Ifosfamide in malignant mesothelioma: a phase II study

Our plain-English summary of Ifosfamide in malignant mesothelioma: a phase II study, by M.K. Andersen, A. Krarup-Hansen, G. Mårtensson, et al (Lung Cancer, 1999).

The study

• Authors: M.K. Andersen, A. Krarup-Hansen, G. Mårtensson, H. Winther-Nielsen, A. Thylen, K. Damgaard, S. Olling, J. Wallin
• Journal: Lung Cancer
• Published: 1999;24(1):39-43
• Cited by: 12 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Malignant mesothelioma is a rare malignancy with a median survival, ranging from 4 to 18 months in untreated patients. In a phase II study of patients with mesothelioma, the efficacy and toxicity of ifosfamide and mesna was evaluated. Twenty-nine previously untreated patients, with histologically proven and unresectable mesothelioma, entered the study. Three patients were later excluded from the study due to revision of the diagnoses. The patients had to have bidimensionally measurable disease by CT scans and a WHO performance status < or = 3. Eligible patients received ifosfamide 3000 mg/m2 per day for 3 days as a 1-h infusion and mesna 1800 mg/m2 per day for 3 days every third week. Dose modifications were made according to the degree of hematologic, neurologic and renal toxicity. Response to treatment was evaluated in accordance with WHO criteria. The median age of patients was 59 years (range 39-68), 18 patients (69%) had a history of asbestos exposure and the median of treatment cycles was four (range 1-10). No complete responses were observed. One patient obtained a partial response after five cycles with a duration of response of 25 months. Nine patients (35%) had stable disease, while 13 (54%) progressed. The median survival for all patients was 10 months. The toxicity of the treatment was considerable. Thirteen patients (50%) had grade 4 leucopenia, ten patients (38%) had grade 3 or 4 reversible neurotoxicity and ten patients (38%) had grade 3 or 4 nausea and vomiting. Eleven patients (42%) went off the study due to the toxicity of the treatment. In conclusion, ifosfamide did not show any substantial activity of relevance in malignant mesothelioma at the dose level investigated, in spite of considerable toxicity.

In plain English

This phase II study tested ifosfamide with mesna in previously untreated patients with malignant mesothelioma that could not be removed surgically. Of 29 patients entered, three were excluded after diagnostic revision, leaving 26 men with median age 59. Twenty-four had pleural and two peritoneal mesothelioma; 18 (69%) had a history of asbestos exposure. Patients received ifosfamide 3000 mg/m2 per day for 3 days every third week. No patient had a complete response. One patient, not previously exposed to asbestos, had a 25-month partial response. Nine patients (35%) had stable disease and 13 progressed (printed as 54%, though 13 of 26 is 50%). Three were not assessable after toxicity limited them to one cycle. The response rate was 4% (95% confidence limits 0 to 11%). Median survival was 10 months. Thirteen (50%) had grade 4 leucopenia (low white cell counts). Ten (38%) had grade 3 or 4 neurotoxicity (confusion, hallucinations) that cleared after treatment stopped. Eleven (42%) left the study because of toxicity. The authors concluded that ifosfamide appears to have no substantial activity in malignant mesothelioma at similar doses.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: phase II (single-drug chemotherapy) clinical trial
• Who was studied: 26 eligible patients from Copenhagen, Denmark and Goteborg, Sweden, all male, median age 59 (range 39 to 68), with unresectable malignant mesothelioma (24 pleural, 2 peritoneal)
• Exposure: Treatment with ifosfamide 3000 mg/m2 per day for 3 days plus mesna, repeated every third week. As background, 18 patients (69%) had a history of asbestos exposure. No fiber types are given.
• Main results:
  • Of 29 patients who entered, three were excluded after the diagnosis was revised on pathology review
  • 18 of the 26 patients (69%) had a history of asbestos exposure
  • No complete responses among the patients
  • One patient had a partial response lasting 25 months
  • The single responder had not been exposed to asbestos
  • Nine patients (35%) had stable disease and 13 patients progressed. The article prints this as 54%, but 13 of 26 is 50%.
  • Three patients were not assessable for response because toxicity limited them to one cycle
  • Response rate 4% (range 0 to 11%, 95% confidence limits), one partial response among 26 patients
  • Median survival for all patients was 10 months (range 1 to 80)
  • Thirteen patients (50%) had grade 4 leucopenia
  • Ten patients (38%) had WHO grade 3 or 4 neurotoxicity (mental confusion, hallucinations) that disappeared after treatment was withdrawn
  • Eleven patients (42%) left the study because of toxicity
• The authors' conclusion: The authors concluded that ifosfamide appears to have no substantial activity in malignant mesothelioma at dose levels similar to those used in this study

Topics

The National Library of Medicine indexes this study under subjects our site covers: Mesothelioma.

Medical terms in this study, explained in our Lexicon: Malignant Mesothelioma, Median Survival, Mesothelioma, Unresectable, CT Scan, Performance Status, Asbestos Exposure.

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