An exception to the rule "no association between antibiotic resistance and decreased disinfectant microbicidal efficacy": Orthophthalaldehyde (OPA) and Pseudomonas aeruginosa isolated from ICU and paraplegic patients.

BACKGROUND: Antibiotic resistance and decreased susceptibility to disinfectants are not usually associated in microorganisms, but we have found an exception to this rule: P. aeruginosa versus orthophthalaldehyde (OPA). METHODS: Bactericidal effect of OPA was measured at 10 minutes on endodoncy files contaminated with an ATCC strain (control) or 206 strains of P. aeruginosa recently isolated from 206 ICU and paraplegic patients in a tertiary university hospital, in two consecutive years. RESULTS: Differences in bactericidal effect of OPA were found between the strains isolated each year (decreased susceptibility in the first period), but in both years the statistical differences (p < 0.05) were maintained according to whether the strains were "susceptible" to antibiotics, "resistant" (to one family of antibiotics) or "multi-resistant" (resistant to more than one family of antibiotics), exhibiting a reduction in their OPA susceptibility in parallel to an increase of their antibiotic resistance. In contrast, there were no differences depending on the type of sample (sputum, urine, faeces, pharynx) or of patient (paraplegic or ICU: adult, newborn, burn). Finally we selected 15 strains with an OPA effect below 3.5 log10 at 10 minutes and repeated the study with an OPA exposure of 15 minutes. In these conditions OPA showed a total bactericidal effect on these P. aeruginosa strains. CONCLUSIONS: There was an association between antibiotic resistance and decreased OPA susceptibility. This normally does not require an increase in disinfection time, but, for endoscope disinfection or instruments from colonized/infected patients with resistant/multiresistant P. aeruginosa, we consider it better to use 15 min of OPA. Regular tests (e.g., once every 12 months) with germ-carriers, should be performed to assess ecological changes in susceptibility to high level disinfectants and must include not only ATCC strains, but also recently isolated microorganisms with different antibiotic sensitivities (susceptible, resistant and multi-resistant).

Erlotinib and chemoradiation in patients with surgically resected locally advanced squamous cell carcinoma of the head and neck: a GICOR phase I trial.

BACKGROUND: Standard treatment of advanced squamous cell carcinoma of the head and neck (SCCHN) is concurrent chemoradiation. Erlotinib is an oral tyrosine kinase inhibitor of epidermal growth factor receptor, which has shown activity in SCCHN. Phase I study aims to determine the maximum tolerated dose and dose-limiting toxicity (DLT) of adding erlotinib to chemoradiation therapy in patients with surgically resected locally advanced SCCHN. PATIENTS AND METHODS: Inclusion criteria--SCCHN patients with T3 or T4 primary lesion (except T3N0 with negative resection margins); pathologic N2-N3 disease; poor prognostic findings; age 18-70 years; Eastern Cooperative Oncology Group performance status of zero to one; no evidence of metastasis; adequate organic function and written informed consent. Study design--dose-escalating phase I study with three cohorts of three to six patients each that received increasing doses of erlotinib (100-150 mg/day p.o.) and cisplatin (30-40 mg/m(2) i.v., day 1) for 7 weeks. Radiotherapy--standard regimen of 1.8 Gy daily (5 fractions/week) to a maximum total dose of 63 Gy in 7 weeks. RESULTS: Thirteen male (median age: 57 years) were enrolled. Overall, the regimen was well tolerated. Two of three patients treated at dose level III (erlotinib: 150 mg/day; cisplatin: 40 mg/m(2)) developed DLT consisting of grade 3 infection and grade 3 mucositis. Other toxic effects included diarrhea, asthenia, and rash. Recommended dose for additional studies: erlotinib 150 mg/day p.o.; cisplatin 30 mg/m(2)/week i.v. CONCLUSION: Erlotinib can be safely combined with chemoradiation without requiring dose reduction of chemo- or radiotherapy in this postsurgical population.

Antimicrobial efficacy of a very stable hypochlorous acid formula compared with other antiseptics used in treating wounds: in-vitro study on micro-organisms with or without biofilm.

BACKGROUND: Many antiseptics have been used to treat wounds. AIM: To compare the microbicidal efficacy of ClHO (Clortech®) with other antiseptics used on wounds, healthy skin and mucous membranes. METHODS: The microbicidal efficacy of 13 antiseptic products on eight micro-organisms (three Gram-positive; three Gram-negative; two yeasts) inoculated on organic germ-carriers was studied. In addition, the loss of efficacy against Staphylococcus aureus and Pseudomonas aeruginosa with biofilm was assessed with the six best-performing products. FINDINGS: Chlorhexidine (1%) had the highest microbicidal effect at 1 min. At 5 min, 500 and 1500 mg/L ClHO showed similar, or better, activity than the other antiseptics studied. The ClHO concentration of 300 mg/L achieved this same efficacy at 10 min. The product that lost the most efficacy due to biofilm was 1% chlorhexidine, while 1% PVP-I and ClHO at either 300 or 500 mg/L were moderately affected by biofilm. The most effective in the presence of biofilm was ClHO at 1500 mg/L. CONCLUSIONS: ClHO at medium-low concentrations (300 or 500 mg/L) is a good antiseptic that can be used on wounds and mucous membranes for 5-10 min. Lower concentrations of ClHO, as well as of the other antiseptics studied, were less effective or more altered by the biofilm. ClHO at a concentration of 1500 mg/L is very effective in the presence or absence of biofilm that can be used on healthy skin for 5 min.

Intermittent versus continuous androgen deprivation therapy to biochemical recurrence after external beam radiotherapy: a phase 3 GICOR study.

PURPOSE: We compared biochemical control and quality of life with intermittent (6 months) versus continuous (36 months) androgen deprivation therapy (ADT) in a non-inferiority randomized phase 3 trial in patients with biochemical failure (BF) after external beam radical radiotherapy (EBRT). MATERIALS AND METHODS: Patients were stratified according to the Gleason score (GS) and were classified as low risk with a GS < 6 and 7 (3 + 4) and high risk with a GS of 7 (4 + 3) and >7. Patients were followed with PSA determinations and quality-of-life assessments (QLQ C-30 and QLQ PR-25) every 6 months for a period of 3 years. BF after radiation was defined as a PSA level of nadir +2 ng/ml. Disease progression (DP) after ADT was defined as PSA ≥4 ng/ml (BF) and/or metastases. RESULTS: Seventy-seven patients were included in this multicenter phase 3 trial from 2005 to 2009. Thirty-eight and 39 patients were included in the intermittent and continuous groups, respectively. The median follow-up for both groups was 48 months (40-68). DP after ADT in the intermittent group was seen in three patients (distant metastases in one patient) versus 0 in the continuous group. The QLQ-C30 and QLQ PR-25 scores did not show any statistically difference between the two ADT groups. CONCLUSIONS: No significant differences were seen in DP and QLQ between intermittent (6 months) and continuous (36 months) ADT in patients with BF after EBRT.

Conservative treatment with transurethral resection, neoadjuvant chemotherapy followed by radiochemotherapy in stage T2-3 transitional bladder cancer.

PURPOSE: Organ preservation has been investigated in patients (p) with infiltrating transitional cell carcinoma (TCC) of the bladder over the past decade as an alternative to radical cystectomy. This is a trimodal schedule study, including transurethral resection of bladder tumor (TURB), neoadjuvant chemotherapy and concomitant radiochemotherapy (RTC). PATIENTS AND METHODS: From April 1996 until August 2005, 29 evaluable patients (p) with T2-T3NXM0 bladder cancer were enrolled. After a transurethral resection of bladder tumor (TURB), we administered 2 cycles of induction chemotherapy with CMV (15 p) or Gemcitabine-Cisplatin (14 p) followed by radiotherapy 45 Gy 1.8 Gy/fraction and two cycles of concomitant cisplatin 70 mg/m(2). 2-3 weeks later, a cystoscopy with tumor-site biopsy was performed. If complete histological response, p were treated with consolidation radiotherapy until 64.8 Gy. For p with residual or recurrent tumor, cystectomy was performed. RESULTS: We included 28 men and 1 women (median age 63, range 39-72 years) with PS (ECOG) 0-1. The stage was: 21 p T2; 6 p T3a; and 2 p T3b. Toxicity was higher in CMV compared with Gem- Cis: grade (3/4) neutropenia 4/15 (26%) vs 1/14 (7%); febrile neutropenia 3/15 (20%) vs 1/14 (7%); grade (3/4) trombocytopenia 2/15 (13%) vs 1/14 (7%). Toxicities with concomitant RCT were low-moderate: urocystitis (26%) and enteritis (18%). RESPONSE: microscopically complete TURB was obtained in 20 p (69%), but not in 9 p (31%) (7 microscopic, and 2 macroscopic residual tumor). We found a complete histologic response after induction RCT in 25 p (86%). After a median follow-up of 69.4 months (m) (range: 8-97.7), there were 8 deaths, with a overall survival of 72%. Furthermore 14 of 29 p (48%) were alive with intact bladder, and median survival time with intact bladder was 63.6 m (50.1-77.2); were predictive of best outcome T2 stage vs T3 (p < 0.0001), and complete histologic resection in initial TURB vs residual tumor (p = 0.0004). CONCLUSIONS: Combined treatment provide high response rates and can be offered as an alternative option to radical cystectomy in selected patients with TCC. Patients with T2 stage and complete histologic resection in initial TURB had the best outcome.

Recommendations of the Spanish Brachytherapy Group of SEOR for HDR endoluminal treatments. Part 1: Oesophagus.

The endoesophageal brachytherapy technique provides good results in the treatment of oesophageal cancer, when indicated. In a consensus meeting, the Spanish Brachytherapy Group of SEOR and the Spanish Society of Medical Physics (SEFM) agreed on the indications, dose, fractionation schedule, prescription and reporting to be performed in endoesophageal brachytherapy. The results of this consensus are presented here as recommendations for medical practice.

[Neoadjuvant treatment with cisplatin, 5-FU and folinic acid in advanced head and neck cancer]. / Tratamiento neoadyuvante en el cáncer avanzado de cabeza y cuello con cisplatino, 5-fluorouracilo y ácido folínico.

From May to February 1992, 32 patients diagnosed as advanced cancer of the head and neck were included in a program of neoadjuvant treatment with cisplatin, 5-FU, and folinic acid, followed by radiotherapy (45 at 70 Gy) and/or surgery. Twenty patients were considered fully evaluable; their global response rate was 75% (7 complete responses and 8 partial responses). Five patients had no appreciable response or progression. Radiotherapy after chemotherapy enhanced the response, yielding complete responses in 4 patients and partial response in 1. Toxicity was moderate, except for mucositis (9 cases grade 3-4), despite high doses of drugs and radiotherapy. Given the clinical results, this combination may be promising as a first-line treatment against advanced cancer of the head and neck.

Quantifying Glosair™ 400 efficacy for surface disinfection of American Type Culture Collection strains and micro-organisms recently isolated from intensive care unit patients.

Microbial contamination of hospital surfaces may be a source of infection for hospitalized patients. We evaluated the efficacy of Glosair™ 400 against two American Type Culture Collection strains and 18 clinical isolates, placed on glass germ-carriers. Carriers were left to air-dry for 60 min and then exposed to a cycle before detection of any surviving micro-organisms. Antibiotic-susceptible Gram-negative bacilli were less susceptible (although not significantly) to this technique than resistant Gram-negative bacilli or Gram-positive cocci and yeasts (3, 3.4 and 4.6 log10 reduction, respectively). In conclusion, in areas that had not been cleaned, aerosolized hydrogen peroxide obtained >3 log10 mean destruction of patients' micro-organisms.

Infrastructures, treatment modalities, and workload of radiation oncology departments in Spain with special attention to prostate cancer.

AIM: The purpose of the study was to describe infrastructures, treatment modalities, and workload in radiation oncology (RO) in Spain, referred particularly to prostate cancer (PC). METHODS: An epidemiologic, cross-sectional study was performed during 2008-2009. A study-specific questionnaire was sent to the 108 RO-registered departments. RESULTS: One hundred and two departments answered the survey, and six were contacted by telephone. Centers operated 236 treatment units: 23 (9.7 %) cobalt machines, 37 (15.7 %) mono-energetic linear accelerators, and 176 (74.6 %) multi-energy linear accelerators. Sixty-one (56.4 %) and 33 (30.5 %) departments, respectively, reported intensity-modulated radiation therapy (IMRT) and image-guided RT (IGRT) capabilities; three-dimensional-conformal RT was used in 75.8 % of patients. Virtual simulators were present in 95 departments (88.0 %), 35 use conventional simulators. Fifty-one departments (47.2 %) have brachytherapy units, 38 (35.2 %) perform prostatic implants. Departments saw a mean of 24.9 new patients/week; the number of patients treated annually was 102,054, corresponding to 88.4 % of patients with a RT indication. In 56.5 % of the hospitals, multidisciplinary teams were available to treat PC. CONCLUSIONS: Results provide an accurate picture of current situation of RO in Spain, showing a trend toward the progressive introduction of new technologies (IMRT, IGRT, brachytherapy).

Consensus on the regional lymph nodes irradiation in breast cancer.

Standard locoregional treatment of early-stage breast cancer currently consists of the conservative surgery and sentinel lymph node biopsy. In the event of positive sentinel node biopsy, an axillary level I-II lymphadenectomy should be carried out. However, recent publications have increasingly supported a tendency not to apply the surgical lymphadenectomy, but simultaneously, it has been developed a new role of regional radiotherapy, even if there is only 1-3 axillary lymph nodes involved. Given these new trends, radiation oncologists are facing the dilemma with regard to deciding about regional irradiation of breast cancer. For such purpose, The Spanish Group of Breast Cancer Radiation Oncology (GEORM as per its Spanish acronym) decided to reach a consensus to issue the respective guidelines for such types of cases. GEORM Managing Commission, gathering 13 members of different Spanish regional communities, issued a questionnaire including different clinical situations. These questions were set as key questions seeking responses, which were answered by 66 % out of the 75 members of the group. Following the response, the guidelines were drafted based on the replies to the mentioned questionnaire. All the respective issues were discussed by means of a virtual platform. In this article, we show the levels of consensus for different clinical situations, depending on the number of nodes involved and the type of surgical procedure performed on the axillary lymph nodes. The ongoing evolution of the oncological treatments obliges the radiation oncologists to take decisions without any existing clarifying evidence, and therefore, the consensus is necessary, which can assist in the decision-making process by the practitioners in such kinds of clinical situations.

Consensus on treatment of endometrium carcinoma with brachytherapy.

Radiotherapy (RT) is commonly used as adjuvant treatment following hysterectomy and double oophorectomy in endometrial carcinoma. Prophylactic vaginal brachytherapy (BT) is the most common treatment in BT units. The PORTEC and GOG 99 studies have attempted to clarify the indications of BT and postoperative external RT, changing treatment standards. However, prophylactic BT regimens are very varied and there is currently no consensus on how to treat patients in terms of dose per fraction and number of fractions. Moreover, unoperated cases of endometrium are uncommon and there is limited experience in their treatment with BT. The 9th Consensus Meeting of the SEOR and SEFM Brachytherapy Group, held in Malaga on 11 March 2011, was therefore dedicated to "Brachytherapy in Endometrial Carcinoma". This article presents the consensus on treatment of endometrial carcinoma in operated (prophylactic vaginal BT) and unoperated (endouterine BT) patients.

In vitro-in vivo sequence studies as a method of selecting the most efficacious alcohol-based solution for hygienic hand disinfection.

The use of alcohol-based hand rubs serves to reduce hospital-acquired infections. Many products of this type are now on offer and it is essential to know how to rank their efficacy. A sequence of tests is proposed here to compare any given new alcohol-based solution against the reference solution (60% 2-isopropyl-alcohol) with 30 s of contact time: (i) in vitro (with pig skin as carrier) testing of >30 species of microorganism; (ii) in vitro assessment of residual efficacy (after 30 min of drying); (iii) in vivo study of transient microbiota (modification of the EN 1500 standard procedure) using four ATCC strains; (iv) in vivo study of resident hand microbiota. After performing the in vitro evaluation of seven alcohol-based hand rubs, the two most efficacious (chlorhexidine-quac-alcohol and mecetronium- alcohol) were chosen and studied, comparatively with the reference solution (60% isopropyl alcohol), in vitro (for chemical sustainability on the skin) and in vivo (against transient and resident microbiota). Chlorhexidine-quac-alcohol proved to be significantly superior to mecetronium-alcohol or the reference solution in all tests, except against resident microbiota for which the improvement was not statistically significant.

Intermittent versus continuous androgen deprivation therapy to biochemical recurrence after external beam radiotherapy: a phase 3 GICOR study

Purpose. We compared biochemical control and quality of life with intermittent (6 months) versus continuous (36 months) androgen deprivation therapy (ADT) in a non-inferiority randomized phase 3 trial in patients with biochemical failure (BF) after external beam radical radiotherapy (EBRT). Materials and methods. Patients were stratified according to the Gleason score (GS) and were classified as low risk with a GS < 6 and 7 (3 + 4) and high risk with a GS of 7 (4 + 3) and >7. Patients were followed with PSA determinations and quality-of-life assessments (QLQ C-30 and QLQ PR-25) every 6 months for a period of 3 years. BF after radiation was defined as a PSA level of nadir +2 ng/ml. Disease progression (DP) after ADT was defined as PSA ≥4 ng/ml (BF) and/or metastases. Results. Seventy-seven patients were included in this multicenter phase 3 trial from 2005 to 2009. Thirty-eight and 39 patients were included in the intermittent and continuous groups, respectively. The median follow-up for both groups was 48 months (40-68). DP after ADT in the intermittent group was seen in three patients (distant metastases in one patient) versus 0 in the continuous group. The QLQ-C30 and QLQ PR-25 scores did not show any statistically difference between the two ADT groups. Conclusions. No significant differences were seen in DP and QLQ between intermittent (6 months) and continuous (36 months) ADT in patients with BF after EBRT (AU)

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Código de buena práctica para el control del dolor oncológico / Good practice code for the management of cancer pain

En muchas ocasiones, los pacientes con cáncer no expresan su dolor por miedo a que el médico desvíe su atención hacia este síntoma, en lugar de centrarse en el tratamiento de su enfermedad principal. No obstante, el paciente debe saber que el tratamiento de su dolor no solo no interfiere con la terapia curativa, sino que colabora con ella. Entre los enfermos, es habitual el temor a que el avance de la enfermedad les lleve a situaciones de sufrimiento insostenible que supere todas las posibilidades médicas, pero es nuestro deber ayudarles a ser conscientes de que la medicina ofrece un abanico de terapias capaces de aliviar su dolor y evitar su sufrimiento. Este conocimiento es esencial para aumentar su confianza en el tratamiento y mejorar la relación médico-paciente. Frente a este desafío, SECPAL (Sociedad Española de Cuidados Paliativos), SED (Sociedad Española del Dolor), SEOM (Sociedad Española de Oncología Médica) y SEOR (Sociedad Española de Oncología Radioterápica) unen sus esfuerzos y crean ALIADO (Alianza Contra el Dolor Oncológico), un grupo de trabajo interdisciplinario que nace con el objetivo de concienciar e implicar a todo el colectivo médico en la necesidad de mejorar la calidad de vida del paciente con dolor oncológico. La primera iniciativa de ALIADO en este sentido es la elaboración del Código de buena praxis para el tratamiento del dolor oncológico, que pretende contribuir al avance en el conocimiento y el manejo de estos pacientes (AU)

Patients with cancer often fail to talk about their pain fearing that their doctor might draw his or her attention to that symptom rather than focus on the management of their underlying disease. However, patients should know that pain management will not interfere with their curative therapy but will supplement it. Fear that the advancing disease will lead to unbearable suffering situations beyond medical possibilities is common among patients, and it is our duty to help them become aware tha medicine offers a number of therapies that actually can suppress pain and relieve suffering. This awareness is key to increase trust in therapy and improve doctor-patient relationships. Facing this challenge SECPAL (Sociedad Española de Cuidados Paliativos), SED (Sociedad Española del Dolor), SEOM (Sociedad Española de Oncología Médica), and SEOR (Sociedad Española de Oncología Radioterápica) unite in a joint venture to create ALIADO (Alianza Contra el Dolor Oncológico), an interdisciplinary work team emerging with the goal of raising awareness and involvement among health providers regarding the need for quality of life improvement in cancer patients with pain. In this respect, ALIADO's first initiative is the development of a good practice code for the management of cancer pain in an attempt to contribute to the further understanding and management of these patients (AU)

Recommendations of the Spanish Brachytherapy Group of SEOR for HDR endoluminal treatments. Part 1: oesophagus

The endoesophageal brachytherapy technique provides good results in the treatment of oesophageal cancer, when indicated. In a consensus meeting, the Spanish Brachytherapy Group of SEOR and the Spanish Society of Medical Physics (SEFM) agreed on the indications, dose, fractionation schedule, prescription and reporting to be performed in endoesophageal brachytherapy. The results of this consensus are presented here as recommendations for medical practice (AU)

No disponible

Consensus on the regional lymph nodes irradiation in breast cancer

Standard locoregional treatment of early-stage breast cancer currently consists of the conservative surgery and sentinel lymph node biopsy. In the event of positive sentinel node biopsy, an axillary level I-II lymphadenectomy should be carried out. However, recent publications have increasingly supported a tendency not to apply the surgical lymphadenectomy, but simultaneously, it has been developed a new role of regional radiotherapy, even if there is only 1-3 axillary lymph nodes involved. Given these new trends, radiation oncologists are facing the dilemma with regard to deciding about regional irradiation of breast cancer. For such purpose, The Spanish Group of Breast Cancer Radiation Oncology (GEORM as per its Spanish acronym) decided to reach a consensus to issue the respective guidelines for such types of cases. GEORM Managing Commission, gathering 13 members of different Spanish regional communities, issued a questionnaire including different clinical situations. These questions were set as key questions seeking responses, which were answered by 66 % out of the 75 members of the group. Following the response, the guidelines were drafted based on the replies to the mentioned questionnaire. All the respective issues were discussed by means of a virtual platform. In this article, we show the levels of consensus for different clinical situations, depending on the number of nodes involved and the type of surgical procedure performed on the axillary lymph nodes. The ongoing evolution of the oncological treatments obliges the radiation oncologists to take decisions without any existing clarifying evidence, and therefore, the consensus is necessary, which can assist in the decision-making process by the practitioners in such kinds of clinical situations (AU)

Consensus on treatment of endometrium carcinoma with brachytherapy

Radiotherapy (RT) is commonly used as adjuvant treatment following hysterectomy and double oophorectomy in endometrial carcinoma. Prophylactic vaginal brachytherapy (BT) is the most common treatment in BT units. The PORTEC and GOG 99 studies have attempted to clarify the indications of BT and postoperative external RT, changing treatment standards. However, prophylactic BT regimens are very varied and there is currently no consensus on how to treat patients in terms of dose per fraction and number of fractions. Moreover, unoperated cases of endometrium are uncommon and there is limited experience in their treatment with BT. The 9th Consensus Meeting of the SEOR and SEFM Brachytherapy Group, held in Malaga on 11 March 2011, was therefore dedicated to "Brachytherapy in Endometrial Carcinoma". This article presents the consensus on treatment of endometrial carcinoma in operated (prophylactic vaginal BT) and unoperated (endouterine BT) patients (AU)