Biweekly oxaliplatin combined with oral capecitabine (OXXEL regimen) as first-line treatment of metastatic colorectal cancer patients : a Southern Italy Cooperative Oncology Group phase II study

• Published in: Cancer chemotherapy and pharmacology Vol. 56; no. 5; pp. 481 - 486
• Main Authors: COMELLA, P, MASSIDDA, B, PALMERI, S, FARRIS, A, DE LUCIA, L, NATALE, D, MAIORINO, L, TAFUTO, S, DE CATALDIS, G, CASARETTI, R
• Format: Journal Article
• Language: English
• Published: Berlin Springer 01.11.2005; Springer Nature B.V
• Subjects: Adult; Aged; Aged, 80 and over; Antimetabolites, Antineoplastic - administration & dosage; Antimetabolites, Antineoplastic - adverse effects; Antineoplastic agents; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Capecitabine; Carcinoma - drug therapy; Carcinoma - pathology; Carcinoma - secondary; Colorectal Neoplasms - drug therapy; Colorectal Neoplasms - pathology; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Disease-Free Survival; Female; Fluorouracil - analogs & derivatives; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Italy; Liver Neoplasms - drug therapy; Liver Neoplasms - secondary; Lung Neoplasms - drug therapy; Lung Neoplasms - secondary; Lymphatic Metastasis; Male; Medical sciences; Middle Aged; Organoplatinum Compounds - administration & dosage; Organoplatinum Compounds - adverse effects; Peritoneal Neoplasms - drug therapy; Peritoneal Neoplasms - secondary; Pharmacology. Drug treatments; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Tumors; Italy; Europe; Antineoplastic agent; Human; Rectal disease; Capecitabine; Fluoropyrimidine derivatives; Colorectal cancer; Oral administration; Metastasis; Malignant tumor; OXXEL regimen; Induction treatment; First line treatment; Colonic disease; Cancerology; Oxaliplatin; Phase II trial; Digestive diseases; Intestinal disease; Advanced stage; Pyrimidine nucleoside; Biweekly treatment; Metastatic colorectal cancer; Platinum II Complexes
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s00280-005-1003-6

Oxaliplatin 100 mg/m(2) iv on day 1, and capecitabine 1,000 mg/m(2) orally bid from day 1 (evening) to day 11 (morning) were administered every 2 weeks (OXXEL regimen) to 38 patients as first-line treatment for metastatic colorectal carcinoma. A total of 318 cycles were administered, with a median of 8 (range, 4-12) cycles per patient. Response rate (RR) was 45% (95% confidence interval (CI), 29%-62%), with 7 complete responses and 10 partial responses; furthermore, 12 patients showed a stable disease, so that a disease control was achieved in 29 (76%) patients. RR was greater among patients with performance status 0 (52%), without weight loss (52%), younger than 65 years (50%), and previously unexposed to adjuvant chemotherapy (48%), while no correlation was found with the actually delivered oxaliplatin dose intensity. Overall, haematological side effects were negligible, with no case of grade 4 toxicity, and only one patient suffering from an episode of grade 3 neutropenic fever. Severe anaemia occurred in 4 (11%) patients, and grade 3 neuropathy affected 9 (24%) patients. Median progression-free survival was 7.9 (95% CI, 6.2-9.6) months, and median overall survival has not been reached yet. In conclusion, the OXXEL regimen resulted safe and active, and it deserves further evaluation in metastatic colorectal cancer patients.