RT +/- Surgery. Concurrent ChemoRT +/- Surgery
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1 Molecular targeted approaches to head and neck cancer Lillian L. Siu Department of Medical Oncology & Hematology Princess Margaret Hospital, University of Toronto
2 Locally Advanced HNSCC
3 Locally Advanced HNSCC RT +/- Surgery Concurrent ChemoRT +/- Surgery?? 2000: MACH-NC meta-analysis analysis 2006: MARCH meta-analysis analysis 2000+: Molecular targeting g Renewed interest in induction chemotherapy Intensity modulated radiation therapy Image-guided guided radiation therapy
4 Concurrent Chemotherapy RT Concurrent LRR Distant mets Survival Compared to RT alone Standard of Care
5 MACH-NC Meta-Analysis of Chemotherapy in Head & Neck Cancer Overall survival (63 trials, pts: ) Chemotherapy timing Risk reduction p-value Absolute benefit at 5 years * Adjuvant 2 % NS 1 % Neoadjuvant 5 % NS 2 % Concomitant 19 % < % Total 10 % < % * 5-year survival rate in control group : 32 % Pignon et al. Lancet 2000;355:949-55
6 MACH-NC Meta-Analysis of Chemotherapy in Head & Neck Cancer Update: Overall survival (87 trials, pts: ) Chemotherapy timing or type Hazard ratio Absolute benefit at 5 yr Concomitant CT+ RT % (Stewart s) ( ) 0.86) 6.5% (Peto s) conventional RT 0.83 altered fractionation RT 0.73 platin monotherapy platin + 5-FU 0.77 Pignon et al. IJROBP 2007;69:S112-4
7 Modified Fractionated Radiotherapy in HNSCC XRT hyperfractionation (same treatment duration, smaller dose per fraction) - to injury on normal tissues XRT acceleration (shorter treatment duration, same fraction size) - to clonogenic tumor cell proliferation
8 MARCH (15 trials, 6515 pts) Altered Fractionation vs Standard Fractionation Regimens Absolute benefit at 5 years Risk reduction p Overall survival Hyperfractionation 8.2 % 22 % AFX ( Total Dose) 2 % 3 % ( Total Dose) 1.7 % 6 % All group 3.4 % 8 % Bourhis et al. Lancet 2007;368:843-54
9 Trial Concurrent Chemotherapy + RT: Toxicity Concurrent Arm Acute Tox Gr 3-4 Late Tox Adelstein Standard d RT + Cis x 3 42% leucopenia Not reported (2003) Jeremic (2004) Standard RT + daily Cis Hyperfr. RT + daily Cis 45% mucositis 52% feeding tube 16% stomatitis 49% stomatitis xerostomia and skin toxicity with hyperfr. RT Denis + Standard RT + 5FU + 71% mucositis Similar Calais Carbo 36% feeding tube betwween (2004) arms Budach Hyperfr. Acc. RT + 5FU 9% leucopenia Similar (2005) + MMC 2% platelets l t between 66% mucositis arms Prophylactic feeding tube in most
10 RTOG 0129 Ph III: SFX + Cisplatin vs AFX-CB + Cisplatin Stage III or IV SCCHN N = 743 R A N D O M I Z E Standard fractionation (SFX) + Cis (D1, 22, 43) Accelerated fractionation by concomitant boost (AFX-CB) + Cis (D1+22) 1º endpoint = OS
11 RTOG 0129: Feeding Tube SFX + CDDP AFX-C + CDDP Before therapy 89/361 (25%) 79/361 (22%) End of therapy 247/361 (68%) 239/357 (67%) At 1 year 98/328* (30%) 88/325** (27%) *39 (40%) and **31 (35%) had feeding tube at baseline
12 Radiation +/- vs Cetuximab in Locally Advanced HNSCC N = 424 pts Median F/U = 38 m Stage III (32%) Stage IV (68%) Oropharynx Hypopharynx Larynx KFS: vs Node: + (20%) vs (80%) T stage: T1-3 (72%) vs T4 (28%) R A N D O M I Z E RT RT + RT: Conc. Boost Daily BID Cetuximab Bonner et al, NEJM 2006;354:567-78
13 Radiation +/- Cetuximab: Overall Survival cetuximab cetuximab Cetuximab + RT (n = 211) RT Alone (n = 213) Hazard Ratio (95% CI) Median overall survival, mo ( ) 0.97) Stratified Log- Rank P Value y survival rate, % Bonner et al, NEJM 2006;354:567-78
14 Incidence of Selected Toxicities Cetuximab + RT % (n = 208) All Grades Grade 3-5 RT % (n = 212) All Grades Grade 3-5 Mucositis Dysphagia Xerostomia Radiation dermatitis Weight Loss Cetuximab did not exacerbate the common toxic effects associated with radiotherapy of the head and neck, including mucositis, xerostomia, dysphagia, pain, weight loss, and performance-status deterioration. Bonner et al, NEJM 2006;354:567-78
15 Late Radiation Toxicity by Site Cetuximab + RT % (n = 208) Any Grade RT % (n = 212) Any Grade Salivary glands Larynx Subcutaneous tissue Mucous membranes Esophagus Skin Higher overall incidence of late radiation toxicities (any grade) in Cetuximab + RT group Similar incidence of Grade 3 or 4 late RT toxicities between both groups ERBITUX TM Product Monograph, September
16 Chemoadditive RTOG 0522 Ph III: AFX-CB + Cis vs AFX-CB + Cis + Cetuximab Accelerated fractionation by concomitant boost (AFX-CB) + Cis SCCHN (D1+22) Stage III or IV N 900 R A N D O M I Z E Accelerated fractionation by concomitant boost (AFX-CB) + Cis (D1+22) + Cetuximab 1º endpoint = DFS
17 N = 320 pts Anatomic: Hypopharynx vs oral cavity vs oropharynx vs larynx Node: N0-1 vs N2-3 T stage: T1-3 vs T4 RT: IMRT vs 3DCRT 1º endpoint = DFS Chemosparing NCIC CTG HN.6: SFX + Cis vs AFX + Panitumumab R A N D O M I Z E Arm 1 Standard d RT: 70 Gy/35 over 7 weeks Cisplatin 100 mg/m 2 days 1, 22, 43 Arm 2 Accelerated RT: 70 Gy/35 over 6 weeks Panitumumab 9 mg/kg Q3w x 3 (starts t 1 week before RT)
18 Metastatic/Recurrent HNSCC
19 Vermorken et al, NEJM 2008; 359:
20
21 Activity of EGFR TK and other kinase inhibitors in recurrent/metastatic HNSCC Drug Setting CR PR SD TTP or OS (%) (%) (%) PFS (m) (m) Gefitinib 1 st or 2 nd line mg 2 nd or 3 rd line Gefitinib 2 nd or 3 rd line mg Erlotinib 1 st or 2 nd line Lapatinib Without prior EGFRi With prior EGFRi Sorafenib 1 st or 2 nd or 3 rd line Sunitinib 1 st or 2 nd line: ECOG 0/1 0 1 st or 2 nd line: ECOG
22 cetuximab, panitumumab trastuzumab bevacizumab aflibercept EGFR HER-2 VEGFR PDGFR Cell membrane PF dasatinib AZD0530 bosutinib Perifosine MK2206 GSK VQD002 XL418 FAK SRC PI3K AKT erlotinib gefinitib lonafarnib RAS Farnesyl transferase fras RAF lapatinib Cyclindependent kinases Nucleus flavopiridol seliciclib Histone UCN-01 deacetylases BMS sorafenib vorinostat PXD101 LBH589 FR MS-275 temsirolimus everolimus AP23573 mtor MEK ERK AZD6244 PHA MK-0457 MP 529 MLN 8054 AZD 1152 Aurora kinases A, B, C Bl 2356 HMN-214 Pololike kinases midostaurin enzastaurin Protein kinase C 26S proteasome bortezomib PROLIFERATION MIGRATION METASTASES ANGIOGENESIS
23 Preclinical Early clinical trial Confirmation and registration strategy t Drug discovery - Target identification in head and neck cancer - Proof of mechanism - Proof of principle - Development of potential biomarkers - Toxicity - Pharmacokinetics Phase I trials - Toxicity - Pharmaco kinetics - Proof of concept - Optimization of fdose - Optimisation of schedule - Search for biological active dose Phase II trials Initial biopsy Final biopsy Baseline evaluation e.g. (pre-operative, or first-line recurrent or metastatic disease): Post-treatment evaluation: - Tumor tissues, serum biomarker, functional - Tumor imaging tissues, serum biomarker, Clinical i l outcome (e.g. functional imaging Progression-free survival, objective response) Correlation between biomarkers and clinical outcome Id tifi ti f Identification of molecular biomarkers of resistance Phase III trials - - Combination strategy - Benchmarking for competitors
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