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: Joint analysis of MILES-3 and MILES-4 randomised phase 3 trials

Alessandro Morabito, Maria Carmela Piccirillo, Paolo Maione, Andrea Luciani, Luigi Cavanna, Laura Bonanno, Virginio Filipazzi, Silvana Leo, Saverio Cinieri, Floriana Morgillo, Marco Angelo Burgio, Domenica Ferrara, Francesco Rosetti, Roberto Bianco, Fabrizio Artioli, Daniele Cortinovis, Vittorio Gebbia, Vittorio Fregoni, Manlio Mencoboni, Claudia SandomenicoAntonio Rossi, Agnese Montanino, Anna Manzo, Gaetano Rocco, Laura Arenare, Gennaro Daniele, Simona Signoriello, Ciro Gallo, Francesco Perrone, Cesare Gridelli

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)62-68
Number of pages7
JournalLung Cancer
Volume133
DOIs
Publication statusPublished - Jul 1 2019

Keywords

  • Cisplatin
  • Elderly patients
  • NSCLC
  • Phase 3
  • Quality of life
  • Randomized

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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