Annual Meeting Proceedings Part 1 - American Society of Clinical ...

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6s Plenary Session 3 Oral Abstract Session, Sat, 3:00 PM-6:00 PM Bendamustine plus rituximab (B-R) versus CHOP plus rituximab (CHOP-R) as first-line treatment in patients with indolent and mantle cell lymphomas (MCL): Updated results from the StiL NHL1 study. Presenting Author: Mathias J. Rummel, Universitaetsklinik, Giessen, Germany The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Sunday, June 3, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Sunday edition of ASCO Daily News. 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. Presenting Author: Maha Hussain, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Sunday, June 3, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Sunday edition of ASCO Daily News. Visit abstract.asco.org and search by abstract for the full list of abstract authors and their disclosure information.
500 Oral Abstract Session, Sun, 8:00 AM-11:00 AM Impact of concurrent (CON) and sequential (SEQ) radiotherapy (RT) with adjuvant aromatase inhibitors (AI) in early-stage breast cancer (EBC): NCIC CTG MA.27. Presenting Author: Abdullah Khalaf Altwairgi, NCIC Clinical Trials Group, Queen’s University, Kingston, ON, Canada Background: Optimal timing of administration of adjuvant (adj) RT and AI in EBC is unknown. Methods: MA.27 was a phase III RCT of exemestane to anastrozole in postmenopausal women with hormone receptor positive EBC (Goss et al. Cancer Res. 70(24, Suppl):75s, 2010). The final trial database was used for this retrospective analysis. Median follow-up was 4.1 years. MA.27 patients received CON-AI [any overlap with AI; 4233 (57%) patients], SEQ-AI [RT preceded AI, no overlap with AI; 1010 (14%) patients] and No RT [AI only; 2128 (29%) patients]. Outcome measures for this analysis were: event free survival (EFS; time to locoregional or distant disease recurrence, new primary BC, or death from any cause), locoregional recurrence (LRFS), distant recurrence (DDFS) and overall survival (OS). RT groups were compared univariately (uni) with stratified log-rank tests, and multivariately (multi) with step-wise stratified Cox regression adjusted by stratification factors: nodal status, adj chemotherapy (chemo), celecoxib, aspirin, and trastuzumab. Results: 7371 eligible women received AI; were included in the analysis; and 71% (5243) received adj RT. CON-AI and SEQ-AI groups were comparable by median age (63 v 63), proportion T1 tumours (75% v 75 %), and mastectomy rate (10% v 11%). The frequency of axillary dissection for CON-AI and SEQ-AI was 48% v 44%, proportion N0 was 73% v 69%, and proportion receiving adj chemo 29% v 41%. CON-AI had similar uni results to SEQ-AI: EFS, HR�0.86, p�0.20; LRFS, HR�0.82, p�0.51; DDFS, HR�0.92, p�0.59; and OS, HR�1.04, p�0.80. In multi analyses, CON-AI had better EFS than SEQ-AI patients [stratified HR of CON-AI to SEQ-AI 0.78 (0.66 – 0.91), p�0.001]; as well, age�70 (p�0.0001), ECOG PS�1 (p�0.0001), L-sided tumours (p�0.02), T2-T4 (p�0.0001), N2/N3 (p�0.0001), and no adj chemo (p�0.01) had significantly shorter EFS. There was no multi difference between CON-AI and SEQ-AI for LRFS (p�0.50), DDFS (p�0.72), or OS (p�0.85). Conclusions: Patients receiving CON-AI had significantly better EFS than SEQ-AI suggesting timing of administration of AI and RT may affect patient outcomes. Further research is necessary to confirm these findings. 502 Oral Abstract Session, Sun, 8:00 AM-11:00 AM Adjuvant therapy with zoledronic acid (AZURE-BIG 01/04): The influence of menopausal status and age on treatment effects. Presenting Author: Helen Marshall, CTRU, Leeds, United Kingdom Background: The AZURE trial evaluated the use of zoledronic acid (ZOL) in addition to standard adjuvant therapy in patients with stage II/III breast cancer. Although analysis of the primary endpoint in the total study population showed no significant effects on disease outcomes, prespecified subgroup analyses identified significant benefit in both invasive disease-free survival (IDFS) and overall survival (OS) in women �5years postmenopause (Coleman et al. NESM. 2011;365:1396–1405). Here we evaluate the treatment modifying effects of both menopausal status and age. Methods: 3360 patients were randomized to receive standard (neo) adjuvant systemic therapy �/- ZOL 4mg iv every 3-4 weeks for 6 doses, then at reduced frequency to complete 5 years treatment. Results: ZOL had no overall effect on IDFS or OS at a median follow-up of 59 months. Pre-specified subgroup analyses showed significant heterogeneity of treatment effect (chi2 1 �7.91; p�.0049) on IDFS between those who were �5 years post-menopause (n�1041; adjusted HR� 0.75; 95% CI 0.59-0.96, p�0.02) and all other (pre, peri and unknown status) menopausal groups (n�2318; adjusted HR� 1.15; 95% CI 0.97-1.36, p�0.11). The treatment interaction between the two menopausal groups was related to differences in first extra-skeletal IDFS events (chi2 1 � 14.00, p�0.0002), rather than first recurrence in bone (chi2 1 � 0.14, p�0.70). In women aged �40, a significant worsening in extra-skeletal IDFS events was seen (HR � 1.68; 95% CI � 1.14-2.47, p�.008). Although the ZOL effect on IDFS improved by age from a negative effect in younger patients (�40) to a beneficial effect for those aged 54 and over (chi2 1(trend) � 5.96, p�0.015, using Cox model analysis to test for an interaction effect between age, menopausal status and treatment for IDFS (using age 55 as a cut-off) showed that the age effect is reversed by menopausal status, with this model providing a significantly better fit (chi2 2 � 22.8, p�.00001) than the aforementioned linear model. Conclusions: These results suggest menopausal status is more informative than age in the selection of patients for treatment with ZOL. In women aged �40, ZOL may increase extraskeletal recurrence. Breast Cancer—HER2/ER 501 Oral Abstract Session, Sun, 8:00 AM-11:00 AM Effect of osteoporosis in postmenopausal breast cancer patients randomized to adjuvant exemestane or anastrozole: NCIC CTG MA.27. Presenting Author: Lois E. Shepherd, NCIC Clinical Trials Group, Queen’s University, Kingston, ON, Canada Background: NCIC CTG MA.27 compared adjuvant steroidal [exemestane (E)] and non-steroidal [anastrozole (A)] aromatase inhibitors (AIs) and showed neither to be superior in breast cancer outcomes. AIs are known to increase the risk of osteoporosis. We examined the effects of baseline or subsequent self reported osteoporosis on disease outcomes. Methods: MA.27 enrolled 7,576 women. Event free survival (EFS) was the primary endpoint. Distant disease-free-survival (DDFS) was a secondary outcome. MA.27 permitted bisphosphonates to prevent or treat osteopenia or osteoporosis unless prohibited by enrollment to one of two cohorts in a bone substudy. Osteoporosis was considered present for this analysis if reported at baseline or prior to relapse or breast cancer death. Multivariate stratified Cox regression was used to examine the effects of trial therapy, osteoporosis, baseline patient and tumour characteristics on EFS; DDFS; bone only relapse; bone concurrent with other relapse; and non-bone recurrence. Bone marrow recurrence (N�8) was excluded. Results: Osteoporosis was reported at baseline by 654 of 7576 (8.6%) women, and prior to relapse by an additional 661 women. EFS events occurred in 693/7576 (9.15%). Osteoporosis was significantly associated with better EFS [HR 0.81 (95% CI 0.66-0.99), p�0.04] with no difference in multivariate HR of E vs A: 1.02, 95% CI 0.88-1.19, p�0.77. Women experienced 313 (4.1%) DDFS events. Osteoporosis was associated with better DDFS [HR 0.71 (95% CI 0.51-0.98), p�0.04], adjusted HR of E to A: 0.94 (95% CI of 0.75-1.17), p�0.56. Both EFS and DDFS interactions of osteoporosis with trial therapy were not significant (p�0.05). Osteoporosis was not significantly associated with the site of relapse. Conclusions: Osteoporosis had a significant prognostic association with improved EFS and DDFS in women treated with AIs. We plan to investigate the use of bisphosphonates, raloxifene treatment prior to randomization, and markers of bone resorption with outcome. 503 Oral Abstract Session, Sun, 8:00 AM-11:00 AM Whole genome sequencing to characterize luminal-type breast cancer. Presenting Author: Matthew James Ellis, Department of Internal Medicine, Division of Oncology, and Siteman Cancer Center, Washington University Medical Center, St. Louis, MO Background: To correlate clinical features of estrogen receptor positive breast cancer with somatic mutations, massively parallel sequencing (MPS) was applied to tumor and normal DNAs accrued from patients treated with neoadjuvant aromatase inhibitors (AI). Methods: MPS was applied to 77 baseline tumor biopsy samples from the preoperative letrozole trial (JACS 2009: 208, 906) and the Z1031 trial (JCO 2011: 29, 2342) followed by targeted sequencing in another 240 trial samples. Standard statistical approaches were used to compare mutation status and clinical parameters and pathway-based correlation was used to assess interactions between signaling perturbations induced by gene mutations and response to neoadjuvant AI. Results: Eighteen genes were significantly mutated above background. Aside from PIK3CA mutations, the list is dominated by loss-of-function mutations in tumor suppressor genes. Five (RUNX1, CBFP, MYH9, MLL3 and SF3B1) have been previously linked to benign and malignant hematopoietic disorders. Clinical correlation revealed that TP53 mutation was associated with PAM50 LumB status, high-grade histology and high proliferation rates whereas loss-of-function mutations in MAP3K1 associate with PAM50 lumA status, low proliferation rates, and low grade histology. Mutations in GATA3 were associated with greater suppression of proliferation upon AI treatment suggesting mut- GATA3 may predict endocrine response. Notably, mutations in MAP3K1 were more common in PIK3CA mutant cases, suggesting cooperation. Pathway analysis demonstrated that rare MAP2K4 mutations produce similar pathway perturbations as MAP3K1 mutation, a logical finding since MAP2K4 is a substrate for MAP3K1. Signaling network patterns driven by lncRNA MALAT1 mutations were associated with multiple poor clinical outcome features. Rare mutations in druggable kinases included two in the kinase domain of HER2. Conclusions: Tumor heterogeneity in luminal-type breast cancer is driven by specific patterns of somatic mutations, however most druggable or potentially prognostic mutations are infrequent. Prospective clinical trials based on these findings will require comprehensive genome sequencing approaches and large scale investigations. Visit abstract.asco.org and search by abstract for the full list of abstract authors and their disclosure information. 7s
Page 1: Volume 30, Issue 15S, Part I of II
Page 4 and 5: Editor: Michael A. Carducci, MD Man
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Page 8 and 9: Letter from the Editor The 2012 ASC
Page 10 and 11: JOURNAL of CLINICAL ONCOLOGY ......
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Author Index Note: Numerals refer t
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Alexanian, Raymond 8093 Alexeev, Bo
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Arkenau, Hendrik-Tobias 2540, 3000,
Page 710 and 711:
Ballen, Karen K. 6606, 6617, 6618,
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Ben-Aharon, Irit 548, 2556, e13080
Page 714 and 715:
Blancas, Isabel e11535, e11545, e21
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Brandes, Johann Christoph 7048, 106
Page 718 and 719:
Cakir, Betul 9567 Calabek, Bernadet
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Ceraulo, Domenica 4017 Cerbone, Lin
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Chinen, Ludmilla T.D. e16046 Chinen
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Come, Steven E. 9071, 9100 Comis, S
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Dahlheimer, Tambra 2546 Dahmane, El
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DeLacure, Mark D. e16052 Delage, Ju
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Domingo, Gelenis 6568, 6575, 6588 D
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El Sherbeiny, Esam e15129 El-Deiry,
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Fayad, Luis 6501, 8067 Fayette, Jer
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Foroni, Chiara e11546 Foroni, Letiz
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Gang, Wu 7091, e14511 Gangaram, Anj
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Gimenez Capitan, Ana 4068, 10596, e
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Granowetter, Linda 9537 Grant, Barb
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Hainsworth, John D. 618, 1018, 1086
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Heerschap, Arend e13111 Heersink, M
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Hong, Seung-Mo 3568 Hong, Sook Hee
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Im, Young-Hyuck 598^, 644, TPS649,
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Ji, Yongling e17527 Jia, Jingquan e
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Kaparelou, Maria 583 Kapaun, Christ
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Kim, Chan Kyu e14688 Kim, Chang Won
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Komatsu, Yoshihiro e14689 Komatsu,
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Laack, Nadia N. 2032, e14507 Laadem
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Lee, Ji-Hyun TPS3114, 6100 Lee, Jih
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Lim, Kian-Huat e14584 Lim, Kiat Hon
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Loupakis, Fotios 3518, 3540, 3546,
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Man, Shan e11061, e15177^ Manaloor,
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Mathieu-Nicot, Florence e19623 Math
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Mergenthaler, Hans-Guenther e15026
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Molero, Xavier e21035 Moles-Moreau,
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Munoz-Sanchez, MM e19590 Munsell, M
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Ng, Daniel e15050 Ng, Dawn Marie e1
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Oguri, Senri 5556 Oh, Do Youn 1003
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Palassini, Elena 10026, 10053, 1006
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Peisker, Uwe 10600 Peker, Deniz e18
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Piwnica-Worms, Helen 3047 Pizzo, Fa
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Rabinowits, Guilherme 5501, 5582, 9
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Reyes-Rivera, Irmarie CRA3503 Reyna
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Rose, Steven C. 3590 Rosell, Rafael
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Sakata, Shinya e18059 Sakata, Yuh 3
Page 796 and 797:
Schenkein, David P. 6606 Schepp, Wo
Page 798 and 799:
Sha, Dan 3564 Sha, Huifang e13528 S
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Silva, Jose D. 5567 Silva, Milton J
Page 802 and 803:
Sousa, Carlos Eduardo Pires 643 Sou
Page 804 and 805:
Su, Xinying 4124 Su, Yu-Chieh e1600
Page 806 and 807:
Tan, Chee Seng 1064, e19523 Tan, Ch
Page 808 and 809:
Tillmanns, Todd D. 5014, e15514 Til
Page 810 and 811:
Uchiyama, Tomotaka e21108 Udovitsa,
Page 812 and 813:
Videtic, Gregory M.M. e14611, e1466
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Wang, Yuan e15124 Wang, Yunfei 547
Page 816 and 817:
Wischnewsky, Manfred 1078 Wischnik,
Page 818 and 819:
Yasuda, Hiromi e14029 Yasuda, Hiroy
Page 820:
Zhang, Xinmin e16022 Zhang, Xu Dong
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