Neodjuvant chemotherapy

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1 Neodjuvant chemotherapy Dr Robert Huddart Senior Lecturer and Honorary Consultant in Clinical Oncology Royal Marsden Hospital and Institute of Cancer Research

2 Why consider neo-adjuvant chemotherapy? Loco-regional and distant relapse are frequent after radical treatment for local disease resulting in 5 yr survival rates of <50% Combination chemotherapy has a significant response rate (50%+) and CR rate (10-20%) in metastatic disease Prolongation of survival occurs but cures do not Chemotherapy could be more effective (and curative) against micro metastatic disease

3 Update of BA06 (neo-adjuvant CMV trial): October 2000 No CMV CMV Hazard ratio No tumour in specimen Overall survivall (3yr) Metastasis free survival Locoregional control Disease free survival 12% 33% 50% 56.5% 0.83 (ci ) 6.5% difference p= % 54% 0.76 p= % 48% 0.84 (ci ) p= % 47% JT Roberts MRC open meeting October 2000

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5 Aim To compare the survival of patients with locally advanced bladder cancer treated with cystectomy alone to that treated with MVAC followed by cystectomy To quantify the downstaging effect

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9 SWOG Neoadjuvant MVAC trial Grossman et al NEJM p859-66

10 SWOG Neoadjuvant MVAC trial: survival Grossman et al NEJM p859-66

11 SWOG Neoadjuvant MVAC trial: survival by response status (pt0 v RD) Grossman et al NEJM p859-66

12 SWOG Neoadjuvant MVAC trial: survival by stage Grossman et al NEJM p859-66

13 Neoadjuvant chemotherapy meta analysis: ABC MAC 2003 Lancet 361 p

14 Advanced Bladder Cancer Metanalysis Collaborative 2003 Lancet 361 p

15 Neoadjuvant chemotherapy meta analysis: Effect v type of treatment ABC MAC 2003 Lancet 361 p

16 : Results for all endpoints by local treatment Endpoint HR (95% CI) Interaction p value Overall survival Cystectomy 0 89 ( ) Radiotherapy 0 90 ( ) Radiotherapy+cystectomy 0 77 ( ) Disease-free survival Cystectomy 0 79 ( ) Radiotherapy 0 92 ( ) Radiotherapy+cystectomy 0 71 ( ) Locoregional disease-free survival Cystectomy 0 86 ( ) Radiotherapy 0 96 ( ) Radiotherapy+cystectomy 0 73 ( ) Metastases-free survival Cystectomy 0 82 ( ) Radiotherapy 0 87 ( ) Radiotherapy+cystectomy 0 73 ( ) 0 649

17 Summary Neoadjuvant chemotherapy produces an approximate 5% absolute benefit in survival No specific groups benefit more than others Similar benefit after chemotherapy or radiotherapy

18 For discussion Should neoadjuvent chemotherapy be standard treatment in the UK? Issues Time to radical treatment Patient selection Treatment toxicity Cost Type of chemotherapy

19 MVAC v Gemcitabine / Cisplatin (1) Multicentre phase III trial GC 420 pts. T4b,N2, M1 Gemcitabine 100 mg/m 2 D1, 8, 15 Cisplatin 70 mg/ m 2 D2 q28 Mtx 30 mg/m 2 D1, 15, 22 MVAC Vinblastine 3 mg/m 2 D1, 15, 22 Adriamycin 30 mg/m 2 D1 Cisplatin 70 mg/m 2 D2 Von der Maase et al 2000 JCO 18 p

20 MVAC v Gemcitabine / Cisplatin (2): Response / Survival MVAC GC n Visceral disease 46% 49% 4 sites 17% 21% Response rate 46% 50% Complete response 12% 12% Median survival (months) * MTTP (months) (* After adjustment for prognostic factors HR 0.95) Von der Maase et al 2000 JCO 18 p

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22 MVAC v Gemcitabine / Cisplatin: Toxicity MVAC Cisplatin / Gemcitabine Neutropenic fever 22% 5% Neutropenic Sepsis 12% 1% Toxic deaths 3% 1% Mucositis 22% 2% Alopecia 55% 11% Admissions days 33 days Antibiotics Anti fungals Von der Maase et al 2000 JCO 18 p

23 MVAC v Escalated MVAC EORTC multicentre study MVAC Methotrexate 30 mg/m 2 D1, 15,22 Vinblastine 3 mg/m 2 D1, 15,22 Adriamycin 30 mg/m 2 D1 263 pts. Cisplatin 70 mg/m 2 M, PSO-2 q28 Esc.MVAC Methotrexate 30 mg/m 2 D1 Vinblastine 3 mg/m 2 D1 Adriamycin 30 mg/m 2 D1 q14 with GCSF Cisplatin 70 mg/m 2 D1 Sternberg et al. ASCO 2000 # 1292

24 MVAC v Escalated MVAC MVAC Esc. MVAC n ORR 58% 72% p=0.008 CR 11% 24% Median Survival (m) year Survival 25% 35% p= yr PFS 11.6% 24.7% Sternberg et al JCO 19 p

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27 Toxicity of Accelerated MVAC v standard MVAC Toxicity (grade 3/4) MVAC Accelerated MVAC P value WBC 62% 20% <0.001 Platelets 17% 22% Mucositis 17% 10% Nausea/ vomiting 29% 36% 0.025

28 Does the use of neoadjuvant chemotherapy offer possibility of testing surgery versus conservative management? T2, T3 TCC bladder PS0,1 Fit for cystectomy Normal renal function MVAC/GC/ CMV x3 Cystectomy Selective bladder preservation

29 Neoadjuvant chemotherapy and BC2001 Neoadjuvant chemotherapy is permitted Patients are eligible for both randomisations Stratification factor Minimum 4 weeks between chemotherapy and commencing radiotherapy Note 8 weeks maximum randomisation to start of treatment

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