From a consecutive sample of 243 eligible women, newly diagnosed with breast cancer, a total of 153 women agreed to participate in the Tailor Dose Trial. Of those, 124 patients (82%) accepted participation in the symptom assessment study (Fig.
1). Of the 124 participants, 67 were randomised to FEC 100 and 57 to FEC 75. The demographic and clinical characteristics of the participants are presented in Table
1.
Table 1
Patients’ demographic and clinical characteristics
Age mean, (range) | 59 (34–79) |
Menopausal status |
Pre | 47 (38) |
0.5–5 years | 11 (9) |
5 years post | 63 (51) |
Uncertain | 3 (2) |
Radical mastectomy |
Yes | 122 (98) |
No | 2 (2) |
Type of mastectomy |
Modified radical mastectomy | 39 (31) |
Other surgery | 1 (1) |
Partial mastectomy + axillary clear | 35 (28) |
Breast conserving surgery | 49 (40) |
Histological grade (Elston Ellis) |
I | 9 (7) |
II | 50 (40) |
III | 64 (52) |
Missing | 1 (1) |
Sentinel node biopsy performed |
Yes | 119 |
No | 5 |
Number of positive nodes |
0 | 70 (57) |
1–3 | 46 (37) |
4–10 | 3 (2) |
>10 | 5 (4) |
Oestrogen receptors positive |
Yes | 96 (77) |
No | 28 (23) |
Receptor negative ER and PgR |
Yes | 27 (22) |
No | 97 (78) |
A majority of the women experienced several, but not all, of the symptoms assessed that contributed to the mean value of symptom scores. The most common mean symptom score value for the variables in this sample ranged between 0.5 and 1.5.
Symptom occurrence and distress
Patients who experienced symptoms reported the following problems in descending order during all cycles; “lack of energy” (range over the different treatment cycles 48–90%), “feeling sad” (48–79%), “difficulty sleeping” (54–78%), “difficulty concentrating” (53–74%), “worrying” (54–74%) and “pain” (29–67%). These were the most common symptoms among the women.
At baseline, “worrying” was the most common symptom (70%), and at all other cycles (one, three and sixth) it was “lack of energy” (76, 84, 85%). The most occurring symptoms, however, were not the most distressing. Symptoms that were less common at baseline, such as “mouth sores”(37%), “I don’t look like myself” (29%), “sexual interest” (28%), “sweats” (27%) were found to be the most distressing. After the last chemotherapy cycle problems with “taste change” (51%), “sexual interest” (44%), “sweats” (41%) were the most distressing symptoms.
Symptom clusters
Cluster 1 at baseline, the “Emotional cluster”, was characterised by the symptoms “worrying” (0.80), “difficulty concentrating”(0.78) and “feeling sad”(0.73). Cluster 2, the “Gastro cluster”, was comprised by symptoms of problems with “taste change” (0.90) “constipation” (0.65), and “diarrhoea” (0.44). Cluster 3 included “breathlessness”(0.63), “dizziness”(0.62), “dry mouth”(0.60) and “nausea”(0.55), defined by five symptoms of a physical nature and was labelled the “Physical cluster”.
At the first cycle of treatment the clusters were quite stable and similar to baseline. In the “Emotional cluster”, “feeling sad”(0.78) was the most predominant symptom. The most predominant symptom in the “Gastro cluster” was “lack of appetite” (0.76). The “Physical cluster” at this assessment point included “hair loss” (0.68) as the most predominant symptom.
The order of symptoms in the clusters changed at cycle 3. A mix of symptoms, including “lack of appetite” (0.75), “breathlessness” (0.64),“feeling nervous” (0.62),“lack of energy” (0.48), “feeling irritable” (0.48), “dizziness” (0.47), and now formed a “Physical cluster”. The most predominant symptom at this time point was “lack of appetite”(0.75). The “Emotional cluster” was dominated by “worrying” (0.67) and “feeling sad” (0.60), and the “Gastro cluster” by “mouth sores” (0.75) and “dry mouth” (0.67).
At cycle 6, the “Emotional cluster” was dominated by “feeling nervous” (0.80) followed by “worrying” (0.77), and “feeling sad” (0.73). The “Gastro cluster” comprised similar symptoms to those reported in the first cycle. The “Physical cluster” was dominated by problems with “sexual relations” (0.71) and also included “sweats” (0.53) and “difficulty sleeping” (0.56).
“Pain” and problems with “sexual relations” changed clusters over time by moving from the “Physical” to the “Emotional” cluster. Nine symptoms were excluded due to low symptom score (mean symptom score < 0.5). Low mean score is a result of low symptom occurrence in addition to a low distress score. The excluded symptoms are as follows: itching, weight loss, changes in skin, difficulty swallowing, swelling of arms or legs, cough, numbness/tingling in hands/feet, problems with urination and vomiting.