Multicentre phase II study of gemcitabine and cisplatin in malignant pleural mesothelioma
2002

Study of Gemcitabine and Cisplatin for Malignant Pleural Mesothelioma

Sample size: 25 publication Evidence: moderate

Author Information

Author(s): van Haarst J M W, Baas P, Manegold C h, Schouwink J H, Burgers J A, de Bruin H G, Mooi W J, van Klaveren R J, de Jonge M J A, van Meerbeeck J P

Primary Institution: Rotterdam Oncological Thoracic Studygroup (ROTS), Department of Pulmonology, University Hospital Rotterdam

Hypothesis

The study aims to investigate the efficacy and toxicity of a gemcitabine and cisplatin combination in selected and chemo-naive patients with malignant pleural mesothelioma.

Conclusion

The trial found a 16% response rate and manageable toxicity, suggesting that this combination therapy cannot be recommended as standard treatment for malignant pleural mesothelioma.

Supporting Evidence

  • The study included 32 eligible patients from four institutes.
  • Four partial responses were observed among 25 evaluable patients.
  • The median survival from diagnosis was 14.6 months.

Takeaway

Doctors tested a combination of two medicines to see if they could help patients with a tough lung cancer, but only a few patients got better.

Methodology

Patients received gemcitabine and cisplatin in a 3-week cycle, with evaluations for response and toxicity according to WHO and NCIC-CTC criteria.

Limitations

The study had a small sample size and a low compliance rate for quality of life assessments beyond two cycles.

Participant Demographics

Patients aged 18 to 75 with histologically confirmed malignant pleural mesothelioma and no prior chemotherapy.

Statistical Information

Confidence Interval

95% CI 1–31%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6600118

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