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Al B Benson, III, MD, FACP Professor of Medicine and Director of Clinical Investigations, Robert H Lurie Comprehensive Cancer Center of Northwestern University Chair, ECOG GI Committee

Edited comments by Dr Benson

Improved survival in metastatic colorectal cancer

Patients with metastatic colorectal cancer are living longer with a better quality of life as a result of combination chemotherapy. More patients are exposed to multiple therapeutic regimens, including irinotecan and oxaliplatin combinations, and are having better survival. A recent European abstract suggested that the long-term sequence of therapy with irinotecan and oxaliplatin results in median survival of 20 to 21 months — almost double the survival of bolus 5-FU regimens. Although we are not where we want to be in terms of outcome, we are making progress.

Oxaliplatin trial in pancreatic cancer

ECOG will soon activate a very large trial for patients with pancreatic cancer comparing fixed-rate infusion gemcitabine combined with oxaliplatin to the standard 30-minute gemcitabine. This will be one of the largest pancreatic trials done in the United States. The rationale for this trial is based on data from French investigators in locally advanced non-surgical disease, and metastatic disease. Both groups actually benefited from the combination of gemcitabine and oxaliplatin with median survivals greater than seven months. The ECOG trial will define the role of oxaliplatin in the combination and whether the combination is truly superior to either fixed-rate or 30-minute dosing of gemcitabine.

Management of oxaliplatin toxicity

We counsel patients about the risks of oxaliplatin, and our patients have actually been fine with it. We’ve not had a lot of difficulty with cold exposure in our patients receiving oxaliplatin — and Chicago is a cold place to live. Patients will describe a tingling feeling in their hands if they reach in the refrigerator and take out a cold bottle of milk. If they drink very cold liquids or have exposure to cold air, they can experience difficulty swallowing or shortness of breath. This generally resolves within the first week of treatment, and most of our patients are able to resume drinking cold beverages after this time. Trials are underway to explore the peripheral neurotoxicity, predictably seen after about eight cycles of therapy. A European trial is evaluating efficacy and tolerability of treating patients with a planned break from oxaliplatin. There are also various maneuvers, such as calcium and magnesium infusions, to control the peripheral neuropathy. We’ll have to see how those play out.

Adjuvant therapy

Historically, in oncology, we would expect the response and survival data seen with oxaliplatin and irinotecan in advanced disease to translate into a survival benefit for patients in the adjuvant setting. We have to be careful, however, in the history of clinical research we’ve made assumptions and then been surprised by how the data unfolds.

We do not know if the efficacy of combination therapy is superior, and there are certainly risks of added toxicity. Two trials designed to answer this question have been completed in the United States. New Intergroup adjuvant trials will further explore the use of combination therapy in the adjuvant setting. We have to wait for the data to emerge from the recently completed trials. We also need to support the future trials looking at this question and the laboratory correlative studies, which hopefully will yield additional biological information that will correlate with tumor response.

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