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International audience; The COVID-19 pandemic has been a source of major disruption for organizations and society. This dramatic situation urged the Information System community to further investigate how potentials of information systems were used to cope with such shocks. The rapid and sporadic growth of the knowledge on this emerging notion of digital resilience calls for a comprehensive review (n=51 papers). In this article, we aim to contribute to a clearer conceptualization of Digital Resilience (DR). First, we distinguish different focus on DR in the literature. Second, using the identified levels of analysis, we focus on the theoretical perspectives used in the literature and discuss them.; La pandémie de la COVID-19 a été une source de perturbation majeure pour les organisations et la société. Cette situation dramatique a poussé la communauté des Systèmes d’Information (SI) à étudier de plus près comment les SI pouvaient être exploités pour faire face à de tels chocs. La croissance rapide et sporadique des connaissances sur cette notion émergente de « résilience digitale » nécessite un examen complet. A l’aide d’une revue de la littérature (n = 51 articles), notre objectif est d’aboutir à une conceptualisation plus claire de la résilience digitale (RD). Premièrement, nous distinguons différents niveaux d’analyse de la RD dans la littérature. Ensuite, en utilisant les niveaux d’analyse identifiés, nous nous concentrons sur les perspectives théoriques utilisées dans la littérature et les discutons.

Background: The open-label, randomised Phase 2 AVATAXHER study (NCT01142778) demonstrated that early PET assessment identified HER2-positive breast cancer patients who responded poorly to neoadjuvant docetaxel plus trastuzumab. Adding neoadjuvant bevacizumab for PET-predicted poor-responders improved pathological complete response (pCR) rates (43.8% vs 24.0%). We investigated long-term study outcomes. Methods: Patients were treated in three groups. All patients initially received two cycles of standard neoadjuvant therapy with [¹⁸F]-FDG PET conducted before each cycle. Those with ≥70% change in the maximum standardised uptake value (∆SUVmax) received four further cycles of standard neoadjuvant therapy (PET responders). PET-predicted poor-responders (∆SUVmax

Introduction Les resultats de l’essai KATHERINE ont demontre un beneficie de Kadcyla® administre en adjuvant sur la survie sans maladie invasive (iDFS) compare a l’Herceptin®, chez des patientes atteintes d’un cancer du sein precoce HER2+ et ayant presente une maladie residuelle invasive au niveau du sein et/ou des ganglions (non-pathological Complete Response, non-pCR) apres traitement neoadjuvant conventionnel. Dans ce contexte, une etude observationnelle (KADor) a ete mise en place afin d’obtenir des donnees sur les caracteristiques et les modalites de prise en charge de ces patientes en France ainsi qu’une estimation de leur nombre. Objectifs L’objectif principal de l’etude etait de decrire les modalites de prise en charge, entre 2014 et 2018, des patientes presentant un cancer du sein HER2+ et relevant d’un traitement medical neoadjuvant initie en 2014. L’estimation de la population cible, de la proportion de patientes non-pCR et de l’iDFS ont ete evaluees en objectifs secondaires. Methodes Etude francaise, observationnelle, retrospective et multicentrique conduite sur les patientes atteintes d’un cancer du sein precoce HER2+ ayant initie un traitement neoadjuvant a base d’Herceptin® en 2014 suivi d’une chirurgie. Un registre a ete mis en place a partir des dossiers patients en vue de recueillir l’exhaustivite des patientes prises en charge dans les centres participants, puis une cohorte de suivi incluant les patientes traitees en adjuvant a base d’Herceptin®. Un redressement a ete applique afin d’assurer la representativite des centres au niveau national. La taille de la population cible nationale a ete estimee par un modele de Poisson base sur les donnees des centres actifs et permettant de predire l’effectif des patientes non-pCR en France metropolitaine. Resultats Sur les 460 centres hospitaliers francais (public/prive) sollicites, 57 ont participe a l’etude. La representativite geographique et par type de centre etait globalement assuree, puis controlee par le redressement. Les populations du registre et de la cohorte etaient respectivement de 306 et 301 patientes. L’âge moyen des patientes incluses dans la cohorte etait de 52 ans (± 12,6). Selon les classifications T (taille de la tumeur) et N (atteinte ganglionnaire) de la tumeur primitive au diagnostic, les patientes etaient majoritairement T2N0 (22,9 %), T2N1 (22,2 %) et T3N1 (13,3 %). Pres de 60 % des patientes presentaient des recepteurs hormonaux. Plus de la moitie (57,1 %) des patientes etaient non-pCR. Le nombre moyen de cycles d’Herceptin® etait de 13,2 cycles avec un intervalle de confiance a 95 % (IC95 %) de [12,8–13,6]. L’hormonotherapie a ete administree a 47,5 % des patientes avec IC 95 % [41,9 %–53,1 %]. A 36 mois, le taux d’iDFS etait estime a 84,1 % avec IC 95 % [79,1 %–87,9 %] sur l’ensemble de la cohorte et respectivement 88,1 % avec IC95 % [80,7 %–92,8 %] chez les patientes pCR et 81,0 % avec IC95 % [73,8 %–86,4 %] chez les non-pCR. Le nombre potentiel de nouvelles patientes sur un an, en France, atteintes d’un cancer du sein precoce HER2+ traitees a base d’Herceptin® en neoadjuvant suivi d’une chirurgie a ete estime a 2015 patientes avec IC95 % [1516–2871]. Parmi elles, le nombre de patientes non-pCR a ete estime a 1152 avec IC95 % [867–1642]. Conclusion L’etude KADor a permis de decrire en vie reelle la prise en charge therapeutique des patientes atteintes d’un cancer du sein precoce HER2+ ayant initie un traitement neoadjuvant a base d’Herceptin® en France suivi d’une chirurgie et d’un traitement adjuvant egalement a base d’Herceptin®. Ces resultats revelent une adequation entre la pratique courante et les recommandations de prise en charge.

e14107 Background: There is increasing interest in using e-health systems for symptom monitoring and alert triggering. ZEMY, a new software medical device, was developed to improve symptom management and enhance patient and health care team interactions. Methods: This was a three-month open-label, interventional, single arm study conducted at five French sites. Adult women with breast cancer (BC) initiating oral and/or parenteral cancer treatment received a smartphone with ZEMY installed and verbal training. Patients started cancer treatment on Day 1 and were followed for three months. Patients entered data for ten prespecified symptoms. The ZEMY software made recommendations to patients on the self-management of symptoms and transmitted automatic messages to the health care team. Primary outcome was patient feasibility response at 3 months (completion of ≥3 symptom reports and a report completion rate of ≥60% per patient). Secondary objectives included ZEMY symptom management, usability and satisfaction, and device deficiencies (DDs). Results: Overall, 54 patients were enrolled (Jun 2018 to Jan 2019) and 52 (96.3%) completed the study. Thirty-one (57.4%) patients were responders; this was not significantly higher than the predefined cut-off and ZEMY feasibility was not demonstrated. Forty-seven (87.0%) patients had ≥3 completed symptom reports and 33 (66.0%) patients had a report completion rate of ≥60% (missing: n = 4). In subgroup analyses, 22/30 (73.3%) patients with locally advanced BC and 24/36 (66.7%) patients aged 40–60 years were responders. ZEMY patient recommendations and health care team automatic messages were considered relevant at least once in > 74% of cases for five of the six symptoms that were reported at least once by more than 1/3 of patients (diarrhea, nausea, fatigue, cutaneous and mucosal toxicities, and anxiety/depression). Using a 0–10 visual analogue scale, mean ZEMY satisfaction score was higher for patients than investigators (6.3 ±2.9 vs 4.4 ±1.5). Overall, 95 DDs were reported in 37 (68.5%) patients. Main reasons for DDs were inappropriate recommendations (n = 51) and device malfunction (n = 36). Conclusions: The primary endpoint of the study was not reached; however, higher response rates were observed in subgroups versus the overall population, indicating that ZEMY may be useful in symptom management in these patients. Generally, patients had a favorable opinion of ZEMY. The DD rate observed indicates the need for better user support in the future. Clinical trial information: NCT03558490.

Background: The open-label, randomised Phase 2 AVATAXHER study demonstrated that early PET assessment identified patients with HER-2 positive breast cancer who responded poorly to standard neoadjuvant therapy (docetaxel plus trastuzumab). Adding bevacizumab to neoadjuvant therapy in PET-predicted poor-responders improved pathological complete response (pCR) rates (from 24·0% to 43·8%). We investigated whether the improved pCR rate translated into improved long-term outcomes. Methods: Patients were treated in three groups. All patients initially received two cycles of standard neoadjuvant therapy with [¹⁸F]-FDG PET conducted before each cycle. Those with a change in the maximum standardised uptake value (∆SUVmax) ≥70% received four further cycles of standard neoadjuvant therapy (PET responder group). PET-predicted poor-responders (∆SUVmax

Clinical trials that combine medical therapy and surgical treatment pose a number of challenges. The ANTHALYA trial investigated the efficacy and safety of adding bevacizumab to neoadjuvant carboplatin-paclitaxel chemotherapy prior to interval debulking surgery (IDS) in patients with ovarian cancer. The success of the trial depended on the efficacy and the safety of the combination and on the surgical effort. Furthermore, at the time of study design, neoadjuvant bevacizumab had not been investigated in ovarian cancer patients and it was unknown if neoadjuvant angiogenic therapy would be well tolerated or would negatively impact the success of IDS. Therefore, safety in the ANTHALYA trial was paramount. To overcome these challenges we conducted the trial in collaboration with French oncologists and surgeons who were experts in the multidisciplinary treatment of ovarian cancer. Toxicity was monitored during the neoadjuvant and IDS periods using a Bayesian approach which provided flexibility in the decision-making process regarding the continuation or rapid discontinuation of the trial in response to a safety signal. We implemented a stopping rule for safety based on a number of pre-defined bevacizumab-related complications of special interest. We also developed an electronic case report form, which greatly facilitated the collection and dissemination of safety information and other trial data. Here we describe how we used these tools to ensure the successful conduct of ANTHALYA and report how it is possible to mix a Bayesian approach for monitoring toxicity and a frequentist approach for evaluating efficacy within the same trial.

Aim To investigate whether adding bevacizumab to neoadjuvant carboplatin-paclitaxel (CP) helps achieve optimal debulking, measured by complete resection rate (CRR) at interval debulking surgery (IDS), in patients with initially unresectable International Federation of Gynecology and Obstetrics stage IIIC/IV ovarian, tubal or peritoneal adenocarcinoma. Methods Multicentre, open-label, non-comparative phase II study. Ninety-five patients randomised (2:1) to receive four cycles of neoadjuvant CP ±3 concomitant cycles of bevacizumab 15 mg/kg (BCP) followed by IDS. Primary objective is to evaluate the CRR at IDS in the BCP group (reference CRR rate defined as 45% CRR). A stopping rule based on bevacizumab-related adverse events (AEs) of special interest was implemented. Results In the BCP group (N = 58), IDS was performed in 40 (69%) patients, of whom 85% had a complete resection. The CRR of this group was therefore 58.6% (34 patients), statistically over pre-defined 45%. The CRR in the CP group was 51.4%: 22 (60%) patients underwent IDS (85% had a complete resection). Grade ≥3 adverse events occurred in 62% of the BCP-treated patients and 63% of the CP-treated patients: mainly blood and lymphatic, gastrointestinal and vascular disorders, without more toxicity with BCP. Postoperative complications (mainly wound, infectious and gastrointestinal complications) occurred in 28% and 36% of the patients, respectively. The pre-specified safety stopping rule was not reached. Conclusion The primary objective was met as the CRR with BCP was significantly higher than the reference rate. Bevacizumab may be safely added to a preoperative program in patients deemed non-optimally resectable, whatever the final surgical decision. Bevacizumab's role in this setting should be further investigated.

5538 Background: ANTHALYA showed that neoadjuvant Bevacizumab (B) added to Carboplatin and Paclitaxel (CP) was well tolerated and achieved encouraging complete resection rates at IDS (58.6%) in unresectable FIGO stage IIIC/IV ovarian, tubal or peritoneal adenocarcinoma (EJC 2017;70:133–42). We report response rates, PFS and long-term safety. Methods: Patients (pts) in ANTHALYA were randomized 2:1 to 4 cycles (c) of neoadjuvant CP ±3 c of B (15 mg/kg), IDS for eligible patients, then 1 c of CP + 3 c CPB + 21 c of B. Response and progression were evaluated by RECIST 1.1 using CT scan and CA-125. Circulating tumor cell counts (CTC) were evaluated at baseline, c2 and IDS. Results: 95 pts were treated in CP (n=37) or BCP (n=58) groups (mean study duration were 16.1 months [mo] and 16.9 mo, respectively). 80 pts (CP: 81% / BCP: 88%) had a CA-125 response (50% reduction in CA-125 level) before IDS. Objective response rates were 65% (62% CP / 67% BCP) before IDS (28 days after c4), 46% at c8 (46% CP/ 47% BCP) and 19% at c26 (19% CP/ 19% BCP). 24 (64.9%) CP pts and 26 (44.8%) BCP pts progressed during follow up (median PFS 21.2 mo [95%CI: 14.5, 26.7] and 23.5 mo [18.5, 30.6], respectively). Median PFS was respectively: 25.8 mo (21.0, 30.0) and 17.1 mo (13.5, 22.2) for pts with/without complete resection at IDS; 21.0 mo (15.0, 25.4) and 25.8 mo (18.5, 27.2) for pts with/without baseline CTCs (n=29 / 59); 21.8 mo (17.5, 27.1) and 22.2 mo (15.3, 38.0) for pts with FIGO IIIC and IV tumors. 36 pts did not receive adjuvant therapy within the study (21 were unresectable for IDS), 59 pts (57% CP / 66% BCP) received it. Of those, 34 pts (52% CP / 61% BCP) had Grade ≥3 adverse events including neutropenia (29% CP / 34% BCP), HBP (10% CP / 8% BCP), proteinuria (10% CP / 0% BCP), deep venous thrombosis (5% CP / 3% BCP), pulmonary embolism (0% CP / 8% BCP). Conclusions: Neoadjuvant BCP followed by IDS and adjuvant BCP achieves high response rates and extended PFS with an acceptable toxicity in this specific population of pts with FIGO stage IIIC/IV ovarian, tubal or peritoneal adenocarcinoma not eligible for primary debulking surgery. IDS outcome and CTC counts should be further explored as long term prognostic factors. Clinical trial information: NCT01739218.