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AIOM PostASCO Review - Bologna, 19 giugno 2010

ASCO NEWS 2010 HEAD & NECK Marco Benasso Oncologia Medica - Savona. AIOM PostASCO Review - Bologna, 19 giugno 2010. ASCO 2010 H&N TOPICS. TT other than Cetuximab ? Which is the best CT/RT combination ? Which is the role of TT into a CT/RT combination ?

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AIOM PostASCO Review - Bologna, 19 giugno 2010

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  1. ASCO NEWS 2010 HEAD & NECK Marco Benasso Oncologia Medica - Savona AIOM PostASCO Review - Bologna, 19 giugno 2010

  2. ASCO 2010 H&N TOPICS TT other than Cetuximab ? Which is the best CT/RT combination ? Which is the role of TT into a CT/RT combination ? Predictive/prognostic factors ready for clinical practice?

  3. 1.TT other than Cetuximab ?(state of the art before ASCO 2010) • Cetuximab is the only TT approved in SSC-HN in combination with CDDP based CT or RT (Extreme trial, Bonner Trial) • Cetuximab is approved in USA (not in Italy) as single agent in second-line CT (based on a large phase II trial). • Several data of activity of some TT in well differentiated thyroid carcinoma and medullary carcinoma

  4. TT in SCC

  5. Seiwert, abs 5501 Cetuximab (60 pts) Phase II R Relapsed after CDDP BIBW 2992 (60 pts)

  6. ZALUTE Trial, abs 5506 BSC (MTX optional) (78% had mtx) (95 pts) Phase III R Relapsed after CDDP (191 pts) * Dose escalation 4 16 mg/kg up to gr.II rash Zalutumumab* p<.07 p<.001

  7. Medullary Tyroid Carcinoma • 3-5% of all thyroid cancers. Hereditary (25%) or sporadic pattern (75%). 1400 cases/yr in USA • Activating RET mutations in almost 100% hereditary and >50% sporadic • Doxorubicina,Dacarbazina, 5-FU, Vincristina, Capecitabina, Talidomide: ORR 10-20% (few months) • Octreotide for symptoms • Yttrium-90-labeled Somatostatin: ORR 9%

  8. TT in medullary thyroid ca.

  9. TT in medullary thyroid ca.

  10. +20%

  11. 2. Which is the best CT/RT combination ?(state of the art before ASCO 2010) • NO randomized trials on different combinations. • More evidences on single agent CDDP, 100 mg/m2 q. 3 wks x 3 during 70 Gy standard fract. • Low dose weekly CDDP or Carboplatin+FU as “evidence based alternatives” Some open questions: Which and How many drugs? Which RT fractionation and dose? Which amount of CT?

  12. 2. Which is the best CT/RT combination ?(state of the art before ASCO 2010) • NO randomized trials on different combinations. • More evidences on single agent CDDP, 100 mg/m2 q. 3 wks x 3 during 70 Gy standard fract. • Low dose weekly CDDP or Carboplatin+FU as “evidence based alternatives” Some open questions: Which and How many drugs? Which RT fractionation and dose? Which amount of CT?

  13. RTOG-129, abs 5507 AFX (72 Gy) + CDDPx2 Phase III R 720 pts (stage III-IV) SFX (70 Gy) + CDDPx3

  14. 3yr: 64% vs 70%

  15. POPART trial, abs 5508 66 Gy in 7 wks Phase III R 147 postop pts enrolled (required 350) 66.5 Gy in 5 wks p= ns p= ns

  16. 3. Which is the role of Cetuximab into a CT/RT combination ?(state of the art before ASCO 2010) • Undefined (only phase II trials)

  17. TT and chemoradiation

  18. TT and chemoradiation

  19. Harrington, abs 5505 Lapatinib CT/RT+Lapatinib Lapatinib (34 pts) Phase II R (33 pts) Placebo CT/RT+placebo Placebo p=ns p=ns p= ns

  20. RTOG 0522: phase III trial CRT vs CRT + ERBITUX Accelerated FXb +CDDP:100 mg/m2, q3w x 2 patients with stage III or IVa SCC of oropharynx, hypopharynx or larynx (n=720) Accelerated FXb + CDDP: 100 mg/m2, q3w x 2 ERBITUX:400 mg/m2, week -1 250 mg/m2/week, weeks 2–8

  21. 4. Predictive/prognostic factors ready for clinical practice? • HPV status prognostic 5510-5525-5526 5527-5529-5537 • IL-8 + HGF prognostic 5509 • PTEN prog-pred 5519 • ERCC1-XPF predictive 5520 no 5537 • ERCC1 no 5539-5537 • EGFRvIII no 5538 • EGFR FISH no 5537

  22. 4. Predictive/prognostic factors ready for clinical practice? • HPV status prognostic 5510-5525-5526 5527-5529-5537 • IL-8 + HGF prognostic 5509 • PTEN prog-pred 5519 • ERCC1-XPF predictive 5520 no 5537 • ERCC1 no 5539-5537 • EGFRvIII no 5538 • EGFR FISH no 5537

  23. ASCO 2010 H&N TOPICS Zalutumumab not cost-effective – BIBW 2992 best RR? Vandetanib in medull. thyroid ca. SFX in CT/RT and postop - 3° CTcourse essential only for LRC TT other than Cetuximab ? Which is the best CT/RT combination ? Which is the role of TT into a CT/RT combination ? Predictive/prognostic factors ready for clinical practice? Waiting for RTOG 0522 trial – Cetux maintenance unnecessary? NOT at now

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