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- Anne Letsch (Kiel, Germany)
- Christina H. Ruhlmann (Odense, Denmark)
2030O - Remote symptom monitoring with electronic patient-reported outcomes (ePROs) during treatment for metastatic cancer: Results from the PRO-TECT trial (Alliance AFT-39)
- Ethan Basch (Chapel Hill, United States of America)
Abstract
Background
During cancer treatment, symptoms are common but often go undetected by clinicians. Remote monitoring with ePROs can detect symptoms early and alert clinicians to intervene, thereby relieving suffering and avoiding complications.
Methods
PRO-TECT was a cluster-randomized trial in 52 US oncology practices. Practices were assigned 1:1 to remote monitoring with ePRO surveys, or usual care. At ePRO practices, patients receiving treatment for metastatic cancer were invited to complete a weekly survey by web or automated telephone system for up to 1 year or until discontinuation of cancer treatment. The survey included 9 PRO-CTCAE symptoms, performance status, and falls. Severe/worsening symptoms generated electronic alerts to nurses, and symptom reports were available to clinicians at visits. Here we report the primary outcome of overall survival after 24 months of follow up, compared between groups using Cox regression incorporating clustering and disease covariates. Other outcomes included mean emergency department (ED) or hospital visits based on chart abstraction and proportion of patients with clinically meaningful benefit in symptoms (EORTC QLQ-C30) at 3 months, compared using mixed modeling and cumulative logistic regression. We previously reported significant benefits in health-related quality of life and physical function ( JAMA 2022 ;327:2413-22).
Results
1191 patients were enrolled 10/2017-03/2020 (593 PRO; 598 usual care). No difference was seen in survival between groups (HR 0.99; p=0.86). The mean number of ED or hospital visits was lower in the ePRO group vs. usual care (1.48 vs 1.81; p=0.006). A greater proportion of patients in the ePRO group experienced benefits in fatigue (OR 1.77; p<0.001), anorexia (OR 1.32; p=0.03), nausea/vomiting (OR 1.40; p=0.01), and sleep (OR 1.73; p<0.001). Patients completed 20,565/22,486 (91.5%) of expected weekly ePRO surveys.
Conclusions
Remote monitoring with ePROs during cancer treatment did not impact survival, but reduced visits to the ED or hospital, and conferred benefits on function and symptoms. Conduct of this trial during the pandemic amidst nursing shortages may have reduced efficacy of the intervention.
Clinical trial identification
NCT03249090.
Legal entity responsible for the study
Alliance Foundation Trials.
Funding
Patient-Centered Outcomes Research Institute (PCORI) award No. IHS-1511-33392.
Disclosure
E. Basch: Financial Interests, Personal, Advisory Role: Resilience Health, Sivan Health, Navigating Cancer, AstraZeneca. D. Schrag, P.A. Spears: Financial Interests, Personal, Advisory Role: Pfizer. C. Snyder: Financial Interests, Institutional, Principal Investigator: Pfizer, Genentech; Financial Interests, Personal, Advisory Role: Janssen. D. Bruner: Financial Interests, Personal, Advisory Role: Flatiron. V. Blinder: Financial Interests, Personal, Advisory Role: Carevive Systems. A. Weiss: Financial Interests, Institutional, Research Funding: Myriad Laboratories. All other authors have declared no conflicts of interest.
2031O - Randomized trial of a telephone-based weight loss intervention in overweight and obese patients (pts) with breast cancer (BC): The MEDEA trial
- Ines V. Vaz Luis (Villejuif, Cedex, France)
Abstract
Background
Elevated Body Mass Index (BMI) is associated with inferior clinical outcomes, impaired quality of life (QOL), and increased cancer related fatigue (CRF) in pts with early BC. MEDEA evaluated the impact of a weight loss intervention on CRF in overweight or obese survivors of BC.
Methods
MEDEA (NCT04304924) is a French multicenter randomized trial. Pts with stage I-III BC within 12 months of primary treatment and BMI ≥25 kg/m2 were eligible. MEDEA compared a telephone-based weight loss program delivered by a coach through 24 semi-structured calls over 12 months and focused on caloric restriction + education (intervention arm) with an education alone program (control arm). The intervention was adapted from the BWEL trial (A011401) and was considered completed if ≥16/24 calls were delivered. The primary endpoint was between-arm difference in CRF (EORTC C30) 12 months (M12) post-randomization, estimated by a linear mixed model. Secondary endpoints included weight, QOL (QLQ C30 / BR23), and satisfaction (Focus groups). The study had 80% power (two-sided α = 0.05) to detect an effect size of 0.40.
Results
220 pts were included. Mean (SD) age was 53.8 years (10.4), mean weight was 83.6 kg (14.0), and 65% of pts received endocrine therapy. At randomization, CRF scores were similar between arms (Mean [SD]: 40.2 [23.5] and 40.2 [27.8]). At M12, CRF was reduced by a mean of -7.8 points (SD 20.8) in the intervention and -2.0 points (SD 27.3) in the control arm. The estimated between arm difference at M12 was 5.9 (SE 3.7) but was not significantly different from zero (p=0.11). Mean and proportional weight loss at M12 was higher in the intervention arm vs control: -6.7 kg (SD 8.3), 10% vs -1.1 kg (SD 5.3), 1% (parm=0.025; parm*time=0.002). There was no detrimental effect on other QOL domains. Satisfaction and adherence to the intervention were high, with 75% completing ≥16/24 calls.
Conclusions
A telephone-based weight loss program did not lead to a significant difference in CRF at 12 months, but did induce significant weight loss among pts with BC. These results suggest a North American weight loss intervention was adaptable and could be disseminated in a different language and cultural context.
Clinical trial identification
NCT04304924; Release date: 20th March 2020.
Legal entity responsible for the study
Gustave Roussy Cancer Center.
Funding
French National Cancer Institute (Institut National du Cancer [InCA]; grant RISP2018-13684.
Disclosure
I.V. Vaz Luis: Financial Interests, Personal, Other, Honoraria: Sandoz; Financial Interests, Institutional, Other, Honoraria: AstraZeneca, Amgen, Pfizer; Financial Interests, Institutional, Officer, Honoraria: Novartis; Financial Interests, Institutional, Research Funding: Resilience Care. A. Di Meglio: Financial Interests, Personal, Advisory Board: Kephren, Medycis, Techspert. O. Tredan: Financial Interests, Personal, Advisory Board: Roche, Pfizer, Novartis-Sandoz, Lilly, MSD, Astra-Zeneca, Pierre Fabre Oncologie, Seagen, Daiichi Sankyo, Gilead, Eisai, Stemline-Menarini. B. Pistilli: Financial Interests, Institutional, Advisory Board: AstraZeneca, Seagen, Lilly, Daiichi Sankyo, MSD; Financial Interests, Institutional, Invited Speaker: Gilead, Novartis; Financial Interests, Personal, Advisory Board: Pierre Fabre, Daiichi Sankyo; Financial Interests, Personal, Other, travel support: AstraZeneca, Pierre Fabre, MSD, Daiichi Sankyo; Financial Interests, Institutional, Steering Committee Member: AstraZeneca, Novartis; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Local PI: AstraZeneca, Gilead, Seagen, MSD, Novartis; Financial Interests, Institutional, Funding: Daiichi Sankyo; Non-Financial Interests, Project Lead: Unicancer. J. Bonastre: Financial Interests, Personal, Advisory Board, Scientific board: BMS, MSD, Janssen; Financial Interests, Institutional, Funding, Funding of the MICADO study: BMS. S. Michiels: Financial Interests, Personal, Other, Statistical advice: Roche; Financial Interests, Personal, Other, DSMB member: Sensorion, Servier, Biophytis, Yuhan, IQVIA, Kedrion. J. Ligibel: Non-Financial Interests, Institutional, Other, Product samples for a research project: Fitbit Corporation, Nestle Health Sciences. All other authors have declared no conflicts of interest.
Invited Discussant 2030O and 2031O
- Anne Letsch (Kiel, Germany)
Q&A
- All Speakers (Lugano, Switzerland)
LBA94 - Effects of short-term fasting on quality of life as an add-on option during chemotherapy
- Daniela A. Koppold (Berlin, Germany)
Abstract
Background
Growing pre- and clinical evidence show that short-term fasting (STF) of 48 to 72 hours around each chemotherapy (CTX) may potentially support CTX, reducing toxicity and adverse effects.
Methods
This randomised multi-center study of breast cancer (BC) patients undergoing CTX was conducted to assess feasibility and health-related quality of life (HRQoL) for 60-72 h STF compared to a plant-based low-sugar diet (PBD). HRQoL was assessed by FACT-G, FACIT-F (fatique) and further questionnaires at baseline (V0) and after each CTX session (day 7) as well as after 4 (V1) and 6 (V2) months. Laboratory parameters were collected at the same time points. CTX consisted of 4 x AC or EC, followed by either 12 x paclitaxel (Pac) (80 mg/m2) weekly or 4 x docetaxel (Doc) three-weekly (100 mg/m2).
Results
106 patients were included in the study and randomized to STF (n=52) or PBD (n=56). 90 (84.9%) patients obtained AC/EC -> Pac and 16 (15.1%) AC/EC -> Doc. The 27-item generic CORE questionnaire FACT-G measuring four domains of HRQoL (physical, social/family, emotional, and functional well-being) showed no significant difference at V0 (STF 82.9; PBD 81.9; p=0.523). STF-patients' FACT-G improved at day 7 from cycle to cycle versus PBD-patients. At cycle 4, day 7, FACT-G for STF was 78.3 (std. error (SE) 2.7; 95% C.I. 72.8-83.7) and for PBD 69.3 (SE 2.6: 95% C.I. 64.0-74.6). The difference 9.0 (SE 3.8) was statistically significant (p = 0.021) and clinically relevant (9.0 > minimal important difference (MID = 5)). The differences between the corresponding FACIT-F Trial Outcome Index resp. Total FACIT-F at cycle 4 day 7 were 13.1 (SE 4.7) resp. 15.8 (SE 5.6), both in favor of STF (> MID= 6, p < 0.007). The mean Total Hospital Anxiety and Depression Score (HADS-T) shows mental distress (HADS-T ≥ 13) for both STF and PBD at V0 and cycle 4 day 7 with no statistically significant differences. At V0 mean platelet counts (MPCs) were 256.6 (SE 10.8) for STF and 266.2 (SE 9.9) for PBD (p=0.512). At cycle 4 day 7 MPCs were 209.5 (SE 13.7) for STF and 177.7 (SE 12.3) for PBD.
Conclusions
Neither STF nor PBD showed serious adverse effects in the studied population. STF during chemotherapy is well tolerated and appears to improve QoL and fatigue during chemotherapy compared to a plant-based low-sugar diet.
Clinical trial identification
NCT03162289 on 22 May 2017.
Legal entity responsible for the study
The authors.
Funding
This study is funded by a private sponsor (G. Müller, Munich, Germany) and a grant from the Günter and Regine KelmFoundation (Zurich, Switzerland).
Disclosure
D.A. Koppold: Financial Interests, Personal, Ownership Interest: Academy for Integrative Fasting (AIF) GbR; Financial Interests, Personal, Advisory Role: Fastic (Mobile App); Financial Interests, Personal, Leadership Role: ÄGHE (Ärztegesellschaft Heilfasten und Ernährung e.V.). C. Kessler: Financial Interests, Personal, Advisory Board: Bruno Zimmer. E. Hanslian: Non-Financial Interests, Personal, Leadership Role: ÄGHE (Ärztegesellschaft Heilfasten und Ernährung e.V.)). A. Michalsen: Financial Interests, Personal, Ownership Interest: Academy for Integrative Fasting (AIF) GbR, Salufast GmbH; Non-Financial Interests, Personal, Leadership Role: ÄGHE (Ärztegesellschaft Heilfasten und Ernährung e.V.). All other authors have declared no conflicts of interest.
LBA95 - Anamorelin and weight gain in patients with advanced non-small cell lung cancer (NSCLC) and cachexia: Efficacy and safety in the multinational phase III SCALA program
- David Currow (Wollongong, Australia)
Abstract
Background
Anamorelin is a potent, selective and well-tolerated orally available ghrelin agonist. It is marketed in Japan for the treatment of cachexia in patients with lung and gastrointestinal malignancies since early 2021. Results of two phase III trials comparing anamorelin versus placebo in cachectic non-Japanese NSCLC patients are described.
Methods
Between March 2019 and August 2022, a total of 636 subjects (318 per study) with advanced NSCLC, ECOG PS 0-2, BMI<20 kg/m2, and unintentional weight loss >2% in the previous six months, were randomized 1:1 to receive 100 mg of anamorelin or a placebo orally QD for 24 weeks in two confirmatory studies with identical design (SCALA-1 and SCALA-2). Primary endpoints were changes from baseline over 12 weeks in scale body weight and in the FAACT anorexia-cachexia 5-domain symptom score (5-IASS).
Results
In both studies, anamorelin significantly increased body weight over 12 weeks compared to placebo (p<0.0001). Least square means (95% CI) treatment difference was +1.37 kg (+0.737; +2.001) for SCALA-1 and +1.30 kg (+0.720; +1.865) for SCALA-2. Changes of 5-IASS scores for anamorelin versus placebo were not significantly different in both studies. Overall, 71.2% (anamorelin) and 73.4% (placebo) of patients experienced any Treatment Emergent Adverse Event (TEAE). There was no difference when serious TEAEs, severe TEAEs, TEAEs leading to discontinuation, and TEAEs of special interest were considered. Severe hyperglycemia was reported only in two patients both receiving anamorelin (0.6%).
Conclusions
The SCALA trials demonstrate that anamorelin improves body weight in individuals with advanced NSCLC and cachexia. The observed effect on body weight is consistent with data from all eight previously conducted double-blind, placebo-controlled studies that randomized 1,696 cancer patients. The positive benefit-risk profile strongly emphasizes the therapeutic potential of anamorelin for treating unintended weight loss in patients with advanced NSCLC and cachexia.
Legal entity responsible for the study
Helsinn Healthcare SA.
Funding
Helsinn Healthcare SA.
Disclosure
D. Currow: Financial Interests, Institutional, Speaker, Consultant, Advisor: Helsinn Healthcare SA, Specialist Therapeutics; Non-Financial Interests, Institutional, Advisory Board: Helsinn Healthcare SA. S. Chessari: Other, Officer, Helsinn Healthcare SA employee: Helsinn Healthcare SA. P. Bonomi: Financial Interests, Personal, Speaker, Consultant, Advisor, Advisor & Consultant, personal financial compensation: Helsinn Healthcare SA; Financial Interests, Institutional, Financially compensated role, Clinical trial investigator, institutional financial compensation: Helsinn Healthcare SA; Financial Interests, Personal, Speaker, Consultant, Advisor, Advisor, personal compensation: Pfizer; Other, Institutional, Non remunerated activity, Manuscript preparation, author on reports for data base studies, no compensation: Pfizer; Financial Interests, Institutional, Financially compensated role, Clinical trial investigator, institutional compensation: Pfizer; Financial Interests, Financially compensated role, Chair of independent data monitoring committee, personal compensation: Roche Genentech. R. Giorgino: Other, Personal, Speaker, Consultant, Advisor: Helsinn Healthcare SA. R. Skipworth: Financial Interests, Personal, Speaker, Consultant, Advisor, Consultant: Helsinn Healthcare SA, Actimed Therapeutics, Faraday Pharmaceuticals; Non-Financial Interests, Personal, Speaker, Consultant, Advisor, Consultant: Artelo Biosciences, Toray Pharmaceuticals.
Invited Discussant LBA94 and LBA95
- Jann Arends (Freiburg im Breisgau, Germany)
Q&A
- All Speakers (Lugano, Switzerland)