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Xeloda: Improving survival in pancreatic cancer

Xeloda: Improving survival in pancreatic cancer. Philippe Rougier H ô pital Ambroise Paré, Boulogne-Billancourt, France. Xeloda monotherapy compares favourably with gemcitabine in pancreatic cancer. Phase III trial 1. 5-FU (n=63). Gemcitabine (n=63). Overall response rate (%). 0. 5.

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Xeloda: Improving survival in pancreatic cancer

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  1. Xeloda: Improving survival in pancreatic cancer Philippe Rougier Hôpital Ambroise Paré, Boulogne-Billancourt, France

  2. Xeloda monotherapy compares favourably with gemcitabine in pancreatic cancer Phase III trial1 5-FU(n=63) Gemcitabine(n=63) Overall response rate (%) 0 5 Overall survival(months) 4 6 Positive CBR (%) 5 24 Grade 3/4 AEs (%) Diarrhoea 5 2 Hand-foot syndrome 0 0 Neutropenia 5 26 Thrombocytopenia 2 10 1. Burris HA et al. J Clin Oncol 1997;15:240313 2. Cartwright TH et al. J Clin Oncol 2002;20:1604

  3. Phase II trial2 Xeloda (n=42) 9.5 6 24 17 17 0 0 Xeloda monotherapy compares favourably with gemcitabine in pancreatic cancer Phase III trial1 5-FU(n=63) Gemcitabine(n=63) Overall response rate (%) 0 5 Overall survival(months) 4 6 Positive CBR (%) 5 24 Grade 3/4 AEs (%) Diarrhoea 5 2 Hand-foot syndrome 0 0 Neutropenia 5 26 Thrombocytopenia 2 10 1. Burris HA et al. J Clin Oncol 1997;15:240313 2. Cartwright TH et al. J Clin Oncol 2002;20:1604

  4. UK NCRI GEMCAP: Xeloda + gemcitabine in advanced pancreatic cancer RANDO MIS ATION GEMCAP Gemcitabine 1000mg/m2 d1, 8, 15 q4w Xeloda 830mg/m2 bid d121 q4w Advanced pancreatic cancer n=508 Gemcitabine 1000mg/m2 weekly x7 q8w, thereafter weekly x3q4w • Primary end-point: overall survival Cunningham D et al. Eur J Cancer 2005;(Suppl. 3):4 (Abst PS11)

  5. GEMCAP: superior response rate Cunningham D et al. Eur J Cancer 2005;(Suppl. 3):4 (Abst PS11)

  6. Hazard ratio: best measure of survival benefit • Relative risk of dying on one treatment vs another • Cox model may be applied • relative risk used to compare risk • HR of 0.80 shows a 20% decrease in risk of death • Uses complete data set from entire Kaplan-Meier (KM) plot • all patients (ITT) • entire study duration • Median is only a ‘snapshot’ at a single time point • HR is comprehensive and reliable • demonstrates clinically meaningful difference • shows extent of difference over time Spruance SL et al. Antimicrob Agents Chemother 2004;48:2787–92

  7. GEMCAP: improved overall survival Patients surviving (%) 12-month survival (%) GEMCAP (n=267) 26 Gemcitabine (n=266) 19 100 75 Hazard ratio: 0.8095% CI: 0.65–0.98 Log-rank p=0.026 50 25 6.0 7.4 0 0 3 6 9 12 15 18 21 24 27 Months Cunningham D et al. Eur J Cancer 2005;(Suppl. 3):4 (Abst PS11)

  8. Gemcitabine (n=145) GEMCAP (n=153) GEMCAP is well tolerated Grade 3/4 AEs Patients (%) 50 40 30 20 10 0 Nausea Anaemia Asthenia Vomiting Hand-footsyndrome Diarrhoea Neutropenia Thrombocytopenia Cunningham D et al. Eur J Cancer 2005;(Suppl. 3):4 (Abst PS11)

  9. Consistent survival benefit in two GEMCAP trials Events/patients GEMCAPbetter GEMbetter GEMCAP GEM SAKK1 142/159 140/157 UK NCRI2 180/267 193/266 HR: 0.83 p=0.02 Pooled 322/426 333/423 or 95% confidence intervals 0.0 0.5 1.0 1.5 2.0 2.0 Hazard ratio 1. Herrmann R et al. Eur J Cancer 2005;(Suppl. 3):203 (Abst 717) 2. Cunningham D et al. Eur J Cancer 2005;(Suppl.3):4 (Abst PS11)

  10. Xeloda-containing combinations:higher response rates and survival Heinemann V et al. Eur J Cancer 2005;(Suppl. 3):209 (Abst 735)

  11. Xeloda: backbone for the treatment of pancreatic cancer • XELOX • well tolerated and effective • second-line overall survival: 5.8 months1 • GEMCAP + Avastin2 • PFS: 8.2 months • overall survival: 9.1 months • Xeloda-based chemoradiation3–5 • early stage disease • overall survival: 10–14 months • favourable safety profile 1. Xiong HQ et al. Proc Am Soc Clin Oncol2006 (Abst 4119) 2. Javle M et al. Proc Am Soc Clin Oncol2006 (Abst 4117) 3. Saif MW et al. J Clin Oncol 2005;23:867987 4. Schneider BJ et al. Int J Radiat Oncol Biol Phys 2005;63:132530 5. Crane CH et al. J Clin Oncol 2006;24:114551

  12. Conclusions: Xeloda combinations improve efficacy in pancreatic cancer • GEMCAP is a new standard treatment • platform to which novel agents can be added • significantly improves survival over gemcitabine • Addition of Avastin shows promising PFS • Xeloda chemoradiation is active and well tolerated • Xeloda should be integrated in the treatment of pancreatic cancer • chemotherapy, radiotherapy, biological agents • Combination with Tarceva could further improve outcomes for patients

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