Tratamiento del cáncer de cabeza y cuello en el año 2013

Transcripción

1 Tratamiento del cáncer de cabeza y cuello en el año 2013 Dra. Elvira del Barco Morillo Hospital Clínico Universitario, Salamanca

2 Cáncer de cabeza y cuello en el año 2013 Intensificación quimiorradioterapia Quimiorradioterapia versus Biorradioterapia Tratamiento Inducción Enfermedad metástasica/recurrente

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4 Intensificación quimiorradioterapia Ongoing RTOG phase III trial (0522) Stages III and IV* SCC of: oropharynx hypopharynx larynx (n=720) R Accelerated RT Cisplatin Accelerated RT Cisplatin CETUXIMAB

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6 QUIMIORRADIOTERAPIA VS BIORRADIOTERAPIA TPF 3 cycles, 1 cycle q3 weeks PR <PR Total laryngectomy + postoperative RT R RT Cisplatin RT CETUXIMAB Response evaluation by endoscopy and CT scan

7 CONCERT 2 (Randomised Phase 2) Radiation + Panitumumab or Cisplatin in 1 st -line Treatment of Stage III or IVa-b (M0) SCCHN Unresected, locally advanced SCCHN (n=150) R 2:3 Stratification by: Site of primary tumour RT delivery modality Nodal status (N0 vs. N+) Tumour stage (T1-3 vs. T4) RT + cisplatin 100 mg/m 2 (on days 1, 22 y 43 of RT) RT + panitumumab 9 mg/kg (on days 1, 22 and 43 of RT) RT: Accelerated fractionation radiation therapy with 70 to 72 Gy delivered over 6 to 6.5 weeks; fracionamiento standar Intensity-modulated (IMRT) or threedimensional conformal modality (3D-CRT) Giralt J, et al. Eur J Cancer Suppl 2009; 7 (2):476, abstract P ClinicalTrials.gov identifier: NCT ; protocol ID: E n d o f t r e a t m e n t L o n g t e r m Primary Endpoint: LRC rate at 2 years f o l l o w u p

8 QUMIOTERAPIA DE INDUCCIÓN ESTUDIO TTCC 2503 ESTUDIO DECIDE ESTUDIO PARADIGM ESTUDIO PACAGNELLA ET AL ESTUDIO GRUPO SHANGAI.

9 Estudio 2503 Grupo español de TTCC. Localmente avanzado irresecable (N = 310) Orofaringe 40% Laringe 20% Hipofaringe 20% C. Oral 20% TPF Docetaxel 75 mg/m 2 Día 1 Cisplatino 75 mg/m 2 Día 1 5-FU 750 mg/m 2 PC, Días 1-5 Cada 3 semanas por 4 ciclos Sin Inducción PF Cisplatino 100 mg/m 2 Día 1 5-FU 1000 mg/m 2 PC, Días 1-5 Cada 3 semanas por 4 ciclos Cirugía de rescate si enfermedad residual antes o después de RT QTRT RT Gy Cisplatino 100 mg/m 2 Días 1, 22, 43

10 Estudio 2503 Grupo español de TTCC Objetivo primario: TTF ( evaluables) ICT + CRT; median 12.5 months CRT; median 5.0 months HR = 0.57; 95% CI, ; p< ICT + CRT CRT E N Number of patients at risk (months)

11 DeCIDE: A phase III randomized trial of docetaxel (D), cisplatin (P), 5- fluorouracil (F) (TPF) induction chemotherapy (IC) in patients with N2/N3 locally advanced squamous cell carcinoma of the head and neck (SCCHN) Ezra E. W. Cohen, Theodore Karrison, Masha Kocherginsky, Chao H Huang, Mark Agulnik, Bharat Bhushan Mittal, Furhan Yunus, Sandeep Samant, Bruce Brockstein, Luis E. Raez, Ranee Mehra, Priya Kumar, Frank G. Ondrey, Tanguy Y. Seiwert, Victoria Meucci Villaflor, Daniel J. Haraf, Everett E. Vokes N2/N3 TPF x 2 ciclos D (75 mg/m 2 ), P (75 mg/m 2 ), F (750 mg/m 2 day 1-5) QTRT RT hiperfracionada + DFHX 400 pt 280 pt QTRT RT hiperfracionada + DFHX 5 days of Docetaxel (25 mg/m 2 ), FU (600 mg/m 2 ), hydroxyurea (500 mg BID), and RT (150 cgy BID) followed by a 9 day break

12 The PARADIGM trial: A phase III study comparing sequential therapy (ST) to concurrent chemoradiotherapy (CRT) in locally advanced head and neck cancer (LANHC). Robert I. Haddad, Guilherme Rabinowits, Roy B. Tishler, Douglas Adkins, Fadlo Raja Khuri, Joseph Clark, Jochen H. Lorch, Sewanti Atul Limaye, Lori J. Wirth, Anne O'Neill, Sarah Riley, Marshall R. Posner Estadio III/IV A TPF x 3 ciclos NR DOCETAXEL SEMANAL x4 RT ACELERADA BOOST (1-5) 6 SEMANAS A1 330 pt. ESPERADOS 145 RECLUTADOS 08/04-12/08 D (75 mg/m 2 ), P (100 mg/m 2 ), F (1000mg/m 2 day 1-4) CR CARBOPLATINO SEMANAL RT (1-5) x7 SEMANAS. A2 CISPATINO SEMANA (1,4) RT ACELERADA BOOST (1-5) 6 SEMANAS. B

13 Cetuximab/RT versus concomitant CT/RT with or without induction TPF in locally advanced H&N squamous cell carcinoma. Preliminary toxicity results of a randomized, 2x2 factorial, phase II-III study (NCT ) QT-RT (PF x2) Localmente avanzado irresecable (N =420) C. Oral OroF. HipoF. RT- cetuximab TPF x 3 TPF x3 QT-RT (PF x2) RT- cetuximab 1, SG a 3 años entre Inducción vs No inducción 2, Incidencia de toxicidad grado 3-4 entre QTRT vs RT-cetX.

14 Estadio III/IV TPF x 2 ciclos CIRUGIA RT ORAL 256 PACIENTES RESECABLES CIRUGIA- RT

15 Enfermedad metástasica/recurrente. PACLITAXEL + CETUXIMAB. ERBITAX. TPEx. Estudio GORTEC CDDP+5FU VS CDDP + 5FU+ PANITUMUMAB. SPECTRUM. GEFITINIB + DOCETAXEL VS DOCETAXEL

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18 SPECTRUM Chemotherapy ± Panitumumab in 1 st -line Treatment of Recurrent or Metastatic SCCHN Recurrent or metastatic SCCHN (n=657) R 1:1 Stratification by: Site of primary tumour Disease status Performance status (ECOG 0 vs.1) Cisplatin 100 mg/m FU 1000 mg/m 2 /d x 4d (Q3W for max. 6 cycles) Cisplatin 100 mg/m FU 1000 mg/m 2 /d x 4d + panitumumab 9 mg/kg (Q3W for 6 cycles) Stöhlmacher J, et al. Eur J Cancer Suppl 2009; 7 (2):474, abstract P ClinicalTrials.gov identifier: NCT ; protocol ID: E n d o f t r e a t m e n t Maintance panitumumab monotherapy Primary Endpoint: Overall survival (OS) Secondary endpoints: Progression-free survival (PFS) Overall response rate (ORR) Duration of response (DoR) Time to progression (TTP) Safety L o n g t e r m f o l l o w u p

19 Estadio III/IV Docetaxel semanal 270 pac irresecables o metastásico Docetaxel semanal + Gefitinb