Special Exceptions and Status Changes
Abstract Policy Exceptions
According to ASCO's Abstract Policy, abstracts submitted to the Annual Meeting are confidential from the time of submission until the specified embargo lift date and time when the data becomes publicly available. Under extenuating circumstances, ASCO may grant a formal exception to its Abstract Policy. Abstract Policy Exceptions require advance approval by ASCO before the information is made public. To request an Abstract Policy Exception, please contact Laura Livingston at firstname.lastname@example.org or 571-483-1352. For general abstract status inquiries, please contact email@example.com.
Abstract Status Changes
Occasionally, an abstract will be withdrawn or removed from the meeting after it has been published as part of the program. Prior to the Annual Meeting, ASCO will post a list of all published abstracts that have subsequently been either withdrawn or removed from the Meeting.
The majority of ASCO Annual Meeting Abstracts for 2010 will be publicly released on ASCO’s website, ASCO.org, on Thursday, May 20 at 6:00 p.m. (EDT). The online abstracts will be fully searchable at that time.
The more than 5,000 abstracts accepted from around the world include a large number of important studies, many of which will have important, and in some cases, immediate implications for patient care. Plenary, Late-Breaking (LBA), and Clinical Review Abstracts will be publicly released on site at the Annual Meeting according to a specific schedule published as part of ASCO’s Annual Meeting Embargo Policy. This process ensures that pivotal research accepted into ASCO’s Annual Meeting is presented and discussed in a peer-review setting. These abstracts will be made publicly available online over the duration of the weekend.
All ASCO Members and Journal of Clinical Oncology (JCO) subscribers will receive the Annual Meeting Proceedings Part I containing the posted abstracts with their May 20th issue of the JCO. The Annual Meeting Proceedings Part II, containing the Plenary, LBA, and CRA abstracts will be distributed onsite at the meeting in print and CD-ROM format, and will mail with the June 20th issue of the JCO. Please note, Proceedings Part I will be provided on site to all meeting attendees in electronic format and also will be available in print upon request.
Reporters and Public Relations representatives should consult ASCO’s Media Policies and Public Relations policies respectively for specific information regarding ASCO’s media embargo.
ASCO has granted formal Policy Exceptions for the following abstracts to allow limited information to be made publicly available in advance of the Annual Meeting due to Securities and Exchange Commission (SEC) requirements:
Lenalidomide maintenance after transplantation for myeloma.
The AVAGAST trial: A randomized, double-blind, placebo-controlled, multicenter phase III study of capecitabine and cisplatin plus bevacizumab or placebo as first-line therapy in patients with advanced gastric cancer.
Denosumab versus zoledronic acid for treatment of bone metastases in patients with castration-resistant prostate cancer.
Phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), or fallopian tube cancer (FTC): A Gynecologic Oncology Group study.
A randomized, double-blind, placebo controlled phase III trial comparing docetaxel, prednisone, and placebo with docetaxel, prednisone, and bevacizumab in men with metastatic castrate-resistant prostate cancer (metCRPC): Survival results of CALGB 90401.
Results from ARQ 197-209: a global randomized placebo-controlled phase 2 clinical trial of erlotinib plus ARQ 197 versus erlotinib plus placebo in previously treated EGPR-inhibitor naive patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
A phase III random assignment trial comparing percutaneous hepatic perfusion with melphalan (PHP-mel) to standard of care for patients with hepatic metastases from metastatic ocular or cutaneous melanoma.
The following abstracts are in violation of ASCO’s embargo policy and are now publicly available:
ACOSOG Z1031: A randomized phase II trial comparing exemestane, letrozole, and anastrozole in postmenopausal women with clinical stage II/III estrogen receptor-positive breast cancer.
Authors: M. J. Ellis, A. Buzdar, G. Babiera, G. W. Unzeitig, L. Esserman, P. K. Marcom, J. M. Guenther, A. M. Leitch, K. Deshryver, D. C. Allred, V. Suman, K. Hunt, J. A. Olson
Background: Neoadjuvant aromatase inhibitor (AI) therapy is a rational and effective approach to improving the breast conservation surgery (BCS) rate for postmenopausal patients with large, estrogen receptor (ER) rich breast cancers. Barriers to adopting this strategy include lack of experience in this management approach in the US and uncertainty regarding the comparative effectiveness of the three approved aromatase inhibitors for this indication.
Methods: ACOSOG Z1031 is a multicenter, open-label, neoadjuvant phase III screening study that randomized postmenopausal women with clinical stage II/III ER rich (Allred score 6-8) breast cancer to 16 weeks of either exemestane (EXE) 25 mg daily, letrozole (LET) 2.5 mg daily, or anastrozole (ANA) 1 mg daily. At baseline study participants were either marginal for BCS (MBCS), candidates for mastectomy only (MO), or inoperable (IO). Planned enrolment was 125 patients per arm in order that the likelihood of the treatment with the "best" 16-week clinical response rate (based on caliper measurements) by WHO criteria (cRR) was included among the subset of treatments with "similar" cRR (90% power). Secondary endpoints included: extent of surgery, radiologic and pathologic response rates.
Results: From 4/1/2006 to 10/1/2009, 377 postmenopausal women with clinical stage II or III ER rich breast cancer were enrolled. 374 women began treatment and were included in an intent-to-treat analysis. Median age was 66 yrs (range: 43-90 yrs), Median tumor size was 4.0 cm (range: 2-13 cm). The 16-week cRR was 60.5% (95%CI: 51.3-69.1%) for EXE; 70.9% (95% CI: 62.2-78.6%) for LET, and 66.7% (95% CI: 57.6-74.9%) for ANA. Seventeen patients did not have surgery due to refusal (12 pts), progression (3 pts) or other medical conditions (2 pts). The BCS rate was 78% (163/207) in MBCS group; 42% (77/163) in MO group; and 75% in IO group (3/4). Surgeons made the decisions regarding procedure choice 75% of the time in both the MBCS and the MO categories.
Conclusions: This large multicenter screening trial selected non-steroidal AIs for further development due to their higher observed cRR. The study demonstrates that high response and breast conservation rates and low rates of disease progression can be achieved through patient selection based on high ER expression. We are currently refining our approach for early detection of poor response to AIs through an assessment of the tumor Ki67 proliferation index at 2 to 4 weeks (Z1031 Cohort B).