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Background.Autologous fat grafting (AFG) is a widely used procedure in breast reconstruction after breast cancer. Indications are in constant increase but there is a lack of dataabout global morbidity, especially fat necrosis and management of local complications. The purpose of this study was to evaluate the complications rate in term of abnormal clinical examination or imaging and the proportion of additional explorations. Methods. We retrospectively reviewed the computerized files of consecutive patients who underwent AFG for breast reconstruction after breast cancer or for preventive surgery and aesthetic sequelae after lumpectomy in the Oscar Lambret center between January 2013 and December 2016. Fat grafts were harvested with a fat trap then processed and injected according the Coleman technique. We collected demographics, operative details, local complications, incidence of palpable masses and/or suspicious breast imaging findings leading to additional explorations (breast imaging or biopsy), and locoregional cancer recurrence. Descriptive statistics were generated. Results. Over a 4-year period, 257 women underwent autologous fat grafting for breast reconstruction and aesthetic sequelae after lumpectomy. Their mean age was 50 years [range 28-75], the mean BMI was 25 [range 18-44], 26% (n=66) were smoking and 74% (n=190) underwent radiotherapy. A total of 303 breasts were operated by 270 mastectomies (89%) or33 lumpectomies (11%). The reconstruction was delayed in 63% (n=171) and the main techniques used were breast implant (44%, n=119) and autologous latissimus dorsi (31%, n=84). The mean number of fat grafting procedures was 1,9 per patient [range 1-7] with a mean volume of 181 mL [range 30-535]. The mean time interval between cancer diagnosis and first fat graft session was 56 months [range 3-285], and the follow-up ranged from 0 to 51 months (mean=16). The prevalence of donor site complications was 6% (n=16) and infections was 2% (n=5). Sixty six (25,6%) patients had a clinically palpable lesion and 54 (21%) underwent additional imagings, mostly by ultrasounds (53 patients, 98%) except the usual follow-up. Twenty one biopsies (8%) were performed and showed 16 benign results (76,2%) and 5 malignant results (23,8%) leading to 6,2% of fat necrosis and 1,9% of locoregional recurrence after AFG in our study.Tobacco (p=0.45), BMI (p=0.95), radiotherapy (p=0.56) and amount of fat grafted ( p=0.09) didn't appear to be risk factors for fat necrosis. Conclusions. A good knowledge of local complications by surgeons and radiologists enables to avoid systematic and repeated further imaging explorations. Multicentric, prospective studies with long term follow up and evaluation of patients reported outcomes are needed to evaluate anxiety generated by biopsies and costs generated by repeated imagings. Key words: autologous fat grafting, breast cancer, local morbidity, fat necrosis. Citation Format: Hannebicque K, Renaudeau C, Giard S, Regis C, Boulanger L, Bogart E, Le Deley M-C, Ceugnart L, Chauvet M-P. Evaluation of autologous fat grafting local morbidity (fat necrosis and biopsy rates) in breast reconstruction after breast cancer: A retrospective study on 257 patients in Oscar Lambret Center [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-16-04.

International audience; Background: The role of both hormonal contraception and pregnancy on the outcomes of desmoid-type fibromatosis (DF) is debatable. Materials and methods: In the present study, we selected female patients of childbearing age from the prospective ALTITUDES cohort. The primary study endpoint was event-free survival (EFS), with an event defined as relapse or progression. We estimated the risk of events according to the use of hormonal contraception [estrogen–progestin (EP) and progestin] and pregnancy status using multivariate time-dependent models, controlling for major confounders. Results: A total of 242 patients (median age, 34.7 years) were included in the present study. The abdominal wall was the most common tumor site (51%). Patients were managed by active surveillance (80%) or surgery (20%). Pregnancy occurred within 24 months before, at the time of, and after DF diagnosis in 33%, 5%, and 10% of the cases, respectively. Exposure to hormonal contraception was documented within 24 months before, at the time of, and after diagnosis in 44%, 34%, and 39% of the cases, respectively. The 2-year EFS was 75%. After adjusting for DF location, tumor size, front-line treatment strategy, and hormonal contraception, we observed an increased risk of events occurring at 24 months after pregnancy [hazard ratio (HR) = 2.09, P = 0.018]. We observed no statistically significant association between the risk of events and current EP exposure (HR = 1.28, P = 0.65), recent EP exposure (within 1-24 months, HR = 1.38, P = 0.39), current progestin exposure (HR = 0.81, P = 0.66), or recent progestin exposure (HR = 1.05, P = 0.91). Conclusions: In our study, a recent history of pregnancy was associated with an increased risk of progression/relapse in patients with newly diagnosed DF, whereas hormonal contraception did not demonstrate an association with progression/relapse.

Additional file 1: Figure 1. Implementation of GUIP1 (a) CRML, (b) TITE-CRM, (c) EWOC, and (d) TITE-EWOC (motivating example).

Introduction/Background Retrospective evaluation of a cohort of patients diagnosed with metastatic endometrial cancer (EC) and to describe the treatment performed as well as the rates of overall survival (OS), progression free survival (PFS) and survival without locoregional recurrence. Methodology Between January 2002 and December 2018, all consecutive patients with EC stade IV were included; patients who did not receive any treatment (CT, RT or surgery) at the time of diagnosis were not included. All treatments performed [chemotherapy (CT), surgery and external radiotherapy (RT)] were collected. Results 56 patients were identified; the median age of the patients was 64 years (39–83); the median follow-up of patients was 4.4 years 95% CI95% [3.4–6]. 53 patients (95%) IVb and 3 patients (5%) Iva. 42 patients (74%) had an endometroid or type 1 histology and 14 patients (26%) had a non-endometroid or type 2 histology. All patients (56) received CT. 37 patients (66%) had surgery, 23 (62%) before CT and 14 (38%) after CT. 25 patients (45%) received adjuvant RT after surgery. 4 patients (7%) presented local-locoregional recurrence, 18 patients (32%) presented metastatic and local-locoregional recurrence and 21 patients (37,5%) isolated metastatic recurrence. The median survival time is 2.9 years 95% CI[1.7–4.8]. 5 year-OS is 33%. The median progression-free survival (PFS) rate is 1.5 years 95% CI [0.91–1.98]. 5 year-PFS is 19%. Cumulative incidence of local-regional recurrence at 1, 3 and 5 years is 17%, 41% and 45%. Conclusion Metastatic EC presents poor prognosis. The use of surgery and adjuvant RT in addition to CT may improve OS, PFS and loco regional recurrence in selected patients. Disclosure Nothing to disclose.

Introduction et but de l’etude Malgre les developpements technologiques (radiotherapie avec modulation d’intensite, ou guidee par l’image), l’escalade de dose dans la radiotherapie du cancer de la prostate reste limitee par le risque de complications, en particulier rectales. La plupart des donnees sur les espaceurs rectaux concerne des dispositifs a base de polyethylene glycol et d’acide hyaluronique. Nous presentons ici une evaluation prospective du ballonnet biodegradable Bioprotect®. Materiel et methodes L’essai intitule BioPro-RCMI ( NCT02478112 ) est une etude interventionnelle portant sur un dispositif medical. L’objectif principal etait d’evaluer le gain relatif dosimetrique pour les organes a risque. Les objectifs secondaires etaient l’evaluation de la toxicite aigue et tardive, des etapes de l’implantation du ballonnet et de sa faisabilite technique, de la qualite de vie au moyen des questionnaires de l’European Organisation for Research and Treatment of Cancer (EORTC) QLQC30 et PR25. Les patients devaient etre atteints d’un cancer de risque intermediaire selon la classification de D’Amico. Une scanographie dosimetrique a ete realise avant et apres la pose de l’espaceur pour evaluer le gain relatif dosimetrique. Nous presentons ici les resultats dosimetriques et cliniques a court terme. Le comite de surveillance independant a recommande l’arret des inclusions apres l’analyse intermediaire compte tenu des resultats positifs. Resultats et analyse statistique Vingt-quatre patients sur 50 initialement prevus ont ete inclus et ont beneficie de l’espaceur. Les dossiers de 22 patients etaient evaluables pour les donnees dosimetriques ( Tableau 1 ). L’âge median etait de 75,5 ans (extremes : 61-81 ans). La concentration serique moyenne d’antigene specifique de la prostate et le volume prostatique medians etaient respectivement de 7,1 ng/ml (extremes : 0,6-19,6 ng/ml) et 34,0 cm3 (extremes : 15,0-89,0 cm3). Onze patients ont beneficie d’une hormonotherapie courte. La dose protocolaire de 78 Gy en 39 fractions a ete delivree chez tous les patients. Les gains dosimetriques etaient tres importants et significatifs au niveau du rectum. Il n’a pas ete retrouve de difference dosimetrique pour la vessie. L’implantation a ete jugee tres facile chez 19 patients (soit 86 % ; deux donnees manquantes) et n’a jamais retarde la radiotherapie. Aucun effet indesirable grave n’a ete rapporte. Six patients ont souffert d’une toxicite aigue rectale, de grades 1 pour cinq patients et de grade 2 pour un patient. Les scores de qualite de vie lies a la fonction digestive n’ont pas ete modifies au cours des 24 mois suivant l’inclusion. Conclusion L’implantation du ballonnet biodegradable Bioprotect® permet un gain dosimetrique majeur pour le rectum, en particulier pour les doses elevees, mais egalement pour les doses intermediaires, et est associee a une tres faible toxicite digestive a court terme.

Introduction et but de l’etude La mucite orale radiochimio induite est un effet secondaire redoutable, et expose a des risques de complications. Notre etude visait a decrire les pratiques de prise en charge de mucite orale radiochimio-induite afin d’identifier les difficultes et l’interet d’elaborer un referentiel simplifie. Materiel et methodes Il s’agissait d’une etude prospective observationnelle et descriptive d’evaluation des pratiques par l’envoi de questionnaires ciblant les praticiens des Hauts-de-France (oncologues, radiotherapeutes, hematologues et specialistes d’organes pratiquant l’oncologie et la chimiotherapie) des hopitaux publics et des cliniques privees. Resultats et analyse statistique Soixante-dix-sept praticiens sur 316 sollicites ont repondu. Quatre-vingt-quinze pour cent des praticiens ont repondu a plus de 90 % du questionnaire. Respectivement, 23, 37 et 46 % consideraient maitriser « pas du tout », « moyennement bien » et « bien » les recommandations de prise en charge de la mucite orale radiochimio induite (Association francophone des soins oncologiques de support [Afsos], Multinational Association of Supportive Care in Cancer [MASCC]/International Society of Oral Oncology [ISOO]). A titre preventif, 91 % des praticiens utilisaient les bains de bouche au bicarbonate de sodium, 24 % des melanges, 22 % des bains de bouche antifongiques et 11 % antiseptiques. La secheresse buccale etait recherchee pour 46 % d’entre eux. Dans leur centre de travail, 71 % des praticiens ne disposaient pas de referentiel de prise en charge et 50 % utilisaient alors les recommandations internationales. Parmi les difficultes identifiees, il s’agissait essentiellement du manque de traitements efficaces et pres d’un tiers des praticiens suggeraient le manque formation. Quatre-vingt-huit pour cent ont trouve un interet en ce questionnaire et 86 % iraient chercher des informations supplementaires pour completer leurs connaissances. Enfin, 83 % indiquaient que le support le plus utile pour ameliorer et simplifier la pratique serait un referentiel de prise en charge sous forme de tableau. Conclusion Dans une population selectionnee d’oncologues exposees aux mucites, 40 % considerent bien maitriser en la gestion. Il existe un interet a l’elaboration d’un referentiel simplifie de prise en charge de la mucite orale radiochimio induite pour faciliter la pratique.

Introduction L’objectif principal des essais cliniques de phase I en oncologie est d’identifier le plus rapidement possible et le plus precisement la dose maximale toleree, definie classiquement comme la dose a laquelle on observe des toxicites intolerables pour une proportion donnee de patients. Plusieurs methodes d’escalade de dose basees sur une modelisation mathematique de la relation dose-toxicite ont ete developpees. Dans ce contexte, la methode de reevaluation continue (« Continual Reassessment Method » [CRM]) introduite par O’Quickley et al. (bayesienne ou frequentiste) a emerge dans les annees 1990. Plus recemment, des variantes telles que l’« Escalation With Overdose Control » (EWOC) qui integre en plus la contrainte ethique de minimiser la probabilite de traiter des patients a des doses excessivement elevees et les methodes « Time To Event » (TITE-CRM et TITE-EWOC) qui prennent en compte le delai d’apparition de l’evenement pour les toxicites tardives ont ete proposees. Plusieurs logiciels implementent chacune des methodes, cependant, aucun ne les rassemble. L’objectif de ce travail est de proposer une interface graphique conviviale et facile a utiliser qui combine l’ensemble des approches et implemente la methode TITE-EWOC. Methodes Differents packages R et fonctions implementant ces methodes ont ete selectionnes. La fonction « crm » du package « dfcrm » pour implementer les methodes CRM ainsi que la fonction « titecrm » de la meme librairie pour la methode TITE-CRM. La fonction « bcrm » du package du meme nom pour la methode EWOC. Enfin, la methode TITE-EWOC qui n’etait pas disponible sous R a ete programmee. Une interface graphique « GUIP1 » pour « Graphical User Interface for Phase 1 » a ete realisee sous le logiciel R en utilisant le langage de programmation TCL/TK via les packages tcltk, tkrplot et tcltk2. Resultats Apres installation de la librairie GUIP1, l’execution de la commande GUIP1() genere une interface permettant d’utiliser l’ensemble des cinq methodes decrites precedemment. Une fenetre est produite par methode avec divers onglets permettant de renseigner les parametres cliniques initiaux et ceux specifiques du modele choisi. L’interface a ete developpee pour a la fois realiser des simulations et gerer un essai clinique en temps reel. Plusieurs options permettant un suivi de l’essai sont disponibles notamment, un export des resultats d’etude et/ou des simulations sous forme de tableaux (par patient et/ou par palier de dose) et de graphiques via des fichiers .pdf et .png, respectivement. Les differentes fonctionnalites seront illustrees a partir d’un exemple concret. Conclusion L’interface GUIP1 permet de realiser des simulations et gerer des essais cliniques de phase I en utilisant des approches recentes de facon simple et conviviale avec une sauvegarde automatique des resultats. Ces methodes d’escalade de dose sont encore sous utilisees en pratique, et, nous esperons que la creation d’un tel package, actuellement en cours de depot sur le CRAN, favorisera et facilitera leur utilisation dans les futurs essais cliniques de phase I.

Background Preclinical studies suggest synergistic antitumour effects of mammalian target of rapamycin (mTOR) inhibitor such as temsirolimus combined with anti-EGFR monoclonal antibody such as cetuximab. Methods Temsirolimus (T) and cetuximab (C) were combined and escalated in cohorts of patients with advanced or metastatic solid tumours, respectively from 15 to 25 mg and 150–250 mg/m2, until the maximum tolerated dose (MTD) was determined. Effort was made in the expansion cohort to enrol patients harbouring a molecular aberration in the human epidermal growth factor receptor (EGFR) and/or phosphoinositide 3-kinase (PI3K) pathways. Paired biopsies were optional to evaluate pathway modulation. Results Among 39 patients enrolled, three experienced dose-limiting toxicities (DLTs): pulmonary embolism (C200 + T20), stomatitis (C250 + T20) and acneiform rash (C250 + T25). The weekly C 250 mg/m2 and T 25 mg dose level was selected as the MTD. The most common treatment-related adverse events were: acneiform rash (97%), oral mucositis (82%), fatigue (59%), nausea (41%) and diarrhoea (36%). The median progression-free survival (PFS) and overall survival (OS) were respectively 2.0 months [95% CI: 1.8, 3.5] and 7.5 months [95% CI: 5.5, 11.9]. Among all patients, partial responses (PRs) and stable diseases (SDs) were observed in 2 (5.1%) and 18 patients (46.2%), respectively. The objective response rate (ORR) in patients with a molecular aberration was 2/14 (14%), versus 0/24 in those without molecular aberration. Conclusions Combination of T + C showed significant but manageable toxicities. Due to modest clinical activity, further evaluation is not recommended. Molecular selection could potentially increase the objective response rate and should be implemented during drug development.

Objectif de l’etude Le sarcome d’Ewing de la cote represente la tumeur thoracique primitive la plus frequente de l’enfant et du jeune adulte, cependant les etudes et donnees specifiques sont rares. Les objectifs principaux de cette etude etaient d’evaluer la survie en fonction du traitement local et de definir des facteurs pronostiques. Materiel et methode Les patients inclus dans l’etude Euro-EWING99 (EE99) etait atteints d’un sarcome d’Ewing localise de la cote, avec ou sans epanchement pleural au diagnostic etaient eligibles. Les donnees ont ete recueillies de maniere prospective grâce a l’etude EE99 et completees retrospectivement. Resultats Les dossiers de 82 patients pris en charge de decembre 1999 a avril 2013 ont ete analyses. Le suivi median etait de 8,4 mois. Cinquante et un pour cent etaient atteints d’un epanchement pleural au moment du diagnostic. Le traitement local comportait une chirurgie d’exerese chez 81/82 patients, le plus frequemment apres une chimiotherapie d’induction. Soixante patients (73 %) ont ete irradies, 28 % dans le lit operatoire, 13 % dans l’hemithorax et 32 % sur les deux. Les probabilites de survie sans recidive et globale a 5 ans etaient respectivement de 69 % et 71 %. Vingt-six tumeurs (31 %) ont recidive en mediane 19 mois apres le diagnostic. La presence d’un epanchement pleural et des marges chirurgicales non saines (R1 ou R2) etaient des facteurs pronostiques independants defavorables de survies globale et sans recidive. L’irradiation de l’hemithorax ameliorait significativement la probabilite de survie globale en cas d’epanchement pleural : 27 % contre 68 % (p = 0,01). L’irradiation du lit operatoire ameliorait significativement la probabilite de survie en cas de mauvaise reponse histologique. Conclusion La presence d’un epanchement pleural au diagnostic et la qualite de l’exerese chirurgicale sont des facteurs pronostiques defavorables independants des sarcomes d’Ewing localises de la cote. L’irradiation hemithoracique ameliore significativement la probabilite de survie en cas d’epanchement pleural initial.

The aim of this study was to assess parental opinions on the advantages and disadvantages of a pediatric oncology day hospital (DH) so that the structure can be better adapted to the children's needs and parents' expectations, and provide a potentially valid alternative to conventional hospitalization (CH).Over a 15-days period, 39 parents of children treated at a DH were approached and asked to fill in a questionnaire on their opinion of the advantages and disadvantages of a DH compared to a CH.The results of this survey were significant. The majority of parents preferred the DH to the CH (69% versus 15%). The illness was perceived as being less severe; and as the child was not continually in the CH context, he/she was able to forget the illness and the hospital to some extent, and was therefore not as anxious. The DH appeared to be better adapted to the child's needs and facilitated the pursuit of normal family life and everyday activities, but imposed constraints on social and professional activities. On the other hand, the CH provided a reassuring treatment context including more comprehensive information, and in particular a better integration of the child and careful monitoring of the disease within the oncology department, and closer relations between the different parents visiting the hospital. In spite of the high preference rate for the DH, in some instances certain disadvantages could outweigh the advantages, e.g., fatigue due to journeys to and from the hospital, or living too far away from the DH; a lack of punctuality, which meant that the parents were unable to plan their day with any certainty; insufficient comfort (noise, a limited number of rooms available); inadequate information; a lack of privacy; and the anxiety connected with having to assume too much responsibility.Overall, it was concluded that the parents appeared to appreciate the aims of the DH (i.e., limiting the treatment constraints imposed on the patient and on the parents themselves, thereby maintaining the quality of family life, assuring adequate treatment, reducing cost of treatment). However, the authors consider that the DH has to be organized in such a way that it takes into account the following: the social aspects, i.e., living conditions, parents' social, economic and professional status; parents' and children's psychological traits, expectations; and access to a local care system. The DH should also have sufficient means and staff at its disposal. Without taking these factors into consideration, the DH and other alternatives to the CH will not be able to adequately care for the patients, or meet the parents' expectations, and may even have a negative effect on the family.

Humoral immunodeficiency after ABMT may worsen the course of infectious complications as already described in this clinical setting; children with low Ig values of the three isotypes during the first week after ABMT experienced more severe infections during the procedure than those with normal values. The aim of the study was to establish the prevalence, the duration and the risk factors of Ig deficiency after ABMT. Serum Ig levels of 160 children treated with high-dose chemotherapy (HDCT) followed by ABMT for solid tumors were studied prospectively before HDCT and weekly from the day after transplantation until the patients were discharged from the unit, as were the associations of the following covariates: patient characteristics, previous conventional chemotherapy (CCT), conditioning regimens, marrow graft and complications following ABMT. Serum Ig deficiency for at least one isotype was already present before HDCT in half of the children and mean serum Ig values decreased after HDCT. Serum Ig deficiency was early (day 7), inconstant, heterogeneous (IgM deficiency was more frequent and lasted longer) and brief (1 month). Children with low Ig values before HDCT were at high risk of profound and prolonged humoral immune deficiency. Previous CCT with more than six different drugs was the main risk factor for low serum IgM values before HDCT, on day 7 and on day 21 post-HDCT. This study shows that Ig replacement therapy could be useful after ABMT provided it is given to the patients defined on the basis of these specific risk factors and serum Ig levels before HDCT.