatin 20mg/m2, Etoposide 75mg/m2 and Ifosfamide 1200mg/m2, day 1 to 4, every 3 weeks.

Patients received a total of 219 cycles of chemotherapy, with a mean of 4,7 cycles per patient. Median age was 63 (range 59-70); performance status (PS) was 0 in 29 patients (63%), 1 in 13 patients (28%) and 2 in 4 patients (9%).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

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Study Type

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Observational

Enrollment (Actual)

Enrollment

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46

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Eligibility Criteria

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Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All eligible patients had histologically or cytologically proven SCLC, with measurable disease defined by RECIST criteria, and received at least one cycle of chemotherapy. Patients with central nervous system (CNS) metastases were included in the study.

Description

Inclusion Criteria:

  • histologically or cytologically proven SCLC
  • measurable disease defined by RECIST criteria

Exclusion Criteria:

Study Plan

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Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

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Outcome Measure
Time Frame
partial response (PR)
Time Frame: 1 year
1 year
complete response (CR)
Time Frame: 1 YEAR
1 YEAR

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Median time to progression (TTP)
Time Frame: 1 YEAR
1 YEAR
overall survival (OS)
Time Frame: 1 YEAR
1 YEAR

Collaborators and Investigators

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Sponsor

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Azienda USL Reggio Emilia - IRCCS

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Study Major Dates

Study Start

Study Start

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December 1, 1998

Primary Completion (Actual)

Primary Completion

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January 1, 2009

Study Completion (Actual)

Study Completion

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December 1, 2010

Study Registration Dates

First Submitted

First Submitted

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December 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

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December 19, 2014

First Posted (Estimated)

First Posted

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December 24, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

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June 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PEI 01

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