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

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: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: ifosfamide

• Study Type: Observational
• Enrollment (Actual): 46

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Median time to progression (TTP)	1 YEAR
overall survival (OS)	1 YEAR

Collaborators and Investigators

• Sponsor: Arcispedale Santa Maria Nuova-IRCCS

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 1998
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 24, 2014

Study Record Updates

• Last Update Posted (Estimate): December 24, 2014
• Last Update Submitted That Met QC Criteria: December 19, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: cisplatin; chemotherapy; small cell lung cancer; etoposide; ifosfamide; limited disease; extended disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Etoposide; Cisplatin; Ifosfamide
• Other Study ID Numbers: PEI 01