TY - JOUR

T1 - Impact of FRAilty screening and Geriatric assessment and INtervention in older patients with epithelial Ovarian Cancer

T2 - A multicenter randomized clinical trial protocol (FRAGINOC)

AU - Daviu Cobián, Cristina

AU - Oreskov, Jakob O.

AU - Blaakaer, Jan

AU - Jespersen, Eva

AU - Jørgensen, Trine L.

AU - Ryg, Jesper

AU - Herrstedt, Jørn

AU - Høgdall, Claus

AU - Lund, Cecilia M.

AU - Seibæk, Lene

AU - Vinther, Anders

AU - Ekmann-Gade, Anne Weng

AU - Schnack, Tine H.

N1 - Funding Information: This work is supported by the Region Sjælland og Region Syddanmarks research fund, the OUH's og Rigshospital fælles research fund, The Danish Cancer Society, the Danish Research Center for Cancer Surgery (ACROBATIC), the Danish Comprehensive Cancer Center, The Arvid Nilssons Foundation, the Academy of Geriatric Cancer Research, the AP. Møller Foundation, The Odense University Hospital Overlægerådets Foundation, Hans and Nora Buchards Foundation and Tornøes and Høyrups Foundation. Funding Information: This work is supported by the Region Sjælland og Region Syddanmarks research fund, the OUH's og Rigshospital fælles research fund, The Danish Cancer Society , the Danish Research Center for Cancer Surgery (ACROBATIC), the Danish Comprehensive Cancer Center , The Arvid Nilssons Foundation, the Academy of Geriatric Cancer Research, the AP. Møller Foundation, The Odense University Hospital Overlægerådets Foundation, Hans and Nora Buchards Foundation and Tornøes and Høyrups Foundation. Publisher Copyright: © 2024 Elsevier Ltd

PY - 2024

Y1 - 2024

N2 - Introduction: Radical surgery combined with chemotherapy is the only potential curative treatment of patients with advanced epithelial ovarian cancer (EOC). However, 43% of older Danish patients with EOC are not referred to surgery due to frailty, age, or fear of complications. Comprehensive geriatric assessment (CGA) has demonstrated ability to reduce frailty in older patients, but there is a knowledge gap regarding its effect before or during treatment in older adults with EOC. This protocol presents a randomized controlled trial (RCT), which evaluates the effect of CGA-based interventions including individualized physical exercise therapy in older adults with EOC during neoadjuvant chemotherapy (NACT). Materials and Methods: This RCT will include patients aged ≥70 years with primary EOC referred to NACT. Patients will be randomized 1:1 to intervention or standard of care, along with neoadjuvant antineoplastic treatment. Stratification for performance status and center of inclusion will be performed. In the intervention arm, a geriatrician will perform CGA and corresponding geriatric interventions and patients will undergo an individualized home-based exercise program managed by a physiotherapist. All patients will be evaluated with Geriatric-8, modified Geriatric-8, clinical frailty scale, and physical tests at randomization. Predictive values (positive/negative) will be evaluated for CGA detected impairments. The primary endpoint is the proportion of patients referred to interval debulking surgery (IDS). Secondary endpoints include the proportion who complete oncological treatment, improvements in physical tests, quality of life measured by European Organization for Research and Treatment of Cancer-Quality of Life questionnaires at inclusion, after three cycles of chemotherapy, and at end of chemotherapy treatment. Furthermore, the association between results of geriatric screening tests, CGA, and physical tests with complication rate and progression free survival will be examined. The primary outcome will be analyzed with logistic regression in the intention-to-treat population. Power calculations reveal the need to enroll 216 patients. Discussion: The present study examines whether CGA-based interventions including individualized physical exercise can increase the referral rate for potential curative IDS in older patients with EOC. If successful, this will result in more patients undergoing surgery and completing chemotherapy, preventing complications, and ultimately improving quality of life and survival. The study setup may establish the basis for direct clinical implementation if proven effective.

AB - Introduction: Radical surgery combined with chemotherapy is the only potential curative treatment of patients with advanced epithelial ovarian cancer (EOC). However, 43% of older Danish patients with EOC are not referred to surgery due to frailty, age, or fear of complications. Comprehensive geriatric assessment (CGA) has demonstrated ability to reduce frailty in older patients, but there is a knowledge gap regarding its effect before or during treatment in older adults with EOC. This protocol presents a randomized controlled trial (RCT), which evaluates the effect of CGA-based interventions including individualized physical exercise therapy in older adults with EOC during neoadjuvant chemotherapy (NACT). Materials and Methods: This RCT will include patients aged ≥70 years with primary EOC referred to NACT. Patients will be randomized 1:1 to intervention or standard of care, along with neoadjuvant antineoplastic treatment. Stratification for performance status and center of inclusion will be performed. In the intervention arm, a geriatrician will perform CGA and corresponding geriatric interventions and patients will undergo an individualized home-based exercise program managed by a physiotherapist. All patients will be evaluated with Geriatric-8, modified Geriatric-8, clinical frailty scale, and physical tests at randomization. Predictive values (positive/negative) will be evaluated for CGA detected impairments. The primary endpoint is the proportion of patients referred to interval debulking surgery (IDS). Secondary endpoints include the proportion who complete oncological treatment, improvements in physical tests, quality of life measured by European Organization for Research and Treatment of Cancer-Quality of Life questionnaires at inclusion, after three cycles of chemotherapy, and at end of chemotherapy treatment. Furthermore, the association between results of geriatric screening tests, CGA, and physical tests with complication rate and progression free survival will be examined. The primary outcome will be analyzed with logistic regression in the intention-to-treat population. Power calculations reveal the need to enroll 216 patients. Discussion: The present study examines whether CGA-based interventions including individualized physical exercise can increase the referral rate for potential curative IDS in older patients with EOC. If successful, this will result in more patients undergoing surgery and completing chemotherapy, preventing complications, and ultimately improving quality of life and survival. The study setup may establish the basis for direct clinical implementation if proven effective.

KW - Comprehensive geriatric assessment

KW - Exercise therapy

KW - Frailty

KW - Older adults

KW - Optimization

KW - Ovarian cancer

KW - Surgery

U2 - 10.1016/j.jgo.2024.101713

DO - 10.1016/j.jgo.2024.101713

M3 - Journal article

C2 - 38326125

AN - SCOPUS:85184002608

VL - 15

JO - Journal of Geriatric Oncology

JF - Journal of Geriatric Oncology

SN - 1879-4068

IS - 3

M1 - 101713

ER -