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Bartelink H.,Netherlands Cancer Institute | Maingon P.,Center Georges Francois Leclerc | Poortmans P.,Institute Verbeeten | Poortmans P.,Radboud University Nijmegen | And 19 more authors.
The Lancet Oncology | Year: 2015

Background: Since the introduction of breast-conserving treatment, various radiation doses after lumpectomy have been used. In a phase 3 randomised controlled trial, we investigated the effect of a radiation boost of 16 Gy on overall survival, local control, and fibrosis for patients with stage I and II breast cancer who underwent breast-conserving treatment compared with patients who received no boost. Here, we present the 20-year follow-up results. Methods: Patients with microscopically complete excision for invasive disease followed by whole-breast irradiation of 50 Gy in 5 weeks were centrally randomised (1:1) with a minimisation algorithm to receive 16 Gy boost or no boost, with minimisation for age, menopausal status, presence of extensive ductal carcinoma in situ, clinical tumour size, nodal status, and institution. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was overall survival in the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT02295033. Findings: Between May 24, 1989, and June 25, 1996, 2657 patients were randomly assigned to receive no radiation boost and 2661 patients randomly assigned to receive a radiation boost. Median follow-up was 17·2 years (IQR 13·0-19·0). 20-year overall survival was 59·7% (99% CI 56·3-63·0) in the boost group versus 61·1% (57·6-64·3) in the no boost group, hazard ratio (HR) 1·05 (99% CI 0·92-1·19, p=0·323). Ipsilateral breast tumour recurrence was the first treatment failure for 354 patients (13%) in the no boost group versus 237 patients (9%) in the boost group, HR 0·65 (99% CI 0·52-0·81, p<0·0001). The 20-year cumulative incidence of ipsilatelal breast tumour recurrence was 16·4% (99% CI 14·1-18·8) in the no boost group versus 12·0% (9·8-14·4) in the boost group. Mastectomies as first salvage treatment for ipsilateral breast tumour recurrence occurred in 279 (79%) of 354 patients in the no boost group versus 178 (75%) of 237 in the boost group. The cumulative incidence of severe fibrosis at 20 years was 1·8% (99% CI 1·1-2·5) in the no boost group versus 5·2% (99% CI 3·9-6·4) in the boost group (p<0·0001). Interpretation: A radiation boost after whole-breast irradiation has no effect on long-term overall survival, but can improve local control, with the largest absolute benefit in young patients, although it increases the risk of moderate to severe fibrosis. The extra radiation dose can be avoided in most patients older than age 60 years. © 2015 Elsevier Ltd.


Aapro M.,Clinique de Genolier | Carides A.,Temple University | Schmoll H.-J.,Martin Luther University of Halle Wittenberg | Zhang L.,Sun Yat Sen University | Warr D.,Princess Margaret Cancer Center
Oncologist | Year: 2015

Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event associated with anticancer treatment that can have a significant adverse impact on patient health-related quality of life and that can potentially undermine the effectiveness of chemotherapy. Traditional regimens to prevent CINV generally involved a combination of a corticosteroid plus a 5-hydroxytryptamine (5HT3) receptor antagonist (RA). In the past 10 years, antiemetic treatment has greatly advanced with the availability of the neurokinin-1 receptor antagonist (NK1 RA) aprepitant and its prodrug fosaprepitant. NK1 RAs have a different mechanism of action in CINV than corticosteroids and 5HT3 RAs, thus their use can complement traditional antiemetic drugs and can enhance control of CINV. This review examined accumulated data regarding the safety and efficacy of aprepitant and fosaprepitant over the decade since the first regulatory approval. Data from key studies of aprepitant and fosaprepitant in the prevention of CINV in patients receiving moderately and highly emetogenic chemotherapy were explored, as were recommendations in currently available guidelines for their use. In addition, their use as antiemetic therapy in special patient populations was highlighted. Future perspectives on potential uses of aprepitant and fosaprepitant for indications other than CINV are presented. © AlphaMed Press 2015.


Aapro M.,Clinique de Genolier | Arends J.,Albert Ludwigs University of Freiburg | Bozzetti F.,University of Milan | Fearon K.,Royal Infirmary | And 7 more authors.
Annals of Oncology | Year: 2014

Background: Weight loss and cachexia are common, reduce tolerance of cancer treatment and the likelihood of response, and independently predict poor outcome. Methods: A group of experts met under the auspices of the European School of Oncology to review the literature and- on the basis of the limited evidence at present-make recommendations for malnutrition and cachexia management and future research. Conclusions: Our focus should move from end-stage wasting to supporting patients' nutritional and functional state throughout the increasingly complex and prolonged course of anti-cancer treatment. When inadequate nutrient intake predominates (malnutrition), this can be managed by conventional nutritional support. In the presence of systemic inflammation/ altered metabolism (cachexia), a multi-modal approach including novel therapeutic agents is required. For all patients, oncologists should consider three supportive care issues: ensuring sufficient energy and protein intake, maintaining physical activity to maintain muscle mass and (if present) reducing systemic inflammation. The results of phase II/III trials based on novel drug targets (e.g. cytokines, ghrelin receptor, androgen receptor, myostatin) are expected in the next 2 years. If effective therapies emerge, early detection of malnutrition and cachexia will be increasingly important in the hope that timely intervention can improve both patient-centered and oncology outcomes. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.


Ortmann O.,University of Regensburg | Pagani O.,Institute of Oncology of Southern Switzerland | Jones A.,Royal Free Hospital | Maass N.,University Clinic for Gynaecology and Obstetrics | And 5 more authors.
Cancer Treatment Reviews | Year: 2011

Menopausal status is a major consideration in adjuvant breast cancer therapy. The variable onset and duration of the menopausal transition and the poor predictive value of bleeding patterns and hormone levels mean many women fall naturally into a "perimenopausal" category. Women becoming amenorrhoeic during cytotoxic or endocrine treatment are also of uncertain status since ovarian function may resume even in older patients after several months without menses. The recent St. Gallen panel acknowledged that aromatase inhibitors (AIs) should form part of standard endocrine therapy for postmenopausal women with receptor-positive tumours. Among perimenopausal women at sufficiently high risk of recurrence, there may also be a case for adjuvant AIs either up-front or after tamoxifen. Such treatment should be initiated only after careful consideration of the patient's age, menstrual history and the effects of tamoxifen (which may make hormone levels an unreliable guide to ovarian function). In treatment-naïve women whose postmenopausal status cannot be confirmed by reliable, serial hormone measurements, treatment should start with tamoxifen. Serial monitoring of hormone levels may enable an AI to be started if postmenopausal status is confirmed. In women with treatment-induced amenorrhoea, any decision to start an AI requires baseline hormone levels consistent with postmenopausal status; and continuation of treatment requires that hormone levels remain postmenopausal during regular monitoring. © 2010 Elsevier Ltd.


Calonge W.M.,Clinique de Genolier | Lesbros-Pantoflickova D.,Clinique de Genolier | Hodina M.,Clinique de Genolier | Elias B.,Reconstructive and Aesthetic Surgery
Aesthetic Plastic Surgery | Year: 2013

The authors report the observation of a 43-year-old woman with severe pain on her right upper abdominal quadrant. Differential diagnoses included acute cholecystitis, spontaneous pneumothorax, perforated appendicitis and a recidive of renal calculus. CT-scan showed a huge subdermal gas bubble along her right flank and anterior abdominal wall up to the submammary fold. Only at this point, the patient admitted to have undergone a carboxytherapy procedure on both thighs one day before onset of pain in a paramedical facility. As some of the injection trajects were still patent on CT-scan, she received prophylactic antibiotic coverage. Though there was a complete resorption of gas after 10 days, dysesthesias and muscle contracture persisted for 3 weeks. To the authors' knowledge this migration and coalescence of injected gas in a single bubble has not been previously reported. Level of Evidence V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors http://www.springer.com/00266. © 2013 Springer Science+Business Media New York and International Society of Aesthetic Plastic Surgery.


Ghadjar P.,University of Bern | Simcock M.,Swiss Group for Clinical Cancer Research Coordinating Center | Studer G.,University of Zürich | Allal A.S.,Kantonsspital Fribourg | And 7 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2012

Purpose: To compare the long-term outcome of treatment with concomitant cisplatin and hyperfractionated radiotherapy versus treatment with hyperfractionated radiotherapy alone in patients with locally advanced head and neck cancer. Methods and Materials: From July 1994 to July 2000, a total of 224 patients with squamous cell carcinoma of the head and neck were randomized to receive either hyperfractionated radiotherapy alone (median total dose, 74.4 Gy; 1.2 Gy twice daily; 5 days per week) or the same radiotherapy combined with two cycles of cisplatin (20 mg/m 2 for 5 consecutive days during weeks 1 and 5). The primary endpoint was the time to any treatment failure; secondary endpoints were locoregional failure, metastatic failure, overall survival, and late toxicity assessed according to Radiation Therapy Oncology Group criteria. Results: Median follow-up was 9.5 years (range, 0.1-15.4 years). Median time to any treatment failure was not significantly different between treatment arms (hazard ratio [HR], 1.2 [95% confidence interval {CI}, 0.9-1.7; p = 0.17]). Rates of locoregional failure-free survival (HR, 1.5 [95% CI, 1.1-2.1; p = 0.02]), distant metastasis-free survival (HR, 1.6 [95% CI, 1.1-2.5; p = 0.02]), and cancer-specific survival (HR, 1.6 [95% CI, 1.0-2.5; p = 0.03]) were significantly improved in the combined-treatment arm, with no difference in major late toxicity between treatment arms. However, overall survival was not significantly different (HR, 1.3 [95% CI, 0.9-1.8; p = 0.11]). Conclusions: After long-term follow-up, combined-treatment with cisplatin and hyperfractionated radiotherapy maintained improved rates of locoregional control, distant metastasis-free survival, and cancer-specific survival compared to that of hyperfractionated radiotherapy alone, with no difference in major late toxicity. © 2012 Elsevier Inc.


Ayestaray B.,Reconstructive and Aesthetic Surgery | Dudrap E.,Clinique de Genolier | Chaibi A.,Clinique Alyssa
Aesthetic Plastic Surgery | Year: 2011

Galactorrhea is a rare event after breast augmentation. The physiopathologic bases of galactorrhea depend on the central secretion of prolactin. These physiopathologic bases must be clearly understood for the prevention and treatment of postoperative galactorrhea. This report describes two cases of a postoperative galactorrhea after aesthetic breast augmentation with silicone implants. The clinical appearance closely resembles a postoperative sepsis without hyperthermia. Bacteriologic samples are negative. Endocrinologic examination finds a characteristic hyperprolactinemia. The evolution is favorable under dopaminergic agonists. © 2010 Springer Science+Business Media, LLC and International Society of Aesthetic Plastic Surgery.


PubMed | Helios Klinikum Berlin Buch, Amgen, Klinikum Frankfurt Hoechst, Evangelina Hospital Bethesda and 3 more.
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2017

120 Background: New data are available from two trials of ESA use in patients with breast cancer receiving chemotherapy. We conducted a meta-analysis of trials of ESA use in this population.A literature search identified reports from 1997-2012 that included mortality data from controlled ESA trials (epoetin alfa, epoetin beta, darbepoetin alfa, biosimilars) in patients with breast cancer receiving chemotherapy. We used data from company databases for Amgen Inc. or Janssen Products LP studies and published data for other studies. Random-effects odds ratios (OR) were calculated to compare results for patients randomized to ESA to patients randomized to control. Analyses were stratified by metastatic stage; mixed stage or treatment; and adjuvant/neoadjuvant treatment.We analyzed 9 studies (N = 4,713; ESA n = 2,346, control n = 2367) (Table).The overall stratified random-effects OR for death was 1.17 (95% confidence interval, 0.99-1.39). Details are presented in the Table.Overall survival OR remains consistent with prior data after including recent results. [Table: see text].


Warr D.,University of Toronto | Aapro M.,Clinique de Genolier | Clark-Snow R.A.,University of Kansas | Einhorn L.,Walther Cancer Institute | And 4 more authors.
Supportive Care in Cancer | Year: 2011

Purpose: An update of the recommendations for the prophylaxis of delayed emesis induced by moderately emetogenic chemotherapy discussed during the third Perugia Consensus Conference (June 2009) sponsored by MASCC-ESMO was presented. The review considered new studies published since the second consensus conference (April 2004). Methods: An online search was used conducting PubMed and the search terms moderately, chemotherapy, and emesis with a restriction to papers in English. Results: Overall, nine randomized controlled studies were included: four evaluating NK1 receptor antagonists, one palonosetron, and four dopamine receptor antagonists. Conclusions: In patients receiving a combination of anthracycline plus cyclophosphamide treated with a combination of aprepitant, a 5-HT3 receptor antagonist and dexamethasone to prevent acute nausea and vomiting, aprepitant is suggested to prevent delayed emesis. In patients who do not receive aprepitant for the prophylaxis for acute emesis and in which palonosetron is recommended, a multiday oral dexamethasone is the preferred treatment for the prevention of delayed emesis. Levels of evidence and of consensus for both recommendations are moderate. © 2010 Springer-Verlag.


Enormous efforts are currently put forth in translational breast cancer research. These efforts are directed to both the development of new drugs and the implementation of novel techniques of local treatment, including radiotherapy. This latter discipline is actually a particularly fertile ground for translational research, since scientists and clinicians are developing novel tools in biology and radiation physics, which reduce the gap between the lab and the clinic, and identify innovative strategies that one didn't even dream, only a few years ago. Nowadays the most recent advances in translational breast cancer research are articulated, in radiation science, around three main domains, namely molecular biology, experimental models for tumour growth and response to treatment, and mechanisms underlying levels of malignant and normal cell radio-sensitivity/radio-resistance. In an attempt to put into perspective what could be the breast cancer radiotherapy of the next decade, these three domains are reviewed and discussed in the present article, at the light of ongoing, " from bench to bedside" studies. © 2009 Elsevier Ltd.

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