Annual Meeting Proceedings II - Newly Released Abstracts for

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GENITOURINARY CANCER 4 Plenary Session, Sun, 1:00 PM-4:00 PM Intermittent (IAD) versus continuous androgen deprivation (CAD) in hormone sensitive metastatic prostate cancer (HSM1PC) patients (pts): Results of S9346 (INT-0162), an international phase III trial. Maha Hussain, Catherine M. Tangen, Celestia S. Higano, E. David Crawford, Glenn Liu, George Wilding, Stephen Prescott, Atif Akdas, Eric Jay Small, Nancy Ann Dawson, Bryan J Donnelly, Peter Venner, Ulka N. Vaishampayan, Paul F. Schellhammer, David I. Quinn, Derek Raghavan, Nicholas J. Vogelzang, Ian Murchie Thompson; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; SWOG Statistical Center, Seattle, WA; Fred Hutchinson Cancer Research Center, Seattle, WA; University of Colorado Health Science Center, Aurora, CO; University of Wisconsin Carbone Cancer Center, Madison, WI; St. James University Hopsital, Leeds, United Kingdom; Marmara University, Istanbul, Turkey; University of California, San Francisco, San Francisco, CA; Georgetown Lombardi Comprehensive Cancer Center, Washington, DC; Prostate Cancer Institute, Calgary, AB, Canada; Cross Cancer Institute, Edmonton, AB, Canada; Karmanos Cancer Institute, Wayne State University, Detroit, MI; Urology of Virginia, Norfolk, VA; University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Carolinas Medical Center, Charlotte, NC; US Oncology Research, LLC, McKesson Specialty Health, The Woodlands, TX, and Comprehensive Cancer Centers of Nevada, Las Vegas, NV; University of Texas Health Science Center at San Antonio, San Antonio, TX Background: Castration resistance occurs in the vast majority of HSM1PC pts treated with AD, with a median survival of 2.5 years (y). It is in part an adaptive process with activation of genes resulting in the production of autocrine/paracrine growth factors that contribute to maintaining the viability of PC cells. Replacing androgens before castration resistance is hypothesized to maintain PC androgen-dependence. Preclinically IAD prolonged time to castration resistance and early clinical data indicated feasibility and potential for better quality of life. Methods: HSM1PC pts with performance status (PS) 0-2, PSA � 5 ng/ml were treated with 7 months (m) of goserelin � bicalutamide. Pts achieving PSA �4 ng/ml on m 6 and 7 were stratified by prior neoadjuvant AD/finasteride, PS and disease extent (minimal, extensive) and randomized to CAD or IAD. Primary objective: To assess if overall survival (OS) with IAD is noninferior to CAD using a one-sided test with an upper bound hazard ratio�1.20, adjusting for stratification factors. Sample size: 756 pts/arm, type I and II error rates of 0.05 and 0.10. Results: 3,040 pts were accrued by SWOG, CALGB, ECOG, NCIC, and EORTC (5/95- 9/08). After 7 m of CAD, 1535 eligible pts achieved PSA �4.0 (median age 70 yrs, 4% PS 2, 48% extensive disease, 12% prior neoadjuvant AD) and were randomized to CAD (759 pts) or IAD (770 pts). Grade 3/4 related adverse events: IAD 30.3%, CAD 32.6%. Median follow-up was 9.2 yrs. Median and 10 yr OS: All eligible pts from study entry: 3.6 yrs, 17%; from randomization CAD: 5.8 yrs, 29%; IAD: 5.1 yrs, 23%, HR (IAD/CAD) � 1.09 (95% CI 0.95, 1.24). No interaction with therapy was significant (p�0.25) except suggestion with disease extent (p�0.08): extensive disease HR�0.96 (95% CI 0.79, 1.15, p�0.64); minimal disease: HR�1.23 (95% CI 1.02, 1.48, p�0.035). PC was cause of death in 56% of CAD and 64% IAD pts. OSby race was not different (p�0.44). Conclusions: In HSM1PC, IAD is not proven to be noninferior to CAD. For extensive disease pts IAD was noninferior; however, IAD was statistically inferior in minimal disease pts suggesting that CAD is the preferred treatment in this group. © 2012 American Society of Clinical Oncology. Reprinted with permission.
BREAST CANCER—HER2/ER LBA506 Oral Abstract Session, Sun, 8:00 AM-11:00 AM Evaluation of lapatinib as a component of neoadjuvant therapy for HER2� operable breast cancer: NSABP protocol B-41. Andre Robidoux, Gong Tang, Priya Rastogi, Charles E. Geyer, Catherine A. Azar, James Norman Atkins, Louis Fehrenbacher, Harry Douglas Bear, Luis Baez-Diaz, J. Phillip Kuebler, Richard G. Margolese, William Blair Farrar, Adam Brufsky, Henry R. Shibata, Hanna Bandos, Soonmyung Paik, Joseph P. Costantino, Sandra M. Swain, Eleftherios P. Mamounas, Norman Wolmark; National Surgical Adjuvant Breast and Bowel Project and Centre Hospitalier de l’Universite de Montreal, Montreal, QC, Canada; NSABP Biostatistical Center and University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA; National Surgical Adjuvant Breast and Bowel Project and University of Pittsburgh Cancer Institute, Pittsburgh, PA; National Surgical Adjuvant Breast and Bowel Project and University of Texas, Southwestern Medical Center, Dallas, TX; National Surgical Adjuvant Breast and Bowel Project and Kaiser Permanente, Denver, CO; National Surgical Adjuvant Breast and Bowel Project and SCCC-CCOP, Goldboro, NC; National Surgical Adjuvant Breast and Bowel Project and Kaiser Permanente Northern California, Vallejo, CA; National Surgical Adjuvant Breast and Bowel Project and Virginia Commonwealth University, Masey Cancer Center, Richmond, VA; National Surgical Adjuvant Breast and Bowel Project and CCOP San Juan, San Juan, PR; National Surgical Adjuvant Breast and Bowel Project and CCOP Columbus, Columbus, OH; National Surgical Adjuvant Breast and Bowel Project and Segal Cancer Centre, Jewish General Hospital, McGill University, Montreal, QC, Canada; National Surgical Adjuvant Breast and Bowel Project and Arthur G. James Cancer Hospital-Richard J. Solous Research Institute at Ohio State University, Columbus, OH; National Surgical Adjuvant Breast and Bowel Project and University of Pittsburgh, Magee-Womens Hospital, Pittsburgh, PA; National Surgical Adjuvant Breast and Bowel Project and McGill University Health Centre, Montreal, QC, Canada; NSABP Biostatistical Center, University of Pittsburgh, Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA; National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA; National Surgical Adjuvant Breast and Bowel Project Biostatistical Center and University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA; National Surgical Adjuvant Breast and Bowel Project and Washington Cancer Institute, MedStar Washington Hospital Center, Washington, DC; National Surgical Adjuvant Breast and Bowel Project and Aultman Hospital, Canton, OH; National Surgical Adjuvant Breast and Bowel Project and Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA Background: The purposes of this trial are to determine the effect of substituting lapatinib (L) for trastuzumab (T) in combination with weekly paclitaxel (WP) following AC as well as adding L to T with WP following AC on pathologic complete response (pCR) rates. Methods: Women with HER2-positive operable breast cancer received standard AC q3wks x 4 cycles followed by WP (80 mg/m 2 ) on days 1, 8, and 15 q28 days x 4 cycles. Concurrently with WP, patients received either T (4 mg/kg load, then 2 mg/kg) weekly until surgery, L (1250 mg) daily until surgery, or weekly T plus L (750 mg) daily until surgery. Following surgery, patients received trastuzumab to complete 52 wks of HER2-targeted therapy. The primary endpoint is pCR breast. For each of the two primary comparisons, the Fisher’s exact test was used to test the equality of pCR rates. A Hochberg-type step-up procedure was applied to address multiple testings and to control the family-wise error rate at 0.05. Results: 51% were clinically node positive and 63% had HR� tumors. pCR assessments were available from 519 of 529 patients. pCR percentage was 52.5% for AC¡WP�T, 53.2% (p�0.9) for AC¡WP�L, and 62% (p�0.075) for AC¡WP�TL. pCR percentages in the HR� subset were 46.7%, 48% (p�0.85), and 55.6% (p�0.18), respectively, and were 65.5%, 60.6% (p�0.57), and 73% (p�0.37) in the HR- cohort. The corresponding pCR breast and nodes percentages were 49.1%, 47.4% (p�0.74), and 60.4% (p�0.04). Grade 3/4 toxicities include diarrhea in 2%, 20%, 27% (p�0.001), and symptomatic Gr 3/4 left ventricular systolic dysfunction in 4%, 4%, and 2% (p�0.49). Conclusions: Substitution of lapatinib for trastuzumab in combination with the chemotherapy program employed in this study resulted in similar high percentages of pCR in both HR� and HR- cohorts. Combined HER2-targeted therapy produced a numerically higher pCR percentage than single agent HER2-directed therapy, but the difference was not statistically significant. Central review of HER2 and ER is being conducted to determine if subsets benefiting from the combined HER2-targeted therapy can be identified. Funding: GlaxoSmithKline. © 2012 American Society of Clinical Oncology. Reprinted with permission.
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