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tracheoesophageal fistula

Dr Pennell

Avastin, Radiation, and Tracheoesophageal Fistulas: Yet another Cautionary Tale

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Look, before I begin this post let me say that I’m really not trying to be a negative person when it comes to Avastin (bevacizumab; see here and here). It is a great drug in the appropriate setting, and is has been proven to prolong survival in first-line treatment of advanced NSCLC patients when combined with chemotherapy. Given this success, as well as proven success in treating renal cell carcinoma, breast cancer, and colorectal cancer, it is understandable that people would keep testing it in new situations. It’s just that all of the recent publications that try and expand the role of Avastin to new areas seem to have disappointing results. Which brings me to today’s topic.

A new online publication in the Journal of Clinical Oncology by Dr. David Spigel and colleagues from the Sarah Cannon Research Institute in Nashville, TN, describes the experiences from 2 phase II trials in small cell (SCLC) and non-small cell lung cancer (NSCLC) using Avastin in combination with chemotherapy and chest radiation. There had been reports of safety concerns in the past with this combination, specifically with regards to something called tracheoesophageal fistula, but this was my own first look at the data.

A tracheoesophageal fistula is a pathologic connection between the esophagus (food pipe) and trachea (windpipe). It doesn’t take a doctor to imagine why it might be a bad thing to empty everything you eat or drink directly into your lungs, but in case you weren’t sure let me assure you this is what we in the business call “a bad thing”. It is always serious and often fatal, although if caught early can be treated with a stent that covers the opening and prevents passage of material between the two sites.

In 2006-07 there were two phase II trials enrolling patients to investigate the role of adding Avastin to chemotherapy and radiation in limited stage SCLC and in locally advanced (stage III) NSCLC. Concurrent chemoradiation represents the standard treatment for both of these conditions, so the only major change was in adding the Avastin. The SCLC study enrolled 29 patients, but stopped early after an unacceptable level of toxicity. In contrast, the NSCLC study only enrolled 5 patients before having to stop. I think these studies represent a cautionary tale, but are also a positive testament to the safety measures put in place to stop trials if they end up causing too much toxicity. Continue reading


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