Safety of a 3-weekly schedule of carboplatin plus pegylated liposomal doxorubicin as first line chemotherapy in patients with ovarian cancer: preliminary results of the MITO-2 randomized trial
2006

Safety of Carboplatin and Pegylated Liposomal Doxorubicin in Ovarian Cancer

Sample size: 50 publication Evidence: moderate

Author Information

Author(s): Sandro Pignata, Giovanni Scambia, Antonella Savarese, Enrico Breda, Paolo Scollo, Rocco De Vivo, Emanuela Rossi, Vittorio Gebbia, Donato Natale, Filomena Del Gaizo, Emanuele Naglieri, Antonella Ferro, Pietro Musso, Alfonso Maria D'Arco, Roberto Sorio, Carmela Pisano, Massimo Di Maio, Giuseppe Signoriello, Annalisa Annunziata, Francesco Perrone

Primary Institution: National Cancer Institute, Naples, Italy

Conclusion

The study found that the combination of carboplatin and pegylated liposomal doxorubicin is a feasible first-line treatment for ovarian cancer, with manageable toxicity.

Supporting Evidence

  • 86% of patients completed the planned number of cycles.
  • No toxic deaths were recorded during the study.
  • Hematological toxicities included grade 3 anemia in 16% and grade 3/4 neutropenia in 36% of patients.
  • Non-haematological toxicity was infrequent, with only 6% reporting pulmonary toxicity.

Takeaway

Doctors tested a new way to treat ovarian cancer using two medicines together, and they found it was safe and didn't cause too many side effects.

Methodology

Patients with ovarian cancer were randomized to receive either carboplatin plus paclitaxel or carboplatin plus pegylated liposomal doxorubicin every 3 weeks for 6 cycles.

Limitations

The study was limited to a small sample size and was primarily a safety analysis without a pre-stated hypothesis.

Participant Demographics

Median age was 60 years, with a range of 34 to 75 years; most had good ECOG performance status.

Digital Object Identifier (DOI)

10.1186/1471-2407-6-202

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