Abstract S3-09: Patient-reported endocrine symptoms, sexual functioning and quality of life (QoL) in the IBCSG SOFT trial: Adjuvant treatment with tamoxifen (T) alone versus tamoxifen plus ovarian function suppression (OFS) in premenopausal women with hormone receptor-po

Author(s):  
Karin Ribi ◽  
Weixiu Luo ◽  
Juerg Bernhard ◽  
Prudence A Francis ◽  
Meritxell Bellet ◽  
...  
2014 ◽  
Vol 32 (35) ◽  
pp. 3948-3958 ◽  
Author(s):  
Amye J. Tevaarwerk ◽  
Molin Wang ◽  
Fengmin Zhao ◽  
John H. Fetting ◽  
David Cella ◽  
...  

Purpose The effects of ovarian function suppression (OFS) on survival and patient-reported outcomes were evaluated in a phase III trial in which premenopausal women were randomly assigned to tamoxifen with or without OFS. Patients and Methods Premenopausal women with axillary node-negative, hormone receptor–positive breast cancer tumors measuring ≤ 3 cm were randomly assigned to tamoxifen alone versus tamoxifen plus OFS; adjuvant chemotherapy was not permitted. Primary end points were disease-free survival (DFS) and overall survival (OS). Secondary end points included toxicity and patient-reported outcomes. Patient-reported outcome data included health-related quality of life, menopausal symptoms, and sexual function. These were evaluated at baseline, 6 months, 12 months, and then annually for up to 5 years after registration. Results In all, 345 premenopausal women were enrolled: 171 on tamoxifen alone and 174 on tamoxifen plus OFS. With a median follow-up of 9.9 years, there was no significant difference between arms for DFS (5-year rate: 87.9% v 89.7%; log-rank P = .62) or OS (5-year rate: 95.2% v 97.6%; log-rank P = .67). Grade 3 or higher toxicity was more common in the tamoxifen plus OFS arm (22.4% v 12.3%; P = .004). Patients treated with tamoxifen plus OFS had more menopausal symptoms, lower sexual activity, and inferior health-related quality of life at 3-year follow-up (P < .01 for all). Differences diminished with further follow-up. Conclusion When added to tamoxifen, OFS results in more menopausal symptoms and sexual dysfunction, which contributes to inferior self-reported health-related quality of life. Because of early closure, this study is underpowered for drawing conclusions about the impact on survival when adding OFS to tamoxifen.


2019 ◽  
Vol 4 (2) ◽  
pp. 45-52
Author(s):  
Bello Arkilla Magaji ◽  
Foong Ming Moy ◽  
Chee Wei Law ◽  
Hoe Leong Sii ◽  
April Camilla Roslani

Aim: Research on patient-reported outcomes in colorectal cancer are scarce in Malaysia. We aimed to determine pattern of health-related quality of life and its associations among patients with colorectal cancer.Methods: A cross-sectional study of 324 patients. Data were drawn from patient’s records and interviews. Research tools included the locally validated European Organization for Research and Treatment of Cancer (EORTC) core QLQ-C30 and colorectal-cancer specific QLQ-CR29 questionnaires.Results: The mean (±standard deviation) age of patients was 62.5 (±13.6) years. Majority of them were Chinese (62.3%) followed by Malays (19.8%), Indians (14.8%) and others (3.1%). Colon cancer was 7-fold more common than rectal cancer (87% vs 13%). Majority of them were presented at Stage II (29.6%) and III (28.1) of TNM Staging. The mean (±SD) score for global health status/quality of life (GHS/QOL) was 73.13 (±14.19). Good overall functionality (mean scores ≥80) was observed for physical, emotional, role, cognitive and social/family for QLQ-C30; body image, anxiety and weight for QLQ-CR29. The mean score for sexual functioning in men (32.95±28.81) and women (17.56±25.60) were low. Commonest symptoms were fatigue (22.29±17.40), urinary frequency (21.96 ± 24.22) and insomnia (18.42 ± 23.32). Those with lower GHS/QOL had stoma (p=0.044) and were of Chinese ethnicity (p<0.001). On multivariate analysis, ethnicity was the only independent predictor of GHS/QOL (95% confidence interval, 2.589 to 6.139, p<0.001). Conclusion: Our results suggest that there is decrease in sexual functioning despite good overall GHS/QOL among our colorectal cancer survivors. Fatigue, sleep loss and urinary frequency were the common symptoms after cancer treatment. Chinese patients had the poorest quality of life.


Breast Cancer ◽  
2018 ◽  
Vol 25 (3) ◽  
pp. 343-349 ◽  
Author(s):  
Yukinori Ozaki ◽  
Yuko Tanabe ◽  
Nobuko Tamura ◽  
Takuya Ogura ◽  
Chihiro Kondoh ◽  
...  

Abstract Introduction Although tamoxifen (TAM) plus ovarian function suppression (OFS) is considered as a standard adjuvant treatment for premenopausal women with hormone receptor-positive breast cancer, the optimal duration of OFS has not yet been established. This retrospective study was designed to assess the duration of OFS and the impact of the duration of OFS on the DFS in these patients. Methods We retrospectively reviewed the data of premenopausal patients with breast cancer who received TAM + OFS (goserelin or leuprorelin) as adjuvant therapy between February 2004 and June 2015. The primary analysis was a comparison of the disease-free survival (DFS) between patients who received OFS for 3 years or less (OFS ≤ 3 years group) and those who received OFS for longer than 3 years (OFS > 3 years group). Results We analyzed the data of 215 premenopausal patients diagnosed as having hormone receptor-positive breast cancer. A propensity score-matched model showed the absence of any significant difference in the DFS between the OFS ≤ 3 years group and OFS > 3 years group (6-year DFS rate, 93.2 vs. 94.0%; log-rank test p = 0.767). Conclusions Our data showed that among premenopausal women with hormone receptor-positive breast cancer who received TAM + OFS as adjuvant endocrine therapy, there was no significant difference in the DFS between the OFS ≤ 3-year group and OFS > 3-year group. A randomized trial is needed to establish the optimal duration of OFS for these patients.


2017 ◽  
Vol 35 (27) ◽  
pp. 3113-3122 ◽  
Author(s):  
Poornima Saha ◽  
Meredith M. Regan ◽  
Olivia Pagani ◽  
Prudence A. Francis ◽  
Barbara A. Walley ◽  
...  

Purpose To describe benefits and toxicities of adjuvant endocrine therapies in women younger than 35 years with breast cancer (n = 582) enrolled in the Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT). Methods In SOFT, women still premenopausal after surgery with or without chemotherapy were randomly assigned to tamoxifen alone, tamoxifen plus ovarian function suppression (OFS), or exemestane plus OFS. In TEXT, all received OFS with or without concomitant chemotherapy and were randomly assigned to exemestane plus OFS or tamoxifen plus OFS. We summarize treatment efficacy, quality of life, and adherence of the cohort of women younger than 35 years in SOFT and TEXT, alongside data from the cohort of older premenopausal women. Results For 240 human epidermal growth factor receptor 2–negative patients younger than 35 years enrolled in SOFT after receiving chemotherapy, the 5-year breast cancer–free interval (BCFI) was 67.1% (95% CI, 54.6% to 76.9%) with tamoxifen alone, 75.9% with tamoxifen plus OFS (95% CI, 64.0% to 84.4%), and 83.2% with exemestane plus OFS (95% CI, 72.7% to 90.0%). For 145 human epidermal growth factor receptor 2–negative patients younger than 35 years in TEXT, 5-year BCFI was 79.2% (95% CI, 66.2% to 87.7%) with tamoxifen plus OFS and 81.6% (95% CI, 69.8% to 89.2%) with exemestane plus OFS. The most prominent quality of life symptom for patients younger than 35 years receiving OFS was vasomotor symptoms, with the greatest worsening from baseline at 6 months (on the order of 30 to 40 points), but loss of sexual interest and difficulties in becoming aroused were also clinically meaningful (≥ 8-point change). The level of symptom burden was similar in older premenopausal women. A total of 19.8% of women younger than 35 years stopped all protocol-assigned endocrine therapy early. Conclusion In women younger than 35 years with hormone receptor–positive breast cancer, adjuvant OFS combined with tamoxifen or exemestane produces large improvements in BCFI compared with tamoxifen alone. Menopausal symptoms are significant but are not worse than those seen in older premenopausal women.


2006 ◽  
Vol 107 (Supplement) ◽  
pp. 18S-19S ◽  
Author(s):  
Vanessa Teplin ◽  
Eric Vittinghoff ◽  
Feng Lin ◽  
Lee A. Learman ◽  
Miriam Kuppermann

2005 ◽  
Vol 23 (28) ◽  
pp. 6890-6898 ◽  
Author(s):  
Joanna B. Madalinska ◽  
Judith Hollenstein ◽  
Eveline Bleiker ◽  
Marc van Beurden ◽  
Heiddis B. Valdimarsdottir ◽  
...  

Purpose Recommendations for women at high risk of ovarian cancer include periodic gynecologic screening (GS) and prophylactic bilateral salpingo-oophorectomy (PBSO). The aim of the current study was to determine the quality-of-life (QOL) effects of PBSO versus GS. Patients and Methods Questionnaire data were obtained from 846 high-risk women who had participated in this nationwide, cross-sectional, observational study. Forty-four percent of the women had undergone PBSO, and 56% had opted for GS. Topics addressed by the questionnaire included generic QOL, cancer-specific distress, endocrine symptoms, and sexual functioning. Results No statistically significant between-group differences were observed in generic QOL (Short Form-36), with women in both the PBSO and GS groups scoring similarly to the general population. Compared with GS, PBSO was associated with fewer breast and ovarian cancer worries (P < .001) and more favorable cancer risk perception (P < .05). However, the PBSO group reported significantly more endocrine symptoms (P < .001) and worse sexual functioning (P < .05) than the GS group. Eighty-six percent of women would choose PBSO again, and 63% would recommend it to a friend with familial risk of ovarian cancer. Conclusion PBSO had no measurable adverse impact on generic QOL of high-risk women. The favorable effects of PBSO in terms of reduced cancer worries and low perceived cancer risk need to be weighed against the increase in endocrine and sexual symptoms. Balanced information will help clinicians and high-risk women to make informed decisions about the optimal preventive health strategy.


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