Abstract P5-11-01: Self-evaluation of duration of adjuvant chemotherapy side effects in breast cancer patients: A prospective study
Authors: Galizia D , Martinello R , Cagnazzo C , Foresto M , Gallizioli S , Longo V , Berchialla P , Solinas G , Calori A , Volpone C , Parola G , Tealdi G , Ballari A , Montemurro F 
Published: March 2017

Abstract
Background: Collection and analysis of chemotherapy-related side-effects (CSE) is critical in the management of cancer patients (pts) both in experimental trials and in the clinical practice. Usually, most of the available conventional systems like the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) capture CSE severity but not their duration. Recently we observed that self-evaluation of CSE incidence and severity by a CTCAE v4.0-based questionnaire was feasible and potentially more informative than doctor reports in pts undergoing standard adjuvant chemotherapy (ACT) for operable breast cancer (Montemurro et al., JAMA Oncol 2; 445-452, 2016). Our questionnaire had also a section for reporting, for each of the considered CSE, day of onset, duration and whether it was still present at the time of the visit. Here we report the analysis of patient self-evaluation of CSE duration.
Methods: The study prospectively enrolled 604 pts receiving ACT for operable breast cancer between January 2011 and October 2013 at 11 sites in Italy. CTCAE v4.0 definitions of grade of severity for nausea, vomiting, constipation, anorexia, dysgeusia, diarrhea, fatigue, pain, paresthesia, and dyspnea were translated into Italian and rephrased. Questionnaires were administered after the first and third cycle of chemotherapy. At each time-point, information on CSE was extracted from the medical charts and compared to patient questionnaires.
Results: Overall 1177 questionnaires were collected, 596 after cycle 1 and 581 after cycle 3 of ACT. A median of 82% of the fields was completely filled-in. 594 and 573 pts-questionnaires had a corresponding MD-questionnaire. Comparison of CSE duration after cycle 1 of chemotherapy as self-assessed by pts versus that reported by doctors is summarized in the table. For all CSE, patient reported longer duration than doctors did. Comparisons of reports after cycle 3 were similar.
PatientsDoctors Item (available paried data)Incidence (%)Mean duration* (SD)Incidence 8%)Mean Duration* (SD)P**Nausea (538)673.7 (3.6)401.6 (2.6)&lt;0.01Vomiting (571)221.8 (1.7)111.2 (1.8)&lt;0.01Constipation (546)492.7 (3.4)121.0 (2.9)&lt;0.01Anorexia (563)533.8 (4.2)71.0 (1.9)&lt;0.01Dysgeusia (556)505.0 (5.7)81.0 (4.1)&lt;0.01Diarrhea (568)152.4 (2.8)40.9 (1.8)&lt;0.01Fatigue (533)756.7 (5.2)250.9 (2.5)&lt;0.01Pain (518)323.6 (4.4)100.5 (2.4)&lt;0.01Paresthesia (582)232.9 (5.2)35.2 (0.8)&lt;0.01Dyspnea (574)256.2 (5.6)25.0 (1.8)&lt;0.01 *5% trimmed mean, ** Student T test for paired samples
Conclusions: self-reporting of CSE duration is feasible in patients receiving ACT after breast cancer surgery by using a CTCAE-derived questionnaire. Because doctors tend to underestimate both incidence and duration of CSE, patient-reported outcomes should be incorporated into the clinical practice because of the potential to provide a better estimate of the total burden of CSE.
Supporte by a grant of the Rete Oncologica Del Piemonte e della Valle d'Aosta.
Citation Format: Galizia D, Martinello R, Cagnazzo C, Foresto M, Gallizioli S, Longo V, Berchialla P, Solinas G, Calori A, Volpone C, Parola G, Tealdi G, Ballari A, Montemurro F. Self-evaluation of duration of adjuvant chemotherapy side effects in breast cancer patients: A prospective study [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P5-11-01.