June, 2006

Chemo vacation possible during FOLFIRI treatment for advanced colorectal cancer

INFORMATION FROM 2006 ASCO MEETING IN ATLANTA

Patients can safely be treated intermittently with FOLFIRI (irinotecan, leucovorin, and continuous infusion 5FU) with no negative effect on overall survival according to a study presented at the meeting of the American Society for Clinical Oncology in Atlanta.

Italian researchers, headed by Dr. Roberto Labianca compared two strategies for administering FOLFIRI to patients with advanced colorectal cancer who had not yet received chemotherapy for their metastatic cancer.

ARM A: Two months of FOLFIRI (irinotecan, leucovorin, and infusional 5FU) followed by a two month “vacation” followed by a 2 month resumption of FOLFIRI. Four month cycles of vacations and treatment were repeated until tumor progression when patients changed to a second line regimen with oxaliplatin.
ARM B: Standard FOLFIRI treatment given every two weeks until tumors progressed. After progression, patients moved to second-line treatment with oxaliplatin.

Results were similar in both arms of the trial:

Response rate was 29% in intermittent arm A and 35% in arm B where treatment was continuous.
Time to tumor progression was 8.8 months in A versus 7.3 months in B.
At a median follow-up time of 27 months, median overall survival was 16.9 months (A) versus 17.6 months (B). This is not the final analysis, but survival curves are almost identical at this point.
The worst toxicity experienced by patients was also similar in both arms.

The research team concluded:

Our results demonstrate that alternatiing FOLFIRI obtains the same survival as continuous treatment, thus reducing the discomfort to patients and the economic costs.

ASCO 2006 Abstract 3505 — Alternating versus continuous “FOLFIRI” in advanced colorectal cancer (ACC): A randomized “GISCAD” trial.

FOLFIRI intermittent chemotherapy

Posted by Kate Murphy on June 8th, 2006
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Chemo-free interval possible during FOLFOX treatment for advanced colorectal cancer

INFORMATION FROM 2006 ASCO MEETING IN ATLANTA

Patients with metastatic can have time off entirely from chemotherapy for metastatic colorectal cancer without sacrificing effectiveness according to the OPTIMOX2 study presented at the American Society of Clinical Oncology meeting in Atlanta.

Oxaliplatin in the FOLFOX chemo regimen can cause tingling, numbness, pain, and other neurological problems in the hands and feet as doses accumulate. Sometimes patients who are still responding to treatment have to stop because of this neuropathy. Strategies to reduce the amount of oxaliplatin received during treatment.can reduce neuropathy, allow therapy to continue, and improve quality of life. A previous study — OPTIMOX1 — used a Stop-and-Go strategy to administer FOLFOX for patients newly diagnosed with advanced colorectal cancer.

Give 6 treatments with FOLFOX4, a combination of oxaliplatin, leucovorin, and infusional 5FU.
Stop oxaliplatin and continue with 12 maintenance doses of infusional 5FU with leucovorin.
Begin FOLFOX7, including oxaliplatin, again and continue until tumors progress.

When the OPTIMOX1 intermittent strategy was compared to standard FOLFOX treatment patients had no significant difference in response rate (58.5% for OPTIMOX1 versus 58.3% for traditional FOLFOX), progression-free survival (9 months vs. 9.2 months), and overall survival (20.0 vs 20.6 months). Fewer patients had severe neurotoxicity in the Stop-and-Go arm (13.3%) compared to the standard approach (18.7%).

OPTIMOX2 sought to find out whether the maintenance treatment could be eliminated completely, giving patients a break from chemotherapy until their cancer began to grow worse. The study compared two approaches.

The intermittent Stop-and-Go regimen used in OPTIMOX1 with slight changes in dosages.
A similar regimen beginning with FOLFOX7 treatments but then moving to a chemotherapy free interval (CFI) until tumor progression. Treatment with FOLFOX resumed when tumors began growing again. However,chemotherapy was not started until tumors reached the size they were at the very beginning of treatment, further extending the CFI for those patients whose cancer responded to the initial therapy.

Two hundred patients were enrolled in the study, half in each arm. Results available at the time of the ASCO presentation:

Duration of disease control (total time of progression free survival before and after the maintenance phase) was the same in both arms of the study.
It is too soon to know whether overall survival times will also be the same.
Overall, patients on the OPTIMOX2 arm had a median 4.6 months without any chemo. Those with good prognostic factors did even better with median 8 months until tumors progressed for the second time and they resumed FOLFOX chemotherapy.
Twelve patients in each arm had tumors reduced enough to have them surgically removed.

Dr. Frederique Maindrault-Goebel presented the results of the trial for the GERCOR team. Concluding her presentation, she said,

“We believe that we can safely stop modified FOLFOX7 after only 6 cycles, especially in patients with response or stabilization and no negative prognostic factors.”

ASCO 2006 Abstract 3504 — OPTIMOX2, a large randomized phase II study of maintenance therapy or chemotherapy-free intervals (CFI) after FOLFOX in patients with metastatic colorectal cancer (MRC). A GERCOR study.

chemotherapy free interval FOLFOX

Posted by Kate Murphy on June 8th, 2006
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Data support 10-year screening interval after negative colonoscopy in average risk individuals

Although guidelines call for repeating colonoscopy 10 years after a completely negative exam in average risk people, there has not been solid evidence to support that timing. A study published in the May 24, 2006 issue of the Journal of the American Medical Association provides statistics to show that reduced incidence of colorectal cancer lasts a full ten years after a negative colonoscopy.

Dr. Harminder Singh and his team reviewed nearly 36,000 colonoscopies performed in Manitoba between 1989 and 2003. They compared the rate of colorectal cancer in people with a negative colonoscopy to the incidence of colorectal cancer in the entire Manitoba population. After 10 years the risk of colorectal cancer in the colonoscopy-screened group was 28% of the incidence in the entire population.

Higher risk individuals with a history of colorectal cancer, inflammatory bowel disease, or previous colorectal surgery were not included in the cohort.

Singh et.al. JAMA. 2006;295:2366-2373

Additional information about the study is discussed in the May 30, 2006 NCI Cancer Bulletin and on Medical News Today.

The US Preventive Services Task Force strongly recommends that all average risk men and women over age 50 be screened for colorectal cancer.