Aurelie Bertaut1, Yann Touchefeu2, Julie Blanc3, Olivier Bouché4, Eric François5, Thierry Conroy6, Pascal Artru7, Antoine Adenis8, Jessica Gobbo9, Christophe Borg10, François Ghiringhelli9, Jaafar Bennouna11. 1. Methodology and Biostatistics Unit, Georges-Francois Leclerc Cancer Center, Dijon, France. Electronic address: abertaut@cgfl.fr. 2. Department of Hepatogastroenterology, Digestive Oncology, Nantes Universitary Hospital, Nantes, France. 3. Methodology and Biostatistics Unit, Georges-Francois Leclerc Cancer Center, Dijon, France. 4. Universitary hospital Robert Debré, Reims, France. 5. Department of Medical Oncology, Antoine-Lacassagne Cancer Center, Nice, France. 6. Lorraine cancer center, Vandoeuvre-Lès Nancy, France. 7. Hospital Jean Mermoz, Lyon, France. 8. Department of Medical Oncology, Montpellier cancer center, Montpellier, France. 9. Department of Medical Oncology, Georges-Francois Leclerc Cancer Center, Dijon, France. 10. Department of Medical Oncology, Universitary hospital of Besançon, Besançon, France. 11. Medical Oncology Department, Hopital Foch, 40 rue Worth, 92150, Suresnes, france.
Abstract
BACKGROUND AND OBJECTIVES: We have previously showed that for patients with wild-type RAS metastatic colorectal cancer (mCRC) progressing after bevacizumab plus chemotherapy, bevacizumab continuation plus a switch of chemotherapy is the most appropriate option (PRODIGE 18 phase II study). Here we aimed to determine treatment impact in patient's Health-Related Quality Of Life (HRQoL) in PRODIGE18 study. METHODS: HRQoL was evaluated in 2 arms bevacizumab or cetuximab-combined with chemotherapy (modified FOLFOX6 [mFOLFOX6] or FOLFIRI) using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 at baseline, first and third tumor evaluation and at the end of the study. The temporal evolution of quality of life scores was investigated using longitudinal linear mixed models of variance. The time until definitive deterioration (TUDD) was estimated using the Kaplan-Meier method and the long-rank test. A univariate Cox model was used to calculate HR with 95% CI. A multivariate Cox model was applied to determine association of TUDD with age and gender. Safety was assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events. RESULTS: HRQoL QLQ-C30 questionnaire compliance was high at baseline (>90%) and declined over time (∼70% in tumor evaluation 1 and ∼ 60% in tumor evaluation 3), but remained similar in both treatment arms. Patient reported mean diarrhea QLQ-C30 score is significantly higher in bevacizumab treatment arm. Clinician reported mild diarrhea was more frequently declared in bevacizumab treatment arm. Cox multivariate analyses showed no statistically significant differences in TUDD for all QLQ-C30 scales between treatments. TUDD of appetite loss was significantly associated to age. CONCLUSIONS: Our study shows that no relevant impairment of patients HRQoL between the 2 treatment arms. So, the analysis of the HRQoL with equal effectiveness does not make it possible to favor one treatment over another.
BACKGROUND AND OBJECTIVES: We have previously showed that for patients with wild-type RAS metastatic colorectal cancer (mCRC) progressing after bevacizumab plus chemotherapy, bevacizumab continuation plus a switch of chemotherapy is the most appropriate option (PRODIGE 18 phase II study). Here we aimed to determine treatment impact in patient's Health-Related Quality Of Life (HRQoL) in PRODIGE18 study. METHODS: HRQoL was evaluated in 2 arms bevacizumab or cetuximab-combined with chemotherapy (modified FOLFOX6 [mFOLFOX6] or FOLFIRI) using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 at baseline, first and third tumor evaluation and at the end of the study. The temporal evolution of quality of life scores was investigated using longitudinal linear mixed models of variance. The time until definitive deterioration (TUDD) was estimated using the Kaplan-Meier method and the long-rank test. A univariate Cox model was used to calculate HR with 95% CI. A multivariate Cox model was applied to determine association of TUDD with age and gender. Safety was assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events. RESULTS: HRQoL QLQ-C30 questionnaire compliance was high at baseline (>90%) and declined over time (∼70% in tumor evaluation 1 and ∼ 60% in tumor evaluation 3), but remained similar in both treatment arms. Patient reported mean diarrhea QLQ-C30 score is significantly higher in bevacizumab treatment arm. Clinician reported mild diarrhea was more frequently declared in bevacizumab treatment arm. Cox multivariate analyses showed no statistically significant differences in TUDD for all QLQ-C30 scales between treatments. TUDD of appetite loss was significantly associated to age. CONCLUSIONS: Our study shows that no relevant impairment of patients HRQoL between the 2 treatment arms. So, the analysis of the HRQoL with equal effectiveness does not make it possible to favor one treatment over another.
Authors: Kaisa Lehtomäki; Hanna P Stedt; Emerik Osterlund; Timo Muhonen; Leena-Maija Soveri; Päivi Halonen; Tapio K Salminen; Juha Kononen; Raija Kallio; Annika Ålgars; Eetu Heervä; Annamarja Lamminmäki; Aki Uutela; Arno Nordin; Juho Lehto; Tiina Saarto; Harri Sintonen; Pirkko-Liisa Kellokumpu-Lehtinen; Raija Ristamäki; Bengt Glimelius; Helena Isoniemi; Pia Osterlund Journal: Cancers (Basel) Date: 2022-03-28 Impact factor: 6.639