The role of the addition of ovarian suppression to tamoxifen in young women with hormone-sensitive breast cancer who remain premenopausal or regain menstruation after chemotherapy (ASTRRA): study protocol for a randomized controlled trial and progress.

BACKGROUND: Ovarian function suppression (OFS) has been shown to be effective as adjuvant endocrine therapy in premenopausal women with hormone receptor-positive breast cancer. However, it is currently unclear if addition of OFS to standard tamoxifen therapy after completion of adjuvant chemotherapy results in a survival benefit. In 2008, the Korean Breast Cancer Society Study Group initiated the ASTRRA randomized phase III trial to evaluate the efficacy of OFS in addition to standard tamoxifen treatment in hormone receptor-positive breast cancer patients who remain or regain premenopausal status after chemotherapy. METHODS: Premenopausal women with estrogen receptor-positive breast cancer treated with definitive surgery were enrolled after completion of neoadjuvant or adjuvant chemotherapy. Ovarian function was assessed at the time of enrollment and every 6 months for 2 years by follicular-stimulating hormone levels and bleeding history. If ovarian function was confirmed as premenopausal status, the patient was randomized to receive 2 years of goserelin plus 5 years of tamoxifen treatment or 5 years of tamoxifen alone. The primary end point will be the comparison of the 5-year disease-free survival rates between the OFS and tamoxifen alone groups. Patient recruitment was finished on March 2014 with the inclusion of a total of 1483 patients. The interim analysis will be performed at the time of the observation of the 187th event. DISCUSSION: This study will provide evidence of the benefit of OFS plus tamoxifen compared with tamoxifen only in premenopausal patients with estrogen receptor-positive breast cancer treated with chemotherapy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00912548 . Registered May 31 2009. Korean Breast Cancer Society Study Group Register KBCSG005 . Registered October 26 2009.

Toxicity and quality of life of Korean breast cancer patients treated with docetaxel-containing chemotherapy without primary G-CSF prophylaxis.

BACKGROUND: The aim of this study was to evaluate the toxicity and quality of life (QoL) of breast cancer patients treated with a docetaxel-containing chemotherapeutic regimen and to compare adriamycin and cyclophosphamide (AC) for four cycles followed by docetaxel (D) for four cycles with docetaxel, adriamycin, and cyclophosphamide (TAC) for six cycles without primary granulocyte colony-stimulating factor (G-CSF) prophylaxis. METHODS: Node-positive breast cancer patients who received surgery from three hospitals were included. Subjects received docetaxel-containing chemotherapy and completed a questionnaire on QoL (EORTC QLQ-C30 and QLQ-BR23) at each cycle. Toxicity was assessed using the National Cancer Institute Common Toxicity Criteria. RESULTS: All 78 eligible subjects and 542 cycles were analyzed. The incidence of dose reduction and grade 3 edema was higher in the AC-D group. The incidence of febrile neutropenia was significantly increased in the TAC group (63.4 %) compared to the AC-D group (29.7 %). Grade 3 or 4 anemia was higher in the TAC group, and grade 3 or 4 arthralgia was higher in the AC-D group. There were no significant differences in severe nausea and vomiting, fatigue, neuropathy, and peripheral edema. Baseline quality of life showed no difference between the two groups. The global health status decreased during chemotherapy and recovered to baseline level 3 months after chemotherapy. CONCLUSION: Although the incidence of febrile neutropenia was high without primary G-CSF prophylaxis and was more severe in the TAC group, QoL revealed comparable results in both regimens; therefore, it could be one of the considerations in the choice of treatment strategy.

Conventional Linear versus Purse-string Skin Closure after Loop Ileostomy Reversal: Comparison of Wound Infection Rates and Operative Outcomes.

PURPOSE: Wound infection after an ileostomy reversal is a common problem. To reduce wound-related complications, purse-string skin closure was introduced as an alternative to conventional linear skin closure. This study is designed to compare wound infection rates and operative outcomes between linear and purse-string skin closure after a loop ileostomy reversal. METHODS: Between December 2002 and October 2010, a total of 48 consecutive patients undergoing a loop ileostomy reversal were enrolled. Outcomes were compared between linear skin closure (group L, n = 30) and purse string closure (group P, n = 18). The operative technique for linear skin closure consisted of an elliptical incision around the stoma, with mobilization, and anastomosis of the ileum. The rectus fascia was repaired with interrupted sutures. Skin closure was performed with vertical mattress interrupted sutures. Purse-string skin closure consisted of a circumstomal incision around the ileostomy using the same procedures as used for the ileum. Fascial closure was identical to linear closure, but the circumstomal skin incision was approximated using a purse-string subcuticular suture (2-0 Polysorb). RESULTS: Between group L and P, there were no differences of age, gender, body mass index, and American Society of Anesthesiologists (ASA) scores. Original indication for ileostomy was 23 cases of malignancy (76.7%) in group L, and 13 cases of malignancy (77.2%) in group P. The median time duration from ileostomy to reversal was 4.0 months (range, 0.6 to 55.7 months) in group L and 4.1 months (range, 2.2 to 43.9 months) in group P. The median operative time was 103 minutes (range, 45 to 260 minutes) in group L and 100 minutes (range, 30 to 185 minutes) in group P. The median hospital stay was 11 days (range, 5 to 4 days) in group L and 7 days (range, 4 to 14 days) in group P (P < 0.001). Wound infection was found in 5 cases (16.7%) in group L and in one case (5.6%) in group L (P = 0.26). CONCLUSION: Based on this study, purse-string skin closure after a loop ileostomy reversal showed comparable outcomes, in terms of wound infection rates, to those of linear skin closure. Thus, purse-string skin closure could be a good alternative to the conventional linear closure.