scholarly journals OUTCOMES OF FROZEN DONOR OOCYTES COMPARED TO FRESH DONOR OOCYTES CYCLES, AN INTENT TO TREAT ANALYSIS

2021 ◽  
Vol 116 (1) ◽  
pp. e35
Author(s):  
Deng J ◽  
Zhao Q ◽  
Behr B ◽  
Lathi RB
Keyword(s):  
Intent To Treat ◽  
Donor Oocytes ◽  
Treat Analysis

scholarly journals Effectiveness of exercise at workplace in physical fitness: uncontrolled randomized study

2014 ◽  
Vol 12 (1) ◽  
pp. 55-60 ◽  
Author(s):  
Antônio José Grande ◽  
Valter Silva ◽  
Sérgio Alencar Parra
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Randomized Study ◽  
Exercise Program ◽  
Employee Health ◽  
Fat Percentage ◽  
Academic Organizations ◽  
Health Related ◽  
Intent To Treat ◽  
Treat Analysis

Objective : To investigate the effectiveness of workplace exercise for employee health by means of health-related physical activity components. Methods : A randomized uncontrolled study with 20 workers was carried out during three months to evaluate a workplace exercise program. The selected outcomes were flexibility, body mass, fat percentage, lean mass, blood pressure, and heart rate. For statistical analysis, the paired t test and the intent-to-treat analysis were used. Results : There was a significant increase in weight, fat percentage, blood pressure, and heart rate. However the clinical significance was 10% in the size of the effect. Conclusion : The changes verified in the outcomes analyzed were not significant; the variables are within normality ranges proposed by academic organizations

Blood tests to predict one- to two-year survival of patients with difficult cancers.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16158-e16158
Author(s):  
Robert L. De Jager ◽  
Howard Bruckner ◽  
Fred Bassali ◽  
Elisheva Dusowitz ◽  
AJ Book ◽  
...  
Keyword(s):  
High Risk ◽  
Hospice Care ◽  
Intrahepatic Bile Duct ◽  
Stage Iv ◽  
Neutrophil Lymphocyte Ratio ◽  
Blood Tests ◽  
Kaplan Meier ◽  
Risk Patients ◽  
Intent To Treat ◽  
Treat Analysis

e16158 Background: A sequence of drug combinations produces > 1 median (M) -strong 2-year (yr) survival (S) (Bruckner et al AACR 14 Antica Res (ACR) 16, 18 SIGO 19). Trials included high-risk patients (pts). Each initial series has 5-yr Ss, after pts were referred for hospice care. Prognostic ALAN blood tests (Ts) have been validated for stage IV (Adv) Cholangiocarcinoma (CCA) (Salati et al EuJCa18). Other Ts predict unexpected favorable (F) S of pts with gastric ca, PS 2-3. Bruckner et al JAMA, 82); but, there is little known about Ts for resistant (R) Ca. Methods: Planned Kaplan-Meier intent to treat analysis to find Ts that: expand eligibility (El) for therapy; identify biomarkers that predict therapy can prolong S and identify new hypotheses for therapy. El pts have:R to test drugs, Pancreatic (PC), Intrahepatic bile duct, CCA, Colon, CRC and new (N) APC. All series: -/+ high risk, -/+ aged, PS 0-2. El: Helsinki criteria- consent, recovered from severe (gr3) toxicity; able to reach office, -/+ help, and S > 6 wks. Inel: CNS involved, IV needed, F clinical factors predict 1 yr MST. Ts include A.L.A.N. scores, (AS) (Salati ibid) and other blood Ts (ACR ibid, Lavin et al CTR 82) Therapy GFLIO in mg/M2: gemcitabine 500, leucovorin 180, fluorouracil 1200, 24 hr infusion. Irinotecan 80 D2 Oxaliplatin 40. Then for progression (pg), add docetaxel 20-25, except CRC mitomycin C 4-6; next pg add cetuximab, except APC or KRAS-M, weekly, and next pg replace cetuximab with bevacizumab 10mg/kg ibid ACR 16. Results: At all ages, overall (O) S is > 1 yr for RCRC, and NAPC and sets with any 1 F or UnF T other than < 3.1 Albumin (Alb) or < 2.1 lymph/monocyte ratio (LMR) b For CCA, 17R/16N, OMS > 2 yrs 66% of pts and ≥ 2 yrs for all test sets except UnF, 26% of pts, MS 17 mos, with low Alb. For CRC: 50R OMS is 16.5 mos; 42% S 2 yrs, Fav Ts: MS > ̃ 2yrs, 39-82% of pts have FTs; Neutrophil Lymphocyte Ratio (NLR); < 3.1, 61% S 2 yrs, p < .02; Lymphs > 1.5, 53% S 2 yrs, p < .02; AS 0; 59% S 2 yrs, p < .06; Platelets < 300,000, 54% S 2 yrs, p < .06; Alb: ≥ 3.5, 48% S 2 yrs, p < .11. For N-APC: 53 pts, OS is 14.5 mos and > 12 mos in sets with any 1 UnF T other than Alb or LMR. FTs: MST 16.4-18 mos. 34-77% of pts have FTs; Alb ≥ 3.5, 34% S 2 yrs, p < 0.001; WBC < 10, 29% S 2 yrs, p < .06; AS 0-2, 35% S 2 yrs, p 2.7E-7. For R-PC: 53 pts, OS is 12 mos for 44% of pts, FTs: MST 13.6-17 mos, 21-70% of pts have FTs: Alb ≥ 3.5 30% S 2 yrs, p .0004; AS: 0, 41% S 2 yrs, p .0006; NLR < 3, 37% S 2 yrs, p < .02. GFLIO’s < 5% gr3 induction toxicity, is reversible, with no hospitalization, neutropenic fever or gr3 neuropathy. Conclusions: Robust Ts identify many difficult pts with median > 1 and testable prospective > 2 yr rates of S. Ts warrant development: validation with GFLIO and other therapy and other cancers; to improve Ts, models for eligibility and geriatric criteria; to identify false -/+ trials; and personalize trials to correct UnF Ts. FTs, with GFLIO, can change prognosis and practice for > 50% of pts now advised “against” any therapy due to a clinical estimate of “less than 6 -10 mos to live.” Clinical trial information: NCT01905150.

Efficacy versus intent-to-treat analysis in the canadian American ticlopidine study

1990 ◽  
Vol 11 (4) ◽  
pp. 259
Author(s):  
Robin S. Roberts ◽  
Jane Sicurella ◽  
Michael Gent
Keyword(s):  
Intent To Treat ◽  
Treat Analysis

Randomized Trial of Radiotherapy Versus Concurrent Chemoradiotherapy Followed by Adjuvant Chemotherapy in Patients With American Joint Committee on Cancer/International Union Against Cancer Stage III and IV Nasopharyngeal Cancer of the Endemic Variety

2005 ◽  
Vol 23 (27) ◽  
pp. 6730-6738 ◽  
Author(s):  
Joseph Wee ◽  
Eng Huat Tan ◽  
Bee Choo Tai ◽  
Hwee Bee Wong ◽  
Swan Swan Leong ◽  
...  
Keyword(s):  
Distant Metastasis ◽  
Nasopharyngeal Cancer ◽  
Disease Free Survival ◽  
Free Survival ◽  
The Difference ◽  
Intent To Treat ◽  
To Receive ◽  
Disease Free ◽  
Treat Analysis

Purpose The Intergroup 00-99 Trial for nasopharyngeal cancer (NPC) showed a benefit of adding chemotherapy to radiotherapy. However, there were controversies regarding the applicability of the results to patients in endemic regions. This study aims to confirm the findings of the 00-99 Trial and its applicability to patients with endemic NPC. Patients and Methods Between September 1997 and May 2003, 221 patients were randomly assigned to receive radiotherapy (RT) alone (n = 110) or chemoradiotherapy (CRT; n = 111). Patients in both arms received 70 Gy in 7 weeks using standard RT portals and techniques. Patients on CRT received concurrent cisplatin (25 mg/m2 on days 1 to 4) on weeks 1, 4, and 7 of RT and adjuvant cisplatin (20 mg/m2 on days 1 to 4) and fluorouracil (1,000 mg/m2 on days 1 to 4) every 4 weeks (weeks 11, 15, and 19) for three cycles after completion of RT. All patients were analyzed by intent-to-treat analysis. The median follow-up time was 3.2 years. Results Distant metastasis occurred in 38 patients on RT alone and 18 patients on CRT. The difference in 2-year cumulative incidence was 17% (95% CI, 14% to 20%; P = .0029). The hazard ratio (HR) for disease-free survival was 0.57 (95% CI, 0.38 to 0.87; P = .0093). The 2- and 3-year overall survival (OS) rates were 78% and 85% and 65% and 80% for RT alone and CRT, respectively. The HR for OS was 0.51 (95% CI, 0.31 to 0.81; P = .0061). Conclusion This report confirms the findings of the Intergroup 00-99 Trial and demonstrates its applicability to endemic NPC. This study also confirms that chemotherapy improves the distant metastasis control rate in NPC.

A Bayesian Framework for Intent-to-Treat Analysis with Missing Data

Biometrics ◽  
1998 ◽  
Vol 54 (1) ◽  
pp. 265 ◽  
Author(s):  
Ken P. Kleinman ◽  
Joseph G. Ibrahim ◽  
Nan M. Laird
Keyword(s):  
Missing Data ◽  
Bayesian Framework ◽  
Intent To Treat ◽  
Treat Analysis

Yttrium-90-Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy After Cytoreduction With ESHAP Chemotherapy In Patients With Relapsed Follicular Non-Hodgkin’s Lymphoma (NHL): Interim Results Of a Phase II Study

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4404-4404 ◽  
Author(s):  
Soham D. Puvvada ◽  
Daniel O. Persky ◽  
Lora Inclan ◽  
Jonathan H. Schatz ◽  
Ellen M Chase ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Median Time ◽  
Residual Disease ◽  
Phase Ii Study ◽  
Time To Progression ◽  
Intent To Treat ◽  
Treat Analysis ◽  
Minimal Residual

Abstract Background Radioimmunoconjugates are effective treatment in relapsed/refractory follicular lymphoma (FL) when used as single agents, and can result in effective disease control (Kaminski et al, NEJM 1993; Witzig, JCO 2002). When used as consolidative treatment following a course of initial chemotherapy for patients with newly diagnosed FL, durable remissions have been noted (Gordon LI et al, Blood 2004). As a pure high energy beta emitting isotope, Zevalin has several advantages and has been well studied in relapsed refractory indolent NHL (Witzig TE et al, JCO 2002). Therefore, our hypothesis is that radioimmunoconjugates significantly change outcome for patients with FL when given in a situation of minimal residual disease, and number of long term remissions would increase with initial cytoreduction. For cytoreduction, we chose to use an outpatient formulation of ESHAP (etoposide, methylprednisolone, cytarabine, cisplatin): ESHAP has excellent efficacy as a salvage regimen in treating relapsed low-grade lymphomas (Rodriguez-Monge EJ et al, Hem Oncol Clin N Am, 1997). Further, it is not utilized by community oncology practices fostering chemo sensitivity in a relapsed setting. Methods Histologically confirmed CD 20 + relapsed FL, ≥1< 4 prior therapies, age 18, ECOG performance status 0–2, measurable disease, signed informed consent, creatinine, bilirubin< 2.0 x ULN , platelet counts ≥150,000 able to receive 0.4 mCi/kg of Zevalin; patients with platelet counts 100,000-150,000 received 0.3mCi/kg dose of Zevalin. Patients were treated with 2 cycles of ESHAP every 28 days. At subsequent restaging, if bone marrow aspirate, biopsy showed<25% involved and expected biodistribution, Zevalin was administered. If Bone marrow involvement was >25 % was noted, patients were taken off study secondary to treatment failure. Results Twenty-eight patients with FL were enrolled with total 8 year follow-up. 6 patients did not complete the study: one patient was ineligible secondary to re-review of path showing DLBCL. Three patients were ineligible for study completion secondary to bone marrow showing residual involvement. Two patients withdrew secondary to toxicities: one from a perforated duodenal ulcer (SAE), and one from side effects of ESHAP chemotherapy including nausea, progressive functional decline. Other Grade 3, 4 adverse events included myelosuppression. Twenty-two patients were evaluable for response. Of the 22 evaluable patients, the overall response rate was 72% (17/22) with another 13 % achieving stable disease. After follow-up of 8 years, the median progression free survival (PFS) was 10 months for both the intent to treat analysis and responders (p=0.14). The median overall survival (OS) in the intent to treat analysis was 63 months, and the median OS in the 8 year follow-up of responders has not been reached (p=0.02). When analyzed by median number of prior therapies, the median PFS for patients with more than one prior chemotherapy regimen was 9, whereas the median PFS for patients with one prior regimen was 22 months. Similarly, for patients with more than one prior therapy, the median OS was 54 months, whereas the median OS for patients with one prior regimen has not been reached at 8 year follow-up. Conclusions In prior long term follow-up data(7 years) of a phase I/II study of Zevalin (Gordon et al, Blood 2004) in NHL including FL, the median time to progression in responders was 12.6 months, and durable responses were noted in 5/51 patients with FL. In a phase II study of relapsed FL treated with Zevalin (Witzig et al, JCO 2002) the median time to progression was 6.8 months, and in a subsequent Phase III study comparing Zevalin to rituximab, the median time to progression was 11.2 months. In comparison to above studies, our study has shown that outpatient ESHAP is an effective cytoreductive regimen. Zevalin is active when administered in a setting of minimal residual disease early in the disease course as evidence by the excellent overall survival of the responders. Disclosures: Off Label Use: Use of the investigational agent MLN8237 in combination in patients with aggressive B-cell NHL. Persky:Millennium: The Takeda Oncology Company: Research Funding.

Comparison of the Efficacy and Safety of Quinapril vs. Captopril in Treatment of Moderate to Severe Hypertension

Angiology ◽  
1989 ◽  
Vol 40 (4_part_2) ◽  
pp. 389-395 ◽  
Author(s):  
Harold W Schnaper
Keyword(s):  
Blood Pressure ◽  
Severe Hypertension ◽  
Dose Titration ◽  
Efficacy And Safety ◽  
Pressure Data ◽  
Double Blind ◽  
Treat Ment ◽  
Blood Pressure Data ◽  
Intent To Treat ◽  
Treat Analysis

The results of this multicenter double-blind comparative study in 172 patients with moderate to severe hypertension indicate that twice daily quinapril (20-80 mg/day) is signifi cantly more effective than captopril (50-200 mg/day) at reducing blood pressure. Following a minimum of four weeks of treatment, the results in evaluable patients showed a signif icantly greater reduction of diastolic blood pressure (DBP) in the quinapril group than in the captopril group (18.6 vs 15.3 mm Hg, respectively, p < 0.05). An intent-to-treat analysis using blood pressure data from all patients having values within an eight-to-sixteen-hour postdose treat ment window showed quinapril to produce a significantly greater re duction in DBP than captopril (18.2 vs 14.8 mm Hg, respectively, p = < 0.05). Throughout the course of the six-week study, quinapril consist ently showed efficacy superior to cap topril despite a faster captopril dose titration.

Results of a Phase II Study With Doxorubicin, Etoposide, and Cisplatin in Patients With Fully Characterized Small-Cell Carcinoma of the Prostate

2002 ◽  
Vol 20 (14) ◽  
pp. 3072-3080 ◽  
Author(s):  
Christos N. Papandreou ◽  
Danai D. Daliani ◽  
Peter F. Thall ◽  
Shi-Ming Tu ◽  
Xuemei Wang ◽  
...  
Keyword(s):  
Performance Status ◽  
Specific Antigen ◽  
Small Cell ◽  
Clinicopathologic Features ◽  
Visceral Metastases ◽  
Grade 3 ◽  
Intent To Treat ◽  
Further Development ◽  
Treat Analysis ◽  
Severe Grade

PURPOSE: To determine the activity and toxicity of doxorubicin in combination with cisplatin and etoposide in patients with small-cell prostate carcinoma (SCPCa) and to characterize the clinicopathologic features of SCPCa. PATIENTS AND METHODS: Patients with SCPCa (pure or mixed), measurable disease, good organ function, and no prior treatment with doxorubicin, etoposide, or cisplatin were treated every 4 weeks with doxorubicin 50 mg/m2 as a 24-hour intravenous (IV) infusion followed by etoposide 120 mg/m2/d and cisplatin 25 mg/m2/d IV on days 2 to 4. RESULTS: Thirty-eight patients (36 assessable for response) were treated for a median of four cycles. Twenty-nine (81%) of 36 patients had prior hormonal therapy. Study patients had visceral metastases, lytic bone disease, and relatively low serum prostate-specific antigen (PSA). We observed 22 partial responses (response rate, 61% in an intent-to-treat analysis); toxicity was severe (grade 3 or 4 neutropenia 100%, thrombocytopenia 66%, mucositis 21%, and infection 68%). Three patients died of toxicity. Median time to progression and overall survival time were 5.8 months and 10.5 months, respectively. Performance status, serum albumin, and number of organs involved (but not PSA, carcinoembryonic antigen, or neuroendocrine markers) were predictors of survival. CONCLUSION: SCPCa presents unique clinicopathologic features. Addition of doxorubicin to the etoposide/cisplatin regimen caused higher toxicity in this patient population and failed to improve outcome. Given these results, we do not recommend further development of this regimen for patients with SCPCa. Improvement in therapy will come from understanding the biology of SCPCa progression and integrating new targeted therapies into the treatment of SCPCa.

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