Phase-II study with the combination of cisplatin and doxorubicin in advanced malignant mesothelioma of the pleura

Our plain-English summary of Phase-II study with the combination of cisplatin and doxorubicin in advanced malignant mesothelioma of the pleura, by H. Henss, H.H. Fiebig, J. Schildge, et al (Onkologie, 1988).

The study

• Authors: H. Henss, H.H. Fiebig, J. Schildge, H. Arnold, J. Hasse
• Journal: Onkologie
• Published: 1988;11(3):118-20
• Cited by: 22 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

The effectiveness of combination chemotherapy with doxorubicin and cisplatin was studied in patients with advanced malignant pleuramesothelioma. 19 patients were treated intravenously with cisplatin 60 mg/m2/day on days 1 and 2, and with adriamycin 40 mg/m2 on day 3 every 4 weeks. 8/19 patients (46%) responded to chemotherapy; 2 achieved complete remissions (CR), and 6 went into partial remissions (PR). Median duration of response was 222 days. Median survival time of all patients was 370 days compared to a median survival of 273 days in a historical control group consisting of 30 patients treated by surgery only. Substantial toxicity was observed, mainly gastrointestinal. We conclude that the combination of cisplatin and adriamycin is effective in malignant pleuramesothelioma. However, the duration of treatment is limited by gastrointestinal toxicity.

In plain English

This was a phase II study of combination chemotherapy for advanced malignant mesothelioma of the pleura. From 1982 to 1986, 19 consecutive patients (17 men, 2 women; median age 57) were treated with cisplatin on days 1 and 2 and adriamycin (doxorubicin) on day 3, repeated every 4 weeks. Most had already had surgery. Eight of the 19 patients responded: 2 had a complete remission and 6 a partial remission. Median duration of remission was 222 days, and median survival of all patients was 370 days. The authors compared this with a median survival of 270 days in a historical group of 30 patients treated by surgery alone. The article reports no statistical test of this comparison. Side effects were substantial, mainly gastrointestinal. All but two patients vomited despite anti-nausea drugs. One patient had severe kidney failure and recovered without dialysis. Toxicity ended chemotherapy in all but one patient after the 5th to 6th cycle. The authors concluded the combination was effective but that toxicity limited how long treatment could last. The article does not report the patients' asbestos exposure.

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 clinical treatment study (single treatment group), with survival compared to a historical control group treated by surgery alone
• Who was studied: 19 consecutive patients with histologically proven malignant mesothelioma of the pleura, entered from 1982 to 1986 (authors at Freiburg institutions). There were 17 men and 2 women, median age 57 years (range 38-71). 17 had prior surgery, 1 prior radiotherapy and 1 biopsy only. None had previous chemotherapy.
• Exposure: Chemotherapy, not asbestos exposure: cisplatin 60 mg/m2 per day intravenously on days 1 and 2, and adriamycin (doxorubicin) 40 mg/m2 on day 3, every 4 weeks. Patients had at least 2 cycles; responders had 5 to 6 cycles. The patients' asbestos exposure is not reported.
• Main results:
  • 8 of 19 patients responded to chemotherapy: 2 complete remissions and 6 partial remissions. The article prints the response rate as 46%, which does not match 8/19.
  • Median duration of remission was 7 months (222 days; range 65 to 640+ days). Median survival of all 19 patients was 12 months (370 days).
  • Median survival in a historical control group of 30 patients treated by surgery alone was 270 days (the article's summary says 273 days). No statistical test of the comparison is reported.
  • Substantial toxicity, mainly gastrointestinal: all but two of the 19 patients vomited despite preventive anti-nausea treatment. Hematologic toxicity was mild.
  • One patient had severe renal failure and recovered with conservative treatment without dialysis. There were 2 cases of neuropathy.
  • Dose reduction was needed in 3 of 19 patients because of gastrointestinal toxicity. 2 patients refused further chemotherapy. Toxicity ended chemotherapy in all but one patient after the 5th to 6th cycle.
  • At the time of writing, 5 of the 8 responding patients had relapsed.
• The authors' conclusion: The authors concluded that the combination of doxorubicin and cisplatin is effective in advanced pleural mesothelioma, but that substantial gastrointestinal toxicity limited the duration of treatment. They suggested that less toxic drugs with similar activity are needed.

Topics

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

Medical terms in this study, explained in our Lexicon: Cisplatin, Doxorubicin, Malignant Mesothelioma, Pleura, Chemotherapy, Median Survival.

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