Advances In Chemotherapy For Hormone Refractory Prostate Cancer. TAX 327 study results & SWOG study results presented at ASCO 2004

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1 Ronald de Wit Rotterdam Cancer Institute The Netherlands Advances In Chemotherapy For Hormone Refractory Prostate Cancer TAX 327 study results & SWOG study results presented at Slide 1

2 Prostate Cancer Epidemiology Prostate cancer is the leading cancer diagnosis in men and the second leading cancer killer, with deaths from this disease in the US alone, each year Slide 2

3 Prostate Cancer Treatment Paradigms Clinically Localized Relapsed and Newly diagnosed M+ Hormone Refractory Local treatment Endocrine Chemotherapy Slide 3

4 Advanced Prostate Cancer: Treatment 1 Androgen ablation has been the standard treatment for advanced prostate cancer for 40 years Despite rapid and dramatic responses, almost all patients progress Median duration of response is 18 months No agent or combination treatment has proven to prolong survival once patients are refractory to androgen ablation (HRPC) Slide 4

5 Advanced Prostate Cancer: Treatment 2 Median survival in HRPC is 6-15 months, depending on symptoms and performance status Mitoxantrone with low-dose prednisone relieves pain due to metastatic disease in 30% of patients, but does not improve survival* * Tannock et al, J Clin Onc 1996;14: * Kantoff et al, J Clin Onc 1999;17: Slide 5

6 * in HRPC is effective chemotherapeutic agent in variety of solid cancers Efficacy of in HRPC in phase I/II trials q 3 weeks weekly schedules / estramustine pain response ranges from 35-70% median survival ranges from months * docetaxel: brandname Taxotere Slide 6

7 A Multicenter Comparison of Given Weekly or Every Three Weeks + Prednisone with Mitoxantrone + Prednisone in HRPC Ronald de Wit M.D., PhD; Mario A.Eisenberger M.D.; Ian Tannock M.D., PhD and TAX-327 investigators Slide 7

8 TAX327 Study Design R A N D O M I Z E 75 mg/m2 Q3 wks + Prednisone 5mg bid 30 mg/m2 wkly 5 of 6 wks +Prednisone 5mg bid Mitoxantrone Q3 wks + Prednisone 5mg bid Slide 8

9 Study Objectives Primary objective Survival Secondary objectives Pain response PSA response Quality of life Objective tumor response PSA Prostate specific antigen Slide 9

10 Patient Characteristics (n=1006) 3-wkly wkly Mitoxantrone Randomized Median age (range) 68(42-92) 69(36-92) 68(43-86) 80 Karnofsky PS (%) Pain level PPI 2 or AS 10 (%) Prior treatment (%) Prostatectomy Radiotherapy Estramustine PS Performance status PPI Present pain intensity scale AS Analog scale Slide 10

11 Patient Characteristics 3-wkly wkly Mitoxantrone Hormonal Manipulations (%) 1-2 > Median PSA (ng/ml) Gleason Grade (%) Not available Bone metastases (%) Visceral disease (%) Slide 11

12 Overall Survival Probability of Surviving Median survival Hazard (mos) ratio P-value Combined: D 3 wkly: D wkly: Mitoxantrone D 3 wkly D wkly Mitoxantrone Months Slide 12

13 Survival in Subgroups 3 wkly vs Mitoxantrone ITT Hazard ratio in favor of Mitoxantrone Age < 65 Age 65 Age 75 Pain no Pain yes KPS 80 KPS 70 ITT Intent to treat Slide 13

14 Secondary Objectives Response Rates 3 wkly wkly Mitoxantrone Pain Response Rate* Pain response rate (%) P-value (vs. Mitoxantrone) PSA Response Rate* PSA response rate (%) P-value (vs. Mitoxantrone) < Tumor Response Rate* PSA response rate (%) P-value (vs. Mitoxantrone) * Determined only for patients with pain or PSA 20 or measurable disease at baseline, respectively Slide 14

15 Grade 3-4 Hematologic Toxicity (%) 3 wkly wkly Mitoxantrone Treated Anemia Neutropenia Neutropenic infection % Febrile neutropenia % Septic death (%) Slide 15

16 Non-hematological Toxicity (%) 3 wkly wkly Mitoxantrone Toxicity All grades 3/4 All grades 3/4 All grades 3/4 Alopecia Fatigue 65 NA NA NA Nausea Diarrhea Neuro-Sensory Nail change NA NA NA Constipation * NA = not applicable NA Not applicable Slide 16

17 Non-hematological Toxicity 3 wkly (%) wkly Mitoxantrone Toxicity All grades 3/4 All grades 3/4 All grades 3/4 Stomatitis Peripheral edema Vomiting Anorexia Dyspnea Tearing Epistaxis Slide 17

18 Quality of Life Response > 16 points FACT-P score compared to baseline 3-wkly wkly Mitoxantrone Evaluable patients Response (%) ( 95% C.I ) 22 (17-27) 23 (18-28) 13 (9-18) P-value* *Compared to mitoxantrone FACT-P Functional Assessment of Cancer Therapy-Prostate 95% CI 95% confidence interval Slide 18

19 TAX weeks schedule improves median survival by 2.5 months (HR 0.76, 95% C.I , p=0.0094) Safe Improves Pain (34% vs. 21%, p=0.01) Reduces PSA (p < ) Improves Quality of Life Measurable Responses HR Hazard ratio Slide 19

20 Randomized phase III trial of + Estramustine vs Mitoxantrone + Prednisone In HRPC Daniel Petrylak, M.D. David Crawford, M.D. and SWOG investigators Slide 20

21 SWOG Study Design R A N D O M I Z E 60 (70) mg/m 2 Q 3 weeks + Estramustine 280 mg PO days 1-5 Mitoxantrone 12 (14) mg/m 2 Q 3 weeks + Prednisone 5 mg PO bid Slide 21

22 SWOG Overall Survival Med. Surv. Med. TTP HR (surv.) P-value + Estramustine (n = 334) 18 (6) Mitoxantrone + Prednisone (n = 332) 15 (3) - - Med Median Surv Survival TTP Time to progression HR Hazard ratio Slide 22

23 Grade 3-4 Non-Hematological Toxicity + Estramustine Mitoxantrone + prednisone N (%) N (%) All grade 3-4 toxicity 175 (54) 109 (34) Gastrointestinal 63 (19) 21 (6) Cardiovascular 44 (13) 20 (6) Toxic deaths 7 (2) 4 (1) Slide 23

24 SWOG Estramustine Improves survival by 3 months (HR 0.77, 95% CI , p = 0.008) Increases gastrointestinal + cardiovascular toxicity Slide 24

25 Treatment of hormone refractory prostate cancer Effective chemotherapy at last: 3-weekly plus prednisone New directions for clinical studies: combining with other new drugs in HRPC investigating in earlier stage prostate cancer Slide 25

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