Microsoft powerpoint - neu fire-posterasco2002.ppt [schreibgesch.tzt]
Irinotecan plus Oxaliplatin versus Irinotecan plus 5-FU/Folinic Acid as First-Line Treatment in Metastatic Colorectal Cancer: Interim Toxicity Analysis of a Randomized Phase III Trial. A. Schalhorn1, M. Stauch2, D. Quietzsch3, P. A. Maubach4, L. Fischer von Weikersthal5, G. Schlimok6, U. Bruntsch7, H. Lambertz8, M. Grundeis9, M. Schulze10, J. Stamp, W. Hiddemann1, and V. Heinemann1 1Medical Dept. III, University of Munich, 2Oncologic Practice, Kronach, 3Dept. of Oncology, Clinic Chemnitz, 4Oncologic Practice, Ingolstadt, 5Medical Dept. II, Clinic St. Marien Amberg, 6Medical Dept. II, Clinic Augsburg, 7Medical Dept.V, Clinic Nuernberg Nord, 8Dept. of Oncology, Clinic Garmisch, 9Oncologic Practice, Chemnitz, 10Dept. of Oncology, Clinic Zittau Abstract: 594
Purpose: This phase III multicenter trial was designed to compare the
• Primary endpoint: Inclusion criteria
efficacy and toxicity of a first-line treatment with 5-FU/FA plus irinotecan
Medizinische Universitätsklinik Würzburg
(arm A) to the combination of irinotecan plus oxaliplatin (arm B) in
• Secondary endpoints:
z histologically proven adenocarcinoma of colon or rectum
metastatic CRC. Patients and Methods: Between July 2000 and
Privatklinik Dr. R. Schindlbeck Herrsching
Fischer von Weikersthal Klinikum St. Marien Amberg
Campto + AIO Campto + Oxaliplatin
November 2001, 159 pts from 36 centres were enrolled. Patients (pts)
z bidimensionally measurable lesions (CT/MRT >20mm, chest X-ray
were randomised to receive either irinotecan 80mg/m2 plus FA 500mg/m2
plus 5-FU 2000 mg/m2 (24h) given weekly for 6 times (arm A) or
oxaliplatin 85mg/m2 (d1, 15, 29) followed by irinotecan 80mg/m2 weekly
z no previous chemotherapy for metastatic disease
times 6 (arm B). Cycles were repeated on day 50 in both arms. A cross-
over design allowed to switch over progressing pts to the respective
Campto + Oxaliplatin Campto + AIO
z clinical evaluation < 3 weeks before randomisation
comparator regimen. Results: To date, toxicity data are evaluable in 42
pts receiving arm A (median age: 65 yrs; male/female: 29/13) in 69 cycles
Stratification: Exclusion criteria
and in 46 pts treated in arm B (median age: 63 yrs; male/female 30/16) in
z Performance Status: Karnofsky Index: 100% vs 70-90%
96 cycles. Dose reductions (<80% of planned dose) were observed for 5-
FU in 29% (arm A), irinotecan in 14%/16% (arm A/B), and for oxaliplatin in
O LDH: < 240 U/L versus >240 U/L
34% of cycles (arm B). Conclusion: Toxicity was acceptable in both
O Adjuvant pretreatment:
treatment arms and no signficant difference was observed in the planned
O clinically symptomatic peritoneal carcinosis (ascites)
CPT 80 mg/m2 0.5h, day 1, 8, 15, 22, 29, 36,
sample size: Irinotecan plus FU/FA Irinotecan plus Oxaliplatin Safety Parameter
O chronic inflammatory GI disease / ileus
based on TTP improvement from 6.7 months to 8.5 months (25%)
O clinical y symptomatic brain metastasis
Hematological Toxicity (per cycle analysis)
Parameter Total (%) Arm A (%) Arm B (%) NCI-CTC Grade 3-4 Toxicity median(range) median(range) median(range) Adjuvant Pretreatment (CPT/FuFA) (CPT/Ox) Total (%) Age (years) 62 (28-76) 63 (32-83) 62 (28-76) (CPT/FuFA) (CPT/Ox) Atropine Gender (m/f) LDH <240 U/l Leucocytopenia Loperamide Dose reduction Colon cancer LDH >240 U/l CPT-11 + FU/FA CPT-11 + Oxaliplatin Rectal cancer Thrombocytopenia Budesonide NCI-CTC Grade Performance status 100% Cycles delayed Leucocytes Octreotide Performance status Neutropenic Fever Previous Thrombocytes radiotherapy HT3-antagonists
Non-Hematological Toxicity (per cycle analysis)
Neutropenic Fever
• Toxicity was acceptable in both treatment arms. NCI-CTC Grade 3-4 Toxicity Vomiting
• Hematotoxicity (grade 3-4) was low and generally
(CPT/FuFA) (CPT/Ox) Diarrhea early Arm A (%) Arm B (%) Diarrhea delayed 23.5 30.9 7.4 (CPT/FuFA) (CPT/Ox)
• Non-hematological toxicity (grade 3-4) occurred in
Total (%) Arm A (%) Arm B (%) Constipation Complete remission
<6% of cycles (apart from delayed diarrhea). (CPT/FuFA) (CPT/Ox) 5-FU / FA Bolus Cholinergic Synd. Alopecia Progression of disease Patients recuited 5-FU / FA High-dose (AIO)
• Delayed diarrhea (grade 3-4) was significantly
Patients evaluable for Radiochemotherapy
more frequent (19.4% vs 6.7%, p=0.0005) in
Mucositis toxicity
patients receiving the CPT-11/oxaliplatin
Toxicity Cycles evaluable for toxicity Immune therapy Neurological Compliance
• Doses were reduced in 25% of cycles and were
What we think of it, the information we get, the people who provide it JULY 2005 Highland Users Group can be contacted through Graham Morgan, Highland Telephone: (01463) 718817 / Fax: (01463) 718818 CONTENTS PAGE What is HUG? Introduction Medication issues- Are we told about the effects of our medication? What happens when we contemplate coming off medication? 10 What inform
the MVP Newsletter for People with Low Back Pain The Spine Column 2007 Volume 1 Osteoporosis By Ellen Levanites BSN, CMSRN CLNC The Bone Thief Osteoporosis is a disease that weakens the bones to the point where they easily break. The bones of the hip, spine, and wrist are particularly vulnerable. It is called the silent disease as it progresses over years but you