ORLANDO—Patients aged 75 and older with metastatic colorectal cancer can be treated with standard combination chemotherapy regimens, despite increased toxicity, according to results of the FFCD 2001-02 trial. French investigators reported planned interim data at the 2008 Gastrointestinal Cancers Symposium (abstract 281).
Older patients have traditionally received “suboptimal management” and have not enjoyed an improvement in survival, said principal investigator
Emmanuel Mitry, MD, of the CHU Ambroise Pare, Boulogne. He said the trial addressed the question, “Should we use combination therapy with irinotecan [Camptosar] and oxaliplatin [Eloxatin], or use 5-FU [fluorouracil] only?”
The study included 209 patients aged 75 or older (median, 80 years) with previously untreated metastatic colorectal cancer. Patients were randomized to receive one of two 5-FU chemotherapy regimens, either alone or in combination with irinotecan. The interim analysis included data from 166 patients; all received at least one chemotherapy cycle.
Response rates were 18% for 5-FU only and 31% for patients who also received irinotecan, with a 1% complete response rate in each arm. Stable disease was seen in 51% and 57%, respectively, for a clinical benefit rate of 69% with 5-FU and 88% when irinotecan was included, Dr. Mitry reported.
Mortality was 57% in each arm, due to progression in the vast majority of cases. The overall 60-day mortality rate was 12.7%.
Irinotecan more toxic
Combination therapy was more toxic, with 48% of patients experiencing grade 3-4 toxicities vs 16% with 5-FU alone. Neutropenia grade 3-4 occurred in 28% and 1%, respectively, and febrile neutropenia in 9% and 1%.
Diarrhea was also more common, occurring in 63% of patients receiving irinotecan vs 39% for 5-FU alone, with severe diarrhea reported by 16% vs 0%, respectively, he said. Toxic deaths were rare and equivalent between the arms (one each).
Dr. Mitry said the results, although “preliminary and only descriptive,” suggest that phase III trials specific to elderly patients with metastatic colorectal cancer are feasible, and that the elderly can receive most standard chemotherapy regimens.