Safety of pregnancy in patients (pts) with history of estrogen receptor positive (ER+) breast cancer (BC): Long-term follow-up analysis from a multicenter study.

2017 ◽  
Vol 35 (18_suppl) ◽  
pp. LBA10066-LBA10066 ◽  
Author(s):  
Matteo Lambertini ◽  
Niels Kroman ◽  
Lieveke Ameye ◽  
Octavi Cordoba ◽  
Alvaro Pinto ◽  
...  

LBA10066 Background: Physicians and pts remain concerned on the safety of pregnancy following BC, particularly in women with history of ER+ disease. Previously, we showed no detrimental effect of pregnancy on BC outcome within the first 5 years following conception (Azim et al. JCO 2013). Here, we report long-term follow-up data. Methods: In this multicenter retrospective study, pts with pregnancy after BC (pregnant cohort) were matched (1:3) according to tumor and treatment characteristics with pts without subsequent pregnancy (non-pregnant cohort). To adjust for guaranteed time bias, each non-pregnant pt should have been disease free for a minimum time not inferior to the time elapsing between BC diagnosis and conception in the matched pregnant one. Primary endpoint was disease-free survival (DFS) in pts with ER+ BC. Secondary endpoints were DFS and overall survival (OS) in ER-negative and all pts irrespective of ER status. We also evaluated the impact of induced abortion on BC outcome. Results: The study included 1,207 pts, 333 pregnant and 874 non-pregnant. A total of 57% of pts had ER+ BC. After 12.5 years from conception, no DFS difference was observed between pregnant and non-pregnant pts with ER+ BC (hazard ratio [HR] 0.94; 95% confidence intervals [CI] 0.70-1.26; p = 0.68), ER- BC (HR 0.75; 95% CI 0.53-1.06; p = 0.10), and all pts (HR 0.85; 95% CI 0.68-1.06; p = 0.15). There was no OS difference between the 2 cohorts in pts with ER+ BC (HR 0.84; 95% CI 0.60-1.18; p = 0.32), but a significant improved OS was observed in the pregnant cohort for ER- pts (HR 0.57; 95% CI 0.36-0.90; p = 0.01) yielding a significant overall estimate (HR 0.72; 95% CI 0.55-0.94; p = 0.02). Abortion did not have any impact on outcome (HR 0.80; 95% CI 0.56-1.13; p = 0.20), irrespective of ER status. Conclusions: This is the largest study addressing the safety of pregnancy in pts with history of ER+ BC. Long-term follow-up confirms that pregnancy is safe and should not be discouraged irrespective of ER status. Our results further strengthen the rationale of the ongoing IBCSG-BIG-NABCG POSITIVE trial (NCT02308085) addressing the role of temporary interruption of adjuvant endocrine therapy to allow pregnancy.

2019 ◽  
Vol 37 (2) ◽  
pp. 105-114 ◽  
Author(s):  
Thomas Ruhstaller ◽  
Anita Giobbie-Hurder ◽  
Marco Colleoni ◽  
Maj-Britt Jensen ◽  
Bent Ejlertsen ◽  
...  

Purpose Luminal breast cancer has a long natural history, with recurrences continuing beyond 10 years after diagnosis. We analyzed long-term follow-up (LTFU) of efficacy outcomes and adverse events in the Breast International Group (BIG) 1-98 study reported after a median follow-up of 12.6 years. Patients and Methods BIG 1-98 is a four-arm, phase III, double-blind, randomized trial comparing adjuvant letrozole versus tamoxifen (either treatment received for 5 years) and their sequences (2 years of one treatment plus 3 years of the other) for postmenopausal women with endocrine-responsive early breast cancer. When pharmaceutical company sponsorship ended at 8.4 years of median follow-up, academic partners initiated an observational, LTFU extension collecting annual data on survival, disease status, and adverse events. Information from Denmark was from the Danish Breast Cancer Cooperative Group Registry. Intention-to-treat analyses are reported. Results Of 8,010 enrolled patients, 4,433 were alive and not withdrawn at an LTFU participating center, and 3,833 (86%) had at least one LTFU report. For the monotherapy comparison of letrozole versus tamoxifen, we found a 9% relative reduction in the hazard of a disease-free survival event with letrozole (hazard ratio [HR], 0.91; 95% CI, 0.81 to 1.01). HRs for other efficacy end points were similar to those for disease-free survival. Efficacy of letrozole versus tamoxifen for contralateral breast cancer varied significantly over time (0- to 5-, 5- to 10-, and > 10-year HRs, 0.62, 0.47, and 1.35, respectively; treatment-by-time interaction P = .005), perhaps reflecting a longer carryover effect of tamoxifen. Reporting of specific long-term adverse events seemed more effective with national registry than with case-record reporting of clinical follow-up. Conclusion Efficacy end points continued to show trends favoring letrozole. Letrozole reduced contralateral breast cancer frequency in the first 10 years, but this reversed beyond 10 years. This study illustrates the value of extended follow-up in trials of luminal breast cancer.


Pneumologia ◽  
2019 ◽  
Vol 68 (3) ◽  
pp. 138-143
Author(s):  
Oxana Munteanu ◽  
Dumitru Chesov ◽  
Doina Rusu ◽  
Irina Volosciuc ◽  
Victor Botnaru

Abstract Pulmonary sequelae related to tuberculosis (TB) are among the major causes of bronchiectasis in Eastern Europe. The role of bacterial colonisation in the pathogenesis of bronchiectasis has been continuously studied over the last decades, less understood remains the impact of fungal infection, alone or in association with bacterial. Although the data on the development of chronic pulmonary aspergillosis (CPA) secondary to TB are scarce, recent evidence suggests a higher prevalence of CPA in patients with a past history of pulmonary TB than it was previously estimated. We present a case of natural evolution of CPA, with a radiological follow-up, in a patient with post-tuberculous bronchiectasis.


Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 326-326
Author(s):  
Charles F. Craddock ◽  
Sudhir Tauro ◽  
Joanne E. Gregory ◽  
Laura Buckley ◽  
Janice Ward ◽  
...  

Abstract Allogeneic stem cell transplantation (SCT) performed using a reduced intensity conditioning (RIC) regimen represents an important new treatment modality in older patients with high risk acute myeloid leukaemia (AML) whose outlook with conventional chemotherapy would be poor. However assessment of its role has been hampered by the absence of long term follow-up data. Furthermore factors determining survival after RIC SCT have not been rigorously defined. In order to examine the anti-leukemic activity of RIC allografts in more detail we have examined the outcome of 170 patients with AML transplanted using a uniform conditioning regimen over a ten year period. Long term follow-up data (maximum 119 months) was collected on patients transplanted using a conditioning regimen consisting of fludarabine (30 mg/m2 x 5 days), melphalan 140 mg/m2 x 1 day and alemtuzemab (10 mg x 5 days). The median age of transplanted patients was 54 years (range 18–71). 88 patients were in CR1 at the time of transplant, 63 CR2/3 and 19 had relapsed or refractory disease. Cytogenetic information was available on 149 patients and of these 33 patients had adverse risk and 116 intermediate risk cytogenetics by MRC criteria. 83 transplants were performed using an HLA identical sibling donor and 87 using a volunteer unrelated donor. The 100 day transplant related mortality was 9%. 29% of patients developed Grade II-IV acute GVHD and 22% chronic GVHD. The 3 year overall survival (OS) for the whole group was 48% and 3 year disease free survival (DFS) 45%. 20 patients remain in remission more than five years post-transplant. Survival was significantly influenced by status at transplant (p=0.01), patient age (p= 0.01) and presentation cytogenetics (p=0.05) as determined by multivariate Cox proportional hazards regression. The 3 yr OS for patients transplanted in CR1 or CR2 was 51% and 52% respectively compared to 13% for patients with relapsed/refractory disease. Three year OS for patients with intermediate risk cytogenetics was 52% compared with 34% for adverse risk patients. Three year OS for patients under 60 years was 51% compared with 36% for older patients. This study demonstrates the ability of RIC allografts to deliver encouraging long term disease free survival rates in high risk AML. Pre-transplant characteristics can be used to predict outcome after a RIC allograft and older patients with active disease at the time of transplant or adverse cytogenetics require novel strategies in order to improve long term survival.


Blood ◽  
1994 ◽  
Vol 84 (12) ◽  
pp. 4061-4063 ◽  
Author(s):  
EH Kraut ◽  
MR Grever ◽  
BA Bouroncle

Twenty-four patients with advanced hairy cell leukemia treated with 2'- deoxycoformycin (dCF) were studied after achieving complete remission to determine the impact of treatment on survival, disease-free survival, long-term complications of treatment, and response to retreatment. At a median follow-up time of 82 months (range, 54 to 104 months), 23 of 24 patients remain alive. One patient has died of recurrent disease refractory to treatment. Of the remaining 23 patients, 11 have relapsed at a median time of 30 months (range, 7 to 80 months) after treatment completion. Of these 11 patients, 7 have been retreated with dCF or 2'-chlorodeoxyadenosine (2-CdA), including one patient that was retreated twice. All seven patients have responded, with five patients achieving second complete remission. Two patients have had normalization of blood cell counts, but repeat bone marrows have not been performed. No serious infections have been seen in dCF-treated patients during follow-up. One case of Hodgkin's disease and three cases of skin malignancies have developed in these 24 patients. From initiation of treatment, survival is 93 months (range, 63 to 116 months). We concluded that dCF significantly prolongs the survival of patients with advanced hairy cell leukemia without resultant long-term complications. It is too early to predict if this therapy will be curative for the patients still in remission.


Pneumologia ◽  
2019 ◽  
Vol 68 (3) ◽  
pp. 138-143
Author(s):  
Oxana Munteanu ◽  
Dumitru Chesov ◽  
Doina Rusu ◽  
Irina Volosciuc ◽  
Victor Botnaru

Abstract Pulmonary sequelae related to tuberculosis (TB) are among the major causes of bronchiectasis in Eastern Europe. The role of bacterial colonisation in the pathogenesis of bronchiectasis has been continuously studied over the last decades, less understood remains the impact of fungal infection, alone or in association with bacterial. Although the data on the development of chronic pulmonary aspergillosis (CPA) secondary to TB are scarce, recent evidence suggests a higher prevalence of CPA in patients with a past history of pulmonary TB than it was previously estimated. We present a case of natural evolution of CPA, with a radiological follow-up, in a patient with post-tuberculous bronchiectasis.


2019 ◽  
Author(s):  
Ayesha Shaikh ◽  
Natasha Shrikrishnapalasuriyar ◽  
Giselle Sharaf ◽  
David Price ◽  
Maneesh Udiawar ◽  
...  

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