Psychometric validation of the Spanish version of the Expanded Prostate Cancer Index Composite-26.

PURPOSE: To assess the validity, reliability, and responsiveness of the Spanish version of the Expanded Prostate cancer Index Composite (EPIC) with 26 items. METHODS: Multicentric longitudinal study of patients diagnosed with localized or locally advanced prostate cancer (any T, any N, M0) treated with active surveillance, surgery, external radiotherapy, or brachytherapy. The EPIC-50 was administered initially to the cohort (n = 324 patients), until it was replaced in November 2019 by the EPIC-26 (n = 543), in both groups before treatment and 12 months after. We assessed confirmatory factor analysis (CFA), reliability with Cronbach's alpha coefficient, criterion validity with the intraclass correlation coefficient (ICC), and responsiveness by testing a priori hypotheses on deterioration effect size (ES). RESULTS: The CFA confirmed the five-domain structure of the EPIC-26 proposed by the original instrument (comparative fit index = 0.95). The agreement between EPIC-50 (gold standard) and EPIC-26 domains was excellent (ICC > 0.90). Cronbach's alpha was > 0.7 in almost all domains, and the floor effect was near zero, although ceiling effect was higher than 50% in urinary incontinence and bowel domains. Hypothesized changes between before and 12 months after treatment were confirmed: ES > 0.8 in both urinary incontinence and sexual domains among patients who underwent surgery; and ES ranging 0.44-0.48 for bowel and sexual domains in patients treated with external radiotherapy. CONCLUSION: The Spanish version of the EPIC-26 has demonstrated adequate metric properties, similar to those of the original version, with acceptable goodness-of-fit indices, good criterion validity, reliability, and responsiveness to detect changes after radical prostatectomy or external radiotherapy.

Randomized Phase III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small-Cell Lung Cancer (PREMER): A GICOR-GOECP-SEOR Study.

PURPOSE: Radiation dose received by the neural stem cells of the hippocampus during whole-brain radiotherapy has been associated with neurocognitive decline. The key concern using hippocampal avoidance-prophylactic cranial irradiation (HA-PCI) in patients with small-cell lung cancer (SCLC) is the incidence of brain metastasis within the hippocampal avoidance zone. METHODS: This phase III trial enrolled 150 patients with SCLC (71.3% with limited disease) to standard prophylactic cranial irradiation (PCI; 25 Gy in 10 fractions) or HA-PCI. The primary objective was the delayed free recall (DFR) on the Free and Cued Selective Reminding Test (FCSRT) at 3 months; a decrease of 3 points or greater from baseline was considered a decline. Secondary end points included other FCSRT scores, quality of life (QoL), evaluation of the incidence and location of brain metastases, and overall survival (OS). Data were recorded at baseline, and 3, 6, 12, and 24 months after PCI. RESULTS: Participants' baseline characteristics were well balanced between the two groups. The median follow-up time for living patients was 40.4 months. Decline on DFR from baseline to 3 months was lower in the HA-PCI arm (5.8%) compared with the PCI arm (23.5%; odds ratio, 5; 95% CI, 1.57 to 15.86; P = .003). Analysis of all FCSRT scores showed a decline on the total recall (TR; 8.7% v 20.6%) at 3 months; DFR (11.1% v 33.3%), TR (20.3% v 38.9%), and total free recall (14.8% v 31.5%) at 6 months, and TR (14.2% v 47.6%) at 24 months. The incidence of brain metastases, OS, and QoL were not significantly different. CONCLUSION: Sparing the hippocampus during PCI better preserves cognitive function in patients with SCLC. No differences were observed with regard to brain failure, OS, and QoL compared with standard PCI.

Treatment Design and Rationale for a Randomized Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for SCLC: PREMER Trial on Behalf of the Oncologic Group for the Study of Lung Cancer/Spanish Radiation Oncology Group-Radiation Oncology Clinical Research Group.

BACKGROUND: Prophylactic cranial irradiation (PCI) is part of the usual treatment in most patients with small-cell lung cancer (SCLC) and response after treatment of the primary tumor. Clinical evidence suggests that radiation dose received by the hippocampus during whole brain radiotherapy might play a role in radiation-induced neurocognitive decline. PATIENTS AND METHODS: This study is a multicenter phase III trial (NCT02397733) randomizing SCLC patients after informed consent, to receive standard PCI treatment or PCI with hippocampus avoidance (PCI-HA) by using intensity modulated radiation therapy or volumetric modulated arc therapy. The primary objective is assessment of hippocampus-dependent memory functioning and safety after PCI with or without hippocampus sparing by the Free and Cued Selective Reminding Test. Secondary objectives are assessment of other neurotoxicity/quality of life, radiological brain abnormalities on magnetic resonance images, and evaluation of the incidence and location of brain metastases after PCI-HA compared with standard PCI. The originally planned sample size (n = 150) has been calculated to detect a 50% difference in the 3-month delayed recall score between the 2 treatment arms, with a statistical power of 80% (ß = 20%) and a significance level of 5% (α = 5%), with a maximum loss to follow-up of 10%. CONCLUSION: This study is an important step in introducing a new therapeutic approach to patients with SCLC candidates for PCI.

Brain Natriuretic Propeptide as an Early Marker of Bronchopulmonary Dysplasia or Death in the Preterm Newborn.

Aim To investigate whether increased brain natriuretic propeptide (NT-proBNP) levels at 48 to 72 h of life are associated with the development of bronchopulmonary dysplasia (BPD) or death in premature neonates. Methods A retrospective study was performed in neonates born before 32 weeks' gestation or with birth weight below 1500 grams, in whom NT-proBNP determination and echocardiography were performed at 48 to 72 h of life. Associations between NT-proBNP levels and the combined outcome BPD or death were analyzed using multivariate logistic regression analysis. Results 117 neonates with mean gestational age 27.8±2.1 weeks and birth weight 949.7±267.5 grams were included. Forty (34.2%) had an outcome of BPD or death. The risk of this combined outcome was found to be 3.95-fold higher (OR 3.95; 95% CI 1.1-14.6) in neonates with NT-proBNP levels above 17800 pg/mL. Conclusion Increased NT-proBNP levels may be associated with a significant decrease in BPD-free survival in very immature newborns.

Toxic compounds from tobacco in placenta samples analyzed by UPLC-QTOF-MS.

Polycyclic aromatic hydrocarbons (PAHs), tobacco-specific nitrosamines (TSNAs) and aromatic amines are carcinogens present in cigarette smoke. These compounds are distributed in the human body and they could be transferred to the foetus during the pregnancy. Placenta is the main barrier to these toxic compounds and its study is the objective of this work. A method based on solid-phase extraction (SPE) with ultra-performance liquid chromatography-tandem quadrupole-time-of-flight mass spectrometry (UPLC-QTOF-MS) has been examined and optimized for the analysis of 9 target analytes (4 tobacco-specific nitrosamines and some of their metabolites, 3 aromatic amines, nicotine and cotinine) in 26 placenta samples from smoking and non-smoking women. Limits of detection (LODs) were in the range of 3-27ng/g of placenta. Nicotine, cotinine, N-nitrosoanatabine (NAT) and 4-(methylnitrosamino)-1- (3-pyridyl)-1-butanone (NNK) metabolite, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) were detected in the placenta samples of smoking woman. Nicotine was detected in 3 out of 8 placentas from smoking women, always below the limit of quantification (88ng/g). This could be expected, as the half-life of nicotine in the body is limited to about 0.5-3h. Cotinine, the main metabolite from nicotine, was detected in all placentas from smoking women at concentrations between 17.2 and 61.8ng/g, reaching the highest values for those women that smoked the highest number of cigarettes. NAT and NNAL were detected in all placentas from smoking women, always below the limit of quantification (40ng/g and 33ng/g respectively).

Can we modify the enrollment in a postpartum smoking cessation intervention in Spain?

OBJECTIVE: it is known that very few women who continue to smoke at the time of delivery stop smoking during the postpartum period. Discovering strategies that can be incorporated during pregnancy to help improve women's participation in postpartum interventions could increase the number of women non-smokers. The aim of this study is to identify the predictors of participation by pregnant women smokers in a postpartum smoking cessation intervention. DESIGN: a cross-sectional study was carried out amongst women smokers who had attended to give birth. SETTING: women attended the University Clinical Hospital 'Lozano Blesa' of Zaragoza (Spain) who were smokers before pregnancy and reported at delivery to have continued smoking during pregnancy were eligible and were invited to participate in the study. FINDINGS: 2044 women completed the questionnaire 24 hours after giving birth. The smoking prevalence during pregnancy was 18.2% (n=372) and 62.9% of them (n=234) participated. The logistic regression model provided five significant predictors for women who participated: intention to breast feed, having less of an urge to smoke the first cigarette of the day before pregnancy, having reduced consumption during pregnancy by 50% or more, having received advice and being willing to get help. CONCLUSIONS AND IMPLICATIONS FOR THE PRACTICE: the factors associated with participation show aspects that can be modified by maternal and child health professionals. Advice to stop smoking, received during pregnancy, encourages participation in a postpartum intervention. From the point of view of public health, the huge increase in the prevalence of smoking women poses the need to take advantage of the pregnancy as an opportunity for giving up smoking definitely. It would be necessary to identify what programmes of smoking cessation have better results in pregnant women and to know how to motivate health professionals to implement them.

Correlation between clinical findings and magnetic resonance imaging for the assessment of local response after standard treatment in cervical cancer.

BACKGROUND: The aim of our study is to evaluate the correlation between gynecological examination and magnetic resonance (MRI) findings for the assessment of local response in cervical cancer patients treated with radiotherapy/chemotherapy (RT/ChT). PATIENTS AND METHODS: This study is a retrospective review of 75 consecutive cervical cancer patients from April 2004 to November 2009 treated with RT/ChT. Clinical and radiological data were subsequently analyzed. Patient's median age was 51 with a FIGO stage from Ib to IVb. Individualized RT/ChT was administered with a median dose of 45 Gy. Sixty-three patients received a complementary brachytherapy. Seventy-one patients received chemotherapy on a weekly basis. Gynecological exam was performed 3 months and 6 months after treatment and these findings were compared to MRI results at the same time. STATISTIC ANALYSIS: We used the Spearman's Rho test to determine the correlation level between the clinical and radiological methods. RESULTS: A correlation of 0.68 (60%) was observed between the clinical and MRI findings at 3 months with a further increase of up to 0.86 (82.6%) at 6 months. In the few cases with a poor correlation, the subsequent assessment and the natural history of the disease showed a greater value of the clinical exam as compared with the MRI findings. CONCLUSIONS: Physical exam remains an essential tool to evaluate the local response to RT/ChT for cervical cancer. The optimal clinical radiological correlation found at 6 months after treatment suggests that the combination of gynecological examination and MRI are probably adequate in patient monitoring.

A proactive smoking cessation intervention in postpartum women.

OBJECTIVE: to analyse the efficacy of a proactive intervention during the postpartum period to prevent a relapse in recent quitters and to promote progress in the behavioural process of change in smokers. DESIGN: randomised controlled trial designed for women at the end of the pregnancy using a proactive intervention. Motivational Interviewing (MI) and relapse prevention served as principles for the programme. In the intervention group, four telephone supporting sessions were performed in weeks 3, 6, 9 and 12. For the control group only two check calls in weeks 3 and 12. SETTING: women who attended the University Clinical Hospital 'Lozano Blesa' of Zaragoza (Spain) to give birth between January 2009 and March 2010. The intervention began after delivery, lasted for 3 months, and finished with a visit to validate abstinence biochemically. FINDINGS: a total of 2,044 women were studied, 30.6% (n=626) smoked before pregnancy; 65.8% (n=412) of them agreed to participate. The results for recent quitters by self-report showed that the probability of remaining abstinent after 12 weeks was 74% for the intervention group and 37% for the control group. Only the half of the sample attended the visit at 3 months to confirm the abstinence biochemically. For smokers, 90.7% of the intervention group said that they would be ready to try to quit in the following 6 months, vs. 18.3% for the control group. CONCLUSIONS AND IMPLICATIONS FOR THE PRACTICE: a proactive intervention in the postpartum period may reduce the probability of relapse in recent quitters and helps female smokers to make progress in the behavioural process of change. Such interventions should be included systematically in mother-child health services.

The white book of radiation oncology in Spain.

The White Book of Radiation Oncology provides a comprehensive overview of the current state of the speciality of radiation oncology in Spain and is intended to be used as a reference for physicians, health care administrators and hospital managers. The present paper summarises the most relevant aspects of the book's 13 chapters in order to bring the message to a wider audience. Among the topics discussed are the epidemiology of cancer in Spain, the role of the radiation oncologist in cancer care, human and material resource needs, new technologies, training of specialists, clinical and cost management, clinical practice, quality control, radiological protection, ethics, relevant legislation, research & development, the history of radiation oncology in Spain and the origins of the Spanish Society of Radiation Oncology (SEOR).

Radiosurgery and whole brain therapy in the treatment of brainstem metastases.

PURPOSE: The incidence of brainstem metastasis (BSM) accounts for 1-3% of brain metastases (BM). They are often associated with multiple BM and produce significant neurological symptoms. We retrospectively analyse the results of treatment with stereotactic radiosurgery (SRS). METHODS AND MATERIAL: We included the medical records of 28 patients aged 52.86+/-11.29 years; 17 (60.7%) were women. The most frequent primary tumours were breast (n=11), lung (n=9) and melanoma (n=4). A total of 30 BSM were treated with radiosurgery (SRS) with a linear accelerator (Linac Scalpel, University of Florida). The 3D planning was with image fusion. RESULTS: The mean time from the diagnosis of the primary tumour to the BM was 3+/-3.35 years; 5 cases were diagnosed simultaneously. Twenty-seven patients (96.4%) received whole brain radiotherapy, 19 before SRS and 8 after. The most usual dose was 30 Gy. Three patients underwent another SRS for other BM. The medium volume of BSM was 1.86+/-2.31 cc. The mean prescribed dose was 1114.33+/-315.6 cGy. The tumour volume did not change significantly with SRS but there was neurological improvement in 13 patients (41.9%). Twenty-four patients (85.7%) died, 22 (78.5%) due to the primary tumour: 12 cases (42.8%) due to progression of BM, 1 case due to progression of BSM and 10 due to local tumour progression or extra-cerebral metastases. Mean survival from diagnosis of BM was 22.8+/-32.4 months and from SRS of BSM, 16.8+/-31.56 months (1 month to 13.54 years). CONCLUSION: The combined treatment of SRS and whole brain radiotherapy treatment is effective in the control of BSM (only one patient died due to progression of BSM), improving the neurological symptoms in 41.9% of patients; therefore an early diagnosis and treatment is important. Many patients die due to causes other than the BSM.

Impact of neoadjuvant hormonal therapy on dose-volume histograms in patients with localized prostate cancer under radical radiation therapy.

INTRODUCTION: Prostate volume involves a defined toxicity predictor in the radiation therapy of localized prostate cancer. Neoadjuvant hormone therapy (nHT) can reduce prostate volume and, therefore, the planned volume. The objective of this study was to establish if the value of nHT reduces the planned volume and if this reduction correlates with a reduction of the dose received in the target organs. MATERIAL AND METHODS: 28 patients diagnosed of localized prostate cancer and referred to our departments for radiation therapy with radical intention, in the period ranging between April 2002 and October 2003, were included prospectively. The patients received nHT (triptorelin + flutamide) for 2 months and adjuvant HT until completing 2 years in the high-risk cases. A transrectal ultrasound study was performed in all patients, simulation CT and planning before the start of HT and after 2 months of treatment. The radiation therapy was carried out with 6 or 18 MV LINAC photons, with a dose fractioning scheme of 5 x 180-200 cGy, a total dosage of 66-72 Gy to prostate, 56 Gy to seminal vesicles and, in the high-risk cases, 46 Gy to pelvic lymph nodes. RESULTS: The distribution according to risk group was: low risk 3.6%, intermediate risk 28.6% and high risk 67.9%. By transrectal ultrasound, prostate volume on diagnosis was 50.65 cc pre HT and 38.97 cc post HT (p < 0.001), which means a volume reduction of 24%. The comparative analysis of the dose-volume histograms of the first versus the second CT shows a reduction in the planned volume GTV1 (prostate) (81.33 cc vs 63.96 cc, p < 0.05), PTV1 (prostate and margin) (197.51 cc vs 168.38 cc, p < 0.001) and PTV2 (prostate, vesicles and margin) (340.5 cc vs 307.26 cc, p < 0.05), a reduction of the maximum dose in the seminal vesicles (70.2 versus 68.75 Gy, p < 0.05), a reduction of the mean dose in the seminal vesicles (65.07 Gy versus 63.07 Gy, p < 0.05), PTV2 (67.72 Gy versus 66.9 Gy, p < 0.01) and PTV3 (prostate, vesicles, pelvic lymph nodes and margin) (58.86 Gy versus 57.21 Gy, p < 0.01), a reduction of the D90 in the seminal vesicles (61.83 Gy versus 60.06 Gy, p < 0.05) and PTV2 (61.04 Gy versus 59.45 Gy, p < 0.05) and a reduction of V60 of the rectum (32.45% versus 28.22%, p < 0.05) and V60 of the bladder (41.78% versus 31.67%, p < 0.005). CONCLUSIONS: Neoadjuvant hormone therapy reduces significantly prostate volume and as a result the planned volume and consequently the rectal and bladder V60 can be significantly reduced.

Impact of neoadjuvant hormonal therapy on dose-volume histograms in patients with localized prostate cancer under radical radiation therapy

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Introduction. Prostate volume involves a definedtoxicity predictor in the radiation therapy of localizedprostate cancer. Neoadjuvant hormone therapy(nHT) can reduce prostate volume and, therefore,the planned volume. The objective of thisstudy was to establish if the value of nHT reducesthe planned volume and if this reduction correlateswith a reduction of the dose received in thetarget organs.Material and methods. 28 patients diagnosed of localizedprostate cancer and referred to our departmentsfor radiation therapy with radical intention,in the period ranging between April 2002 andOctober 2003, were included prospectively. The patientsreceived nHT (triptorelin + flutamide) for 2months and adjuvant HT until completing 2 yearsin the high-risk cases. A transrectal ultrasoundstudy was performed in all patients, simulation CTand planning before the start of HT and after 2months of treatment. The radiation therapy wascarried out with 6 or 18 MV LINAC photons, with adose fractioning scheme of 5 x 180-200 cGy, a totaldosage of 66-72 Gy to prostate, 56 Gy to seminalvesicles and, in the high-risk cases, 46 Gy to pelviclymph nodes.Results. The distribution according to risk groupwas: low risk 3.6%, intermediate risk 28.6% and highrisk 67.9%. By transrectal ultrasound, prostate volumeon diagnosis was 50.65 cc pre HT and 38.97 ccpost HT (p < 0.001), which means a volume reductionof 24%. The comparative analysis of the dosevolumehistograms of the first versus the second CTshows a reduction in the planned volume GTV1(prostate) (81.33 cc vs 63.96 cc, p < 0.05), PTV1(prostate and margin) (197.51 cc vs 168.38 cc, p <0.001) and PTV2 (prostate, vesicles and margin)(340.5 cc vs 307.26 cc, p < 0.05), a reduction of themaximum dose in the seminal vesicles (70.2 versus68.75 Gy, p < 0.05), a reduction of the mean dose inthe seminal vesicles (65.07 Gy versus 63.07 Gy, p <0.05), PTV2 (67.72 Gy versus 66.9 Gy, p < 0.01) andPTV3 (prostate, vesicles, pelvic lymph nodes andmargin) (58.86 Gy versus 57.21 Gy, p < 0.01), a reductionof the D90 in the seminal vesicles (61.83 Gyversus 60.06 Gy, p < 0.05) and PTV2 (61.04 Gy versus59.45 Gy, p < 0.05) and a reduction of V60 of the rectum(32.45% versus 28.22%, p < 0.05) and V60 of thebladder (41.78% versus 31.67%, p < 0.005).Conclusions. Neoadjuvant hormone therapy reducessignificantly prostate volume and as a resultthe planned volume and consequently the rectaland bladder V60 can be significantly reduced

Electrocardiographic and echocardiographic findings in malnourished children.

OBJECTIVE: To compare heart abnormalities in a group of malnourished children with a control group and to describe their predictive variables. METHODS: Thirty children with malnutrition were matched with thirty healthy children. Anthropometry, plasma levels of albumin and electrolytes were determined. Among others, corrected QT interval (QTc) and QT dispersion (QTd: difference between the maximum and the minimum QT) were measured in 12-lead electrocardiogram; and left ventricular mass (LVm) and left ventricular mass index (LVmi) were measured by echocardiography. Regression analyses were performed with cardiac findings as dependent variables and anthropometric and biochemical data as independent variables. RESULTS: Plasma levels of albumin, potassium and calcium were lower in malnourished children. QTc and QTd were significantly greater in patients with malnutrition than in controls (QTc: 445.9 +/- 31.4 vs. 400.9 +/- 17.7 ms, p = 0.000; QTd: 76.4 +/- 34.1 vs. 47.9 +/- 10.2 ms, p = 0.000). LVm and LVmi were significantly lower in malnourished children (LVm: 55.3 +/- 10.3 vs. 71.4 +/- 6.9 g, p = 0.000; LVmi: 46.5 +/- 6.6 vs. 60.5 +/- 4.9 g/m2, p = 0.000). The body mass index (kg/m2) was the most powerful predictor of the variability in QTc (39.1%), LVm (48.1%) and LVmi (51.2%). CONCLUSIONS: Important electrocardiographic and echocardiographic abnormalities have been found in malnourished children associated with their nutritional status. Special precaution must be taken about the possibility of occurrence of arrhythmias and sudden death related with malnutrition.