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p53 adapted neoadjuvant therapy for esophageal cancer: Pilot study

p53 adapted neoadjuvant therapy for esophageal cancer: Pilot study. Gastrointestinal (Non colorectal) cancer Poster discussion session Sat, June 2, 2007. The two largest trials produced conflicting results. Therapy. #. median survival. OVS 2y. p. CIS/5FU +SURGERY. 233. 15. 35%.

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p53 adapted neoadjuvant therapy for esophageal cancer: Pilot study

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  1. p53 adapted neoadjuvant therapy for esophageal cancer: Pilot study Gastrointestinal (Non colorectal) cancer Poster discussion session Sat, June 2, 2007

  2. The two largest trials produced conflicting results Therapy # median survival OVS 2y p CIS/5FU +SURGERY 233 15 35% ns SURGERY vs 234 16 37% CIS/5FU +SURGERY 400 17 43% 0.004 SURGERY vs 402 13 34% …indicating moderate efficiency of standard neoadjuvant therapy INT NEJ 1988 MRC Lancet 2002

  3. Pathologic response to neoadjuvant therapy improves overall survival significanty

  4. 40% 60% Esophageal Cancer - Neoadjuvant Therapy: …Overall failure rate = p53 mutation rate (60%)…

  5. PILOT STUDY:Prospective evaluation of hypothesis 38 operable esophageal cancer patients, prospectively recruited between 2004-2006 Neoadjuvant therapy: 30 patients CIS/5FU Cisplatin 80mg/m2 d1, 5FU 1000mg/m2 d1-5 2 cycles q21d 8 patients Docetaxel off label Docetaxel 75mg/m2 2 cycles q21d

  6. The presence of p53 mutations must not be assessed by immunohistochemistry sequence analysis immunohistochemistry …sequence analysis is the golden standard

  7. Neoadjuvant treatment 1: CIS/5FU 30 patients p=0,0001

  8. Neoadjuvant treatment 2 : Docetaxel 8 patients off label *including 4 CR

  9. p53 mutation by histology p53 mutation frequency

  10. Correct response prediction in 36/38 patients (95%).

  11. p53 adjusted versus non adjusted therapy median follow up: 15,4 months p=0,042 p=0,027 Overall survival p53 adjusted p53 not adjusted months

  12. side effects costs Benefit Failure …Selection of the appropriate therapy based on the p53 genotype … could significantly improve likelihood of response

  13. PANCHO:P53 Adapted Neoadjuvant Chemotherapy for Oesophageal cancer Prospective, randomized controlled, PREDICTIVE MARKER TRIAL …designed to test the p53 predictive factor question

  14. S U R G E R Y p53 normal Patients with resectable esophageal cancer p53 gene analysis Cisplatin 80 mg/m², day 1, 3 cycles 5-FU 1000 mg/m² days 1-5; q 21,3 cycles Pancho : trial design Cisplatin 80 mg/m², day 1, 3 cycles 5-FU 1000 mg/m² days 1-5; q 21,3 cycles randomize stratify * Docetaxel 75 mg/m², day 1, q 21, 3 cycles p53 mutant stratify * randomize Docetaxel 75 mg/m², day 1, q 21, 3 cycles * Stratification for adeno- and squamous cell cancer Primary endpoint: RESPONSE to neaoadjuvant therapy

  15. PANCHO • Start: Mai 2007 • 84 patients to be randomized within 18 months • Intended bywww.p53.at • Sponsored by the ASSO (Austrian Society for Surgical Oncology)

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