scholarly journals Tamoxifen treatment and its outcome in breast cancer patients at a hospital-based cancer registry in Kerala

2020 ◽  
Vol 8 (10) ◽  
pp. 3665
Author(s):  
Reema A. Thomas ◽  
Catherin Nisha
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Cancer Patients ◽  
Cancer Registry ◽  
Endometrial Thickness ◽  
Tamoxifen Treatment ◽  
Accurate Information ◽  
Breast Cancer Patients ◽  
Study Objective ◽  
Systemic Adjuvant Therapy

Background: Endocrine therapy for breast cancer is directed at reducing oestrogen synthesis or alternatively blocking oestrogen receptors (ER) in tumour-sensitive tumors. Despite side effects, the use of systemic adjuvant therapy after local management of breast cancer substantially improves survival and reduces the risk of relapse. The study objective was to assess the recurrence of breast cancer and the complications seen in breast cancer patients on tamoxifen therapy at a hospital-based cancer registry, Thrissur, Kerala.Methods: After obtaining institutional ethical clearance, included 75 patients of histologically diagnosed breast carcinoma currently on tamoxifen, diagnosed in the year of 2016. Data was obtained from the patient files and by personal intimation.Results: Of the 75 patients on tamoxifen, four (5.33%) patients had history of recurrence. 22.6% of patients on tamoxifen were noted to have increased endometrial thickness. Other side effects noted were weight gain, TIA, bone pain and vaginal discharge.Conclusions: It was found that the recurrence rate at three years for the study population was 5.33%. More studies from developing countries, with larger sample size and clinical trials will give us more accurate information regarding the efficacy of the drug.

scholarly journals Sonographic Study of Female Pelvic Organs in Breast Cancer Patients Taking Tamoxifen: Clinical Correlation

2020 ◽  
Vol 7 (1) ◽  
pp. 17-23
Author(s):  
Rafia Parveen ◽  
Shaikh Shofiur Rahman ◽  
Taposhi Sarker ◽  
Syed Muhammad Baqui Billah ◽  
Zakir Hossain Habib
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Endometrial Thickness ◽  
Tamoxifen Therapy ◽  
Tamoxifen Treatment ◽  
Breast Cancer Patients ◽  
Group Iii ◽  
Group I ◽  
Group Ii ◽  
Uterine Volume

Background: As most of breast cancer patients are treated with Tamoxifen, different effects of this drug in patients should be evaluated since no such study is carried out in Bangladesh till date. Objective: The purpose of the present study was to evaluate sonographic changes of female genital organs in breast cancer patients treated with Tamoxifen and to correlate these changes with duration of Tamoxifen treatment and gynecological symptoms. Methodology: This randomized double-blind clinical trial was carried out in Delta Medical College Hospital, Dhaka, Bangladesh from May 2017 to April 2018 for a period of one (1) year. The participants were breast cancer patients which were divided into three groups named as group I patients. The patients of these group were on Tamoxifen therapy. The patients of group II were without Tamoxifen therapy. The patients of group III had completed Tamoxifen therapy. All participants underwent ultrasonography. Results: Patients receiving Tamoxifen therapy had significantly more thickened endometrium compared to other groups (26.6% in group I, 5% in group II and3% in group III). Similarly, abnormal sonographic findings and mean uterine volume were higher in group I compared to other two groups. Endometrial thickness and uterine volume showed significant positive correlation with duration of Tamoxifen therapy (p <0.0001). The endometrial thickness and uterine volume greatly increased after two years of Tamoxifen therapy while it was reverse in group III. Gynecological symptoms had no significant relations with sonographic abnormalities and thickened endometrium. Conclusion: Tamoxifen therapy is associated with increased endometrial thickness, uterine volume and abnormal sonographic findings, compared to patients without Tamoxifen or completing Tamoxifen therapy. Journal of Current and Advance Medical Research 2020;7(1): 17-23

Risk of Endometrial Cancer in Breast Cancer Patients under Long-Term Adjuvant Treatment with Tamoxifen

1998 ◽  
Vol 84 (1) ◽  
pp. 21-23 ◽  
Author(s):  
Silvia Cecchini ◽  
Stefano Ciatto ◽  
Rita Bonardi ◽  
Antonia Mazzotta ◽  
Paolo Pacini ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Endometrial Cancer ◽  
Cancer Patients ◽  
Endometrial Thickness ◽  
Postmenopausal Breast Cancer ◽  
Cancer Surveillance ◽  
Tamoxifen Treatment ◽  
Adjuvant Tamoxifen ◽  
Breast Cancer Patients

Aims To evaluate the relative risk of endometrial cancer with respect to the expected underlying incidence in breast cancer patients undergoing long-term adjuvant tamoxifen therapy. Methods A total of 1010 postmenopausal breast cancer patients receiving adjuvant tamoxifen and with a first negative endometrial ultrasonography (cutoff for abnormal endometrial thickness >5 mm) were followed by annual transvaginal ultrasonography. Abnormal endometrial thickness prompted an outpatient endometrial biopsy or curettage under anesthesia in the case of cervical stenosis and increasing endometrial thickness. The standardized incidence ratio (SIR) with respect to underlying incidence was determined. Results A total of 1,010 eligible subjects who had been receiving tamoxifen for an average of 51 months were enrolled and followed for a total of 2,361 patient-years between January 1993 and December 1996. Five cases of endometrial cancer were observed in the study period: 1 was detected at screening, and 4 were diagnosed for vaginal bleeding in the interval between screening examinations. SIR was 4.0 (95% confidence interval, 1.39.4) and increased to 4.8 (CI, 1.6-10.5) when the single cancer detected at first screening was considered as incident. Conclusions This study adds evidence to the hypothesis that long-term tamoxifen treatment may be responsible for a relevant increase in the risk of developing endometrial cancer. Surveillance based on endometrial ultrasonography was poorly sensitive, but the favorable stage at diagnosis of screen-detected or interval endometrial cancers does not support a more aggressive screening approach.

Effect of PK-guided tamoxifen dose escalation on endoxifen serum concentrations in CYP2D6 intermediate and poor metabolizers.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 595-595
Author(s):  
Frans Opdam ◽  
Vincent O. Dezentje ◽  
Jan den Hartigh ◽  
Henk-jan Guchelaar ◽  
Trees Hessing ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Cancer Patients ◽  
Dose Escalation ◽  
Poor Metabolizers ◽  
Tamoxifen Treatment ◽  
Extensive Metabolizers ◽  
Breast Cancer Patients ◽  
One Step ◽  
Intermediate Metabolizers

595 Background: Breast cancer patients with absent or reduced CYP2D6 activity may benefit less from tamoxifen treatment because of impaired biotransformation to the active metabolite endoxifen. We investigated whether a temporary one-step dose escalation of tamoxifen in CYP2D6 poor (PM) and intermediate metabolizers (IM) could increase endoxifen serum concentration to a similar level observed in CYP2D6 extensive metabolizers (EM) without increasing toxicity. Methods: From a prospective study population of early breast cancer patients using tamoxifen, 12 CYP2D6 poor and 12 intermediate metabolizers were selected and included in a one-step tamoxifen dose escalation study during two months. The escalation dose (120 mg maximum) was calculated by multiplying the individual’s endoxifen level divided by the median endoxifen concentration (33.7 nM) observed in CYP2D6 extensive metabolizers by 20 mg. Toxicity was assessed and all patients returned to the standard dose of 20 mg after two months. Results: Tamoxifen dose escalation in CYP2D6 poor and intermediate metabolizers significantly increased endoxifen concentrations (PMs: from 8.0 nM to 27.3 nM, p<0.001; IMs: from 17.8 nM to 30.3 nM, p=0.002) without increasing side effects. In intermediate but not in poor metabolizers dose escalation increased endoxifen to levels comparable with those observed in extensive metabolizers using tamoxifen 20 mg once daily (33.7 nM). Conclusions: CYP2D6 genotype and endoxifen guided tamoxifen dose escalation increased endoxifen concentrations without increasing short term side effects. Whether such tamoxifen dose escalation is effective and safe in view of long term toxic effects is uncertain and needs to be explored. Clinical trial information: NTR1509.

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.

scholarly journals Clinical CYP2D6 Genotyping to Personalize Adjuvant Tamoxifen Treatment in ER-Positive Breast Cancer Patients: Current Status of a Controversy

Cancers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 771
Author(s):  
Tessa A. M. Mulder ◽  
Mirjam de With ◽  
Marzia del Re ◽  
Romano Danesi ◽  
Ron H. J. Mathijssen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Outcome ◽  
Cancer Patients ◽  
Plasma Concentrations ◽  
Tamoxifen Treatment ◽  
Current Status ◽  
Endocrine Treatment ◽  
Breast Cancer Patients ◽  
Er Positive ◽  
Positive Breast Cancer

Tamoxifen is a major option for adjuvant endocrine treatment in estrogen receptor (ER) positive breast cancer patients. The conversion of the prodrug tamoxifen into the most active metabolite endoxifen is mainly catalyzed by the enzyme cytochrome P450 2D6 (CYP2D6). Genetic variation in the CYP2D6 gene leads to altered enzyme activity, which influences endoxifen formation and thereby potentially therapy outcome. The association between genetically compromised CYP2D6 activity and low endoxifen plasma concentrations is generally accepted, and it was shown that tamoxifen dose increments in compromised patients resulted in higher endoxifen concentrations. However, the correlation between CYP2D6 genotype and clinical outcome is still under debate. This has led to genotype-based tamoxifen dosing recommendations by the Clinical Pharmacogenetic Implementation Consortium (CPIC) in 2018, whereas in 2019, the European Society of Medical Oncology (ESMO) discouraged the use of CYP2D6 genotyping in clinical practice for tamoxifen therapy. This paper describes the latest developments on CYP2D6 genotyping in relation to endoxifen plasma concentrations and tamoxifen-related clinical outcome. Therefore, we focused on Pharmacogenetic publications from 2018 (CPIC publication) to 2021 in order to shed a light on the current status of this debate.

Subsequent endometrial carcinoma with adjuvant tamoxifen treatment in Japanese breast cancer patients

2001 ◽  
Vol 11 (4) ◽  
pp. 272-276 ◽  
Author(s):  
N. Nishimura ◽  
T. Hachisuga ◽  
T. Saito ◽  
T. Kawarabayashi
Keyword(s):  
Breast Cancer ◽  
Endometrial Carcinoma ◽  
Cancer Patients ◽  
Myometrial Invasion ◽  
Tamoxifen Treatment ◽  
Adjuvant Tamoxifen ◽  
Serous Carcinoma ◽  
Breast Cancer Patients ◽  
Two Stage ◽  
Endometrial Carcinomas

Abstract.Nishimura N, Hachisuga T, Saito T, Kawarabayashi T. Subsequent endometrial carcinoma with adjuvant tamoxifen treatment in Japanese breast cancer patients.This study aimed to detail the clinicopathologic features of endometrial carcinomas that developed in Japanese patients receiving adjuvant tamoxifen treatment for breast cancer patients. Ten endometrial carcinomas in tamoxifen-treated breast cancer patients were collected from two medical centers. The endometrial carcinomas included two stage Ia, four stage Ib, two stage Ic and two stage IIIc. Three tumors were Grade 1, six were Grade 2, and one was Grade 3. The tumor was limited to the endometrium in two cases. Myometrial invasion was limited to the inner half of the myometrium in five cases and involved the outer half in three. A mild degree of lymphovascular space invasion was identified in five cases. Deep cervical invasion was recognized in one case. The cell types comprised nine endometrioid adenocarcinomas and one serous carcinoma. Five of eight postmenopausal endometrial carcinomas were associated with polypoid endometrial lesions composed of cystically dilated atrophic and proliferative glands widely separated by fibrotic stroma. Two patients with retroperitoneal lymph node metastases died of endometrial cancer. One patient developed a contralateral breast cancer during tamoxifen treatment. No patient died of breast cancer. We did not demonstrate a higher frequency of either high-grade tumors or unfavorable histologic subtypes in tamoxifen-treated Japanese breast cancer patients.

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