Concurrent administration of Docetaxel and Stealth® liposomal doxorubicin with radiotherapy in non-small cell lung cancer: excellent tolerance using subcutaneous amifostine for cytoprotection
2002

Docetaxel and Doxorubicin with Radiotherapy in Lung Cancer

Sample size: 25 publication 10 minutes Evidence: moderate

Author Information

Author(s): Koukourakis M I, Romanidis K, Froudarakis M, Kyrgias G, Koukourakis G V, Retalis G, Bahlitzanakis N

Primary Institution: Democritus University of Thrace

Hypothesis

Can subcutaneous administration of amifostine reduce the toxicity of a highly aggressive chemo-radiotherapy scheme with Stealth® liposomal doxorubicin and Docetaxel in non-small cell lung cancer?

Conclusion

The subcutaneous administration of amifostine during high dose Taxotere®/Caelyx® chemo-radiotherapy is effective in reducing toxicity to levels expected from conventional radiotherapy.

Supporting Evidence

  • Grade 3 esophagitis occurred in 36% of patients.
  • The complete response rate was 40% in the highest dose level.
  • Overall response rate was 87% in the highest dose level.
  • No grade 2 neutropenia was observed.
  • Subcutaneous amifostine reduced mucosal toxicity significantly.

Takeaway

This study tested a new way to give cancer treatment that helps patients feel better while still fighting the cancer. It showed that a special medicine can make the treatment less harsh.

Methodology

A phase I/II dose escalation trial with 25 patients receiving a combination of Docetaxel and Stealth® liposomal doxorubicin during radiotherapy, with subcutaneous amifostine for cytoprotection.

Potential Biases

Potential bias due to the lack of a control group and the open-label design of the trial.

Limitations

The study was limited to a small sample size and focused on short-term toxicity and response rates.

Participant Demographics

Patients with stage IIIb non-small cell lung cancer, histologically confirmed, with specific exclusion criteria.

Statistical Information

P-Value

0.009

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6600486

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