scholarly journals Comparing the Efficacy and Side Effects of PDLASTA® (Peg-Filgrastim) with PDGRASTIM® (Filgrastim) in Breast Cancer Patients; A Non-inferiority Randomized Clinical Trial

2020 ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Single Dose ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Injection Site Reaction ◽  
Study Groups ◽  
Breast Cancer Patients ◽  
Significant Difference

Abstract Background: The objective of this study was to compare the efficacy and side effects of to evaluate the efficacy and safety of a single dose (Peg-Filgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial.Methods: In this randomized clinical trial, 80 patients recruited and allocated randomly in two equal arms. In one group, a single subcutaneous dose of 6 mg of PDL was injected the day after receiving a chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of 300 micrograms per day for six consecutive days in each course of treatment. Side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight courses of chemotherapy.Results: hematologic parameters showed no significant difference in each course of treatment between two groups of study. The comparison of the WBC (p=0.527), Hgb (p=0.075), Platelet (p=0.819), Neutrophil (p=0.575), Lymphocyte (p=705) and ANC (p=0.675) changes during eight courses of treatment identified no statistically significant difference between two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs.Conclusion: Regarding our results, PDL is completely non- inferior in efficacy and also less toxic compared to PDG. Prescribing in single-dose and lower expenses of PDL introduces it as a cost-effective drug in the treatment of chemotherapy-induced neutropenia. Trial registration number, date of registration: IRCT20190504043465N1, May 2019https://www.irct.ir/search/result?query=IRCT20190504043465N1

scholarly journals Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Single Dose ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Injection Site Reaction ◽  
Study Groups ◽  
Breast Cancer Patients ◽  
Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

Randomized clinical trial of tamoxifen alone or combined with fluoxymesterone in postmenopausal women with metastatic breast cancer.

1988 ◽  
Vol 6 (5) ◽  
pp. 825-831 ◽  
Author(s):  
J N Ingle ◽  
D I Twito ◽  
D J Schaid ◽  
S A Cullinan ◽  
J E Krook ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Metastatic Breast Cancer ◽  
Side Effects ◽  
Postmenopausal Women ◽  
Randomized Clinical Trial ◽  
Statistical Significance ◽  
Metastatic Breast ◽  
Rank Test ◽  
Breast Cancer Patients

A randomized clinical trial was performed to determine if combination hormonal therapy with tamoxifen (TAM) and fluoxymesterone (FLU) was more efficacious than TAM alone for the treatment of postmenopausal women with metastatic breast cancer. Patients failing TAM could subsequently receive FLU. The dose of both drugs was 10 mg orally twice daily. Objective responses were seen in 50 of 119 TAM patients (42%) and 63 of 119 TAM plus FLU patients (53%) (one-sided P = .05). Time to disease progression distributions were better for TAM plus FLU (median, 350 days v 199 days), but the log rank test only approached statistical significance (one-sided P = .07). Duration of response and survival distributions were similar between the two treatment arms. Toxicities, in terms of androgenic side effects, were greater on the TAM plus FLU regimen. Fifty-two patients are evaluable for response with FLU following TAM and 21 (40%) have achieved a response. We conclude that the advantages in terms of response rate and time to progression observed with TAM plus FLU probably represent a biological effect, but are not of sufficient magnitude to justify the routine clinical use of this combination given the lack of survival advantage and side effects encountered.

scholarly journals Citalopram and group psychotherapy in breast cancer patients: A randomized clinical trial

2018 ◽  
Vol 32 (1) ◽  
pp. 394-399
Author(s):  
Novin Nikbakhsh ◽  
Sussan Moudi ◽  
Sara Alvarzandi ◽  
Maede Niazifar ◽  
Nazila Farnoush ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Group Psychotherapy ◽  
Breast Cancer Patients

Study of pregabalin effect on postsurgical pain in breast cancer patients: A double‐blind randomized clinical trial using placebo

2020 ◽  
Vol 26 (11) ◽  
pp. 2286-2288
Author(s):  
Ali Mir ◽  
Niayesh Mohebbi ◽  
Ramesh Omranipour ◽  
Mojtaba Sedaghat ◽  
Marzieh Lashkari ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Postsurgical Pain

scholarly journals EVA-Scalp: Evaluation of Patient Satisfaction with a Scalp Cooling Device to Prevent Chemotherapy-Induced Alopecia in Breast Cancer Patients

Breast Care ◽  
2019 ◽  
Vol 15 (2) ◽  
pp. 171-177
Author(s):  
Franz-Ferdinand Bitto ◽  
Alexander König ◽  
Thuy  Phan-Brehm ◽  
Thomas Vallbracht ◽  
Julian Gregor Koch ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Patient Satisfaction ◽  
Side Effects ◽  
Cancer Patients ◽  
Well Being ◽  
Scalp Cooling ◽  
Breast Cancer Patients ◽  
Significant Difference ◽  
Patient Selection Criteria

Purpose: Scalp cooling (SC) offers a chance to reduce hair loss (HL), but patient satisfaction, the effect on well-being, as well as patient selection criteria have not been sufficiently assessed yet. Methods: In the EVAScalp trial, SC was offered to 70 breast cancer patients who received chemotherapy between November 2015 and September 2018. For SC, the Paxman-Orbis-II System was used. Satisfaction was measured by a questionnaire evaluating the level of depression with the WHO-5 well-being index (WHO-5) plus questions addressing the patient’s experiences and side effects using the SC device. To evaluate efficacy, documentation by photo, by a physician, and by an HL-diary was conducted. Results: Regarding efficacy, a significant difference between chemotherapy regimens is seen. Anthracycline-based therapies led to a stop of SC in 71% of the patients, whereas taxane-based therapies without anthracyclines were associated with a high acceptance of SC, and 88% of patients with paclitaxel-based therapies continued SC throughout their chemotherapy. Overall, only 7.69% of the patients stopped because of side effects. As an indicator for quality of life, WHO-5 was higher (65.8%) in patients with successful SC compared to in patients who stopped SC because of HL or side effects (only 53.0%). The majority of patients (82.22%) with successful SC would recommend SC to other patients. Conclusions: Patients tolerated SC as long as HL was successfully prevented. The well-being of patients with successful SC was significantly higher than that of patients who stopped SC prematurely. In general, SC is a promising approach and improves patient well-being, but there are still limitations to its utility depending on the chemotherapy regimen used.

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