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

NCT02324296 | Completed

• 1 other identifier: PEI 01
• Study Type: observational
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

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%).

Conditions

Small Cell Lung Cancer

Keywords

small cell lung cancer; extended disease; limited disease; chemotherapy; cisplatin; etoposide; ifosfamide

Outcome Measures

Primary Outcomes (2)

• partial response (PR)

  1 year

• complete response (CR)

  1 YEAR

Secondary Outcomes (2)

• Median time to progression (TTP)

  1 YEAR

• overall survival (OS)

  1 YEAR

Interventions

ifosfamide DRUG

PEI regimen may be a possible therapeutic option, with high activity and an acceptable toxicity profile.

Also known as: cisplatin, etoposide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Related Publications (1)

• Boni C, Pagano M, Baldi L, Gnoni R, Braglia L, Savoldi L, Zanelli F. Pei regimen: a therapeutic option in small cell lung cancer? A retrospective monoinstitutional analysis of 46 consecutive cases. J Transl Med. 2015 Apr 24;13:130. doi: 10.1186/s12967-015-0491-3.

  PMID: 25903963 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Ifosfamide; PE regimen

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 24, 2014
• Study Start: December 1, 1998
• Primary Completion: January 1, 2009
• Study Completion: December 1, 2010
• Last Updated: June 11, 2025

Record last verified: 2014-12