Stop-and-go oxaliplatin effective in elderly colon cancer patients

April 11, 2008

NEW YORK (Reuters Health) - Elderly patients with metastatic colon cancer, those between 76 and 80 years of age, have response and survival rates similar to their younger counterparts when given a treatment approach that includes stop-and-go oxaliplatin.

Elderly patients with metastatic colon cancer are generally excluded from randomized clinical trials, but were included in the OPTIMOX1 trial, led by Dr. Arie Figer of Beth Sourasky Medical Center in Tel Aviv, Israel. OPTIMOX1 was an evaluation of FOLFOX7, a simplified leucovorin (LV) and 5-fluorouracil (5FU) regimen (sLV5FU2) with high-dose oxaliplatin, in a new oxaliplatin stop-and-go strategy.

The study included 620 previously untreated patients between 76 and 80 years of age with metastatic colon cancer who were randomized to one of two arms of treatment.

One group received FOLFOX4, consisting of leucovorin followed by a bolus of 5-fluorouracil (5FU) and a 22-hour infusion of 5FU and oxaliplatin on day 1 every 2 weeks, which was given until disease progression occurred.

The other group received FOLFOX7, which consisted of leucovorin followed by a 46-hour infusion of 5FU and oxaliplatin started on day 1 every 2 weeks, for six cycles. This was followed by 12 cycles without oxaliplatin (i.e., sLV5FU2 only), and then reintroduction of FOLFOX7.

Dr. Figer and colleagues report in the December 15 issue of Cancer that "the overall response rate was 59.4%, comparable to younger patients (59%)."

"Median progression-free survival was 9.0 months and median overall survival was 20.7 months. These results did not differ from that in patients 75 years and younger in the OPTIMOX1 study," the investigators report.

The older patients had more grade 3/4 toxicity than younger patients, at 65% and 48%, respectively. This consisted primarily of more neutropenia, occurring in 41% of older patients and 24% of younger patients, and neurotoxicity, occurring in 22% of older patients compared with 11% of younger patients.

"Tolerability, however, was manageable and no toxic death occurred in this elderly population," the investigators report.

They assert that "performance status and geriatric assessment are surely better criteria than age to predict the efficacy and toxicity of chemotherapy." In older patients deemed able to tolerate FOLFOX, this stop-and-go oxaliplatin management plan can be offered.