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Higher rate of severe toxicities in obese patients receiving dose-dense (dd) chemotherapy according to unadjusted body surface area: results of the prospectively randomized GAIN study

BackgroundIn routine clinical practice, chemotherapy doses are frequently capped at a body surface area (BSA) of 2.0 m2 or adjusted to an ideal weight for obese patients due to safety reasons.Materials and methodsBetween August 2004 and July 2008, a total of 3023 patients were enrolled in the GAIN s...

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Main Authors: Furlanetto, Jenny (Author) , Eiermann, Wolfgang (Author) , Marmé, Frederik (Author) , Reimer, Toralf (Author) , Reinisch, Mattea (Author) , Schmatloch, Sabine (Author) , Stickeler, Elmar (Author) , Thomssen, C. (Author) , Untch, Michael (Author) , Denkert, Carsten (Author) , Minckwitz, Gunter von (Author) , Lederer, B. (Author) , Nekljudova, Valentina (Author) , Weber, K. (Author) , Loibl, S. (Author) , Möbus, Volker (Author)
Format: Article (Journal)
Language:English
Published: 8 August 2016
In: Annals of oncology
Year: 2016, Volume: 27, Issue: 11, Pages: 2053-2059
ISSN:1569-8041
DOI:10.1093/annonc/mdw315
Online Access:Verlag, kostenfrei, Volltext: http://dx.doi.org/10.1093/annonc/mdw315
Verlag, kostenfrei, Volltext: https://academic.oup.com/annonc/article/27/11/2053/2440231/Higher-rate-of-severe-toxicities-in-obese-patients
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Author Notes:J. Furlanetto, W. Eiermann, F. Marmé, T. Reimer, M. Reinisch, S. Schmatloch, E. Stickeler, C. Thomssen, M. Untch, C. Denkert, G. von Minckwitz, B. Lederer, V. Nekljudova, K. Weber, S. Loibl and V. Möbus
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Summary:BackgroundIn routine clinical practice, chemotherapy doses are frequently capped at a body surface area (BSA) of 2.0 m2 or adjusted to an ideal weight for obese patients due to safety reasons.Materials and methodsBetween August 2004 and July 2008, a total of 3023 patients were enrolled in the GAIN study, a randomized phase III adjuvant trial, comparing two types of dose-dense (dd) regimen [epirubicin, docetaxel and cyclophosphamide (iddETC) versus epirubicin and cyclophosphamide (EC) followed by docetaxel (T) plus capecitabine (X)]. We retrospectively evaluated a total of 555 patients with a BMI of ≥30 for safety and outcome.ResultsEighteen percent of all patients were obese: 31% of those received chemotherapy according to an unadjusted BSA. For the remaining patients, BSA was adjusted to ideal weight or was capped at 2.0 m2. A total of 15% of obese patients receiving full (unadjusted) dose of chemotherapy versus 6% of obese patients with an adjusted BSA experienced febrile neutropenia (P = 0.003) and 9% versus 3% high-grade thrombopenia (P = 0.002). Overall, 17% versus 10% had a thromboembolic event (P = 0.017), which was high grade in 13% versus 6%, respectively (P = 0.019), and 3% versus 0.3% high-grade hot flushes (P = 0.013). Dizziness (5% versus 11%; P = 0.016), diarrhea (19% versus 27%; P = 0.033) and an increase in serum creatinine (7% versus 14%; P = 0.019) were higher in the adjusted group. However, no differences in disease-free survival (DFS) and overall survival (OS) were observed between non-obese patients, obese patients receiving full-dose chemotherapy or according to an adjusted BSA [5-year DFS 81% (confidence interval 79% to 83%) versus 82% (75% to 87%) versus 81% (76% to 84%); P = 0.761; 5-year OS 90% (88% to 91%) versus 86% (80% to 91%) versus 88% (84% to 91%); P = 0.143].ConclusionObese patients receiving dd chemotherapy according to their real BSA have a higher risk of developing severe toxicities without influencing survival. Therefore, a dose adjustment of intense dd chemotherapy should be carried out to avoid life-threatening complications.
Item Description:Gesehen am 18.10.2017
Physical Description:Online Resource
ISSN:1569-8041
DOI:10.1093/annonc/mdw315

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