Decreased hypersensitivity reactions with carboplatin-pegylated liposomal doxorubicin compared to carboplatin-paclitaxel combination

Analysis from the GCIG CALYPSO relapsing ovarian cancer trial

Florence Joly*, Isabelle Ray-Coquard, Michel Fabbro, Mark Donoghoe, Karin Boman, Akira Sugimoto, Michelle Vaughan, Alexander Reinthaller, Ignace Vergote, Gabriella Ferrandina, Tiziana Dell'Anna, Jens Huober, Eric Pujade-Lauraine

*Corresponding author for this work

Research output: Contribution to journalArticle

47 Citations (Scopus)

Abstract

Objective: To describe and analyze observed hypersensitivity reactions (HSR) from the randomized, multicenter phase III CALYPSO trial that evaluated the efficacy and safety of the combination of carboplatin and pegylated liposomal doxorubicin (CD) compared with standard carboplatin-paclitaxel (CP) in patients with platinum-sensitive relapsed ovarian cancer (ROC). Methods: HSR documented within case report forms and SAE reports were specifically analyzed. Analyses were based on the population with allergy of any grade and for grade > 2 allergy. Results: Overall 976 patients were recruited to this phase III trial, with toxicity data available for 466 and 502 on the CD and CP arms, respectively. There was a 15.5% HSR rate associated with CD (2.4% grade > 2) versus 33.1% with CP (8.8% grade > 2), p < 0.001. HSRs occurred more often during first cycle in the CD (46%) arm than in the CP arm (16%). Multivariate predictors of allergy were chemotherapy regimen and age; patients randomized to CD and patients 70 years old on CP had less allergy. Few patients (< 6%) stopped treatment due to allergy. Allergy rates were higher in patients who did not receive prior supportive treatment; however there was no relationship between allergy and the type of carboplatin product received, or response rate. Conclusions: Use of PLD with carboplatin instead of paclitaxel and older age were the only 2 factors predicting a low rate of HSRs in patients with ROC. CD has previously demonstrated superior progression-free survival and therapeutic index than CP. Taken together these data support the use of CD as a safe and effective therapeutic option for platinum-sensitive ROC.

Original languageEnglish
Pages (from-to)226-232
Number of pages7
JournalGynecologic Oncology
Volume122
Issue number2
DOIs
Publication statusPublished - Aug 2011
Externally publishedYes

Keywords

  • Allergy
  • Carboplatin
  • Hypersensitivity reaction(s)
  • Ovarian cancer
  • Pegylated liposomal doxorubicin

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