A phase III trial of topotecan and whole brain radiation therapy for patients with CNS-metastases due to lung cancer
2009

Topotecan and Whole Brain Radiation Therapy for Lung Cancer Patients

Sample size: 96 publication Evidence: low

Author Information

Author(s): Neuhaus T, Ko Y, Muller R P, Grabenbauer G G, Hedde J P, Schueller H, Kocher M, Stier S, Fietkau R

Primary Institution: Johanniter-Krankenhaus, Bonn, Germany

Hypothesis

Does the combination of topotecan and whole brain radiation therapy improve overall survival in patients with brain metastases from lung cancer compared to whole brain radiation therapy alone?

Conclusion

The study found no significant advantage for concurrent radiochemotherapy with topotecan for patients with lung cancer brain metastases.

Supporting Evidence

  • Only 96 patients were recruited over 34 months, leading to an interim analysis.
  • Overall survival and progression-free survival did not differ significantly between treatment arms.
  • Grade 3/4 haematological toxicities were more common in the radiochemotherapy arm.

Takeaway

Doctors wanted to see if adding a drug called topotecan to radiation therapy would help lung cancer patients with brain tumors live longer, but it didn't seem to make a difference.

Methodology

This was an open-label, prospective, multicentric, randomised phase III trial comparing WBRT alone with WBRT plus topotecan.

Potential Biases

Potential bias due to slow recruitment and the amendment allowing inclusion of newly diagnosed patients.

Limitations

The study had a low recruitment rate, with only 96 patients enrolled instead of the projected 320.

Participant Demographics

Patients aged 18-75 with histologically proven lung cancer and intracerebral metastases.

Statistical Information

Confidence Interval

95% CI (0.83; 2.10) for overall survival; 95% CI (0.73; 2.43) for progression-free survival.

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604835

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