Table 1. Studies with HRQoL as primary endpoint.
| Author | Study type | Phase of trial | No. of studies | Sample size | Sample size (HCC) | No. of patients who received treatment | Intervention | Post-surgery or post-liver directed therapy | HRQoL tools used | Notes |
|---|---|---|---|---|---|---|---|---|---|---|
| Poon et al. 2001 (19) | Descriptive | 1 | 76 | 76 | 66: surgical resection; 10: TACE | Partial hepatectomy vs. TACE (if unresectable) | Yes | FACT-G | Preoperative and postoperative QoL using FACT-G for upto 2 years after surgery (at 3, 6, 9, 12, 18, 24 months). Hepatic resection results in a significant enhancement of QoL in patients with HCC. Development of recurrence is the main factor leading to deterioration in QoL over time after resection of HCC | |
| Tanabe et al. 2001 (20) | Descriptive | 1 | 123 | 123 | NS: repeat hepatic resection; NS: hepatic arterial infusion chemotherapy | Recurrence of HCC after hepatic resection: comparison of repeat hepatic resection vs. hepatic arterial infusion chemotherapy | Yes | 4 item questionnaire | ||
| Brans et al. 2002 (21) | Descriptive | 1 | 20 | 20 | 20: 131I-lipoidal therapy; 10/20: cisplatin | 131I-lipoidal therapy (±2 doses of HAI cisplatin) | Yes | EORTC QLQ-C30 | Intra-arterial 131I-lipoidal therapy with or without cisplatin: Questionnaires were completed 1 week before, 1 and 3 months subsequent to the therapy | |
| Ueno et al. 2002 (22) | Descriptive | 1 | 96 | 96 | 96: partial hepatectomy | Partial hepatectomy | Yes | 14 item questionnaire | ||
| Zhao et al. 2002 (23) | Descriptive | 1 | 175 | 175 | NS | TACE | Yes | QoL-LC | ||
| Bianchi et al. 2003 (24) | Case-control | 1 | 303 | 101 | NS | Any treatment | No | SF-36, Nottingham Health Profile Questionnaires | Data stresses the relevance of pain in poor perceived health status of HCC patients, and the importance of minor symptoms, such as, sleep disorders | |
| Steel et al. 2004 (25) | Validation | Phase II, non-randomized study | 1 | 28 | 28 | 14: HAI of cisplatin; 14: infusional radiotherapy | HAI cisplatin vs. yttrium microspheres | Yes | FACT-Hep | Patients assessed at baseline, then every 3 months for first 6 months and then followed up at 1 year |
| Chen et al. 2004 (26) | Descriptive | 1 | 36 | 30 | 30: major and minor hepatectomy | Surgical resection | Yes | GQLI | ||
| Steel et al. 2005 (27) | Descriptive | 1 | 82 | 82 | 82: HCC; 82: proxies | Any treatment | No | FACT-Hep | ||
| Wang et al. 2005 (28) | Descriptive | 1 | 160 | 160 | 80: RFA; 40: TACE; 40: RFA+TACE | RFA, TACE-RFA, TACE | Yes | QoL-LC V2.0 | ||
| Eid et al. 2006 (29) | Descriptive | 1 | 40 | 7 | 3/24: major hepatectomy; 1/8: minor hepatectomy; 3/8: radiofrequency ablation | Hepatic resection or ablation | Yes | FACT-Hep, FHSI-8, POMS; EORTC-QLQ-PAN; EORTC QLQ-C30 | Patients were assessed at 5 time points: initial visit, initial postoperative visit, visit at 6 weeks, 3 months and 6 months | |
| Steel et al. 2006 (5) | Meta-analysis | 3 | 158 | 135 | 93:TACE; 42: Yttrium | TACE or yttrium microspheres | Yes | FACT-Hep version 4.0 | ||
| Yeo et al. 2006 (16) | Meta-analysis | 2 | 233 | 233 | 156 patients out of a total of 188 patients from chemo study and 77 patients out of a total of 324 patients from the hormonal study—both studies were phase 3 randomized controlled trials | Doxo alone, combination cisplatin/IFN/Doxo/5-FU | No | EORTC QLQ-C30 | ||
| Lee et al. 2007 (30) | Descriptive | 1 | 161 | 161 | 121: surgery; 31: TACE; 8: percutaneous ethanol injection; 1: supportive | Per treating physician | Yes | WHOQOL-BREF Taiwan version, EORTC QLQ-C30, VAS, Standard Gamble | ||
| Wang et al. 2007 (31) | Validation | Phase II | 1 | 83 | 83 | 40: TACE; 43: TACE+ RFA | TACE followed by RFA vs. TACE alone | Yes | FACT-G version 4 | Questionnaires completed at baseline and 3 months after treatment, TACE-RFA group resulted in a significantly higher total QoL score, social-family well-being score, and functional well-being scores than TACE group, 3 months after respective treatment |
| Kondo et al. 2007 (32) | Case-control | 1 | 194 | 97 | 97: percutaneous ablation-RFA or alcohol | Prior percutaneous ethanol or RFA in case group | Yes | SF-36 | Raw scores were transformed using norm-based scoring | |
| Steel et al. 2007 (33) | Descriptive | 1 | 272 | 83 | 83: untreated; 51: chronic liver disease; 138: general population | Untreated | No | FACT-Hep | ||
| Martin et al. 2007 (34) | Descriptive | 1 | 32 | 4 | 3/ 24: major hepatectomy(>2 segments); 1/8: minor hepatectomy | Hepatic resection | Yes | FACT-Hep, FACT-FHSI-8, EORTC QLQ-C30, POMS, EORTC-QLQ-Pan2 Ca, Global Rating Scale | QoL assessed at the time of consent, discharge, first postoperative visit, 6 weeks, 3 months, 6 months and 12 months | |
| Sun et al. 2008 (35) | Descriptive | 1 | 45 | 22 | 22: any treatment | Yttrium microspheres, TACE, chemotherapy, surgery | Yes | FACT-Hep, FACIT-Sp-12 | Patients were assessed monthly for 3 months | |
| Mendez et al. 2008 (36) | Validation | Phase I/II | 1 | 28 | 9 | 9: external radiotherapy | Liver stereotactic body radiation therapy | Yes | EuroQoL-5D, EuroQoL-VAS, EORTC QLQ-C30 | Quality of life was assessed before, 1,3 and 6 months after treatment, first study to report quality of life associated with liver stereotactic body radiation therapy |
| Nowak et al. 2008 (37) | Validation | Phase II | 1 | 46 | 46 | NS | Octreotide LAR | No | FACT-Hep, patient DATA form, patient benefit form | Not found in original PUBMED search, recapitulates Cebon et al. 2006 (38) |
| Bonnetain et al. 2008 (39) | Meta-analysis | 2 | 538 | 538 | Doffoël 2008 (40): 122; Barbare 2005 (41): 416 | Tamoxifen vs. supportive care or transarterial lipoidal chemoembolization | Yes | Spitzer QoL index | Articles included are Doffoël 2008 (40) and Barbare 2005 (41) | |
| Wible et al. 2010 (42) | Descriptive | 1 | 73 | 73 | 73: TACE; 23/73 patients underwent 3 or more chemoembolisation procedures | TACE | Yes | SF-36 | Baseline HRQoL scores were evaluated and again measured during 4, 8, 12 months of treatment, and separately within a subset of 23 patients who underwent 3 or more chemoembolisation procedures | |
| Shun et al. 2012 (43) | Descriptive | 1 | 89 | 89 | 89: TACE | TACE | Yes | SDS; HADS; SF-12 | Pre and post discharge factors related to changes in physical and mental domains of QoL over a period of 2 months. Data were collected 3 times—within 3 days prior to discharge, at 4th and 8th weeks after discharge | |
| Qiao et al. 2012 (15) | Descriptive | 1 | 140 | 140 | Any treatment | Any treatment | No | FACT-Hep | HRQoL of patients with hepatocellular carcinoma worsens gradually with progression of TNM stage | |
| Eltawil et al. 2012 (44) | Validation | Phase II | 1 | 48 | 46 | 46: TACE | TACE | Yes | WHO-QoL-BREF | QOL was compared to the pre-intervention state |
| Diouf et al. 2013 (45) | Validation | Phase III | 1 | 271 | 271 | 134: Long acting octreotide; 137: placebo | Long acting octreotide | No | EORTC QLQ-C30 | |
| Fan et al. 2013 (46) | Descriptive | 1 | 286 | 286 | 117: surgery; 96: TACE; 73: chemotherapy | Surgery, TAE/TACE, chemotherapy | Yes | EORTC QLQ-C30, EORTC-QLQ-HCC18 | ||
RFA, radiofrequency ablation; TACE, transarterial chemoembolisation; NS, not specified; GQLI, gastrointestinal quality of life index; POMS, profile of mood states; EORTC-QLQ-PAN, European Organization for Research and Treatment of Cancer QoL Questionnaire for patients with pancreatic cancer; SDS, symptom distress scale; HADS, hospital anxiety and depression scale; SF-12, short form -12 health survey; HRQoL, health-related quality of life; HCC, hepatocellular carcinoma..