Activity of high-dose epirubicin combined with gemcitabine in advanced non-small-cell lung cancer: a multicenter phase I and II study
2000

Epirubicin and Gemcitabine for Lung Cancer

Sample size: 61 publication Evidence: moderate

Author Information

Author(s): van Putten J W G, Eppinga P, Erjavec Z, de Leede G, Nabers J, Smeets J B E, Sleijfer D Th, Groen H J M

Primary Institution: University Hospital, Groningen, The Netherlands

Hypothesis

The study aimed to evaluate the efficacy and tolerance of epirubicin and gemcitabine as first-line chemotherapy in patients with advanced non-small-cell lung cancer.

Conclusion

The combination of epirubicin and gemcitabine showed a tumor response rate of 49% and a median survival time of 42 weeks in patients with advanced non-small-cell lung cancer.

Supporting Evidence

  • Eighteen patients were included in the phase I part of the study.
  • Forty-three chemotherapy-naive patients were included in the phase II part.
  • Granulocytopenia CTC grade 4 occurred in 32.5% of cycles.
  • Febrile neutropenia occurred in six patients.
  • Non-haematological toxicity was mainly mucositis CTC grade 2 and 3 in 35% of patients.

Takeaway

Doctors tested a new medicine combination to help people with a type of lung cancer, and it worked for about half of the patients.

Methodology

A phase I study with escalating doses of epirubicin and a fixed dose of gemcitabine was conducted, followed by a phase II study with a fixed dose of both drugs.

Limitations

The study had a small sample size and was limited to chemotherapy-naive patients.

Participant Demographics

The median age of participants was 60 years, with a range of 26 to 75 years, and most were in stage IV of the disease.

Statistical Information

Confidence Interval

95% CI 35–63% for tumor response rate; 95% CI 13–69 for median survival time.

Digital Object Identifier (DOI)

10.1054/bjoc.1999.1003

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