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Pujade-Lauraine E et al. ASCO 2009; Abstract LBA5509. (Oral Presentation)

CALYPSO Trial: Carboplatin & Pegylated Liposomal Doxorubicin (PLD) versus Carboplatin & Paclitaxel in Relapsed, Platinum-Sensitive Ovarian Cancer. Pujade-Lauraine E et al. ASCO 2009; Abstract LBA5509. (Oral Presentation). Introduction.

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Pujade-Lauraine E et al. ASCO 2009; Abstract LBA5509. (Oral Presentation)

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  1. CALYPSO Trial: Carboplatin & Pegylated Liposomal Doxorubicin (PLD) versus Carboplatin & Paclitaxel in Relapsed, Platinum-Sensitive Ovarian Cancer Pujade-Lauraine E et al. ASCO 2009; Abstract LBA5509. (Oral Presentation)

  2. Introduction • Choice of treatment for relapsed ovarian cancer is dependent upon the interval since prior platinum-based therapy • Relapse within six months: platinum-resistant disease • Relapse > six months: platinum-sensitive disease • Carboplatin/paclitaxel (CP) is a standard treatment in platinum-sensitive, relapsed ovarian cancer • Due to risk of cumulative neuropathy and hair loss, other carboplatin-based combinations are needed • Pegylated liposomal doxorubicin (PLD) is a rationale partner for carboplatin • PLD resulted in significant improvements in PFS and OS compared to topotecan in platinum-sensitive ovarian cancer (JCO 2001;19:3312) • Safety and efficacy (median PFS: 9.4 months) of carboplatin/PLD was demonstrated in a phase II trial (Ann Oncol 2007;18:263) • Current study objectives: • Evaluate PFS and safety of carboplatin/PLD (CD) versus CP in patients with platinum-sensitive, relapsed ovarian cancer Source: Pujade-Lauraine E et al. ASCO 2009;Abstract LBA5509.

  3. CALYPSO: Open Label Phase III Non-Inferiority Study Design Experimental arm: CD PLD 30 mg/m2 IV d1 Carboplatin AUC 5 d1 Q28 days x 6* R (N = 976) Control arm: CP Paclitaxel 175 mg/m2 IV d1 Carboplatin AUC 5 d1 Q21 days x 6* *or until disease progression in patients with SD or PR Source: Pujade-Lauraine E et al. ASCO 2009;Abstract LBA5509.

  4. Progression-Free Survival: ITT(Median Follow-Up = 22 months) 1.0 0.8 0.6 0.4 0.2 0.0 CD Proportion notProgressing CP 0 6 12 18 24 30 Months from Randomization Source: With permission from Pujade-Lauraine E. ASCO 2009;Abstract LBA5509.

  5. Hematologic Toxicity NS = not significant Source: Pujade-Lauraine E et al. ASCO 2009;Abstract LBA5509.

  6. Non-Hematologic Toxicity Treatment discontinuation related to toxicity*: CD = 6% vs CP = 15% *P < 0.001; †Grade 3/5 Source: Pujade-Lauraine E et al. ASCO 2009;Abstract LBA5509.

  7. EORTC OV28: Quality of Life - Peripheral Neuropathy Score Over Time 60 50 40 30 20 10 Treatment Arm CD CP MeanQoL scale score Randomization 3 6 9 12 15 Months from Randomization Error bars: 95% CI Source: With permission from Pujade-Lauraine E. ASCO 2009;Abstract LBA5509.

  8. Summary and Conclusions • In relapsed, platinum-sensitive ovarian cancer carboplatin/pegylated liposomal doxorubicin (CD) was non-inferior to CP • 18% reduction in risk of progression (HR = 0.82, p = 0.005) • Overall survival data is immature • CP associated with more severe toxicity (carboplatin hypersensitivity), alopecia and long-lasting toxicity (neuropathy) — more toxicity-related treatment discontinuation • CP = 15% vs CD = 6% (p < 0.001) • CD associated with moderate, reversible hand-foot syndrome, more mucositis and more nausea/vomiting • Overall, CD demonstrated a superior therapeutic index (benefit/risk ratio) versus the current standard CP • CD offers an evidence-based option for patients with relapsed, platinum-sensitive ovarian cancer Source: Pujade-Lauraine E et al. ASCO 2009; Abstract LBA5509.

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