PANKREASKARZINOM. adjuvante + neoadjuvante + palliative Therapie
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1 PANKREASKARZINOM adjuvante + neoadjuvante + palliative Therapie
2 Pankreaskarzinom Therapieoptionen Resektabel sicher resektabel borderline resektabel Resektion Neoadjuvante CT Neoadjuvante RCT Adjuvante CT Adjuvante RCT Nachsorge Resektion
3 Pankreaskarzinom adjuvante Therapie MORE RECENT & ONGOING ADJUVANT TRIALS Treatment arm PFS (mos) OS (mos) 3 / 5 yrs (%) total R0 R1 CONKO-001 control arm mos / 11.5 (n = 368) gemcitabine for 6 mos mos / 22.5 p = Treatment regimen med.survival 3-yr survival RTOG 9704 cifu (3 wks) > CRT > cifu (12 wks) 16.7 mos 21% (n = 380) gem (3 wks) > CRT > gem (12 wks) 18.8 mos 31% P=0.05* PFS OS ESPAC 3 gemcitabine for 6 mos 14.3 mos 23.0 mos (n = 990) FU/Leucovorin for 6 mos 14.1 mos 23.6 mos Gemcitabine was better tolerated (14% in GEM vs. 7.5% in FU/LV reported SAEs)
4 Pankreaskarzinom adjuvante Therapie Adjuvante Chemotherapie ist akzeptierter Standard Aufgrund der hohen R1/R2- Resektionsrate Wegen der frühzeitigen Fernmetastasierung Welches Schema? Effektivität: Gemcitabine = 5-FU/LV Verträglichkeit: Gemcitabine > 5-FU/LV Radiochemotherapie: keine Evidenz keine randomisierte Studie positiv Alle Meta-Analysen negativ
5 R1 Additive Therapie R1 + CRT 10.9 Monate (95% CI ) R1 no CRT 12.1 Monate (95% CI ) R0 + CRT 15.9 Monate (95% CI )
6 R1 Additive Therapie n = 875 (R1 278, 32%)
7 Pankreaskarzinom adjuvante Therapie Treatment med. surv. DFS EORTC Gemcitabine (4 mos) 24 mos 11mos (n = 90) Gem (2 mos) > CRT > Gem (2 mos) 24 mos 12 mos CRT: Gemcitabine 300mg/m 2 /1x/Woche RT plus RT (50.4 Gy, ED 1.8 Gy) CT: Gemcitabine 1000mg/m 2,Tag 1, 8, 15, alle 18 Tage Primäre Endpunkte waren allerdings : dass nicht <60% der Patienten, die geplante Therapie erhalten (73%) dass nicht >40% Grad 4 hämatologische oder GI-Nebenwirkungen erleiden (4.7%) adjuvant gemcitabine-based CRT is feasible adding this treatment to full-dose adjuvant gemcitabine after resection should be evlauted in a phase III trial GK
8 mögliches Proposal R1 adjuvant Additive Radiochemotherapie nach R1Resektion Arm 1: CT* für 3 Mo > RCIT ** > CT* für 3 Mo Arm 2: RCIT ** > CT* für 5 Mo * Gemcitabine ** RT (50.4 Gy, ED 1.8 Gy) + Capecitabine + Erlotinib Was bringt mehr Vorteile nach R1- Resektion, rasche RT (Lokalkontrolle) oder zuerst CT (Metastasen)? Staging vor postoperativer Therapie Patienten mit Progress fallen aus der Studie Beide Arme mu ssen in der Woche 4 8 nach OP begonnen werden GK
9 Pankreaskarzinom Therapieoptionen Resektabel sicher resektabel borderline resektabel Resektion Neoadjuvante CT Neoadjuvante RCT CT oder MRI + CA 19-9/β-HCG Adjuvante CT Adjuvante RCT Nachsorge Resektion
10 Pankreaskarzinom neoadjuvante Therapie 42 Evans et al. Arch Surg 127: 1335, 1992; 43 Pisters et al. J Clin Oncol 16: 3843, Hoffmann et al. J Clin Oncol 16: 317, White and Tyler Surg Oncol Clin N Am 13: 675, Pisters et al. J Clin Oncol 20: 2537, Evans et al. J Clin Oncol 26: 3496, Varadhachary et al. J Clin Oncol 26: 3487, Wochen 18-23%
11 Pankreaskarzinom Therapieoptionen sicher resektabel Resektabel borderline resektabel Resektion CT oder MRI und CA 19-9 Adjuvante CT Adjuvante RCT Nachsorge Resektion
12 Pankreaskarzinom neoadjuvante Therapie Borderline resectable Folfirinox (oder Xelirinox) 2-4 Monate Wenn resektabel -> OP -> CT für 3 Monate Wenn (noch) nicht resektabel -> RCT (-> OP?) Wenn progredient -> palliative Protokolle Resectable ( minimal ) liver mets GemOx+Erlotinib für 2-3 Monate Wenn keine PD und Läsioenen resektabel: Resektion GemOx+Erlotinib für 3 weitere Monate GK
13 1997: Gemcitabine improves survival over previous standard of care 100 Patients surviving (%) FU Median survival (months) Gemcitabine Gemcitabine (n=63) 5-FU (n=63) p value Time (months) FU = 5-fluorouracil Burris H: J Clin Oncol, 15, 6, 1997: Fig 3A Reprinted with permission from the American Society of Clinical Oncology
14 Addition of other agents to gemcitabine in pancreatic cancer Marimastat 5-FU bolus 2004 Tipifarnib 5-FU/LV Oxaliplatin Xeloda Exatecan Irinotecan Pemetrexed Cisplatin Oxaliplatin Docetaxel Xeloda Erlotinib Avastin Cetuximab Gemcitabine Gemcitabine + Erlotinib = No significant benefit observed versus gemcitabine alone = Significant benefit versus gemcitabine alone
15 Limited benefit of combination chemotherapy in pancreatic cancer Meta-analyses of gemcitabine versus gemcitabine plus other chemotherapies HR 95% CI p value Gemcitabine versus gemcitabine + irinotecan Gemcitabine versus gemcitabine + Xeloda* Gemcitabine versus gemcitabine + 5-FU Gemcitabine versus gemcitabine + platinum Gemcitabine versus gemcitabine combo 1.0 ( ) ( ) ( ) ( ) ( ) Favours gemcitabine combo Favours gemcitabine alone *Includes interim analysis of Cunningham D, et al. Eur J Cancer Suppl 2005;3(4):12 (Abs. PS11) HR = hazard ratio; CI = confidence interval Sultana A, et al. J Clin Oncol 2007;25:
16 Degree of rash correlates with overall survival: 1.0 Grade 0 (n=79) Grade 1 (n=108) Grade 2 (n=103) 0.8 Median survival (months) Survival probability Grade 0 Grade 1 Grade 2 1-year survival (%) HR (rash)=0.71, p< Time (months) Moore M: J Clin Oncol, 25, 15, 2007: Fig 3 Reprinted with permission from the American Society of Clinical Oncology Roche, data on file
17 A SWOG phase III study of gemcitabine + cetuximab versus gemcitabine in patients with APC Philip, ASCO 2007, abstract LBA4509
18 A CALGB double-blind, placebo-controlled, randomized phase III trial of gemcitabine + bevacizumab vs. gemcitabine + placebo in APC: Kindler, ASCO 2007, abstract 4508
19 PA.3: significant improvement in OS with addition of erlotinib to gemcitabine 1.00 n Median OS (months) 1-year survival (%) Survival probability G+E G+P HR=0.82 (95% CI: ) p= Time (months) OS = overall survival G = gemcitabine; E = erlotinib; P = placebo Moore M, et al. J Clin Oncol 2007;25:1960 6
20 Pankreaskarzinom palliative Therapieoptionen PS 0-2 PS 3-4 Gemcitabine BSC Gem Cap/Gem Ox Gem +Erlotinib Rash <G2 nach 2 Zyklen
21 FOLFIRINOX Improves Survival over Gemcitabine for Metastatic Pancreatic Adenocarcinoma Arm A: Gemcitabine 1000mg/m 2,Tag 1, 8, 15, alle 18 Tage Arm B: Oxaliplatin 85 mg/m 2 + Irinotecan 180 mg/m 2, + LV 400mg/m FU bolus 400mg/m 2 + 5FU (46h) 2,400 mg/m 2, Day 1, q2w ORR med. surv. PFS Gem 9.4% 6.8 mos 3.3mos Folfirinox 31% 11.1mos 6.4 mos
22 Pankreaskarzinom palliative Therapie Metastasiertes Pankreaskarzinom 1 st -line Folfirinox Xelirinox Gemox + Erlotinib 2 nd -line Gemcitabine + Erlotinib Folfiri Xeliri
23 Pankreaskarzinom neue Therapieoptionen und Studien resektabel nicht-resektabel Resektion CT oder MRI CA 19-9 lokal fortgeschritten Fernmetastasen neoadjuvant CT >> RCT potentiell resektabel nichtresektabel Gemcitabine evtl. Resektion Folfirinox/ Xelirinox Gem+/-Ox +Erlotinib
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