The role of surgery during management of advanced GISTs with molecular targeted therapy

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1 M. Sklodowska-Curie Memorial Cancer Center-Institute of Oncology Warsaw, POLAND The role of surgery during management of advanced GISTs with molecular targeted therapy Piotr Rutkowski 28th June 2009, Lisbon

2 Background Fields for surgery during TKI therapy of advanced GISTs: Removal of residual lesions, which have remained despite TKI therapy after previous response Resection of progressive disease to delay resistance to TKI Treatment of emergency complications during TKI therapy (gastrointestinal bleeding, bowel obstruction, perforation)

3 Surgery for residual disease - rationale * Dramatic efficacy of imatinib is time-limited * Complete responses during therapy of TKI are rare * In other advanced sarcomas metastasectomy is the only potentially curative treatment * Common persistence of viable GIST cells after imatinib therapy probability of developing resistant clones of GIST cells is proportional to the tumor mass

4 TKIs do not cure all patient progress over time Verweij, Lancet 2006 Demetri, Lancet 2006 and no cure without CR

5 AIMs for surgery of residual disease - prolongation of durable responses (cure?) - prolongation of time to progression - prevention of secondary mutations

6 Heterogeneity of Imatinib-Resistant Mutations in GISTs KIT D560V / T670I KIT D560V KIT D560V / D820Y KIT D560V / V654A KIT D560V / D823Y KIT D560V / V654A None of the second-line TK inhibitor is effective against all imatinib-resistant mutations By courtesy of M. Debiec-Rychter

7 Inoperable/metastatic GIST, CD117/+/ imatinib 400mg po/d progression SURGERY? Imatinib 800mg po/d Sunitinib

8

9

10 Viable GIST cells were not detected histologically in resection specimens in 12% patients only Immunohistochemistry positive staining for CD 117 of gastric GIST before imatinib treatment (diffuse staining) and of the specimen after partial gastrectomy after IM therapy (single cells) Rutkowski et al. CTOS 2006

11 Responding patients after surgery of residual disease have durable (prolonged?) complete remissions

12

13 Do not stop imatinib after resection of residual disease PD - 03/2004 (abdominal cavity, rib), without laboratory abnormalities, reintroduction of imatinib 400 mg; again PR

14 Progression-free survival in group of patients after surgical resection during imatinib therapy (from date of operation): IA resection of residual disease after CR/PR and continuing IM (41 patients); IB resection of residual disease after CR/PR and IM discontinuation (5 patients); II patients operated during progression on IM (9 patients). 1,0 0,9 p<0,0001 0,8 0,7 Probability of PFS 0,6 0,5 0,4 0,3 0,2 0,1 IA IB II 0, Time [days] Rutkowski, Ruka; unpublished data

15 SUNITINIB therapy - p.a502_y503dup exon 9

16 Several published studies Conclusions: Maintenance of imatinib therapy after surgery is crucial; Final impact on survival and time of implementation of surgery is controversial; Bias of this study? super-selection of the cases?

17 Best timing for operation? The plot of the response to imatinib therapy in time (years from the date of the first IM administration) in group of 72 patients responding to IM therapy After maximal response; Before secondary resistance; Usually 6 18 months from imatinib start (estimation of GEE model with gamma distribution and link function ln with empirical confidence interval)

18 surgery during TKI on individual basis.. as part of clinical trials..

19

20

21 Advanced GIST Imatinib Metastatic GIST in response on IM Follow for PFS & OS Imatinib + surgery at best response (within 1 yr) PK analysis, correlation of pathological response with outcomes; genotyping

22 QoL study

23 Surgery of focal progression - median time to secondary progression 6-12 months

24 Median time to secondary progression 6.3 months

25 Conclusions: 1. Surgical removal of residual disease during imatinib treatment may allow for complete remission (approx. 20%) in selected GIST patients after response to therapy, probably prolonging durable remission. Surgery does not substitute the need of IM continuation 2. We are convinced that surgical downstaging of GIST patients during imatinib therapy is beneficial, however it is not formally demonstrated. (EORTC trial!) 3. The time of the implementation of surgical treatment warrants further studies. 4. In localized progression surgery can be considered one of the available tools to face secondary resistance (a further median of 6-12 months interval can be obtained, which is in the range of all other second line treatments)

26 Emergency procedures disease/treatment related complications Group IM: 3 pts (1.3%) Group SU: 4 pts (9.5%) χ 2 = bleeding from ruptured 1 bleeding from ruptured, liver tumor (1 mo IM) necrotic tumor (3.5 mo SU) 2 bowel perforations on tumor 3 bowel perforations on tumor with intraperitoneal abscess (2 mo IM) (2 days, 20 days and 5 mo) IM restarted 5-8 days after operation - 2 pts died subsequently SU restarted days after operation TKI therapy complications 2 TKI therapy complications - 3 Disease complication 1 Disease complications - 1 NO COMPLICATIONS in WOUND HEALING; 1 urinary tract infection Rutkowski et al. SSO 2008

27 Case 1. Bleeding from ruptured, intraperitoneal tumor (2.5 mo SU); patient operated and continued SU, event interpreted as dramatic response to therapy; pt still alive; p.a502_y503dup exon 9 KIT

28 Case 2. Perforation of the bowel with enterocutaneous fistula (20 days SU); patient operated and continued IM therapy, event interpretation ambiguous, but finally classified as PD; Primary mutation: 1654_1671del18 (p.m552_w557del) exon 11 KIT; secondary mutation: D820Y exon 17 KIT

29 Case 3. Bleeding from ruptured, liver metastatic tumor (1 mo IM) patient operated and continued IM therapy, event interpreted as treatment-related; pt still alive after 5 yrs; wild-type genotype

30 Case 4. Perforation of the bowel with abscess and fistula between intestines (2 mo IM); patient operated and therapy was changed to SU, event due to disease progression; mutation D842V exon 18 PDGFRA

31 Discussion Lack of studies oriented on emergency surgery during TKI therapy in GIST in contrary to studies of emergency operations in primary GISTs Case report: Reichardt et al. J Clin Pathol 2004 Raut et al. JCO patients with disease progression operated for emergency indications Phase II/III trials on IM in GIST: tumor bleeding or perforation, grade 3/4 2.7% Phase II/III SU trials in GIST: bleeding (from tumor; grade 3/4 3-5%)

32 Discussion The interpretation of the event relation to excessive disease response or disease resistance may be difficult. Is surgery of complications one of the new roles of surgical oncology in the era of molecular therapy of solid tumors? Is there a role for prophylactic surgical interventions to prevent life-threatening surgical emergencies during targeted therapy? Extent of surgical procedures in urgent situations during targeted therapy in solid tumours

33 Conclusions: 1. The emergency operations related to disease or therapy during imatinib treatment of advanced GISTs is a rare event. 2. The frequency of emergency operations during sunitinib therapy is considered to be higher than during first line therapy with imatinib, what may be related to more advanced and more resistant disease in these cases or direct mechanism of sunitinib action combining cytotoxic and antiangiogenic activities leading to dramatic tumor response. 3. Molecular targeted therapy in GISTs should always be conducted in cooperation with experienced surgeon.

34 ACKNOWLEDGEMENTS Cancer Center Institute; Warsaw: W. Ruka, Z. Nowecki, W. Dziewirski, J. Siedlecki, U. Grzesiakowska, W. Michej, E. Bylina, A, Głuszcz All doctors participating in Polish Clinical GIST Registry and our patients (especially Polish GIST Advocacy Group) EORTC STBSG members: A. Gronchi, P. Casali, P. Reichardt, F. van Coevorden, P. Hohenberger, J.I. Blay, P. Schofski, M. Debiec-Rychter..

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