Radiation Oncology/Mesothelioma/Randomized

Mesothelioma Randomized Evidence

Unresectable disease

British MS01 (2001 - 2006) - Active Symptom Control vs. ACS + MVP vs. ACS + vinorelbine
- Randomized, 3 arms. 409 patients with malignant pleural mesothelioma. Arm 1) Active symptom control (steroids, analgesics, bronchodilators, palliative RT) vs. Arm 2) ASC + MVP (mitomycin 6 mg/m2, vinblastine 6mg/m2, cisplatin 50mg/m2) vs. Arm 3) ASC + vinorelbine 20 mg/m2
- 2008 PMID 18486741 -- "Active symptom control with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma (MS01): a multicentre randomised trial." (Muers MF, Lancet. 2008 May 17;371(9625):1685-94.)
  - Outcome: median OS ASC 7.6 months vs. ASC + chemo 8.5 months (NS); subset trend benefit for vinorelbine 9.5 months (p=0.08)
  - Toxicity: No difference
  - Conclusion: Addition of MVP or vinorelbine to active symptom control offered no significant benefit

EORTC-NCIC 08983 (2000-2003) - Cisplatin vs. Cisplatin + Raltitrexed
- Randomized. 250 patients with advanced malignant pleural

mesothelioma. Arm 1) cisplatin 80 mg/m2 vs. Arm 2) cisplatin 80 mg/m2 + raltitrexed 3 mg/m2

- 2005 PMID 16192580 -- "Randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an intergroup study of the European Organisation for Research and Treatment of Cancer Lung Cancer Group and the National Cancer Institute of Canada." (van Meerbeeck JP, J Clin Oncol. 2005 Oct 1;23(28):6881-9.)
  - Outcome: median OS cisplatin 9 months vs. cisplatin + raltitrexed 11 months (SS); 1-year OS 40% vs. 46% (SS)
  - Conclusion: Raltitrexed and cisplatin improves survival compared with cisplatin alone

Pemetrexed Trial (1999-2001) - Cisplatin vs. Cisplatin + Pemetrexed
- Randomized. 456 patients with chemo-naive and inoperable mesothelioma. Arm 1) cisplatin 75 mg/m2 vs. Arm 2 cisplatin 75 mg/m2 + pemetrexed 500 mg/m2
  - 2003 PMID 12860938 -- "Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma." (Vogelzang NJ, J Clin Oncol. 2003 Jul 15;21(14):2636-44.)
  - Outcome: median OS cisplatin 9 months vs cisplatin/pemetrexed 12 months (SS); time-to-progression 3.9 months vs. 5.7 months (SS)
  - Conclusion: Pemetrexed + cisplatin + vitamin supplements resulted in superior outcome compared with cisplatin alone