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Table 1 Literature Review Summary Results for RCC Symptoms or HRQL

From: Symptom burden among patients with Renal Cell Carcinoma (RCC): content for a symptom index

Citation Number Study Design Instrument Results of Symptom and/or HRQL assessment
MRC Renal Cancer 1999 [8] N = 335 Randomized Rotterdam Symptom Checklist Most frequent symptoms at 4 weeks: tired (57%), lack of energy (53%), lack of appetite (33%), dry mouth (27%), nausea (15%), shivering (13%), heartburn (12%)
Motzer et al. 2000 [9] N = 284 Randomized FACT-BRM QOL decreased from baseline to 8 weeks for treatment arms. Item analysis of FACT-BRM indicates items that address the following likely to be important at baseline: energy, pain, sex life, overall well-being, sleep, fatigue, appetite, energy, weakness (Cella D, personal communication, September 2003)
Capuron et al. 2001 [10] N = 33 Non-randomized MADRS Positive correlation between depressive symptoms and the variation in the cytokine levels in the first week of therapy.
Heinzer et al. 1999 [11] N = 20 Non-randomized EORTC-QLQ-30 Most frequent symptoms: fatigue (29%), nausea (23%), cough (16%).
Atzpodien et al. 2003 [12] N = 22 Observational SF-36 EORTC-QLQ-30 Significant worsening in physical, social, and role functioning. Significant worsening in symptoms of appetite loss, nausea/vomiting, sleep disturbance, diarrhea, pain
Bukowski et al. 2002 [13] N = 70 Observational AE events Most frequently reported adverse events over 1 year: fatigue (38%), anorexia (34%), pain (34%), headache (31%), myalgia (28%), weight loss (28%), nausea (24%), alopecia (21%), coughing: (21%), dyspnea (21%), fever (21%), rigors (21%)
Cohen et al. 2002 [14] N = 36 Observational SF-36 Changes from baseline to 3 weeks indicate improvement in physical functioning, role limitations (physical), bodily pain, vitality, and social functioning
Joffe et al. 1996 [15] N = 55 Observational Rotterdam Symptom Checklist During 8-week treatment cycle, significant worsening in symptoms: loss of appetite, dry mouth, lack of energy, feeling nervous, lack of sexual interest, shivering, nausea, tiredness
Naglieri et al. 2002 [16] N = 42 Observational Graded toxicities Total prevalence: fatigue (100%), cutaneous erythema (100%), fever (76%), anemia (10%), hypotension (5%), nausea/vomitting (2%), fluid retention (2%)
Shamash et al. 2003 [17] N = 33 Observational EORTC Mean baseline scores indicate greatest impairment in pain, sleep, weakness, daily activities, tired, leisure/social
Stark et al. 2002 [18] N = 178 Observational HAD-A EORTC-QLQ-30 Patients diagnosed with anxiety had higher scores for symptoms of fatigue, nausea, insomnia, appetite loss, constipation, diarrhea
Whitehead et al. 2002 [19] N = 37 Observational Graded toxicity Most common side effects (% with any grade toxicity): nausea/vomiting/diarrhea: 88%, headache/pain: 82%, malaise/fatigue/lethargy: 78%, fever/chills: 57%, edema: 51%, CNS: 43%, anemia/bleeding: 33%, myalgia/arthralgia: 31%, renal: 29%, pulmonary: 27%, rash/urticaria: 24%, hypertension: 8%, cardiac: 4%, hypotension: 4%