TY - JOUR
T1 - Effect on quality of life of cisplatin added to single-agent chemotherapy as first-line treatment for elderly patients with advanced non-small cell lung cancer
T2 - Joint analysis of MILES-3 and MILES-4 randomised phase 3 trials
AU - Morabito, Alessandro
AU - Piccirillo, Maria Carmela
AU - Maione, Paolo
AU - Luciani, Andrea
AU - Cavanna, Luigi
AU - Bonanno, Laura
AU - Filipazzi, Virginio
AU - Leo, Silvana
AU - Cinieri, Saverio
AU - Morgillo, Floriana
AU - Burgio, Marco Angelo
AU - Ferrara, Domenica
AU - Rosetti, Francesco
AU - Bianco, Roberto
AU - Artioli, Fabrizio
AU - Cortinovis, Daniele
AU - Gebbia, Vittorio
AU - Fregoni, Vittorio
AU - Mencoboni, Manlio
AU - Sandomenico, Claudia
AU - Rossi, Antonio
AU - Montanino, Agnese
AU - Manzo, Anna
AU - Rocco, Gaetano
AU - Arenare, Laura
AU - Daniele, Gennaro
AU - Signoriello, Simona
AU - Gallo, Ciro
AU - Perrone, Francesco
AU - Gridelli, Cesare
PY - 2019/7/1
Y1 - 2019/7/1
N2 - Objectives: To evaluate the effect on quality of life (QOL)of the addition of cisplatin to single-agent chemotherapy in the treatment of elderly patients with advanced non-small cell lung cancer (NSCLC)enrolled in two parallel phase 3 trials, MILES-3 and MILES-4. Patients and methods: Advanced NSCLC pts, >70 years old, performance status (PS)0–1, were eligible. Patients were randomly assigned to chemotherapy without or with cisplatin. EORTC QLQ C30 and LC13 questionnaires were planned at baseline, end of cycle 1 and end of cycle 2 in both trials and were used for joint QOL analysis. Trial-specific data including questionnaires at non-shared time-points were used for additional analyses. Intention-to-treat strategy was applied. Analyses were adjusted for baseline QOL, stage, performance status, gender, age, size of centre, trial, histotype and non-platinum companion drug. Results: Overall, 458/531 pts (86%)answered baseline questionnaire and missing rates over treatment were slightly higher among patients receiving cisplatin. Mean change in sore mouth after cycle 2 was worse with cisplatin (P = 0.02). The size of differences between arms was in the small-medium range for peripheral neuropathy and alopecia (0.25 and 0.31 after one and 0.28 and 0.36 after two cycles, respectively)and for nausea/vomiting, sore mouth and dysphagia after two cycles (0.26, 0.38 and 0.25, respectively)always in the direction of worsening with cisplatin. Using a 10% change from baseline as clinically relevant threshold to categorize response, there was no significant difference between the arms. Time to deterioration of sore mouth and alopecia, with progression/death as competitive risk, was shorter with cisplatin (HR 1.72 95%CI 1.02–2.89, P = 0.04 and HR 1.84 95%CI 1.09–3.10, P = 0.02, respectively). Conclusion: The addition of cisplatin to single agent chemotherapy worsens sore mouth and alopecia and does not improve any QOL items in elderly patients with advanced NSCLC.
AB - Objectives: To evaluate the effect on quality of life (QOL)of the addition of cisplatin to single-agent chemotherapy in the treatment of elderly patients with advanced non-small cell lung cancer (NSCLC)enrolled in two parallel phase 3 trials, MILES-3 and MILES-4. Patients and methods: Advanced NSCLC pts, >70 years old, performance status (PS)0–1, were eligible. Patients were randomly assigned to chemotherapy without or with cisplatin. EORTC QLQ C30 and LC13 questionnaires were planned at baseline, end of cycle 1 and end of cycle 2 in both trials and were used for joint QOL analysis. Trial-specific data including questionnaires at non-shared time-points were used for additional analyses. Intention-to-treat strategy was applied. Analyses were adjusted for baseline QOL, stage, performance status, gender, age, size of centre, trial, histotype and non-platinum companion drug. Results: Overall, 458/531 pts (86%)answered baseline questionnaire and missing rates over treatment were slightly higher among patients receiving cisplatin. Mean change in sore mouth after cycle 2 was worse with cisplatin (P = 0.02). The size of differences between arms was in the small-medium range for peripheral neuropathy and alopecia (0.25 and 0.31 after one and 0.28 and 0.36 after two cycles, respectively)and for nausea/vomiting, sore mouth and dysphagia after two cycles (0.26, 0.38 and 0.25, respectively)always in the direction of worsening with cisplatin. Using a 10% change from baseline as clinically relevant threshold to categorize response, there was no significant difference between the arms. Time to deterioration of sore mouth and alopecia, with progression/death as competitive risk, was shorter with cisplatin (HR 1.72 95%CI 1.02–2.89, P = 0.04 and HR 1.84 95%CI 1.09–3.10, P = 0.02, respectively). Conclusion: The addition of cisplatin to single agent chemotherapy worsens sore mouth and alopecia and does not improve any QOL items in elderly patients with advanced NSCLC.
KW - Cisplatin
KW - Elderly patients
KW - NSCLC
KW - Phase 3
KW - Quality of life
KW - Randomized
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U2 - 10.1016/j.lungcan.2019.05.009
DO - 10.1016/j.lungcan.2019.05.009
M3 - Article
AN - SCOPUS:85065520913
VL - 133
SP - 62
EP - 68
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
ER -