9 januari 2018: lees ook dit artikel:

https://kanker-actueel.nl/s-1-plus-irinotecan-plus-bevacizumab-versus-mfolfox6-of-capeox-plus-bevacizumab-voor-uitgezaaide-darmkanker-geeft-betere-overall-overleving-en-minder-bijwerkingen.html

Klik op deze link voor dit artikel: Ibuprufen gaat diarree tegen van xeloda - capecitabine gebruik

29 maart 2011: Bron: J Clin Oncol 2011

Oraal Xeloda - Capecitabine in combinatie met intraveneus oxaliplatin geeft de beste resultaten op ziektevrije tijd en overlevingstijd bij darmkanker stadium III, vergeleken met het volledig intraveneus gegeven Fa/FO regiem. 20% minder mensen uit de xeloda groep hadden in vergelijking met de FA/FO groep na 5 jaar een recidief of waren overleden. Dit blijkt uit een 5-jarige gerandomiseerd uitgevoerde fase III studie in meerdere ziekenhuizen. De bijwerkingen als hand/voet syndroom en diarree bleken in de Xeloda groep iets hoger maar wegen minder zwaar door relatief gemakkelijke manier van oraal innemen tegenover de belasting van intraveneus toedienen van het FA/FO regiem en bijbehorende bijwerkingen plus uiteraard de efffecten op ziektevrije tijd en overall overleving.

Lees voor tegengaan van hand en voetsyndroom en diarree het artikel over ibuprofen bij Xeloda in linkerkolom. Medscape schrijft artikel over deze studie onder andere dat artsen voor orale toediening van medicijnen geen vergoeding ontvangen maar voor intraveneus in een ziekenhuis wel geld ontvangen en dat dit een reden kan zijn dat artsen minder vaak oraal voorschrijven. Lees deze citaten uit artikel van Medscape. Onderaan staat abstract van de studie uit Clinical Oncology

In the U.S. study, patients with locally advanced, node-positive colon cancer were randomized to receive either a standard bolus, FA/FU adjuvant regimen (n=942) or a capecitabine plus oxaliplatin regimen (n=944) within 8 weeks of surgical resection.

The FA/FU treatment regimens were either the Mayo Clinic (n=664; 24 weeks, 6 cycles) or Roswell Park (278; 32 weeks, 4 cycles) standard protocols. Patients in the capecitabine plus oxaliplatin, or XELOX, arm received a 2-hour intravenous infusion of oxaliplatin 130 mg/m2 on day 1 and oral capecitabine 1,000 mg/m2 twice daily on days 1 to 14 of a 3-week cycle for eight cycles.

Disease-free survival was the main outcome measure in the study, and patients were followed for a median duration of 55 months.

When enrollment was closed, 31.3% of patients in the XELOX group had relapsed, developed a new colon cancer, or died, compared with 37.5% of the FU/FA group.

In terms of disease-free survival, patients taking XELOX also had a 20% reduction in relative risk (HR 0.80; P=.0045).

Four- and five-year disease-free-survival rates were also better in the XELOX group (68.5% vs. 62.3% and 66.1% vs. 59.8%, respectively), "demonstrating that superior efficacy of XELOX versus FU/FA was maintained over time," the investigators, led by Dr. Daniel Haller at the University of Pennsylvania, write.

Capecitabine, which is given orally, is potentially more convenient to administer than intravenous FU-based regimens. However, the cheaper costs of oral chemotherapy could be outweighed by an increase in adverse events found in the XELOX group.

"A central venous catheter is sometimes required for the administration of oxaliplatin anyway, and management of the increased toxicity with (capecitabine plus oxaliplatin) also costs money," said Dr. O'Connell.

In the study, 55% of patients in the XELOX group suffered a grade 3/4 adverse event, compared with 47% of patients in the FU/FA group (P<.05). Neurosensory toxicity was also far more common in the XELOX group, with 78% of patients reporting some level of neurotoxicity versus 8% in the FU/FA group.

Dr. Cassidy said the adverse events reported with XELOX in the trial were acceptable, but that "some oncologists still feel it's a bit more toxic in everyday usage -- particularly with respect to diarrhea."

Another barrier, he added, is that physicians may be paid less for switching to an oral-based regimen. "In some countries the clinician or institution gets a payment for IV drug administration but gets much less -- sometimes nothing -- for prescription of an oral drug. So there can be perverse incentives for sticking with an all-IV regimen," he said.

Capecitabine Plus Oxaliplatin Compared With Fluorouracil and Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer

+ Author Affiliations

From the Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; Vall d'Hebron University Hospital, Barcelona, Spain; Ottawa Regional Cancer Center, Ottawa, Canada; Istituto Europeo di Oncologia, Milan, Italy; The Queen Elizabeth Hospital, Adelaide, Australia; University Hospital Gasthuisberg, Leuven, Belgium; Kent Oncology Centre, Maidstone, Kent, United Kingdom; F. Hoffmann-La Roche, Basel, Switzerland; F. Hoffmann-La Roche, Nutley, NJ; and Martin Luther University, Halle, Germany.

Corresponding author: Daniel G. Haller, MD, Abramson Cancer Center, 3400 Civic Center Blvd, Philadelphia, PA 19104; e-mail: daniel.haller@uphs.upenn.edu.

Abstract

Purpose This multicenter, randomized trial compared capecitabine plus oxaliplatin (XELOX) with bolus fluorouracil (FU) and folinic acid (FA) as adjuvant therapy for patients with stage III colon cancer.

Patients and Methods Patients who had undergone curative resection were randomly assigned to XELOX (oxaliplatin 130 mg/m² on day 1 plus capecitabine 1,000 mg/m² twice daily on days 1 to 14 every 3 weeks for 24 weeks) or a standard bolus FU/FA adjuvant regimen (Mayo Clinic for 24 weeks or Roswell Park for 32 weeks). The primary study end point was disease-free survival (DFS).

Results The intention-to-treat population comprised 1,886 patients; 944 patients were randomly assigned to XELOX and 942 to FU/FA (Mayo Clinic, n = 664; Roswell Park, n = 278). After 57 months of follow-up for the primary analysis, 295 patients (31.3%) in the XELOX group had relapsed, developed a new primary colon cancer, or died compared with 353 patients (37.5%) in the FU/FA group (hazard ratio for DFS, 0.80; 95% CI, 0.69 to 0.93; P = .0045). The 3-year DFS rate was 70.9% with XELOX and 66.5% with FU/FA. The HR for overall survival (OS) for XELOX compared to FU/FA was 0.87 (95% CI, 0.72 to 1.05; P = .1486). The 5-year OS for XELOX and FU/FA were 77.6% and 74.2%, respectively. Follow-up is ongoing. Preplanned multivariate and subgroup analyses supported the robustness of these findings.

Conclusion The addition of oxaliplatin to capecitabine improves DFS in patients with stage III colon cancer. XELOX is an additional adjuvant treatment option for these patients.

capecitabine, oxaliplatin, xeloda, FA/FO regiem, overlevingstijd, ziektevrije tijd, darmkanker, 5-FU