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BACKGROUND Older adults suffering from cancer receive a treatment that, in most cases, causes symptoms such as fatigue, weakness, sleep disturbances, and lethargy. Moreover, the toxicity of the chemotherapy itself can also affect the physical function and the quality of life of cancer patients. Since a poor general health status reduces the chances of survival and these patients are most likely to also suffer from sarcopenia, it is therefore important to be able to improve their physical function through adapted physical activity (APA) as part of a supportive care management. Unfortunately, APA is too often saved for patients in an advanced stage of blood cancer. As a result, there is a lack of data regarding the impact of a regular practice of physical activity (that is concomitant to the administration of chemotherapy) on cancer survival. OBJECTIVE The aim of this study is to assess a new and open rehabilitation program suitable for a frail population of patients that are treated for diffuse large B-cell lymphoma (DLBCL). METHODS PHARAOM (Physical Activity program for the survival of elderly patients with lymphoma) is a phase 3 (1:1) randomized study focusing on a frail population of patients treated for DLBCL. It will include a total of 186 elderly DLBCL patients (aged over 65 years) receiving rituximab plus cyclophosphamide, hydroxydaunorubicin, vincristine, and prednisone (R-CHOP); of these, 93 patients (the investigational group) will receive APA that will be supervised by a dedicated qualified kinesiologist, in addition to chemotherapy. The primary endpoint of this study will be the patients’ event-free survival. Secondary endpoints will include the overall survival, the progression-free survival, the prevalence rates of sarcopenia and undernutrition, as well as the patients’ quality of life. RESULTS The study has been approved by the internal Ethical Committee, and was registered as a clinical trial (NCT04670029) on December 16, 2020. The study will be undertaken in accordance with the Declaration of Helsinki. CONCLUSIONS This study will highlight the benefits of regular APA on the survival of patients treated for a DLBCL. This study could also contribute to our understanding of how an adapted physical program can reduce sarcopenia in cancer patients, and improve their quality of life. By documenting the prevalence and the relationship between sarcopenia and exercise load, we might be able to help physicians to plan better interventions in DLBCL patients. CLINICALTRIAL Clinical Trial: NCT04670029

BACKGROUND Evidence regarding the analgesic effect of distraction through immersion in virtual reality (VR) for care-induced pain, has been documented in several phase II trials but comparison with standard treatments in large-randomized studies are needed. OBJECTIVE In this open-label multicenter randomized phase III trial (ClinicalTrials.gov identifier: NCT 03483194), we evaluated the safety and efficacy of a novel VR therapy solution for distraction in the context of bone marrow (BM) biopsy. METHODS Bliss© is a VR software with four imaginary interactive environments in three dimensions with a binaural sound (head-mounted display). Efficacy was evaluated on pain intensity using a visual analog scale (score from 0-10) immediately after the biopsy. The primary endpoint was patient-assessed pain intensity after BM procedure, with a visual analog scale (VAS). Secondary endpoints were anxiety and tolerance. Overall, 126 patients with previously documented untreated or suspected malignant hemopathy between September 6, 2018, and May 18, 2020, were randomly assigned in a 1:1 ratio to receive pain prevention with a mixture of nitrous oxide/oxygen (MEOPA) (n=63) or VR (n=63) before and during BM biopsy. All patients received local anesthesia (lidocaine) before biopsy. Modified intention-to-treat analysis was performed. RESULTS Participants’ median age was 65.5 (range 18-87) years and 54.2% of patients were male. The average pain intensity was 3.5 (SD 2.6) for the MEOPA group and 3.0 (SD 2.4) for the VR group without any significant difference in age, sex, center or hemopathy (P=.26). Concerning anxiety, 67.5% of patients were afraid before the biopsy and anxiety scores were moderate to very high in 26.3% of patients before the biopsy (fear of pain and revised STAI questionnaires) and 9.0% after the biopsy for all patients without any significant difference between the 2 groups (P=.83). Immersion in VR was well tolerated by the majority of patients in the VR group. CONCLUSIONS The intensity of pain and did not significantly differ between both arms. VR was well tolerated, and satisfaction of patients, nurses and physicians was very high. Virtual reality could be an alternative treatment in case of contraindication or intolerance to MEOPA. CLINICALTRIAL ClinicalTrials.gov identifier: NCT 03483194

BACKGROUND Delays in the diagnosis of neurodevelopmental disorders (NDDs) in toddlers and postnatal depression (PND) in mothers are major public health issues. In both cases, early intervention is crucial. OBJECTIVE We aimed to assess if a mobile app named Malo can reduce delay in the recognition of NDD and PND. METHODS We performed an observational, cross-sectional, data-based study in a population of young parents with a minimum of 1 child under 3 years of age at the time of inclusion and using Malo on a regular basis. We included the first 4000 users matching the criteria and agreeing to participate between November 11, 2021, and January 14, 2022. Parents received monthly questionnaires via the app, assessing skills on sociability, hearing, vision, motricity, language of their infants, and possible autism spectrum disorder. Mothers were also requested to answer regular questionnaires regarding PND, from 4-28 weeks after childbirth. When any patient-reported outcomes matched predefined criteria, an in-app notification was sent to the user, recommending the booking of an appointment with their family physician or pediatrician. The main outcomes were the median age of the infant at the time of notification for possible NDD and the median time of PND notifications after childbirth. One secondary outcome was the relevance of the NDD notification for a consultation as assessed by the physicians. RESULTS Among 4242 children assessed by 5309 questionnaires, 613 (14.5%) had at least 1 disorder requiring a consultation. The median age of notification for possible autism spectrum, vision, audition, socialization, language, or motor disorders was 11, 9, 17, 12, 22, and 4 months, respectively. The sensitivity of the alert notifications of suspected NDDs as assessed by the physicians was 100%, and the specificity was 73.5%. Among 907 mothers who completed a PND questionnaire, highly probable PND was detected in 151 (16.6%) mothers, and the median time of detection was 8-12 weeks. CONCLUSIONS The algorithm-based alert suggesting NDD was highly sensitive with good specificity as assessed by real-life practitioners. The app was also efficient in the early detection of PND. Our results suggest that the regular use of this multidomain familial smartphone app would permit the early detection of NDD and PND. CLINICALTRIAL ClinicalTrials.gov NCT04958174; https://clinicaltrials.gov/ct2/show/NCT04958174

152 Background: In castrate-resistant oligo metastatic prostate Cancer (CRoligoMPC), the benefit of metastases-directed ablative radiotherapy (MDRT) is poorly investigated. Our study retrospectively reviewed the cases of CR oligoMPC treated with MDRT. Methods: Patients receiving MDRT in CRoligoMPC were retrospectively reviewed. Patients were included if: they had < 5 metastases on metabolic work-up, testosterone is < 50 ng/mL, metastases received MDRT. Patients and disease's data were collected: age, Gleason score, time to metastases, time to castration resistance; medical treatments, metastases location (bone versus node); radiotherapy regimens, PSA (PSA doubling time PSADT at the time of MDRT and PSA response). Progression was assessed according to PCWG criteria. PFS and OS are defined as the time from MDRT to first progression, for PFS and death date for OS. Kaplan-Meier analysis was used to summarize time-to-event variables and curves were compared with the log-rank test. A logistic regression was used to identify predictive factors of PFS. Results: the median follow up is 25.6 months.107 patients met inclusion criteria, among those 197 metastases received MDRT. Median age at MDRT time was 73 years. Median hormonosensitivity duration was 38 months (4-225). Forty six patients had metastases at the time of hormonosensitivity and 61 developed metastases in the castration resistance (CR)period (spartan-like population). PSA doubling time at the time of MDT RT was < 12 months in 88%. A median number of 2 metastases per patient was treated (1-4), 54% had RT on bony metastases only, 38% on nodes, 8% on bone + node. In 61 patients with metastases at the time of CRPC, 34.5% received a CR systemic medication before or concomitantly to MDRT, 39% received CR medication at progression, 23.5% never received CR treatment (unknown in 3%). OS is 93% at 2 years and 81.4% at 3 years. For node-only metastases, 2y OS is 100% versus 89% for bone metastases. Median PFS is 12.6 months (IC 95% [9.6; 17]). Metastases location, grade group, PSA or hormonosensitivity duration were not related to PFS in a univariate survival analysis. PFS was 10.2 months when PSA Doubling time was < 6 months, versus 18.2 months when it exceeded 6 months (NS). The PSA 50% response was studied in the Spartan like population, it was 83.4% in patients receiving MDRT AND new generation hormonotherapy; 31% in those who received MDRT without new generation hormonotherapy, and 20% in those who received MDRT at the time of progression of oligometastases occurring under new generation hormonotherapy. Conclusions: In a population of CR oligoM PC with short PSA DT, MDRT leads to a PFS of 12.6 months and to a 3y OS of 81.4%. In this setting, androgen receptor targeting agents are the standard of care. Whether adding MDRT could improve prognosis should be prospectively evaluated.

IntroductionWe aimed to quantify the benefit of olfactory training and visual stimulation assisted by a dedicated web application for patients who experienced olfactory dysfunction for ≥1 month after Sars-Cov-2 infection and compared it with published cohorts of spontaneous recoveries.Materials and MethodsWe performed a prospective observational study. Participants performed olfactory training and visual stimulation assisted by a dedicated web-application. Improvement was defined as a 2-point increase on a 10-point, self-assessed olfactory visual analogue scale.ResultsIn total, 1155 patients were assessable. Improvement was observed in patients who trained 4 weeks and 4 to 8 weeks with high concentration oils in 63.0% (58/92) and 72.9% (137/188) respectively, whereas in historical cohorts, a spontaneous improvement was observed in 7% to 27% without training respectively (p

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Persistent olfactory dysfunction is a significant complication of SARS-CoV-2 infection. Olfactory training involving aromatic oils has been recommended to improve olfactory recovery, but quantitative data are missing.We aimed to quantify the benefit of olfactory training and visual stimulation assisted by a dedicated web application for patients who experienced olfactory dysfunction for ≥1 month.We performed an observational, real-life, data-based study on a cohort of patients who experienced at least 1 month of persistent olfactory dysfunction between January 30 and March 26, 2021. An analysis was performed after a mean olfactory training time of 4 weeks, and at least 500 patients were assessable for primary outcome assessment. Participants exposed themselves twice daily to odors from 4 high-concentration oils and visual stimulation assisted by a dedicated web application. Improvement was defined as a 2-point increase on a 10-point, self-assessed olfactory visual analogue scale.In total, 548 patients were assessable for primary outcome assessment. The mean baseline, self-assessed olfactory score was 1.9 (SD 1.7), and this increased to 4.6 (SD 2.8) after a mean olfactory training time of 27.7 days (SD 17.2). Olfactory training was associated with at least a 2-point increase in 64.2% (352/548) of patients. The rate of patients' olfactory improvement was higher for patients who trained for more than 28 days than that rate for patients who trained for less than 28 days (73.3% vs 59%; P=.002). The time to olfactory improvement was 8 days faster for patients with hyposmia compared to the time to improvement for patients with anosmia (P.001). This benefit was observed regardless of the duration of the olfactory dysfunction.Olfactory training and visual stimulation assisted by a dedicated web application was associated with significant improvement in olfaction, especially after 28 days of olfactory training.

BackgroundPersistent olfactory dysfunction (OD) is a significant complication of SARS-CoV-2 infection. Olfactory training (OT) using aromatic oils are recommended to improve olfactory recovery, but quantitative data are missing.ObjectiveWe aimed to quantify the benefit of OT associated with visual stimulation assisted by a dedicated web-application on patients with 1-month or more OD.MethodsWe performed an observational real-life data-based study on a cohort of patients with at least 1-month persistent OD included between 1/30/21 and 3/26/2021. Analysis was performed after a 4-weeks mean time of OT and at least 500 patients assessable for primary outcome. Participants exposed themselves twice daily to odors from four high concentration oils and visual stimulation assisted by a dedicated web-application. Improvement was defined as a 2/10 points increase on self-assessed olfactory visual analogue scale.Results548 were assessable for primary outcome assessment. The mean baseline self-assessed olfactory score was 1.9/10 (SD 1.7) and increase to 4.6 (SD 2.8) beyond a mean time of olfactory training of 27.7 days (SD 17.2). Olfactory training was associated with at least 2-points increase in 64.2% (n=352). The rate of patients with improvement was higher in patients having trained for more than 28 days versus patients having trained for less than 28 days (72.2% vs 59.0% respectively, p=.002). The kinetic of improvement was 8 days faster in hyposmic than in anosmic patients (pConclusionsOT associated with visual stimulation assisted by a dedicated web-application was associated with significant improvement in olfaction, especially if OT duration was superior to 28 days.

Background Persistent olfactory dysfunction is a significant complication of SARS-CoV-2 infection. Olfactory training involving aromatic oils has been recommended to improve olfactory recovery, but quantitative data are missing. Objective We aimed to quantify the benefit of olfactory training and visual stimulation assisted by a dedicated web application for patients who experienced olfactory dysfunction for ≥1 month. Methods We performed an observational, real-life, data-based study on a cohort of patients who experienced at least 1 month of persistent olfactory dysfunction between January 30 and March 26, 2021. An analysis was performed after a mean olfactory training time of 4 weeks, and at least 500 patients were assessable for primary outcome assessment. Participants exposed themselves twice daily to odors from 4 high-concentration oils and visual stimulation assisted by a dedicated web application. Improvement was defined as a 2-point increase on a 10-point, self-assessed olfactory visual analogue scale. Results In total, 548 patients were assessable for primary outcome assessment. The mean baseline, self-assessed olfactory score was 1.9 (SD 1.7), and this increased to 4.6 (SD 2.8) after a mean olfactory training time of 27.7 days (SD 17.2). Olfactory training was associated with at least a 2-point increase in 64.2% (352/548) of patients. The rate of patients’ olfactory improvement was higher for patients who trained for more than 28 days than that rate for patients who trained for less than 28 days (73.3% vs 59%; P=.002). The time to olfactory improvement was 8 days faster for patients with hyposmia compared to the time to improvement for patients with anosmia (P Conclusions Olfactory training and visual stimulation assisted by a dedicated web application was associated with significant improvement in olfaction, especially after 28 days of olfactory training.

BACKGROUND Persistent olfactory dysfunction is a significant complication of SARS-CoV-2 infection. Olfactory training involving aromatic oils has been recommended to improve olfactory recovery, but quantitative data are missing. OBJECTIVE We aimed to quantify the benefit of olfactory training and visual stimulation assisted by a dedicated web application for patients who experienced olfactory dysfunction for ≥1 month. METHODS We performed an observational, real-life, data-based study on a cohort of patients who experienced at least 1 month of persistent olfactory dysfunction between January 30 and March 26, 2021. An analysis was performed after a mean olfactory training time of 4 weeks, and at least 500 patients were assessable for primary outcome assessment. Participants exposed themselves twice daily to odors from 4 high-concentration oils and visual stimulation assisted by a dedicated web application. Improvement was defined as a 2-point increase on a 10-point, self-assessed olfactory visual analogue scale. RESULTS In total, 548 patients were assessable for primary outcome assessment. The mean baseline, self-assessed olfactory score was 1.9 (SD 1.7), and this increased to 4.6 (SD 2.8) after a mean olfactory training time of 27.7 days (SD 17.2). Olfactory training was associated with at least a 2-point increase in 64.2% (352/548) of patients. The rate of patients’ olfactory improvement was higher for patients who trained for more than 28 days than that rate for patients who trained for less than 28 days (73.3% vs 59%; P=.002). The time to olfactory improvement was 8 days faster for patients with hyposmia compared to the time to improvement for patients with anosmia (P001). This benefit was observed regardless of the duration of the olfactory dysfunction. CONCLUSIONS Olfactory training and visual stimulation assisted by a dedicated web application was associated with significant improvement in olfaction, especially after 28 days of olfactory training.

Background Prognostic factors can impact the quality of life and overall survival in metastatic situations: sarcopenia and nutritional status disorders. Methods We conducted a non-interventional, observational prospective study during 3 consecutive months (SPACE trial, ClinicalTrials.gov identifier: NCT04714203). Performance status, lumbar skeletal muscle index (by CT scan), albumin, C-reactive protein, or LDH, were collected from medical records in the classic balance sheet at inclusion and then at 3 and 6 months after the day of inclusion. Results 38 patients were included with a median age of 68 years old and 31 were evaluable for sarcopenia. 58.1% of patients with metastatic cancer were sarcopenic at the diagnosis and 61% at 6 months. At the inclusion, 87.5% of sarcopenic patients were men (p

BACKGROUND We developed a questionnaire on a web application for analyzing COVID-19 contamination circumstances in France during the second wave of the pandemic. OBJECTIVE This study aims to analyze the impact on contamination characteristics before and after the second partial lockdown in France to adapt public health restrictions to further prevent pandemic surges. METHODS Between December 15 and 24, 2020, after a national media campaign, users of the sourcecovid.fr web application were asked questions about their own or a close relative’s COVID-19 contamination after August 15, 2020, in France. The data of the contamination’s circumstances were assessed and compared before and after the second partial lockdown, which occurred on October 25, 2020, during the second wave of the pandemic and was ongoing on December 24, 2020. RESULTS As of December 24, 2020, 441,000 connections on the web application were observed. A total of 2218 questionnaires were assessable for analysis. About 61.8% (n=1309) of the participants were sure of their contamination origin, and 38.2% (n=809) thought they knew it. The median age of users was 43.0 (IQR 32-56) years, and 50.7% (n=1073) were male. The median incubation time of the assessed cohort was 4.0 (IQR 3-5) days. Private areas (family’s or friend’s house) were the main source of contamination (1048/2090, 50.2%), followed by work colleagues (579/2090, 27.7%). The main time of day for the contamination was the evening (339/961, 35.3%) before the lockdown and was reduced to 18.2% (86/473) after the lockdown (PPP CONCLUSIONS Modalities of transmissions significantly changed before and after the second lockdown in France. The main sources of contamination remained the private areas and with work colleagues. Work became the main location of contamination after the lockdown, whereas contaminations in collective places were strongly reduced. CLINICALTRIAL ClinicalTrials.gov NCT04670003; https://clinicaltrials.gov/ct2/show/NCT04670003

BACKGROUND Patient self-assessment via a mobile app detects actionable symptoms and has been shown to detect lung cancer relapses early, thereby lengthening survival. OBJECTIVE The purpose of this study was to assess the incidence of chief symptoms associated with the main tobacco-induced pathologies in both current and ex-smokers through a self-assessment smartphone app and to evaluate the app’s capacity to encourage users to quit smoking or reduce consumption, as well as its impact on early lung cancer stages at the time of diagnosis. METHODS Current and ex-smokers were recruited through an advertising campaign in Sarthe county (France) proposing the free download of a smartphone app. App users were asked to answer 13 questions related to symptoms associated with tobacco-induced diseases (chronic obstructive pulmonary disease [COPD], cardiovascular diseases, cancer). In the event of any positive answer, a message was displayed recommending the user to consult a physician. In addition, they were asked about smoking cessation intention before and after answering these 13 questions. Finally, incidence of stage 1 or 2 lung cancers diagnosed during the launch period of our application was evaluated by comparing data from various sources to those from the same period during the previous year. RESULTS Of the 5671 users who were eligible for evaluation, an alert was sent to the majority (4118/5671, 72.6%), with a higher incidence for current smokers (2833/3679, 77.0% vs 1298/1992, 65.2%; PP=.04), whereas it remained unchanged in the neighboring county of Maine-et-Loire. CONCLUSIONS A majority of current and ex-smokers showed worrying symptoms, and the use of a self-assessment smartphone app may drive a majority of smokers toward the intention of smoking cessation or decreasing consumption. A randomized study should be performed to confirm this intention and to support the potential increase of symptomatic lung cancer detection at early, surgery-accessible stages. CLINICALTRIAL ClinicalTrials.gov NCT04048954; https://www.clinicaltrials.gov/ct2/show/NCT04048954

Background Patient self-assessment via a mobile app detects actionable symptoms and has been shown to detect lung cancer relapses early, thereby lengthening survival. Objective The purpose of this study was to assess the incidence of chief symptoms associated with the main tobacco-induced pathologies in both current and ex-smokers through a self-assessment smartphone app and to evaluate the app’s capacity to encourage users to quit smoking or reduce consumption, as well as its impact on early lung cancer stages at the time of diagnosis. Methods Current and ex-smokers were recruited through an advertising campaign in Sarthe county (France) proposing the free download of a smartphone app. App users were asked to answer 13 questions related to symptoms associated with tobacco-induced diseases (chronic obstructive pulmonary disease [COPD], cardiovascular diseases, cancer). In the event of any positive answer, a message was displayed recommending the user to consult a physician. In addition, they were asked about smoking cessation intention before and after answering these 13 questions. Finally, incidence of stage 1 or 2 lung cancers diagnosed during the launch period of our application was evaluated by comparing data from various sources to those from the same period during the previous year. Results Of the 5671 users who were eligible for evaluation, an alert was sent to the majority (4118/5671, 72.6%), with a higher incidence for current smokers (2833/3679, 77.0% vs 1298/1992, 65.2%; P Conclusions A majority of current and ex-smokers showed worrying symptoms, and the use of a self-assessment smartphone app may drive a majority of smokers toward the intention of smoking cessation or decreasing consumption. A randomized study should be performed to confirm this intention and to support the potential increase of symptomatic lung cancer detection at early, surgery-accessible stages. Trial Registration ClinicalTrials.gov NCT04048954; https://www.clinicaltrials.gov/ct2/show/NCT04048954

To investigate the use of metabolic parameters as early prognostic factors during concomitant chemoradiotherapy for locally advanced cervix carcinoma (LACC). Between February 2008 and January 2012, 34 consecutive patients treated for LACC (International Federation of Gynecology and Obstetrics Staging System stage IB2-IVA) were included in a retrospective study. Treatment was standard of care: total dose of 45 Gy in 1.8 Gy per fraction with concurrent cisplatin followed by brachytherapy. 18F-FDG PET-CT modalities were performed before treatment and per-treatment (at 40 Gy). The analyzed parameters were: maximum standardized uptake value (SUVmax), SUVmax variations of the primary tumor between the 2 investigations (DSUVmax), metabolic tumor volume (MTV), and total lesion glycolysis (TLG). Survival was assessed according to early metabolic changes during chemoradiotherapy. Median follow-up was 16 months (range, 5.3 to 32.4 mo). Median SUVmax before treatment was 13.15 (5.9 to 31) and was 5.05 (0 to 12) per-treatment. Median DSUVmax was 63.97% (0% to 100%). Median MTV before treatment was 44.16 mL (3.392 to 252.768 mL) and was 5.44 mL (0 to 69.88 mL) per-treatment. Median TLG before treatment was 249.82 mL (13.40 to 1931.10 mL) and was 20.14 mL (0 to 349.99 mL) per-treatment. At 40 Gy, SUVmax≥6, DSUVmax≤40%, MTV≥5.6 mL, and TLG≥21.6 mL were significantly associated with overall survival and progression-free survival reduction. MTV predicted progression with a sensitivity of 80% and a specificity of 87.5% and TLG with a sensitivity of 80% and a specificity of 83.3%. PET-CT imaging could be useful as an early prognostic factor during treatment for LACC. MTV and TLG seem to provide better prognostic information than SUVmax and DSUVmax.

Symptom monitoring during chemotherapy via web-based patient-reported outcomes (PROs) was previously demonstrated to lengthen survival in a single-center study. A multicenter randomized clinical trial comparedweb-based monitoring vs standard scheduled imaging to detect symptomatic recurrence in patients with lung cancer following initial treatment. A planned interim analysis (9-month follow-up) founda significant survival benefit (19-month survival in the PRO group vs 12 months in the control group). We now present the final overall survival analysis.

6573 Background: The prevention of care-induced pain is a central concern for all healthcare teams in hematology units. Use of MEOPA (Oxygen + Nitrous Oxide) is today a standard of care for relaxation procedure. Distraction through immersion in virtual reality (VR) has already documented its analgesic effects in several phase II trials but comparison with standard treatments in a large randomized study is needed. Methods: We conducted an open-label multicenter randomized phase III trial (ClinicalTrials.gov identifier: NCT03483194). We assessed the safety and efficacy of a new therapeutic virtual reality solution for pain distraction, Bliss, in prevention of pain and anxiety before performing a bone marrow biopsy. Bliss is a VR software with four imaginary interactive environments in three dimensions with binaural sound (head-mounted display). Efficacy was evaluated by pain intensity with visual analog scale (score from 0 to 10) just after the biopsy and anxiety by 2 questionnaires (fear of pain before the biopsy and revised STAI questionnaire before and after the biopsy). The primary end point was patient-assessed pain intensity after the bone marrow procedure. Results: A total of 126 patients were enrolled with previously untreated malignant hemopathy between September 6, 2018 and May 18, 2020. They were randomly assigned in a 1:1 ratio to receive pain prevention with MEOPA (n=63) or Bliss (n=63) before and during their bone marrow biopsy. All patients received a local anesthesia with lidocaïne before the biopsy. Median age of the study population was 65.5 years old (range 18 to 87) and 54,2% were men. The average pain intensity was 3.5 (standard deviation 2.6) for the MEOPA group and 3.0 (SD 2.4) for the VR group (p=0,26) without any significant difference according to age, gender or hemopathy. Concerning anxiety, 67.5% of patients were afraid before the biopsy and anxiety scores were moderate to very high in 26.3% of patients before the biopsy (STAI questionnaire) and 9.0% after the biopsy for all patients (17.3% of reduction in anxiety for the MEOPA group and 17.2% for the VR group, p=0.83). Immersion in VR was well tolerated in 100% of patients included in the VR group. Physicans were very satisfied by the relaxation procedure in 64.9% of cases (52.5% in the MEOPA group and 77.6% in the VR group, p=0.01) and recommended re-use of the technique in 54.2% in the MEOPA group and 79,1% in the VR group (p=0.02). Conclusion: The intensity of pain did not significantly differ in both arms. Bliss-based relaxation method was well tolerated and the satisfaction of patients and physicians was very high in VR group. This study validates the use of immersion in VR with Bliss as a new digital therapeutics and support the integration of the software in the panel of supportive care. Key words: virtual reality, bone marrow biopsy, pain. Clinical trial information: 03483194.

Background We developed a questionnaire on a web application for analyzing COVID-19 contamination circumstances in France during the second wave of the pandemic. Objective This study aims to analyze the impact on contamination characteristics before and after the second partial lockdown in France to adapt public health restrictions to further prevent pandemic surges. Methods Between December 15 and 24, 2020, after a national media campaign, users of the sourcecovid.fr web application were asked questions about their own or a close relative’s COVID-19 contamination after August 15, 2020, in France. The data of the contamination’s circumstances were assessed and compared before and after the second partial lockdown, which occurred on October 25, 2020, during the second wave of the pandemic and was ongoing on December 24, 2020. Results As of December 24, 2020, 441,000 connections on the web application were observed. A total of 2218 questionnaires were assessable for analysis. About 61.8% (n=1309) of the participants were sure of their contamination origin, and 38.2% (n=809) thought they knew it. The median age of users was 43.0 (IQR 32-56) years, and 50.7% (n=1073) were male. The median incubation time of the assessed cohort was 4.0 (IQR 3-5) days. Private areas (family’s or friend’s house) were the main source of contamination (1048/2090, 50.2%), followed by work colleagues (579/2090, 27.7%). The main time of day for the contamination was the evening (339/961, 35.3%) before the lockdown and was reduced to 18.2% (86/473) after the lockdown (P Conclusions Modalities of transmissions significantly changed before and after the second lockdown in France. The main sources of contamination remained the private areas and with work colleagues. Work became the main location of contamination after the lockdown, whereas contaminations in collective places were strongly reduced. Trial Registration ClinicalTrials.gov NCT04670003; https://clinicaltrials.gov/ct2/show/NCT04670003

Introduction A multicenter randomized clinical trial in France found an overall survival benefit of web-based patient-reported outcome (PRO)–based surveillance after initial treatment for lung cancer compared with conventional surveillance. The aim of this study was to assess the cost-effectiveness of this PRO-based surveillance in lung cancer patients. Methods This medico-economic analysis used data from the clinical trial, augmented by abstracted chart data and costs of consultations, imaging, transportations, information technology, and treatments. Costs were calculated based on actual reimbursement rates in France, and health utilities were estimated based on scientific literature review. Willingness-to-pay thresholds of €30,000 per quality-adjusted life year (QALY) and €90,000 per QALY were used to define a very cost-effective and cost-effective strategy, respectively. Average annual costs of experimental and control surveillance approaches were calculated. The incremental cost-effectiveness ratio was expressed as cost per life-year gained and QALY gained, from the health insurance payer perspective. One-way and multivariate probabilistic sensitivity analyses were performed. Results Average annual cost of surveillance follow-up was €362 lower per patient in the PRO arm (€941/year/patient) compared to control (€1,304/year/patient). The PRO approach presented an incremental cost-effectiveness ratio of €12,127 per life-year gained and €20,912 per QALY gained. The probabilities that the experimental strategy is very cost-effective and cost-effective were 97% and 100%, respectively. Conclusions Surveillance of lung cancer patients using web-based PRO reduced the follow-up costs. Compared to conventional monitoring, this surveillance modality represents a cost-effective strategy and should be considered in cancer care delivery.

Background : during 2008 we have collected one hundred observations of persistent significant alopecia (PSA). FEC 100-docetaxel 100 mg/msq regimen was mostly concerned. We therefore decided to evaluate exact incidence of this relevant side effect through women points of view. Methods : ERALOP is a retrospective study using a self-questionnaire targeting patients (pts) treated with this sequential regimen from 2008 to 2009. The primary objective was to estimate the incidence of a PSA at 6 months after last course of docetaxel with CTCAE 4.0 classification : grade 1 : hair loss of up to 50% not obvious from a distance, a different hair style may be required to cover the hair loss, grade 2 : hair loss > 50% with a psychosocial impact. The sample size calculation of 635 patients took into account : PSA incidence of 3.2% (TAC regimen), precision of 0.015, α risk at 0.05, 20% patients lost for follow up. ERALOP study was approved by local ethic comitee. Results: from July 2012 to October 2012, 829 pts received a self-questionnaire. 176 pts (21%) did not answer and were considered as without PSA. 653 (79%) answers with medical data fully documented were collected. Median age of patients was 56 years. Six months after last docetaxel course, PSA incidence grade 2 : 8.6% (71 pts), grade 1 : 32.6% (271 pts), grade 0 : 56% (466 pts), NA : 2.5% (21 pts). 73% of pts with PSA received hormonotherapy. At the time of the inquiry (median follow up of 3.7 years), PSA incidence grade 2 was 3.5% (29 pts), grade 1 : 30% (248 pts), grade 0 : 63,8% (529 pts), for a global PSA incidence of 33.4%. Between 6 months after last course of docetaxel and time of the inquiry, it appears slight or total regrowth for 40 pts with PSA grade 2 and 187 with PSA grade 1.Three pts still wore a wig, and many pts had suboptimal regrowth of eyelash (31%), eyebrow (47%), pubic hair (27%), and nail disorders (27%). A multivariate analysis was performed to look for PSA risk factors. All the oral treatments, including dexpanthenol, biotin, methionine cysteine and cystin-vitamin B6 proved to have no efficacy. Treatment by topical minoxidil could have a little efficacy. Impairment of health-related quality of life will be assesed by Dermatology Life Quality Index (DLQI) and alopecia grade will be evaluated at the end of hormonotherapy. Conclusions: Physicians and patients should be aware of this new distressing side-effect. This high level of PSA lead us to conduct ALOPREV trial to investigate, in spite of FEC induced alopecia, the properties of cooling cap prevention trial during docetaxel infusion. Preliminary results are encouraging and this option could be considered. Citation Format: Hugues Pierre Bourgeois, Aurélie Jamet, Françoise Grudé, Carole Adounkpe, Pierre Kerbrat, Remy Delva, Hélène Simon, Philippe Deguiral, Bertrand Diquet, Pascale Lainé, Anne-Lise Septans. ERALOP study: Post adjuvant FEC - docetaxel chemotherapy for early breast cancer: Hair regrowth in the real life [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P5-21-05.

BACKGROUND AND PURPOSE We performed a retrospective single-center study to assess if midtreatment 18F-FDG PET/CT could predict local control and survival in patients with locally advanced non-small cell lung cancer treated with concurrent chemoradiotherapy. METHODS Thirty-one consecutive patients with unresectable or locally advanced lung cancer (T2-4 N0-3 M0) were treated with concurrent chemoradiotherapy in our center. Each patient received 18F-FDG PET/CT before treatment and at midtreatment time when a radiation therapy dose of 30 Gy was delivered. We assessed several PET/CT parameters as follows: SUV max, ΔSUV mean, ΔSUV max, variation of hypermetabolic tumor volume, and the variation of tumor total lesion glycolysis (ΔTLG). Univariate analysis was performed, and a stepwise procedure was used to define final multivariate model. RESULTS The ΔTLG was statistically correlated to overall survival (OS) (P = 0.035), progression-free survival (P = 0.023), and local control (P = 0.043) in univariate analysis. A decrease in TLG over 15% was statistically correlated to a better OS (P = 0.007; hazards ratio [HR], 7.439; 95% confidence interval [CI], 1.168-28.897) and progression-free survival (P = 0.010; HR, 5.695; 95% CI, 1.506-21.537) in univariate analysis. In multivariate analysis, ΔTLG superior to -15% was significantly correlated to a worse OS (P = 0.020; HR, 5.973; 95% CI, 1.324-26.953). CONCLUSIONS Early assessment of TLG response by 18F-FDG PET/CT during concomitant radiochemotherapy of non-small cell lung cancer might be associated with survival.

WOS:000410799200009; International audience; Background: The use of web-based monitoring for lung cancer patients is growing in interest because of promising recent results suggesting improvement in cancer and resource utilization outcomes. It remains an open question whether the overall survival (OS) in these patients could be improved by using a web-mediated follow-up rather than classical scheduled follow-up and imaging. Methods: Advanced-stage lung cancer patients without evidence of disease progression after or during initial treatment were randomly assigned in a multicenter phase III trial to compare a web-mediated follow-up algorithm (experimental arm), based on weekly self-scored patient symptoms, with routine follow-up with CT scans scheduled every three to six months according to the disease stage (control arm). In the experimental arm, an alert email was automatically sent to the oncologist when self-scored symptoms matched predefined criteria. The primary outcome was OS. Results: From June 2014 to January 2016, 133 patients were enrolled and 121 were retained in the intent-to-treat analysis; 12 deemed ineligible after random assignment were not subsequently followed. Most of the patients (95.1%) had stage III or IV disease. The median follow-up was nine months. The median OS was 19.0 months (95% confidence interval [CI] = 12.5 to non-calculable) in the experimental and 12.0 months (95% CI = 8.6 to 16.4) in the control arm (one-sided P = .001) (hazard ratio = 0.32, 95% CI = 0.15 to 0.67, one-sided P = .002). The performance status at first detected relapse was 0 to 1 for 75.9% of the patients in the experimental arm and for 32.5% of those in the control arm (two-sided P \textless .001). Optimal treatment was initiated in 72.4% of the patients in the experimental arm and in 32.5% of those in the control arm (two-sided P \textless .001). Conclusions: A web-mediated follow-up algorithm based on self-reported symptoms improved OS due to early relapse detection and better performance status at relapse.

The palliative treatment for cervico-thoracic spinal metastases is based on a three-dimensional conformal radiation therapy (3D-CRT). Digestive toxicities are common and cause a clinical impact frequently underestimated in patients. We performed a retrospective study of digestive side effects occurring after palliative 3D-CRT for cervico-thoracic spinal metastases. All patients receiving palliative 3D-CRT at Jean Bernard Center from January 2013 to December 2014 for spinal metastases between the 5th cervical vertebra (C5) and the 12th thoracic vertebra (T12) were eligible. Three-dimensional conformal RT was delivered by a linear accelerator (CLINAC, Varian). Premedication to prevent digestive toxicities was not used. Adverse events (“esophagitis” and “nausea and/or vomiting”) were evaluated according to the NCI-CTCae (version 4). From January 2013 to December 2014, 128 patients met the study criteria. The median age was 68.6 years [31.8; 88.6]. Most patients (84.4%) received 30 Gy in 10 fractions. The median overall time of treatment was 13 days [3–33]. Forty patients (31.3%) suffered from grade ≥ 2 of “esophagitis” (35 grade 2 (27.4%) and 5 grade 3 (3.9%)). Eight patients (6.3%) suffered from grade ≥ 2 of “nausea and/or vomiting” (6 grade 2 (4.7%), 1 grade 3 (0.8%), and 1 grade 4 (0.8%)). The high incidence of moderate to severe digestive toxicities after palliative 3D-CRT for cervico-thoracic spinal metastases led to consider static or dynamic intensity-modulated radiation therapy (IMRT) to reduce the dose to organ at risk (the esophagus and stomach). Dosimetric studies and implementation in the clinic should be the next steps.

We retrospectively compared survivals in patients with a lung cancer history and followed by the so-called sentinel Web-application that allows early detection of relapse and early palliative care initiation versus a conventional follow-up in our center. The survival in 98 consecutive patients with lung cancer was assessed. The first part of them (the control arm) was retrospectively recruited between March 2011 and August 2012. The second half of them (the experimental arm) was prospectively recruited between August 2012 and December 2013 to weekly fill a form of 11 self-assessed symptoms, then processed by the “sentinel” Web-application. Data were sent to this sentinel application in real-time between planned visits. An email alert was sent to the oncologist when self-scored symptoms matched some predefined criteria. Follow-up visit and imaging were then organized after a phone call for confirming the suspect symptoms. In the control arm (49 patients), a common follow-up was applied (visit and imaging every 2 to 6 mo according to stage of tumor and kind of treatment). Median follow-up duration was 12.3 months in the experimental arm and 16.7 months in the control arm (P=0.27). Survival was significantly better in the sentinel arm than in the control arm (P=0.0014). Median survival was 16.7 months in the control arm and 22.4 months in the experimental arm. One-year survival was 86.6% in the experimental arm and 59.1% in the control arm. Survival may be improved by early detection of relapse and early palliative care initiation by using sentinel-like Web-application.

Concurrent radiochemotherapy (CRC) is a standard treatment in patients with inoperable locoregionally advanced ear-nose-throat (ENT) cancer. We report the safety and efficacy of CRC with daily fractionated 5-fluorouracil and cisplatin ('F' 5FU-CDDP) in a monocentric retrospective cohort. From January 2006 to August 2012, all patients with unresectable (or inoperable) nonmetastatic locoregionally advanced ENT cancer treated curatively by means of radiotherapy (normal fractionated 70 Gy to the macroscopic tumor and prophylactic 50 Gy) with three courses (week 1-week 4-week 7) of 'F' 5FU-CDDP regimen (800 mg/m/day of 5-fluorouracil and 20 mg/m/day of CDDP from day 1 to day 4) were included. Seventy patients underwent CRC (86% men, median age 58 years old, 100% squamous cell carcinoma, 97% stage III/IV). Fifty-six patients received the three complete courses of chemotherapy with cumulative doses of CDDP of 217 mg/m/patient (dose intensity ratio of 90.5%). After a median follow-up period of 30.7 months, median overall and disease-free survivals were 34.1 [95% confidence interval (CI) (21.6-56.8)] and 50.2 months [95% CI (17.4-NA)] with 71% [95% CI (57.5-81)] and 67% [95% CI (51.8-78.5)] for locoregional control at 2 and 5 years, respectively. In all, 58.5% of grade 3 or higher mucositis and 24% of radioepithelitis were observed, but only 11.5, 3, and 1.5% of grade 3 or higher neutropenia, nephrotoxicity, and neurotoxicity were observed, respectively. No deaths from toxicity occurred. CRC with three courses of 'F' 5FU-CDDP appears effective and could be an alternative to standard CRC treatment. Randomized studies are required to be able to use this treatment regimen routinely.

6500Background: In a previous interim analysis, we found a 7-month median overall survival (OS) benefit (p = 0.002) associated with web-based monitoring to detect recurrence in lung cancer patients...

e11562 Background: the use of oral cancer chemotherapy (OCT) or targeted therapy (OTT) is in constant increase, because of new pharmacological presentations, patient convenience or in order to increase health cost effectiveness. In a self administered medication, patient’s compliance has to be considered. Nevertheless, little is known about OCT or OTT compliance. It appeared of interest to evaluate the compliance rate in France for such therapies. Methods: the primary objective was compliance assessed based on Medication Possession Ratio (MPR): number of doses taken divided by number of doses expected. At each cycle a pharmacist counted tablets taken and remaining ones. Tolerance and dose adaptation were assessed through patient’s diary and adverse events. QOL, treatment perception and understanding from patient’s side were secondary objectives. Ethic committee’s approval was obtained. Population: patients >18 years, OCT and/or OTT planned for cancer, willing to participate, able to manage oral treatment ...

e14539 Background: A multicenter phase II trial explored individual 3-drug simultaneous tailoringfor advanced colorectal cancer patients treated with FOLFIRI-Cetuximab regimen using pharmacogenetic...

LBA9006 Background: We developed a web-application for an early detection of symptomatic relapse, complications and early supportive care in high-risk lung cancer patients between visits. A dynamical analysis of the weekly self-reported symptoms automatically triggered physician visit. Methods: We performed a national multi-institutional phase 3 prospective randomized study to compare web-application follow-up (experimental arm) for which patient’s self-scored symptoms that were weekly sent (between planned visits) to the oncologist and a clinical routine assessment with a CT-scan (every 3-6 months or at investigator’s discretion - standard arm). High risk lung cancer patients without progression and with a 0-2 performance status (PS) after an initial treatment were included. Maintenance chemotherapy or TKI therapy were allowed. In the experimental arm, an email alert was sent to the oncologist when some predefined clinical criteria were fulfilled: an imaging was then quickly prescribed. Early supportive cares were provided if adequate. The primary endpoint was to detect an improvement of 12% in 9 months survival in favor of the experimental arm (α = 5%, β = 20%, unilateral test). The boundary for declaring superiority with respect to overall survival at the pre-planned interim analysis was a p-value of less than 0.006. The PS at relapse, the quality of life (QOL) and cost-effectiveness were also investigated. Results: 121 patients were included in the intent-to-test survival analysis (90% were stage III/IV, median age: 65 y): 60 (61) in the experimental (standard) arms with equivalent baseline characteristics. Median follow-up was 9 months. Median overall survival in months was 19 (11.8), p=0.0014 (n = 121; HR = 0.33; 95 % CI, 0.16-0.67) and the PS at the first relapse was 0-1 for 81.5% (35.3%) of the patients (p