Phase III trial comparing paclitaxel poliglumex vs docetaxel in the second-line treatment of non-small-cell lung cancer
2008

Comparing Paclitaxel Poliglumex and Docetaxel for Lung Cancer Treatment

Sample size: 849 publication 10 minutes Evidence: moderate

Author Information

Author(s): Paz-Ares L, Ross H, O'Brien M, Riviere A, Gatzemeier U, Von Pawel J, Kaukel E, Freitag L, Digel W, Bischoff H, García-Campelo R, Iannotti N, Reiterer P, Bover I, Prendiville J, Eisenfeld A J, Oldham F B, Bandstra B, Singer J W, Bonomi P

Hypothesis

Does paclitaxel poliglumex provide similar survival outcomes to docetaxel in second-line treatment for non-small-cell lung cancer?

Conclusion

Paclitaxel poliglumex and docetaxel produced similar survival results but had different toxicity profiles.

Supporting Evidence

  • Median survival was 6.9 months in both treatment arms.
  • Patients receiving PPX had less febrile neutropenia and alopecia.
  • 34% of patients in the PPX arm discontinued due to adverse events compared to 16% in the docetaxel arm.
  • Grade 3 or 4 neuropathy was more common in the PPX arm.

Takeaway

This study looked at two treatments for lung cancer and found that they worked about the same, but one had fewer side effects.

Methodology

A phase III trial comparing overall survival in patients treated with paclitaxel poliglumex versus docetaxel.

Potential Biases

Potential bias due to open-label design.

Limitations

The study did not achieve noninferiority for paclitaxel poliglumex compared to docetaxel.

Participant Demographics

72% male, 92% Caucasian, median age 61 years.

Statistical Information

P-Value

P=0.257 for median survival, P=0.134 for one-year survival, P<0.001 for adverse events.

Confidence Interval

95% CI=0.94–1.27

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604372

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