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DOI 10.1016/j.ejca.2020.04.048

Медицинская библиотека · European journal of cancer (Oxford, England : 1990) · 2020

Health-related quality of life in patients with RAS wild-type metastatic colorectal cancer treated with panitumumab-based first-line treatment strategy: A pre-specified secondary analysis of the Valentino study.

Raimondi Alessandra, Di Maio Massimo, Morano Federica, Corallo Salvatore, Lonardi Sara, Antoniotti Carlotta, Rimassa Lorenza, Sartore-Bianchi Andrea, Tampellini Marco, Ritorto Giuliana, Murialdo Roberto, Clavarezza Matteo, Zaniboni Alberto, Adamo Vincenzo, Tomasello Gianluca, Petrelli Fausto, Antonuzzo Lorenzo, Giordano Monica, Cinieri Saverio, Longarini Raffaella, Bergamo Francesca, Niger Monica, Antista Maria, Peverelli Giorgia, de Braud Filippo, Di Bartolomeo Maria, Pietrantonio Filippo

Клиническое исследование II фазыСравнительное исследованиеEquivalence TrialСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАПеревод в очереди

Аннотация

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.

Для цитирования: Raimondi Alessandra, Di Maio Massimo, Morano Federica, Corallo Salvatore, Lonardi Sara, Antoniotti Carlotta, Rimassa Lorenza, Sartore-Bianchi Andrea, Tampellini Marco, Ritorto Giuliana, Murialdo Roberto, Clavarezza Matteo, Zaniboni Alberto, Adamo Vincenzo, Tomasello Gianluca, Petrelli Fausto, Antonuzzo Lorenzo, Giordano Monica, Cinieri Saverio, Longarini Raffaella, Bergamo Francesca, Niger Monica, Antista Maria, Peverelli Giorgia, de Braud Filippo, Di Bartolomeo Maria, Pietrantonio Filippo. Health-related quality of life in patients with RAS wild-type metastatic colorectal cancer treated with panitumumab-based first-line treatment strategy: A pre-specified secondary analysis of the Valentino study.. European journal of cancer (Oxford, England : 1990). 2020. DOI: 10.1016/j.ejca.2020.04.048.

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