Table 2.

Summary of the main findings of QoL

Study	Functional status at baseline (functional status during adjuvant therapy if reported)	Comorbid condition at baseline	Toxicity/adverse effect	Supportive care where reported	Global or overall QoL scores (scale range)	Global or overall QoL scores Adjuvant chemotherapy and/or radiotherapy			Findings of global or overall QoL (Other QoL domains/subscales if reported)	Authors’ conclusions
					Baseline	In the middle	At the time of completion	Follow-up period
					Mean±SD No. of participants
Arraras 2008a16	KPS mean 94.9 During therapy: KPS decreased from baseline to last dose of RT (mean difference 4.7 (0–100) but returned to baseline 6 weeks after RT)	Limiting comorbidity 62.5%	At last day of RT: Levels 2–3 skin toxicity 8.4% Level 2 dysphagia 4.2% Level 2 fatigue 4.2% Level 2 pain 2.1%	NR	Global QoL (0–100) 59.5±12 n=48		56.4±11.2 n=48	66.5±14.8 (6 weeks after RT) n=46	Global QoL improved significantly from baseline to final evaluation* Subscales Significant worsening in physical and role functioning, and fatigue, pain and breast symptoms in last day of RT but improved at 6 weeks after RT (final evaluation)*	QoL data indicate RT was well tolerated by elderly women with localised breast cancer
Browall 200817	NR	one or two comorbidity 61% ≥3 comorbidities 3%	NR	NR17	Global QoL (0–100) 76±20 n=39	60±23 n=35	61±22 n=32	70±24 (4 months after CT and about 7 weeks after RT) n=30	Global QoL decreased significantly from baseline to midtreatment and last dose of CT. The decrease in global health status had not fully recovered to baseline level at 4 months post-CT* Subscales Physical, role, social and cognitive functioning decreased significantly from baseline to last dose of CT* The decrease in physical and role functioning had not fully recovered to baseline levels at 4 months post-CT No significant change in future perspective, emotional and sexual functioning over time	There was a significant decrease in global QoL, body image, physical & role functioning during and after CT, but the decrease was independent of age
Crivellari 200018	ECOG ≤2 for participants to be eligible	No specific data reported for those 58 participants who completed baseline QoL measurement	Grade 3 haematological toxicity 9.2% Other grade 3 toxicity 6.6%	NR	Perceived adjustment to chronic illness QoL (0–100) Median 59 n=58 (CMF plus tamoxifen)	Median 68 n=55		Median 82 (18 months after first day of CT) n=55	QoL improved progressively across study points (within CMF plus tamoxifen group)	Adding CMF to tamoxifen provided little survival benefits for the older patients, and patients continued to report more effort to cope (low QoL) in the tamoxifen plus CMF group compared with the tamoxifen alone group across time CMF tolerability and effectiveness were reduced for elderly patients with breast cancer
Dees 200019	NR	NR	Neutropenic complications and alteration in cardiac function were not significantly age related, no clinically significant age-related trends in toxicity		Overall QoL (0–10) 7.65±0.88 n=11		6.63±1.48 n=7	(authors mentioned to collect data at 2 and 6 months after completing CT, but they did not report the results/data)	Overall QoL decreased from baseline to last dose of CT but not significant	There was no evidence of decline QoL in older patients with breast cancer treated with adjuvant AC compared with younger ones
Hurria 200620	NR	CCI mean 3	Grade 3 or 4 haematological toxicity 27% Grade 3 or 4 non-haematological toxicity 31%	NR	Overall QoL (0–148) 116 (no information on SD) n=49		116 (no information on SD) n=49	119 (no information on SD) (6 months post-CT) n=48	No significant longitudinal change in overall QoL across all time points Subscales No significant longitudinal change in physical, social, emotional and functional well-being across all time points	Despite about half of patients experiencing grade 3 or 4 toxicity, from the perspective of QoL and functional outcomes, women tolerated adjuvant CT with no decline in QoL, functional status (patients maintained their baseline ability to perform ADLs and IADLs), comorbid or psychological status
Kornblith 201121	ECOG 0–2 for participants to be eligible Grade 0–1, 96% Grade 2, 4%	0 comorbidity 4.9% 1 comorbidity 11.4% 2–3 comorbidities 21.1% 4–10 comorbidities 16.3%	Participants treated with capecitabine has significantly fewer adverse effects during and at the completion of CT	NR	Global QoL (0–100) 75.4±18.3 n=170 (standard CT) 76.5±18.7 n=156 (capecitabine)	63.1±18.4 n=150 (standard CT) 73.1±17.6 n=137 (capecitabine)	63.2±17.3 n=153 (standard CT) 75.8±17.5 n=136 (capecitabine)	78.8±17.8 n=141 (standard CT) (12 months post-CT) 77.4±17.6 n=137 (standard CT) (18 months post-CT) 77.2±17.6 n=137 (standard CT) (24 months post-CT) 77.3±18.0 n=127 (capecitabine) (12 months post-CT) 78.2±17.1 n=114 (capecitabine) (18 months post-CT) 76.5±17.7 n=109 (capecitabine) (24 months post-CT)	Global QoL decreased across all time points within group but no information of P value (Participants treated with capecitabine had significantly better global QoL, role and social functioning, less fatigue, less nausea and vomiting, less constipation and better appetite, and less psychological distress than standard CT group. This difference had resolved by 12 months with no further difference at 24 months)	As reported in the original study, standard CT was associated with a significant improvement in relapse-free survival and overall survival compared with capecitabine The short period of poorer QoL with standard CT is a modest price to pay for a chance at improved survival
Watters 200322	Baseline KPS—NR During therapy: KPS declined during and by the completion of CT, but did not differ from baseline at follow-up	NR	NR	NR	Global QoL (0–100) 78±16 n=20	77±14 n=20	66±20 n=20	73±22 (6 months post-CT) n=20	Global QoL decreased significantly from baseline to the time of completion of CT but improved at 6 months post-CT* Subscales Role and social functioning decreased significantly from baseline to the time of completion of CT but improved at 6 months post-CT*	Selected older women tolerated anthracycline-based adjuvant CT for breast cancer well
Perrone 201523	ECOG Grade 0, 83% Grade 1, 17%	No comorbidity 60% 1 comorbidity 31% ≥2 comorbidities 8%	Severe (grade >2) haematological toxicity was suffered by 70% of participants with CMF and 9% with docetaxel, while severe non-haematological toxicity was reported in 19% participants with CMF and 28% with docetaxel	G-CSF and erythropoietin were used according to standard guidelines. G-CSF was also recommended for prophylaxis when grade ≥2 neutropaenia occurred	No information on mean or median n=252	No information on mean or median			Global QoL decreased from baseline to midtreatment in both standard CMF and docetaxel groups but between-group difference was not significant. No information on within-group difference. Subscales Physical, role, social and cognitive functioning decreased from baseline to midtreatment in both standard CMF and docetaxel groups but between-group differences were not significant. No information on within-group difference. (A statistically significant worsening with docetaxel was found for systemic therapy side effects, future perspective, nausea and vomiting, diarrhoea, appetite loss, upset by hair loss and body image domains)	There was no significant interaction of treatment arms & geriatric scales measuring patients’ ability or comorbidities Docetaxel is not superior to standard CMF in survival. Docetaxel worsens several QoL subscales and causes more non-haematological toxicity
Gállego Pérez-Larraya 201124	Baseline: KPS <70 for participants to be eligible During therapy: 33% improved their KPS by ≥10, before disease progression	NR	Grade 3 or 4 haematological toxicity 25% Most adverse events were mild or moderate According to MMSE, Patient’s cognitive function improved over time	NR	No information on mean or median n=59	1.4 points increase per month n=35			Global QoL improved significantly over time* Subscales Physical, role, cognitive and social functioning scores improved significantly over time* For QLQ-BN20, scores on motor dysfunction, drowsiness and bladder control improved over time before disease progression	Temozolomide was generally well tolerated Temozolomide appears to increase survival, and is associated with a significant improvement of QoL and functional status before tumour progression
Keime-Guibert 200725	Baseline KPS ≥70 for participants to be eligible During therapy: KPS declined over time	NR	No severe adverse effects related to RT	Corticosteroids and anticonvulsant agents, physical and psychological support, management by a palliative care team	Global QoL (0–100) 62.9±3.4 n=35 (supportive care+RT)		55.6±3.9 n=NR	58.8±4.5 (~3 months post-RT) n=26	Global QoL did not deteriorate significantly over time (supportive care+RT) Subscales During and after treatment, scores were significantly worse over time on physical, cognitive and social functioning, and fatigue and motor dysfunction*	Supportive care+RT was superior to supportive alone in survival benefit. Global assessment of deterioration of QoL over time did not differ significantly between supportive care+RT group and supportive care group alone RT results in a modest improvement in survival without reducing QoL
Minniti 200926	Baseline: KPS ≥60 for participants to be eligible KPS median 70 KPS did not change significantly during the study period	Diabetes 19% out of 43 Hypertension 33% out of 43 Cardiovascular disease 16% out of 43	Grade 2–3 confusion and/or somnolence during or after RT 14% out of 43 Grade 3–4 haematological during CT 28% out of 43 (which led to the early discontinuation of CT in half of participants) Moderate-to-severe fatigue 35% out of 43, nausea 10% out of 43, constipation 22% out of 43, skin rash 9% out of 43	Anticonvulsants and dexamethasone	Global QoL (0–100) 58.3±3.7 n=36		54.3±5.1 (completion of RT) n=36 57.9±6.8 (mid-CT; RT followed by CT) n=36		Score of global health status did not change significantly Subscales During treatment, scores of functioning subscale, nausea and vomiting and insomnia did not change significantly Fatigue and constipation scales worsened slightly from baseline through treatment * role and social functioning, and fatigue deteriorated significantly between baseline and the second follow-up*	Temozolomide is well tolerated The association of hypofractionated RT and temozolomide had no negative effect on QoL A short course of RT followed by temozolomide may provide survival benefit while maintaining QoL
Minniti 201327	KPS ≥60 for participants to be eligible KPS median 70	NR	NR	NR	Global QoL (0–100) 61.5±20.8 n=65	60.0 (no information on SD) (1 month after RT and concomitant temozolomide) n=53 72.0 (no information on SD) (6 month from the start of RT) n=27			Global QoL improved significantly between baseline and 6 months from the start of RT (in the midst of adjuvant temozolomide)* Subscales Social and cognitive functioning improved significantly between baseline and 6 months from the start of RT* Fatigue worsened significantly between baseline and 4-month follow-up*	A short course of RT in combination with temozolomide was associated with survival benefit (median survival and 1-year survival rates of 12.4 months and 58%, respectively) without a negative effect on QoL
Mohile 201128	NR	NR	NR	NR	Overall QoL (0–10) 2.07 (no information on SD) n=368		2.37 (no information on SD) n=368		There was an increase of interference with QoL score after RT, however, no information about the P value Subscales The prevalence of memory difficulties and sleep disturbance, and the severity of fatigue and distress significantly increased over the course of RT*	There were no differences in the change in interference with QoL between older and younger patients during RT
Arraras 2008b29	KPS mean 96.1	NR	NR	NR	Global QoL (0–100) 66.8±17.9 n=137		66.7±20.9 n=132	71.3±18.6 (1.5 months after completion of RT) n=126	No change in global QoL score from baseline to last dose of RT but significantly improved from last dose to 1.5 months after RT Subscales There was a significant worsening of physical, cognitive and social functioning from baseline to last dose of RT, but physical functioning improved significantly from last dose to 1.5 months after RT*	There was a tendency to a worsening of QoL at the end of the treatment, with a recovery in most scales in the follow-up measurement that could be due to RT low toxicity level
Bouvier 200830	NR	NR	NR	NR	Global QoL (0–100) 60 (no information of SD) n=11	No information on mean or median	No information on mean or median		Graph shows the mean scores of global QoL increased over time, but no information about the P value Subscales The overall mean score for physical functioning was significantly higher for participants treated with CT than untreated patients regardless of follow-up period. Emotional functioning were found to significantly increase between at diagnosis and 6 months after diagnosis*	Global QoL for patients with stage III colon cancer treated with adjuvant CT did not vary significantly from that of patients who did not receive CT across time
Chang 201231	ECOG Grade 0, 4.9% Grade 1, 63.4% Grade 2, 31.7% (data for the original sample of 82)	CACI ≤7, 75.6% ≥8, 24.4% (data for the original sample of 82)	Grade 3 or 4 haematological toxicity <1% Grade 3 hand-foot syndrome 25.6% (data for the original sample of 82)	NR	Global QoL (0–100) 59 (no information of SD) n=57	No information on mean or median n=55		No information on mean or median (3–6 months after completion of CT) n=48	No significant worsening of global QoL during CT Subscales No significant worsening of functional QoL during CT A slight and insignificant deterioration in social and cognitive functioning at 3 months during CT but recovered over time No symptoms were significantly exacerbated during therapy	By using a tailored-dose escalation strategy, unnecessary dose reduction could be avoided without an increment of toxic effects in patients receiving capecitabine. The toxicity profiles were favourable. Compromised QoL after surgery was not worsened by adjuvant capecitabine and improved after the completion of CT
Caffo 200332	NR	NR	The mean no. of daily stools progressively increased during the treatment	Participants experiencing grade 3–4 diarrhoea were given loperamide with adequate water and saline support. If loperamide was ineffective, treatment with octreotide was planned	Overall QoL (daily card) (1 – 4) (No data reported for EORTC) 2.11±0.75 n was not reported	2.46±0.67 n was not reported	2.55±1.05 n was not reported		Global QoL score improved progressively across study points, and from baseline to final evaluation (during RT), but no information about the P value	The authors’ conclusion is not related to QoL
Park 201333	ECOG 0–1 for participants to be eligible	0 comorbidity 71.2% Any comorbid conditions 28.8%	Grade 3 neutropaenia 39.4%, anaemia 4.5%, thrombocytopaenia 1.5%	NR	Global QoL (0–100) 53 (no information of SD) n=66	No information on mean or median (after second cycle of CT) n=63	No information on mean or median (after fourth cycle of CT) n=60		Global QoL did not significantly deteriorate over time	Postoperative CT did not substantially reduce QoL in elderly patients with NSCLC

*Significant difference reported by the study authors (P<0.05).

ADLs, activities of daily living; BMI, body mass index; BOMC, Blessed Orientation-Memory-Concentration test; CACI, Charlson-Age Comorbidity Index; CCI, Charlson Comorbidity Index; CT, chemotherapy; ECOG, Eastern Cooperative Oncology Group; GDS, Geriatric Depression Scale; IADLs, instrumental activities of daily living; KPS, Karnofsky Performance Status Scale; MMSE, Mini-Mental State Examination; NCI CTC, National Cancer Institute Common Toxicity Criteria; NR, not reported; OARS, Older American Resources and Services Questionnaire; RT, radiotherapy.