Skip to main content
main-content

05.12.2016 | Original Article – Cancer Research | Ausgabe 3/2017

Journal of Cancer Research and Clinical Oncology 3/2017

Relationship between physician-adjudicated adverse events and patient-reported health-related quality of life in a phase II clinical trial (NCT01143402) of patients with metastatic uveal melanoma

Zeitschrift:
Journal of Cancer Research and Clinical Oncology > Ausgabe 3/2017
Autoren:
Thomas M. Atkinson, Jennifer L. Hay, Alexander Shoushtari, Yuelin Li, Daniel J. Paucar, Sloane C. Smith, Ragini R. Kudchadkar, Austin Doyle, Jeffrey A. Sosman, Jorge Fernando Quevedo, Mohammed M. Milhem, Anthony M. Joshua, Gerald P. Linette, Thomas F. Gajewski, Jose Lutzky, David H. Lawson, Christopher D. Lao, Patrick J. Flynn, Mark R. Albertini, Takami Sato, Karl Lewis, Brian Marr, David H. Abramson, Mark Andrew Dickson, Gary K. Schwartz, Richard D. Carvajal
Wichtige Hinweise
The Department of Cancer Treatment and Diagnosis at the National Cancer Institute provided selumetinib for the clinical trial (NCT01143402).

Abstract

Purpose

Clinical trials commonly use physician-adjudicated adverse event (AE) assessment via the common terminology criteria for adverse events (CTCAE) for decision-making. Patient-reported health-related quality of life (HRQoL) data are becoming more frequent in oncology; however, the relationship between physician-adjudicated AE assessment and HRQoL is understudied.

Methods

Data from a phase II trial (clinicaltrials.gov identifier: NCT01143402) where patients with metastatic uveal melanoma were randomized to receive selumetinib, an oral MEK inhibitor, or chemotherapy were analyzed. Patients reported HRQoL at baseline, after 1 month, and end of treatment (n = 118), whereas physicians adjudicated AEs via CTCAE. Mean HRQoL scores were compared between patient randomization arms, as well as between those patients who did/did not receive dose modifications.

Results

Ninety-four percent had a CTCAE grade ≥1 for at least one treatment-associated AE, with 18% undergoing dose modification due to toxicity. Mean HRQoL scores did not significantly differ at each of the three time points. Patient and physician-adjudicated reports of nausea were significantly correlated at the start (r = 0.31, p < 0.01) and end of treatment (r = 0.42, p < 0.05). There were no significant correlations between need for dose modification and HRQoL scores.

Conclusions

Despite the high rate of physician-adjudicated AEs and need for dose modifications with selumetinib, patient-reported HRQoL was not impacted by treatment. Since HRQoL did not differ in the subgroup of patients who received dosage reductions due to AEs, patients may be willing to tolerate select AEs without dose modification (if medically appropriate). More research is needed to determine how to best integrate HRQoL data into clinical trial conduct.

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

★ PREMIUM-INHALT
e.Med Interdisziplinär

Mit e.Med Interdisziplinär erhalten Sie Zugang zu allen CME-Fortbildungen und Fachzeitschriften auf SpringerMedizin.de. Zusätzlich können Sie eine Zeitschrift Ihrer Wahl in gedruckter Form beziehen – ohne Aufpreis.

Bis zum 22.10. bestellen und 100 € sparen!

Weitere Produktempfehlungen anzeigen
Literatur
Über diesen Artikel

Weitere Artikel der Ausgabe 3/2017

Journal of Cancer Research and Clinical Oncology 3/2017Zur Ausgabe
  1. Das kostenlose Testabonnement läuft nach 14 Tagen automatisch und formlos aus. Dieses Abonnement kann nur einmal getestet werden.

  2. Das kostenlose Testabonnement läuft nach 14 Tagen automatisch und formlos aus. Dieses Abonnement kann nur einmal getestet werden.

Neu im Fachgebiet Onkologie

 

 

 
 

Mail Icon II Newsletter

Bestellen Sie unseren kostenlosen Newsletter Update Onkologie und bleiben Sie gut informiert – ganz bequem per eMail.

Bildnachweise