1480O - Symptomatic toxicities experienced during anti-cancer treatment: comparison of patients' and physicians' reporting in three randomized controlled t...

Date 27 September 2014
Event ESMO 2014
Session Supportive and palliative care
Topics Complications/Toxicities of Treatment
Supportive Measures
Presenter Massimo Di Maio
Citation Annals of Oncology (2014) 25 (suppl_4): iv517-iv541. 10.1093/annonc/mdu356
Authors M. Di Maio1, M.C. Piccirillo1, G. Daniele2, F. Nuzzo3, C. Gridelli4, V. Gebbia5, F. Ciardiello6, S. De Placido7, A. Ceribelli8, A. Favaretto9, A. De Matteis3, R. Feld10, C.A. Butts11, N. Leighl12, A. Morabito1, J. Bryce2, S. Signoriello13, C. Gallo13, F. Perrone1
  • 1Clinical Trials Unit, Istituto Nazionale Tumori – I.R.C.C.S - Fondazione Pascale, 80131 - Napoli/IT
  • 2Clinical Trials Unit, Istituto Nazionale Tumori di Napoli, IT-80131 - Napoli/IT
  • 3Senology, Istituto Nazionale Tumori – I.R.C.C.S - Fondazione Pascale, Napoli/IT
  • 4Medical Oncology, Azienda Ospedaliera S. Giuseppe Moscati, 83100 - Avellino/IT
  • 5Medical Oncology Unit, La Maddalena Clinic for Cancer, Palermo/IT
  • 6Dip. Medico Chirurgico Di Internistica, Seconda Università Studi di Napoli Policlinico Federico II, 80131 - Napoli/IT
  • 7Medical Oncology, Azienda Ospedaliera Universitaria Policlinico Federico II-AOU Federico II, Napoli/IT
  • 8Medical Oncology A, Regina Elena Cancer Institute, 00147 - Roma/IT
  • 9Oncologia Medica 2, Istituto Oncologico Veneto IOV-IRCCS, IT-35128 - Padova/IT
  • 10Dept. Of Medical Oncology And Hematology, Princess Margaret Hospital, M5G 2M9 - Toronto/CA
  • 11Department Of Oncology, University of Alberta Cross Cancer Institute, T6G 1Z2 - Edmonton/CA
  • 12Medical Oncology, Princess Margaret Hospital, Toronto/CA
  • 13Medical Statistics, Second University, Napoli/IT




Information available about symptomatic toxicities of anti-cancer treatments is based on reports made by clinicians in clinical trials, not on direct reporting by patients (pts). Therefore, some side effects could be under-reported. This analysis aims to compare reporting by pts and physicians of six key toxicities.


Pts enrolled in 3 RCTs (NCT00331097, NCT00349219, NCT00385606) were included. In one RCT, elderly pts with breast cancer received adjuvant chemotherapy, in the other two RCTs pts with advanced non-small cell lung cancer received first-line treatment. Toxicity was prospectively collected by investigators. At the end of each treatment cycle, pts filled in EORTC quality of life (QoL) questionnaires. Cycles were evaluable if both toxicity evaluation and QoL were available. Analysis was limited to the first three cycles. Rates of anorexia, nausea, vomiting, constipation, diarrhea and hair loss reported by pts and physicians are described. For each, relative under-reporting is calculated (cycles with toxicity reported by pts but not physicians).


Overall, 1090 pts and 2482 cycles were included. Toxicity rates reported by physicians were always lower than reported by pts (Table). For cycles when pts reported toxicity (any severity), the proportion of relative under-reporting by physicians ranged from 54.2% to 80.2%. Examining only cycles when patients reported “very much” toxicity, the proportion of relative under-reporting by physicians ranged from 22.2% to 62.1%.

Toxicity Toxicity reported by pts (% cycles) Toxicity reported by pts and by physicians (% cycles) % under-reporting
Anorexia 46.2 9.2 80.2
Nausea 45.3 20.8 54.2
Vomiting 16.8 7.2 57.4
Constipation 37.5 7.8 79.2
Diarrhea 22.7 8.9 61.0
Hair loss 42.7 13.9 67.4


Subjective toxicities are at high risk of under-reporting by physicians, even when prospectively collected within RCTs. Our findings strongly support the incorporation of patient-reported information into toxicity reporting in clinical trials.


All authors have declared no conflicts of interest.