Background

The National Comprehensive Cancer Network (NCCN) Guidelines for Distress Management recommend that cancer patients should be promptly treated if the patient are distressed (more than 4 DT score). Numerous interventions, such as cognitive-behavioral therapy (CBT), relaxation, and psychosocial therapy, have been shown in randomized controlled trials to be efficacious in addressing distress in patients with cancer. However, many of these interventions have a low potential for implementation as part of routine care because of their complexity, the number of resources required to deliver them, and the limited range of distress-related problems they address. We aimed to evaluate whether psychosocial services for newly diagnosed distressed cancer patients would reduce the risk of 1 year mortality using real-world data.

Methods

We conducted a retrospective cohort study of 4,961 newly diagnosed cancer patients who underwent distress screening within three months after diagnosis and reported distress scores of 4 or higher between July 2014 and December 2017. For this study, it was considered that a patient used a psychosocial service if they had in-depth counseling by a social worker, visited the Supportive Care Center (SCC), or took any education program at the Cancer Education Center (CEC). The primary endpoint was all-cause mortality within one year until December 31, 2018.

Results

There were 18% had access to psychosocial services. During 4,652 person-years of follow-up, patients who used psychosocial services had a lower risk of 1-year mortality than those who did not (Hazard Ratio (HR) = 0.64; 95% CI = 0.47, 0.87). Among participants who used psychosocial services, the fully adjusted HR (95% CI) for 1-year mortality among participants who used psychosocial services within a month after distress screening was 0.52 (95% CI = 0.28, 0.98) compared to participants who used psychosocial services a month after screening. The association between psychosocial services and all-cause mortality was consistent between all subgroups analyzed.

Conclusions

This large real-world study suggests that timely psychosocial care would benefit newly diagnosed distressed cancer patients.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Background

To successfully implement exercise programs for patients with metastatic breast cancer, services and education on expected benefits and how to overcome barriers should be aligned with patient preferences, values, and goals. Hence, gaining insight into patients’ perspectives on exercise and exercise programming is crucial.

Methods

In this cross-sectional survey, we recruited patients from 13 centers in the Netherlands, Germany, Poland, Spain, and Sweden. We collected data on patients’ knowledge about exercise and outcome expectations. We identified barriers to and facilitators for participation in exercise programs, and patients’ preferences for content and modes of exercise delivery.

Results

420 patients completed the survey. Respondents were on average 56 years old and 70% had bone metastases. 65% reported having sufficient skills to engage in aerobic exercise, but only 34% did so for resistance exercise. Overall, respondents expected exercise to have multiple physical benefits, but a few expected exercise to worsen their pain (5%) or fatigue (4%). Feeling too tired (22%) and/or weak (23%) and not having access to an exercise program for cancer patients (26%) were the most prominent barriers. Facilitators for exercising regularly were previous positive physical (70%) and emotional (66%) experiences from exercising, and getting personalized advice from a physiotherapist (60%). Patients were most interested in walking and preferred exercising at a public gym, physiotherapy practice or outdoors, with inter-country differences. 56% did not know whether their insurance company reimburses exercise programs and only 9% would be willing to pay > €50 per month to participate.

Conclusions

A large proportion of patients with metastatic breast cancer reported not having the necessary skills to engage in regular exercise as recommended by current exercise guidelines for people with cancer. Patients may benefit from personalized advice and training facilities where they receive instructions and can practice safe and effective exercises. When implementing exercise interventions for patients with metastatic breast cancer, attention should be given to reimbursement and willingness-to-pay.

Legal entity responsible for the study

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital.

Funding

European Union’s Horizon 2020 research and innovation programme.

Disclosure

A.M. May: Financial Interests, Institutional, Advisory Role: COMPASS. K. Steindorf: Financial Interests, Personal, Expert Testimony, < €5,000: Institut National contre le cancer (INCA), Paris, France; Financial Interests, Personal, Expert Testimony, Member of Data Monitoring Board; < €1,000: Swiss Group for Clinical Research (SAAK), Switzerland; Financial Interests, Personal, Invited Speaker, < €1,000: Adviva, Heidelberg, Germany, Pierre Fabre, Freiburg, Germany, Takeda, Breast Cancer Care Center, Unna, Germany, Audi Health Care Insurance, Ingolstadt, Germany, University of Mainz, Germany; Financial Interests, Personal, Invited Speaker, Lecturer fee in Master Course, < €2,000: University of Heidelberg, Germany; Financial Interests, Personal, Expert Testimony, compensation of travel costs, no further fees: German Research Foundation (DFG), Bonn, Germany; Financial Interests, Personal, Expert Testimony, < €1,000: University of Vienna, Vienna, Austria. All other authors have declared no conflicts of interest.

Background

(Neurotoxic) Chemotherapy can have extensive negative effects at the biopsychosocial level. This secondary analysis of a randomized controlled exercise intervention study aimed to investigate whether a sensorimotor- (SMT) and resistance training (RT) may affect sleep quality and fatigue during neurotoxic chemotherapy.

Methods

170 cancer patients were randomized to SMT, RT or usual care (UC). Patients in the SMT or RT group exercised 3×/week (105 min/week) during neurotoxic chemotherapy (mean length: 20 weeks). Subjectively perceived sleep quality (PSQI), fatigue (MFI), and chemotherapy-induced peripheral neuropathy (CIPN) symptoms (EORTC CIPN20) were assessed before and three weeks after last neurotoxic chemotherapy cycle. Analysis-of-covariance models were applied on changes from baseline to post-intervention assessment (covariates: age, gender, neurotoxic chemotherapy class, baseline value of the respective dependent variable, and optional CIPN symptoms).

Results

At baseline, 50% of patients reported good sleep quality. Overall sleep quality remained unchanged during chemotherapy, while general, physical, and mental fatigue increased in all groups (p<0.05). Intention-to-treat analyses (N=159) revealed no differences regarding analyzed outcomes. Exploratory per-protocol analyses (training attendance rate ≥67%; N=89) revealed that general and physical fatigue as well as reduced activity increased less during chemotherapy in the adherent exercisers (pooled group: SMT+RT) compared to UC (p≤0.02, ES≥0.47). Inclusion of CIPN symptoms as a covariate resulted in non-significant effects for all fatigue dimensions except general fatigue.

Conclusions

In a cancer population at high risk for developing CIPN, sleep quality was not affected by exercise. This result is in contrast to other research findings and might be due to the type of exercise and/or a ceiling effect. However, SMT and/or RT may alleviate several fatigue dimensions, if an appropriate training stimulus is achieved. Of note, the intervention effects on fatigue appeared to be influenced by CIPN symptoms, raising the question if the MFI is a valid PRO for detecting fatigue in CIPN patients. A methodological aspect which needs to be addressed in future research.

Clinical trial identification

NCT02871284.

Legal entity responsible for the study

Heidelberg University Hospital.

Funding

This project was supported by an intramural funding programme: Proof of concept trials 3.0, National Center for Tumor Diseases, Heidelberg, Germany (G876).

Disclosure

All authors have declared no conflicts of interest.

Background

Patient-reported outcomes (PROs) are widely used, but little is known of the impact of applying PROs in specific cancer diagnoses. We report the results of a randomized controlled trial (RCT) of PROs in patients with muscle-invasive or metastatic bladder cancer (BC) undergoing medical oncological treatment (MOT) with focus of determining the effects of using PROs during chemo- or immunotherapy.

Methods

This multicenter RCT recruited patients at four Danish university hospitals from 2019–2021. Inclusion criteria were: BC stages T2-T4NxMx, initiating chemo- or immunotherapy. Patients were randomized 1:1 between answering selected PRO-CTCAE questions from home electronically once weekly (QW) with a built-in alert-algorithm as a supplement to standard procedure for handling of side effects (intervention arm (IA)) vs standard procedure for handling of side effects (control arm (CA)). Depending on the severity of PRO-CTCAE symptoms in the IA, patients were instructed how to handle a given side effect (either self-handling or contact to oncological nurse or physician). Patient responses in the intervention arm were available for the treating physicians, who were requested to review these at each clinical visit. The co-primary clinical endpoints were hospital admissions and rate of treatment completion. Secondary endpoints were overall survival (OS), quality of life (EORTC’s QLQ-C30 and QLQ-BLM30), dose reductions, PRO-CTCAE scoring.

Results

228 patients with bladder cancer were included, 76% were male. 141 (62 %) of the patients had metastatic disease at study entry, evenly dispersed between the two groups. 49 % of patients in the IA did not complete treatment vs. 44 % of patients in the CA, OR 0.83 (95% CI: 0.48-1.44, p=0.51). 41 % of patients in the IA experienced hospitalization vs. 32 % in the CA, OR 1.48 (95% CI: 0.83-2.65, p=0.17). OS was comparable between the two arms (IA: median 22.3mo (95% CI: 17.0-NR) vs. CA: median 23.1mo (95% CI: 17.7-NR). Questionnaire completion rate was high (73-87%), as was physician viewing of completed questionnaires in the intervention arm (94%).

Conclusions

This RCT did not show an effect on completion of treatment, hospitalization, or overall survival of the active use of PROs for BC patients during MOT, despite a high level of patient and physician compliance.

Clinical trial identification

NCT03584659.

Legal entity responsible for the study

The authors.

Funding

Danish Cancer Society, Dagmar Marshalls Fond, Einar Willumsens Mindelegat, A.P. Møller Lægefonden, Christian Larsen og Dommer Ellen Larsens Legat, Rigshospitalets Fond til støtte for onkologisk formål, Onkologisk Forskningsfond and Rigshopitalets Jubilæumsfond.

Disclosure

All authors have declared no conflicts of interest.

Background

CIPN is a common side-effect of anti-neoplastic drugs with no level 1 supportive treatment (Tx) approvals. Management of the adverse event (AE) is restricted to dose reductions and Tx interruptions. GTX is a PSP phycotoxin that reversibly binds voltage-gated sodium channel receptor sites on excitable cells, inhibiting membrane depolarization and nerve impulse conduction. Initial data indicates that GTX (topical formulation) improves PN-symptoms related to anti-HIV drugs. The aim of this study is to evaluate the effect of GTX on sensory symptoms of pts with grade 2 or higher (G≥2) CIPN.

Methods

Multicenter trial divided into 2 parts (P1and P2) evaluating the effect of GTX on tactile sensation assessed by Semmens-Weinstein monofilament test (SWMT) on pts with CIPN. P1 is a two-stage, single-arm, open-label study where pts with G≥2 CIPN secondary to taxanes (Cohort 1, C1) and other anti-neoplastic drugs (Cohort 2, C2) are enrolled. The transition to placebo controlled randomized P2 will be determined by the observed efficacy in P1 (minimum 20% response rate in each cohort and overall population). Key exclusion criteria included PN secondary to other causes and ongoing systemic Tx with neurotoxic anti-neoplastic drugs. P1 provides an overall 99.9% power on the primary endpoint. Secondary endpoints included pts reported symptoms and quality of life evaluation.

Results

We report the results of the first stage of P1 where 21 pts were included (C1:11 and C2:10), 60.8% were women with breast or gynecological cancer. All pts had an altered SWMT at baseline, improvement of tactile sensations was seen in 64% in C1 and in 30% in C2. 18,2% had a normal SWMT test after 4 weeks in C1 and 10% in C2, respectively. Overall GTX was well tolerated with no Tx interruption due to AE. At safety visit, 21% pts reported recurrence of PN-related symptoms. 95% of pts reported moderate/severe symptoms at baseline and 62% after 4 weeks of Tx as assessed by patient neuropathy questionnaire (PNQ).

Conclusions

GTX is safe and shows promising activity in the treatment of CIPN, particularly in taxane-treated pts. The primary endpoint for first stage was met, and recruitment in the randomized P2 is ongoing.

Clinical trial identification

NCT05052398 obtained on 21/09/2021.

Legal entity responsible for the study

Grupo Oncoclinicas.

Funding

Has not received any funding.

Disclosure

M.S.F. Dias: Financial Interests, Personal, Advisory Board: Janssen, Astellas, Roche; Financial Interests, Personal, Invited Speaker: Janssen, Astellas, Astellas, AstraZeneca, MSD, Bayer, Amgen, Zodiac; Financial Interests, Personal, travel expenses: AstraZeneca, Janssen, Zodiac; Financial Interests, Institutional, Invited Speaker: Janssen, BMS. F.N. Copati: Non-Financial Interests, Personal, Invited Speaker: Lilly Brazil. M.S. Mano: Non-Financial Interests, Personal, Invited Speaker: Roche, Novartis, Pfizer, MSD, AstraZeneca, Daiichi-Sankyo, MD genomic Health, Lilly; Non-Financial Interests, Personal, Educational Support: Roche, Novartis, Daiichi-Sankyo; Non-Financial Interests, Institutional, Principal Investigator: Roche, Lilly, Novartis; Financial Interests, Personal, Stocks/Shares: Hypera, Grupo Fleury, Qualicorp, Grupo Oncoclinicas. R. Dienstmann: Financial Interests, Personal, Invited Speaker: Servier, Sanofi, Roche, Merck Sharp & Dohme, Libbs, Ipsen, Boehringer Ingelheim, Amgen, Lilly, AstraZeneca; Financial Interests, Personal, Advisory Board: Roche, Bayer; Financial Interests, Personal, Stocks/Shares: Trialing; Financial Interests, Personal, Research Grant: Merck. All other authors have declared no conflicts of interest.

Background

Sexual concerns are a major unaddressed need among survivors of BC with significant negative effect on quality of life.

Methods

Patients (pts) with stage I-III BC were prospectively included from CANTO providing data at diagnosis (T0), 1 (T1), and 2 (T2) years afterwards. Study outcomes were poor body image (score ≤91/100), poor sexual functioning (≤16/100) poor sexual enjoyment (≤66/100) and sexual inactivity (item 45=1) at T2 assessed by EORTCQLQ-B23 (Karsten EJC 2022). Multivariable logistic regression models assessed associations with sexual concerns adjusting for age, sociodemographic, tumor, treatment and clinical characteristics.

Results

Analysis included 7,895 pts. At T0, 32.1% of pts already presented poor body image, 39.3% poor sexual functioning, 29.1% poor sexual enjoyment, and 39% were sexually inactive. The proportion of pts reporting sexual concerns increased over time: 52.6% and 38.1% reported poor body image and sexual enjoyment at T2, respectively. Factors consistently associated with sexual concerns at T2 included: presence of the same concern at T0, endocrine therapy (ET) use and emotional distress. Gynecologist consultation was associated with lower likelihood of reporting sexual concerns at T2 – Table. Dimension specific associations with poor body image included higher education (OR 1.4 [95%CI 1.1-1.8), prior smoking (1.3[1.1-1.6]), mastectomy (2[1.6-2.4]), receipt of chemotherapy (1.5[1.3-1.8]), fatigue (1.5[1.3-1.8]) and pain (1.3[1.0-1.5]) reported at T1, whereas poor sexual enjoyment was associated with lower education (1.6[1.0- 2.6]). Table: 1558MO

Associations with sexual concerns at T2: OR; 95% CI

Conclusions

Sexual concerns seem to substantially increase from BC to the after treatment period reaching more than half of pts 2y after diagnosis. This study identified a number of factors associated with sexual concerns. Communication on sexual health must exist across the whole cancer care continuum so that pts can be identified and receive proper multidisciplinary counselling.

Clinical trial identification

NCT01993498.

Legal entity responsible for the study

Unicancer.

Funding

National Research Agency (grant ANR-10-COHO-0004 for the Cancer Toxicity study); Gustave Roussy Foundation (INTERVAL).

Disclosure

M. Lambertini: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, Lilly, Novartis, Exact Sciences, MSD, Seagen, Gilead; Financial Interests, Personal, Invited Speaker: Pfizer, Takeda, Sandoz, Ipsen, Libbs, Knight. F. Joly Lobbedez: Financial Interests, Personal, Advisory Board: GSK, AstraZeneca, MSD, Janssen, ipsen, BMS, Bayer, Esai; Financial Interests, Personal, Invited Speaker: GSK, AstraZeneca, MSD, Janssen, Ipsen, Amgen, Astellas; Financial Interests, Institutional, Invited Speaker: GSK, AstraZeneca; Financial Interests, Institutional, Research Grant: BMS; Travel: MSD, GSK. B. Pistilli: Financial Interests, Personal, Advisory Board: Puma, Pierre-Faber, Novartis, Myriad Genetics, AstraZeneca, Daiichi/Sankyo; Financial Interests, Institutional, Research Grant: Pfizer, Puma Biotechnology, Merus, Daiichi/Sankyo. I.V. Luis: Financial Interests, Institutional, Invited Speaker: Amgen, AstraZeneca, Pfizer/Edimark, Novartis. All other authors have declared no conflicts of interest.

Background

COVID-19 (C19) has significantly affected patients (pts) with cancer and exposed unanticipated challenges in securing optimal cancer care across disciplines. ESMO-CoCARE is an international, real-world database, collecting data on the natural history, management and outcomes of pts with cancer and SARS-CoV-2.

Methods

This is the 2^nd CoCARE analysis, jointly with Belgian (BSMO) and Portuguese (PSMO) registries, from Jan 2020 to Dec 2021. The aim is to identify significant prognostic factors for the primary C19 outcomes of hospitalization and mortality, and the secondary outcomes of Intensive Care Unit admission (ICU-adm) and overall survival (OS). Subgroup analysis by pandemic phase and vaccination status is performed.

Results

The analysis cohort includes 3294 pts (CoCARE: 2049; BSMO: 928, all hospitalised by eligibility criteria; PSMO: 317), diagnosed in 4 distinct pandemic phases (Jan-May/20: 36%; Jun-Sep/20: 9%; Oct/20-Feb/21: 41%; Mar-Dec/21: 12%). The C19 hospitalization rate is 54% (CoCARE and- PSMO data), ICU-adm 14% and C19 mortality 22% (all data). At a 6-month median follow-up, 1013 deaths were recorded, with 73% 3-mo OS rate. No significant change was observed in C19 mortality among hospitalized pts across the 4 pandemic phases (30-33%). Hospitalizations and ICU-adm decreased significantly (from 78% to 34% and 16% to 10%). Among 1522 pts, 70% were non-vaccinated, 24% had incomplete and 7% complete vaccination at C19 diagnosis. Complete vaccination had a protective effect on hospitalization (OR: 0.24; 95%CI [0.14 - 0.38]), ICU-adm (OR: 0.29 [0.09 - 0.94]) and OS (HR: 0.39 [0.20 - 0.76]). In multivariable analyses, C19 hospitalization was associated with pt/cancer characteristics, the 1^st pandemic phase, the presence of C19-related symptoms or inflammatory biomarkers, while C19 mortality was significantly higher in symptomatic pts, male gender, older age, ethnicity other than Asian/Caucasian, ECOG PS≥2, BMI<25, haematological malignancy, PD vs NED and advanced cancer stage.

Conclusions

The updated CoCARE analysis, jointly with BSMO and PSMO, highlights factors that significantly affect C19 outcomes, providing actionable clues for further reducing mortality.

Legal entity responsible for the study

ESMO and Institut Curie.

Funding

ESMO.

Disclosure

E. Romano: Financial Interests, Institutional, Research Grant, Research fundings: BMS, AstraZeneca, Amgen, Janssen; Financial Interests, Invited Speaker: Light Chain Biosciences. E. de Azambuja: Financial Interests, Personal, Advisory Board: Roche/GNE, Novartis; Financial Interests, Personal, Invited Speaker: Seattle Genetic, Zodiac, Libbs, Pierre Fabre; Financial Interests, Institutional, Research Grant: Roche/GNE, AstraZeneca, GSK/Novartis, Servier; Financial Interests, Institutional, Other, Travel Grant: Roche/GNE. J. Oliveira: Financial Interests, Personal and Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Invited Speaker: GSK, Janssen, Novartis, Roche, Bayer, MSD, Eisai, AstraZeneca, Pierre Fabre, BMS. S. Susnjar: Financial Interests, Personal, Advisory Board: Roche, Pfizer, Novartis, AstraZeneca, Amicus. D. Vinal Lozano: Financial Interests, Personal, Sponsor/Funding: MSD; Financial Interests, Personal, Invited Speaker: Servier. R. Lee: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal and Institutional, Funding: BMS. D. Arnold: Financial Interests, Personal, Advisory Board: AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Sanofi (Genzyme), Terumo, Samsung Bioepis, Pierre Fabre Pharma, Boston Scientific; Financial Interests, Personal, Invited Speaker: AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Sanofi (Genzyme), Terumo, Boston Scientific, Amgen, Roche, Merck (Serono), Samsung Bioepis, Pierre Fabre Pharma, Servier, Ipsen; Financial Interests, Personal, Invited Speaker, CME Provider: PRMA Consulting, Tactics MD LLC, WebMD Health Corp, From Research to Practice, Aptitude Health, art tempi media, ACE Oncology, Imedex, streamitup Germany, MedAhead (Austria), Clinical Care Options (CCO); Financial Interests, Personal, Advisory Board, Consulting Agency: CRA International, Ketchum; Financial Interests, Personal, Advisory Board, CME Provider, App Producer: onkowissen; Financial Interests, Personal, Other, Roles as Assoc. Editor for ESMO Open and Ann Oncol: Elsevier; Financial Interests, Personal, Other, Role as Associate Editor Ann Oncol: Oxford University Press; Financial Interests, Personal, Other, Role as Associate Editor Clin Colorect Cancer: Elsevier; Financial Interests, Institutional, Other, DSMB chair: Sanofi (Genzyme); Financial Interests, Institutional, Invited Speaker: Bristol Myers Squibb, Pierre Fabre Pharma, Roche, OncoLytics; Financial Interests, Institutional, Funding, Educational Grant: AbbVie; Non-Financial Interests, Project Lead: OncoLytics; Non-Financial Interests, Leadership Role, GI Group Steering Committee: EORTC; Non-Financial Interests, Leadership Role, Steering Committee Member: AIO (German Cancer Society); Non-Financial Interests, Member: ASCO, ESO, DGHO. K.J. Harrington: Financial Interests, Institutional, Advisory Board: Amgen, AstraZeneca, BMS, Boehringer Ingelheim, Merck, MSD, Pfizer, Replimune, Oncolys, Vyriad, Idera; Financial Interests, Institutional, Other, Honoraria for lectures: Amgen, AstraZeneca, BMS, Boehringer Ingelheim; Financial Interests, Institutional, Advisory Board, Advisory board for CD47 assets: Arch Oncology; Financial Interests, Institutional, Advisory Board, Development of DDR assets: ARTIOS; Financial Interests, Institutional, Advisory Board, Development of exosomal STING agonist: Codiak; Financial Interests, Institutional, Advisory Board, Development of oncolytic adenovirus: PsiVac; Financial Interests, Institutional, Funding, Research: AstraZeneca, Boehringer Ingelheim, MSD; Financial Interests, Institutional, Funding, Development of oncolytic HSV platform.: Replimune; Non-Financial Interests, Leadership Role, Chair of Steering Committee: ART NET; Non-Financial Interests, Other, Member of Global Steering Committee: MR - Linac. O.A. Michielin: Financial Interests, Institutional, Invited Speaker: BMS, Amgen, Pierre Fabre, Roche, BMS; Financial Interests, Institutional, Advisory Board: BMS, Amgen, Roche, Novartis, Pierre Fabre, MSD; Financial Interests, Personal, Other, Advisory Role: BMS, MSD, Roche, Novartis, Pierre Fabre, Amgen, GSL; Financial Interests, Institutional, Research Grant: BMS, MSD, Pierre Fabre, Amgen, Merck; Financial Interests, Institutional, Funding: BMS, MSD, Pierre Fabre, Amgen, MSD; Non-Financial Interests, Principal Investigator: BMS, MSD, Amgen, Roche, Pierre Fabre, Novartis. U. Dafni: Financial Interests, Personal, Other, Member of the Tumor Agnostic Evidence Generation working Group: ROCHE. G. Pentheroudakis: Financial Interests, Personal, Full or part-time Employment, Chief Medical Officer: ESMO; Non-Financial Interests, Member: ASCO, Hellenic Cooperative Oncology Group (HeCOG), Hellenic Society of Medical Oncology. S. Peters: Financial Interests, Institutional, Advisory Board: Vaccibody, Takeda, Seattle Genetics, Sanofi, Roche/Genentech, Regeneron, Phosplatin Therapeutics, PharmaMar, Pfizer, Novartis, Mirati, Merck Serono, MSD, Janssen, Incyte, Illumina, IQVIA, GlaxoSmithKline, Gilhead, Genzyme, Foundation Medicine, F-Star, Eli Lilly, Debiopharm, Daiichi Sankyo, Boehringer Ingelheim, Blueprint Medicines, Biocartis, Bio Invent, BeiGene, Bayer, BMS, AstraZeneca, Arcus, Amgen, AbbVie, iTheos, Novocure; Financial Interests, Institutional, Invited Speaker: Takeda, Sanofi, Roche/Genentech, RTP, Pfizer, PRIME, PER, Novartis, Medscape, MSD, Imedex, Illumina, Fishawack, Eli Lilly, Ecancer, Boehringer Ingelheim, BMS, AstraZeneca, OncologyEducation, RMEI, Mirati; Financial Interests, Personal, Other, Associate Editor Annals of Oncology: Elsevier; Financial Interests, Institutional, Invited Speaker, MERMAID-1: AstraZeneca; Financial Interests, Institutional, Invited Speaker, MERMAID-2, POSEIDON, MYSTIC: AstraZeneca; Financial Interests, Institutional, Invited Speaker, Clinical Trial Steering committee CheckMate 743, CheckMate 73L, CheckMate 331 and 451: BMS; Financial Interests, Institutional, Invited Speaker, RELATIVITY 095: BMS; Financial Interests, Institutional, Invited Speaker, BGB-A317-A1217-301/AdvanTIG-301: Beigene; Financial Interests, Institutional, Invited Speaker, Clinical Trial Chair ZEAL-1: GSK; Financial Interests, Institutional, Invited Speaker, Clinical Trial steering Committee PEARLS, MK-7684A: MSD; Financial Interests, Institutional, Invited Speaker, Clinical Trial Steering Committee SAPPHIRE: Mirati; Financial Interests, Institutional, Invited Speaker, LAGOON: Pharma Mar; Financial Interests, Institutional, Invited Speaker, phase 1/2 trials: Phosplatin Therapeutics; Financial Interests, Institutional, Invited Speaker, Clinical Trial Chair Skyscraper-01; chair ALEX; steering committee BFAST; steering committee BEAT-Meso; steering committee ImPower-030, IMforte: Roche/Genentech; Financial Interests, Institutional, Invited Speaker, Phase 2 Inupadenant with chemo: iTeos; Non-Financial Interests, Officer, ESMO President 2020-2022: ESMO; Non-Financial Interests, Officer, Council Member & Scientific Committee Chair: ETOP/IBCSG Partners; Non-Financial Interests, Officer, Vice-President Lung Group: SAKK; Non-Financial Interests, Other, Involved in Swiss politics: Swiss Political Activities; Non-Financial Interests, Officer, President and Council Member: Ballet Béjart Lausanne Foundation; Non-Financial Interests, Principal Investigator, Involved in academic trials: ETOP / EORTC / SAKK; Non-Financial Interests, Member: Association of Swiss Physicians FMH (CH), ASCO, AACR, IASLC; Non-Financial Interests, Leadership Role, ESMO President: ESMO; Non-Financial Interests, Member, Vice-President Lung Group: SAKK; Non-Financial Interests, Leadership Role, Vice -President: SAMO; Non-Financial Interests, Member, Association of Swiss interns and residents: ASMAC/VSAO. All other authors have declared no conflicts of interest.

Background

Metastasis-directed therapy (MDT) has the potential to improve clinical outcomes and even overall survival (OS). However, prognostication and appropriate patient selection for MDT remain challenging. We aimed to develop a unifying model predictive of OS for patients with intracranial and extracranial disease to refine patient selection for MDT and clinical trials.

Methods

We assembled a multi-institutional cohort of patients treated with MDT to spine, brain, and/or lung metastases. Treatments included stereotactic body radiation therapy, radiosurgery, and whole brain radiation therapy. Candidate variables for recursive partitioning analysis were selected per prior studies: ECOG performance status, time from primary diagnosis (TPD), number of additional non-target organ systems involved (NOS), and intracranial metastases.

Results

A database of 1,362 patients was assembled with 424 intracranial, 352 lung, and 607 spinal treatments (n=1,383). Of patients treated for intracranial disease, 75% also had extracranial disease. Treatments were split into training (TC) (70%, n=968) and internal validation (IVC) (30%, n=415) cohorts. The TC had median ECOG of 0 (interquartile range [IQR]: 0-1), NOS of 1 (IQR: 0-1), and OS of 18 months (IQR: 7-35). The resulting model components and weights were: ECOG = 0, 1, and > 1 (0, 1, and 2); 0, 1, and > 1 NOS (0, 1, and 2); and intracranial target (2). The model demonstrated high concordance in the TC (0.72) and IVC (0.72). The score demonstrated concordance of 0.65-0.71 for each target site (spine, brain, and lung), and each variable used in the model met statistical significance (p<0.0001).

Conclusions

This pre-treatment decision tool identifies patients with the longest survival after MDT, indicating a patient population with systemic disease who may benefit most from aggressive local therapy. This model represents a unifying model applicable in settings of both intracranial and extracranial disease. Carefully selected patients may benefit from MDT even in the presence of intracranial disease.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

R.O. Kowalchuk: Financial Interests, Personal, An immediate family member of Dr. Kowalchuk is employed by GE Healthcare: GE Healthcare. All other authors have declared no conflicts of interest.

Background

Limited data exists on end-of-life (EOL) health care utilization in older patients (pts) with cancer. Via data linkage, this study aims to describe EOL care for older pts with cancer and explore the association between geriatric screening and assessment (GS/GA) results at cancer diagnosis and EOL care.

Methods

Data linkage of GS/GA, cancer registry and administrative health data was performed based on a unique patient identifier. GS/GA data were derived from a large Belgian study (n=22 centers; 2009-2015) where pts aged ≥70 years were screened with G8 followed by GA in case of an abnormal G8 result (≤14/17). For this study pts with a new diagnosis were included when they died before end of follow-up (1/3/2019). Tumor characteristics and vital status were derived from cancer registry data and cause of death from death certificates. Place of death was derived from healthcare reimbursement data.

Results

4,475 pts who died after a median of 13 months were included. The median age was 79 (range: 70–100) and 52.0% were female. Lung, breast and colon cancer were the most common diagnoses and 40.5% had stage IV disease. 81.8% of pts had an abnormal baseline G8. For 81.0% of pts the underlying cause of death was cancer (Table). The majority of pts died in a non-palliative care unit of the hospital (42.3%), followed by at home (25.4%), the palliative care unit of the hospital (16.8%) and nursing home (15.5%). When comparing pts with a normal and abnormal baseline G8 score, there were no major differences in cause and place of death except for a higher percentage with abnormal G8 dying in a nursing home (16.9% vs 9.3%). Table: 1265MO

Conclusions

When older pts with a new cancer diagnosis die in the following years, cancer is the underlying cause of death for >80%, both for pts with normal and abnormal baseline G8 score. The majority of pts die in a hospital and only a quarter of pts die at home. This knowledge is important for incorporation of advanced care planning within this patient population.

Legal entity responsible for the study

The authors.

Funding

Kom op tegen Kanker (Stand up to Cancer).

Disclosure

L. Decoster: Financial Interests, Institutional, Advisory Role: Bristol-Myers Squibb, AstraZeneca, Merck Sharp & Dohme; Financial Interests, Institutional, Speaker’s Bureau: AstraZeneca, Merck Sharp & Dohme; Financial Interests, Institutional, Travel: Roche Belgium, Merck Sharp & Dohme; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim. P.R. Debruyne: Financial Interests, Personal, Travel: Janssen; Financial Interests, Personal, Stocks/Shares: Alkermes, Biocartis; Financial Interests, Personal, Royalties: Bristol-Myers Squibb, Merck/Pfizer, MSD, Roche, Bayer; Financial Interests, Institutional, Research Grant: Pfizer. D. Bron: Financial Interests, Personal, Advisory Role: Abbvie; Financial Interests, Personal, Travel: Abbvie. V. Verschaeve: Financial Interests, Personal, Advisory Board: Janssen, MSD, Astellas Pharma. H.F.M. van den Bulck: Financial Interests, Personal, Advisory Role: AstraZeneca. J. Flamaing: Financial Interests, Personal, Advisory Role: Pfizer, GlaxoSmithKline; Financial Interests, Personal, Expert Testimony: Pfizer, GlaxoSmithKline. H. Wildiers: Financial Interests, Institutional, Advisory Board: Roche, Lilly, AstraZeneca, Daiichi Sankyo, PSI Cro AG, KCE, MSD, MSD, E Squared Communications LLC; Financial Interests, Institutional, Invited Speaker: Eisai, AstraZeneca; Financial Interests, Institutional, Consultancy fee: AbbVie, Immutep Pty; Financial Interests, Institutional, Expert Testimony: Daiichi-Sankyo; Financial Interests, Institutional, Consultancy: Daiichi Sankyo; Financial Interests, Institutional, Research Grant, Grant to the Leuven Breast Center to support the research database: Roche; Financial Interests, Institutional, Research Grant, Grant to institute to perform a multicentric national academic trial: Novartis; Travel & accomodations: Pfizer; Travel & accommodation: Roche; Subscription fee: Gilead. All other authors have declared no conflicts of interest.