Place of chemotherapy in the management of brain metastases. Pr Antoine Carpentier, hôpital Avicenne

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1 Place of chemotherapy in the management of brain metastases Pr Antoine Carpentier, hôpital Avicenne

2 Management of brain metastases -Symptomatic treatment - Oncological treatment

3 Symptomatic treatment Anti-oedematous agents Anti-convulsivants Anti-coagulants

4 Anti-oedematous agents Hyperosmolar agents (Mannitol): NO except emergency cases transient action more efficient when blood brain barrier is intact rebond mechanism? Corticosteroids through inhibition of VEGF sécrétion Restaure blood brain barrier Ki Vd for Gado N=11, Andersen et al, 1998 Vecht 1994; Sturdza 2008

5 Anti-oedematous agents Corticosteroids Per os or IV 10 to 100mg/d (equivalent predinsolone), in the morning at the minimale dose required ++ Ususally 30mg/d sufficient during radiotherapy Vecht 1994; Sturdza 2008

6 Anti convulsivants Seizures: # 20 % of the patients 1 ) prophylactic if no seizure history? NO - Except during and just after neurosurgery - Except in melanoma? (50% of pts will have seizures) 2 ) curative - efficient in 2/3 of the cases - avoid Enzyme-inducer AE (Dihydan, Tégretol, Gardenal) rather use : Keppra, Lamictal, Dépakine Byrne et al, 1983; Lwu et al, 2010; Mashio et al 2009

7 Anti-coagulants thrombophlebitic events - Deep veinous thrombosis : 5% of patients - Risk increased if inferior limb paresia Management - LMWH (low molecular weight heparine) or heparine - At curative doses if needed (even allowed if small brain hemorrage, under close CT scan monitoring) Wun et al, 2009

8 Management of brain metastases -oncological treatment

9 Oncological Managment of brain metastases: 2 cases Metastase eligible for surgical resection or radiosurgery #10% Metastase non eligible for surgical resection or radiosurgery #90%

10 Chirurgie et Radiothérapie Patchell, NEJM 1990

11 Surgical resection or Radiosurgery? Surgery if size> 30mm Single met If histology required Radiosurgery if Size < 30mm Up to 3 (or 4) metastases Nothing if Poor prognosis/ palliative care Diffuse metastastic disease

12 Is radiotherapy needed after surgery or radiosurgery? - No clear cut answer - 3 randomized trials adressed this question : Chirurgie +/- RT in toto (Patchell, 1998) RCS +/- RT in toto (Aoyama, 2006) RCS ou Chirurgie +/- RT in toto (EORTC, Kocher JCO 2011)

13 Kocher JCO 2011

14 Kocher JCO 2011

15 Kocher JCO 2011

16 Is radiotherapy needed after surgery or radiosurgery? - No impact on survival - Local recurrence is more frequent without RT..but RT can still be made at time of relapse Recommandations : no RT if complete surgical or radiosurgical resection?

17 Managment of brain metastases: Metastase eligible for surgical resection or radiosurgery 2 cases Metastase non eligible for surgical resection or radiosurgery

18 Whole brain radiotherapy (WBRT) standard protocol = 30 Gy in 10 fractions /12 days radiological response rate: # 30% in NSCLC # 50% in breast cancer Metha, 2003 ; Stea, 2006 ; Suh, 2006

19 Place de la chimiotéhrapie: «La BHE est le problème» BHE est elle vraiment fonctionnelle?

20 Chemotherapy and brain metastases Erlotinib

21 BHE et Chimiothérapie Relation entre perméabilité BHE et coefficient de partition octanol/eau Absorption cérébrale suffisante Absorption cérébrale limitée Log de l absorption cérébrale (ml/s/g) Log du coefficient de distribution octanol/eau Pour les molécules lipophiles, passage de la BHE limité par rapport à la diffusion théorique : rôle des transporteurs d efflux Neuwelt et al. The Lancet

22 Place of chemotherapy in the management of brain metastases

23 Chemotherapy and brain metastases Non small cell Lung cancer No previous chemotherapy No previous radiotherapy Auteurs date chimiothérapie n RR cérébrale Thomas 1990 cisplatine 30 27% RR systémique Minotti 1998 cisplatine + téniposide 23 35% 26% Crino 1999 cisplatine + gemcitabine 26 41% 37% Franciosio 1999 cisplatine + étoposide 43 30% Fugita 2000 cisplatine + ifosfamide + irinotecan 30 50% 62% Robinet 2001 cisplatine + vinorelbine 86 27% 35% Cortes 2003 cisplatine + Taxotère + vinorelbine/gemcitabine 25 38% 50% Cortot 2006 cisplatine + TMZ 50 12% 12% Barlesi 2011 Cisplatine+Alimta 43 42% Bailon 2012 Carboplatine+Alimta 30 40% platine + others 32% 33% Brain metastases are chemosensitive

24 Chemotherapy and brain metastases Non small cell Lung cancer No previous chemotherapy No previous radiotherapy Auteurs date chimiothérapie n RR cérébrale Thomas 1990 cisplatine 30 27% RR systémique Minotti 1998 cisplatine + téniposide 23 35% 26% Crino 1999 cisplatine + gemcitabine 26 41% 37% Franciosio 1999 cisplatine + étoposide 43 30% Fugita 2000 cisplatine + ifosfamide + irinotecan 30 50% 62% Robinet 2001 cisplatine + vinorelbine 86 27% 35% Cortes 2003 cisplatine + Taxotère + vinorelbine/gemcitabine 25 38% 50% Cortot 2006 cisplatine + TMZ 50 12% 12% Barlesi 2011 Cisplatine+Alimta 43 42% 35% Cisplatine + others 32% 33% Same chemosensitivity for brain/lung lesions

25 Robinet et al, 2001 NSCLC No previous treatment Brain met Chemotherapy alone 27% brain RR Chemotherapy + WBRT 33% brain RR CT: n=86 CT+RT: n=85 Global PFS survival

26 New drugs - Anti-angiogenic -Targeted therapies -Breast HER2+: lapatinib + Xeloda - NSCLC: (etude EGFR, KRAS, BRAF, HER2, PIK3CA, ALK) - si malk: crizotinib -Si megfr: Erlotinib or Gefitinib - melanoma with mbraf: vemurafenib, dabrafenib - immunotherapy with Ipilimumab, anti-pd1

27 Brain metastases and anti-angiogenic ttt Sorafenib: renal carcinoma, n=47. RR= 4%. Stadler, cancer, 2010 Sunitinib, renal carcinoma, n=213. RR=12% Gore, cancer, 2011 Bevacizumab: ASCO 2013 abst 513 breast cancer, n=38 Bev + Carbo RR45% Bevacizumab: essai BRAIN (ASCO 2013 abst 8059 ) NSCLC, n=67 Bev + CisP Alimta RR: 61% NSCLC n=24 B+Erlotinib (2 ligne) RR : 21%

28 Riely et al, 2013

29 Tyrosine kinase inhibitors (TKI) NSCLC + Brain metastases Treatment with TKI (upfront in #50%) Ref TKI n Brain RR Extra neural RR Kim 2009 Gefitinib or Erlotinib 23 74% 70% Kim 2010 (asco) Gefitinib 23 70% Porta 2011 Erlotinib 17 82% 88%

30 Melanoma Fotemustine ou TMZ: #5-25% de réponses radiologiques BRAF-positive melanoma. vemurafenib RR= 50% (ASCO 2013 abst 9081) Dabrafenib RR#35% (etude BREAK 3, Long 2012) Anti-CTLA4 (+/- SRS) OS 28 vs 7m (ASCO2013 abst 3032 ) Anti-PD1..

31 But is RT really useless? Potential synergic effects - Increase drug penetration through the BBB - Pro-inflammatory (for immunotherapy?)

32 Blood brain barrier permeability after RT Temps après irradiation (h) After a single fraction 20 Gy Perméabilité ( 10-7 cm/s) Avant hours Jours après début d irradiation After 20 fractions of 2 Gy, 5/week X 4 weeks Perméabilité ( 10-7 cm/s) days (1) Yuan et al. Brain Research, 2003, 969 (1-2), (2) Yuan et al. International Journal of Radiation Oncology, 2006, 66 (3),

33 Place of RT still difficult to define - WBRT or SRS? -RT, then immediate CT? or concomittant RT and CT? Need for randomized trial ++ Chemotherapy (and delayed WBRT) Chemotherapy + RT

34 Place of RT still difficult to define Toxicity of concomittant RT and CT? (high dose) WBRT +SRS + Erlo toxic in a phase 3 (Sperdutto IJROBP, 2013)

35 Chemotherapy in a prophylactic setting?

36 Brain metastasis Blood-brain-barrier 1 ary tumor Tumor-Blood seeding Brain invasion & micrometastasis Brain metastasis

37 stage IV melanoma, without evidence of CNS metastases - TMZ + Cisplatine + IL2 n= 74 - Dacarbazine + Cisplatine + IL2 n= 75 Cumulative incidence of central nervous metastases Survival DTIC TMZ

38 Brain metastasis Blood-brain-barrier 1 ary tumor seeding invasion angiogenesis

39 Bevacizumab and NSCLC first-line treatment of non- squamous NSCLC without CNS metastases Phase III trial Ttt n brain met incidence E4599 cisplat +paclitaxel % Id + bevacizumab % AVAIL cisplat +gemzar % Id + bevacizumab % Archer et al, 2008, ASCO # 3349, ESMO 2013

40 Current standart of care Metastase eligible for surgical resection or radiosurgery Metastase non eligible for surgical resection or radiosurgery surgical resection or radiosurgery Whole brain RT (WBRT) If partial resection immediate WBRT Chemotherapy? Alone if asymptomatic patient? in association with WBRT? If complete resection RT at relapse? Clinical trials on-going

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