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Title: Delayed Symptom Progression, Better Tolerability Found With Pegylated Liposomal Doxorubicin Plus Carboplatin for Ovarian Cancer: Presented at ASCO

"Delayed Symptom Progression, Better Tolerability Found With Pegylated Liposomal Doxorubicin Plus Carboplatin for Ovarian Cancer: Presented at ASCO"

By Deborah Brauser ORLANDO, Fla -- June 4, 2009 -- Pegylated liposomal doxorubicin (PLD) combined with carboplatin delays progression of symptoms and causes milder side effects compared with carboplatin plus paclitaxel for relapsed, platinum-sensitive patients with advanced ovarian cancer, according to results from a phase 3 trial presented here at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO). Eric Pujade-Lauraine, MD, Université de Paris Descartes, Paris, France, presented the late-breaking results here on May 30 on behalf of the Gynecologic Cancer Intergroup (GCIG). In the study, 976 patients with ovarian cancer (having relapsed >6 months after treatment with platinum-based therapy) were enrolled at sites in 15 countries from April 2005 to September 2007. A total of 974 were randomised to receive either PLD 30 mg/m[² IV plus carboplatin area under the curve (AUC) 5 IV on day 1 then every 4 weeks (n = 466; median age 60.5 years) or carboplatin AUC 5 IV plus paclitaxel 175 mg/m² IV on day 1 then every 3 weeks (n = 508; median age 61 years).

A total of 85% of the patients in the carboplatin-PLD group and 78% of those in the carboplatin-paclitaxel group received >=6 cycles.

The primary endpoint was progression-free survival, with secondary endpoints including toxicity and overall survival.

With a median follow-up of 21 months, there were 308 deaths. As overall survival rate was deemed too early to report, the final analysis for progression-free survival and toxicity were the focus of this presentation.

The results showed a significantly higher rate of progression-free survival in the carboplatin-PLD group at 11.3 months compared with 9.4 months for those in the carboplatin-paclitaxel group (hazard ratio [HR], 0.821; 95% confidence interval [CI], 0.72-0.94; P = .005).

Patients in the PLD group had significantly less grade 2 neuropathy (4% vs 24%, P < .001) and grade 2 alopecia (7% vs 84%, P < .001) than those in the standard-care group, and a lower rate of early treatment discontinuation due to toxicity (6% vs 15%, P < .001).

In addition, carboplatin-related hypersensitivity reactions were also significantly lower in the carboplatin-PLD group at 3% and 2% for grade 2 and grade 3/4, respectively vs 10% and 9% for the standard-care group (P < .001).

"This was an unexpected, but important finding with clinical implications," said Dr. Pujade-Lauraine. "When you treat a patient with carboplatin, there is often a high rate of hypersensitivity reaction, but it was significantly less when combined with PLD instead of with paclitaxel."

"In this trial, carboplatin-PLD demonstrated a superior therapeutic index versus the current standard of carboplatin and paclitaxel," he concluded. "We believe these results will change practice as carboplatin-PLD offers an evidence-based option for patients with platinum-sensitive recurrent ovarian cancer."

[Presentation title: A Randomized, Phase III Study of Carboplatin and Pegylated Liposomal Doxorubicin Versus Carboplatin and Paclitaxel in Relapsed Platinum-Sensitive Ovarian Cancer (OC): CALYPSO Study of the Gynecologic Cancer Intergroup (GCIG). Abstract LBA5509]

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