Initiating epoetin alfa (EPO) 120,000 U every three weeks (Q3W) in pts with chemotherapy (CT)-induced anemia (CIA)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19564-19564 ◽  
Author(s):  
J. Glaspy ◽  
V. Charu ◽  
V. Moyo ◽  
M. Kamin ◽  
F. E. Wilhelm
Keyword(s):  
Randomized Study ◽  
Intervention Group ◽  
Target Range ◽  
Future Research ◽  
Final Visit ◽  
Open Label ◽  
The Mean ◽  
Dosing Intervals ◽  
To Receive ◽  
Prescribing Information

19564 Background: Emerging data suggest that initiating EPO therapy earlier (at a higher hemoglobin [Hb] trigger) in the setting of active CT may provide better maintenance of Hb within a target range with no adverse safety consequence. Reported here are the final results of the first study to explore the efficacy and safety of early vs standard intervention with EPO initiated Q3W at 120,000 U. Methods: This 16-wk open-label randomized study enrolled pts with non-myeloid malignancy, baseline (BL) Hb =11.0 and =12.0 g/dL, and CT planned for =9 wks. Pts were randomized (1:1) to receive EPO 120,000 U subcutaneously Q3W immediately (early intervention group, EIG) or when their Hb fell to <11.0 g/dL (standard intervention group, SIG). If, at any dosing visit after the first EPO dose, Hb decreased to <10.0 g/dL, pts were switched to EPO 40,000 U weekly (QW). Dose was withheld for Hb >13.0 g/dL at any dosing visit; dose was reduced for Hb >12.0 g/dL or Hb increase >1.5 g/dL in a 3-wk period (current prescribing information recommends target Hb not to exceed 12 g/dL). Hb response was defined as Percent Values in Range (PVR; the mean proportion of weekly Hb levels that were =11.0 and =13.0 g/dL) and by mean Hb change from BL. Hb data following switch to 40,000 U QW were censored. Results: A total of 136 pts were randomized (68 per group). Demographics were similar; BL Hb was 11.5 g/dL in both groups. PVR was 60% in the EIG and SIG. Mean Hb change from BL to final value on Q3W dosing was -0.1 g/dL in both groups. Among the 51 pts whose Hb fell below 11 g/dL in the SIG, their Hb decreased to a mean of 10.4 g/dL before initiation of EPO. Their subsequent mean Hb increase was 0.7 g/dL at the final visit on Q3W therapy. PRBC transfusion rates after the first 4 wks of EPO treatment were 8.8% (6/68) and 7.8% (4/51) for the EIG and SIG, respectively. In the EIG vs SIG, EPO was withheld in 38% vs 22% of pts and reduced in 43% vs 26% of pts. Two deaths and 6 clinically relevant TVEs while on EPO treatment were reported in each group. Conclusions: This is the first study to show EPO may be initiated at 120,000 U every 3 wks. Hb outcomes in the EIG and SIG were similar. These data provide further evidence that half-life of erythropoietins may not correlate with their effectiveness when used at extended dosing intervals. Future research is warranted. No significant financial relationships to disclose.

Initiating epoetin-alpha (EPO) 120,000 units (U) every three weeks (Q3W) in patients with chemotherapy (CT)-induced anemia (CIA) and a hemoglobin (Hb) of <11 g/dL

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19589-19589
Author(s):  
F. E. Wilhelm ◽  
V. Charu ◽  
J. Glaspy ◽  
V. Moyo ◽  
M. Kamin
Keyword(s):  
Randomized Study ◽  
Intervention Group ◽  
Screening Methods ◽  
Transfusion Rate ◽  
Open Label ◽  
Epoetin Alpha ◽  
Changes Over Time ◽  
To Receive ◽  
Prescribing Information ◽  
Over Time

19589 Background: Reported here are the final Hb results for the group of patients enrolled under an amendment to a larger study that was the first to compare early vs standard intervention with EPO 120,000 U Q3W in patients with CIA and Hb of 11 to 12 g/dL. The amendment allowed for treatment of patients who had a Hb value <11g/dL at screening. Methods: The larger study was a 16-week open-label randomized study that enrolled patients with non-myeloid malignancy, baseline (BL) Hb =11.0 and =12.0 g/dL, and CT planned for =9 weeks. Patients were randomized (1:1) to receive EPO 120,000 U subcutaneously Q3W immediately (early intervention group, EIG) or when their Hb fell to <11.0 g/dL (standard intervention group, SIG). If, at any dosing visit after the first EPO dose, Hb decreased to <10.0 g/dL, patients were switched to EPO 40,000 U weekly (QW). An amendment was added to the larger study to allow similar patients whose Hb was <11 g/dL at screening to be treated with EPO 120,000 U Q3W. EPO was withheld for Hb >13.0 g/dL at any dosing visit; dose was reduced for Hb >12.0 g/dL or Hb increase >1.5 g/dL in a 3-week period (current prescribing information recommends target Hb not to exceed 12 g/dL). Hb response was analyzed using an observed case approach and Hb data following switch to 40,000 U QW were censored. Results: Fifty patients were enrolled under the amendment. BL characteristics were: mean age, 62.0 years; 67% female; mean Hb 10.1 g/dL. Mean Hb changes over time from BL for patients receiving Q3W dosing are shown in the table . PRBC transfusion rate after 4 weeks on treatment was 24.5%. 18.0% of patients had at least one dose withheld and 22.0% had at least one dose reduction. Five deaths and 6 clinically relevant TVEs were reported. Conclusions: This study shows that EPO is effective in raising Hb when initiated in patients with CIA and a Hb of <11 g/dL at 120,000 U every 3 weeks. Further studies are warranted. No significant financial relationships to disclose. [Table: see text]

scholarly journals Banded Sleeve Gastrectomy Improves Weight Loss Compared to Nonbanded Sleeve: Midterm Results from a Prospective Randomized Study

2020 ◽  
Vol 2020 ◽  
pp. 1-7 ◽  
Author(s):  
Paolo Gentileschi ◽  
Emanuela Bianciardi ◽  
Leandro Siragusa ◽  
Valeria Tognoni ◽  
Domenico Benavoli ◽  
...  
Keyword(s):  
Weight Loss ◽  
Sleeve Gastrectomy ◽  
Weight Regain ◽  
Randomized Study ◽  
Banded Sleeve Gastrectomy ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
To Receive

Background. Weight regain after laparoscopic sleeve gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short term. We report the results of a randomized study comparing LSG and laparoscopic banded sleeve gastrectomy (LBSG) over a 4-year follow-up. Objectives. To evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the midterm. Methods. Between 01/2014 and 01/2015, we randomly assigned 50 patients to receive one of the two procedures. Patients’ management was exactly the same, apart from the band placement. We analyzed differences in weight loss, operative time, complication rate, and mortality, with a median follow-up of 4 years. Results. Twenty five patients were assigned to receive LSG (Group A) and 25 LBSG (Group B). The mean preoperative BMI (body mass index) was 47.3 ± 6.58 kg/m2 and 45.95 ± 5.85 kg/m2, respectively. There was no significant difference in the operative time. No intraoperative or postoperative complications occurred. At 12-month follow-up, the mean BMI was 29.72 ± 4.40 kg/m2 in Group A and 27.42 ± 4.47 kg/m2 in Group B (p=0.186). After a median follow-up of 4 years, the mean BMI in Group B was significantly lower than Group A (24.10 ± 4.52 kg/m2 vs 28.80 ± 4.62 kg/m2; p=0.00199). Conclusions. LBSG is a safe procedure, with no impact on postoperative complications. The banded sleeve showed a significant greater weight loss in the midterm follow-up. Considering the issue of weight regain observed after LSG, the placement of a perigastric ring during the first procedure may be a strategy to improve the results. This trial is registered with NCT04228185.

scholarly journals A Randomized, Open-Label Study to Assess Efficacy of Weekly Assumption of Cholecalciferol Versus Calcifediol in Older Patients With Hypovitaminosis D

2021 ◽  
Author(s):  
Chukwuma Okoye ◽  
Valeria Calsolaro ◽  
Filippo Niccolai ◽  
Alessia Maria Calabrese ◽  
Riccardo Franchi ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Older Patients ◽  
Randomized Study ◽  
Hypovitaminosis D ◽  
Clinical History ◽  
Open Label ◽  
Open Label Study ◽  
The Mean

The aim of this single-center, open-label, non-controlled randomized study was to evaluate which formulation of vitamin D between cholecalciferol and calcifediol is most effective in the treatment of hypovitaminosis D in older adults. Demographic characteristics, clinical history and comprehensive geriatric assessment were recorded at admission. Eligible patients randomly received an equivalent vitamin D supplement either with cholecalciferol or calcifediol from hospital admission to three months after discharge. Among the 140 older patients included (mean age 83&plusmn;6.6, 57.8% females), 69 received cholecalciferol and 71 calcifediol. The mean plasma values of 25OH-Vitamin D3 found at the enrollment were 16.8 &plusmn; 9.9 ng/mL in patients receiving cholecalciferol and 18.8 &plusmn; 13.3 ng/mL in those treated with calcifediol (p =0.31). At the 3-month follow up, the mean concentration of 25OH-Vitamin D3 was significantly higher in patients treated with calcifediol than in patients treated with cholecalciferol (respectively, 30.7 &plusmn; 8.4 vs 45.4 &plusmn; 9.8 ng/mL, p &amp;lt;0.001). Supplementation with cholecalciferol or calcifediol results in both cases effective in reaching optimal circulating values of 25OH-VitaminD3 in the older patients suffering from hypovitaminosis D. However, supplementation with calcifediol led to average circulating values of 25OH- VitaminD3 significantly higher (over 50%) than those obtained with cholecalciferol.

scholarly journals Bioequivalence of levamlodipine besylate tablets in healthy Chinese subjects: A single-dose and two-period crossover randomized study

2020 ◽  
Author(s):  
Li Xin ◽  
Chenjing Wang ◽  
Ting Li ◽  
Yanping Liu ◽  
Shuqin Liu ◽  
...  
Keyword(s):  
Single Dose ◽  
Randomized Study ◽  
Plasma Concentrations ◽  
Bioequivalence Study ◽  
Pharmacokinetic Parameters ◽  
Open Label ◽  
Liquid Chromatography Tandem Mass ◽  
The Mean ◽  
Healthy Chinese ◽  
Chinese Subjects

Abstract Background: Levamlodipine, a calcium channel blocker, has been show act as a cardiovascular drug. To compare the pharmacokinetic parameters between levamlodipine (test formulation) at a single dose of 5 mg and amlodipine (reference formulation) at a single dose of 10 mg, the bioequivalence study was carried out.Methods: A single-dose randomized, open-label, two-period crossover study was designed in healthy Chinese subjects. 48 subjects were divided into fasted and fed groups equally. The subjects randomly received the test or reference formulations at the rate of 1:1. Following a 21-day washout period, the alternative formulations were received. The blood samples were collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours later. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) was applied to determine the plasma concentrations of levamlodipine. Adverse events were recorded.Results: The 90% confidence intervals (CIs) of the ratio of geometric means (GMRs) of Cmax, AUC0-t, and AUC0-∞ under both fasted and fed conditions were within the prespecified bioequivalence limits between 80~125%. Under fasted conditions, 24 subjects were enrolled and completed the study. The mean Cmax was (2.70±0.49) ng/mL, AUC0-t was (141.32±36.24) ng×h/mL and AUC0-∞ was (157.14±45.65) ng×h/mL after a single dose of 5 mg levamlodipine. The mean Cmax was (2.83±0.52) ng/mL, AUC0-t was (153.62±33.96) ng×h/mL and AUC0-∞ was (173.05±41.78) ng×h/mL after a single dose of 10 mg amlodipine. Under fed conditions, 24 subjects were enrolled and completed the study. The mean Cmax was (2.73±0.55) ng/mL, AUC0-t was (166.93±49.96) ng×h/mL and AUC0-∞ was (190.99±70.89) ng×h/mL after a single dose of 5 mg levamlodipine. The mean Cmax was (2.87±0.81) ng/mL AUC0-t was (165.46±43.58) ng×h/mL and AUC0-∞ was (189.51±64.70) ng×h/mL after a single dose of 10 mg amlodipine. Serious adverse event was not observed.Conclusion: The trial confirmed that levamlodipine at a single dose of 5 mg and amlodipine at a single dose of 10 mg were bioequivalent under both fasted condition and fed condition.Trial registration: Cinicaltrials, NCT04411875. Registered 3 June 2020 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009W1Q&selectaction=Edit&uid=U00050YQ&ts=3&cx=-6iqkm8

scholarly journals Safety and tolerability of ranibizumab in uni/bilateral neovascular age-related macular degeneration: 12-month TWEYEs study

2019 ◽  
Vol 104 (1) ◽  
pp. 64-73
Author(s):  
Francesco Bandello ◽  
Giovanni Staurenghi ◽  
Federico Ricci ◽  
Edoardo Midena ◽  
Francesco Viola ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Open Label ◽  
Age Related ◽  
Risk Period ◽  
The Mean ◽  
Low Incidence ◽  
To Receive ◽  
Systemic Drug

BackgroundTo evaluate the safety and tolerability of ranibizumab 0.5 mg in patients with uni/bilateral neovascular age-related macular degeneration (nAMD) and best-corrected visual acuity (BCVA)<2/10 and/or second eye affected, regardless of BCVA.MethodsIn this 12-month, prospective, multicentre, open-label, single arm, pragmatic interventional study, patients (N=941) aged ≥ 50 years were to receive ranibizumab as per approved label, monthly until maximum stable visual acuity (VA) was achieved (initially, three or more injections may be required). Thereafter, patients were to be monitored monthly for VA and treatment was to be resumed if VA was reduced due to disease activity.ResultsOf the 936 patients treated with ranibizumab at least once during the study, 823/113 were unilaterally/bilaterally (not simultaneously) treated . The mean (SD) number of ranibizumab injections during the study was 5.4 (2.9)/10.6 (5.0) injections in uni/bilaterally treated patients. Three systemic drug-related adverse events (AEs) (all serious, all in unilaterally treated patients) and 18 systemic AE of special interest (AESIs) (11 serious, 16/2 in unilaterally/bilaterally treated patients) occurred during the study. The annual incidence rate (AIR) (events/1000 person-years) for systemic drug-related AEs, considering a 15-day/30-day risk period, 11.0/8.5 for unilaterally treated patients. Considering the same risk period, the AIR (events/1000 person-years) for systemic AESIs for unilaterally treated patients was 22.1/19.9. Considering a 30-day risk period, the AIR (events/1000 treated eye-years) of ocular drug-related AEs was 23 and AESIs was 11.5.ConclusionsThe low incidence of AEs and AESIs demonstrated the good safety and tolerability of ranibizumab in unilaterally/bilaterally treated patients with nAMD in this real-world setting.

scholarly journals The FAFA Trial: A Phase 2 Randomized Clinical Trial on the Effect of a Fan Blowing Air on the Face to Relieve Dyspnea in Filipino Patients with Terminal Cancer

2020 ◽  
Vol 6 (01) ◽  
pp. 03-09 ◽  
Author(s):  
Frederic Ivan Ting ◽  
Sachiko Estreller ◽  
Heinrik Martin Jude Strebel
Keyword(s):  
Intervention Group ◽  
Standard Of Care ◽  
Mean Difference ◽  
Control Group ◽  
Published Data ◽  
Terminal Cancer ◽  
Phase 2 ◽  
Open Label ◽  
Phase 2 Trial ◽  
The Mean

Abstract Introduction Fan therapy has been suggested by some studies as one of the nonpharmacological supportive interventions to alleviate breathlessness for dyspneic patients with terminal cancer. Unfortunately, data among Asians are limited and there are currently no published data showing that this intervention works among Filipinos—thus this study. Study Design This study was an open-label, randomized, placebo-controlled, crossover Phase 2 trial. The experimental group had a fan blowing air directly to the patient’s face for 5 minutes, and the control group had a fan blowing air to the patient’s legs. Treatment crossover was done after a washout period of 1 hour. The primary outcome, which is dyspnea, was measured subjectively using the Modified Borg Scale (MBS). Differences in the patient’s respiratory rate (RR) and oxygen saturation were also measured. Results A total of 48 patients were enrolled in this trial. The mean age of the patients enrolled was 51 years, and the most common primary tumor was lung cancer (21%). In the control group, results showed that the mean difference before and after intervention in the MBS was 0.15, and the mean difference in RR was 0.25. On the other hand, the intervention group showed a statistically significant decrease in the patient’s dyspnea as evidenced by a mean MBS decrease of 2.79 (p < 0.0001), and a mean RR decrease of 1.88 (p < 0.0001). Conclusion The results of this study reveal that fan on face (FAFA) therapy in terminally ill Filipino cancer patients in addition to the prescribed standard of care can significantly alleviate their level of dyspnea. Thus, FAFA therapy should be considered as an adjunct to standard of care for these patients.

scholarly journals Mobilization of Stem Cells Using G-CSF for Acute Ischemic Stroke: A Randomized Controlled, Pilot Study

2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
Kameshwar Prasad ◽  
Amit Kumar ◽  
Jitendra Kumar Sahu ◽  
M. V. P. Srivastava ◽  
Sujata Mohanty ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Randomized Study ◽  
Intervention Group ◽  
Preliminary Evidence ◽  
Potential Safety ◽  
Efficacy Outcome ◽  
Significant Difference ◽  
And Control ◽  
To Receive

Background. There is emerging evidence to support the use of granulocyte colony-stimulating factor (G-CSF) therapy in patients with acute ischemic stroke.Aims. To explore feasibility, safety, and preliminary efficacy of G-CSF therapy in patients with acute ischemic stroke.Patients and Method. In randomized study, 10 patients with acute ischemic stroke were recruited in 1 : 1 ratio to receive 10 μg/kg G-CSF treatment subcutaneously daily for five days with conventional care or conventional treatment alone. Efficacy outcome measures were assessed at baseline, one month, and after six months of treatment included Barthel Index (BI), National Institute of Health Stroke Scale, and modified Rankin Scale.Results. One patient in G-CSF therapy arm died due to raised intracranial pressure. No severe adverse effects were seen in rest of patients receiving G-CSF therapy arm or control arm. No statistically significant difference between intervention and control was observed in any of the scores though a trend of higher improvement of BI score is seen in the intervention group.Conclusion. Although this study did not have power to examine efficacy, it provides preliminary evidence of potential safety, feasibility, and tolerability of G-CSF therapy. Further studies need to be done on a large sample to confirm the results.

Therapeutic non-contraceptive properties of the drug containing ethinylestradiol 0.03 mg and drospirenone 3 mg

GYNECOLOGY ◽  
2019 ◽  
Vol 21 (5) ◽  
pp. 65-68
Author(s):  
Natalia V Artymuk ◽  
Olga A Tachkova
Keyword(s):  
Body Mass Index ◽  
Body Weight ◽  
Body Mass ◽  
Randomized Study ◽  
Clinical Effectiveness ◽  
The Body ◽  
Reproductive Age ◽  
Anthropometric Parameters ◽  
To Receive ◽  
Prescribing Information

Aim. To compare effects of the drug containing ethinylestradiol (EE) 0.03 mg and drospirenone (DRSP) 3 mg and the drug containing EE 0.02 mg and DRSP 3 mg on the skin and anthropometric parameters. Materials and methods. A prospective comparative randomized study included 40 women of reproductive age who didn’t have contraindications to use of combined oral contraceptive (COCs). The first group consisted of 20 women who were administrated EE 0.03 mg and DRSP 3 mg in the 21/7 regimen according to a prescribing information; the 2nd group included 20 patients who were administrated EE 0.02 mg and DRSP 3 mg in the 24/4 regimen according to a prescribing information. The study protocol included 8 visits: at the 0th visit, the inclusion and exclusion criteria were evaluated, at the 1st visit patient were randomized (envelope method) to receive one or another drug, at the 2nd - 7th visits (once a month) blood pressure was measured, anthropometric parameters were determined including body weight, height, waist, hips as well as body mass index, a degree of hirsutism (with Ferriman-Gallwey scale), skin and hair skin oiliness, acne (with a 10-point visual scale) were evaluated. Results. The use of EE 0.03 mg and DRSP 3 mg for 6 months did not significantly affect the body weight and body mass index, waist and hips. In the 6th month, the use of EE 0.03 mg and DRSP 3 mg lead to a statistically significant decrease in skin oiliness, severity of acne and hirsutism, which was comparable to a clinical effectiveness of EE 0.02 mg and DRSP 3 mg. Conclusions. EE 0.03 mg and DRSP 3 mg has a similar effect on skin oiliness, severity of acne and hirsutism with EE 0.02 mg and DRSP 3 mg, without significantly affecting the main anthropometric parameters. It is likely that the effect of DRSP-containing COCs on androgen levels and adipose tissue is due precisely to the effect of DRSP, and not to the dose of EE.

Phase 3, open-label, randomized study of first-line pembrolizumab (pembro) vs investigator-choice chemotherapy for mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal carcinoma (mCRC): KEYNOTE-177.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS3618-TPS3618 ◽  
Author(s):  
Luis A. Diaz ◽  
Dung T. Le ◽  
Takayuki Yoshino ◽  
Thierry Andre ◽  
Johanna C. Bendell ◽  
...  
Keyword(s):  
Disease Progression ◽  
Performance Status ◽  
Randomized Study ◽  
Immune Checkpoints ◽  
First Line ◽  
Open Label ◽  
Phase 3 ◽  
Ecog Performance Status ◽  
End Points ◽  
To Receive

TPS3618 Background: About 5% of mCRCs are dMMR, leading to high levels of MSI. CRCs with MSI-H have abundant lymphocyte infiltrates and strong expression of immune checkpoints. In the phase 2 KEYNOTE-016 study, the anti-programmed death 1 (PD-1) antibody pembro provided an ORR of 40% in patients (pts) with progressive dMMR mCRC vs 0% in pts with MMR-proficient mCRC. KEYNOTE-177 (ClinicalTrials.gov, NCT02563002) is an international, randomized, open-label, phase 3 study designed to evaluate the efficacy and safety of pembro vs standard-of-care (SOC) chemotherapy in the first-line setting for dMMR or MSI-H mCRC. Methods: Key eligibility criteria include age ≥ 18 years, locally confirmed dMMR or MSI-H stage IV CRC, measurable disease per RECIST v1.1 by local site assessment, ECOG performance status 0-1, no active autoimmune disease or brain metastases, and no prior therapy for mCRC. Pts are to be randomized 1:1 to receive either pembro 200 mg Q3W or investigator’s choice of SOC chemotherapy, which must be chosen prior to randomization; options include mFOLFOX6 or FOLFIRI alone or in combination with bevacizumab or cetuximab. Treatment is to continue until disease progression, unacceptable toxicity, pt/investigator decision, or completion of 35 cycles (pembro only). Response is to be evaluated Q9W per RECIST v1.1 by central imaging vendor review and per RECIST adapted for immunotherapy response patterns. Pts in the SOC arm who have disease progression and meet crossover criteria may be eligible to receive pembro for up to 17 treatment cycles. Eligible pts may continue pembro beyond initial RECIST-defined progression. AEs are to be assessed throughout treatment and for 30 days thereafter (90 days for serious AEs) and graded per NCI CTCAE v4.0. Pts are to be followed for survival Q9W. Primary end point is PFS per RECIST v1.1 by central imaging vendor review. Secondary end points include ORR per RECIST v1.1 by central imaging vendor review, OS, and safety and tolerability. Other end points include DOR and HRQoL. Planned enrollment in KEYNOTE-177 is 270 pts across 21 countries. Clinical trial information: NCT02563002.

Improvements in Fatigue Are Associated with Early Treatment with Every-3-Week (Q3W) Darbepoetin alfa (DA) Treatment in Anemic Patients (pts) Receiving Chemotherapy (Ctx).

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 233-233 ◽  
Author(s):  
V. Charu ◽  
B. Saidman ◽  
A. Ben-Jacob ◽  
G. R. Justice ◽  
A. S. Maniam ◽  
...  
Keyword(s):  
Missing Values ◽  
Intervention Group ◽  
Target Range ◽  
Trend Test ◽  
P Value ◽  
Early Group ◽  
Open Label ◽  
Point Change ◽  
End Of Treatment ◽  
The Impact

Abstract Background: We recently reported final results of a randomized, open-label, multicenter study assessing the efficacy of DA (Aranesp®) 300 mcg Q3W (Rearden et al, ASCO 2004). In this study of 201 pts, pts with grade 1 anemia were treated early with DA (n=102; early group) compared with pts treated late after developing grade 2/3 anemia (ie, hemoglobin [Hb] &lt; 10 g/dL; n=99; observation/late intervention group [obs]). When pts were untreated in the obs group, Hb declined. DA treatment maintained Hb within the NCCN Hb target range for pts in the early group and increased Hb once administered in the obs group. The objective of this analysis was to explore the impact of declining Hb levels on pt-reported outcomes using the FACT-Fatigue (FACT-F) subscale. Methods: Pts with baseline (BL) Hb ≥10.5 and ≤12 g/dL were randomized 1:1 to either the early or obs group for up to 22 weeks. To analyze pt-reported fatigue, the FACT-F subscale was administered Q3W and at the end of treatment. The FACT-F analysis set included pts who were randomized, received study drug, and had a BL and at least 1 post-BL FACT-F score. Analyses of changes in FACT-F scores during treatment from BL were conducted; missing values were not imputed. Results: In 201 randomized and treated pts, mean BL (SD) Hb was similar for each group, 11.1 (0.7) g/dL for the early and 11.2 (0.6) g/dL for the obs groups. In the early group, mean Hb increased to near 12 g/dL in approximately 7 weeks, and due to dose-withholding rules, remained near 12 g/dL for the remainder of the study. In the obs group, Hb declined to &lt; 10 g/dL in 65% of pts. The FACT-F analysis set included 94 pts in the early group and 86 in the obs group. Mean (SD) FACT-F scores at BL were 31.6 (11.7) for the early group and 27.7 (12.8) for the obs group. With categories of Hb change at the end of treatment, a significant trend towards greater improvements in fatigue with increasing Hb levels was observed in both groups (table). In pts in whom Hb was stabilized or improved, no decrease in fatigue scores was noted. However, when Hb declined (Hb change &lt; 0 g/dL), a statistically significant and clinically meaningful (&gt;3 point change in FACT-F score) increase in fatigue was observed (negative change in FACT-F score). Consistent with previous studies, pts with Hb change &gt; 2 g/dL had clinically and statistically significant improvements in fatigue. Conclusion: In the absence of treatment, most mildly anemic cancer pts receiving ctx are at risk of developing grade 2/3 anemia within approximately 7 weeks. This decline in Hb is associated with a statistically significant and clinically meaningful increase in pt-reported fatigue. Our results indicate that DA 300 mcg Q3W may effectively ameliorate the impact of ctx on Hb levels and consequently prevent a decline in fatigue. Further, Q3W DA may provide benefits associated with less-frequent dosing. Mean (95%CL) Change in FACT-F Scores At End of Treatment By Change in Hb Category Early Obs N=94 N=86 Categories of Hb Change &lt; 0 g/dL −6.2 (−12.9, 0.6) −2.8 (−7.2, 1.5) n=23 n=38 &gt;0 to 2 g/dL 0.9 (−2.2, 4.0) 1.7 (−3.9, 7.3) n=52 n=32 &gt; 2 g/dL 8.3 (3.3, 13.2) 6.4 (0.3, 12.5) n=19 n=16 P -value (Jonckheere-Terpstra Trend Test) 0.0003 0.049

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