Paclitaxel for malignant pleural mesothelioma: a phase II study of the EORTC Lung Cancer Cooperative Group

Our plain-English summary of Paclitaxel for malignant pleural mesothelioma: a phase II study of the EORTC Lung Cancer Cooperative Group, by J. van Meerbeeck, C. Debruyne, N. van Zandwijk, et al (British Journal of Cancer, 1996).

The study

• Authors: J. van Meerbeeck, C. Debruyne, N. van Zandwijk, P.E. Postmus, M.C. Pennucci, F. van Breukelen, D. Galdermans, H. Groen, P. Pinson, M. van Glabbeke, E. van Marck, G. Giaccone
• Journal: British Journal of Cancer
• Published: 1996;74(6):961-3
• Cited by: 60 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

The EORTC Lung Cancer Cooperative Group undertook a phase II study of paclitaxel in 25 chemotherapy-naive patients with malignant pleural mesothelioma. Paclitaxel was given intravenously at a dose of 200 mg m-2 as a 3 h infusion every 3 weeks, after standard premedication with corticosteroids and antihistamines. This regimen was well tolerated, with < 4% of cycles resulting in severe toxicity. No major objective responses were observed and ten patients had stable disease. Median survival time was 39 weeks and the 1 year survival rate was 30%. In conclusion, paclitaxel at the dose and schedule investigated in this trial had no major activity in the treatment of malignant pleural mesothelioma.

In plain English

This was a phase II trial by the EORTC Lung Cancer Cooperative Group. It tested the chemotherapy drug paclitaxel in people with malignant pleural mesothelioma who had not had chemotherapy before. The study looked at a treatment, not at asbestos exposure. Between April and October 1993, 25 patients were registered at eight European institutes. Response and side effects were analysed in the 23 eligible patients. Paclitaxel was given into a vein at 200 mg per square metre as a 3-hour infusion every 3 weeks. No patient had a major tumour response (response rate 0%, 95% confidence interval 0% to 15%). Ten patients (44%) had stable disease and 12 (52%) had disease progression. Median survival was 9 months. Thirty percent of patients were alive at 12 months and 10% at 18 months. Severe neutropenia, a drop in a type of white blood cell, occurred in 4% of treatment cycles. Seventeen patients (74%) developed peripheral neuropathy (nerve damage). The authors concluded that paclitaxel at this dose and schedule had no major activity in malignant pleural mesothelioma.

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: Multicentre phase II clinical trial of a chemotherapy drug (single treatment group, two-stage Gehan design planned)
• Who was studied: 25 chemotherapy-naive patients with histologically confirmed malignant pleural mesothelioma, registered between April and October 1993 from eight institutes in Europe. 24 were treated, 23 were eligible and analysed for response and toxicity. There were 20 men and 4 women, median age 63 (range 36-73).
• Exposure: Not an asbestos exposure study. The exposure was the drug paclitaxel, 200 mg per square metre intravenously as a 3-hour infusion every 3 weeks (up to ten cycles), after premedication with corticosteroids and antihistamines.
• Main results:
  • No major objective responses among the 23 eligible patients: response rate 0%, 95% confidence interval 0% to 15%
  • Ten patients (44%) had stable disease during chemotherapy; the remaining 12 (52%) showed disease progression
  • Median duration of stabilisation was 30 weeks (range 18-63 weeks)
  • Median survival time was 9 months; 12-month survival rate 30% and 18-month survival rate 10%
  • A total of 128 cycles were given; median four cycles per patient (range 2-10)
  • Neutropenia grade 3 or more was the most frequent severe toxicity, occurring in 4% of cycles
  • 17 of the 23 eligible patients (74%) developed peripheral neuropathy, which increased in grade with more cycles
  • Seven patients had a hypersensitivity reaction, never severe; no cardiac toxicity was observed
• The authors' conclusion: The authors concluded that paclitaxel at the dose and schedule used was well tolerated but had no major activity in malignant pleural mesothelioma.
• Limitations the authors state:
  • Because accrual was rapid, the planned two-stage design could not be applied, and more patients were entered than needed to exclude a 20% response rate

Topics

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

Medical terms in this study, explained in our Lexicon: Pleural Mesothelioma, Lung Cancer, Chemotherapy, Median Survival.

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