Eight-year update of a prospective study of wide excision alone for small low- or intermediate-grade ductal carcinoma in situ (DCIS).

Whether wide excision with margins ≥1 cm is sufficient treatment for small low- or intermediate-grade ductal carcinoma in situ (DCIS) is unclear. This is an updated analysis of a phase II, single-arm, prospective trial testing this hypothesis. A total of 158 patients with low- or intermediate-grade DCIS who underwent wide excision alone (without radiation or tamoxifen) were entered onto the trial from 1995 to 2002. Entry criteria included mammographic extent ≤2.5 cm, predominantly low or intermediate nuclear grade, and excision with final microscopic margins ≥1 cm. Eight-year minimum potential follow-up was required for inclusion in the analysis; the final population comprised 143 patients. Cumulative incidence curves were generated to assess rates of local recurrence (LR) or other events. Median follow-up time was 11 years. Nineteen patients (13 %) had LR as a first event within 8 years. Thirteen LR (68 %) were DCIS only and six (32 %) were invasive. Fourteen (74 %) occurred in the original quadrant. The 10-year estimated cumulative incidence of LR was 15.6 %. The estimated annual percentage rate of LR was 1.9 % per patient-year. With longer follow-up, there remains a substantial and ongoing risk of LR in patients with favorable DCIS treated with wide excision margins without radiation. This information should be useful as patients and clinicians weigh the options of wide excision with and without radiation.

Correlates of heterosexual anal intercourse among at-risk adolescents and young adults.

OBJECTIVES: We sought to learn what factors are associated with anal intercourse among adolescents and young adults. We examined demographic, behavioral, relationship context, attitudinal, substance use, and mental health correlates of recent heterosexual anal intercourse among adolescents and young adults who reported engaging in recent unprotected sex. METHODS: Among 1348 at-risk adolescents and young adults aged 15 to 21 years in 3 US cities, we assessed sexual risk behavior with each sexual partner in the past 90 days. Data were collected from 2000 to 2001. RESULTS: Recent heterosexual anal intercourse was reported by 16% of respondents. Females who engaged in anal intercourse were more likely to be living with a sexual partner, to have had 2 or more partners, and to have experienced coerced intercourse. For males, only a sexual orientation other than heterosexual was a significant predictor of engaging in heterosexual anal intercourse. CONCLUSIONS: Our findings document the prevalence of heterosexual anal intercourse among adolescents and young adults who had recent unprotected sex. Among females, the variables associated with anal intercourse relate to the context and power balance of sexual relationships. Different influences for males and females suggest different foci for interventions.

Prospective study of wide excision alone for ductal carcinoma in situ of the breast.

PURPOSE: It has been hypothesized that wide excision alone with margins > or = 1 cm may be adequate treatment for small, grade 1 or 2 ductal carcinoma in situ (DCIS). To test this hypothesis, we conducted a prospective, single-arm trial. METHODS: Entry criteria included DCIS of predominant grade 1 or 2 with a mammographic extent of < or = 2.5 cm treated with wide excision with final margins of > or = 1 cm or a re-excision without residual DCIS. Tamoxifen was not permitted. The accrual goal was 200 patients. RESULTS: In July 2002, the study closed to accrual at 158 patients because the number of local recurrences met the predetermined stopping rules. The median age was 51 and the median follow-up time was 40 months. Thirteen patients developed local recurrence as the first site of treatment failure 7 to 63 months after study entry. The rate of ipsilateral local recurrence as first site of treatment failure was 2.4% per patient-year, corresponding to a 5-year rate of 12%. Nine patients (69%) experienced recurrence of DCIS and four (31%) experienced recurrence with invasive disease. Twelve recurrences were detected mammographically and one was palpable. Ten were in the same quadrant as the initial DCIS and three were elsewhere within the ipsilateral breast. No patient had positive axillary nodes at recurrence or subsequent metastatic disease. CONCLUSION: Despite margins of > or = 1 cm, the local recurrence rate is substantial when patients with small, grade 1 or 2 DCIS are treated with wide excision alone. This risk should be considered in assessing the possible use of radiation therapy with or without tamoxifen in these patients.

"Islands of Risk": subgroups of adolescents at risk for HIV.

OBJECTIVE: To use cluster analysis to determine profiles of adolescents at risk for HIV. METHODS: Adolescents 15-21 years old (N = 1153) with a history of unprotected sex were assessed in five domains of risk (unprotected sex, alcohol/marijuana use, other drug use, mental health crises, and arrest/school dropout) as well as demographic, contextual, and behavioral variables. RESULTS: Cluster analysis revealed separate three-cluster solutions for males and females. Among males, clusters were characterized by (a) mental health crises and unprotected sex, (b) alcohol/marijuana use and unprotected sex, and (c) lower risk. Among females, clusters were distinguished by (a) unprotected sex, (b) substance use and mental health crises, and (c) lower risk. Cluster membership was associated with secondary variables related to sexual risk. CONCLUSIONS: Even within populations of high-risk adolescents, subgroups exist for which specific risk factors co-occur, particularly unprotected sex, mental health crises, and substance use. These patterns suggest that effective HIV prevention interventions may need to target the association between mental health and/or substance abuse with sexual risk for some adolescents.

Condom failure among adolescents: implications for STD prevention.

This study of 921 adolescents found condom failure (past 90 days) was experienced by at least one-third of the sample, regardless of gender. Frequency of condom failure was positively associated with STD diagnosis (AOR = 1.22, 95% CI = 1.01-1.48), with the odds of testing positive increasing 22% for each added event of failure.

Sequencing of chemotherapy and radiation therapy in early-stage breast cancer: updated results of a prospective randomized trial.

PURPOSE: The optimal integration of chemotherapy with radiation (RT) for patients with early-stage breast cancer remains uncertain. We present the long-term results of a prospective randomized trial to address this question. PATIENTS AND METHODS: Two hundred forty-four patients were randomly assigned after conservative breast surgery to receive 12 weeks of cyclophosphamide, doxorubicin, methotrexate, fluorouracil, and prednisone (CAMFP) before RT (CT-first) or after RT (RT-first). Median follow-up for surviving patients was 135 months. RESULTS: There were no significant differences between the CT-first and RT-first arms in time to any event, distant metastasis, or death. Sites of first failure were also not significantly different. CONCLUSION: Among breast cancer patients treated with conservative surgery, there is no advantage to giving RT before adjuvant chemotherapy. However, this study does not have enough statistical power to rule out a clinically important survival benefit for either sequence.

A prospective study of concurrent cyclophosphamide/methotrexate/5-fluorouracil and reduced-dose radiotherapy in patients with early-stage breast carcinoma.

BACKGROUND: Concurrent administration of chemotherapy and radiotherapy has the potential advantage of delaying neither treatment and providing radiation sensitization. However, the optimal approach to concurrent treatment in women with early-stage breast carcinoma remains undefined. We present updated results of a prospective protocol of concurrent cyclophosphamide/methotrexate/5-fluorouracil (CMF) and reduced-dose radiotherapy, focusing on tumor control and patient tolerance. METHODS: One hundred twelve women with AJCC Stage I or Stage II breast carcinoma with 0-3 positive axillary lymph nodes were enrolled in a prospective single-arm study of concurrent CMF and reduced-dose radiotherapy (39.6 gray [Gy] to the whole breast, 16-Gy boost). A high proportion of women had risk factors associated with an increased risk of local disease recurrence, including age <40 (32%), close or positive margins (37%), or lymphatic/vascular invasion (51%). The median follow-up period was 94 months. RESULTS: The 5-year overall survival rate was 94%. By 60 months, 5 patients (4%) experienced local disease recurrence and 19 patients (17%) experienced distant metastasis. There were no isolated regional lymph node recurrences. Local disease recurrence occurred in 1 of 25 patients (4%), 1 of 16 patients (6%), and 3 of 70 patients (4%) with positive, close (<1 mm), and negative margins, respectively. One patient developed acute myelogenous leukemia. An additional patient developed Grade 2 pneumonitis. Cosmetic results were not recorded uniformly for all patients and therefore could not be reliably analyzed. CONCLUSIONS: Concurrent CMF and reduced-dose radiotherapy resulted in a low level of late toxicity and excellent local tumor control, despite the large proportion of patients with substantial risk factors for local disease recurrence. Future studies of concurrent regimens, particularly in patients at high risk of local disease recurrence, are warranted.