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台北榮民總醫院 婦產部 主治醫師 吳 華 席
Introduction • Ovarian cancer • The lethal gynecologic cancer • The major prognostic factors • Residual tumor at primary surgery • Sensitivity to platinum-based C/T • In platinum-resistant cancers • None of drugs currently used showed superiority in phase II studies
RCTs for platinum-resistant ovarian cancer patients • PLD vs Topotecan • Equivalent in TTP & OS • More hematologic toxicity & alopecia in Topotecan group • More PPE, stomatitis & mucosities in PLD group (Gordon, JCO, 19:3312, 2001) • Gemzar vs PLD • PLD : 50 mg/m2 q4wks (by FDA) PPE 23% • Higher mucositis /stomatitis than 40 mg/m2 q4wks (Mutch, JCO, 25:2811, 2007)
Fig 1. Study design P/T only; recurrence/progression in 12 months Pegylated liposomal doxorubicin 40 mg/m2 q4w Gemcitabine 1000 mg/m2 on D1, D8 & D15 q4w Ferrandina, G. et al. J Clin Oncol; 26:890-896 2008
Clinical Responses Overall response: p=0.066 16 vs 29% L vs G Clinical benefit: p=0.085 58 vs 71%
Fig 2. Kaplan-Meier estimate of (A) time to progression (TTP) and (B) overall survival (OS) curves In TTP, p= 0.411 In OS, p=0.048 Ferrandina, G. et al. J Clin Oncol; 26:890-896 2008
Results • The rate of response was lower in pts experiencing recurrence within 6 months versus pt with a PFI of 7-12 months (15% vs 31%, p=0.032) • Progression of disease: 88% Died of disease: 62%
Fig 3. Box-whiskers plots of the global quality of life (QoL) scores for patients treated with pegylated liposomal doxorubicin (PLD; n = 60 at baseline) and gemcitabine (GEM; n = 61 at baseline) Ferrandina, G. et al. J Clin Oncol; 26:890-896 2008
Discussion • GEM is not superior to PLD in terms of TTP in Pt with recurrence either within 6 months or 7-12 months • Although there was a trend for more favorable OS in the PLD arms, the relative low number of patients, the borderline statistical significance, and the scarcity of data on post-progression chemotherapyregimens do not allow any firm conclusion to be drawn.
Conclusion • Gemcitabine • Does not provide an advantage compared to LPD • Could be considered in salvage setting • LPD • Proved to be more manageable compared with GEM, because • The schedule • Negligible hematologic toxicity • Low rate of mucositis and skin toxicity favorable therapeutic index of LPD