Body Mass Index and patient-reported measures of function, quality of life and treatment toxicity in women receiving adjuvant chemotherapy for breast cancer

doi:10.21203/rs.3.rs-1632995/v1

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Research Article

Body Mass Index and patient-reported measures of function, quality of life and treatment toxicity in women receiving adjuvant chemotherapy for breast cancer

https://doi.org/10.21203/rs.3.rs-1632995/v1

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Background: This study investigates whether high body mass index (BMI) in women diagnosed with early breast cancer (BC) is associated with patient-reported symptom severity during chemotherapy.

Methods: Women with Stage I-III BC completed toxicity reports for 17 side effects during regularly scheduled chemotherapy infusions. Toxicity reports were compared in women with obesity (BMI >=30) versus no obesity (BMI <30). Fisher’s exact tests and 2-sample t-tests compared baseline patient characteristics. Risk ratios (RR) for women with obesity as compared to no obesity were estimated for individual symptoms that were patient-rated as moderate, severe or very severe (MSVS) severity, adjusting for marital status and race.

Results: In a sample of 286 patients, Black women comprised 23% of the sample. The obesity rate was 76% among Black patients and 31% among White patients (p<.0001). Women with obesity rated an average of 6.9 side effects (standard deviation, SD 4.2) as MSVS vs 5.5 side effects (SD 3.7) among women with no obesity (p=.003). In adjusted analysis, women with obesity had significantly greater risk for MSVS fatigue (RR 1.18, 95% CI 1.01-1.36), dyspnea (RR 1.71, 95% CI 1.09-2.69), arthralgia (RR 1.47, 95% CI 1.10-1.97), peripheral neuropathy (RR 1.45, 95% CI 1.01-2.08), edema of limbs (RR 1.84, 95% CI 1.18-2.88), and abdominal pain (RR 1.75, 95% CI 1.07-2.87). There were no inter-group differences in BC stage or phenotype, chemotherapy treatment modifications, or hospitalizations.

Conclusions: Among women with early BC, patients with obesity reported higher chemotherapy toxicity as compared to patients without obesity; however, this did not result in differences in treatment completion.

obesity

breast cancer

chemotherapy

toxicities

A majority of women with breast cancer (BC) are overweight or have obesity at diagnosis^1–4. Obesity is associated with higher incidence of more severe BC (Stage III/IV BC and grade 3–4 tumors)^5,6 and elevated risk for adverse BC outcomes^6–8. These findings are of particular concern in Black women diagnosed with non-metastatic BC, where the rate of obesity can be twice as high (62%) as in White women (32%)^1,9. High BMI also presents added challenges for chemotherapy dosing and efficacy^10,11. Chemotherapy treatment completion without modification produces highest efficacy¹² with the current gold standard being least 85% completion^13,14.

Toxicity is an important consideration in chemotherapy treatment and is monitored using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE)^15,16. Dose reduction or early treatment discontinuation due to symptom severity occurs in about 80% of women receiving chemotherapy for early BC¹⁷ and can impact treatment efficacy^18,19. In some studies, higher BMI has been associated with increased risk for unplanned changes in the treatment plan^20,21. Some studies have reported lower or no risk for treatment toxicity in patients with high BMI or body surface area (BSA)^11,22 while other studies have reported higher risk for side effects, such as chemotherapy-induced peripheral neuropathy (CIPN)^23,24. It is clear that the evidence is mixed regarding the impact of obesity on symptom severity and treatment completion.

In a sample of women with non-metastatic BC (Stage I-III) seen in current clinical practice, we compared women with obesity (BMI ≥ 30) to no obesity (BMI < 30) with regard to self-reported treatment toxicity, treatment modifications and hospitalizations during chemotherapy administered with curative intent. Our aim was to identify inter-group differences (obesity vs. no obesity) that should be monitored and, if possible, addressed through early intervention.

Study Participants

This is an ancillary analysis of data from three studies investigating moderate exercise during chemotherapy for early BC -- age 21–64 years (NCT02167932), age 65 or older (NCT02328313), and age 21 or older (NCT03761706). NCT02328313 was a multi-site study that included the University of North Carolina at Chapel Hill (UNC) N.C. Cancer Hospital, UNC Rex Healthcare, Duke University Medical Center, MD Anderson Cancer Center, and Ohio State University Comprehensive Cancer Center. The other two studies were conducted at the N.C. Cancer Hospital only. The studies were approved by the institutional review boards of participating sites and by the University of North Carolina Lineberger Comprehensive Cancer Center Protocol Review Committee.

Enrollment into the studies was from February 2014 through February 2020. The protocols were identical between all three studies, as described in previous publications^25–28. Daily clinic schedules were reviewed for potential study patients, and eligible patients were recruited and consented 1–2 weeks prior to the initiation of planned neoadjuvant or adjuvant chemotherapy.

Measures

Chemotherapy Regimens. Depending on tumor stage²⁹ and phenotype, chemotherapy regimens were determined by the treating oncologists in consultation with their patients. The most common regimens were (a) doxorubicin/cyclophosphamide before/after paclitaxel (AC-T), (b) docetaxel/cyclophosphamide plus/minus anti-HER-2 therapy (TC), (c) docetaxel/carboplatin plus anti-HER-2 therapy (TCH), and (d) doxorubicin/cyclophosphamide before/after paclitaxel/carboplatin (AC-TC) and comprised 81 percent of all regimens. Growth factors (pegfilgrastim) were used for docetaxel/cyclophosphamide and docetaxel/carboplatin regimens and for doxorubicin/cyclophosphamide when administrated every 2 weeks (dose dense).

Assessments and Patient-Reported Outcome (PRO) Measures. Prior to the start of chemotherapy, research staff conducted three assessments: Short Physical Performance Battery (SPPB)³⁰, Timed Up and Go (TUG)^31,32, and Blessed Orientation Memory Concentration test (BOMC)^33,34. Questionnaires completed by study patients were the following: Instrumental Activities of Daily Living (IADL)³⁵, Mental Health (Mental Health Index/MHI)³⁶ (subscales Depression and Anxiety), Physical Function³⁷, Social Activities³⁸, Social Support (subscales Emotional and Tangible)³⁹, Quality of Life (Functional Assessment of Cancer-General/FACT-G)⁴⁰, and Fatigue (Functional Assessment of Chronic Illness Therapy/FACIT-Fatigue)⁴¹. Patient age, race, education, marital status, alcohol consumption, and engagement in rigorous physical activity were also self-reported.

Patient-Reported Symptoms. Patients were queried about 17 commonly occurring side effects of (neo)adjuvant chemotherapy: fatigue, insomnia, anxiety, depression, dyspnea, peripheral neuropathy, joint pain/arthralgia, muscle pain/myalgia, abdominal pain, general pain, lymphedema/edema of the extremities, constipation, diarrhea, nausea, vomiting, mucositis, and hot flashes. Research staff collected symptom data prior to chemotherapy initiation (baseline) and then at infusion visits throughout chemotherapy treatment by asking the patients to rate their symptoms using paper or electronic tablet. Symptom reports were collected at every infusion visit for patients receiving chemotherapy every 2 or 3 weeks, and every other week for patients receiving weekly infusions. The reporting format for two studies (NCT02167932 andNCT02328313) was the patient-validated Patient-Reported Symptom Monitoring (PRSM) (Appendix 1)⁴². For the most recent study (NCT03761706), the NCI’s PRO-CTCAE was used, as it became publicly available in April 2016 (Appendix 2)^43,44. The PRSM and PRO-CTCAE formats are similar and entail 7-day recall questions regarding symptom “severity” and symptom “interference with daily activities” using a 5-point Likert-type scale. “Severity” was dichotomized as “none/mild” versus “moderate/severe/very severe”, and “interference” was dichotomized as “not at all/a little bit” versus “somewhat/quite a bit/very much”. Our previously reported studies have similarly combined results collected from both instruments^25–28.

Electronic Medical Record (EMR). Research staff extracted the following EMR data: height and weight for BMI, comorbidities, BC diagnosis and treatment, and adverse events during chemotherapy (dose delay, dose reduction, early treatment discontinuation, hospitalization).

Statistical Considerations

Descriptive statistics were computed at baseline. Comparisons of patients with and without obesity were conducted using Fisher’s exact tests and chi-square tests for categorical variables and two-sample t-tests for continuous variables. Multivariable analyses, adjusting for race and marital status, were performed with log-binomial models to compare the two BMI groups for the 17 side effect measures as outcomes. Two-sided p-values less than 0.05 were considered statistically significant. Analyses used SAS statistical software (V9.4 SAS Institute Inc, Cary, NC)

Patient Characteristics

In a sample of 286 patients, Black women comprised 23% of the sample (Table 1). Forty-one percent of the patients (N = 118) had obesity (BMI 30 or higher). The obesity rate was 31% among White patients and 76% among Black patients (p < .0001). The marriage rates was 62% among patients without obesity and 45% among patients with obesity (p = .008).

Table 1

Participant Characteristics at Baseline (pre-chemotherapy initiation)
Variable	Overall N = 286	BMI < 30 N = 168 (59%)	BMI > = 30 N = 118 (41%)	p-value
Demographics
Age – mean (SD) years	57.6 (13.1) Range 23–83	56.5 (13.4) Range 27–83	59.1 (12.6) Range 23–83	.11
Race White Black/AA	220 (77%) 66 (23%)	152 (90%) 16 (10%)	68 (58%) 50 (42%)	< .0001
Education High school or less More than high school	44 (15%) 240 (85%)	20 (12%) 147 (88%)	24 (21%) 93 (79%)	.07
Employed more than 32 hours/week No Yes	198 (70%) 85 (30%)	114 (69%) 52 (31%)	84 (72%) 33 (28%)	.60
Married No Yes	127 (45%) 156 (55%)	63 (38%) 103 (62%)	64 (55%) 53 (45%)	.008
Living alone No Yes	225 (80%) 58 (20%)	137 (83%) 29 (17%)	88 (75%) 29 (25%)	.14
Comorbidities	Overall	BMI < 30	BMI > = 30	p-value
Number of comorbidities -Mean (SD)	1.7 (1.6) Range 0–11	1.3 (1.4) Range 0–9	2.3 (1.7) Range 0–11	< .0001
Comorbidities by category 0 1–2 3–4 5 or more	69 (25% 139 (51%) 53 (19%) 13 (5%)	54 (33%) 86 (53%) 17 (10%) 5 (3%)	15 (13%) 53 (47%) 36 (32%) 8 (7%)	< .0001
Hypertension	91 (33%)	32 (20%)	59 (53%)	< .0001
Diabetes Mellitus	33 (12%)	7 (4%)	26 (24%)	< .0001
Stomach or intestinal disorders	30 (11%)	17 (11%)	13 (12%)	.84
Arthritis or rheumatism	97 (36%)	45 (28%)	52 (47%)	.002
Heart disease	10 (4%)	4 (3%)	6 (5%)	.33
Liver or kidney disease	7 (3%)	1 (1%)	6 (5%)	.02
Circulation disorders	21 (8%)	8 (5%)	13 (12%)	.06
Glaucoma	12 (4%)	1 (1%)	11 (10%)	.0003
Emphysema, chronic bronchitis	9 (3%)	2 (1%)	7 (6%)	.03
Osteoporosis	28 (10%)	20 (12%)	8 (7%)	.22
Stroke	6 (2%)	1 (1%)	5 (4%)	.04
Breast cancer diagnosis and treatment	Overall	BMI < 30	BMI > = 30	p-value
Breast cancer stage, N (%) I II III	71 (25%) 145 (51%) 69 (24%)	44 (26%) 88 (52%) 36 (21%)	27 (23%) 57 (49%) 33 (28%)	.43
HER2, N (%) Negative Positive	213 (75%) 71 (25%)	130 (77%) 38 (23%)	83 (72%) 33 (28%)	.27
Hormone receptor (HR), N (%) Negative Positive	59 (38%) 96 (62%)	31 (35%) 57 (65%)	28 (42%) 39 (58%)	.41
Triple negative, N (%) No Yes	112 (72%) 43 (28%)	62 (70%) 26 (30%)	50 (75%) 17 (25%)	.59
Lymph node surgery Axillary Sentinel	80 (29%) 196 (71%)	41 (25%) 121 (75%)	39 (34%) 75 (66%)	.14
Breast surgery None Lumpectomy Mastectomy	8 (3%) 132 (48%) 135 (49%)	3 (2%) 71 (44%) 87 (54%)	5 (4%) 61 (54%) 48 (42%)	.09
Radiation No Yes	67 (26%) 187 (74%)	49 (33%) 100 (67%)	18 (17%) 87 (83%)	.006
Chemotherapy timing Neoadjuvant Adjuvant Both	107 (38%) 173 (61%) 2 (1%)	63 (38%) 102 (61%) 1 (1%)	44 (38%) 71 (61%) 1 (1%)	1.00
Chemotherapy regimen Not anthracycline-based Anthracycline-based	158 (55%) 127 (45%)	95 (57%) 73 (43%)	63 (54%) 54 (46%)	.72
Taxane regimen Docetaxel Paclitaxel/Nab-paclitaxel	128 (48%) 139 (52%)	84 (53%) 75 (47%)	44 (41%) 64 (59%)	.06
Chemotherapy regimen – specific AC-T AC-TC TC TCH Other	86 (30%) 21 (7%) 78 (28%) 43 (15%) 55 (19%)	43 (26%) 18 (11%) 56 (33%) 26 (15%) 25 (15%)	43 (37%) 3 (3%) 22 (19%) 17 (15%) 30 (26%)	.0008
Legend: AC-T (Doxorubicin/Cyclophosphamide plus Paclitaxel); AC-TC (Doxorubicin/Cyclophosphamide plus Paclitaxel/Carboplatin); TC (Docetaxel/Cyclophosphamide +/- HER-2); TCH (Docetaxel/Carboplatin/anti-HER-2)

Mean number of comorbidities was 2.3 (SD 1.7) in women with obesity vs 1.3 (SD 1.4) in patients with no obesity (p < .0001). Patients with obesity had higher rates of the following comorbidities: hypertension 53% vs 20% (p < .0001), diabetes mellitus 24% vs 4% (p < .0001), arthritis or rheumatism 47% vs 28% (p = .002), liver of kidney disease 5% vs 1% (p = .03), glaucoma 10% vs 1% (p = .0003), emphysema or chronic bronchitis 6% vs 1% (p = .04), and stroke 4% vs 1% (p = .04).

There were no significant differences in BC stage or phenotype between patients with and without obesity. However, the proportion of patients receiving radiation treatment was lower in women with no obesity (67%) as compared to obesity (83%) (p = .006). And women with no obesity included higher proportions of women receiving chemotherapy regimens AC-TC (11% vs 3%) and TC (33% vs 19%), but lower proportion of “Other” regimens (15% vs 26%) (p = .0008).

Pre-Chemotherapy Measures of Function, Quality of Life and Symptoms

Assessments Conducted by Research Staff. Mean scores on the Short Physical Performance Battery (SPPB) were worse among women with obesity as compared to no obesity (p = .002) (Table 2). A higher proportion of women with obesity scored “lower cognition” (BOMC > = 5) (28%) as compared to women with no obesity (17%) (p = .02).

Table 2

Baseline (pre-chemotherapy) Assessments and Patient-Reported Outcome (PRO) Measures and Symptoms
Baseline Assessments	Overall	BMI < 30 N = 168 (59%)	BMI > = 30 N = 118 (41%)	p-value
Timed Up and Go (TUG) – 14 seconds or more No Yes	237 (88%) 32 (12%)	140 (89%) 18 (11%)	97 (87%) 14 (13%)	.85
Short Physical Performance Battery (SPPB) – range 0 = worst to 12 = best performance	10.5 (SD 1.8) Range 3–12	10.8 (SD 1.6) Range 3–12	10.1 (SD 2.1) Range 4–12	.002
Blessed Orientation Memory Concentration Test/BOMC -- lower cognition score > = 5 <5 >=5	219 (78%) 60 (22%	136 (83%) 27 (17%)	83 (72%) 33 (28%)	.02
Patient-Reported Health Behavior		BMI < 30	BMI > = 30	p-value
History of falls in the past 6 months None 1 or more	241 (88%) 32 (12%)	149 (93%) 12 (7%)	92 (82%) 20 (18%)	.01
Self-reported history of walking minutes per week – Average (SD)	127.1 (SD 136.7)	149 (SD 136)	95 (SD 131)	.001
Vigorous physical activity Never, a few times a week 1–2 times a week 3 or more times a week	128 (48%) 57 (21%) 82 (31%)	57 (36%) 36 (23%) 67 (42%)	71 (66%) 21 (20%) 15 (14%)	< .0001
Smoking history Never Past smoker Current smoker	163 (60%) 90 (33%) 19 (7%)	98 (61%) 52 (32%) 11 (7%)	65 (59%) 38 (34%) 8 (7%)	.94
Alcohol Use No, almost never Yes	170 (62%) 104 (38%)	92 (57%) 70 (43%)	78 (70%) 34 (30%)	.03
Patient-Reported Outcomes (PRO) Scales	Overall	BMI < 30	BMI > = 30	p-value
Instrumental Activities of Daily Living/IADL – range 0–14 <14 = limitations 14 = no limitations	42 (15%) 232 (85%)	16 (10%) 144 (90%)	26 (23%) 88 (77%)	.006
Mental Health Index/MHI – range 0–43 Depressed score > = 12 Not depressed Depressed	195 (74%) 68 (26%)	123 (79%) 33 (21%)	72 (67%) 35 (32%)	.04
Mental Health Index/MHI – range 0–20 Anxious score > = 6 Not anxious Anxious	148 (54%) 125 (46%)	88 (54%) 74 (46%)	60 (54%) 51 (46%)	1.00
Physical Function – range 0–20 20 = high function <20 = lower function	77 (34%) 150 (66%)	53 (39%) 83 (61%)	24 (26%) 67 (74%)	.06
Social Support-Emotional -- range 0-100 >=50 high support < 50	218 (96%) 9 (4%)	129 (98%) 3 (2%)	89 (94%) 6 (6%)	.17
Social Support-Tangible (range 0-100) >=50 high support < 50 low support	216 (94%) 13 (6%)	129 (97%) 4 (3%)	87 (91%) 9 (9%)	.05
Functional Assessment of Cancer Therapy/FACT-General (higher score = higher wellbeing) Physical well-being (range 0–28) Social/family wellbeing (range 0–28) Emotional wellbeing (range 0–24) Functional wellbeing (range 0–28)	24.8 (SD 3.9) Range 8–28 24.7 (SD 4.6) Range 4–28 19.1 (SD 3.8) Range 1–24 20.9 (SD 5.7) Range 0–28	25.4 (SD 3.5) Range 11–28 25.3 (SD 3.8) Range 6–28 19.3 (SD 3.6) Range 4–24 21.5 (SD 5.1) Range 6–28	23.9 (SD 4.2) Range 8–28 23.7 (SD 5.4) Range 4–28 18.9 (SD 4.1) Range 1.2–24 19.9 (SD 6.3) Range 0–28	.001 .003 .46 .02
Functional Assessment of Chronic Illness Therapy/FACIT-Fatigue (reverse scored so that higher score = less fatigue) (range 0-160)	43.1 (SD 8.8) Range 5–52	44.2 (SD 7.8) Range 19–52	41.3 (SD 9.8) Range 5–52	.006
Carolina Frailty Index Frail Pre-frail Robust	8 (3%) 62 (22%) 210 (75%)	2 (1%) 23 (14%) 140 (85%)	6 (5%) 39 (34%) 70 (61%)	< .0001
Symptoms rated moderate, severe or very severe (MSVS) prior to chemotherapy initiation	Overall	BMI < 30	BMI > = 30	p-value
Fatigue	45 (19%)	18 (13%)	27 (27%)	.007
Anxiety	67 (26%)	38 (25%)	29 (26%)	1.00
Depression	41 (16%)	22 (15%)	19 (17%)	.61
Insomnia	81 (31%)	43 (29%)	38 (34%)	.42
Hot flashes	25 (10%)	13 (9%)	12 (11%)	.67
Dyspnea	8 (3%)	0 (0%)	8 (7%)	.001
Aching joints/arthralgia	32 (12%)	12 (8%)	20 (18%)	.02
Aching muscles/myalgia	21 (8%)	10 (7%)	11 (10%)	.36
Peripheral neuropathy	9 (3%)	2 (1%)	7 (6%)	.04
Edema limbs	8 (3%)	2 (1%)	6 (5%)	.07
Abdominal pain	5 (2%)	4 (3%)	1 (1%)	.40
General pain	40 (15%)	21 (14%)	19 (18%)	.49
Constipation	31 (12%)	20 (13%)	11 (9%)	.56
Diarrhea	27 (10%)	14 (9%)	13 (12%)	.55
Nausea	5 (2%)	3 (2%)	2 (2%)	1.00
Vomiting	1 (.5%)	1 (1%)	0 (0%)	1.00
Mucositis oral	2 (1%)	2 (1%)	0 (0%)	0.51
Legend: Short Physical Performance Battery/SPPB, Blessed Orientation Memory Concentration Test/BOMC, Mental Health Index/MHI, Instrumental Activities of Daily Living/IADL, Functional Assessment of Cancer Therapy/FACT, Functional Assessment of Chronic Illness Therapy/FACIT

Patient-Reported Health Behavior. A higher proportion of patients with obesity as compared to no obesity reported one or more falls in the past 6 months (18% vs 7%), p = .01), fewer walking minutes per week (average 95 vs 149 minutes, p = .001), and never or only a few times a week engaging in physical activity (66% vs 36%, p < .0001) (Table 2). A higher proportion of women with no obesity reported alcohol use (43%) as compared to women with obesity (30%) (p = .03).

Patient-Reported Outcome (PRO) Measures. Limitations in Instrumental Activities of Daily Living (IADL) were more prevalent among women with obesity than without obesity (23% vs 10%, p = .006) (Table 2). A higher proportion of patients with Mental Health Index (MHI) scores indicating depression was observed in patients no obesity as compared to no obesity (32% vs 21%) (p = .04). Patients with obesity more frequently reported lower tangible social support as compared to patients with no obesity (9% vs 3%, p = .05). Patients with obesity scored lower quality of life for physical well-being (p = .001), social/family wellbeing (p = .003), and functional well-being (p = .02), as well as higher fatigue (p = .006). On the Carolina Frailty Index, a higher proportion of women with no obesity as compared to patients with obesity were rated “robust” (85% vs 61%) (p < .0001).

Symptoms. Prior to the start of chemotherapy (Table 2), a higher proportion of women with obesity as compared to no obesity reported moderate, severe or very severe (MSVS) fatigue (27% vs 13%, p = .007), dyspnea (7% vs 0%), p = .001), arthralgia (18% vs 8%, p = .02), and peripheral neuropathy (6% vs 1%, p = .04).

Symptom Reports During Chemotherapy

Symptom Severity. At any time during chemotherapy treatment, patients with obesity rated 6.9 (SD 4.2, range 0–17) symptoms as moderate, severe or very severe (MSVS) severity as compared to 5.5 (SD 3.7, range 0–16) among patients with no obesity (p = .003). Higher proportions of women with obesity rated individual symptom severity as MSVS (Fig. 1): fatigue 79% vs 66% p = .03), arthralgia 50% vs 34% (p = .01), peripheral neuropathy 43% vs 27% (p = .005), edema of limbs 36% vs 17% (p = .0003), dyspnea 29% vs 18% (p = .04), and abdominal pain 26% vs 15% (p = .02).

In Table 3, we report Relative Risk (RR) for MSVS patient-reported symptom severity, with multivariable (MV) analyses adjusted for race and marital status. Women with obesity as compared to no obesity were more likely to report MSVS fatigue (RR 1.18, 95% CI 1.02,1.36), dyspnea (RR 1.71, 95% CI 1.09,2.69), arthralgia (RR 1.47, 95% CI 1.10,1.97), peripheral neuropathy (RR 1.45, 95% CI 1.01,2.08), edema of limbs (RR 1.84 (95% CI 1.18.2.88), and abdominal pain (RR 1.75, 95% CI 1.07,2.87).

Table 3

Patient-reported symptoms during chemotherapy, Relative Risk (RR) unadjusted and adjusted for marital status and race (shown for associations significant at alpha = .05 level)
Symptom Severity (% MSVS)	Overall	BMI < 30 N = 168 (59%)	BMI > = 30 N = 118 (41%)	Unadjusted RR (95% Confidence Interval	Adjusted RR 95% Confidence Interval
Fatigue	203 (72%)	111 (67%)	92 (79%)	1.18 (1.02,1.36)	1.18 (1.01,1.36)
Anxiety	128 (45%)	71 (43%)	57 (48%)
Depression	85 (30%)	48 (29%)	37 (31%)
Insomnia	171 (60%)	94 (56%)	77 (65%)
Hot flashes	94 (33%)	54 (32%)	40 (34%)
Dyspnea	64 (22%)	30 (18%)	34 (29%)	1.60 (1.04,2.47)	1.71 (1.09,2.69)
Aching joints/arthralgia	116 (41%)	57 (34%)	59 (50%)	1.46 (1.11, 1.93)	1.47 (1.10, 1.97)
Aching muscles/myalgia	112 (39%)	58 (35%)	54 (46%)
Peripheral neuropathy	96 (34%)	45 (27%)	51 (43%)	1.60 (1.16, 2.22)	1.45 (1.01, 2.08)
Edema limbs	71 (25%)	28 (17%)	43 (36%)	2.17 (1.44, 3.29)	1.84 (1.18, 2.88)
Abdominal pain	56 (20%)	25 (15%)	31 (26%)	1.75 (1.10, 2.81)	1.75 (1.07, 2.87)
General pain	114 (40%)	63 (38%)	51 (43%)
Constipation	107 (38%)	66 (40%)	41 (35%)
Diarrhea	128 (45%)	68 (41%)	60 (51%)
Nausea	102 (36%)	54 (32%)	48 (41%)
Vomiting	26 (9%)	14 (8%)	12 (10%)
Mucositis oral	66 (23%)	36 (22%)	30 (25%)
Symptom Interference with Daily Activities	Overall	BMI < 30	BMI > 30	Unadjusted RR (95% Confidence Interval	Adjusted RR 95% Confidence Interval
Fatigue	186 (65%)	98 (59%)	88 (75%)	1.27 (1.08, 1.50)	1.27 (1.07, 1.51)
Anxiety	70 (25%)	40 (24%)	30 (25%)
Depression	50 (18%)	23 (14%)	27 (23%)
Insomnia	116 (41%)	62 (37%)	54 (46%)
Hot flashes	58 (20%)	34 (20%)	24 (21%)
Dyspnea	60 (21%)	27 (16%)	33 (28%)	1.74 (1.11, 2.74)	1.65 (1.01, 2.68)
Aching joints/arthralgia	90 (32%)	40 (24%)	50 (43%)	1.78 (1.27, 2.51)	1.74 (1.22, 2.49)
Aching muscles/myalgia	78 (27%)	36 (22%)	42 (36%)	1.67 (1.14, 2.43)	1.54 (1.03, 2.30)
Peripheral neuropathy	58 (20%)	24 (14%)	34 (29%)	2.02 (1.27, 3.22)	1.53 (0.93, 2.51)
Edema limbs	48 (17%)	18 (11%)	30 (26%)	2.38 (1.39, 4.06)	1.92 (1.08, 3.41)
Abdominal pain	43 (15%)	16 (10%)	27 (23%)	2.41 (1.36, 4.27)	2.34 (1.27, 4.29)
General pain	90 (32%)	44 (26%)	46 (39%)	1.48 (1.05, 2.08)	1.50 (1.05, 2.15)
Constipation	58 (20%)	32 (19%)	26 (22%)
Diarrhea	92 (32%)	42 (25%)	50 (42%)	1.68 (1.20, 2.36)	1.55 (1.08, 2.23)
Nausea	94 (33%)	51 (31%)	43 (37%)
Vomiting	31 (11%)	15 (9%)	16 (14%)
Mucositis oral	36 (13%)	17 (10%)	19 (16%)
Legend: RR values provided only for statistically significant associations. MSVS = moderate, severe or very severe rating at any time during chemotherapy.
Interference is defined as patients with self reported ‘somewhat/quite a bit/very much’ interference.

Symptom Interference with Daily Activity. Patients with obesity rated an average of 5.4 (SD 4.2, range 0–17) symptoms as “somewhat/quite a bit/very much” interfering with daily living as compared to an average of 3.7 (SD 3.3, range 0–16) symptoms interfering with this intensity among patients without obesity (p = .0002). In both BMI categories, symptom interference with daily living was rated lower than the symptom’s severity. Higher proportions of women with obesity as compared to no obesity reported greater symptom interference (Fig. 1): fatigue 75% vs 59% (p = .006), diarrhea 42% vs 25% (p = .003), myalgia 36% vs 22% (p = .01), arthralgia 43% vs 24% (p = .001), general pain 39% vs 26% (p = .002), peripheral neuropathy 29% vs 14% (p = .004), edema of the limbs 26% vs 11% (p = .001), dyspnea 28% vs 16% (p = .02), and abdominal pain 23% vs 10% (p = .002). In MV analyses adjusted for race and marital status (Table 3), patients with obesity were more likely to report greater interference for fatigue (RR 1.27, 95% CI 1.07,1.51), dyspnea (RR 1.65, 95% CI 1.01,2.68), arthralgia (RR 1.74 95% CI 1.22, 2.49), myalgia (RR 1.54, 95% CI 1.03, 2.30), edema of limbs (RR 1.92, 95% CI 1.08,3.41), abdominal pan (RR 2.34, 95% CI 1.27,4.29), general pain (RR 1.50 (95% CI 1.05,2.15), and diarrhea (RR 1.55, 95% CI 1.08,2.23).

During Chemotherapy Adverse Events and Patient-Reported Symptoms

Overall, 18% of patients were hospitalized, 33% had at least one chemotherapy dose reduction, 23% had an infusion delay, and 17% had their chemotherapy treatment terminated early. For all of these measures, there were no significant differences between patients with obesity and no obesity (Table 4).

Table 4

Adverse Events during Chemotherapy
Variable	Overall	BMI < 30	BMI > = 30	p-value
Hospitalized No Yes	205 (82%) 45 (18%)	125 (86%) 21 (14%)	80 (77%) 24 (23%)	.10
Dose reduction No Yes	168 (67%) 83 (33%)	100 (69%) 45 (31%)	68 (64%) 38 (36%)	.50
Dose delay No Yes	194 (77%) 57 (23%)	113 (77%) 34 (23%)	81 (78%) 23 (22%)	.88
Early treatment discontinuation No Yes	209 (83%) 42 (17%)	126 (86%) 20 (14%)	83 (79%) 22 (21%)	.17

In this study, we examined whether women with early breast cancer and obesity have a different toxicity profile as compared to women without obesity when they receive chemotherapy with curative intent, and whether symptom experience impacts treatment completion. This is an important question because high BMI is common at BC diagnosis⁴ and women often experience weight gain after diagnosis^1,2 which, in turn, can impact BC incidence, severity and outcomes^45–50. The obesity-breast cancer link is of particular concern in states experiencing ever-rising obesity rates and within minoritized populations that have been especially burdened by the obesity epidemic^4,51.

In our sample of 286 patients, 41% had obesity at BC diagnosis, with more than twice the rate of obesity observed among Black patients as compared to White. Unmarried patients also had significantly higher rates of obesity compared to married patients. Patients with obesity had higher mean number of comorbidities, most of them obesity related. There were no significant differences between patients with and without obesity with regard to BC stage or phenotype, although there were significant differences in specific chemotherapy regimens.

Prior to chemotherapy initiation, patients with obesity performed worse on the Short Physical Performance Battery and a higher proportion scored “lower cognition”. Patients with obesity reported more falls and being less physically active, but they also reported less alcohol consumption compared to patients with no obesity. Higher proportions of patients with obesity reported limitations in instrumental activities of daily living, more depression, lower tangible social support, and lower physical, social/family, and functional well-being. A higher proportion of women with no obesity as compared to patients with obesity were rated “robust” on the Carolina Frailty Index. Prior to start of chemotherapy, higher proportions of patients with obesity reported moderate, severe or very severe (MSVS) fatigue, dyspnea, arthralgia, and peripheral neuropathy. The findings would suggest a potential for patients with obesity to have greater difficulties with treatment toxicities as compared to patients without obesity.

In multivariable (MV) analyses of symptom severity during chemotherapy treatment adjusted for race and marital status, patients with obesity in fact had significantly higher risk for MSVS fatigue, dyspnea, arthralgia, peripheral neuropathy, edema of arms and legs, and abdominal pain. Similarly, in MV analyses of symptom interference with daily activities adjusted for race and marital status, patients with obesity were more likely to report greater interference for symptoms related to dyspnea, arthralgia, myalgia, edema of the limbs, abdominal pain, general pain, diarrhea, and peripheral neuropathy. As an exploratory finding, we also report that unmarried patients were more likely to report MSVS symptom severity for dyspnea, peripheral neuropathy, and edema of the limbs, as well as greater interference with daily living with regard to arthralgia, myalgia, peripheral neuropathy, and general pain.

Yet, despite higher risk for symptom severity and symptom interference with activities of daily living among patients with obesity, there were no significant inter-group differences in hospitalizations during chemotherapy or chemotherapy dose reductions, dose delays or early treatment discontinuation. This finding is corroborated by other studies showing no significant association between BMI and receipt of adjuvant chemotherapy³. This is a key finding, but does not detract from the overall caution that women with obesity reported greater sensitivity to chemotherapy side-effects.

Our study has some limitations. Our sample was limited to patients who agreed to participate in a moderate exercise program during chemotherapy. As such, both the patients and their treating clinicians deemed the patients able to participate in a self-directed walking intervention. Our sample also includes a high proportion of women with more than a college education. These “fitness” and education characteristics limit the generalizability of our sample to the larger population of women with early breast cancer scheduled to receive chemotherapy. However, this does not limit the overall purpose of our analysis, which is a comparison of similarly “fit” patients with and without obesity.

Our study contributes to the on-going exploration of the potential impact of obesity on cancer treatment. Because of the tradition of basing chemotherapy dosing on Body Surface Area⁵² (BSA) and concerns that under-dosing may undermine the effectiveness of cytotoxic agents^53–55, best practice is for patients with obesity to receive higher doses of chemotherapy as compared to patients with no obesity^10,56,57. One would expect higher doses in women with obesity to be associated with greater symptom severity leading, in turn, to reduced treatment completion, but this was not found in our study.

In our sample, there were no significant inter-group differences in breast cancer stage and phenotype. The proportion of patients receiving anthracycline-based regimens was somewhat higher in women with obesity (59%) compared to women without obesity (47%); however, the difference failed to reach statistical significance (p = 0.06). This may contribute to the higher rates of MSVS peripheral neuropathy reported among patients with obesity, along with their higher rate of peripheral neuropathy symptoms prior to chemotherapy initiation. Nevertheless, we found no significant differences in treatment completion between patients with or without obesity, nor in dose delays, dose reductions or hospitalizations during chemotherapy.

Our overall observation that women with obesity had greater fatigue, dyspnea, arthralgia, peripheral neuropathy, edema of the limbs, and abdominal pain most likely reflects the higher doses of chemotherapy they are receiving. Greater symptom severity among patients with obesity during treatment may also be a function of their greater symptom reports prior to chemotherapy initiation. Our findings point to the need for extra vigilance in monitoring chemotherapy toxicities in women with obesity treated with weight-appropriate doses, with the aim of offering interventions that may help them maintain quality of life as they continue receiving treatment at full dosage.

Competing Interest: The authors have not competing interests to report.

Author contributions: All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Kirsten A. Nyrop, Jane Monaco, and Sanah Vohra. The first draft of the manuscript was written by Kirsten A. Nyrop and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Data Availability: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Ethics Approval: This is an observational study and was approved by the University of North Carolina Institutional Review Board and the IRBs of participating study sites.

Consent to Participate: Informed consent was obtained from all individual participants included in the study.

Funding Support: Breast Cancer Research Foundation of New York (New York; Muss PI, BCRF-21-114); Kay Yow Foundation (Raleigh NC; Muss PI).

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Body Mass Index and patient-reported measures of function, quality of life and treatment toxicity in women receiving adjuvant chemotherapy for breast cancer

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Abstract

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Introduction

Methods

Study Participants

Measures

Statistical Considerations

Results

Patient Characteristics

Pre-Chemotherapy Measures of Function, Quality of Life and Symptoms

Symptom Reports During Chemotherapy

During Chemotherapy Adverse Events and Patient-Reported Symptoms

Discussion

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