. 2018 Jan 24;8(1):e018101. doi: 10.1136/bmjopen-2017-018101

Table 1.

Characteristics of the included studies

Study /country	Type of study	Age (years) Mean±SD	Sample size (≥65 years cohort)	No. of participants completed baseline QoL measurement (%)	Gender (% female)	Type of cancer	CT/RT	Measurement of CGA domains	Measurement of CT/RT-related toxicity/adverse effect	QoL scale (domains/subscales and score ranges)	QoL measurement time point
Arraras et al (2008a),¹⁶ Spain	Descriptive longitudinal	72.3±5.7 (range 65–87)	48	48 (100)	100	Breast (stage I–III)	RT: local, locoregional, regional (no details on dosage)	KPS Comorbidity Daily activities	Selected items from NCI CTCAE	EORTC QLQ-C30³⁸ (30 items—global QoL; physical, role, cognitive, emotion and social functioning scales; fatigue, nausea/vomiting and pain symptom scales; five single-item assessing additional symptoms and one single-item assessing perceived financial impact; all scales and single-item measure scores are transformed to a scale of 0–100, a higher score for the QoL/a functional scale indicates a better level of QoL/functioning and a higher score on a symptom scale/item represents a worse level of symptom) EORTC QLQ-BR23³⁹ (23 items — symptoms and side effects related to different treatment modalities, body image, sexuality and future perspective specific to breast cancer; all items and scale scores are transformed to a 0–100 scale, a higher score for the functional scale indicates a better level of functioning and a higher score on a symptom scale/item represents a worse level of symptom)	•First day of RT •Last day of RT •6 weeks after RT
Browall et al (2008),¹⁷ Sweden	Descriptive longitudinal	No information on mean age (range 65–77)	39	39 (100)	100	Breast (stage I–IIIa)	FEC: flurouracil 600 mg/m², epirubicin 75 mg/m², cyclophosphamide 600 mg/m² for six cycles or CMF: cyclophosphamide 100 mg/m², methothrexate 40 mg/m², flurouracil 600 mg/m² for six cycles (30 women also had the CT combined with RT; a 5-week RT course starting 3–4 weeks after CT)	Comorbidity	NR	EORTC QLQ-C30 EORTC QLQ-BR23	•Baseline •1 week after first, second, third and last cycle of CT •4 months post-CT
Crivellari et al (2000),¹⁸ multicountries	RCT (longitudinal) (elderly women was a subset of the original study)	No information on mean age (age ≥65 years)	76	58 (76.3)	100	Breast (stage I–III)	Tamoxifen for 5 years or Tamoxifen plus three early courses of CMF (cyclophosphamide 100 mg/m², methotrexate 40 mg/m², 5-fluorouracil 600 mg/m² every 28 days for four cycles)	ECOG Comorbidity	Modified WHO toxicity criteria	PACIS⁴⁰ (a single-item measure—assessing the amount of effort it costs to cope with illness which influences subjective well-being and QoL; score range 0–100*)	•Baseline •2 months after first day of adjuvant therapy then every 3 months until 24 months
Dees et al (2000),¹⁹ USA	Descriptive longitudinal	71.4 (range 65–79)	17	11 (64.7)	100	Breast (early stage)	AC: doxorubicin 60 mg/m², cyclophosphamide 600 mg/m² for four cycles	NR	Myelosuppression Cardiotoxicity	BCQ⁴¹ (30 items—overall QoL; consequences of alopecia, positive well-being, physical symptoms, inconvenience associated with treatment, fatigue, emotional dysfunction and nausea subscales; score range 0–10*)	•Day 1 of each cycle •2 months after completing CT •6 months after completing CT
Hurria et al (2006),²⁰ USA	Descriptive longitudinal	68 (range 65–84)	49	49 (100)	100	Breast (stage I–III)	CMF: cyclophosphamide 600 mg/m², methrotrexate 40 mg/m², 5-fluorouracil 600 mg/m² every 3 weeks for eight cycles or AC: dhoxorubicin 60 mg/m², cyclophosphamide 600 mg/m² every 2 or 3 weeks for four cycles or ACT: AC followed by paclitaxel 175 mg/m² every 2 or 3 weeks for four cycles or AC followed by paclitaxel 175 mg/m² weekly for 12 cycles or ACT-H: ACT followed by trastuzumab 2 mg/kg weekly for 52 weeks (CT regimen was at the discretion of the treating physician)	CCI ADL IADL MMSE GDS BMI	NCI CTCAE	FACT-B⁴² (44 items covering FACT-General plus the Breast Cancer Subscale—overall QoL (total FACT-B score including all the subscales, score range 0–144); breast well-being (score range 0–36), emotional well-being (score range 0–24), functional well-being (score range 0–28), physical well-being (score range 0–28) and social well-being subscales (score range 0–28)	•Prior to CT •On completion of CT •6 months after CT
Kornblith et al (2011),²¹ USA	RCT (longitudinal) (QoL was a substudy)	Standard CT (CMF or AC) group 72±4.6 Capecitabine group72±5.0	350	326 (93.1)	100	Breast (stage I–III)	Standard CT CMF: cyclophosphamide 100 mg/m² from days 1 to 14, methotrexate 40 mg/m² and 5-fluorouracil 600 mg/m² on days 1 and 8 for six cycles or AC: adriamycin 60 mg/m², cyclophosphamide 600 mg/m² on day 1 for four cycles or test cytotoxic drug Capecitabine 2000 mg/m² for 14 days; dose increased to 2500 mg/m² if no toxic effect after first cycle for six cycles	ECOG OARS (comorbidity) HADS BOMC Neurobehavioral Functioning and Activities of Living Scale Social Support Survey	NCI CTCAE Systemic adverse effects subscale of EORTC BR23	EORTC QLQ-C30† EORTC BR23†	•Baseline •Mid-CT (about day 77 for CMF, day 29 for AC, day 63 for capecitabine) •Post-CT (6–7 months for CMF, 4–5 months for AC and capecitabine) •12 months postbaseline •18 months postbaseline •24 months postbaseline
Watters et al (2003),²² Canada	Descriptive longitudinal	70±5 (range 65 to 80)	20	16 (80)	100	Breast (stage I–III)	Anthracycline-based adjuvant CT Fluorouracil 500 mg/m², doxorubicin 50 mg/m², cyclophosphamide 500 mg/m² at 21 days interval for six cycles	KPS	NR	EORTC QLQ-C30 EORTC QLQ-BR23 SF-36⁴³ (36 items —physical functioning, role limitations because of physical health problems, bodily pain, social functioning, general mental health, role limitations because of emotional health problems, vitality and general health perceptions domains; all domain scores are transformed to a scale of 0–100; these domain scores then combined to calculate the physical and mental component scores; score range 0–100)	•Prior to CT •Before the third cycle •Completion of CT •6 months post-CT
Perrone et al (2015),²³ Italy	RCT (longitudinal)	CMF: median 71 (range 65–79) Docetaxel: median 71 (range 65–79)	299	252 (84.3)	100	Breast (stage I–III)	CMF: cyclophosphamide 600 mg/m², methotrexate 40 mg/m², fluorouracil 600 mg/m² on days 1 and 8 every 4 weeks for 4 or six cycles or docetaxel 35 mg/m² on days 1, 8 and 15 every 4 weeks for four or six cycles	ECOG CCI ADL IADL	NCI CTCAE	EORTC QLQ-C30† EORTC QLQ-BR23†	•Baseline •End of first CT cycle •End of second CT cycle •End of third CT cycle
Gállego Pérez-Larraya et al (2011),²⁴ France	Descriptive longitudinal (phase II trial)	Median 77 (range 70–87)	70	59 (84.3)	60	Glioblastoma	Temozolomide (150–200 mg/m² for 5 days every 4 weeks for 12 cycles/until disease progression) (adjusted based on toxicity)	KPS (<70 as eligibility criteria) MMSE	NCI CTCAE	EORTC QLQ-C30† EORTC QLQ-BN20⁴⁴ †(20 items—functional deficits, symptoms, toxic effects of treatment and uncertainty about the future; all items and scale scores are transformed to a 0–100 scale, with higher scores of functioning indicating greater functioning and higher scores on symptoms reflecting worse symptoms)	•Baseline At least every month (restricted to the period of temozolomide period due to poor prognosis)
Keime-Guibert et al (2007),²⁵ France	RCT (longitudinal)	Supportive care+RT group Median 75 (range 70–84)	39	35 (89.7)	37	Glioblastoma	Supportive care (corticosteroids and anticonvulsant agents, physical and psychological support, management by a palliative care team) and RT (1.8 Gy given 5 days per week, total dose of 50 Gy)	KPS (≥70 as eligibility criteria) MMSE	NCI CTCAE	EORTC QLQ-C30† EORTC QLQ-BN20†	•Baseline •Day 30 •Day 60 •Day 90 •Day 135
Minniti et al (2009),²⁶ Italy	Descriptive longitudinal	Median 73 (range 70–79)	43	36 (83.7)	51.2	Glioblastoma	Focal hypofractionated RT (total dose of 30 Gy in 6 fractions over 2 weeks) followed by adjuvant temozolomide 5 days every 28 days up to 12 cycles; 150 mg/m² for first cycle and adjusted based on toxicity for subsequent cycles	KPS (≥60 as eligibility criteria) Comorbidity	NCI CTCAE	EORTC QLQ-C30†	•Before RT •After RT •second, fourth & sixth cycles of temozolomide
Minniti et al (2013),²⁷ Italy	Descriptive longitudinal (phase II trial)	Median 73 (range 70–81)	71	65 (91.5)	49.2	Glioblastoma	Focal hypofractionated RT (total dose of 40 Gy in 15 fractions) plus concomitant temozolomide 75 mg/m² given 7 days/week followed by adjuvant temozolomide 5 days every 28 days for 12 cycles (adjuvant was started 4 weeks after the completion of RT); 150 mg/m² for first cycle and 200 mg/m² from second cycle onwards	KPS MMSE	NR	EORTC QLQ-C30† EORTC QLQ-BN20†	•Before RT •4 weeks after RT (before the start of adjuvant temozolomide) •Every 8 weeks during treatment until disease progression
Mohile et al (2011),²⁸ USA	Descriptive before/after	Median 74.1 (range 65–92)	368	368 (100)	58.4	Breast (17.1%) Genitourinary (30.4%) Lung (15.8%) Brain and peripheral nervous system (6.5%) Alimentary (10.1%) Haematologic (4.9%) Head and neck (6.3%) Soft tissue sarcoma (1.6%) Bone and cartilaginous (1.4%) Skin (3.3%) Gynecologic (0.8%) Melanoma (0.3%)	RT Median total dose of 57.6 Gy (range 30–161)	NR	NR	Symptom Inventory (10 items adapted from the core set of symptom items and five items adapted from symptom interference items of the MD Anderson Symptom Inventory⁴⁵ — symptoms and side effects related to cancer and its treatment, and interference of symptoms; and an additional item of interference with overall QoL; score range 0–10, with higher scores indicating worse symptoms/worse interference with QoL)	•Before RT •During the last week of RT
Arraras et al (2008b),²⁹ Spain	Descriptive longitudinal (validation)	70.9±5.2	137	137 (100)	0	Prostate (localised)	Lower risk: RT alone (total dose of 72 Gy) Intermediate risk: neoadjuvant and concomitant combination of an anti-androgen and an LHRH analogue (6 months)+RT (total dose of 76 Gy) High risk: neoadjuvant and concomitant combination of an anti-androgen and an LHRH analogue (6 months)+RT (total dose of 76 Gy)+adjuvant LHRH analogue	KPS	NR	EORTC QLQ-C30	•First day of RT •Last day of RT •6 weeks after RT
Bouvier et al (2008),³⁰ France	Descriptive longitudinal survey	No information on mean age (range 75–85+)	11 (only 11 patients with stage III colon cancer treated with adjuvant CT and their QoL scores were reported)	11 (100)	NR	Colon	Flurouracil or oxaliplatin plus flurouracil or capecitabine (no details on dosage))	NR	NR	EORTC QLQ-C30	•At the time of diagnosis •3 months after diagnosis •6 months after diagnosis (CT was given within 6 months after surgery) •12 months after diagnosis
Chang et al (2012),³¹ South Korea	Descriptive longitudinal	Median 74.5 (range 70–90)	82	57 (69.5)	64	Colon (stage II–III)	Capecitabine (oral, 750–1250 mg/m², twice daily on days 1–14 every 3 weeks for eight cycles) (dose level was determined a/c toxicity effects during the first and preceding cycles)	ECOG PS (0–2 as eligibility criteria) CACI	NCI CTCAE (adequate haematologic, hepatic and renal function status as eligibility criteria)	EORTC QLQ-C30	•Baseline •3 months during CT •6 months during CT •3–6 months after completion of CT
Caffo et al (2003),³² Italy	Descriptive longitudinal	Median 62.5 (range 46–81)	25 (no information on the breakdown of sample size by age group)	-	100	Cervical endometrium	Postoperative external pelvic RT (median total dose of 50.4 Gy, range 45–66.6 Gy, at a dose of 1.8–2.0 Gy five times/week)	NR	Diarrhoea	Diary card⁴⁶ (12 items—global QoL, physical side effects observed during external pelvic RT, daily activities and psychological well-being; score range 1–4, with higher scores of QoL, psychological well-being and daily activities indicating better condition and higher scores on symptoms reflecting intense symptoms) EORTC QLQ-C30	Diary card: •At the start of RT •Daily during RT period (reported as mean weekly scores) EORTC QLQ-C30: •Before RT •After RT
Park et al (2013),³³ South Korea	Descriptive longitudinal	Median 69 (range 65–82)	66	66 (100)	9.1	Non-small-cell lung carcinoma (completely resected stage Ib, II or IIIa)	NP: cisplatin 80 mg/m² on day 1, vinorelbine 25 mg/m² on days 1 and 8 at 3-week interval for four cycles (n=30, 45.5%) or PC: carboplatin, paclitaxel 175 mg/m² on day 1 at 3-week interval for four cycles (n=36, 54.5%) (at the physician’s discretion)	ECOG Comorbidity	NCI CTCAE	EORTC QLQ-C30 EORTC QLQ-LC13⁴⁷ (13 items—lung cancer-related symptoms, treatment-related adverse effects and the use of pain medication; all items and scale scores are transformed to a 0–100 scale, with higher scores of functioning indicating greater functioning and higher scores on symptoms reflecting worse symptoms)	•Before first dose of CT at each cycle •1 month after fourth cycle

*Higher scores indicating better quality of life unless specified otherwise.

†Quality of life is the secondary end point if indicated.

BCQ, Breast Cancer Chemotherapy Questionnaire; CGA, Comprehensive Geriatric Assessment; CT, chemotherapy; EORTC QLQ-BN20, European Organization for Research and Treatment of Cancer-specific module for brain cancer; EORTC QLQ-BR23, European Organization for Research and Treatment of Cancer-specific module for breast cancer; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer QLQ-C30 general questionnaire; EORTC QLQ-LC13, European Organization for Research and Treatment of Cancer for lung-specific questionnaire; FACT-B, Functional Assessment of Cancer Therapy-Breast cancer; NR, not reported; PACIS, perceived adjustment to chronic illness scale; QoL, quality of life; RCT, randomised controlled trial; RT, radiotherapy; SF-36, 36-item short-form survey.