First line chemotherapy with planned sequential administration of gemcitabine followed by docetaxel in elderly advanced non-small-cell lung cancer patients: a multicenter phase II study
2008

Sequential chemotherapy in elderly advanced NSCLC

Sample size: 56 publication Evidence: moderate

Author Information

Author(s): Tibaldi C, Vasile E, Antonuzzo A, Di Marsico R, Fabbri A, Innocenti F, Tartarelli G, Amoroso D, Andreuccetti M, Dico M Lo, Falcone A

Primary Institution: Division of Oncology, Department of Oncology, UO Oncologia Medica, Presidio Ospedaliero, Azienda USL-6 of Livorno, Italy

Hypothesis

The planned sequential administration of gemcitabine followed by docetaxel may improve response rate with good tolerability in elderly advanced non-small-cell lung cancer patients.

Conclusion

Sequential gemcitabine and docetaxel is a well-tolerated and effective regimen in elderly advanced NSCLC patients.

Supporting Evidence

  • According to intention-to-treat analysis, the objective response rate was 16.0%.
  • Median time to progression was 4.8 months.
  • Median duration of survival was 8.0 months.
  • The 1-year survival rate was 34%.
  • No grade 4 haematological toxicity was observed.
  • Grade 3 neutropenia and thrombocytopenia were reported in 5.4% and 3.6% of patients, respectively.
  • Five patients converted from stable disease to partial response after docetaxel treatment.

Takeaway

This study tested a new way to give chemotherapy to older patients with lung cancer, and it found that the treatment was safe and worked pretty well.

Methodology

This multicenter phase II study evaluated the activity, efficacy, and tolerability of a sequential regimen consisting of three courses of gemcitabine followed by three courses of docetaxel in chemotherapy-naive patients aged 70 and older with advanced NSCLC.

Limitations

Quality of life assessment data was insufficient due to a high rate of missing questionnaires.

Participant Demographics

The median age of participants was 76 years, with 82% male and 18% female.

Statistical Information

P-Value

0.82

Confidence Interval

95% CI 7.6–28.3%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604187

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