Randomized study of early intervention compared to standard intervention with darbepoetin-alpha (DA) for chemotherapy-induced anemia (CIA) in early stage breast cancer (ESBC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19538-19538
Author(s):  
L. Blakely ◽  
L. S. Schwartzberg ◽  
D. Henry ◽  
K. Sabbath ◽  
D. Fu ◽  
...  
Keyword(s):  
Early Intervention ◽  
Early Stage ◽  
Randomized Study ◽  
Target Range ◽  
Inadequate Response ◽  
Time Interaction ◽  
Iron Deficient ◽  
Chemotherapy Dose ◽  
Dose Dense ◽  
Q 14

19538 Background: Dose dense chemotherapy (DDC) with sequential doxorubicin/ cyclophosphamide followed by paclitaxel Q 14 days has an established place in the treatment of ESBC. However, moderate/severe CIA is a common consequence and therapeutic intervention is frequent. We sought to determine if early intervention at the onset of anemia with DA could reduce the emergence of more severe anemia during therapy and maintain quality of life compared to later intervention. Material and Methods: Non-iron deficient (ferritin > 50) patients (pts) with hemoglobin (Hb) levels >11.0 g/dl scheduled to receive adjuvant or neoadjuvant DDC for ESBC were recruited. Pts were randomly assigned prior to chemotherapy to initiate treatment with DA 200 μg q2w SQ when Hb < 11.5 g/dl (early intervention, EARLY), or DA 200 μg q2w SQ when Hb < 10.0 g/dl (standard intervention, STD) with end of treatment defined as 14 days after the last cycle of chemotherapy. Dose escalation for inadequate response of < 1 g/dl after 6 weeks of DA and dose withholding/reduction for Hb >13 g/dl were pre-specified. Results: The complete sample of 149 pts have been accrued (median age of 53.1, range 28.7 - 74.5). Analysis of fatigue ratings show a trend towards lower fatigue scores in EARLY at Hb nadir, and at end of study,(ANOVA, Group x Time interaction, p=.07). Discussion: Early intervention with DA significantly reduces the risk of developing moderate/severe CIA and increases time spent in the target range during DDC for ESBC. [Table: see text] No significant financial relationships to disclose.

scholarly journals Dose-dense chemotherapy: ready for prime time

2005 ◽  
Vol 8 (5) ◽  
Author(s):  
C. T. Dang ◽  
C. A. Hudis
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Early Stage ◽  
Developed Countries ◽  
Prime Time ◽  
Postoperative Adjuvant Chemotherapy ◽  
Chemotherapy Dose ◽  
Dose Dense ◽  
Risk Of Relapse ◽  
Related Mortality

Breast cancer is one of the leading causes of cancer mortality in women in developed countries even though most women with the disease die of other causes. Postoperative adjuvant chemotherapy with anthracycline-based regimens has been proven to decrease the risk of relapse and cancer-related mortality in women with early stage breast cancer contributing to the improving survival seen with this disease. The taxanes have been effective additions to several adjuvant regimens based on recent prospective randomized studies. In the quest to further improve outcomes with adjuvant chemotherapy, dose and schedule modifications based on kinetic models have been compared with standard regimens. In this paper we review of several key trials testing a specific modification called ‘dose-dense’ chemotherapy.

Dose-dense (DD) cyclophosphamide, methotrexate, and fluorouracil (CMF) at 14-day intervals: A pilot study of every 14- and 10–11-day dosing intervals for women with early-stage breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 590-590
Author(s):  
P. Drullinsky ◽  
M. N. Fornier ◽  
S. Sugarman ◽  
G. D'Andrea ◽  
T. Troso-Sandoval ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Hematologic Toxicity ◽  
Type I ◽  
Initial Cohort ◽  
Grade 3 ◽  
Dose Dense ◽  
Q 14 ◽  
Dosing Intervals

590 Background: CMF (C 600 mg/m2, M 40 mg/m2, F 600 mg/m2) is an option for adjuvant therapy for patients with low risk early stage breast cancer. DD regimens as predicted by mathematical models of cancer growth and treatment response are superior. We previously demonstrated the safety of DD EC (epirubicin/cyclophosphamide) followed by paclitaxel at 10–11 day (d) intervals. We investigated the feasibility of administering DD adjuvant CMF every 14 d and then every 10–11 d in a 2-stage phase II trial. Methods: An initial cohort (A) was treated q 14 d with PEG-filgrastim (Neulasta) support. A second cohort (B) was treated every 10–11 d with filgrastim/Neupogen x 5 d and then, based on feasibility, modified (cohort C) to use 7 d filgrastim. The primary end point was feasibility defined as having ANC > 1.5 x 103/uL on day 1 of planned treatment for all 8 cycles with no grade 3 or higher non-hematologic toxicity. All three cohorts were tested using a Simon's two-stage optimal design with type I and type II errors set at 10%. This design would effectively discriminate between true tolerability (as protocol-defined) rates of< 60% and> 80%. Cohort A: 38 pts with early stage breast cancer were accrued from 3/2008 though 6/2008. Cohort B: 7 pts were accrued from June 2008 through August 2008. Cohort C: Is still open with 16 pts accrued from August 2008 through December 5, 2008. Results: Median age 51: range 38 to 78. Cohort A: 29/38 pts completed 8 cycles of CMF. The regimen was considered feasible. 2 other pts completed 7 cycles and were withdrawn for depression and grade 2 transaminitis. The 7 other pts completed between 1 and 6 cycles of CMF were withdrawn as follows: 3 personal, 1 (grade 3) bone pain, 2 allergy unrelated to CMF, and 1 seizure. Cohort B: 7 pts were accrued. 6 out of 7 pts could not complete 8 cycles of chemotherapy secondary to neutropenia and 1 secondary to grade 3 ALT elevation. Cohort C: Accrual has not been completed. 16 pts are currently enrolled. Conclusions: Dose dense adjuvant CMF is feasible at 14 d intervals with PEG-filgrastim support. Adjuvant CMF every 10–11 days with filgrastim given for 5 days beginning day 2 is not feasible. Accrual is ongoing for CMF at 10–11 days with filgrastim x 7 days. Updated results will be available for Cohort C. [Table: see text]

scholarly journals Direct endoscopic necrosectomy in infected pancreatic necrosis using lumen-apposing metal stents: Early intervention does not compromise outcome

2021 ◽  
Vol 09 (03) ◽  
pp. E490-E495
Author(s):  
David Albers ◽  
Alexander Meining ◽  
Alexander Hann ◽  
Younan Kabara Ayoub ◽  
Brigitte Schumacher
Keyword(s):  
Early Intervention ◽  
Pancreatic Necrosis ◽  
Early Stage ◽  
Clinical Success ◽  
Infected Pancreatic Necrosis ◽  
Metal Stents ◽  
Optimal Timing ◽  
Stent Insertion ◽  
Endoscopic Necrosectomy ◽  
Walled Off Necrosis

Abstract Background and study aims Infection of pancreatic necrosis is a dreaded complication requiring an intervention. Nevertheless, the optimal timing of the first intervention is unclear, and consensus data are sparse. This retrospective two-center study evaluated direct endoscopic necrosectomy using lumen apposing metal stents in case of proven or suspected infected pancreatic necrosis in an early stage of the disease. Patients and methods Forty-nine patients with infected pancreatic necrosis were included. Sequent direct endoscopic necrosectomies after lumen apposing metal stent insertion (LAMS) were performed until the resolution of necrosis. In all patients, the first endoscopic intervention was performed within the first 30 days after first proof of pancreatic necrosis. Primary outcome parameters were inflammatory activity, days spent in the Intensive Care Unit (ICU), and mortality. Results The patient cohort received median 4 necrosectomies (3–5) after a median of 7 days (3–11) after first proof of pancreatic necrosis. Technical and clinical success were achieved in 98.3 % and 87.8 %, respectively; the mortality rate was 8.2 %. The median C-reactive protein level decreased from 241 mg/L (182.9–288.9) before the intervention to a median of 23.3 mg/L (18–60) after therapy. The median time period in the ICU was 5 days (3–9). Conclusions Early endoscopic therapy in the form of direct endoscopic necrosectomy after LAMS placement within the first 30 days after proof of pancreatic necrosis is effective and does not result in poor outcome. Our retrospective data suggest that early intervention before walled-off necrosis is formed is tenable when it is essential due to the patient's clinical deterioration.

Age of onset of mental disorders and use of mental health services: needs, opportunities and obstacles

2011 ◽  
Vol 21 (1) ◽  
pp. 47-57 ◽  
Author(s):  
G. de Girolamo ◽  
J. Dagani ◽  
R. Purcell ◽  
A. Cocchi ◽  
P. D. McGorry
Keyword(s):  
Early Intervention ◽  
Mental Disorders ◽  
Transition To Adulthood ◽  
Psychotic Disorders ◽  
Age Of Onset ◽  
Early Stage ◽  
Early Adulthood ◽  
Special Focus ◽  
Long Term Effects ◽  
Health Services Needs

Purpose of review.In this review, we provide an update of recent studies on the age of onset (AOO) of the major mental disorders, with a special focus on the availability and use of services providing prevention and early intervention.Recent findings.The studies reviewed here confirm previous reports on the AOO of the major mental disorders. Although the behaviour disorders and specific anxiety disorders emerge during childhood, most of the high-prevalence disorders (mood, anxiety and substance use) emerge during adolescence and early adulthood, as do the psychotic disorders. Early AOO has been shown to be associated with a longer duration of untreated illness, and poorer clinical and functional outcomes.Summary.Although the onset of most mental disorders usually occurs during the first three decades of life, effective treatment is typically not initiated until a number of years later. There is increasing evidence that intervention during the early stages of disorder may help reduce the severity and/or the persistence of the initial or primary disorder, and prevent secondary disorders. However, additional research is needed on effective interventions in early-stage cases, as well as on the long-term effects of early intervention, and for an appropriate service design for those with emerging mental disorders. This will mean not only the strengthening and re-engineering of existing systems, but is also crucial the construction of new streams of care for young people in transition to adulthood.

scholarly journals Ischemic Colitis Associated with Paclitaxel and Carboplatin Combination

2017 ◽  
Vol 10 (2) ◽  
pp. 689-693 ◽  
Author(s):  
Ahmed Gamal Elsayed ◽  
Roma Srivastava ◽  
Toni Pacioles ◽  
Teresa Limjoco ◽  
Maria Tria Tirona
Keyword(s):  
Gastrointestinal Bleeding ◽  
Ischemic Colitis ◽  
Triple Negative ◽  
Early Stage ◽  
Lower Gastrointestinal Bleeding ◽  
White Female ◽  
Adjuvant Setting ◽  
History Of ◽  
Bowel Rest ◽  
Dose Dense

A 62-year-old white female with a history of early-stage triple-negative breast cancer on a combination of carboplatin and paclitaxel in the adjuvant setting presented with lower gastrointestinal bleeding. She tolerated 4 cycles of dose-dense adriamycin/cyclophosphamide with no major symptoms. After 6 cycles of weekly paclitaxel in combination with carboplatin every 3 weeks, she presented with diarrhea and lower gastrointestinal bleeding. Colonosopic examination showed erythema and inflammation in the splenic flexure, descending colon, and sigmoid colon consistent with ischemic colitis. Pathology favored the same diagnosis. She was treated conservatively with intravenous fluids and bowel rest. Chemotherapy was held for 2 weeks and resumed after recovery without carboplatin. She was able to tolerate the remaining 6 cycles of paclitaxel with no recurrence of her symptoms.

Early Intervention Could Be Beneficial In Early-Stage Nontuberculotic Mycobacterium Lung Disease

2012 ◽  
Author(s):  
Ykiko Namba ◽  
Shinichi Sasaki ◽  
Ryo Ko ◽  
Ayako Ishimori ◽  
Maskata Yoshioka ◽  
...  
Keyword(s):  
Early Intervention ◽  
Lung Disease ◽  
Early Stage
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