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Old 05-18-2014, 01:34 PM   #1
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Post Upcoming Abstracts for Her2 Breast Cancer ASCO 2014

http://abstracts.asco.org/144/CatAbs...44_413_AT.html
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Old 05-18-2014, 01:35 PM   #2
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Re: Upcoming Abstracts for Her2 Breast Cancer ASCO 2014

2014 ASCO Annual MeetingAbstract No:
623
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2014 ASCO Annual Meeting!


Session: Breast Cancer - HER2/ER
Type: General Poster Session
Time: Monday June 2, 8:00 AM to 11:45 AM
Location: S Hall A2
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Author(s): Dimitrios Mavroudis, Nikolaos A. Malamos, Stylianos Kakolyris, Ioannis Boukovinas, Pavlos Papakotoulas, Nikolaos Ziras, Vassilis Georgoulias; Hellenic Oncology Research Group (HORG), Athens, Greece
Abstract Disclosures

Abstract:

Background: Adjuvant trastuzumab in combination with chemotherapy improves outcome of women with HER2 positive early breast cancer. However, the optimal duration of treatment remains unknown. In this study we compared 6 versus 12 months of adjuvant trastuzumab. Methods: Axillary node positive or high risk node negative women with HER2 overexpressing or amplified early breast cancer were randomized following surgery to receive either 6 (arm A) or 12 (arm B) months of adjuvant trastuzumab in combination with dose dense G-CSF-supported Docetaxel (75mg/m2 every 14 days for 4 cycles) following FEC (5FU 700mg/m2, epirubicin 75mg/m2, cyclophosphamide 700mg/m2 every 14 days for 4 cycles). The primary endpoint of the study was the 3-year disease-free survival (DFS). Results: Four hundred eighty one patients were randomized; 240 on arm A and 241 on arm B. Of them 83 (34%) and 100 (41%) were premenopausal, 200 (83%) and 180 (75%) were node positive, 165 (69%) and 156 (65%) were hormone receptor positive in arm A and B, respectively. Chemotherapy was completed in 98% and 99% of patients while trastuzumab therapy in 96% and 100% of patients in arm A and B, respectively. After a median follow up of 43.5 and 42 months there were 26 (10.8%) and 15 (6.2%) (p=0.07) disease relapses and the median DFS has not yet been reached (p=0.08) while the 3-year DFS rate was 92.4% and 95.1% for arm A and B, respectively. Conclusions: Preliminary results of this study in terms of disease relapse and DFS are in favor of 12 months of adjuvant trastuzumab administration. Clinical trial information: NCT00615602.
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Old 05-18-2014, 01:38 PM   #3
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Re: Upcoming Abstracts for Her2 Breast Cancer ASCO 2014

A phase II study with lead-in safety cohort of cabazitaxel (C) plus lapatinib (L) as therapy for HER2+ metastatic breast cancer (MBC) with intracranial metastases (mets).

Abstract No:
TPS667
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Session: Breast Cancer - HER2/ER
Type: General Poster Session
Time: Monday June 2, 8:00 AM to 11:45 AM
Location: S Hall A2
Personalize your Meeting experience with a suggested or customized itinerary!

Author(s): Denise A. Yardley, John D. Hainsworth, Erika Paige Hamilton, Lowell L. Hart, Mythili Shastry, Laura M. DeBusk, Howard A. Burris; Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN; Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Florida Cancer Specialists/SCRI, Fort Myers, FL; Sarah Cannon Research Institute, Nashville, TN
Abstract Disclosures

Abstract:

Background: Although HER2-targeted therapy has improved outcomes in HER2+ breast cancer (BC) patients (pts), CNS mets continue to be a significant source of morbidity and mortality. Inability of drugs like trastuzumab to cross the blood-brain barrier (BBB) renders the CNS a sanctuary site for mets. L is a small molecule tyrosine kinase EGFR1/HER2 inhibitor that crosses the BBB and is active against CNS mets. C is a new taxane approved for prostate cancer that is also active in taxane-resistant metastatic breast cancer (MBC) and distinguishes itself by its ability to cross the BBB. The activity shown by C in taxane-resistant MBC as well as the CNS penetrance of both C and L make this an attractive combination for HER2+ MBC pts with CNS mets. Methods: This is an open-label, non-randomized, phase II study with a lead-in safety cohort (NCT01934894). Pts ≥ 18 yrs with HER2+ (by FISH or IHC 3+) MBC and CNS mets are eligible. Patients must have either at least 1 untreated measurable CNS lesion ≥ 5mm in longest dimension on MRI or at least 1 previously treated (by WBRT and or/SRS) CNS lesion with evidence of intra-cranial disease progression following WBRT or SRS. Pts must have had at least 1 prior HER2 therapy; first line MBC pts are eligible only if they progressed during or within 6 mos of adjuvant therapy. Prior treatment (tx) with C is not permitted. During the lead-in, cohorts of 3 pts will be treated with escalating doses of q 3 weeks (wks) C and daily L to determine the tolerability and optimal dose. Subsequent pts will be treated with the identified optimal dose combination. Each tx cycle is 3 wks and systemic and intra-cranial disease restaging will occur every 2 cycles for the first 8 cycles and then every 3 cycles until PD or unacceptable toxicity. The primary study objectives are to determine the safety and CNS ORR (ORR=CR+PR) of the combination of C and L in HER2+ MBC pts. Secondary objectives include evaluation of the clinical benefit rate ([CBR]CR+PR+SD ≥ 6 mos), 3- and 6-mo PFS rate for CNS mets, and response rate and CBR for extra-cranial mets. The trial is ongoing. Clinical trial information: NCT01934894.
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Old 05-18-2014, 01:39 PM   #4
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Re: Upcoming Abstracts for Her2 Breast Cancer ASCO 2014

A study of the anatomic distribution of brain metastases in HER2+ breast cancer: Implications for hippocampal avoidance PCI.



Abstract No:
e11578
Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2014 ASCO Annual Meeting but not presented at the Meeting, can be found online only.

Author(s): Jacob Witt, Timothy J. Pluard, Daniel John Ferraro, Jerry Jeff Jaboin, Maria Anne Thomas, Imran Zoberi, Cliff Grant Robinson; Washington University in St. Louis, St. Louis, MO; Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO; Washington University School of Medicine in St. Louis, St. Louis, MO
Abstract Disclosures

Abstract:

Background: While only 20% of all breast cancer is HER2+, it represents a disproportionate majority of breast cancer brain metastases, and up to half of these patients will die of CNS disease. Prophylactic cranial irradiation (PCI) reduces the risk of brain metastases and improves survival in small cell lung cancer, but at the cost of neurocognitive decline in 30-40%. RTOG 0933 demonstrated a reduction in neurocognitive decline with hippocampal-avoidance (HA) whole brain radiation compared with historic controls. HA-PCI may represent an approach to reduce the risk of symptomatic HER2+ brain metastases while simultaneously reducing the risk of neurotoxicity, presuming the incidence of metastases within the HA zone is low. Methods: Patients with HER2+ breast cancer and brain metastases treated with whole brain radiation (WBRT) or stereotactic radiosurgery (SRS) from 1/2004-2/2012 were identified from registries in the Department of Radiation Oncology. Pretreatment T1-weighted, postcontrast axial MRI images were reviewed, and metastases were scored as being within a 5 mm HA zone (as done in RTOG 0933), and further subdivided by whether (1) any portion was within the avoidance zone or (2) the nidus (assuming concentric growth of the metastasis) was within the HA zone. Results: Seventy-three patients with 513 metastases were identified. The median age was 52.2. The median number of brain metastases per patient was 7.03 (range, 1-157). 40 of the patients were treated with WBRT and 21 were treated with SRS, with the remainder undergoing unknown or no radiation therapy. Eleven patients (15.1%) and 14 metastases (2.7%) had any portion of the metastasis within the HA zone while only 5 patients (6.85%) and 5 metastases (0.97%) had the tumor nidus within the HA zone. Conclusions: Metastases within the HA zone are uncommon. Use of a 5 mm expansion from the hippocampus to create a HA zone for HA-PCI would be projected to result in a 1-3% excess risk of failure. Such a low risk of failure would be acceptable, particularly with the ability to salvage such patients with techniques such as SRS. A pilot study of HA-PCI for HER2+ metastatic breast cancer is in development.
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Old 05-18-2014, 01:41 PM   #5
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Re: Upcoming Abstracts for Her2 Breast Cancer ASCO 2014

Adjuvant and neoadjuvant trastuzumab in combination with vinorelbine for HER2+ breast cancer.

Abstract No:
e11585
Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2014 ASCO Annual Meeting but not presented at the Meeting, can be found online only.

Author(s): Khashayar Esfahani, Cristiano Ferrario, Philippe Le, Lawrence C. Panasci; Lady Davis Institute, Jewish General Hospital, Montreal, QC, Canada; McGill University, Montreal, QC, Canada
Abstract Disclosures

Abstract:

Background: Growing evidence suggest that even small early stage HER2+ breast cancers (BCs) should be treated with adjuvant chemotherapy to reduce recurrence rates. Some patients are not candidate for anthracycline-based chemotherapy, given their frailty or preference to avoid chemotherapy-related toxicities. Phase III randomized trials of Herceptin with vinorelbine (HV) in metastatic breast cancer patients have shown good response rates and favorable toxicity profiles of HV over taxane-based regimens. We herein report our experience with patients receiving HV at our institution. Methods: Retrospective data was collected on all stage I-III patients receiving HV as the only chemotherapy regimen in the adjuvant and neoadjuvant settings. Most patients received HV on a weekly basis (one week off for V every 3–4 weeks) for 6 months, followed by 6 more months of H. Results: Between 2003 and 2012, 46 HER2+ patients were identified (adjuvant: n=36; neoadjuvant: n=10). Median age was 65. 81% of patients in the adjuvant arm had Stage I disease, and 61% of all patients were ER/PR+. 3 patients in the neoadjuvant arm had a complete pathological response. All patients treated in the neo-adjuvant arm have remained disease-free. Only one patient had a local recurrence following a short course of HV (3 months). She was retreated with the same regimen following surgical resection, and has remained disease-free since. Overall survival and disease-free survival were 94% and 98% respectively at 5 years of median follow-up. One patient with significant medical comorbidities died of febrile neutropenia induced sepsis, and two others died of comorbidities unrelated to their cancer or treatment. Grade 3-4 adverse effects included neutropenia (22%), febrile neutropenia (8%), fatigue and anemia (2% each). During therapy, 6 patients had an asymptomatic 10–20% drop in the LVEF (Grade 1), with complete recovery on follow-up MUGA scans. Conclusions: HV is a reasonable alternative to standard adjuvant chemotherapy for patients with non-metastatic breast cancer that are not candidates for standard chemotherapy. Further prospective data is required to establish the role of HV in stage I HER2+ BC, for which no standard treatment is defined.
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Old 05-18-2014, 01:44 PM   #6
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Re: Upcoming Abstracts for Her2 Breast Cancer ASCO 2014

Association of basal marker expression with outcome and trastuzumab resistance in HER2-positive breast cancer.



Abstract:

Background: Herceptin resistance is a significant challenge in the treatment of Her2-positive (Her2+) breast cancer. A subset of Her2+ breast cancers are known to express basal genes (basal Her2). We investigated the effect of basal gene expression on cell viability and Herceptin response in Her2+ breast cancer cell lines and on prognosis in patients with Her2+ breast cancer who received Herceptin. Methods: We selected 4 cell lines to represent basal Her2 (HCC1569, HCC1954) and non-basal Her2 (BT474, SKBR3) breast cancer based on their basal gene signature in microarray analysis, and treated each with vehicle, Herceptin (H), Paclitaxel (P), and H + P. Cell viability was assessed by MTT assays. Her2 pathway suppression was compared between groups using immunoblotting with anti-Her2, p-AKT, p-ERK antibodies. Expression of CK5/6, CK14, and EGFR was evaluated after immunohistochemical staining in paraffin-embedded tissue of 88 patients with Stage 1-3 Her2+ breast cancer treated with chemotherapy and Herceptin. Groups with and without basal gene expression were compared with respect to clinicopathologic parameters and survival. Results: All cell lines expressed similar levels of Her2. Both H and P alone inhibited proliferation of non-basal cell lines, and H + P had an additive cytotoxic effect. Basal cells were resistant to H, P inhibited proliferation, but H + P had no additive cytotoxic effect on cell growth in basal cells. Immunoblotting showed a significant decrease in p-Akt levels after treatment with H or H + P in non-basal cells but not in basal cells. No alterations were observed in p-ERK levels in the 4 cell lines when treated with H and H + P. Of the Her2+ patients, 33/88 (37.5%) expressed at least one basal gene. Basal Her2 tumors were associated with higher grade (p=0.04) and more ER/PR-negativity (p<0.01). CK14 expression correlated with worse overall survival by log-rank test (p=0.02), while EGFR showed a similar trend (p=0.06). Conclusions: Basal Her2 cell lines are resistant to Herceptin. This resistance is associated with Herceptin refractory PI3K/Akt activity. CK14 expression is predictive of worse prognosis in Her2+ breast cancer patients treated with Herceptin.
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Old 05-18-2014, 01:48 PM   #7
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Re: Upcoming Abstracts for Her2 Breast Cancer ASCO 2014

Association of genomic analysis of immune function genes and clinical outcome in the NCCTG (Alliance) N9831 adjuvant trastuzumab trial.



Abstract No:
509
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Session: Harnessing Biology and Immunology to Develop Novel Biomarkers
Type: Clinical Science Symposium
Time: Saturday May 31, 1:15 PM to 2:45 PM
Location: N Hall B1
Personalize your Meeting experience with a suggested or customized itinerary!

Author(s): Edith A. Perez, E. Aubrey Thompson, S. Keith Anderson, Yan W. Asmann, Krishna R. Kalari, Jeanette Eckel-Passow, Amylou C. Dueck, Kathleen S. Tenner, Jin Jen, Jian-Bing Fan, Xochiquetzal Geiger, Ann E. McCullough, Beiyun Chen, Michael Zschunke, Robert B. Jenkins, George W. Sledge, Eric P. Winer, Julie Gralow, Monica Madden Reinholz, Karla V. Ballman; Mayo Clinic, Jacksonville, FL; Mayo Clinic, Rochester, MN; Mayo Clinic, Scottsdale, AZ; Illumina, Inc., San Diego, CA; Stanford University, Palo Alto, CA; Dana-Farber Cancer Institute, Boston, MA; Seattle Cancer Care Alliance, Seattle, WA
Abstract Disclosures

Abstract:

Background: Some 20-25% of patients with HER2+ disease relapse after adjuvant trastuzumab (H). We used a genomic approach to define biological processes that predict benefit from H. Methods: Whole genome DASL technology was used to identify genes associated with relapse-free survival (RFS) among 1,282 patients enrolled in the N9831 adjuvant H trial (NCT00005970). Cox proportional hazard ratios (HR), adjusted for significant clinical/pathological risk factors, were used to determine the association of each gene with RFS (median follow-up 6years, 11months) for 433 patients who received chemotherapy alone and 849 patients who received chemotherapy plus H. Functional ontology analysis and network modeling were used to identify key biological processes associated with RFS in patients who received chemotherapy alone or chemotherapy plus trastuzumab. Results: Using probes with HR p<0.01, 10/13 significantly enriched biological processes associated with increased RFS (p<0.01) were linked to immune functions. These 10 processes defined a cohort of 87 immune function genes. Patients defined as immune function positive based on the 87 genes experienced a favorable outcome when treated with H (HR=0.55, p=0.0005). Patients who did not exhibit immune function enrichment and were treated with H did not have better RFS than patients with immune function enrichment who were treated with chemotherapy alone (HR=0.93, p=0.72). Among patients who received chemotherapy alone, enriched immune function was not associated with increased RFS (HR=1.01, p=0.96). Conclusions: Improved RFS following treatment with adjuvant H appears to be associated with a heightened state of immunological function. This observation may define a significant biological process that is linked to the efficacy of HER2-targeted therapy, may provide a means of predicting probability of relapse following adjuvant trastuzumab, and suggests possible routes of therapeutic enhancement.
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Old 05-18-2014, 01:50 PM   #8
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Re: Upcoming Abstracts for Her2 Breast Cancer ASCO 2014

AVATAXHER: An open-label, randomized, multicenter study investigating the addition of bevacizumab (B) to neoadjuvant trastuzumab (T) plus docetaxel (D) in patients with early stage HER2-positive breast cancer (HER2+ BC) stratified according to PET change after one therapy cycle.

Abstract No:
507
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2014 ASCO Annual Meeting!


Session: Breast Cancer - HER2/ER
Type: Oral Abstract Session
Time: Saturday May 31, 3:00 PM to 6:00 PM
Location: N Hall B1
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Author(s): Bruno P. Coudert, Jean-Yves Pierga, Marie-Ange Mouret-Reynier, Khaldoun Kerrou, Jean-Marc Ferrero, Thierry Petit, Pierre Kerbrat, Pierre-Francois Dupre, Thomas Denis Bachelot, Philippe Gabelle, Sylvia Giard, David Coeffic, Philippe Bougnoux, Jean Briac Prevost, Gilles Paintaud, Gilles Thibault, Juana Hernandez, Mathieu Coudert, Laurent Arnould, Alina Berriolo-Riedinger; Department of Medical Oncology, Centre Georges-Francois Leclerc, Dijon, France; Department of Medical Oncology, Institut Curie, Paris, France; Department of Medical Oncology, Centre Jean Perrin, Clermont-Ferrand, France; Department of Nuclear Medicine, Hopital Tenon, Paris, France; Centre Antoine Lacassagne, Department d'Oncologie Medicale, Nice, France; Department of Medical Oncology, Centre Paul Strauss, Strasbourg, France; Centre Eugène Marquis, Rennes, France; Service de Gynécologie, Hôpital Cavale Blanche, Brest, France; Département d'Oncologie Médicale, Centre Léon Berard, Lyon, France; Department of Surgery, Institut Daniel Hollard, Grenoble, France; Department of Surgery, Centre Oscar Lambret, Lille, France; Department of Medical Oncology, Clinique Hartmann, Neuilly sur Seine, France; Department of Medical Oncology, CHU Bretonneau, Tours, France; Department of Medical Oncology, Centre Pierre Curie, Beuvry, France; Pharmacology Department, CHU Bretonneau, Tours, France; Immunology Department, CHU Bretonneau, Tours, France; Roche SAS, Boulogne-Billancourt, France; Experis IT, Nanterre, France; Department of Pathology, Centre Georges-Francois Leclerc, Dijon, France; Department of Nuclear Medicine, Centre Georges-Francois Leclerc, Dijon, France
Abstract Disclosures

Abstract:

Background: T-based neoadjuvant chemotherapy achieves pCR rates of ~50% in HER2+ BC, enabling frequent conservative surgery. Pre-clinical and clinical data support the synergistic combination of B and T. The ph II AVATAXHER trial (EUDRACT 2009-013410-26) investigated whether adding B to neoadjuvant T+D improved pCR rates in tumors with a low likelihood of attaining pCR (predicted based on relative change in FDG tumoral uptake [ΔSUV] after one cycle of T+D). Methods: Patients were ≥18 yrs old with stage T2/3, N0/1 HER2+ BC. Patients received two 3-weekly cycles of T (8 mg/kg, then 6 mg/kg) and D (100 mg/m2). Those with ≥70% ΔSUV in PET values between cycle 1 and 2 received four more cycles of T+D, one cycle of T, then surgery (standard arm). Those with <70% ΔSUV were randomized 2:1 to four cycles of T+D+B (15 mg/kg; arm a) or T+D (arm b), then one T cycle and surgery. The primary endpoint was pCR rate at surgery. The positive (PPV) and negative predictive value (NPV) of ΔSUV on pCR rate and safety were also investigated. Results: 152 patients were recruited at 26 sites (10 were withdrawn pretreatment; ITT=142). 37/69 (53.6%) patients in the standard arm achieved pCR, 21/48 (43.8%) in arm a and 6/25 (24.0%) in arm b. pCR rates in patients with hormone receptor –ve/+ve disease were: 69.0%/42.5% (standard arm), 57.9%/34.5% (arm a), and 40.0%/13.3% (arm b). Surgery (133 pts) was conservative in 84.8% of patients with surgery in the standard arm, 67.4% in arm a, and 62.5% in arm b. In patients without B, ΔSUV after one cycle predicted pCR with a PPV of 52.9% and a NPV of 75%. Toxicity was mild and included asthenia, myalgia, and increased lacrimation (all pts had ≥1 AE). Grade 3/4 AEs (in 31% of pts) included neutropenia (8.6% pts), febrile neutropenia (3.6%), myalgia (3.6%), asthenia (2.9%), and nail toxicity (2.9%). Conclusions: Adding B to neoadjuvant T+D, in tumors with a low likelihood of pCR predicted by PET ΔSUV, increased the pCR rate from 24.0% to 42.5%. PET ΔSUV, by selecting low responding HER2+ tumors, may be a useful tool for optimizing neoadjuvant therapy for HER2+ BC. Clinical trial information: 2009-013410-26.
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