Twin-Twin Transfusion Syndrome with Anemia-Polycythemia: Prevalence, Characteristics, and Outcome

The aim of this study was to estimate the prevalence of co-existing anemia-polycythemia (AP) in twin pregnancies with twin-twin transfusion syndrome (TTTS) prior to laser surgery, and to evaluate the characteristics and outcomes in TTTS twins with and without AP. All TTTS cases treated with laser between 2001 and 2019 were retrospectively reviewed for the presence of AP before surgery. AP was defined as delta middle cerebral artery–peak systolic velocity > 0.5 multiples of the median. The primary outcome was a composite of perinatal survival and severe neurodevelopmental impairment (NDI). Secondary outcomes included procedure-related characteristics, severe neonatal morbidity, and disease-free survival. In total, 66% (461/696) of TTTS twin pregnancies were eligible for analysis. AP was detected in 15% (70/461) of the TTTS twins prior to laser surgery. Gestational age at laser was higher in the TTTS+AP group compared to the TTTS-only group—21.0 weeks (interquartile rage (IQR): 18.8–24.0) versus 19.3 weeks (IQR: 17.3–21.9), respectively (p < 0.0001). Fewer placental anastomoses were detected in the TTTS+AP group than in the TTTS-only group—five (IQR: 4–6) versus six (IQR: 5–8), respectively (p < 0.0001). Perinatal survival was 77% (599/782) in the TTTS-only group and 83% (118/142) in the TTTS+AP group (p = 0.130). Severe NDI was 8% (28/370) in TTTS-only and 3% (2/74) in TTTS+AP. TTTS-only twins showed more severe neonatal morbidity than twins with TTTS+AP—23% (132/575) versus 11% (13/115), respectively (p = 0.005). Disease-free survival was lower in the TTTS-only group compared to the TTTS+AP group—62% (341/548) versus 73% (72/98), respectively (p = 0.046). Thus, AP complicates 15% of TTTS twins prior to laser. TTTS+AP twins show a different placental angioarchitecture, a later time of onset of the disease, and a more favorable outcome.

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Evaluating Mortality with Erythropoietin Stimulating Agents (ESAs) in the Oncology Setting: The Importance of Selecting Trials That Include Survival or Loco-Regional Tumor Control as a Primary Endpoint

Blood ◽

10.1182/blood.v112.11.4681.4681 ◽

2008 ◽

Vol 112 (11) ◽

pp. 4681-4681

Author(s):

Athena T Samaras ◽

Sara E Barnato ◽

Benjamin Kim ◽

Stephen Y Lai ◽

A. Oliver Sartor ◽

...

Keyword(s):

Overall Survival ◽

Primary Outcome ◽

Disease Free Survival ◽

Progression Free Survival ◽

Tumor Control ◽

Free Survival ◽

Primary Endpoints ◽

Meta Analyses ◽

Disease Free ◽

Safety Signals

Abstract In February 2008, we reported increased risks of mortality (hazard ratio (HR) 1.10, 95% confidence interval (CI) 1.01–1.20) and venous thromboembolism (VTE) (relative risk (RR) 1.57, 95% CI 1.31–1.87) among anemic cancer patients. Fifty-one trials including 13,611 patients and 38 trials including 8,172 patients were included in the mortality and VTE analyses, respectively. At ASH 2007, we reported that trials within the nephrology setting that measure survival as a primary or secondary safety endpoint should be used over trials that measure efficacy as a primary or secondary endpoint to detect significant safety signals. Herein, we compare the percentage of trials and patients included in various published meta-analyses within the cancer setting that prospectively evaluated overall survival, disease-free survival, progression-free survival and/or loco-regional tumor control as a primary outcome, to determine whether these studies can better identify safety signals than studies that do not include these primary endpoints. Randomized trials of ESA administration to anemic cancer patients that evaluated survival or loco-regional control as primary endpoints were selected for review. Overviews published since 2006 were identified in Medline databases. HRs for mortality and 95% CIs were evaluated for the survival-focused meta-analyses and published overviews. A subset analysis of our 2008 meta-analysis including studies that prospectively evaluated overall survival, disease-free survival, progression-free survival and/or loco-regional tumor control as a primary outcome resulted in an increased risk of mortality (hazard ratio (HR) 1.18, 95% confidence interval (CI) 1.04, 1.35). Among recently reported meta-analyses, safety signals are most apparent when the percentage of patients and trials that evaluated survival or loco-regional tumor control as a primary outcome is greatest, emphasizing the importance of trial selection when conducting safety-focused meta-analyses. Wilson et al. 2007 Bohlius et al. 2006 Seidenfeld et al. 2006 Bennett et al. 2008 Bennett et al. subset analysis 2008 # of trials (# of patients) 28 (5,308) 42 (8,167) 35 (6,918) 51 (13,611) 14 (5,785) Median/Mean # of patients 146/216 147/201 147/201 223/271 370/413 % of trials included that prospectively evaluated overall survival, disease –free survival, progression-free survival, or loco-regional tumor control as a primary outcome (# included, total #) 7.1% (2/28) 16.7% (7/42) 17.1% (6/35) 27.5% (14/51) 100% (14/14) % of patients included that prospectively evaluated overall survival, disease –free survival, progression-free survival, or loco-regional tumor control as a primary outcome (# included, total #) 24.3% (1,290/5,308) 26.7% (2,181/8,167) 29..9% (2,068/6,918) 39.1% (5,324/13,611) 100% (5,787/5,787) HR for mortality(95% CI) 1.03 (0.92–1.16) 1.08 (0.99–1.18) 1.11 (0.99–1.23) 1.10 (1.01–1.20) 1.18 (1.04, 1.35)

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Primary outcome analysis of invasive disease-free survival for monarchE: abemaciclib plus adjuvant endocrine therapy for high-risk early breast cancer

10.1055/s-0041-1730206 ◽

2021 ◽

Author(s):

M Reinisch ◽

J O’Shaughnessy ◽

P Rastogi ◽

S Johnston ◽

M Martin ◽

...

Keyword(s):

Breast Cancer ◽

High Risk ◽

Endocrine Therapy ◽

Early Breast Cancer ◽

Primary Outcome ◽

Disease Free Survival ◽

Invasive Disease ◽

Outcome Analysis ◽

Free Survival ◽

Disease Free

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Comparison of therapeutic effects of chemo-radiotherapy with neoadjuvant chemotherapy before radical surgery in patients with bulky cervical carcinoma (stage IB3 & IIA2)

BMC Cancer ◽

10.1186/s12885-021-08416-0 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Setareh Akhavan ◽

Abbas Alibakhshi ◽

Mahdieh Parsapoor ◽

Abbas Alipour ◽

Elahe Rezayof

Keyword(s):

Cervical Cancer ◽

Neoadjuvant Chemotherapy ◽

Medical Records ◽

Primary Outcome ◽

Disease Free Survival ◽

Therapeutic Effects ◽

Cancer Stage ◽

Free Survival ◽

Disease Free ◽

Timely Treatment

Abstract Background Cervical cancer is one of the most common malignancies among women. Appropriate and timely treatment of these patients can reduce the complications and increase their survival. The objective of this study was to compare neoadjuvant chemotherapy plus radical hysterectomy (NACTRH) and chemo-radiotherapy (CRT) in patients with bulky cervical cancer (stage IB3 & IIA2). Material and methods The medical records of patients with bulky cervical cancer (stage IB3 & IIA2) that received NACTRH or CRT between 2007 and 2017 were evaluated for therapeutic effects. Demographic characteristics, complications of chemo-radiotherapy and neoadjuvant chemotherapy, were collected in a researcher-made questionnaire. Our primary outcome was comparison of overall survival (OS), and disease-free survival (DFS) between two groups receiving NACTRH and CRT modalities. Results One-hundred and twenty three patients were enrolled in the study. The median age and the proportion of patients with stage IIA2 were higher in the CRT group compared to the NACTRH group (p < 0.05). The medians (95% CI) OS were 3.64 (3.95–6.45) and 3.9 (3.53–4.27) years in the NACTRH and CRT groups, respectively (P = 0.003). There were 16 (34.8%) and 22 (43.1%) recurrences in the NACTRH and CRT group, respectively (P = 0.4). The median (95% CI) DFS was 4.5 (3.88–5.12) years in the NACTRH group and 3.6 (2.85–4.35) years in the CRT group (P = 0.004). The 3-year OS rate in NACTRH and CRT groups were 97 and 90% respectively. The 3-year DFS rate in NACTRH and CRT groups were 88 and 66% respectively. Conclusions NACTRH is associated with a higher OS and DFS compared to CRT.

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The PERSEPHONE trial: Duration of trastuzumab with chemotherapy in women with HER2-positive early breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.tps660 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. TPS660-TPS660

Author(s):

Helena Margaret Earl ◽

David A. Cameron ◽

David Miles ◽

Andrew M. Wardley ◽

Emma Ogburn ◽

...

Keyword(s):

Breast Cancer ◽

Cost Effectiveness ◽

Early Breast Cancer ◽

Primary Outcome ◽

Disease Free Survival ◽

Phase Iii ◽

Her2 Positive ◽

Free Survival ◽

Disease Free

TPS660 Background: Persephone is a phase III randomised controlled trial comparing six months of trastuzumab to the standard 12 month duration in patients with HER2 positive early breast cancer in respect of disease free survival, safety and cost-effectiveness. A Persephone sister study, the PHARE trial run by the National Institute for Cancer, successfully closed to recruitment in 2010. A prospective meta-analysis is planned once each trial has reported individually. Methods: A total of 4000 patients will be randomised into each of the two treatment groups. The power calculations assume that the disease-free survival (DFS) of the standard treatment of 12 months trastuzumab will be 80% at 4 years. On this basis, with 5% 1-sided significance and 85% power, a trial randomising 2000 in each arm will have the ability to prove non-inferiority of the experimental arm defining non-inferiority as ‘no worse than 3%’ below the control arm 4 year DFS. Primary outcome is disease-free survival non-inferiority (equivalence) of 6 months trastuzumab compared with 12 months in women with early breast cancer. Secondary outcomes are overall survival non-inferiority (equivalence); expected incremental cost effectiveness; cardiology function and analysis of predictive factors for development of cardiac damage. Two mandatory sub-studies are: Tumour block collection to discover molecular predictors of survival with respect to duration of trastuzumab treatment and blood sample collection, used to discover single nucleotide polymorphisms (SNPs) as genetic/pharmaco-genetic determinants of prognosis, toxicity and treatment outcome. A third optional sub-study is the quality of life questionnaires. Results: Persephone opened to recruitment in October 2007. To date, 1847 patients (46%) of its total have been randomised from 147 UK sites. Recruitment is due to complete by December 2013 and the first planned interim analysis of the primary outcome will be mid-2016. The IDSMC last reviewed the trial in June 2011 and congratulated the Trial Management Group on the conduct of the trial and the quality of the data. No safety concerns were identified, and the IDSMC proposed that the trial continue to planned recruitment.

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