This article is more than 5 years old. Information may no longer be current.

Adding oxaliplatin to 5-FU did not improve response in locally advanced rectal cancer

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

2009 ASCO Annual Meeting

The addition of oxaliplatin to standard preoperative radiochemotherapy with 5-FU did not increase local tumor response and significantly increased toxicities in patients with locally advanced rectal cancer, according to data from a secondary endpoint analysis of the STAR-01 phase-3 trial.

“However, the lower number of occult metastases found at surgery suggests a potential effect on distant metastases,” Carlo Aschele, MD, PhD, said at the 2009 ASCO Annual Meeting.

Aschele, attending physician and lead clinician in colorectal/gastrointestinal cancer in the department of medical oncology and cancer prevention at E.O. Ospedali Galliera in Genoa, Italy, and colleagues randomly assigned 747 patients to radiation plus 5-FU or radiation plus 5-FU and weekly oxaliplatin 60 mg/m². Surgery was scheduled six to eight weeks after treatment completion.

The primary endpoint of the study is OS; this presentation was a protocol-planned analysis of local tumor response to preoperative treatment.

No significant differences were found between the two arms for tumor reduction. Sixteen percent of patients in both groups had no tumor present at the time of surgery and about 30% of patients in both arms had mildly invasive tumors without nodal involvement.

However, the analysis did find differences in safety between the two arms. Patients assigned oxaliplatin had more severe toxicity of any type (24% vs. 8%; P<.001), diarrhea (15% vs. 4%; P<.001), radiation dermatitis (2% vs. 5%; P=.04), and neurosensory toxicity (0.5% vs. 37%; P<.001). Despite this, Aschele said that the increased toxicity is manageable and that mortality was not affected.

Finally, in an unplanned analysis of intra-abdominal disease spread at the time of resection of the primary tumor, the researchers found that only 0.5% of patients in the oxaliplatin group had distant metastases vs. 3% in the control group (P=.014).

Follow-up on DFS and OS is ongoing.

For more information:

• Aschele C. #CRA4008. Presented at the: 2009 ASCO Annual Meeting; May 29-June 2, 2009; Orlando, Fla.

More ASCO Meeting Highlights >>