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Purpose: The primary objective of this study was to determine the feasibility of electromagnetic transponder implantation in patients with locally advanced unresectable pancreatic cancer. Secondarily, the use of transponders to monitor inter- and intrafractional motion, and the efficacy of breath holding for limiting target motion, were examined., Methods and Materials: During routine screening laparoscopy, 5 patients without metastatic disease were implanted with transponders peri-tumorally. The Calypso System's localization and tracking modes were used to monitor inter- and intrafractional motion, respectively. Intrafractional motion, with and without breath holding, was also examined using Calypso tracking mode., Results: Transponder implantation was well tolerated in all patients, with minimal migration, aside from 1 patient who expulsed a single transponder. Interfractional motion based on mean shifts from setup using tattoos/orthogonal imaging to transponder based localization from 164 treatments was significant in all dimensions. Mean shift (in millimeters), followed by the standard deviation and p value, were as follows: X-axis: 4.5 mm (1.0, p = 0.01); Y axis: 6.4 mm (1.9, p = 0.03); and Z-axis 3.9 mm (0.6, p = 0.002). Mean intrafractional motion was also found to be significant in all directions: superior, 7.2 mm (0.9, p = 0.01); inferior, 11.9 mm (0.9, p < 0.01); anterior: 4.9 mm (0.5, p = 0.01); posterior, 2.9 mm (0.5, p = 0.02); left, 2.2 mm (0.4, p = 0.02); and right, 3.1 mm (0.6, p = 0.04). Breath holding during treatment significantly decreased tumor motion in all directions., Conclusions: Electromagnetic transponder implantation appears to be safe and effective for monitoring inter- and intrafractional motion. Based on these results a larger clinical trial is underway., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Purpose: To investigate patients' willingness to participate (WTP) in a randomized controlled trial (RCT) comparing intensity-modulated radiotherapy (IMRT) with proton beam therapy (PBT) for prostate cancer (PCa)., Methods and Materials: We undertook a qualitative research study in which we prospectively enrolled patients with clinically localized PCa. We used purposive sampling to ensure a diverse sample based on age, race, travel distance, and physician. Patients participated in a semi-structured interview in which they reviewed a description of a hypothetical RCT, were asked open-ended and focused follow-up questions regarding their motivations for and concerns about enrollment, and completed a questionnaire assessing characteristics such as demographics and prior knowledge of IMRT or PBT. Patients' stated WTP was assessed using a 6-point Likert scale., Results: Forty-six eligible patients (33 white, 13 black) were enrolled from the practices of eight physicians. We identified 21 factors that impacted patients' WTP, which largely centered on five major themes: altruism/desire to compare treatments, randomization, deference to physician opinion, financial incentives, and time demands/scheduling. Most patients (27 of 46, 59%) stated they would either "definitely" or "probably" participate. Seventeen percent (8 of 46) stated they would "definitely not" or "probably not" enroll, most of whom (6 of 8) preferred PBT before their physician visit., Conclusions: A substantial proportion of patients indicated high WTP in a RCT comparing IMRT and PBT for PCa., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Purpose: To describe practice patterns associated with androgen suppression (AS) stratified by disease risk group in patients undergoing external-beam radiotherapy (EBRT) for localized prostate cancer., Methods and Materials: We identified 2,184 low-risk, 2,339 intermediate-risk, and 2,897 high-risk patients undergoing EBRT for nonmetastatic prostate cancer diagnosed between January 1, 2004, and December 31, 2005, in the linked Surveillance, Epidemiology, and End Results-Medicare database. We examined the association of patient, clinical, and demographic characteristics with AS use by multivariate logistic regression., Results: The proportions of patients receiving AS for low-risk, intermediate-risk, and high-risk prostate cancer were 32.2%, 56.3%, and 81.5%, respectively. AS use among men in the low-risk disease category varied widely, ranging from 13.6% in Detroit to 47.8% in Kentucky. We observed a significant decline in AS use between 2004 and 2005 within all three disease risk categories. Men aged ≥75 years or with elevated comorbidity levels were more likely to receive AS., Conclusion: Our results identified apparent overuse and underuse of AS among men within the low-risk and high-risk disease categories, respectively. These results highlight the need for clinician and patient education regarding the appropriate use of AS. Practice patterns among intermediate-risk patients reflect the clinical heterogeneity of this population and underscore the need for better evidence to guide the treatment of these patients., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Purpose: Prostate gland segmentation is a critical step in prostate radiotherapy planning, where dose plans are typically formulated on CT. Pretreatment MRI is now beginning to be acquired at several medical centers. Delineation of the prostate on MRI is acknowledged as being significantly simpler to perform, compared to delineation on CT. In this work, the authors present a novel framework for building a linked statistical shape model (LSSM), a statistical shape model (SSM) that links the shape variation of a structure of interest (SOI) across multiple imaging modalities. This framework is particularly relevant in scenarios where accurate boundary delineations of the SOI on one of the modalities may not be readily available, or difficult to obtain, for training a SSM. In this work the authors apply the LSSM in the context of multimodal prostate segmentation for radiotherapy planning, where the prostate is concurrently segmented on MRI and CT., Methods: The framework comprises a number of logically connected steps. The first step utilizes multimodal registration of MRI and CT to map 2D boundary delineations of the prostate from MRI onto corresponding CT images, for a set of training studies. Hence, the scheme obviates the need for expert delineations of the gland on CT for explicitly constructing a SSM for prostate segmentation on CT. The delineations of the prostate gland on MRI and CT allows for 3D reconstruction of the prostate shape which facilitates the building of the LSSM. In order to perform concurrent prostate MRI and CT segmentation using the LSSM, the authors employ a region-based level set approach where the authors deform the evolving prostate boundary to simultaneously fit to MRI and CT images in which voxels are classified to be either part of the prostate or outside the prostate. The classification is facilitated by using a combination of MRI-CT probabilistic spatial atlases and a random forest classifier, driven by gradient and Haar features., Results: The authors acquire a total of 20 MRI-CT patient studies and use the leave-one-out strategy to train and evaluate four different LSSMs. First, a fusion-based LSSM (fLSSM) is built using expert ground truth delineations of the prostate on MRI alone, where the ground truth for the gland on CT is obtained via coregistration of the corresponding MRI and CT slices. The authors compare the fLSSM against another LSSM (xLSSM), where expert delineations of the gland on both MRI and CT are employed in the model building; xLSSM representing the idealized LSSM. The authors also compare the fLSSM against an exclusive CT-based SSM (ctSSM), built from expert delineations of the gland on CT alone. In addition, two LSSMs trained using trainee delineations (tLSSM) on CT are compared with the fLSSM. The results indicate that the xLSSM, tLSSMs, and the fLSSM perform equivalently, all of them out-performing the ctSSM., Conclusions: The fLSSM provides an accurate alternative to SSMs that require careful expert delineations of the SOI that may be difficult or laborious to obtain. Additionally, the fLSSM has the added benefit of providing concurrent segmentations of the SOI on multiple imaging modalities.

Purpose: To assess whether whole-pelvis (WP) intensity modulated radiation therapy (IMRT) for prostate cancer (PCa) after prostatectomy is associated with increased toxicity compared to prostate-bed only (PB) IMRT., Methods and Materials: All patients (n = 67) undergoing postprostatectomy IMRT to 70.2 Gy at our institution from January 2006 to January 2009 with minimum 12-month follow-up were divided into WP (n = 36) and PB (n = 31) comparison groups. WP patients received initial pelvic nodal IMRT to 45 Gy. Pretreatment demographics, bladder and rectal dose-volume histograms, and maximum genitourinary (GU) and gastrointestinal (GI) toxicities were compared. Logistic regression models evaluated uni- and multivariate associations between pretreatment demographics and toxicities., Results: Pretreatment demographics including age and comorbidities were similar between groups. WP patients had higher Gleason scores, T stages, and preoperative prostate-specific antigen (PSA) levels, and more WP patients underwent androgen deprivation therapy (ADT). WP minimum (Dmin) and mean bladder doses, bladder volumes receiving more than 5 Gy (V5) and V20, rectal Dmin, and PB bladder and rectal V65 were significantly increased. Maximum acute GI toxicity was Grade 2 and was increased for WP (61%) vs. PB (29%) patients (p = 0.001); there was no significant difference in acute Grade ≥2 GU toxicity (22% WP vs. 10% PB; p = 0.193), late Grade ≥2 GI toxicity (3% WP vs. 0% PB; p = 0.678), or late Grade ≥2 GU toxicity (28% WP vs. 19% PB; p = 0.274) with 25-month median follow-up (range, 12-44 months). On multivariate analysis, long-term ADT use was associated with Grade ≥2 late GU toxicity (p = 0.02)., Conclusion: Despite dosimetric differences in irradiated bowel, bladder, and rectum, WP IMRT resulted only in clinically significant increased acute GI toxicity in comparison to that with PB IMRT, with no differences in GU or late GI toxicity., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objective: Little data exist on assessing pain medication utilization among lung cancer patients or on the reasons they fail to receive optimal analgesic treatment. This study evaluates those reasons and investigates perceived causes of pain among individuals with lung cancer., Design: An institutional review board-approved Internet-based questionnaire was posted on http://www.oncolink.org that included 22 queries evaluating analgesic utilization, pain control, and attitudes regarding analgesics., Patients and Participants: Between November 2005 and July 2008, 90 respondents with lung malignancies participated. Respondents were Caucasian (89 percent), male (54 percent), and had non-small-cell lung cancer (79 percent), small-cell lung cancer (12 percent), or mesothelioma (9 percent)., Results: Respondents underwent surgery (48 percent), chemotherapy (58 percent), and radiotherapy (44 percent). Most respondents (92 percent) reported experiencing pain, with 52 percent attributing pain directly to cancer, 38 percent to cancer treatment, and 67 percent unsure of the primary cause. Among respondents experiencing pain, 33 percent did not use analgesics. Analgesic utilization was less in men (p = 0.050) but did not differ by minority status (p = 0.127), education level (p = 0.37), or lung cancer histology (p = 0.134). Analgesic use was higher in subjects receiving radiotherapy (p = 0.002) and chemotherapy (p = 0.013) but not surgery (p = 0.16). Reasons for not taking analgesics included fear of addiction/dependence (76 percent), healthcare providers not recommending medications (71 percent), and inability to pay for analgesics (56 percent). Participants pursued physical therapy (76 percent) and other complementary modalities (24 percent) for pain control., Conclusions: Many individuals with lung cancer perceive pain from both their disease and their cancer treatment. However, some study respondents did not use analgesics due to concerns of addiction, cost, or their healthcare providers not recommending analgesics. Medicalprofessionals providing medical management for lung cancer patients should make pain management a priority and regularly discuss pain symptoms and pain management with patients.

Purpose: Cancer-Related Fatigue (CRF) negatively affects quality of life among cancer patients. This study seeks to evaluate the outcome and patient receptiveness of a brief counseling program based on National Cancer Institute (NCI) PDQ® information to manage CRF when integrated into Radiation Therapy (RT)., Methods: We conducted a prospective cohort study among patients undergoing non-palliative RT. Patients with stage I-III tumors and with Karnofsky score 60 or better were given a ten-minute behavioral counseling session during the first two weeks of RT. The Brief Fatigue Inventory (BFI) was administered at baseline/end of RT., Results: Of 93 patients enrolled, 89% found the counseling useful and practical. By the end of RT, 59% reported increased exercise, 41.6% sought nutrition counseling, 72.7% prioritized daily activities, 74.4% took daytime naps, and 70.5% talked with other cancer patients. Regarding counseling, patients who had received chemotherapy prior to RT had no change in fatigue (-0.2), those who received RT alone had mild increase in fatigue (0.7, p=0.02), and those who received concurrent chemotherapy experienced a substantial increase in fatigue (3.0 to 5.2, p=0.05). Higher baseline fatigue and receipt of chemotherapy were predictive of worsened fatigue in a multivariate model (both p<0.01)., Conclusion: Our data suggests that brief behavioral counseling based on NCI guidelines is well accepted by patients showing an uptake in many activities to cope with CRF. Those who receive concurrent chemotherapy and with higher baseline fatigue are at risk for worsening fatigue despite of guideline-based therapy.

Purpose: To prospectively investigate intrafraction prostate motion during radiofrequency-guided prostate radiotherapy with implanted electromagnetic transponders when daily endorectal balloon (ERB) is used., Methods and Materials: Intrafraction prostate motion from 24 patients in 787 treatment sessions was evaluated based on three-dimensional (3D), lateral, cranial-caudal (CC), and anterior-posterior (AP) displacements. The mean percentage of time with 3D, lateral, CC, and AP prostate displacements>2, 3, 4, 5, 6, 7, 8, 9, and 10 mm in 1 minute intervals was calculated for up to 6 minutes of treatment time. Correlation between the mean percentage time with 3D prostate displacement>3 mm vs. treatment week was investigated., Results: The percentage of time with 3D prostate movement>2, 3, and 4 mm increased with elapsed treatment time (p<0.05). Prostate movement>5 mm was independent of elapsed treatment time (p=0.11). The overall mean time with prostate excursions>3 mm was 5%. Directional analysis showed negligible lateral prostate motion; AP and CC motion were comparable. The fraction of time with 3D prostate movement>3 mm did not depend on treatment week of (p>0.05) over a 4-minute mean treatment time., Conclusions: Daily endorectal balloon consistently stabilizes the prostate, preventing clinically significant displacement (>5 mm). A 3-mm internal margin may sufficiently account for 95% of intrafraction prostate movement for up to 6 minutes of treatment time. Directional analysis suggests that the lateral internal margin could be further reduced to 2 mm., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Purpose: The present study was performed to compare outcomes after breast conservation treatment with iridium-192 implant boost vs. electron boost., Methods and Materials: From 1977 to 1983, 141 patients were treated with whole breast radiotherapy followed by iridium-192 boost after breast-conserving surgery. They were matched 1:1 to patients treated with electron boost. Outcome measures included survival, local recurrence, cosmesis, and complications., Results: Median follow-up was 16.7 and 12.6 years for the implant vs. electron groups (p < 0.001). Rates of local recurrence, freedom from distant metastases, and overall survival at 10/20 years did not differ between the groups, nor did patterns of first failure. Patients in the electron group were more likely to have excellent/good cosmesis than those in the implant group 1 year after radiotherapy (p = 0.014); this trend continued through 10 years but did not reach statistical significance at years 5/10. Complication rates were similar, although patients receiving electron boost seemed less likely to develop breast fibrosis than did those receiving implant boost (23/141 vs. 58/141, respectively, incidence rate ratio 0.7, p = 0.17)., Conclusions: Twenty-year data demonstrate no difference in rates of local recurrence, freedom from distant metastases, overall survival, or patterns of failure between groups treated with these two well-described radiotherapy boost techniques. Better cosmesis was observed in the electron group 1 year after radiotherapy, with a trend continuing for 10 years. The incidence of complications was similar between the groups, with a trend toward increased fibrosis in patients receiving implant boost., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Objective: Emerging research suggests that yoga may be beneficial for reducing symptoms and improving quality of life among breast cancer patients. However, very little is known about the characteristics of breast cancer patients who use yoga; thus, this study seeks to identify the sociodemographic and clinical characteristics of yoga users among this population., Design: A cross-sectional survey study was conducted., Setting: The study was conducted at an outpatient breast oncology clinic at a large university hospital., Participants: Three hundred postmenopausal breast cancer patients currently receiving aromatase inhibitors were included in this study., Main Outcome Measurement: Self-reported use of yoga following the cancer diagnosis was collected along with sociodemographic and clinical data. Multivariate logistic regression was used to identify independent predictors of yoga use among breast cancer patients., Results: Of 300 participants, 53 (17.7%) reported having used yoga following cancer diagnosis. White patients were significantly more likely to use yoga than nonwhite patients (P = .02). Higher education level, lower BMI (body mass index), part-time employment status, previous chemotherapy, and radiation therapy were all associated with greater yoga use (all P < .05). Controlling for other factors, greater yoga use was independently associated with higher education level (adjusted odds ratio [AOR] 2.72, 95% confidence interval [CI], 1.15-6.46), and lower BMI (AOR 0.25, 95% CI, 0.09-0.66)., Conclusion: Yoga use following breast cancer diagnosis was substantially higher for white patients and those with lower BMI and higher education levels. Considering its potential benefits for symptom management in cancer, more research is needed to understand the attitudes and barriers to yoga use among individuals with nonwhite race, lower education, and higher BMI level. Such investigation will help design yoga programs that are aligned to the needs of these populations., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Purpose: To assess whether whole-pelvis (WP) intensity-modulated radiation therapy (IMRT) is associated with increased toxicity compared with prostate-only (PO) IMRT., Methods and Materials: We retrospectively analyzed all patients with prostate cancer undergoing definitive IMRT to 79.2 Gy with concurrent androgen deprivation at our institution from November 2005 to May 2007 with a minimum follow-up of 12 months. Thirty patients received initial WP IMRT to 45 Gy in 1.8-Gy fractions, and thirty patients received PO IMRT. Study patients underwent computed tomography simulation and treatment planning by use of predefined dose constraints. Bladder and rectal dose-volume histograms, maximum genitourinary (GU) and gastrointestinal (GI) Radiation Therapy Oncology Group toxicity grade, and late Grade 2 or greater toxicity-free survival curves were compared between the two groups by use of the Student t test, Fisher exact test, and Kaplan-Meier curve, respectively., Results: Bladder minimum dose, mean dose, median dose, volume receiving 5 Gy, volume receiving 20 Gy, volume receiving 40 Gy, and volume receiving 45 Gy and rectal minimum dose, median dose, and volume receiving 20 Gy were significantly increased in the WP group (all p values < 0.01). Maximum acute GI toxicity was limited to Grade 2 and was significantly increased in the WP group at 50% vs. 13% the PO group (p = 0.006). With a median follow-up of 24 months (range, 12-35 months), there was no difference in late GI toxicity (p = 0.884) or in acute or late GU toxicity., Conclusions: Despite dosimetric differences in the volume of bowel, bladder, and rectum irradiated in the low-dose and median-dose regions, WP IMRT results only in a clinically significant increase in acute GI toxicity, in comparison to PO IMRT, with no difference in GU or late GI toxicity., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Purpose: To evaluate dosimetric consequences of daily isocenter correction during prostate cancer radiation therapy using the Calypso 4D localization system., Methods and Materials: Data were analyzed from 28 patients with electromagnetic transponders implanted in their prostates for daily target localization and tracking. Treatment planning isocenters were recorded based on the values of the vertical, longitudinal, and lateral axes. Isocenter location obtained via alignment with skin tattoos was compared with that obtained via the electromagnetic localization system. Daily isocenter shifts, based on the isocenter location differences between the two alignment methods in each spatial axis, were calculated for each patient over their entire course. The mean isocenter shifts were used to determine dosimetric consequences of treatment based on skin tattoo alignments alone., Results: The mean SD of the percentages of treatment days with shifts beyond 0.5 cm for vertical, longitudinal and lateral shifts were 62% 28%, 35% 26%, and 38% 21%, respectively. If daily electromagnetic localization was not used, the excess in prescribed dose delivered to 70% of the rectum was 10 Gy and the deficit in prescribed dose delivered to 95% of the planning target volume was 10 Gy. The mean isocenter shift was not associated with the volumes of the prostate, rectum, or bladder, or with patient body mass index., Conclusions: Daily isocenter localization can reduce the treatment dose to the rectum. Correcting for this variability could lead to improved dose delivery, reduced side effects, and potentially improved treatment outcomes., (Copyright 2010 Elsevier Inc. All rights reserved.)

Background: Anemia is common among patients with newly diagnosed cancer, may be exacerbated by cancer therapies, and leads to radioresistance by lowering oxygen levels in the tumor microenvironment. Herein, the effect of breast irradiation on hemoglobin levels and outcomes in breast conservation therapy is reported., Patients and Methods: Medical records of 1368 women with stage 0, I, and II breast cancer treated with breast conservation therapy from 1977-2002 were reviewed. Hemoglobin levels at baseline as well as during and after radiation were recorded. Patterns of hemoglobin changes and the effect of anemia on local control and survival outcomes were assessed. Median follow-up time was 8 years for the normal group and 6 years for the anemic group., Results: Baseline anemia was seen in 18% of the patients, 90% of whom had mild anemia (hemoglobin, 11.9-10.0 g/dL). Anemia was recorded in 21% during radiation. Among patients with normal baseline hemoglobin levels, 6.5% of the patients became anemic during radiation. Of those with baseline anemia, 72% had stable to improved hemoglobin levels during radiation, and 22% declined by a median of 0.3 g/dL. There were no significant differences in local or regional recurrence, overall, disease-free, cause-specific, or distant disease-free survival between patients with baseline anemia or with normal hemoglobin., Conclusion: Radiation does not contribute significantly to anemia during breast conservation treatment, and mild anemia does not affect outcomes. It is unnecessary to obtain routine hemoglobin levels during radiation therapy. There is no difference in outcomes based on hemoglobin levels; thus, there is no reason to transfuse or provide erythropoiesis-stimulating agents for hemoglobin levels > 10 g/dL during radiation treatment of the breast.

Cancer patients are at increased risk for potentially life-threatening infections. Patient safety goals recently issued by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and current Centers for Disease Control and Prevention (CDC) guidelines recommend vaccinations for all cancer patients over the age of 65 (for Pneumococcus) and 50 years of age (annually, for Influenza). The authors investigated vaccination practices in patients over a season of risk at a university-based outpatient cancer treatment clinic. Of 204 patients recruited, 196 (93%) completed the survey. Overall, 30% of patients reported never receiving the Influenza vaccine (33% of patients >50 years old), and 56% reported never receiving the Pneumococcal vaccine (30% of patients >65 years old). Only 7% of patients reported being asked or informed about vaccination by their oncologists. Substantial proportions of patients undergoing cancer treatment have not received vaccinations as recommended by national guidelines. The reasons cited for lack of compliance seem correctable, and doing so would potentially prevent mortality and morbidity, thereby improving the care of cancer patients. Recommended vaccinations may now include that for the Influenza A virus (H1N1).

Management of ductal carcinoma in situ (DCIS) of the breast is controversial, as not all patients progress to invasive carcinoma. This report analyzes the outcomes after breast conservation treatment (BCT) with radiation in patients with DCIS following prior malignancy at another anatomic site. The study cohort was comprised of 14 women with DCIS who were treated between 1978 and 2003. The median age at diagnosis of DCIS was 54 years (mean 56; range 37-78) and for the prior nonbreast malignancy was 44 years (mean 47; range 27-76). All patients underwent breast conservation surgery followed by whole breast radiation and tumor bed boost. The median and mean follow-up times after treatment of DCIS were 8.0 and 9.1 years, respectively (range 2-18). The median and mean interval period between the prior malignancy and DCIS was 6.0 and 8.2 years, respectively (range 1-30). There was one (7%) local failure, two (14%) contralateral breast cancers, and one (7%) death from breast cancer that occurred 7 years after BCT following contralateral invasive breast cancer. In this cohort of 14 patients treated for DCIS of the breast after a prior nonbreast malignancy, treatment for DCIS resulted in a high rate of local control and should be considered for curative intent.

Background: Primary androgen deprivation therapy (PADT) is frequently used as a sole modality of treatment in men with localized prostate cancer, despite a lack of clinical trial data supporting its use., Objective: To measure the impact of treatment with PADT compared to observation on overall survival in men with organ-confined prostate cancer., Design, Setting, and Participants: The design was for an observational cohort from Surveillance, Epidemiology, and End Results (SEER) Medicare data. The cohort consisted of 16,535 men aged 65-80 yr at diagnosis with organ-confined well-differentiated or moderately differentiated prostate cancer who survived >1 yr past diagnosis and did not undergo treatment with prostatectomy or radiation therapy within 6 mo of diagnosis. They were diagnosed between 1991 and 1999 and followed until death or until the end of the study period (December 31, 2002)., Intervention: Study subjects were selected to receive PADT alone if they received luteinizing hormone-releasing hormone agonists or bilateral orchiectomy in the first 6 mo after diagnosis, and they were selected to be observed if they did not have claims for PADT during the same interval., Measurements: Overall survival., Results and Limitations: After adjusting for potential confounders (ie, tumor characteristics, comorbidities, and demographics), patients who received ADT had a worse overall survival rate than patients who were observed (hazard ratio: 1.20; 95% confidence interval: 1.13-1.27). In observational studies there may be unmeasured differences between the treated and untreated groups. The SEER database does not provide information on prostate-specific antigen levels., Conclusions: This large, population-based study suggests that PADT did not improve survival in men with localized prostate cancer, but it suggests that PADT may instead result in worse outcomes compared with observation. Patients and physicians should be cognizant of the potential long-term side effects of ADT in a patient population for which expectant observation is an acceptable treatment strategy.

Background: Triple-negative breast carcinoma is defined by a primary tumor that is estrogen receptor negative, progesterone receptor negative, and HER2 negative. The current study was performed to determine the relationship of triple-negative tumor status to outcome after breast conservation treatment with radiation., Patients and Methods: A total of 519 women with early-stage invasive breast carcinoma underwent breast conservation treatment with radiation. Of the 519 primary breast carcinomas, 90 (17%) were triple negative and 429 (83%) were not triple negative. The median follow-up after treatment was 3.9 years., Results: Compared with the patients without a triple-negative tumor, the patients with a triple-negative tumor had a higher 8-year rate of any local failure (8% vs. 4%, respectively; P = .041) and a lower 8-year rate of freedom from distant metastases (81% vs. 92%, respectively; P = .0066). There were no differences between the 2 groups for local-only first failure, overall survival, or contralateral breast cancer (all P >or= .3). On multivariate analysis, triple-negative tumors had an increased risk for any local failure (hazard ratio, 2.58), although this difference was not statistically significant (P = .097)., Conclusion: After breast conservation treatment with radiation, women with a triple-negative tumor had a higher rate of local failure compared with women without a triple-negative tumor. However, the absolute difference in local failure between the 2 groups was relatively small and therefore does not preclude breast conservation treatment with radiation for triple-negative early-stage invasive breast carcinoma.

PET imaging has become an integral component of the diagnosis and management of a substantial number of lymphatic and solid malignancies. One of the greatest dilemmas in prostate cancer remains the need for greater personalization of treatment recommendations based on the true extent of disease, so that patients with extraprostatic, micrometastatic disease can be identified early and managed accordingly. These sites currently remain under the level of detection with standard imaging and continue to confound clinicians. Novel PET tracers to complement anatomic data from CT and MR imaging can truly make a difference, and ongoing research holds the greatest promise.

Purpose: To report the long-term outcomes for women presenting with regional lymph node recurrence after breast conservation treatment with radiotherapy for Stage I and II invasive breast carcinoma., Methods and Materials: Of the women with pathologic Stage I and II invasive breast carcinoma treated with breast conservation treatment at the University of Pennsylvania, 29 developed regional nodal recurrence as their first site of failure. An analysis of the patterns of regional nodal recurrence and their prognosis after recurrence was undertaken. The median follow-up from regional nodal recurrence was 5.4 years., Results: The pattern of regional nodal recurrence was as follows: 14 (48%) with simultaneous local and axillary recurrence, 7 (24%) with recurrence in the axilla only, 5 (17%) with recurrence in the supraclavicular region only, and 3 (10%) with multiple nodal sites of recurrence. For the entire study group, the 5-, 10-, and 15-year overall survival rate was 70%, 37%, and 28%, respectively. The 10-year overall survival rate for patients with locoregional recurrence was 32% compared with 45% for patients with regional-only recurrence (p = 0.50). The 10-year overall survival rate for patients with axillary recurrence discovered on pathologic examination of the mastectomy specimen was 31% compared with 42% for patients with palpable regional lymphadenopathy (p = 0.83)., Conclusion: Patients with regional nodal recurrence after breast conservation treatment with radiotherapy for early-stage breast carcinoma are potentially salvageable. The prognosis after regional nodal recurrence was not significantly different when stratified by the presence or absence of simultaneous in-breast recurrence or the method of detection.

Purpose: Little information has been reported regarding outcomes after treatment for patients with early-stage invasive breast cancer and a prior nonbreast malignancy. This report analyzes the outcomes in patients with Stage I and II breast cancer after breast conservation treatment (BCT) with a prior nonbreast malignancy., Methods and Materials: The study cohort comprised 66 women with invasive breast cancer and a prior nonbreast malignancy. All patients were treated with breast conservation surgery followed by definitive breast irradiation between 1978 and 2003. Median ages at diagnosis of invasive breast cancer and prior malignancy were 57 and 50 years, respectively. The median interval between the prior malignancy and breast cancer was 7.0 years. Median and mean follow-up times after BCT were 5.3 and 7.0 years., Results: The 5-year and 10-year overall survival rates were 94% (95% confidence interval [CI], 82-98%) and 78% (95% CI, 59-89%), respectively. There were 4 patients (6%) with local failure and 10 patients (15%) with distant metastases. The 10-year rate of local failure rate was 5% (95% CI, 2-16%) and freedom from distant metastases was 78% (95% CI, 61-88%). No obvious differences in survival or local control were noted compared with the reported results in the literature for patients with invasive breast cancer alone., Conclusions: Both overall survival and local control at 5 and 10 years were comparable to rates observed in early-stage breast cancer patients without a prior malignancy. Prior nonbreast malignancy is not a contraindication to BCT, if the primary cancer is effectively controlled.

Purpose: Pain is a common symptom among cancer patients, yet many patients do not receive adequate pain management. Few data exist quantifying analgesic use by radiation oncology patients. This study evaluated the causes of pain in cancer patients and investigated the reasons patients fail to receive optimal analgesic therapy., Methods and Materials: An institutional review board-approved, Internet-based questionnaire assessing analgesic use and pain control was posted on the OncoLink (available at www.oncolink.org) Website. Between November 2005 and April 2006, 243 patients responded. They were predominantly women (73%), white (71%), and educated beyond high school (67%) and had breast (38%), lung (6%), or ovarian (6%) cancer. This analysis evaluated the 106 patients (44%) who underwent radiotherapy., Results: Of the 106 patients, 58% reported pain from their cancer treatment, and 46% reported pain directly from their cancer. The pain was chronic in 51% and intermittent in 33%. Most (80%) did not use medication to manage their pain. Analgesic use was significantly less in patients with greater education levels (11% vs. 36%, p = 0.002), with a trend toward lower use by whites (16% vs. 32%, p = 0.082) and women (17% vs. 29%, p = 0.178). The reasons for not taking analgesics included healthcare provider not recommending medication (87%), fear of addiction or dependence (79%), and inability to pay (79%). Participants experiencing pain, but not taking analgesics, pursued alternative therapies for relief., Conclusions: Many radiation oncology patients experience pain from their disease and cancer treatment. Most study participants did not use analgesics because of concerns of addiction, cost, or failure of the radiation oncologist to recommend medication. Healthcare providers should have open discussions with their patients regarding pain symptoms and treatment.

Purpose: Activation of the phosphatidylinositol 3-kinase/Akt pathway in tumors leads to radiation resistance, and inhibition of this pathway radiosensitizes tumors in laboratory models. Several first-generation human immunodeficiency virus (HIV) protease inhibitors (HPIs) inhibit Akt activation and are radiosensitizers. In order to validate a biomarker of Akt activity in anticipation of clinical trials using HPIs combined with radiotherapy, we sought to determine whether Akt activation was inhibited in leukocytes of HIV+ patients that were already taking these agents., Results: Patients taking these "active" radiosensitizing protease inhibitors had low levels of phospho-Akt compared to HIV+ patients taking either no medications or other anti-retroviral regimens. We found no significant differences in acute toxicities or in the ability to finish radiation treatment between 14 patients taking radiosensitizing HPIs and the 28 controls., Methods and Materials: Peripheral blood mononuclear cells from HIV+ patients either taking radiosensitizing HPIs (nelfinavir, saquinavir, amprenavir) or not were analyzed by Western blotting for phospho-Akt. In order to determine whether these radiosensitizing HPIs increase the toxicity of radiotherapy, we performed a retrospective cohort study of HIV+ cancer patients treated with radiation and compared patients on radiosensitizing HPIs to controls not taking these agents., Conclusions: These results demonstrate the proof of principle that HPIs can inhibit Akt activation in patients taking normally prescribed anti-retroviral doses and are not associated with excessive toxicity. Radiosensitizing HPIs are excellent candidates for Phase I clinical trials as radiation sensitizers, and peripheral blood mononuclear cells can be used as a drug activity biomarker for Akt pathway inhibition.

Purpose: To determine the patterns and factors predictive of positive ipsilateral breast biopsy after conservation therapy for early-stage breast cancer., Methods and Materials: We performed a retrospective review of Stage I-II breast cancer patients initially treated with lumpectomy and radiotherapy between 1977 and 1996, who later underwent post-treatment ipsilateral breast biopsies., Results: A total of 223 biopsies were performed in 193 treated breasts: 171 single and 22 multiple biopsies. Of the 223 biopsies, 56% were positive and 44% were negative for recurrence. The positive biopsy rate (PBR) was 59% for the first and 32% for subsequent biopsies. The median time to the first post-treatment biopsy was 49 months. Of the patients with negative initial biopsy findings, 11% later developed local recurrence. The PBR was 40% among patients with physical examination findings only, 65% with mammographic abnormalities only, and 79% with both findings (p = 0.001). Analysis of the procedure type revealed a PBR of 86% for core and 58% for excisional biopsies compared with 28% for aspiration cytology alone (p = 0.025). The PBR varied inversely with age at the original diagnosis: 49% if >or=51 years, 57% if 36-50 years, and 83% if 180 months after completing postlumpectomy radiotherapy (p = 0.01). The PBR was not linked with recurrence location, initial pathologic T or N stage, estrogen receptor/progesterone receptor status, or final pathologic margins (all p >or= 0.15)., Conclusion: After definitive radiotherapy for early-stage breast cancer, a greater PBR was associated with the presence of both mammographic and clinical abnormalities, excisional or core biopsies, younger age at the initial diagnosis, and longer intervals after radiotherapy completion.

Purpose: Complementary and alternative medicine use is prevalent in both healthy and oncologic populations. However, few data exist to quantify complementary and alternative medicine initiation specifically after cancer diagnosis. This study evaluated patients' complementary and alternative medicine usage patterns, reasons, and general perceptions after cancer diagnosis and during or after conventional cancer therapy., Methods: An Internet- and clinic-based piloted questionnaire was distributed from July 2004 through September 2004. In total, 604 responses were analyzed (64% Internet, 36% oncology clinics). Patients were predominantly white females; almost half held college or graduate degrees. Respondents reported past or present history of >or=1 conventional treatment(s), primarily chemotherapy and radiotherapy., Results: Initiation of >or=1 complementary and alternative medicine after diagnosis was reported by 54% of those surveyed. Complementary and alternative medicine users were more likely than non-users to have a history of chemotherapy (P=0.003) and enrollment in clinical trials (P=0.007). Complementary and alternative medicine use was greater in females (P=0.004) and patients with higher education levels (P<0.001), but not in whites compared to non-whites (P=0.34). The most commonly cited reason for complementary and alternative medicine use after diagnosis was "general overall health." Less than one-third of patients cited their healthcare providers as primary sources of complementary and alternative medicine information. The vast majority of users (86%) expressed satisfaction with complementary and alternative medicine as a cost-effective approach., Discussion: About one-half of adult cancer patients initiate complementary and alternative medicine therapy after diagnosis and during or after conventional oncologic treatments. Healthcare providers should be aware of patients' reasons for complementary and alternative medicine use, both for symptom management and quality-of-life. Healthcare providers should also be familiar with patients' complementary and alternative medicine information sources and should supplement these sources with discussions of pertinent safety profiles and potential interactions with standard therapies.

Background: The importance of negative final resection margins for optimal local control has been established for women with ductal carcinoma in situ (intraductal carcinoma) undergoing breast conservation treatment. This study evaluated long-term outcome after breast conservation treatment and whether reexcision or the presence of residual tumor in the reexcision specimen predicted for local recurrence in patients with ductal carcinoma in situ with negative margins., Methods: The study cohort consisted of 192 women with ductal carcinoma in situ treated with breast conservation treatment at the University of Pennsylvania from 1978 to 2000. Analysis was performed for unilateral, mammographically detected, intraductal breast carcinomas. Study endpoints of interest included rates of local recurrence, overall survival, and cause-specific survival. The median follow-up was 6.2 years (mean, 7 years; range, 0.1-21.4 years)., Results: The 10-year overall survival and 10-year cause-specific survival rates were 87% and 99%, respectively. There were 11 local failures (6%) in the treated breast, with a 10-year actuarial local failure rate of 10% and a median time to local failure of 7.4 years (mean, 6.6 years; range, 1.6-10.2 years). Among the subset of 124 patients with negative final resection margins, there was no statistically significant difference in the 8-year actuarial local recurrence rates among patients who underwent single excision (7%), reexcision with residual tumor (8%), or reexcision with no residual tumor (0%)., Discussion: The use of breast conservation treatment in patients with ductal carcinoma in situ remains an effective and durable treatment approach. The need for reexcision to achieve negative margins and the presence of residual ductal carcinoma in situ in the reexcision specimen do not negatively impact local recurrence rates in the current study. These findings suggest that requiring more than one surgery to obtain clear resection margins is not an adverse prognostic factor for local failure.

Background: To determine the effect of treatment time-related factors on outcome in patients treated with surgery and postoperative radiation therapy (RT) for locally advanced squamous cell carcinoma of head and neck (SCCHN) METHODS: A retrospective review was performed on 208 consecutive patients treated from 1992 to 1997 with surgery and postoperative RT (> or =55 Gy) for SCCHN. The treatment time factors considered were (1) interval from surgery to the start of RT; (2) RT duration; and (3) the total time from surgery to completion of RT (treatment package time). Treatment package time was dichotomized into short (< or =100 days) vs long (>100 days) categories. Other variables considered were clinical and pathologic staging, margin status, RT dose, and tumor site. Patients were also divided into intermediate- and high-risk groups on the basis of eligibility for RTOG 95-01. Univariate (logrank) and multivariate analyses were performed., Results: Median follow-up for surviving patients was 24 months. Actuarial 2-year locoregional control (LRC) and survival rates were 82% and 71%, respectively. In univariate analysis, factors associated with higher locoregional failure were high-risk group (p =.011), margin status (p =.038), pathologic stage (p =.035), clinical N stage (p =.006), package time (p =.013), and RT treatment time (p =.03). Package time was also a significant predictor of survival in univariate analysis (p =.021). The other two individual time factors, tumor factors, and RT dose were not significant. Both risk status and treatment package time were significant factors in a multivariate model of LRC., Conclusions: A total treatment package time of <100 days is associated with improved tumor control and survival. Every effort should be made to keep the time from surgery to the completion of postoperative RT to <100 days., (Copyright 2002 John Wiley & Sons, Inc.)

Background: The prognosis of children with high-grade astrocytomas of the central nervous system is grim and has not been substantially improved by conventional chemoradiotherapy. We performed a multi-institutional phase I study to determine the toxicities and tolerance of concurrent external beam radiation of the brain and a unique dose-schedule of paclitaxel as a radiation sensitizer., Procedure: Paclitaxel was delivered intravenously as a continuous 24 h/day, 7 days/week infusion during the entire 6-week course of fixed schedule standard radiation therapy. The dose of paclitaxel was escalated in patient cohorts in standard phase I design., Results: Eleven patients (eight brain stem gliomas, one glioblastoma multiforme, and two gliomatosis cerebri) were treated. Dose-limiting toxicity was encountered in the two patients treated at 6 mg/(m(2)/24 h), both of whom developed severe obstipation requiring prolonged hospitalization., Conclusions: We have shown in this first study of its kind that paclitaxel can be administered safely to children as a 6-week continuous infusion concurrent with cranial irradiation. The maximally tolerated and recommended phase II dose is 4 mg/(m(2)/day). The benefits of taxanes as clinical radiation sensitizers for children with high-grade gliomas, if any, remain to be determined., (Copyright 2001 Wiley-Liss, Inc.)