Chemotherapy (CTX) treatment patterns for early-stage breast cancer (ESBC): Changing use of anthracyclines (A).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 1083-1083
Author(s):  
Katherine M. Serrurier ◽  
Jimmy Hwang ◽  
Joseph P. McGuire ◽  
Daphne Lichtensztajn ◽  
Ann C. Griffin ◽  
...  
Keyword(s):  
Cancer Registry ◽  
Early Stage ◽  
Tumor Stage ◽  
Phase Iii ◽  
Two Phase ◽  
Receptor Status ◽  
Treatment Practice ◽  
Phase Iii Trials ◽  
The Impact

1083 Background: Anthracyclines (A), given in sequence or combination, have been the mainstay of adjuvant CTX for ESBC. Recent molecular studies have questioned the value of A for ESBC. Trials for ESBC, presented primarily in 2005, have demonstrated similar or improved efficacy with non-anthracycline (NA) CTX. We sought to understand changing use of A for ESBC from 2000-2010 as reported in the population-based 9-county Greater Bay Area Cancer Registry (GBACR). Methods: Using the GBACR database, we recorded use of A or NA based CTX regimens in women with ESBC and no prior CTX from 2000-2010, and correlated type of CTX with tumor stage, receptor status, and age. We evaluated the use of A vs. NA (80% taxane-based) CTX from 2000-2005 and 2006-2010. Results: 16,476 patients (pts) met criteria for inclusion; 2,032 (12%) were excluded (missing information, or CTX not given). Pt characteristics were: median age 52 (range 21-94), stage I (25%), II (56%), and III (19%), 69% HR+. From 2000-2010, 83% received A; overall use of A decreased (87% to 57%), and use of NA increased (13% to 43%). The Table compares use of NA CTX during the two time periods by clinical variables. With short follow-up there was no difference in survival based on use of A vs. NACTX. Conclusions: Use of NA CTX significantly increased during 2006-2010; this trend was independent of age or receptor status and was more pronounced in earlier stage disease. The timing of this change correlated with the presentation of two phase III trials, emphasizing the impact of early data from phase III trials on treatment practice, and confirming results from a large claims database (Giordano). Potential outcome differences will be evaluated in NSABP-B49 and with longer follow-up of this cohort. This study was supported by the UCSF Cancer Registry and CPIC. [Table: see text]

Impact of Different Chemotherapy Regimen in Comorbid Patients with Advanced Chronic Lymphocytic Leukemia: Metaanalysis of Two Phase-III-Trials of the German CLL Study Group.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2840-2840 ◽  
Author(s):  
Paula Cramer ◽  
Valentin Goede ◽  
Petra Jenke ◽  
Raymonde Busch ◽  
Michael Hallek ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Chemotherapy Regimen ◽  
Lymphocytic Leukemia ◽  
Phase Iii ◽  
Prognostic Impact ◽  
Concomitant Disease ◽  
Two Phase ◽  
Phase Iii Trials ◽  
The Impact ◽  
Dose Reductions

Abstract Introduction: Since chronic lymphocytic leukemia (CLL) is a disease of elderly patients (pts) comorbidity is a frequent feature which has already been shown to be associated with survival-shortening in lymphoma patients. It has been hypothesized that intensity of chemotherapy may interfere with treatment outcome, but the precise mechanisms underlying the impact of comorbidity are still not understood. Consequently, comorbitity currently keeps away oncologists from administering intense combined (immuno−)chemotherapy to pts with CLL and concomitant diseases. Patients & methods: 554 pts treated in two different phase-III-trials of the GCLLSG were eligible for this analysis: 362 pts (65%) younger than 65 years were treated on the CLL4-protocol with Fludarabine (F) or Fludarabine-Cyclophosphamide (FC) and 192 pts (35%) aged 65 years and older on the CLL5-protocol with F or Chlorambucile (Clb). The mean age for all pts was 61 years; 68% of the pts were male. Results: Comorbidity was present in 53% of the pts, 25% had at least two comorbidities. The most common comorbidities were: hypertension (19%), lipometabolic disorders (16%), diabetes mellitus (10%) and coronary heart disease (7%). Progression free survival (PFS) and overall survival (OS) were significantly shorter in comorbid pts (median OS: 43,5 vs. 51,6 months, p=0,01; median PFS: 20,3 vs. 23,5 months, p=0,03). Survival was also impaired if pts had a higher number of comorbidities (PFS & OS: p=0,0001) or more severe concomitant diseases (PFS: p=0,007, OS: p=0,0000). Whereas this impact of comorbidity on OS was not significant in the FC- and Clb-arm, comorbid pts treated with F had a significantly shorter survival (median OS: 38,29 vs. 51,58 months, p=0,0452). Notably only the younger F-treated comorbid pts were affected by this disadvantage (CLL4: p=0,0221). Although myelotoxicity, infections and all grade III–IV adverse effects were not influenced by comorbidity, pts with concomitant disease had a higher rate of treatment terminations (38% vs. 25%, p=0,002). The higher percentage of dose reductions and treatment terminations for comorbid pts were only significant in the subgroup of F-treated pts (dose reduction: 31% vs. 19,1%, p=0,029; treatment termination in the younger CLL4-pts: 28,2% vs. 18,0%, p=0,023). Administration of more intense chemotherapy-regimen improved the survival of pts with concomitant disease (median OS: FC: not reached, F: 38,29 and Clb: 33,72 months, p=0,0248; median PFS: FC: not reached, F: 18,8 and Clb: 14,1 months, p=0,0000). A multivariate analysis on the prognostic impact of comorbidity and different chemotherapy regimen will be presented. Conclusions: Due to the here presented results the wide impact of comorbidity in CLL pts is apparent. It should be considered when it comes to treatment decisions eventhough this population was selected due to the strict criteria of the clinical trial. The mechanism of survival shortening in comorbid pts with CLL is not yet understood, but seems to be related with dose reductions and treatment terminations. Additional harm to these pts by an insufficient treatment and a poor control of the CLL ought to be avoided. As more intense chemotherapy-regimen, like FC are feasible for pts with comorbidity, more trials surveying these therapies in pts with more severe concomitant disease are needed.

Chemotherapy treatment patterns for early-stage breast cancer (ESBC): Decreasing use of anthracycline-based regimens.

2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 141-141
Author(s):  
Katherine M. Serrurier ◽  
Jimmy Hwang ◽  
Joseph P. McGuire ◽  
Ann C. Griffin ◽  
Michelle E. Melisko ◽  
...  
Keyword(s):  
Cancer Registry ◽  
Early Stage ◽  
Prospective Trial ◽  
Marked Change ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Stage Iii ◽  
Publication Date ◽  
Time Periods ◽  
The Impact

141 Background: Anthracyclines (A), given in sequence or combination with other agents, have been the mainstay of adjuvant chemotherapy (CTX) for ESBC for more than two decades. Recent molecular studies have questioned the value of A for lower risk disease. A single prospective trial presented in 2005 and published in 2006 (Jones et al) compared docetaxel and cyclophosphamide (TC) to doxorubicin and cyclophosphamide and reported improved disease free survival (2006) and overall survival (2009) with TC. We sought to understand the impact of this study on the type of CTX regimens used to treat ESBC. Methods: Using the UCSF Cancer Registry database and including patients who received at least one cycle of CTX at UCSF, we recorded use of A or non-anthracycline (NA) based CTX regimens in women with ESBC and correlated type of CTX with tumor stage, receptor status, and age. Based on the publication date of TC we looked at the use of A versus NA based CTX during two time periods, 2000-2005 and 2006-2010. Results: 1,116 patients met criteria for inclusion; 17 were excluded due to inadequate information. Patient characteristics were: median age 49 (range 21-78), stage I (24%), stage II (56%), and stage III (20%), 50% hormone receptor (HR) +, 25% HER2 +, 17% HR-/HER2-. From 2000-2010, 80% received A CTX. Overall use of A decreased from 95% to 65%, while use of NA based CTX increased from 5% to 35%. The table compares use of NA CTX during the two time periods by clinical variables. Conclusions: Use of NA CTX increased significantly over the 2nd half of the last decade in all cases except those patients with stage III disease. The timing of this marked change correlates with publication of TC, and emphasizes the impact of positive phase III trials on treatment practice. This study was supported by the UCSF Cancer Registry. [Table: see text]

Causes of death in intermediate- and high-risk prostate cancer treated with radiotherapy with or without androgen deprivation therapy: Analysis from two phase III trials.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 34-34
Author(s):  
Abdenour Nabid ◽  
Nathalie Carrier ◽  
Eric Vigneault ◽  
André-Guy Martin ◽  
Luis Souhami ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
High Risk ◽  
Statistical Difference ◽  
Causes Of Death ◽  
Phase Iii ◽  
Second Cancer ◽  
Two Phase ◽  
Phase Iii Trials

34 Background: The purpose of this analysis was to establish causes of death in a population of intermediate-risk (IR) and high-risk (HR) prostate cancer treated on two phase III trials. Methods: From October 2000 to September 2010, 1,230 patients were randomized: 630 with HR (ClinicalTrials.gov, #NCT00223171) and 600 with IR (#NCT00223145). HR was defined as T3-4, PSA >20 g/ml, Gleason >7 (with at least one of these 3 factors). IR was defined as T1-T2, Gleason < 6 and PSA 10-20 ng/ml or T1-T2, Gleason 7 and PSA < 20 ng/ml. Causes of death were compiled until July 2015 and were established from data sent by the different investigators and centrally reviewed. Causes of death were mainly based on data from clinical records, then by family members, obituaries, death certificates and family physicians. Results: The median follow-up for the 1,230 patients was 7.5 years (HR 8 vs. IR 6.8 years, p<0.001). 30.2% (372/1,230) patients had died: (HR 37% vs. IR 23.2%, p<0.001). A total of 8% (99/1,230) patients developed local, regional, and metastatic prostate cancer recurrences: (HR 11.6% vs. IR 4.3%, p<0.001) and 4.4% (54/1,230) died from prostate cancer: (HR 7.3% vs. IR 1.3%, p<0.001). The most frequent cause of death was a second cancer (120/1,230, 9.8%): (HR 10.6% vs. IR 8.8%, p=NS). Cardiovascular deaths occurred in 6.3% (78/1,230) (HR 7.1% vs. IR 5.5%, p=NS) with no statistical difference between the different durations of androgen deprivation therapy (ADT) 0, 6, 18, or 36 months. Other causes of death were pulmonary (3.7%), digestive (1.1%), others (3.3%), and unknown (1.7%). Majority of deaths occurred between 3 and 9 years after randomization (HR 70% and IR 73%). Prostate cancer deaths were distributed over all the follow-up period. The 5/10 year overall survival between HR and IR were 88.6%, 91.8%, and 61.6%, 69.8%, respectively with significant differences (p=0.045 and p=0.016). Conclusions: In patients with localized HR and IR prostate cancer, the first cause of death was a second cancer and prostate cancer came as the third one after cardiovascular disease. There was no statistical difference in the incidence of cardiovascular deaths in patients treated with different durations of ADT. Clinical trial information: Clinical Trials, gov. #NCT00223145 - Clinical Trials, gov. #NCT00223171.

Novel Intranasal Delivery of Sumatriptan as a Route to Rapid and Sustained Relief in the Acute Treatment of Migraine

US Neurology ◽  
2016 ◽  
Vol 12 (02) ◽  
pp. 84
Author(s):  
Deborah I Friedman ◽  
Keyword(s):  
Pain Relief ◽  
Acute Treatment ◽  
Drug Exposure ◽  
Early Stage ◽  
Phase Iii ◽  
Migraine Treatment ◽  
Two Phase ◽  
Oral Medications ◽  
Medication Delivery ◽  
Phase Iii Trials

Migraine remains a common debilitating condition that exerts a high social and economic burden worldwide. Despite the widespread availability of various medications for migraine, many patients are dissatisfied with their treatment. Rapid and effective treatment at an early stage in an attack is vital in migraine to prevent central sensitization leading to attacks that are difficult to treat. Most migraineurs prefer oral medications but this is not always the most rapid or efficient route into the bloodstream. Intranasal administration of migraine treatment provides a rapid, convenient and reliable alternative to oral and other routes. AVP-825 is an intranasal medication delivery system approved by the US Food and Drug Administration in January 2016 as ONZETRA™ Xsail™ (sumatriptan nasal powder [Avanir Pharmaceuticals, Aliso Viejo, CA]) for the acute treatment of migraine with or without aura in adults. AVP-825 contains low dose sumatriptan powder and takes advantage of some unique aspects of the nasal anatomy to confer rapid pain relief in the acute treatment of migraine. In two Phase III trials, AVP-825 was well tolerated and showed significantly faster migraine pain relief and relief from other symptoms including photophobia, phonophobia, and nausea than placebo or oral sumatriptan. This benefit was achieved with substantially lower drug exposure than oral sumatriptan. Additional analyses of data from the Phase III trials show that significantly more patients with migraine receiving AVP-825 reported clinically meaningful relief, sustained relief, pain freedom, lower migraine-related disability and more consistent relief across multiple attacks than those receiving oral sumatriptan. The rapid and sustained action of AVP-825 and its convenience creates the potential for this unique treatment to reduce the burden of migraine in many patients.

scholarly journals Lenalidomide Maintenance with or without Prednisone in Newly Diagnosed Myeloma Patients: A Pooled Analysis

Cancers ◽  
2019 ◽  
Vol 11 (11) ◽  
pp. 1735 ◽  
Author(s):  
Bonello ◽  
Pulini ◽  
Ballanti ◽  
Gentile ◽  
Spada ◽  
...  
Keyword(s):  
Overall Survival ◽  
Progression Free Survival ◽  
Pooled Analysis ◽  
Phase Iii ◽  
Newly Diagnosed ◽  
Two Phase ◽  
Free Survival ◽  
Phase Iii Trials ◽  
Grade 3 ◽  
The Impact

: We conducted a pooled analysis of two phase III trials, RV-MM-EMN-441 and EMN01, to compare maintenance with lenalidomide-prednisone vs. lenalidomide in newly diagnosed transplant-eligible and -ineligible myeloma patients. Primary endpoints were progression-free survival, progression-free survival 2 and overall survival with both regimens. A secondary aim was to evaluate the impact of duration of maintenance on overall survival and on outcome after relapse. A total of 625 patients (lenalidomide-prednisone arm, n = 315; lenalidomide arm, n = 310) were analyzed. The median follow-up was 58 months. Median progression-free survival (25 vs. 19 months; p = 0.08), progression-free survival 2 (56 vs. 49 months; p = 0.9) and overall survival (73 months vs. NR; p = 0.08) were not significantly different between the two arms. Toxicity profiles of lenalidomide-prednisone and lenalidomide were similar, with the exception of neutropenia that was higher in the lenalidomide arm (grade ≥ 3: 9% vs. 19%, p < 0.001), without an increase in the rate of infections. Overall survival (median NR vs. 49 months, p < 0.001), progression-free survival from relapse (median 35 vs. 24 months, p = 0.004) and overall survival from relapse (median not reached vs. 41 months, p = 0.002) were significantly longer in patients continuing maintenance for ≥2 years. We showed that the addition of prednisone at 25 or 50 mg every other day (eod) to lenalidomide maintenance did not induce any significant advantage.

scholarly journals Quality assurance of radiotherapy in the ongoing EORTC 1420 “Best of” trial for early stage oropharyngeal, supraglottic and hypopharyngeal carcinoma: results of the benchmark case procedure

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
J-J Stelmes ◽  
E. Vu ◽  
V. Grégoire ◽  
C. Simon ◽  
E. Clementel ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Early Stage ◽  
Prospective Trial ◽  
Similarity Index ◽  
Phase Iii ◽  
Current Phase ◽  
Hypopharyngeal Carcinoma ◽  
Transoral Surgery ◽  
Swallowing Function ◽  
The Impact

Abstract Introduction The current phase III EORTC 1420 Best-of trial (NCT02984410) compares the swallowing function after transoral surgery versus intensity modulated radiotherapy (RT) in patients with early-stage carcinoma of the oropharynx, supraglottis and hypopharynx. We report the analysis of the Benchmark Case (BC) procedures before patient recruitment with special attention to dysphagia/aspiration related structures (DARS). Materials and methods Submitted RT volumes and plans from participating centers were analyzed and compared against the gold-standard expert delineations and dose distributions. Descriptive analysis of protocol deviations was conducted. Mean Sorensen-Dice similarity index (mDSI) and Hausdorff distance (mHD) were applied to evaluate the inter-observer variability (IOV). Results 65% (23/35) of the institutions needed more than one submission to achieve Quality assurance (RTQA) clearance. OAR volume delineations were the cause for rejection in 53% (40/76) of cases. IOV could be improved in 5 out of 12 OARs by more than 10 mm after resubmission (mHD). Despite this, final IOV for critical OARs in delineation remained significant among DARS by choosing an aleatory threshold of 0.7 (mDSI) and 15 mm (mHD). Conclusions This is to our knowledge the largest BC analysis among Head and neck RTQA programs performed in the framework of a prospective trial. Benchmarking identified non-common OARs and target delineations errors as the main source of deviations and IOV could be reduced in a significant number of cases after this process. Due to the substantial resources involved with benchmarking, future benchmark analyses should assess fully the impact on patients’ clinical outcome.

scholarly journals Serum C-reactive protein metabolite (CRPM) is associated with incidence of contralateral knee osteoarthritis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anne-Christine Bay-Jensen ◽  
Asger Bihlet ◽  
Inger Byrjalsen ◽  
Jeppe Ragnar Andersen ◽  
Bente Juhl Riis ◽  
...  
Keyword(s):  
Phase Iii ◽  
Response To Treatment ◽  
C Reactive Protein ◽  
Two Phase ◽  
Knee Oa ◽  
Reactive Protein ◽  
Inflammatory Phenotype ◽  
The Mean ◽  
Using Data

AbstractThe heterogeneous nature of osteoarthritis (OA) and the need to subtype patients is widely accepted in the field. The biomarker CRPM, a metabolite of C-reactive protein (CRP), is released to the circulation during inflammation. Blood CRPM levels have shown to be associated with disease activity and response to treatment in rheumatoid arthritis (RA). We investigated the level of blood CRPM in OA compared to RA using data from two phase III knee OA and two RA studies (N = 1591). Moreover, the association between CRPM levels and radiographic progression was investigated. The mean CRPM levels were significantly lower in OA (8.5 [95% CI 8.3–8.8] ng/mL, n = 781) compared to the RA patients (12.8 [9.5–16.0] ng/mL, n = 60); however, a significant subset of OA patients (31%) had CRPM levels (≥ 9 ng/mL) comparable to RA. Furthermore, OA patients (n = 152) with CRPM levels ≥ 9 ng/mL were more likely to develop contra-lateral knee OA assessed by X-ray over a two-year follow-up period with an odds ratio of 2.2 [1.0–4.7]. These data suggest that CRPM is a blood-based biochemical marker for early identification OA patients with an inflammatory phenotype.

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