Lani
05-18-2011, 10:47 PM
or HER2+ MBC pts with newly diagnosed Brain mets
LANDSCAPE: An FNCLCC phase II study with lapatinib (L) and capecitabine (C) in patients with brain metastases (BM) from HER2-positive (+) metastatic breast cancer (MBC) before whole-brain radiotherapy (WBR).
Sub-category:
HER2+
Category:
Breast Cancer - HER2/ER
Meeting:
2011 ASCO Annual Meeting
Abstract No:
509
Citation:
J Clin Oncol 29: 2011 (suppl; abstr 509)
Attend this session at the
ASCO Annual Meeting!
Session: Breast Cancer - HER2/ER
Type: Oral Abstract Session
Time: Sunday June 5, 9:00 AM to 12:00 PM
Location: McCormick Place Hall B1
Personalize your Annual Meeting experience with a suggested or customized itinerary!
Author(s): T. D. Bachelot, G. Romieu, M. Campone, V. Dieras, C. Cropet, H. H. Roche, M. Jimenez, E. Le Rhun, J. Pierga, A. Gonçalves, M. Leheurteur, J. Domont, M. Gutierrez, H. Cure, J. Ferrero, C. Labbe; Centre Leon Berard, Lyon, France; C.R.L.C. Val D'Aurelle, Montpellier, France; Centre René Gauducheau, Saint-Herblain, France; Department of Medical Oncology, Institut Curie, Paris, France; Centre Léon Bérard - Unité de Biostatistique et d'Evaluation des Thérapeutiques, Lyon, France; Institut Claudius Regaud, Toulouse, France; FNCLCC, Paris, France; Centre Oscar Lambret, Lille, France; Institut Curie, Paris, France; Medical Oncology, Institut Paoli-Calmettes, Marseille, France; Centre Henri Becquerel, Rouen, France; Institut Gustave Roussy, Villejuif, France; Institut Curie-Hôpital René Huguenin, Saint-Cloud, France; Institut Jean Godinot, Reims, France; Centre Antoine-Lacassagne, Nice, France; Centre René Gauducheau, Nantes, France
Abstract Disclosures
Abstract:
Background: With an incidence of 30%-40%, BM are common complications of HER2+ MBC. Their therapeutic management remains a challenge. As responses on central nervous system (CNS) localization have been reported with L+C combination after WBR, we sought to evaluate the clinical interest of this combination as 1st line treatment for BM in HER2+ MBC patients (pts) with the aim to avoid or to delay WBR. Methods: Eligible pts had HER2+ MBC with BM not previously treated with WBR, C or L. Pts received L1250 mg/day and C2000 mg/m2/day, days 1-14, every 21 days. The primary endpoint was a centrally assessed CNS objective response (CNS-OR) defined as a ≥50% volumetric reduction of CNS lesions in the absence of increasing steroid use, progressive neurologic symptoms, or progressive extra-CNS disease. Using a Simon’s optimal two-stage design with a minimum interesting CNS-OR rate of 20%, 41 evaluable patients were needed. Secondary endpoints included: time to progression (TTP) for both CNS and extra CNS disease; time to WBR; prognostic and predictive value of circulating tumor cells (CTC) and toxicity. Results: From 04 /2009 to 08/2010, 45 pts were enrolled. Median age was 56 (range 35 to 79), 37 pts had multiple metastatic sites, PS was 0 (17 pts), 1 (25 pts) or 2 (2 pts); 36 pts had two or more BM and 42 had previously received trastuzumab. 41 pts received at least 2 cycles of study treatment. 43 pts were evaluable for efficacy endpoints, with a median follow-up of 10 months (range 2.9-16.5). The CNS-OR rate was 67% (95%CI 51-81), with a median time from inclusion to response of 1.8 month. Median TTP was 5.5 months (95% CI 3.9-5.9) and median time to WBR was 8.3 months (95% CI 5.1-11.7). At baseline, 21/42 pts had ≥ 1CTC, vs 7/39 at day 21, p<0.01 (correlation study ongoing). 20 patients (44%) experienced grade 3 or 4 treatment related toxicity, treatment was discontinued due to toxicity in 3 pts. At the time of analysis, 21 pts had received WBR and 10 pts had died. Conclusions: With a high response rate, L + C is an active treatment option and a viable alternative to immediate WBR for HER2+ MBC pts with newly diagnosed Brain mets
LANDSCAPE: An FNCLCC phase II study with lapatinib (L) and capecitabine (C) in patients with brain metastases (BM) from HER2-positive (+) metastatic breast cancer (MBC) before whole-brain radiotherapy (WBR).
Sub-category:
HER2+
Category:
Breast Cancer - HER2/ER
Meeting:
2011 ASCO Annual Meeting
Abstract No:
509
Citation:
J Clin Oncol 29: 2011 (suppl; abstr 509)
Attend this session at the
ASCO Annual Meeting!
Session: Breast Cancer - HER2/ER
Type: Oral Abstract Session
Time: Sunday June 5, 9:00 AM to 12:00 PM
Location: McCormick Place Hall B1
Personalize your Annual Meeting experience with a suggested or customized itinerary!
Author(s): T. D. Bachelot, G. Romieu, M. Campone, V. Dieras, C. Cropet, H. H. Roche, M. Jimenez, E. Le Rhun, J. Pierga, A. Gonçalves, M. Leheurteur, J. Domont, M. Gutierrez, H. Cure, J. Ferrero, C. Labbe; Centre Leon Berard, Lyon, France; C.R.L.C. Val D'Aurelle, Montpellier, France; Centre René Gauducheau, Saint-Herblain, France; Department of Medical Oncology, Institut Curie, Paris, France; Centre Léon Bérard - Unité de Biostatistique et d'Evaluation des Thérapeutiques, Lyon, France; Institut Claudius Regaud, Toulouse, France; FNCLCC, Paris, France; Centre Oscar Lambret, Lille, France; Institut Curie, Paris, France; Medical Oncology, Institut Paoli-Calmettes, Marseille, France; Centre Henri Becquerel, Rouen, France; Institut Gustave Roussy, Villejuif, France; Institut Curie-Hôpital René Huguenin, Saint-Cloud, France; Institut Jean Godinot, Reims, France; Centre Antoine-Lacassagne, Nice, France; Centre René Gauducheau, Nantes, France
Abstract Disclosures
Abstract:
Background: With an incidence of 30%-40%, BM are common complications of HER2+ MBC. Their therapeutic management remains a challenge. As responses on central nervous system (CNS) localization have been reported with L+C combination after WBR, we sought to evaluate the clinical interest of this combination as 1st line treatment for BM in HER2+ MBC patients (pts) with the aim to avoid or to delay WBR. Methods: Eligible pts had HER2+ MBC with BM not previously treated with WBR, C or L. Pts received L1250 mg/day and C2000 mg/m2/day, days 1-14, every 21 days. The primary endpoint was a centrally assessed CNS objective response (CNS-OR) defined as a ≥50% volumetric reduction of CNS lesions in the absence of increasing steroid use, progressive neurologic symptoms, or progressive extra-CNS disease. Using a Simon’s optimal two-stage design with a minimum interesting CNS-OR rate of 20%, 41 evaluable patients were needed. Secondary endpoints included: time to progression (TTP) for both CNS and extra CNS disease; time to WBR; prognostic and predictive value of circulating tumor cells (CTC) and toxicity. Results: From 04 /2009 to 08/2010, 45 pts were enrolled. Median age was 56 (range 35 to 79), 37 pts had multiple metastatic sites, PS was 0 (17 pts), 1 (25 pts) or 2 (2 pts); 36 pts had two or more BM and 42 had previously received trastuzumab. 41 pts received at least 2 cycles of study treatment. 43 pts were evaluable for efficacy endpoints, with a median follow-up of 10 months (range 2.9-16.5). The CNS-OR rate was 67% (95%CI 51-81), with a median time from inclusion to response of 1.8 month. Median TTP was 5.5 months (95% CI 3.9-5.9) and median time to WBR was 8.3 months (95% CI 5.1-11.7). At baseline, 21/42 pts had ≥ 1CTC, vs 7/39 at day 21, p<0.01 (correlation study ongoing). 20 patients (44%) experienced grade 3 or 4 treatment related toxicity, treatment was discontinued due to toxicity in 3 pts. At the time of analysis, 21 pts had received WBR and 10 pts had died. Conclusions: With a high response rate, L + C is an active treatment option and a viable alternative to immediate WBR for HER2+ MBC pts with newly diagnosed Brain mets