Alessandra Raimondi1, Massimo Di Maio2, Federica Morano1, Salvatore Corallo1, Sara Lonardi3, Carlotta Antoniotti4, Lorenza Rimassa5, Andrea Sartore-Bianchi6, Marco Tampellini7, Giuliana Ritorto8, Roberto Murialdo9, Matteo Clavarezza10, Alberto Zaniboni11, Vincenzo Adamo12, Gianluca Tomasello13, Fausto Petrelli14, Lorenzo Antonuzzo15, Monica Giordano16, Saverio Cinieri17, Raffaella Longarini18, Francesca Bergamo3, Monica Niger1, Maria Antista1, Giorgia Peverelli1, Filippo de Braud19, Maria Di Bartolomeo1, Filippo Pietrantonio20. 1. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy. 2. Department of Oncology, University of Turin, Ordine Mauriziano Hospital, Torino, Italy. 3. Medical Oncology Unit 1, Department of Oncology, Istituto Oncologico Veneto - IRCCS, Padua, Italy. 4. Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy. 5. Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center - IRCCS, Rozzano, Italy. 6. Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy; Oncology and Hemato-oncology Department, University of Milan, Milan, Italy. 7. Department of Oncology, AOU San Luigi di Orbassano, University of Torino, Orbassano, Italy. 8. Colorectal Cancer Unit, Medical Oncology Division 1, Azienda Ospedaliero-Universitaria Città Della Salute e Della Scienza, Torino, Italy. 9. Department of Internal Medicine, University of Genoa and IRCCS AOU San Martino-IST, Genoa, Italy. 10. Medical Oncology Unit, Ente Ospedaliero Ospedali Galliera, Genoa, Italy. 11. Medical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy. 12. Medical Oncology Unit A.O. Papardo & Department of Human Pathology, University of Messina, Messina, Italy. 13. Medical Oncology Unit, ASST Ospedale di Cremona, Cremona, Italy. 14. Medical Oncology Unit, Oncology Department, ASST Bergamo Ovest, Treviglio, Italy. 15. Department of Medical Oncology, Oncology Unit, AOU Careggi, Florence, Italy. 16. Medical Oncology Unit, Azienda Socio Sanitaria Territoriale Lariana, Como, Italy. 17. Medical Oncology Unit, Ospedale Antonio Perrino, Brindisi, Italy. 18. Medical Oncology Unit, Azienda Ospedaliera San Gerardo, Monza, Italy. 19. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy; Oncology and Hemato-oncology Department, University of Milan, Milan, Italy. 20. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy; Oncology and Hemato-oncology Department, University of Milan, Milan, Italy. Electronic address: filippo.pietrantonio@istitutotumori.mi.it.
Abstract
BACKGROUND: Quality of life (QoL) patient-reported outcomes (PROs) data from pivotal first-line trials in metastatic colorectal cancer (mCRC) are poor. The Valentino study showed that de-escalation to single-agent panitumumab after 4-month induction with panitumumab-FOLFOX is inferior to panitumumab-5-FU/LV in patients with RAS wild-type mCRC, although slightly reducing toxicity. We report QoL, a secondary end-point. METHODS: PROs were assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30), EORTC QLQ-CR29, EuroQol EQ-5D questionnaires, at baseline and every 8 weeks until disease progression. First two evaluations correspond to induction treatment (identical in both arms), while subsequent to maintenance. To describe QoL changes over time, mean changes from baseline at each time point were calculated in overall population. To compare maintenance between two arms, mean changes and proportion of improved/stable/worse patients versus baseline were compared for each item. RESULTS: In arm A/B, 91.5%/92.0% of enrolled patients completed questionnaires at baseline. No significant differences in the two arms were reported in compliance, baseline scores and mean changes versus baseline for the three questionnaires during maintenance (24/32/40 weeks). Overall, mean changes versus baseline showed an early deterioration during induction with partial recovering during maintenance for global QoL, functional scales and several symptoms/items of QLQ-C30 (fatigue, nausea/vomiting, appetite loss, diarrhoea) and QLQ-CR29 (body image, dry mouth, hair loss, taste, faecal incontinence, sore skin), and EQ-5D Visual Analogue Scale (VAS) score. CONCLUSION: In patients with RAS wild-type mCRC, induction with oxaliplatin-containing chemotherapy plus anti-EGFRs induces a transient significant QoL deterioration. After induction phase, treatment deintensification determines an overall recovery of health-related QoL, besides the expected prevention of oxaliplatin-related neurotoxicity.
BACKGROUND: Quality of life (QoL) patient-reported outcomes (PROs) data from pivotal first-line trials in metastatic colorectal cancer (mCRC) are poor. The Valentino study showed that de-escalation to single-agent panitumumab after 4-month induction with panitumumab-FOLFOX is inferior to panitumumab-5-FU/LV in patients with RAS wild-type mCRC, although slightly reducing toxicity. We report QoL, a secondary end-point. METHODS: PROs were assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30), EORTC QLQ-CR29, EuroQol EQ-5D questionnaires, at baseline and every 8 weeks until disease progression. First two evaluations correspond to induction treatment (identical in both arms), while subsequent to maintenance. To describe QoL changes over time, mean changes from baseline at each time point were calculated in overall population. To compare maintenance between two arms, mean changes and proportion of improved/stable/worse patients versus baseline were compared for each item. RESULTS: In arm A/B, 91.5%/92.0% of enrolled patients completed questionnaires at baseline. No significant differences in the two arms were reported in compliance, baseline scores and mean changes versus baseline for the three questionnaires during maintenance (24/32/40 weeks). Overall, mean changes versus baseline showed an early deterioration during induction with partial recovering during maintenance for global QoL, functional scales and several symptoms/items of QLQ-C30 (fatigue, nausea/vomiting, appetite loss, diarrhoea) and QLQ-CR29 (body image, dry mouth, hair loss, taste, faecal incontinence, sore skin), and EQ-5D Visual Analogue Scale (VAS) score. CONCLUSION: In patients with RAS wild-type mCRC, induction with oxaliplatin-containing chemotherapy plus anti-EGFRs induces a transient significant QoL deterioration. After induction phase, treatment deintensification determines an overall recovery of health-related QoL, besides the expected prevention of oxaliplatin-related neurotoxicity.