Dose-dense adjuvant chemotherapy in premenopausal breast cancer patients: A pooled analysis of the MIG1 and GIM2 phase III studies

2017 ◽  
Vol 71 ◽  
pp. 34-42 ◽  
Author(s):  
Matteo Lambertini ◽  
Marcello Ceppi ◽  
Francesco Cognetti ◽  
Giovanna Cavazzini ◽  
Michele De Laurentiis ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Pooled Analysis ◽  
Phase Iii ◽  
Breast Cancer Patients ◽  
Premenopausal Breast Cancer ◽  
Dose Dense ◽  
Phase Iii Studies

scholarly journals Independent replication of polymorphisms predicting toxicity in breast cancer patients randomized between dose-dense and docetaxel-containing adjuvant chemotherapy

Oncotarget ◽  
2017 ◽  
Vol 8 (69) ◽  
pp. 113531-113542 ◽  
Author(s):  
Annelot G.J. van Rossum ◽  
Marleen Kok ◽  
Danielle McCool ◽  
Mark Opdam ◽  
Nienke C. Miltenburg ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Breast Cancer Patients ◽  
Independent Replication ◽  
Dose Dense

Determinants of recovery from amenorrhea in premenopausal breast cancer patients receiving adjuvant chemotherapy in the taxane era

2009 ◽  
Vol 20 (6) ◽  
pp. 503-507 ◽  
Author(s):  
Alessandro Marco Minisini ◽  
Jessica Menis ◽  
Francesca Valent ◽  
Claudia Andreetta ◽  
Barbara Alessi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Breast Cancer Patients ◽  
Premenopausal Breast Cancer

Efficacy and safety of balugrastim in chemotherapy-induced neutropenia: Integrated analysis of two randomized phase III studies.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17572-e17572
Author(s):  
Oleg Gladkov ◽  
Constantin D. Volovat ◽  
Steven Barash ◽  
Anton Buchner ◽  
Noa Avisar ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Medical Condition ◽  
Phase Iii ◽  
Severe Neutropenia ◽  
Integrated Analysis ◽  
Efficacy And Safety ◽  
Breast Cancer Patients ◽  
Myelosuppressive Chemotherapy ◽  
Phase Iii Studies

e17572 Background: Balugrastim is a recombinant fusion protein composed of human serum albumin and human granulocyte colony-stimulating factor, which allows for once-per-chemotherapy cycle administration. We present a combined analysis of two double-blind, randomized Phase III studies comparing efficacy and safety of balugrastim vs pegfilgrastim in breast cancer patients receiving myelosuppressive chemotherapy (CTx). Methods: All patients were treated with doxorubicin 60 mg/m2 followed by docetaxel 75 mg/m2 administered by i.v. infusion on Day 1 of a 21-day cycle for up to 4 cycles. For each cycle, patients received a single s.c. injection of balugrastim approximately 24 hours after administration of CTx. The primary endpoint for both studies was duration of severe neutropenia (DSN) in Cycle 1. Safety of balugrastim was assessed by evaluating the type, frequency, and severity of adverse events (AEs); changes in laboratory parameters and vital signs, and immunogenicity over time. Analyses were performed in the per-protocol population. Results: A total of 469 patients were randomized to receive balugrastim 40 mg (N=235) or pegfilgrastim 6 mg (N=234). Mean DSN in Cycle 1 was 1.1±1.11 days in patients receiving balugrastim (n=236) and 1.0±1.14 days in patients receiving pegfilgrastim (n=234). Non-inferiority was demonstrated by statistical analysis for balugrastim vs pegfilgrastim for reduction in DSN across studies. Patients treated with balugrastim had a significantly shorter time to ANC recovery in Cycle 1 vs pegfilgrastim (2.0 vs 2.3 days; P=0.015). No other significant differences were seen between treatment groups in either study for any other secondary endpoints in Cycles 1–4. The safety profile was similar for both drugs, with the incidence of AEs consistent with the underlying medical condition and administration of myelosuppressive CTx. Conclusions: In both Phase III studies, non-inferiority was clearly demonstrated for balugrastim 40 mg vs pegfilgrastim 6 mg. Balugrastim is a safe and effective alternative to long-acting pegfilgrastim for reducing DSN in breast cancer patients receiving myelosuppressive chemotherapy. Clinical trial information: 2010-019001-42.

PAM50 HER2-enriched subtype as an independent prognostic factor in early-stage HER2+ breast cancer following adjuvant chemotherapy plus trastuzumab in the ShortHER trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 544-544 ◽  
Author(s):  
Pier Franco Conte ◽  
Gaia Griguolo ◽  
Maria Vittoria Dieci ◽  
Giancarlo Bisagni ◽  
Alba Ariela Brandes ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Prognostic Factor ◽  
Cancer Patients ◽  
Early Breast Cancer ◽  
Prognostic Value ◽  
Independent Prognostic Factor ◽  
Phase Iii ◽  
Breast Cancer Patients ◽  
Pam50 Subtype

544 Background: We investigated the prognostic role of the PAM50 HER2-enriched (HER2-E) subtype in HER2+ early breast cancer enrolled in the randomized Phase III ShortHER trial. Methods: The ShortHER study randomized 1254 HER2+ early breast cancer patients to receive 9 weeks vs 1 year of adjuvant trastuzumab combined with chemotherapy. Gene expression measured using nCounter platform was available for 438 surgical samples. Intrinsic subtyping was determined using the research-based PAM50 predictor. Metastasis-free survival (MFS) was calculated from randomization to distant disease recurrence or death (median follow up 72 months). Uni- and multi-variable analysis were performed using Cox models. Results: PAM50 subtype distribution was: HER2-E 53% (N = 233), Luminal A 20% (N = 87), Luminal B 10% (N = 43), Normal-like 11% (N = 48) and Basal-like 6% (N = 27). HER2-E subtype was associated with hormone receptor-negative status (p < 0.001) and TILs ≥20% (p < 0.001), but not with stage and age ( < or ≥60 yrs). HER2-E subtype was associated with worse MFS vs other PAM50 subtypes overall (HR 2.78, p = 0.001), in the short (HR 2.24, p = 0.046), and in the long arm (HR 4.04, p = 0.011). Multivariable Cox model confirmed the independent prognostic value of HER2-E subtype (Table). HER2-E subtype added significant prognostic value on top of clinicopathological variables (Likelihood ratio test p < 0.001). Conclusions: HER2-E intrinsic subtype is an independent prognostic factor for HER2+ early breast cancer patients treated with adjuvant chemotherapy and trastuzumab. Integration of PAM50 subtype in prognostic algorithms can help refine risk stratification. These findings warrant independent validation. Clinical trial information: NCT00629278. [Table: see text]

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