Added Value of Extragenital Sexually Transmitted Infection Testing in "IWantTheKit" Program Users.

BACKGROUND: The 2021 Centers for Disease Control and Prevention sexually transmitted infection treatment guidelines recommend extragenital testing for gonorrhea and chlamydia in men who have sex with men and for women based on reported behaviors and exposures. The "IWantTheKit (IWTK)" program is a free online platform for specimen self-collection and mail-in for combined chlamydia/gonorrhea testing. We sought to assess the additional diagnostic value of extragenital testing compared with genital testing only for chlamydia/gonorrhea and determine factors associated with a positive extragenital test result among IWTK users. METHODS: From August 2013 to January 2022, 7612 unique IWTK users returned swabs for testing; 3407 (45%) users requested both genital and extragenital tests and were included in this analysis. Descriptive statistics were summarized for demographic characteristics, reported behaviors, and genital and extragenital test results, and data were stratified by gender and age group. A logistic regression model was used to estimate associations between factors and extragenital sexually transmitted infection positivity. RESULTS: Chlamydia positivity rates were 4.7%, 2.4%, and 1.5% at genital, extragenital, and both sites, respectively; for gonorrhea, 0.4%, 1.1%, and 0.4% were positive at those sites, respectively. Among women, age 25 years and younger was significantly associated with extragenital chlamydia (odds ratio [OR], 4.0; P = 0.010). Being in high-risk quiz score group was associated with extragenital chlamydia (OR, 2.6; P = 0.005) and extragenital gonorrhea in men and women (OR, 8.5; P = 0.005). CONCLUSIONS: Extragenital testing detected additional chlamydia and gonorrhea cases in the IWTK user population that would have been missed by genital-only testing, especially for women younger than 25 years and people reported to be at high risk.

Rapid Uptake of Testing for Chlamydia, Gonorrhea, and HIV From an Online Platform, April-October 2020.

The Baltimore City Health Department (Baltimore, MD) promoted IWantTheKit for chlamydia, gonorrhea, and HIV testing to city residents and clinic patients when COVID-19 restricted in-person clinic services. From April to October 2020, monthly online IWantTheKit orders increased by 645%. A high prevalence of chlamydia and gonorrhea was detected, and 96% of users who tested positive for chlamydia and gonorrhea were successfully contacted for treatment. Uptake by Baltimore City Health Department priority populations and excellent treatment linkage demonstrated how a public health-academic partnership successfully addressed a service gap during the pandemic. (Am J Public Health. 2022;112(7):985-989. https://doi.org/10.2105/AJPH.2022.306835).

Performance of the Atlas Genetics Rapid Test for Chlamydia trachomatis and Women's Attitudes Toward Point-Of-Care Testing.

PURPOSE: This study compared performance of the Atlas io polymerase chain reaction-based, point-of-care (POC) assay for Chlamydia trachomatis (CT), to Aptima Combo 2, a standard of care nucleic acid amplification assay, and evaluated patient attitudes toward POC testing. METHODS: Women 14 years or older undergoing CT screening/testing were recruited from Teen Health Center and a sexually transmitted disease clinic. Participants provided self-obtained vaginal swabs for testing with the Atlas io and Aptima Combo 2, and completed questionnaires assessing attitudes toward POC testing. RESULTS: Of 296 women recruited, 284 (192 from sexually transmitted disease clinic, 92 from Teen Health Center) had Aptima Combo 2 and Atlas io results available; 273 completed the questionnaire. Average age was 27.4 years (SD, 10.8 years). Sensitivity and specificity of the Atlas io test were 83.9% (26/31 specimens; 95% confidence interval [CI], 70.9-96.8%) and 98.8% (250/253 specimens; 95% CI, 97.5-100%), respectively. When specimens with discrepant results were included in the analyses, adjudicated sensitivity and specificity were 92.9% (26/28 specimens; 95% CI, 83.3 to 100%) and 98.8% (253/256 specimens; 95% CI, 97.5 to 100%), respectively.A majority (70%) of women preferred to collect vaginal self-swab if a POC test were available. Most (61%) were willing to wait up to 20 minutes, and 26% were willing to wait up to 40 minutes for results, if they could be treated before leaving clinic. CONCLUSIONS: A POC polymerase chain reaction test detecting CT had high sensitivity and specificity when testing prospective, vaginal swab samples. Availability of CT results during patients' visits may decrease time to treatment.

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.

Clinically significant cardiac disease in patients with Hodgkin lymphoma treated with mediastinal irradiation.

This study assessed the cumulative incidence of clinically significant cardiac disease in 1279 Hodgkin lymphoma patients treated with mediastinal irradiation and quantified the standard incidence ratios (SIRs) and absolute excess risks of cardiac procedures compared with a normal matched population. Cox regression analysis was used to explore factors associated with cardiac complications. Poisson regression analysis of SIRs was used to estimate the excess risk of cardiac interventions from mediastinal irradiation. After a median follow-up of 14.7 years, 187 patients experienced 636 cardiac events and 89 patients required a cardiac procedure. 5-, 10-, 15-, and 20-year cumulative incidence rates of cardiac events were 2.2%, 4.5%, 9.6%, and 16%. SIRs for cardiac procedures were increased for coronary artery bypass graft (3.19), percutaneous intervention (1.55), implantable cardioverter defibrillator or pacemaker placement (1.9), valve surgery (9.19), and pericardial surgery (12.91). Absolute excess risks were 18.2, 19.3, 9.4, 14.1, and 4.7 per 10 000 person-years, respectively. Older age at diagnosis and male sex were predictors for cardiac events. However, younger age at diagnosis was associated with excess risk specifically from radiation therapy compared with the general population. These results may help guideline development for both the types and timing of cardiac surveillance in survivors of Hodgkin lymphoma.

The Healthcare Journey of Women With Advanced Gynecological Cancer From Diagnosis Through Terminal Illness: Qualitative Analysis of Progress Note Data.

OBJECTIVE: To examine women's journeys with gynecologic cancer from before diagnosis through death and identify elements of their healthcare experience that warrant improvement. METHODS: This exploratory study used longitudinal progress notes data from a multispecialty practice in Northern California. The sample included women with stage IV gynecological cancer diagnosed after 2011 and who died before 2018. Available progress notes from prior to diagnosis to death were qualitatively analyzed. RESULTS: We identified 32 women, (median age 61 years) with mostly uterine (n=17) and ovarian (n=9) cancers and median survival of 9.2 months (min:2.9 and max:47.5). Sixteen (50%) received outpatient palliative care and 18 (56%) received hospice care. The analysis found wide variation in documentation about communication about diagnosis, prognosis, goals of care, stopping treatment, and starting hospice care. Challenges included escalating/severe symptoms, repeated urgent care/emergency department/hospital encounters, and lack of or late access to palliative and hospice care. Notes also illustrated how patient background and goals influenced care trajectory and communication. Documentation styles varied substantially, with palliative care notes more consistently documenting conversations about goals of care and psychosocial needs. CONCLUSION: This analysis of longitudinal illness experience of women with advanced gynecological cancer suggests that clinicians may want to (1) prioritize earlier discussion about goals of care; (2) provide supplemental support to patients with higher needs, possibly through palliative care or navigation; and (3) write notes to enhance patient understanding now that patients may access all notes.

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.

Health practice in long-term survivors of Hodgkin's lymphoma.

PURPOSE: To compare the health practice of Hodgkin's lymphoma (HL) survivors and their siblings, and to assess the impact of socioeconomic status and disease history on health practice of HL survivors. METHODS AND MATERIALS: We conducted a questionnaire study on long-term HL survivors and their siblings on health care utilization, health habits, and screening behavior. RESULTS: A total of 511 HL survivors (response rate of 50%, including survivors lost to contact) and 224 siblings (response rate, 58%) participated. Median time from HL diagnosis was 15 years. Significantly more survivors than siblings had a physical examination in the past year (63% vs. 49%, p = 0.0001). Male survivors were significantly more likely than siblings to perform monthly self-testicular examinations (19% vs. 9%, p = 0.02). Among survivors, higher household income (p = 0.01) independently predicted for having had a physical examination in the past year. Lower educational level (p = 0.0004) and history of relapsed HL (p = 0.03) were independent predictors for smoking, moderate/heavy alcohol use, and/or physical inactivity. CONCLUSIONS: Compared with siblings, long-term HL survivors have a higher level of health care utilization and better screening practice. Survivors from lower socioeconomic background had lower adherence to routine health care and greater report of unhealthy habits. Survivors with history of relapsed HL were also more likely to engage in unhealthy habits.

Condom use among high-risk adolescents: anticipation of partner disapproval and less pleasure associated with not using condoms.

OBJECTIVE: We determined the association of demographic, psychosocial, and contextual factors with condom use among a large community sample of at-risk adolescents recruited from four locations in the U.S. METHODS: We enrolled 1,410 adolescents/young adults between the ages of 15 and 21 with a history of unprotected sex in the past 90 days at four study sites. Subjects completed an audio-assisted, computerized assessment that gathered information about sexual behavior and its contexts, substance use, and relevant risk and protective attitudes. RESULTS: Nearly two-thirds of adolescents did not use condoms at the time of last intercourse and adolescents reported a mean of 15.5 (median = 5) unprotected intercourse occasions in the past 90 days. Controlling for relevant demographic variables, not using condoms was associated with the perception that condoms reduce sexual pleasure, the perception that partners will not approve of condom use, and less discussion with partners about condoms. CONCLUSIONS: Even across racial/ethnic groups, gender, and geographic locations, several important correlates of adolescents' sexual risk reduction were identified. Many adolescents may feel that condoms reduce their sexual pleasure and fear partner reactions if they initiate condom use. These attitudes may be malleable through clinical and community-based interventions.

Incidence of major corrective surgery after post-mastectomy breast reconstruction and radiation therapy.

To evaluate the likelihood of requiring major corrective surgery (MCS) after modified radical mastectomy (MRM), immediate reconstruction and radiation therapy (RT) to the reconstructed breast. The study population consisted of 62 patients who underwent MRM and immediate breast reconstruction between 1990 and 1999, had postoperative radiation and at least one follow-up visit or procedure > or = 2 months after radiation. Reconstruction consisted of a pedicled transverse rectus abdominis myocutaneous flap in 42 patients, latissimus dorsi flap in five, latissimus dorsi plus implant in six, and implant alone in nine. Median follow-up time after reconstruction was 13 months (range: 2-58) for non-implant patients and 10 months (range: 4-57) for implant patients. The primary endpoint was the incidence of major complications requiring MCS. Ten patients (16%) underwent MCS between 1 and 28 months after radiation (median in these patients of 8 months). 4/47 non-implant patients (9%) underwent MCS, compared to 6/15 implant patients (40%). Of patients followed > or = 6 months after RT, 0/38 non-implant patients underwent MCS within 6 months compared to 3/13 (23%) implant patients (p = 0.01); of patients followed for > or = 12 months after RT, the rates of MCS within 12 months were 1/24 (4%) and 2/7 (29%), respectively (p = 0.12). Patients who undergo immediate reconstruction after mastectomy using an implant followed by radiation have a high rate of subsequent MCS. The difference in the rate of MCS between the implant and non-implant groups is significant in early follow-up. Patients considering an implant followed by RT should be apprised of this increased risk. Prospective studies of these risks and the cosmetic outcomes are warranted.

Comparison of the Cepheid GeneXpert CT/NG assay to the Hologic Aptima Combo2 assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in self-collected rectal swabs.

Self-collected rectal-swabs were tested for CT and NG on GeneXpert CT/NG as compared to APTIMA Combo2. Of 448 rectal-swabs, 22 were positive for CT; 7 for NG on both assays; two were discordant. Sensitivity and specificity of GeneXpert was 95.5% and 99.7% for chlamydia, respectively; for gonorrhea both were 100%.

Reduced Mortality Risk in the Recent Era in Early-Stage Hodgkin Lymphoma Patients Treated With Radiation Therapy With or Without Chemotherapy.

PURPOSE: To determine the effect of treatment changes over time on all-cause mortality risk in patients with early-stage Hodgkin lymphoma (HL) after radiation therapy. The long-term survivorship of those with HL necessitates quantification of the late risk of mortality from HL and other causes. METHODS AND MATERIALS: An institutional review board-approved retrospective study was conducted using a multi-institutional database of 1541 stage I and II HL patients treated from 1968 to 2007 with radiation therapy alone or combined-modality treatment. The analytic methods included cumulative incidence function, Kaplan-Meier estimates and log-rank tests for overall survival (OS) differences, and Cox proportional hazards modeling. RESULTS: The median age at diagnosis was 27 years. At a median follow-up of 15.2 years (35% of patients with >20 years of follow-up), 395 patients had died of all causes, including 85 HL, 168 second malignancy (25 hematologic and 143 nonhematologic), 70 cardiovascular, and 21 pulmonary deaths. The cumulative incidence of non-HL mortality had surpassed HL mortality at 8.3 years. For patients treated from 1968 to 1982, 1983 to 1992, and 1993 to 2007, the 15-year OS rates were 78%, 85%, and 88%, respectively (P=.0016). On Cox proportional hazards analysis, age, B symptoms, and number of disease sites were significantly associated with all-cause mortality in the first decade of follow-up, with a trend toward significance for radiation field extent. CONCLUSIONS: The all-cause mortality risk was significantly lower for patients treated in the most recent era during the first decade of follow-up, likely due to improved HL therapy resulting in a higher cure rate and lower treatment-related toxicity from smaller radiation fields. Current efforts toward radiation treatment reduction might further reduce the long-term mortality risk for these patients.

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 conservative surgery without radiation therapy in select patients with Stage I breast cancer.

PURPOSE: The effectiveness of radiation therapy (RT) in reducing local recurrence after breast-conserving surgery (BCS) in unselected patients with early stage invasive breast cancer has been demonstrated in multiple randomized trials. Whether a subset of women can achieve local control without RT is unknown. In 1986, we initiated a prospective one-arm trial of BCS alone for highly selected breast-cancer patients. This report updates those results. METHODS AND MATERIALS: Eighty-seven (of 90 planned) patients enrolled from 1986 until closure in 1992, when a predefined stopping boundary was crossed. Patients were required to have a unicentric, T1, pathologic node-negative invasive ductal, mucinous, or tubular carcinoma without an extensive intraductal component or lymphatic-vessel invasion. Surgery included local excision with margins of at least 1 cm or a negative re-excision. No RT or systemic therapy was given. RESULTS: Results are available on 81 patients (median follow-up, 86 months). Nineteen patients (23%) had local recurrence (LR) as a first site of failure (average annual LR: 3.5 per 100 patient-years of follow-up). Other sites of first failure included 1 ipsilateral axilla, 2 contralateral breast cancers, and 4 distant metastases. Six patients developed other (nonbreast) malignancies. Nine patients have died, 4 of metastatic breast cancer and 5 of unrelated causes. CONCLUSIONS: Even in this highly selected cohort, a substantial risk of local recurrence occurred after BCS alone with margins of 1.0 cm or more. These results suggest that with the possible exception of elderly women with comorbid conditions, radiation therapy after BCS remains standard treatment.

Long-term outcome and mortality trends in early-stage, Grade 1-2 follicular lymphoma treated with radiation therapy.

PURPOSE: To analyze long-term outcomes and causes of death in patients receiving radiation therapy (RT) for localized, low-grade follicular lymphoma. METHODS AND MATERIALS: Between 1972 and 2000, 106 patients with Stage I-II, Grade 1-2 follicular lymphoma received RT alone or radiation and chemotherapy (RT/CT). Seventy-four percent had Stage I, and 26% had Stage II disease. Seventy-six percent received RT alone, and 24% received combined RT/CT. Second malignancy rates were compared with an age- and sex-matched population. RESULTS: Median follow-up was 12 years. Median survival time was 19 years. The 5-, 10-, and 15-year overall survival (OS) rates were 93%, 75%, and 62%, respectively. Age > or = 60 was the only significant adverse prognostic factor with respect to OS. There were 35 deaths, 20 of which were attributable to lymphoma. Freedom from treatment failure (FFTF) rates at 5, 10, and 15 years were 72%, 46%, and 39%, respectively. Forty-seven patients (48%) relapsed. Tumor size > 3 cm was the only significant adverse factor for FFTF. Observed incidence of second malignancy did not significantly exceed expected incidence. CONCLUSIONS: Although patients with early-stage, low-grade follicular lymphoma have long median survival, the leading cause of death remains lymphoma. However, patients receiving RT do not have significantly elevated cumulative incidence of second malignancy.

Successful use of nicotine replacement therapy to quit e-cigarettes: lack of treatment protocol highlights need for guidelines.

Although use of electronic nicotine delivery system devices, such as e-cigarettes and vapor pens, is on the rise, no treatment protocols exist to help such users quit. We report the case of a 24-year-old patient in a tobacco treatment program who successfully quit e-cigarette use by using nicotine replacement therapy.

Long-term survival and competing causes of death in patients with early-stage Hodgkin's disease treated at age 50 or younger.

PURPOSE: To analyze the long-term survival and the pattern and timing of excess mortality in patients with early-stage Hodgkin's disease. PATIENTS AND METHODS: Between 1969 and 1997, 1,080 patients age 50 or younger were treated for clinical stage IA to IIB Hodgkin's disease. Overall survival was determined, and prognostic factors were assessed. Relative risk and absolute excess risk (AR) of mortality were calculated for the entire cohort and by prognostic groups (on the basis of B symptoms, mediastinal status, and number of sites, modified from the European Organization for Research and Treatment of Cancer). RESULTS: The median follow-up was 12 years. The 15- and 20-year Kaplan-Meier survival estimates were 84% and 78%, respectively. Cox proportional hazards models showed that number of involved sites (P =.006), mediastinal status (P =.02), and histology (P =.02) were independent predictors of death from all causes. The AR of mortality in patients with a favorable prognosis increased over time, whereas for those with an unfavorable prognosis, the AR peaked in the first 5 years, predominantly from Hodgkin's disease. The relative risk of mortality from all causes, causes other than Hodgkin's disease, second tumors, and cardiac disease remained significantly elevated more than 20 years after treatment. CONCLUSION: Patients treated for early-stage Hodgkin's disease have a sustained excess mortality risk despite good control of the disease. Treatment reduction efforts in patients with early-stage, favorable-prognosis disease should continue, but for patients with an unfavorable prognosis, modified treatment may not be advisable. The excess mortality noted beyond two decades underscores the importance of long-term follow-up care in patients treated for Hodgkin's disease.

Radiation therapy for orbital lymphoma.

PURPOSE: To describe radiation techniques and evaluate outcomes for orbital lymphoma. METHODS AND MATERIALS: Forty-six patients (and 62 eyes) with orbital lymphoma treated with radiotherapy between 1987 and 2003 were included. The majority had mucosa-associated lymphoid tissue (48%) or follicular (30%) lymphoma. Seventeen patients had prior lymphoma at other sites, and 29 had primary orbital lymphoma. Median follow-up was 46 months. RESULTS: The median dose was 30.6 Gy; one-third received <30 Gy. Electrons were used in 9 eyes with disease confined to the conjunctiva or eyelid, and photons in 53 eyes with involvement of intraorbital tissues to cover entire orbit. Local control rate was 98% for all patients and 100% for those with indolent lymphoma. Three of the 26 patients with localized primary lymphoma failed distantly, resulting in a 5-year freedom-from-distant-relapse rate of 89%. The 5-year disease-specific and overall survival rates were 95% and 88%, respectively. Late toxicity was mainly cataract formation in patients who received radiation without lens block. CONCLUSIONS: A dose of 30 Gy is sufficient for indolent orbital lymphoma. Distant relapse rate in patients with localized orbital lymphoma was lower than that reported for low-grade lymphoma presenting in other sites. Orbital radiotherapy can be used for salvage of recurrent indolent lymphoma.

Mid- and post-ABVD gallium scanning predicts for recurrence in early-stage Hodgkin's disease.

PURPOSE: To determine the efficacy of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) for patients with Hodgkin's disease and to identify predictors of outcome with this regimen. METHODS: Between 1987 and 1998, 175 patients with Stage I-IV Hodgkin's disease received ABVD as part of initial treatment. Overall survival (OS), freedom-from-treatment-failure (FFTF), and progression-free survival (PFS) were calculated using the Kaplan-Meier technique. Log-rank tests were used to identify univariate predictors of OS, FFTF, and PFS. Specifically, restaging gallium scan results and clinical response after chemotherapy were separately evaluated. RESULTS: The median follow-up time was 64 months. The 5-year OS, FFTF, and PFS rates were 90%, 85%, and 82%, respectively. For Stage I-II patients, restaging gallium scan results and clinical response after chemotherapy were highly predictive of OS, FFTF, and PFS (p < 0.0001). Other significant predictors for higher OS included age <50 (p = 0.002), female gender (p = 0.047), and absence of B symptoms (p = 0.043). Of the 20 patients with a positive restaging gallium scan, 4 received high-dose therapy and 16 continued with conventional-dose therapy or received no further treatment. Of these 16 patients, 11 (69%) were disease-free at last follow-up. CONCLUSIONS: Although a positive mid- or postchemotherapy gallium scan was an adverse prognostic factor for OS, FFTF, and PFS, continued treatment with conventional-dose therapy may be adequate in selected patients with positive scans.

Prognosis after local recurrence after conservative surgery and radiation for early-stage breast cancer.

PURPOSE: To determine the long-term prognosis of patients who develop a local recurrence (LR) after conservative surgery (CS) and radiation therapy (RT) for early-stage invasive breast cancer. METHODS AND MATERIALS: Between 1970 and 1987, 2102 patients with clinical Stage I-II breast cancer were treated with CS+RT. LR was defined as any recurrence within the ipsilateral breast with or without simultaneous regional nodal or distant metastasis. Patients were at risk for a LR until the first of distant metastases, second nonbreast malignancy, or death (DF/S/D). The final study population comprised 341 patients with LR. The median time to LR was 72 months. The median follow-up time after LR was 85 months. A proportional hazards model of time from LR to DF/S/D was done to investigate the influence of factors at initial diagnosis and at LR on subsequent outcome. RESULTS: The actuarial freedom from DF/S/D 5 years after LR was 65% and the survival was 81%. Variables significantly associated with time to DF/S/D were: LR histology (invasive vs. ductal carcinoma in situ, hazard ratio [HR] = 4.1, p < 0.0001); local therapy for LR (none vs. mastectomy or unknown, HR = 3.2, p < 0.0001; and CS +/- RT vs. mastectomy or unknown, HR = 2.0, p = 0.02); time to LR (< or =2 years vs. >5 years, HR = 2.6, p < 0.0001; and 2-5 years vs. >5 years, HR = 1.8, p = 0.006); and age at initial diagnosis (> or =60 vs. <60, HR = 1.6, p = 0.01). CONCLUSIONS: Many patients with LR after CS+RT have prolonged distant disease-free survival, particularly those able to be treated with mastectomy. Patients with a noninvasive LR, longer interval to LR, or age <60 had a longer time to distant failure, second malignancy, or death than other patients.