Search

12010 Background: Despite high prevalence of functional status (FS) and physical performance (PP) impairments among older adults with cancer, standardized assessments and interventions are not routinely used in oncology care. This study characterized how oncologist knowledge of Geriatric Assessment (GA) results influenced conversations and GA-guided recommendations addressing FS and PP concerns. Methods: Data were from a NCORP funded (UG1CA189961) nationwide cluster randomized controlled trial (ClinicalTrials.gov: NCT02107443; PI: Mohile), with inclusion criteria: age ≥70, stage III/IV solid tumor or lymphoma with palliative treatment intent, and ≥1 GA domain impairment. All subjects underwent baseline GA including standardized FS ([instrumental] activities of daily living) and PP (Timed Up and Go, Short Physical Performance Battery, Older Americans Resources and Services Physical Health scale, falls in past 6 months) measures. Oncologists in Intervention arm practices received full GA results and validated recommendations for each patient, while those in the usual care (UC) arm were only notified of depression or severe cognitive impairment. One clinical encounter per patient within 4 weeks of GA was audio-recorded, transcribed and blind coded using a priori content-analysis scheme to categorize conversations and oncologist response (dismissed, acknowledged, or addressed with recommendation) by GA domain. Frequencies, raw and adjusted (for site using generalized linear mixed models) proportions were compared using the Chi square test. Results: 541 patients (mean age: 77, range 70-96) were included. More FS and PP conversations occurred in Intervention (PP=532, FS=164) than UC (PP=183, FS=87) arm (p

143 Background: Caregivers of older adults with advanced cancer often have a different understanding of the patient’s prognosis compared with their oncologist. Among patients, accurate prognostic awareness is associated with greater depressive symptoms, except when patients utilize more adaptive coping skills. We examined the relationship between caregiver-oncologist prognostic concordance and caregiver depressive symptoms and explored whether this relationship differed by caregiver mastery, the capacity to cope, adjust, and adapt to problems. Methods: We utilized data from a national geriatric assessment cluster-randomized trial (URCC 13070: PI Mohile) that recruited patients aged ≥70 with incurable cancer considering any line of cancer treatment at community oncology practices, their caregivers, and oncologists. At enrollment, caregivers and oncologists estimated the patient’s prognosis (0-6 months, 7-12 months, 1-2 years, 2-5 years, > 5 years); same response was considered concordant. Caregivers completed Ryff’s mastery subscale (range 7-35, higher is better) at enrollment and depression screen (the Patient Health Questionnaire (PHQ)-2 (range 0-6) 4-6 weeks later. To assess the association of prognostic concordance with caregiver depressive symptoms, we used generalized estimating equations in models adjusted for cancer type, study arm, practice sites, and caregiver demographics. We then assessed moderation effect of caregiver mastery on this association. Results: Among 410 caregiver-oncologist dyads, mean caregiver age was 66.5, 75% were female, and 26% were caregivers of patients with lung cancer. Mean mastery score at enrollment was 27.6 (SD 4.7) and 19% screened positive on PHQ-2 at week 4-6. Among dyads who provided response (N = 370), 28% were concordant. Prognostic concordance was associated with higher caregiver depressive symptoms (β = 0.30; p = 0.04). Significant moderation effect was found between concordance and mastery for caregiver depressive symptoms (p = 0.02). Among caregivers with low mastery ( < median), prognostic concordance was associated with higher depressive symptoms (β = 0.68; p = 0.003). Among caregivers with high mastery (≥median), concordance was not associated with depressive symptoms (β = -0.06; p = 0.67). Conclusions: There is a need to study how prognostic understanding might lead to depression in at-risk caregivers. Interventions targeting caregiver prognostic understanding need to consider its relationship with depressive symptoms, while seeking to increase caregiver mastery.

Purpose Painful oral mucositis (OM) is a significant toxicity during radiotherapy for head and neck cancers. The aim of this randomized, double-blind, placebo-controlled trial was to test the efficacy of doxepin hydrochloride in the reduction of radiotherapy-induced OM pain. Patients and Methods In all, 155 patients were randomly allocated to a doxepin oral rinse or a placebo for the treatment of radiotherapy-related OM pain. Patients received a single dose of doxepin or placebo on day 1 and then crossed over to receive the opposite agent on a subsequent day. Pain questionnaires were administered at baseline and at 5, 15, 30, 60, 120, and 240 minutes. Patients were then given the option to continue doxepin. The primary end point was pain reduction as measured by the area under the curve (AUC) of the pain scale using data from day 1. Results Primary end point analysis revealed that the AUC for mouth and throat pain reduction was greater for doxepin (−9.1) than for placebo (−4.7; P < .001). Crossover analysis of patients completing both phases confirmed that patients experienced greater mouth and throat pain reduction with doxepin (intrapatient changes of 4.1 for doxepin-placebo arm and −2.8 for placebo-doxepin arm; P < .001). Doxepin was associated with more stinging or burning, unpleasant taste, and greater drowsiness than the placebo rinse. More patients receiving doxepin expressed a desire to continue treatment than did patients with placebo after completion of each of the randomized phases of the study. Conclusion A doxepin rinse diminishes OM pain. Further studies are warranted to determine its role in the management of OM.

11544 Background: Older patients with advanced cancer face considerable uncertainty related to their disease and treatment. The aim of our study was to evaluate the associations of uncertainty with psychological status and QoL. Methods: This is a secondary analysis of baseline data from a national geriatric assessment (GA) cluster randomized trial (URCC 13070; PI: Mohile). Patients aged ≥70 years with ≥1 GA domain impairment (e.g., function, cognition) and advanced cancer who were considering or receiving any line of cancer treatment were enrolled (n=541). Uncertainty was measured using the modified 9-item Mishel Uncertainty in Illness (MUIS), where respondents with higher scores perceive more uncertainty (range 9-45). QoL and psychological measures consisted of Functional Assessment of Cancer Therapy-General (FACT-G), emotional wellbeing (EWB; FACT-G subscale), distress (distress thermometer), anxiety (Generalized Anxiety Disorder-7), and depression (Geriatric Depression Scale-15). Multiple linear regressions were used to evaluate the associations of MUIS scores with each measure, adjusted for demographics, cancer type, and number of impaired GA domains. Results: Mean age was 77 years (SD 5, range 70-96); 26% had gastrointestinal cancer and 26% had lung cancer. Mean number of GA domain impairments was 4 (SD 1, range 1-7). Mean MUIS score was 20 (SD 5, range 9-37). On multivariate analyses, higher MUIS score was associated with lower QoL (β=-1.08, SE=0.11) and EWB (β=-0.29, SE=0.03), as well as higher distress (β=0.12, SE=0.02), anxiety (β=0.11, SE=0.04), and depression (β=0.09, SE=0.03; all P

114 Background: Despite national guidelines recommending early palliative care (EPC) for individuals newly-diagnosed with metastatic cancer, it is rarely available in rural community cancer centers serving underserved populations. We conducted the first implementation trial of EPC in rural cancer centers using the evidence-based ENABLE (Educate, Nurture, Advise, Before Life Ends) model of early, concurrent oncology palliative care. Methods: Mixed methods case study of a 4-year American Cancer Society-funded 4-site, implementation trial using a virtual learning collaborative in AL and SC. Guided by the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework, we gathered qualitative and quantitative data via monthly reports and yearly in-person site visits using: 1) a RE-AIM Self-Assessment Tool completed by site staff to measure reach, adoption, implementation, and maintenance; 2) EPC General Organizational Index (GOI) to measure capacity for EPC services and implementation progress; and 3) field notes from site interviews and final reports. Results: Across the 4 sites, 62 patients (range: 4–31; mean: 15) and 46 caregivers (range: 2–22; mean: 12) participated. Baseline patient characteristics included: mean age of 58, 70% female, 17% Black or minority, 57% some college or college, 49% rural dwelling, and 57% non-gynecologic cancer. Sites enrolled at least 58% of the patients they planned to enroll (range: 58%–100%; average: 84%), of which 44% received 100% of ENABLE content and nearly 60% received two-thirds. Reasons for not completing all six sessions included death, unrecorded contacts, or lost to follow up. Longitudinal GOI scores indicated a trend of improved capacity for EPC services at three of the four sites. Qualitative data from site lead interviews revealed administrative (presence or lack of palliative ‘champions’), clinical (having adequate training), and economic (reimbursement) implementation barriers and facilitators. Conclusions: This pilot implementation study demonstrated feasibility and areas to enhance implementation in a larger comparative effectiveness trial to enhance scaling and spreading EPC in community practices.

e23530Background: Rising healthcare costs and patient financial toxicities are a pressing issue for the 70,000 AYAs diagnosed annually in the US. To address both of these issues, Bon Secours St. Fr...

Purpose: To test the concept of taxane sequencing in combined-modality therapy, this phase II trial (S9504) evaluated consolidation docetaxel after concurrent chemoradiotherapy in patients with pathologically documented stage IIIB non–small-cell lung cancer (NSCLC). Results were compared with those of the predecessor study (S9019) with identical eligibility, staging criteria, and treatment, excepting docetaxel consolidation. Patients and Methods: Treatment consisted of cisplatin 50 mg/m2 on days 1, 8, 29, and 36, etoposide 50 mg/m2 on days 1 through 5 and 29 through 33, and concurrent thoracic radiotherapy (total dose of 61 Gy). Consolidation docetaxel started 4 to 6 weeks after chemoradiotherapy at an initial dose of 75 mg/m2. Results: Stage subsets (tumor-node-metastasis system) in 83 eligible patients were as follows: T4N0/1, 31 patients (37%); T4N2, 22 patients (27%), and T1–3N3, 30 patients (36%). Concurrent chemoradiotherapy was generally well tolerated, but two patients died from probable radiation-associated pneumonitis. Neutropenia during consolidation docetaxel was common (57% with grade 4) and most frequent during escalation to 100 mg/m2. Median progression-free survival was 16 months, median survival was 26 months, and 1-, 2-, and 3-year survival rates were 76%, 54%, and 37%, respectively. Brain metastasis was the most common site of failure. In S9019, median survival was 15 months and 1-, 2-, and 3-year survival rates were 58%, 34%, and 17%, respectively. Conclusion: Consolidation docetaxel after concurrent chemoradiotherapy in stage IIIB NSCLC is feasible and generally tolerable, and results compare favorably with the predecessor trial S9019. Nevertheless, this study remains hypothesis-generating and does not provide definitive evidence of the benefit of this approach. Phase III trials evaluating the S9504 regimen have been initiated to validate these results.

2049Background: Vascular toxicities, including hypertension and thrombosis, are commonly associated with anti-angiogenic agents, such as Bevacizumab. Risk factors for toxicity have yet to be identi...

215 Background: Psychosocial distress is a well‐recognized consequence of cancer therapy, but psychosocial care for cancer survivors remains fragmented. Through the use of telemedicine, establishing an integrated, information technology‐based infrastructure between community‐based cancer programs may enhance coordination of survivorship care and increase psychosocial distress screening and intervention. We describe a one year pilot program intended to bridge institutional and geographic gaps in psychosocial intervention for cancer survivors through the use of telemedicine. Methods: There are 17 Commission on Cancer-accredited sites in South Carolina-only 31% of sites routinely conduct distress screening. This SC Cancer Alliance-supported pilot was designed as a quality care improvement project between two community-based cancer programs. The development and execution of the telemedicine project will be described. A survey-based, qualitative assessment of patient satisfaction with psychosocial intervention with between both physical and virtual counselling was performed and scored. Results: All patients seen in survivorship clinics at both institutions received psychosocial distress screening. By the end of the pilot project, 9 cancer survivors from the Spartanburg area were identified as having significant psychosocial distress, participated in counselling and reported on their experiences. Patients were seen either via face-to-face and/or virtual encounters. Counselling sessions performed via telemedicine were well accepted and that there was no difference in patient satisfaction as compared to face-to-face sessions. Anecdotal experiences and comments will be highlighted. Conclusions: Our pilot project demonstrates that psychosocial screening and intervention via telemedicine is feasible and may be effective at reducing psychosocial distress in cancer survivors. Psychosocial intervention via telemedicine may serve as a viable method of providing counselling services to resource poor areas, but significant barriers exist, including reimbursement, institutional variations in screening and care and information technology.

e17605 Background: The NCI Community Cancer Centers Program (NCCCP) pilot was launched in 2007 with aims to: improve quality, reduce disparities and increase clinical trial (CT) participation. Hosp...

6512 Background: ASCO described minimum standards and exemplary attributes for CT sites to improve research quality (Zon et al JCO 2008, JOP 2011; Baer et al JOP 2010). Based on these attributes, the NCI Community Cancer Centers Program (NCCCP) developed and piloted the CT AIM Tool to facilitate research program improvements through self-assessment and benchmarking. The tool identified 9 attributes (see Table) each with 3 progressive levels for research sites to “score” their program from less (Level 1) to more (Level 3) exemplary CT infrastructure (e.g. Level 1- only phase 3 treatment trials open vs. Level 3 – Phase 1/2/3, cancer control and prevention trials open). Methods: From 2011-13, 21 NCCCP sites self assessed their CT programs annually using the tool. Results: See Table. Conclusions: Statistically significant increases (p < 0.0001) occurred in Level 3 (more exemplary) infrastructure ratings from 2011 to 2013 across all 9 attribute categories assessed at the 21 sites. Statistically significant gai...

9507 Background: Impaired sexual satisfaction is a prevalent and distressing issue for female cancer survivors. The aim of this study was to evaluate the impact of vaginal DHEA on vaginal atrophy s...

207 Background: Palmetto Hematology Oncology (PHO) is the medical oncology practice of Spartanburg Regional Healthcare System (SRHS) and has participated in QOPI since 2009 and earned QOPI certification in September 2011. Emotional well-being assessments and documentation of interventions were selected for a performance improvement project based on QOPI measures from Fall 2009. Methods: Several articles were identified supporting the use of the NCCN Distress Thermometer following a comprehensive literature search and approval was obtained for use. The NCCN Distress Thermometer was administered to all new patients through inclusion in “new patient” paperwork packets. Two physician offices within the practice were piloted with the physicians reviewing the patient reported assessments and documenting any required interventions. All completed NCCN Distress Thermometer forms were also reviewed by the medical social work team, and for scores > 3, interventions by phone or face-to-face were completed by them and documented in the patients’ electronic medical records. Results: Due to the success of the pilot efforts the assessment/intervention process for emotional well-being was expanded throughout the PHO practice, the Gibbs Infusion Center, and Radiation Oncology. The QOPI emotional well-being indicator revealed an increase from the Fall 2009 to Spring 2012 of 36.25% to 96.25%. Conversely, our compliance with intervention by the second office visit decreased from 94.44% to 69.44%, respectively. Conclusions: Although PHO’s scores for the emotional well-being assessment have dramatically improved with implementation of the process improvement initiative, opportunity remains for improving emotional well-being intervention documentation. This initiative highlighted the lack of psychiatric/psychological services available to PHO patients. References: NCCN Clinical Practice Guidelines in Oncology: Distress Management, Version 3.2012; Available at: http://www.nccn.org/professionals/physician_gls/pdf/distress.pdf . QOPI The Quality Oncology Practice Initiative; Available at: http://qopi.asco.org/program .

130 Background: Palmetto Hematology Oncology (PHO) is the medical oncology practice of Spartanburg Regional Healthcare System (SRHS) and has participated in QOPI since 2009 and earned QOPI certification in September 2011. Our Fall 2010 QOPI Patient Consent for Chemotherapy score was 70.73%, lower than the QOPI aggregate score of 86.46%. Methods: A workgroup was convened to address chemotherapy consent documentation compliance. QOPI data revealed the need for a uniform, system-wide chemotherapy consent process. A chemotherapy consent form specifically for our cancer center was created following an extensive literature review and benchmarking with American Society of Clinical Oncology guidelines, NCI Designated Cancer Centers, NCI Community Cancer Centers Program (NCCCP funded with federal funds from the NCI, Contract # HHSN261200800001E) resources, and other healthcare institutions. Our chemotherapy administration policy was revised to include a “hard stop” if a signed chemotherapy consent was not available prior to administration of chemotherapy in all areas of our institution. Results: Patient Consent for Chemotherapy QOPI scores revealed an increase from Fall 2010 to Spring 2012 of 70.73% to 100%. As a result of the workgroup’s efforts, it was approved by our Cancer Care Committee to develop a Chemotherapy Safety Committee (CSC) to standardize chemotherapy practices throughout our system. The CSC integrated key staff responsible for chemotherapy administration. The CSC was instrumental in reviewing and updating policies and procedures during our QOPI certification efforts. Conclusions: Our participation in QOPI provided data to support efforts for a system-wide chemotherapy consent revision and process implementation. The availability of ASCO, Oncology Nursing Society, and other key resources provided turn key processes for this performance improvement project. Practice scores for the Patient Consent for Chemotherapy have reached 100% compliance signifying our performance at a “best practice” level. References: QOPI The Quality Oncology Practice Initiative, available at: http://qopi.asco.org/program .

9047 Background: Symptomatic adverse events (AE) in cancer trials are reported by clinicians using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE). To integrate the patient perspective into AE reporting, NCI contracted (HHSN261201000043C) to create a patient-reported outcomes companion tool (PRO-CTCAE). We report the validity and reliability of PRO-CTCAE’s 124 items reflecting 78 symptomatic AEs. Methods: English-speaking subjects (n=869; 44% male; median [mdn] age 59; 32% racial/ethnic minority; 34% high school or less; 17% ECOG Performance Status [PS] 2-4) receiving treatment for a range of cancers at 4 NCI-designated cancer centers and 5 sites in NCI's Community Cancer Centers Program completed a web-based survey in clinic including PRO-CTCAE and EORTC QLQ-C30. Pearson correlations were computed between PRO-CTCAE items and QLQ-C30 scales. Differences in PRO-CTCAE item scores between clinician-reported ECOG PS (0-1 vs 2-4) groups were computed. Test-retest reliability of 48 prespecified items was evaluated in a subset (n=79). Results: Correlations in the expected direction were observed for 116/124 PRO-CTCAE items with the QLQ-C30 global health scale (mdn r=-.21; range .08 to -.57). Stronger correlations were seen for PRO-CTCAE items with conceptually related QLQ-C30 domains: fatigue with physical, role and social functioning (-.54 to -.66); anxiety and depression with emotional functioning (-.54 to -.70); and concentration and memory problems with cognitive functioning (-.62 to -.72) [all p

6110 Background: The NCCCP has engaged in special programs to enhance clinical trial accrual among underserved populations. These include cultural awareness webinars, nurse/lay navigators with tran...

e16539 Background: One of the goals of the NCCCP pilot is to disseminate the use of multidisciplinary case conferences/clinics (MDC) across community cancer centers. There are studies to show that ...

9139 Background: Hot flashes are a common, undesirable complication of androgen-deprivation therapy in men with prostate cancer. A previous randomized trial indicated that gabapentin (900 mg/day) w...

9531 Background: Chemotherapy induced peripheral neuropathy (CIPN) is a prevalent dose limiting toxicity for several important cancer treatment agents. CIPN can impair function and cause distress. There are no proven pharmacologic treatments for established CIPN currently. This double blind randomized placebo controlled trial evaluated a compounded topical gel for this problem. The novelty of this treatment is that it might incorporate several agents with different mechanisms of action to provide relief locally without negative systemic effects. Methods: Patients with CIPN (rated ≥4 out of 10) for at least one month, related to previous and/or concurrent exposure to neurotoxic agents, were randomized to baclofen 10 mg, amitriptyline HCL 40 mg and ketamine 20 mg in a pluronic lecithin organogel (BAK-PLO) vs placebo (PLO) to determine its effect on numbness, tingling, pain, and motor function. Exclusion criteria included other causes and/or current treatment for peripheral neuropathy. The primary endpoint was the baseline adjusted sensory subscale of the EORTC QLQ-CIPN20, at 4 weeks. Results: Between February and May 2008, 208 patients were enrolled onto this trial. Four week data are shown in the table below, higher numbers being better. The percentage of patients that had improvements of at least 10, on a 100 point scale, in the motor subscale was statistically significantly higher in the BAK-PLO arm, p=.04. There were no unwanted toxicities associated with the BAK-PLO that were significantly different from placebo and no evidence of CNS or systemic toxicity. Conclusions: Topical treatment with BAK-PLO appears to moderately improve symptoms of CIPN. This topical gel was well tolerated without systemic side effects. [Table: see text] No significant financial relationships to disclose.

8507 Background: Problems with sexual functioning are an issue negatively affecting the quality of life of female cancer survivors. Testosterone has been implicated as an important hormone in sexual functioning such as libido. Studies of transdermal testosterone have shown benefit in enhancing libido in women who have been diagnosed with hypoactive sexual desire disorder after bilateral oophorectomy. This phase III placebo-controlled clinical trial evaluated whether transdermal testosterone would increase libido in female cancer survivors. Methods: Women with a history of cancer, currently without evidence of disease, were eligible if they reported a decrease in sexual desire and had a sexual partner. Women must have been postmenopausal. Eligible women were randomized to receive 2% testosterone in Vanicream (10 mg daily) versus placebo Vanicream for four weeks, then crossed over to the opposite treatment. The primary endpoint, libido, was measured via the desire subscales of the Changes in Sexual Functioning Questionnaire (CSFQ), which were completed at baseline and at the end of 4 and 8 weeks of treatment. The primary endpoint was the average intra-patient change from baseline to four weeks in the CSFQ subscales between the two arms. A total of 64 patients per group were needed to provide 80% power to detect a difference of 8 units between the treatment means. Two-sided alternative hypothesis testing and a 5% Type I error rate were used. Results: One hundred fifty women were enrolled onto this study. Complete data were available for 132 women. For those on active testosterone cream, serum bioavailable testosterone levels increased significantly over placebo, with a mean change from baseline of 12 and 10 ng/dl for the first and second period, respectively (p No significant financial relationships to disclose.

4028 Background: The role of preoperative chemoradiation in patients (pts) with localized esophageal cancer remains unclear. Most preoperative regimens produce 20–30% pathologic complete response (pCR) rates, which predicts improved survival. Our community-based multicenter group performed sequential trials evaluating a novel paclitaxel-containing preoperative chemoradiation regimen, now with median followup > 6 years. Methods: Eligibility: untreated adenocarcinoma or squamous carcinoma of esophagus or GE junction; clinical stage I-III; surgical candidate; ECOG PS 0–2, adequate organ function; informed consent. Pts received paclitaxel 200mg/m2 IV and carboplatin AUC 6.0 IV, days 1, 22; 5FU 225mg/m2, 24 hr continuous infusion, days 1–42; RT 45 Gy in 1.8 Gy/d single daily fractions. Surgical resection was performed 6–10 weeks after completion. Results: 226 pts with the following characterstics were treated: median age 58 years; adenocarcinoma 74%; distal/GE junction 79%; clinical stage II/III 84%. 220 pts (97%) completed preoperative therapy, and 199 pts (88%) had resection. Responses in resected pts: pCR 45% (39% of entire group), PR (microscopic residual) 29%, PR (macroscopic) 15%. After median followup of 75 months, median PFS and overall survival for the entire group were 19 and 26 months, respectively; 3- and 5-year survivals were 40% and 33%, respectively. Median survival was better in pts with pCR vs others (33 vs 21 mo; p=.026). 3-yr survival comparisons of other potential prognostic factors: adeno vs squamous, 43% vs 42%; clinical stage I vs II/III, 63% vs 36% (p=.001); distal location vs others, 38% vs 45% (p=.45). Toxicity data have been previously published; overall 13 pts (6%) had treatment-related death (preop 2, postop 11). Conclusions: This preoperative combined modality regimen was feasible and highly active in a community-based setting. This is one of the largest series of patients treated with an identical preoperative approach and with long-term followup is curative in one-third of pts with localized esophageal cancer. [Table: see text]

704 Background: Gemcitabine is an exciting novel deoxcytidine analog demonstrating synergism, when combined with trastuzumab, in human breast cancer cell lines. Trastuzumab plus chemotherapy, has y...

7123 Background: Adjuvant therapy with P (200mg/m2)/C (AUC=6) every 3 weeks for 4 cycles is associated with a 13% increase of survival in stage IB NSCLC patients (pts) (Late/breaking abstracts from...

8014 Background: Hot flashes are a prominent symptom in breast cancer survivors. Available data demonstrate that both venlafaxine and progestational agents substantially decrease hot flashes. This trial was developed to compare these two agents. Methods: 227 women, reporting at least 14 hot flashes/wk were randomized to venlafaxine (37.5 mg/day for a wk, then 75 mg/d, 109 pts) versus MPA (400 mg IM, 109 pts) versus MPA (500 mg IM q 2 w for 3 doses, 9 pts, arm closed early due to slow initial study accrual), after being stratified for age, tamoxifen use, raloxifene use, and the duration and frequency of hot flash symptoms. Assuming 109 pts per each of the 2 main study arms, this study had 90% power to detect a difference between the two treatments of 1 hot flash per day, or a drop of 16% from baseline, with a 5% Type I error. Results: At this time, data are reported for 185 evaluable pts (81%). All examined pretreatment factors were equally balanced between the two major treatment groups. 90% of participan...