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The Front Line
The Front Line: Charles D. Blanke, MD, SWOG Chair

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Glimpses of the Future: S1222, Fulvestrant, and SWOG-CTI

Dec 19, 2014 - Federal support of cancer research in recent years has yada, yada .... I can probably stop there. You know the rest. And you also know it means, more than ever, that we need to cast a wider net to find support for critical trials -- from industry, foundations, even Kilimanjaro climbs. SWOG-Clinical Trials Initiative, or SWOG-CTI, is our framework for channeling that support from disparate sources into our clinical research. SWOG-CTI has provided non-federal funds to many trials over the last six years, but there's only one study for which it has been the sole means of support -- the current phase III breast cancer study S1222.

A three-arm trial comparing fulvestrant alone to fulvestrant with everolimus to fulvestrant with everolimus and anastrozole in patients with metastatic, HR+ breast cancer, S1222 may be a model for how more of our future studies may be conducted. It was activated back in May, but it's taking its time getting up to full speed in terms of site participation and patient accrual. Today, 146 institutions have opened the study. Together those sites have enrolled 29 patients.

To help us all refocus on this critical study and perhaps bump it up on our crowded priority lists, I want to let you know about some findings reported at the San Antonio Breast Cancer Symposium last week that make S1222 all the more essential. Researchers on the European phase II FIRST study reported that for patients with advanced, HR+ breast cancer, median overall survival was better with first-line fulvestrant (54.1 months) than with first-line anastrozole (48.4 months). In corresponding about the importance of these results, SWOG Executive Officer Julie Gralow put it pretty succinctly: "I really think FIRST makes a strong case for fulvestrant first-line as the control arm in S1222. ... And we [emphasis mine] are asking can we do even better than fulvestrant alone?" The FIRST findings ratchet up the possible benefits we could see in answering S1222's questions about adding everolimus and anastrozole to first-line fulvestrant, and its translational medicine questions about the value of liquid biopsies to identify molecular markers of treatment response by analyzing DNA from circulating tumor cells.

And of course having a successful working model for fully funding trials in a brave, new world with less federal support wouldn't be a bad thing either.

If you do not have S1222 open at your site, please let us know why. If you have it open but are finding it a challenge to enroll patients, again please let us know why. We will do what we can to help you meet those challenges! We're working hard to meet our original goals with this study design, and we know you will too. If accrual continues to lag, however, we would have to consider making some changes to the study's statistical design within the next year. It would of course be highly desirable to avoid that step!

P.S.: Some of you have had questions about funding for this study. To clarify, the latest S1222 funding memo is pasted below. You can read the full S1222 funding memo online.


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