Patient-Reported Symptoms and Quality of Life During Treatment With Tamoxifen or Raloxifene for Breast Cancer Prevention. The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 Trial

Abstract

Numerous trials have concluded that laparoscopic hysterectomy, compared with total abdominal hysterectomy, causes less postoperative pain and shortens the hospital stay. Many view this approach as being more cost-effective, but a recent large, randomized trial demonstrated more major complications after the laparoscopic procedure. The present study compared the length of time in the hospital, time to convalescence, and long-term patient satisfaction in 47 consecutive women who were to have supravaginal hysterectomy. Twenty-three of them were randomized to undergo abdominal supravaginal hysterectomy (ASH) and 24 laparoscopic supravaginal hysterectomy (LSH). Pre-and postoperative procedures were comparable in the 2 groups, and there were no significant differences in demographic features or physical characteristics.The postoperative hospital stay was comparable after ASH and LSH. Operating times were significantly longer with LSH, but estimated blood loss was greater in the ASH group. No intraoperative complications occurred in either group, and no patient was transfused. Self-rated pain 6 hours postoperatively was less in women having LSH. Follow up at 6 weeks showed that patients having ASH required approximately 10 more disability days than those in the LSH group. There were no differences in the number of days analgesics were required or the time needed to resume normal activities. At 6 months, 87% of women having ASH and 91% of those in the LSH group were satisfied or very satisfied with the overall results. More than 90% of women in both groups would recommend their procedure to others.When using a multimodal intervention program of postoperative care, the choice between ASH or LSH may be less important than is generally believed with regard to postoperative time in the hospital and long-term patient satisfaction. EDITORIAL COMMENT(What is with the idea of supracervical hysterectomy? There may be some patients who think that preservation of the cervix has less risk of interfering with sexual function or producing urinary incontinence. However, several prospective, randomized trials from the United States, Holland, England, and Denmark have shown that these ideas are not true-preservation of the cervix does not help with sexual, bladder, or bowel function.Learman et al reported on a relatively small, prospectively randomized series of 135 women from 4 U.S. academic medical centers who were followed for 2 years after hysterectomy (Obstet Gynecol 2003;102:453). They found no statistically significant difference in rate of complication, length of hospital stay, or clinical outcomes specifically related to symptoms of bladder or bowel dysfunction and pelvic and back pain between the total and supracervical abdominal hysterectomy GYNECOLOGY Volume 61, Number 10 OBSTETRICAL AND GYNECOLOGICAL SURVEY ABSTRACT Endometriosis is among the most important causes of chronic pelvic pain (CPP) in women of reproductive age; it reportedly is present in as many as one third of women having diagnostic laparoscopy for pain. This ...

Amenorrhea in premenopausal women on the doxorubicin-and-cyclophosphamide-followed-by-docetaxel arm of NSABP B-30 trial

“…Patient-reported symptoms were collected by means of a checklist on the QOL questionnaire, using a 7-day recall period. The symptom checklist was based on those used in the NSABP breast cancer prevention trials [8][9][10]. The severity of each symptom was graded from 0 ('not at all bothered') to 4 ('bothered very much').…”

Recommendations for research priorities in breast cancer by the Coalition of Cancer Cooperative Groups Scientific Leadership Council: systemic therapy and therapeutic individualization

“…This observation generated interest in evaluating tamoxifen in healthy women at increased risk because of family history or other factors, and several studies confirmed that a 5-years course of tamoxifen reduces BC risk by 50% in both pre-and postmenopausal women; it appears to only reduce the risk of developing hormone-receptor (HR)-positive disease and does not reduce BC mortality [16][17][18][19][20][21][22]. Adverse effects include hot flushes and gynecological effects that contribute to nonadherence in up to 25% [23,24] and more serious problems such as thromboembolic effects and uterine carcinoma in postmenopausal women that alter the benefit-risk ratio [25]. More recently, raloxifene was shown to be comparable to tamoxifen in reducing invasive BC risk in postmenopausal women but was slightly less effective for preventing in situ disease; it was also associated with a lower risk of thromboembolic disease, uterine cancer, cataracts, and need for cataract surgery [22].…”

“…Health related quality of life measurements may be particularly important for individuals receiving adjuvant or preventive endocrine therapy who are treated chronically for 5-10 years with endocrine therapies [24,144,147,148]. In addition, there is concern about the long-term adverse effects of chemotherapy, including preservation of fertility in young women [149], acute leukemia [150][151][152][153], cardiac dysfunction after anthracyclines and/or irradiation [154,155], peripheral neuropathy after taxanes [156], and cognitive dysfunction [157].…”

Tamoxifen or Raloxifene in Postmenopausal Women for Prevention of Breast Cancer: A Tale of Two Choices—Counterpoint

“…The initial assessment of the primary end point of the STAR Trial would seemingly indicate that this hope was realized. Compared with tamoxifen, women randomized to 5 years of raloxifene in the STAR trial had a similar incidence of invasive breast cancer and similar quality of life but a lower incidence of serious side effects (7,8). Women randomized to raloxifene had 30% fewer thromboembolic events, 25% fewer uterine cancers, and 21% fewer cataracts compared with those randomized to tamoxifen.…”

“…In the STAR trial, both drugs were associated with similar effects on quality of life but raloxifene was associated with a higher incidence of dyspareunia, musculoskeletal complaints, and weight gain, whereas tamoxifen was associated with a higher incidence of hot flashes, vaginal discharge, bladder control problems, and leg cramps but better overall sexual function (8). Women already troubled by loss of libido and dyspareunia might then chose tamoxifen over raloxifene.…”