Capecitabine plus Irinotecan (XELIRI regimen) compared to 5-FU/LV plus Irinotecan (FOLFIRI regimen) as neoadjuvant treatment for patients with unresectable liver-only metastases of metastatic colorectal cancer: a randomised prospective phase II trial

<p>Abstract</p> <p>Background</p> <p>Phase II studies have shown that the combination of capecitabine and irinotecan (the XELIRI regimen) is active in metastatic colorectal cancer (MCRC). There are, however, no data about the use of the XELIRI regimen in the neoadjuvant treatment.</p> <p>Methods</p> <p>Patients with unresectable liver-only metastases of MCRC with ≤ 75 years of age were randomised to either the XELIRI (irinotecan 250 mg/m²given on day one and capecitabine 1000 mg/m²twice daily from day 2–15, every 21 days) or the FOLFIRI arm (irinotecan 180 mg/m², 5-FU 400 mg/m², LV 200 mg/m², 5-FU 2400 mg/m²(46-h infusion) – all given on day one, every 14 days). Primary end points were objective response rate (ORR) and rate of radical (R0) surgical resection. Secondary end points were progression-free survival (PFS), overall survival (OS) and safety.</p> <p>Results</p> <p>Altogether 87 patients were enrolled (41 pts in the XELIRI and 46 pts in the FOLFIRI arm). The median age was 63 years (63 years in the XELIRI and 62 years in the FOLFIRI arm) (p = 0.33). ORR was 49% in the XELIRI and 48% in the FOLFIRI arm (p = 0.76). The rate of radical R0 resection was 24% in both arms of patients. At the end of treatment, 37% of patients in the XELIRI and 26% of patients in the FOLFIRI arm were without evidence of the disease (CR+R0 resection) (p = 0.56). There were no statistical differences in grade 3 or 4 adverse events between both arms: diarrhoea 7% vs. 6%, neutropenia 5% vs. 13%, ischemic stroke 0 vs. 2%, acute coronary syndrome 2% vs. 4%, respectively. At the median follow up of 17 (range 1–39) months, the median PFS was 10.3 months in the XELIRI and 9.3 months in the FOLFIRI arm (p = 0.78), the median OS was 30.7 months in the XELIRI arm and 16.6 months in the FOLFIRI arm (p = 0.16).</p> <p>Conclusion</p> <p>The XELIRI regimen showed similar ORR as the FOLFIRI regimen in the neoadjuvant treatment of patients with MCRC. In addition, the XELIRI regimen showed similar PFS and OS with acceptable toxicity compared to the FOLFIRI regimen.</p> <p>Trial Registration</p> <p>Current Controlled Trials ISRCTN19912492</p

A patient with primary metastatic rectal carcinoma with metastases in the liver - a case study

Rak debelega črevesa in danke (RDČD) je najpogostejši rak v Sloveniji. Po podatkih Registra raka Slovenije za leto 2008 je v Sloveniji zbolelo 1.450 ljudi(1). Z naraščajočo incidenco narašča tudi umrljivost bolnikov, saj bolezen pri polovici bolnikov še vedno ugotovimo v napredovali obliki. Razsejana bolezen je neozdravljiva bolezen, sta se pa prognoza in preživetje teh bolnikov močno izboljšala, saj zadnjih deset let z uporabo novih zdravil, to je kombinacijo citostatikov (kapecitabin, irinotekan, oksaliplatin) in tarčnih zdravil (cetuksimab, bevacizumab, panitumumab), dosegamo srednja preživetja, ki so daljša od 30 mesecev(2). Kadar kombiniramo sistemsko in kirurško zdravljenje pri bolnikih s samo jetrnimi zasevki, še posebej, če gre za solitarne zasevke, pa 5-letno preživetje lahko presega 50 %. V tem prispevku opisujemo primer bolnice s primarno razsejanim karcinomom danke z zasevki v jetrih, kjer smo v okviru multidisciplinarnega pristopa, s kombinacijo sistemske terapije in večkratne operacije jetrnih zasevkov ter tudi drugimi terapevtskimi pristopi dosegli preživetje, daljše od 50 mesecev.Colorectal cancer (CC) is the most common cancer in Slovenia. According to the Cancer Registry of the Republic of Slovenia, a total of 1,450 people were diagnosed with colorectal cancer in Slovenia in 2008(1). The increasing incidence also means increasing morbidity, as in half of the patients, the disease is diagnosed when already at an advanced stage. Metastatic disease is incurable, but the prognosis and the survival of these patients have improved considerably, as in the last decade, with the use of new drugs, namely a combination of cytostatics (capecitabine, irinotecan, oxaliplatin) and target drugs (cetuximab, bevacizumab, panitumumab) we have achieved a median survival of more than 30 months(2). When combining systemic and surgical treatment in patients with liver metastases, in particular if these are solitary metastases, the 5-year survival can exceed 50%. In this paper, we present a case of a patient with primary metastatic rectal carcinoma with metastases in the liver. Within the framework of a multidisciplinary approach with a combination of systemic therapy and multiple surgeries of liver metastases, and using also other therapeutic approaches, we have achieved a survival of more than 50 months

Updated Guidelines for Systemic Treatment of Patients with Advanced Colorectal Cancer - 2009

Metastatski rak debelega črevesa in danke je večinoma še vedno neozdravljiva bolezen, vendar sta se prognoza in preživetje teh bolnikov v zadnjih 6 letih močno izboljšala. Od srednjega 10-mesečnega preživetja, ki smo ga dosegali z zdravljenjem s 5-fluorouracilom, ki je bilo pred nekaj leti edino učinkovito zdravilo za zdravljenje teh bolnikov, smo prešli na preživetje, daljše od 20 mesecev, kar so omogočili novi citostatiki. Kombinirano zdravljenje omogoča boljšo kakovost življenja in daljše remisije, s tem pa tudi daljše celostne preživetje. Uporaba kombinacije citostatikov s tarčnimi zdravili vodi v nadaljnje podaljšanje srednjega preživetja teh bolnikov, srednje preživetje je tako daljše od 30 mesecev. To zdravljenje v kombinaciji z operacijo pljučnih ali jetrnih zasevkov pa omogoča tudi zazdravitve. Pomembna letošnja novost je določanje mutacij na genu KRAS. Za raka debelega črevesja in danke je gen KRAS prvi biomarker, ki napoveduje, kako se bodo bolniki odzvali na neko zdravljenje.In most cases, metastatic colorectal cancer is incurablehowever, the prognosis and survival of these patients have significantly improved in the last six years. A few years back, the only efficient drug for colorectal carcinoma, 5-fluoruracil, yielded the mean survival of 10 months, whereas today, the survival rates of 20 months or more may be obtained by using new citostatics. In the last six years, six new drugs were registered for the treatment of metastatic colorectal cancer. These are three citostatics (capecitabine, irinotecan, oxaliplatin) and three target drugs (cetuximab, bevacizumab, panitumumab). A combined treatment assures a better quality of life, and longer remissions and overall survival. The combination of cytostatics and target drugs improves particularly the mean survival rate which may be longer than 30 months. These combinations of drugs used together with surgical treatment of lung and liver metastases may result in complete remission. An important research achievement of this year is the determination of KRAS mutations. The KRAS gene is the first biomarker that predicts how well patients will respond to certain combination of treatment

Dopolnjena priporočila za sistemsko zdravljenje bolnikov z napredovalim karcinomom želodca, 2010

No abstract.Ni abstrakta