bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase III trial of low-level laser therapy to prevent induced oral mucositis in head and neck cancer patients submitted to concurrent chemoradiation.
Authors: Antunes H. S. , Herchenhorn D. , Araujo C. M. , Cabral E. , Ferreira E. M. d. S. , Small I. A. , Rampini M. P. , Teich N. , Rodrigues P. C. , Silva T. G. P. d. , Dias L. F. , Ferreira C. G. M. 
Published: February 2017

LBA5524 Background: Oral mucositis (OM) remains a limiting factor in in head and neck squamous cell carcinomas (HNSCC) patients (pts) treated with chemoradiation (CRT) leading to pain, dysphagia, and weight loss. Low-level laser therapy (LLLT) emerges as a promising, preventive therapy of CRT-induced OM. Yet, a definitive randomized trial supporting its use is lacking. This study was designed to assess the efficacy of LLLT in reducing the incidence and/or severity of OM. Methods: Assuming OM grade (G3) for placebo 0.4 (P0); LLLT 0.15 (P1) ; β=0.2; α=0.05, sample size was 94 pts. From Jun 2007 to Dec 2010, 47 LLLT and 47 placebo pts bearer of HNSCC of nasopharynx, oropharynx and hipopharynx entered a prospective, randomized, double blind, placebo-controlled, phase III trial. CRT consisted of conventional RT 70.2 Gy (1.8Gy/d, 5 times/wk) + concurrent cisplatin 100 mg/m2 every 3 wks. Main endpoints were OM incidence and severity, RT interruptions due to OM and pain intensity. The LLLT used daily was a diode InGaAlP (660nm-100mW-4J/cm²). OM evaluation was done by WHO and OMAS scale. Results: Mean age was 54.6 and 87.2% of pts were male. Primary site: oropharynx (74 pts), nasopharynx (9 pts), hypopharynx (11 pts). In the LLLT arm the incidence of OM G 3/4 was only 6.4% versus 48% in the placebo arm; HR of 0.13 (IC 95%, p<0.001). Besides in the LLLT arm 51% of pts did not have ulcers versus 17% in placebo arm (p<0.001). LLLT pts had less severe pain (p=0.012), used less narcotic analgesic, HR 0.33 (IC 95%, p<0.001) and required less gastrostomia, HR 0.037 (IC 95%, p= 0.005). No LLLT pts had RT interrupted due to OM. EORTC QLQ-C30 and its specific head and neck module QLQ-H&N35 were applied. Results clearly favored the LLLT arm. In QLQ-C30 benefit was seen in both physical and emotional functioning (p=0.037), fatigue (p=0.011), pain (p=0.043); and in QLQ-H&N35, pain (p=0.007), swallowing (p=0.001) and trouble with social eating (p=0.026). Conclusions: Our results indicate that upfront LLLT in HNSCC pts submitted to CRT is an effective tool in reducing G 3/4 OM, oral pain, use of narcotic and gastrostomia. QoL data supports the efficacy findings. Thereby LLLT should be the new standard of care in this setting.
Efficacy, tolerability, and biomarker analyses from a phase III, randomized, placebo-controlled, parallel group study of gefitinib as maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC; INFORM; C-TONG 0804).
Authors: Zhang L. , Shenglin M. , Song X. , Han B. , Cheng Y. , Huang C. , Yang S. , Liu X. , Yun-Peng L. , Wang M. , Zhang X. 
Published: February 2017

LBA7511 Background: INFORM (a phase III, randomized, multicenter, parallel group study; NCT00770588 ) investigated the efficacy, safety and tolerability of gefitinib (G) vs. placebo (P) as maintenance therapy in pts with locally advanced/metastatic NSCLC following standard first-line platinum based chemotherapy. Methods: Pts (≥18 years, with stage IIIB/IV NSCLC and WHO performance status 0-2) had completed 4 cycles of first-line platinum based doublet chemotherapy without progression/unacceptable toxicity. Pts were randomized 1:1 to G 250mg/day or P on discontinuation of first-line therapy. Progression-free survival (PFS; primary endpoint) was assessed in the intent to treat population (Cox proportional hazards adjusted for histology [adenocarcinoma vs. non-adenocarcinoma], smoking status [never-smoker vs. smoker], EGFR mutation status [positive vs. negative vs. unknown] and best response to first-line chemotherapy [complete response/partial response vs. stable disease]). PFS was considered superior with gefitinib if the G:P hazard ratio (HR) upper confidence interval (CI) was <1.00. Secondary endpoints included overall survival (OS), objective response rate, disease control rate, symptom improvement and tolerability. Results: 296 pts (n=148 G, n=148 P) were randomized (27 centers in china; 26 September 2008-10 August 2009). PFS data cutoff on 24 January 2011. Median duration of follow-up was 16.8 months: 91% pts progressed; 59% deaths. Demography was balanced between treatments; overall, 54.1% pts were never-smokers, 70.6% had adenocarcinoma, and 40.9% were female. For G vs. P, PFS HR=0.42; 95% CI 0.32-0.54; p<0.0001; median PFS 4.8 vs. 2.6 months. Most common AEs (any grade) with G were rash (49.7%), diarrhea (25.2%), and ALT increase (21.1%) which were generally mild/moderate. Overall incidence of serious AEs: G (6.8%); P (3.4%). Other secondary endpoint data (including OS and biomarkers) will be presented. Conclusions: PFS was significantly longer with G compared with P as maintenance therapy in Chinese patients with locally advanced NSCLC.
Multilumen breast brachytherapy in patients with 5 mm or less balloon surface-skin distance using the Contura brachytherapy catheter.
Authors: Reed D. R. 
Published: February 2017

108 Background: To evaluate the toxicity of multilumen breast brachytherapy in patients with 5 mm or less balloon surface-skin distance (BSD) treated with the Contura catheter. Methods: From September 2008 through February 2010 a total of 411 patients with early-stage breast cancer (stages 0, I, IIA) were treated with multilumen HDR brachytherapy for definitive APBI using the Contura brachytherapy catheter. Of those patients 92 had a balloon surface-skin distance (BSD) of 5 mm or less, with 6 months clinical follow-up. All patients received 34 Gy in 10 fractions bid over 5 days. The PTV_EVAL (cc) defined as a 1 cm expansion from the anterior surface of the device; BSD (mm) defined as the distance from the closest point on the balloon to the closet point on the skin surface; maximum skin dose (% and cGy); the volume of breast tissue (cc) receiving 150% and 200% of the prescription dose (V150, V200). Patient toxicity was evaluated at 1 week, 1 month, and 6 months following brachytherapy including; skin reaction (RTOG Acute Radiation Morbidity Scoring Criteria), pigmentation, telangiectasia, pain, fat necrosis, symptomatic seroma. Results: The mean BSD was 3.7 mm, with a range of 1-5 mm. The mean maximum skin dose was 4508 cGy (132.5%). The mean V150 was 21 cc and the V200 was 4.7 cc. The mean PTV_EVAL V90 was 93.7%. 49% of patients had skin reaction, including at 1 week; 47% Grade 1, 0% Grade 2 or 3. At 1 month; 31% Grade 1, 14% Grade 2 and 0% Grade 3. At 6 months; 2% Grade 1, 2% Grade 2 and 0% Grade 3. 6.5 % developed pigmentation changes (hypo or hyper). 5.4% developed telangiectasias, 9.7% reported pain. No patients had fat necrosis, and 15.2 % had a symptomatic seroma. 1 patient had wound dehiscence (maxium skin dose 4195 cGy, 123.4% of prescribed dose). Patients that experienced toxicity had no difference in BSD (3.6 vs 3.9 mm) or in the maximum skin dose (132.6% vs. 132.6%) compared to those that did not experience toxicity. Conclusions: Breast brachytherapy in patients with 5 mm or less BSD has acceptable toxicity with proper planning using the Contura multilumen catheter. Careful attention to maximum skin dose must be used, and we recommend not exceeding 145 % (4,930 cGy) of the prescribed dose.
Efficacy analysis of high-risk breast cancer patients treated with accelerated partial breast irradiation from a single institution.
Authors: Chen P. Y. , Vicini F. A. , Mitchell C. , Wallace M. , Benitez P. , Dekhne N. , Shah C. , Wilkinson J. B. , Martinez A. 
Published: February 2017

111 Background: We present the results of an analysis of high-risk breast cancer patients as defined by the NSABP B-39/RTOG 0413 phase III trial, all treated with accelerated partial breast irradiation (APBI) from a single institution. Methods: Between July 1993 and August 2010, 130 patients with any combination of at least one of the high-risk features of estrogen receptor (ER) negativity, age < 50, and/or axillary nodal positivity were treated with 1 of 3 forms of APBI. Sixty-seven patients were treated with interstitial needle-catheter brachytherapy, 44 balloon-based brachytherapy and 19 with 3D conformal external beam radiation therapy. Aside from the high-risk features, general eligibility criteria included infiltrating ductal carcinoma, with inclusion of invasive lobular and DCIS since 2003, margins > 2 mm, and surgically staged axilla. One-hundred eighteen patients had one high-risk factor, 11 had two, and 1 had all three factors. The median tumor size was 12.0 mm with margins > 2 mm in 80% of patients. Greater than 75% had T1 tumors and 50% were ER negative. Thirty-one percent of patients were node positive. Based upon the ASTRO Consensus Guidelines for use of APBI (2009) none of these patients were suitable, 38% cautionary and 62% were unsuitable. Results: Median age was 56.5 yrs (range 40-90). With a median follow-up of 5.3 yrs (0.02-16.9) the 5-yr actuarial local recurrence rate (LR) was 4.2%; regional recurrence (RR) was 2.1%. Median time to LR and RR were 1.2 and 2.8 yrs, respectively. On univariate analysis, the only factor significant for LR was a close/positive margin (p=0.031), as ER/PR, age, nodal status, tumor size, histology, grade, hormonal or chemotherapy were all NS. The 5-yr actuarial cause specific, disease-free, and overall survivals as well as distant metastasis were 94%, 91%, 90%, and 6.4%, respectively. Conclusions: This cohort of NSABP B-39/RTOG 0413 identified high-risk patients who have undergone APBI has yielded local-regional control rates and survival outcomes comparable to standard risk patients undergoing partial breast irradiation. Continued follow-up will be needed to assess the long-term efficacy of such high-risk breast cancer patients treated with APBI.
An update on the dosimetric analysis of concurrent radiation therapy and trastuzumab on early cardiac events.
Authors: Keene K. S. , Klepczyk L. C. , Meredith R. , Forero-Torres A. , Carpenter J. T. , Krontiras H. , Hyatt M. , Li Y. , De Los Santos J. F. 
Published: February 2017

121 Background: The impact of radiation therapy (RT) with concurrent trastuzumab on early cardiac morbidity is relatively unknown. Trastuzumab’s radiosensitizing properties may augment both early and late effects of RT. This retrospective review update provides an analysis of cardiac event (CE) development in patients treated with concurrent RT and trastuzumab with a focus on RT heart dose. Methods: Sixty-five patients treated with concurrent RT (30 left, 33 right, 2 bilateral) and trastuzumab at the University of Alabama at Birmingham were identified. Patient data for pre-existing heart disease, cardiac risk factors, drug regimen, and CEs were recorded. Dosimetric parameters of maximum heart dose, mean heart dose, heart volume receiving 5, 10, 15, 20 and 30Gy (V5, V10, V15, V20, V30) were also analyzed. Endpoints include the occurrence of CEs at any time in relation to RT and those specifically after the start of RT. Results: In addition to receiving trastuzumab, 80% of patients received doxorubicin. 15.4% had preexisting heart disease. The mean heart dose for all patients was 248cGy. With a median follow-up of 24.5 months, six patients developed CEs (9.2%), and three of these cases occurred after RT initiation (4, 4, and 0.5 months post-RT). All six CEs occurred during treatment with trastuzumab and consisted of congestive heart failure. Analysis of the heart dose maximum, mean, V5, V10, V15, and V20, V30 were similar in patients with and without CEs, and small differences between groups did not reach statistical significance. CE incidence was significantly associated with smoking (p=0.0037) but not hypertension, diabetes or pre-existing heart disease. Conclusions: This updated retrospective dosimetric analysis did not find a correlation between concurrent trastuzumab and RT on the development of early cardiac events. Modern era RT with 3D conformal planning, the use of heart blocks, and breath hold techniques will continue to decrease the dose to the heart. Longer follow-up will be needed for analysis of the impact of modern technologic advances and late cardiac morbidity.
Predictive factors for oligometastatic versus non-oligometastatic involvement of the central nervous system by brain metastases from breast cancer.
Authors: Garg S. , Marsh J. C. , Rao R. D. , Griem K. L. 
Published: February 2017

123 Background: To assess rates of oligometastatic (1-3 metastases) versus non-oligometastatic (4 or more) involvement of the central nervous system (CNS) from breast cancer and determine whether rates vary for different breast cancer subtypes. Methods: We reviewed records of 65 patients with brain metastases from breast cancer. Fisher’s Exact Test compared incidence of oligometastatic versus nonoligometastatic CNS involvement and presence of visceral metastatic disease between groups. Paired Student's t test compared mean age and interval from initial diagnosis to development of brain metastases. Results: 25 patients (38.5%) developed oligometastatic and 40 (61.5%) developed non-oligometastatic CNS disease. Subtypes predictive of oligometastatic disease included ER+ (p .04) and PR+ (p .008). Subtypes predictive of non-oligometastatic disease included HER2+ (p .05). HER2+ patients trended toward a lower incidence of visceral metastases compared to ER+ or PR+ patients (p .07). Non-oligometastatic and HER2+ patients developed brain metastases sooner after initial diagnosis (p .046 and .03, respectively). Conclusions: ER+ breast cancer patients are more likely to develop oligometastatic CNS involvement and may be excellent candidates for stereotactic radiosurgery (SRS) alone. HER+ patients are likely to develop non-oligometastatic CNS involvement and may be better treated initially with whole brain radiotherapy (WBRT) even with apparent initial oligometastatic CNS involvement.
Use of intraoperative digital specimen mammography to improve operative efficiency.
Authors: Valero M. , Dominici L. S. , Golshan M. 
Published: February 2017

138 Background: The traditional method of confirming excision of a targeted lesion during wire localized breast biopsy has been with standard specimen mammograms (SSM). More recently, intraoperative digital specimen mammograms (IDSM) have been used to provide immediate specimen evaluation for the surgeon in the operating room. We sought to evaluate operative time with the use of IDSM versus SSM. Methods: A retrospective chart and electronic operating room record review of consecutive patients of a single breast surgical oncologist at a quaternary care academic center. Three hundred and forty-four (344) consecutive patients from 2003 to 2010 who underwent wire localized excisional biopsy or wire localized lumpectomy without lymph node evaluation, with specimen evaluation by IDSM or SSM. Operative time, defined as documented time of incision to documented time of closure, was recorded for SSM versus IDSM. Results: We compared demographics of the two groups transitioning from SSM to IDSM (Table). During the study period, median operative time decreased from 50 minutes in the SSM group to 37 minutes in the IDSM group (p<0.001). Conclusions: Operative times with the use of IDSM are significantly shorter than with SSM. Downstream effects include decreases in anesthetic time, anesthetic use, operating room charges, and increasing surgeon productivity. [Table: see text]
Outpatient mastectomy clinical pathway.
Authors: Boughey J. C. , Jakub J. W. , Degnim A. C. , Osborn J. B. , Brodt J. K. , Vanderlei L. K. , Case J. K. , Dilger J. A. , Duncan C. M. , Hebl J. R. 
Published: February 2017

144 Background: Many patients require hospitalization after mastectomy, predominantly for pain management and treatment of postoperative nausea and vomiting (PONV). In order to improve a woman's perioperative experience after mastectomy and facilitate mastectomy on an outpatient basis, we initiated a clinical pathway for perioperative management of unilateral mastectomy patients at Mayo Clinic Rochester. Methods: The clinical pathway consists of preoperative oral medications (celecoxib and gabapentin), preoperative ultrasound guided paravertebral block using bupivacaine, intraoperative anesthesia management with total intravenous anesthetic, and minimal use of long-acting opioids and postoperative acetaminophen and oxycodone. All patients are evaluated by the surgical team on the afternoon after surgery and if patients are recovering well are discharged on the day of surgery. The following morning, the surgical team telephones the patient to follow up on management of pain, nausea or vomiting, and drain output. Results: Eighteen patients have been treated on this clinical pathway. Mean age of patients was 66 (range 51-81). Majority of patients (n=16, 89%) underwent unilateral mastectomy with sentinel lymph node biopsy, with 1 patient undergoing bilateral mastectomy and 1 patient undergoing mastectomy and axillary dissection. All patients are evaluated by the surgical team on the afternoon of surgery. Fourteen patients (78%) were without evidence of hematoma or PONV, pain was well-controlled on oral medications and they were discharged on the day of surgery. On morning after telephone calls, pain scale ratings ranged from 1 to 3 and no patients verbalized complaints of nausea. Four patients (22%) treated on this clinical pathway required overnight observation in the hospital, one for urinary retention, two for pain control, and one for high sanguineous drain output. Conclusions: The clinical pathway presented provides preemptive analgesia and regional anesthesia for patients undergoing mastectomy, enabling the majority of patients to be discharged on the day of surgery. The clinical pathway is a safe and effective way to improve the perioperative experience of breast surgery patients and decrease hospital admission.
Surgical resection of the primary tumor in patients with distant metastatic breast cancer at diagnosis: Results of a retrospective series.
Authors: Arifi S. , Hijri f. Z. , Benbrahim Z. , Bendahou K. , Akasbi Y. , Nejjari C. , El Mesbahi O. 
Published: February 2017

145 Background: Among women with de novo stage IV breast cancer, the primary tumor is treated only when it causes symptoms. Recent data suggest that resection of in-breast tumors may avoid uncontrolled chest wall disease and may improve long-term survival. The authors evaluated the effect of surgery on chest wall status, and time to first progression (TTP) in such patients. Methods: We reviewed the records of all stage IV breast cancer patients, treated at our institution between 2007 and 2010, who underwent a surgery for their primary tumor. Information collected included demographics, tumor characteristics, treatments, disease progression. Prognostic factors affecting loco regional relapse and TTP were assessed. Results: Of 36 patients identified, 14 (38.9%) had postoperative diagnosis of distant metastases, and 22 (68.75%) were presented with intact primary tumor. The mean patient age was 50.22 (range 22–75) years. 52.8 were pre-menopausal women. 88.9% of tumors were hormone receptors (HR) positive while 11.1% were HR negative. HER2 was assessed in 18 cases and was positive in 16.7%. 77.7% women presented with locally advanced breast cancer, 61% were T4 with 25% T4d, and 16.7% were T3. Node status was N0 (16.6%), N1 (38.8%), N2 (16.6%), and N3 (13.8%). 86.1% patients had bone metastasis, 39% liver, 25.1% lung metastasis and 2.8% brain metastasis. All patients underwent mastectomy. Excision margins were positive in 2 cases. 55.6% had axillary lymph node dissection. All women received systemic therapy. Preoperative systemic therapy was given in 68.75%. First-line therapy consisted of anthracycline-based regimen (n=36) and/or taxane (n=9) and/or endocrine therapy (n= 30). None of the HER2-positive patients received trastuzumab. pCR occurred in 5 patients. Loco regional radiotherapy (RT) was given to 4 women (11.1%). Local recurrence (LR) occurred in 6 patients (16.7%). Median time to first progression was 17 months. LR was related to axillary lymph node dissection (p=0.027). Conclusions: Most of our patients had locally advanced breast cancer and the mastectomy improved local symptoms in this group of patients, with acceptable rate of LR and TTP.
Needs and preferences of breast cancer survivors: A cross-sectional survey.
Authors: Stan D. L. , Pruthi S. , Jenkins S. , Lackore K. , Thompson C. A. 
Published: February 2017

147 Background: The Institute of Medicine recommends development of cancer survivorship care models that are patient centered. We designed a cross-sectional survey to determine the medical and psychosocial needs and preferences of breast cancer survivors. Methods: We identified a random sample, stratified by age and chemotherapy usage, of 600 women from MN, WI, and IA, ages 18-99, within 1-5 years of diagnosis of stage 0-3 breast cancer and seen at our institution. Results: We received 329 surveys (response rate 55%). Respondents were a mean age of 58 years (range 26-89) and a mean of 3.3 years from cancer diagnosis (range 1.2-5.4). 96% were white and stage distribution was: 15% stage 0, 35% stage 1, 32% stage 2, 15% stage 3, and 3% missing. Treatment included mastectomy (60%), lumpectomy (40%), radiation (61%), chemotherapy (55%) and hormonal therapy (50%). Most common treatment-related sequelae were neuropathy (38%), chest wall or arm pain (27%), and lymphedema (26%). Over half (52%) report worry and 45% report fatigue as a problem in the past week. 74% stated that their medical needs were met, whereas 49% said their psychological and spiritual needs were met (p<0.01). 68% understood the follow-up plan after treatment was complete. Perceived barriers to follow up care were anxiety (30%) and lack of coordination (10%). When queried about post-treatment care, the following aspects were considered important (% of patients ranking ≥7 on scale 0-10: 0=not important, 10=very important): breast/chest wall exam (88%); screening for osteoporosis (71%), colorectal cancer (69%), and heart disease (65%); educational materials (64%); mammography (63%); physical therapy (61%); diet and exercise counseling (60%); and complementary/alternative medicine information (53%). Less important were psychology (44%), gynecology (43%), chaplain services (35%), support groups (32%), social work (20%), and infertility experts (4%). 60% expressed interest in attending a survivorship clinic. Conclusions: This survey provides unique data on breast cancer survivors, and efforts should be made to optimize medical and psychosocial care in line with their needs and preferences. These results will be imperative in designing a wellness and survivorship clinic.