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Tomudex® Plus Platinol® and Platinol Alone Reduce Dyspnea in Patients with Mesothelioma

Researchers affiliated with the European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer Group and the National Cancer Institute of Canada have reported that the combination of Tomudex (raltitrexed) and Platinol® (cisplatin) or Platinol alone decrease dyspnea in patients with malignant pleural mesothelioma (MPM). The details of this randomized phase III trial evaluating quality of life parameters were reported in the March 20, 2006, issue of the Journal of Clinical Oncology.[1]

Malignant pleural mesothelioma is a rare cancer caused by chronic exposure to asbestos. Patients with this disease often have a decreased quality of life from symptoms caused by the cancer, such as shortness of breath, cough, pain, fatigue, and the inability to eat. This type of cancer is resistant to most therapies, which consist of surgery, chemotherapy, and/or radiation therapy. Furthermore, most people do not learn they have malignant pleural mesothelioma until the disease has progressed to an advanced stage when treatment with surgery or radiation is not an option. Therefore, identification of a chemotherapy regimen that can improve quality of life or survival is essential for improving care in this population.

Mesothelioma is regarded as relatively chemo-resistant, but recent studies have shown that significant palliation is possible with newer chemotherapy approaches. Platinol alone has been the standard by which other regimens are judged. However, there is emerging evidence that combining an anti-metabolite with a platinum compound may now be the current best approach to treating patients with MPM.

The anti-metabolite that has been studied the most is Alimta® (pemetrexed) which has been combined with Platinol producing results superior to Platinol alone. Tomudex is another anti-metabolite that is approved in Europe and Canada for use in the treatment of colon cancer. Tomudex is a prodrug that is converted to polyglutamates, which inhibit thymidylate synthase. Single agent Tomudex has demonstrated activity in the treatment of MPM.[2]

In the current trial, 25 patients with untreated MPM were randomly allocated to receive treatment with Platinol alone or Platinol plus Tomudex. The details of response and survival were reported last year in the Journal of Clinical Oncology and summarized below in Related News.[3] Essentially this study showed that the addition of Tomudex improved the response from 13% to 23.6% and prolonged median survival from 8.8 months to 11.4 months.

The current analyses report short term treatment-related complications and quality of life results. Assessments were made at baseline, after each treatment cycle, at the end of treatment and every 6 weeks for 6 months. This analysis confirmed the survival benefit of combination therapy reported in the original trial. This study did not find major differences in quality of life parameters between patients receiving Platinol alone or Platinol plus Tomudex. However, they did report that patients receiving either therapy had improvement in dyspnea after cycle 2 of therapy.

Comments: This study suggests that both therapies improve quality of life to the same degree. However, combination chemotherapy would be preferable since survival is improved.

Related News:

The Combination Oxaliplatin and Raltitrexed is Effective For Treatment of Inoperable Malignant Pleural Mesothelioma: Results of a Pilot Study(5/14/2002)

Alimta® Approved for Mesothelioma(2/5/2004)

Pemexetred (Altima®) plus Platinol® Extends Survival in Mesothelioma: First Therapy to Make a Difference (7/14/2003)

References

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[1] Bottomley A, Gasfa R, Manegold C, et al. Short-term treatment-related symptoms and quality of life: Results from an International Randomized Phase III Study of cisplatin with or without raltitrexed in patients with malignant pleural mesotheliama: An EORTC Lung Cancer Group and National Cancer Institute, Canada, Intergroup Study. Journal of Clinical Oncology. 2006;24:1435-1442.
[2] Baas P, ardizzoni A, Grossi F, et al. EORTC Lung Cancer Group: The activity of raltitrexed (Tomudex) in malignant pleural mesothelioma: An EORTC phase II study (08992). European Journal of Cancer. 2003;39:353-357.

[3] Van Meerbeeck JP, Gaafar R, Manegold C, et al. Randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an intergroup study of the European Organisation for Reserch and Treatment of Cancer Lung Cancer Group and the National Cancer Institute of Canada. Journal of Clinical Oncology. 2005;23:6881-6889.

Asbestos find suspends search
By AP

NEW YORK -- Officials suspended the search for human remains on the roof of an empty building near the World Trade Center site after asbestos was discovered there.

Nearly 600 bone fragments and other human remains have been found on the former Deutsche Bank building in recent months as workers clean it in preparation for tearing the building down later this year.

Environmental Protection Agency spokesman Mary Mears said yesterday that the search for more remains was suspended after an EPA and department of labour inspection found the roof area was "not properly cleaned."

Follow-up testing by the Lower Manhattan Development Corp., which owns the building, determined some dust particles contained asbestos.

The 41-storey building was severely damaged during the Sept. 11, 2001, attack, when the trade centre's south tower partially collapsed on it.