Isacco Montroni1, Siri Rostoft2, Antonino Spinelli3, Barbara L Van Leeuwen4, Giorgio Ercolani5, Nicole M Saur6, Michael T Jaklitsch7, Ponnandai S Somasundar8, Nicola de Liguori Carino9, Federico Ghignone1, Flavia Foca10, Chiara Zingaretti11, Riccardo A Audisio12, Giampaolo Ugolini1. 1. U.O. Chirurgia Generale, Ospedale "per gli Infermi", Faenza, AUSL Romagna, Italy. 2. Department of Geriatric Medicine, Oslo University Hospital, University of Oslo, Norway. 3. Division of Colon and Rectal Surgery, Humanitas Clinical and Research Center, Rozzano (MI), Italy. 4. Department of Surgical Oncology, University Medical Center Groningen, University of Groningen, The Netherlands. 5. U.O. Chirurgia Generale e Terapie Oncologiche Avanzate, Ospedale "GB.Morgagni-L.Pierantoni", Forlì, AUSL Romagna, Italy. 6. University of Pennsylvania, Perelman School of Medicine, Department of Surgery, Division of Colon and Rectal Surgery, Philadelphia, USA. 7. Division of Thoracic Surgery, Division of Aging, Brigham and Women's Hospital, Boston, MA, USA. 8. Roger Williams Medical Center, Boston University, Providence (RI), USA. 9. HPB Unit, Manchester Royal Infirmary, University of Manchester, UK. 10. Unit of Biostatistics and Clinical trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST IRCCS, Meldola, Italy. 11. Unit of Biostatistics and Clinical trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST IRCCS, Meldola, Italy. Electronic address: chiara.zingaretti@irst.emr.it. 12. Department of Surgery, Institute of Clinical Sciences Blå Stråket 5, Sahlgrenska University Hospital, Göteborg, Sweden.
Abstract
OBJECTIVE: Older patients with cancer value functional outcomes as much as survival, but surgical studies lack functional recovery (FR) data. The value of a standardized frailty assessment has been confirmed, yet it's infrequently utilized due to time restrictions into everyday practice. The multicenter GOSAFE study was designed to (1) evaluate the trajectory of patients' quality of life (QoL) after cancer surgery (2) assess baseline frailty indicators in unselected patients (3) clarify the most relevant tools in predicting FR and clinical outcomes. This is a report of the study design and baseline patient evaluations. MATERIALS & METHODS: GOSAFE prospectively collected a baseline multidimensional evaluation before major elective surgery in patients (≥70 years) from 26 international units. Short-/mid-/long-term surgical outcomes were recorded with QoL and FR data. RESULTS: 1003 patients were enrolled in a 26-month span. Complete baseline data were available for 977(97.4%). Median age was 78 years (range 70-94); 52.8% males. 968(99%) lived at home, 51.6% without caregiver. 54.4% had ≥ 3 medications, 5.9% none. Patients were dependent (ADL < 5) in 7.9% of the cases. Frailty was either detected by G8 ≤ 14(68.4%), fTRST ≥ 2(37.4%), TUG > 20 s (5.2%) or ASAIII-IV (48.8%). Major comorbidities (CACI > 6) were detected in 36%; 20.9% of patients had cognitive impairment according to Mini-Cog. CONCLUSION: The GOSAFE showed that frailty is frequent in older patients undergoing cancer surgery. QoL and FR, for the first time, are going to be primary outcomes of a real-life observational study. The crucial role of frailty assessment is going to be addressed in the ability to predict postoperative outcomes and to correlate with QoL and FR.
OBJECTIVE: Older patients with cancer value functional outcomes as much as survival, but surgical studies lack functional recovery (FR) data. The value of a standardized frailty assessment has been confirmed, yet it's infrequently utilized due to time restrictions into everyday practice. The multicenter GOSAFE study was designed to (1) evaluate the trajectory of patients' quality of life (QoL) after cancer surgery (2) assess baseline frailty indicators in unselected patients (3) clarify the most relevant tools in predicting FR and clinical outcomes. This is a report of the study design and baseline patient evaluations. MATERIALS & METHODS: GOSAFE prospectively collected a baseline multidimensional evaluation before major elective surgery in patients (≥70 years) from 26 international units. Short-/mid-/long-term surgical outcomes were recorded with QoL and FR data. RESULTS: 1003 patients were enrolled in a 26-month span. Complete baseline data were available for 977(97.4%). Median age was 78 years (range 70-94); 52.8% males. 968(99%) lived at home, 51.6% without caregiver. 54.4% had ≥ 3 medications, 5.9% none. Patients were dependent (ADL < 5) in 7.9% of the cases. Frailty was either detected by G8 ≤ 14(68.4%), fTRST ≥ 2(37.4%), TUG > 20 s (5.2%) or ASAIII-IV (48.8%). Major comorbidities (CACI > 6) were detected in 36%; 20.9% of patients had cognitive impairment according to Mini-Cog. CONCLUSION: The GOSAFE showed that frailty is frequent in older patients undergoing cancer surgery. QoL and FR, for the first time, are going to be primary outcomes of a real-life observational study. The crucial role of frailty assessment is going to be addressed in the ability to predict postoperative outcomes and to correlate with QoL and FR.
Authors: Isacco Montroni; Giampaolo Ugolini; Nicole M Saur; Siri Rostoft; Antonino Spinelli; Barbara L Van Leeuwen; Nicola De Liguori Carino; Federico Ghignone; Michael T Jaklitsch; Ponnandai Somasundar; Anna Garutti; Chiara Zingaretti; Flavia Foca; Bernadette Vertogen; Oriana Nanni; Steven D Wexner; Riccardo A Audisio Journal: J Natl Cancer Inst Date: 2022-07-11 Impact factor: 11.816