Some reflections on ASCO 2009
This year saw a very intriguing annual meeting in many ways.
Firstly, with the insanely packed schedule and the ban on chotckhes many doctors stayed away from the exhibit hall, making it much easier to find people although it did leave me with the distinct impression that it was mostly Pharma people spying on other Pharma people. After all, finding out how many sales reps on a new launch is hardly going to affect a brand's strategy, but knowing how they might be competing on the breadth and depth of clinical trials is compelling and more likely to affect their competitive advantage.
Secondly, the wealth of early data in an enormous variety of pathways in phase I and II research was very encouraging indeed for the future, although for medical oncologists the meeting might be perceived as a little disappointing from the perspective of new regimens that will change current treatment practice. I'll cover an extensive review tomorrow about the up and coming drugs and pathways.
The only real dramatic positive data was the Herceptin TOGA trial in gastric cancer. Currently, there is no real standard of care for the treatment of this disease, which is far more common in Asia than Europe or North America. Eric van Cutsem presented a fascinating study on behalf of the European EORTC group, although centres from around the world were included from multiple continents.
The main rationale behind the use of Herceptin in this trial is that similarly to breast cancer, some gastric cancers overexpress HER2. In fact, 3807 patients were screened to reveal 810 HER1-3 patients, of whom 584 (22.1%) entered the trial. Patients were randomised to receive either the combination of 5FU or capecitabine with cisplatin or 5FU/capecitabine and cisplatin plus trastuzumab (Herceptin).
The primary endpoint of the study was overall survival, with a multitude of secondary endpoints including PFS, TTP, ORR, CBR etc. The trial was powered to detect an improvement in median OS from 10 to 13 months. 97% of patients had metastatic disease and 90% had measurable disease.
The overall results were as follows:
FCT FC
OS 13.8 mon 11.1 mon HR 0.74, P<0.0046
PFS 6.7 mon 5.5 mon HR 0.71, P<0.002
In addition, when looking at the HER2+ subset:
OS 16.0 mon 11.8 mon HR 0.68
Adverse events were as expected for the drugs given and no additional toxicities were seen with the combination.
The authors concluded that the TOGA trial met it's primary endpoint, ie detecting a significant improvement in overall survival by the addition of trastuzumab to chemotherapy in gastric cancer. The impact of Herceptin reduced the risk of death by 26% and prolonged median survival by 4 months in HER2+ gastric cancer.
The discussant, Dr Dan Cunningham from the Royal Marsden Hospital in London, concluded that Herceptin added to chemotherapy represents a new safe and effective treatment option and standard of care for HER2+ patients in gastric cancer.
The most rewarding part of ASCO, though, is catching up with old friends and suppliers as well as existing clients and meeting new people, both live and on Twitter. Twitter has been an incredible tool for keeping up to date with the meeting and hearing snippets from other sessions is wonderful, because after all, you can't be there in every session with so many parallel tracks every day. It was a truly delight to meet a bunch of Twitter buddies in person, a very fine set of people I must say. They ran the gamut from patient advocacy, physicians, pharmacists, science writers, researchers, publishers and pharma people to name a few.
For those of you that missed it, you can still follow everyone's comment in the ASCO stream from Twitter here. Even I am still checking it out for things missed!