Malignant pleural mesothelioma: a phase II trial with docetaxel

Our plain-English summary of Malignant pleural mesothelioma: a phase II trial with docetaxel, by D.A. Vorobiof, B.L. Rapoport, M.R. Chasen, et al (Annals of Oncology, 2002).

The study

• Authors: D.A. Vorobiof, B.L. Rapoport, M.R. Chasen, R.P. Abratt, N. Cronje, L. Fourie, G. McMichael, D. Hacking
• Journal: Annals of Oncology
• Published: 2002;13(3):412-5
• Cited by: 20 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Current cytotoxic therapy has been of limited benefit to patients with malignant pleural mesothelioma. Single agent chemotherapy has been extensively evaluated in small series of phase II clinical trials, with disappointing responses. Docetaxel, an effective taxane in the treatment of advanced breast cancer and non-small-cell lung cancer, was administered intravenously at a dose of 100 mg/m2 every 3 weeks to 30 chemotherapy naive patients with malignant pleural mesothelioma in a prospective multi-institutional phase II clinical trial. An objective response rate (partial responses) of 10% was documented. Additionally, 21% of the patients had minor responses (intention-to-treat analysis). Three patients died within 2 weeks post-first cycle of therapy, although only one patient's death was directly attributed to the investigational drug, whilst in the majority of the patients, manageable and treatable toxicities were encountered. In this phase II clinical trial, docetaxel proved to be mildly effective in the treatment of patients with malignant pleural mesothelioma.

In plain English

This was a phase II clinical trial, run at several oncology centres in South Africa. It tested the chemotherapy drug docetaxel in people with malignant pleural mesothelioma who had not had chemotherapy before. Between September 1997 and November 1999, 31 patients were enrolled. One was later found to have lung adenocarcinoma instead. Patients received docetaxel at 100 mg/m2 by one-hour intravenous infusion every 3 weeks. Of 29 patients who could be assessed, three (10%) had a partial response, six (21%) had a minor response, and eleven had stable disease. Median time to progression was 107 days. Median survival was 371 days (range 6 to more than 820 days). Thirteen patients had no documented side effects. Three patients died early in treatment, two 6 days and one 15 days after the first cycle; one of these deaths was considered related to the chemotherapy. The authors concluded that docetaxel was mildly effective in this disease. They noted that there are no uniform criteria for measuring response in mesothelioma and that the disease is hard to measure on CT scans.

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: prospective multi-institutional national phase II clinical trial (single-arm drug trial)
• Who was studied: 31 patients enrolled at oncology centres in South Africa between September 1997 and November 1999. All had histologically confirmed malignant pleural mesothelioma and no prior chemotherapy. One was unevaluable because the diagnosis was actually lung adenocarcinoma. Of the 30 evaluable patients, 25 were male and 5 female, with a median age of 58 (range 33–72). The patients' asbestos exposure was not reported.
• Exposure: Docetaxel 100 mg/m2 given intravenously over 1 hour every 3 weeks, with oral dexamethasone premedication. A median of four cycles was given (range one to nine). This was a drug treatment study, not a study of asbestos exposure.
• Main results:
  • Of 29 patients assessable for response, three had a partial response (10%)
  • Of the same 29 patients, six had minor responses (21%)
  • Median duration of response was 126 days (range 44 to more than 473 days)
  • Median time to progression was 107 days (range 15 to 746 days)
  • Median survival was 371 days (range 6 to more than 820 days)
  • 13 patients had no documented side effects
  • Three patients died during treatment. Two died 6 days after the first cycle; the third died 15 days after the first cycle.
  • One of the three early deaths (a 58-year-old man with colon damage at autopsy) was considered chemotherapy related; for the other two the link was unclear
• The authors' conclusion: The authors concluded that docetaxel was mildly effective in treating patients with malignant pleural mesothelioma.
• Limitations the authors state:
  • There are no uniform criteria for measuring and evaluating response in malignant pleural mesothelioma.
  • The diffuse growth pattern of the tumour is often difficult to assess and measure on CT scans.

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, Chemotherapy, Clinical Trial, Lung Cancer.

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• Paclitaxel for malignant pleural mesothelioma: a phase II study of the EORTC Lung Cancer Cooperative Group — J. van Meerbeeck, C. Debruyne, et al. (1996)
• miR-34a expression, cell cycle arrest and cell death of malignant mesothelioma cells upon treatment with radiation, docetaxel or combination treatment — T. Ghawanmeh, U. Thunberg, et al. (2011)
• Phase II study of gemcitabine plus docetaxel as second-line treatment in malignant pleural mesothelioma: a single institution study — I. Tourkantonis, N. Makrilia, et al. (2011)
• Unusually favorable outcome of 6 consecutive patients with diffuse malignant peritoneal mesothelioma treated with repeated doses of intraperitoneal paclitaxel. A case series — P.H. Sugarbaker, O.A. Stuart (2020)

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