Current patient journey in SCCHN
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- Mervin Parrish
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2 Contents Current patient journey in SCCHN 1 st line options for R/M SCCHN 2 nd line treatmens options for R/M SCCHC The evolving continuum of care in R/M SCCHH
3 Current patient journey in SCCHN 1. Mabanta SR, et al. Head Neck 1999;21: ; 2. Goodwin WJ Jr. Laryngoscope 2000;110:1 18; 3. Vermorken JB, Specenier P. Ann Oncol 2010;21(Suppl 7):vii252 vii261; 4. Vermorken JB, et al. N Engl J Med 2008;359: ; 5. Spencer SA, et al. Head Neck 2008;30: ; 6. Balermpas P, et al. Int J Radiat Oncol Biol Phys 2012;83:e377 e383;
4 Goals of R/M SCCHN treatment Symptom control Prevention of new cancer-related symptoms Improvement in QoL Objective tumor response Disease stabilization Overall survival Progression-free survival Vermorken JB and Specenier P. Ann Oncol 2010;21(Suppl 7):vii252 vii261
5 R/M SCCHN is associated with a high morbidity 1 1. Jackson LK, et al. Am J Hosp Palliat Care 2016;33:
6 The current patient s journey in R/M SCCHN 1. Argiris A, et al. Front Oncol 2017;7:72; 2. Ferris RL, et al. N Engl J Med 2016;375: ; 3. Bauml J, et al. J Clin Oncol 2017;35:
7 EXTREME: first line option for fit patients Vermorken JB, et al. N Engl J Med 2008;359:
8 EXTREME: significant relief of symtomps with similar quality of life Mesía R, et al. Ann Oncol 2010;21:
9 EXTREME: survival long term results n=117 mos: 12,4 meses Vermorken JB, et al. ASCO 2014; abstract Siano M, et al. Oral Oncol 2017; 69: 33-7.
10 Cetuximab maintenance is an integral part of the EXTREME regimen Phase III study: EXTREME 1 Cetuximab + CT* 1 Median duration: 15 weeks 5 chemo cycles Cetuximab maintenance 1 Median duration: 11 weeks 1 Real-world data: DIRECT 2,3 Cetuximab + CT* 2 Median duration: 12 weeks 4 chemo cycles Cetuximab maintenance 3 Median duration: 16 weeks 1. Vermorken JB, et al. N Engl J Med 2008;359: ; 2. Guigay J, et al. ESMO 2014 (Abstract 996P); 3. Guigay J, et al. ESMO 2016 (Abstract 967P).
11 Efficacy of bi-weekly cetuximab maintenance: DIRECT study Guigay J, et al. ESMO 2016 (Abstract 967P)
12 1 st line treatment options for R/M SCCHN: Summary The internationally recommended standard of care for 1st line* treatment of R/M SCCHN is cetuximab + CT followed by cetuximab maintenance until progression (the EXTREME regimen) 1 3 Patients treated with EXTREME regimen benefit from high rates of tumor response (36%) and disease control (81%); these outcomes accompany both extended OS and PFS 3 The ORR seen in the EXTREME study is accompanied by extended OS in both the randomized controlled trial (10.1 month mos) and real-world (11 12 months mos) settings 4 6 Cetuximab maintenance treatment is an essential part of the EXTREME regimen to achieve the outcomes seen in clinical studies and real-world data NCCN Clinical Practice Guidelines in Oncology: Head and Neck Cancers V2.2017; 2. Grégoire V et al. Ann Oncol 2010;21 (Suppl 5):v ; 3. Vermorken JB, et al. N Engl J Med 2008;359: ; 4. Guigay J, et al. Ann Oncol 2014;25:iv Hecht M, et al. Annals of Oncol 2016;27(Suppl. 6):Vi343 (Abstract 994P); 6. de Mello RA, et al. PLoS One 2014;9:e86697
13 Options in 1 st line treatment CDDP/5FU/Cetuximab Fit and no CDDP contraindication Platinum free interval > 6 months. CBDCA/5FU/cetuximab Fit and CDDP contraindication or previous CDDP > 200 mg/m 2. Platinum free interval > 6 months. Weekly paclitaxel plus cetuximab* Platinum free interval < 6 months. Unfit and/or ECOG 2. Age > years. Fit and CDDP contraindication or previous CDDP > 200 mg/m 2. Negative to central venous catheter (TPEx*).
14 Retrospective study of cetuximab and paclitaxel in R/M SCCHN 1. Pajares Bernad I, et al. ESMO 2016 (Abstract 991P); 2. Hitt R, et al. Ann Oncol 2012;23:
15 Efficacy of cetuximab in combination with docetaxel and platinum-based CT: The GORTEC study 1. Guigay J, et al. Ann Oncol 2015;26:
16 2 nd line treatment options for R/M SCCHN 1. Argiris A, et al. Front Oncol 2017;7:72; 2. Ferris RL, et al. N Engl J Med 2016;375: ; 3. Bauml J, et al. J Clin Oncol 2017;35:
17 CheckMate 141: 2-year results Ferris RL, et al. Multidisciplinary Head and Neck Cancer Symposium. Scottsdale, USA. February 2018.
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19 Other second line options: monotherapy Drug Methotrexate 1 (40 mg/m 2 /w) Paclitaxel 2 (80 mg/m 2 /w) Docetaxel 3 (35 mg/m 2 /w) Cetuximab 4 (standard dose) Type of study Phase III Phase II rand. Phase III Phase II Number of patients ORR 6% 14% 6% 13% mpfs (months) 1,7 3,5 2,1 2,3 mos (months) 6,4 6, Machiels S, et al. Lancet Oncol 2015; 16: Souliéres D, et al. Lancet Oncol 2017; 18: Argiris A, et al. J Clin Oncol 2013; 31: Vermorken JB, et al. J Clin Oncol 2007; 25:
20 Erbitax: high ORR in second line treatment Retrospective studies Number of patients Málaga 1 Barcelona 2 Lyon ORR 55% 55% 38% mpfs (months) 5,4 4 3,9 mos (months) 9,1 10 7,6 Dose of paclitaxel (mg/m 2 /w) Jiménez B, et al. Oral Oncol 2013; Sosa AR, et al. Eur Arch Otorhinolaryngol 2014; 271: Peron J, et al. Anticancer Drugs 2012; 23:
21 Hyperprogressions rate (n=34) All patiens: 29%. L/R disease: 39%. Metastases only: 9%. Pseudo-progressions: 0%.
22 Factors that influence the choice of second-line treatment Related to the patient: Performance status, comorbidities and age. Symptomatology Patient s opinion. Related to the disease: Recurrence pattern (L/R and/or MTS). Evolution (speed of growth). Predictive biological factors (PD-L1, p16...). Related to previous treatment: Number and type. Time since the last treatment. Response and PFS. Toxicity.
23 The evolving continuum of care in R/M SCCHH Head and neck cancer can look to other cancers for how the continuum of care can be key to patient outcomes The concept of sequence of treatment (continuum of care) Maximizing the number of therapies administered to deliver the maximum benefit to the maximum number of patients
24 Metastatic colorectal cancer: the availability of more treatment options and line of therapy over time has increased the median overall survival 1. Erlichman C, et al. J Clin Oncol 1988;6:469 75; 2. Ducreux M, et al. J Clin Oncol 1999;17: Andre T, et al. Ann Oncol 1998;9:1251 3; 4. Hurwitz H, et al. N Engl J Med 2004;350: Bokemeyer C, et al. Ann Oncol 2011;22: ; 6. Douillard JY, et al. J Clin Oncol 2010:28: Stintzing S, et al. Lancet Oncol 2016 [Epub ahead of print] 8. Argiles G, et al. Eur J Cancer 2015;51: Folprecht G, et al. Ann Oncol 2016;27:1273 9; 10. Kim ST, et al. BMC Cancer 2014;14:883
25 The new continuum of care for fit patients in R/M SCCHN may extend overall survival Continuum of care 1st line EXTREME regimen EXTREME regimen 1 Cetuximab + platinum-based CT* (up to 6 cycles) followed by cetuximab maintenance until PD PD 2nd line Potential new options Taxanes +/- cetuximab PD Methotrexate Cetuximab 2,3 Checkpoint inhibitors may provide a new treatment option 4,5
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