An explorative study to assess the association between health-related quality of life and the recommended phase II dose in a phase I trial: Idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma

BMJ Open

Volumn 6, Issue 6, 2016, Pages

  Anota, Amélie ^a,b   Boulin, Mathieu ^c,d   Dabakuyo Yonli, Sandrine ^a,e   Hillon, Patrick ^c,d   Cercueil, Jean Pierre ^c,d   Minello, Anne ^c,d   Jouve, Jean Louis ^c,d   Paoletti, Xavier ^f   Bedenne, Laurent ^c,d   Guiu, Boris ^g   Bonnetain, Franck ^a,b  

^a National Quality of Life in Oncology Platform   (France)

^b UNIVERSITY HOSPITAL OF BESANÇON   (France)

^c UNIVERSITÉ DE BOURGOGNE   (France)

^d DIJON UNIVERSITY HOSPITAL   (France)

^e CENTRE GEORGES FRANÇOIS LECLERC   (France)

^f INSTITUT GUSTAVE ROUSSY   (France)

^g HÔPITAL SAINT ELOI   (France)

Author keywords

Health related Quality of Life; longitudinal analysis; oncology clinical trial; phase I; time to deterioration

Indexed keywords

BILIRUBIN; CREATINE; IDARUBICIN; ANTINEOPLASTIC ANTIBIOTIC;

ADULT; AGED; ARTICLE; BILIRUBIN BLOOD LEVEL; CANCER FATIGUE; CANCER PAIN; CANCER PATIENT; CHEMOEMBOLIZATION; CLINICAL ARTICLE; DRUG DOSE ESCALATION; DRUG HYPERSENSITIVITY; EXPLORATORY RESEARCH; FEMALE; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; HEALTH STATUS; HEART ARRHYTHMIA; HUMAN; INFECTION; LIVER CELL CARCINOMA; LONGITUDINAL STUDY; MALE; MAXIMUM TOLERATED DOSE; NEUTROPHIL COUNT; OPEN STUDY; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL; QUALITY OF LIFE; QUALITY OF LIFE ASSESSMENT; SIDE EFFECT; THROMBOCYTE COUNT; CHEMICALLY INDUCED; CLINICAL TRIAL; DISEASE FREE SURVIVAL; FATIGUE; LIVER TUMOR; MIDDLE AGED; MORTALITY; PAIN;

AGED; ANTIBIOTICS, ANTINEOPLASTIC; CARCINOMA, HEPATOCELLULAR; CHEMOEMBOLIZATION, THERAPEUTIC; DISEASE-FREE SURVIVAL; FATIGUE; FEMALE; HUMANS; IDARUBICIN; LIVER NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; PAIN; QUALITY OF LIFE;

EID: 84976628075     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2015-010696     Document Type: Article

References (32)

1. Ferlay J, Shin HR, Bray F, et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010; 127: 2893-917
2. Wood TF, Rose DM, Chung M, et al. Radiofrequency ablation of 231 unresectable hepatic tumors: indications, limitations, and complications. Ann Surg Oncol 2000; 7: 593-600
3. Eltawil KM, Berry R, Abdolell M, et al. Quality of life and survival analysis of patients undergoing transarterial chemoembolization for primary hepatic malignancies: a prospective cohort study. HPB (Oxford) 2012; 14: 341-50
4. Ahmed S, de Souza NN, Qiao W, et al. Quality of life in hepatocellular carcinoma patients treated with transarterial chemoembolization. HPB Surg 2016; 2016: 6120143
5. Doffoël M, Bonnetain F, Bouché O, et al. Multicentre randomised phase III trial comparing Tamoxifen alone or with Transarterial Lipiodol Chemoembolisation for unresectable hepatocellular carcinoma in cirrhotic patients (Fédération Francophone de Cancérologie Digestive 9402). Eur J Cancer 2008; 44: 528-38
6. Boulin M, Guiu S, Chauffert B, et al. Screening of anticancer drugs for chemoembolization of hepatocellular carcinoma. Anticancer Drugs 2011; 22: 741-8
7. Boulin M, Hillon P, Cercueil JP, et al. Idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma: results of the IDASPHERE phase I trial. Aliment Pharmacol Ther 2014; 39: 1301-13
8. National Cancer Institute. Common Terminology Criteria for Adverse Events v3. 0 (CTCAE). Cancer Therapy Evaluation Program, 2006
9. Postel-Vinay S, Arkenau HT, Olmos D, et al. Clinical benefit in phase-I trials of novel molecularly targeted agents: does dose matter?. Br J Cancer 2009; 100: 1373-8
10. Le Tourneau C, Razak AR, Gan HK, et al. Heterogeneity in the definition of dose-limiting toxicity in phase I cancer clinical trials of molecularly targeted agents: a review of the literature. Eur J Cancer 2011; 47: 1468-75
11. Basch E. Patient-reported outcomes in drug safety evaluation. Ann Oncol 2009; 20: 1905-6
12. Verweij J, Disis ML, Cannistra SA. Phase I studies of drug combinations. J Clin Oncol 2010; 28: 4545-6
13. Stephenson CM, Levin RD, Spector T, et al. Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of high-dose intravenous ascorbic acid in patients with advanced cancer. Cancer Chemother Pharmacol 2013; 72: 139-46
14. Rouanne M, Massard C, Hollebecque A, et al. Evaluation of sexuality, health-related quality-of-life and depression in advanced cancer patients: a prospective study in a phase I clinical trial unit of predominantly targeted anticancer drugs. Eur J Cancer 2013; 49: 431-8
15. Anota A, Hamidou Z, Paget-Bailly S, et al. Time to health-related quality of life score deterioration as a modality of longitudinal analysis for health-related quality of life studies in oncology: do we need RECIST for quality of life to achieve standardization?. Qual Life Res 2015; 24: 5-18
16. Bonnetain F, Dahan L, Maillard E, et al. Time until definitive quality of life score deterioration as a means of longitudinal analysis for treatment trials in patients with metastatic pancreatic adenocarcinoma. Eur J Cancer 2010; 46: 2753-62
17. Hamidou Z, Dabakuyo TS, Mercier M, et al. Time to deterioration in quality of life score as a modality of longitudinal analysis in patients with breast cancer. Oncologist 2011; 16: 1458-68
18. Bruix J, Sherman M, Llovet JM, et al. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol 2001; 35: 421-30
19. O?Quigley J, Pepe M, Fisher L. Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics 1990; 46: 33-48
20. O?Quigley J, Shen LZ. Continual reassessment method: a likelihood approach. Biometrics 1996; 52: 673-84
21. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365-76
22. Fayers PM, Aaronson NK, Bjordal K, et al. EORTC QLQ-C30 scoring manual. 3rd edn. Brussels: EORTC 2001 ed2001. 2001
23. Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 1998; 16: 139-44
24. A new prognostic system for hepatocellular carcinoma: a retrospective study of 435 patients: the Cancer of the Liver Italian Program (CLIP) investigators. Hepatology 1998; 28: 751-5
25. Llovet JM, Bruix J. Prospective validation of the Cancer of the Liver Italian Program (CLIP) score: a new prognostic system for patients with cirrhosis and hepatocellular carcinoma. Hepatology 2000; 32: 679-80
26. Llovet JM, Bru C, Bruix J. Prognosis of hepatocellular carcinoma: the BCLC staging classification. Semin Liver Dis 1999; 19: 329-38
27. Schoenfeld D. Partial residuals for the proportional hazards regression model. Biometrika 1982; 69: 239-41
28. Atkinson TM, Li Y, Coffey CW, et al. Reliability of adverse symptom event reporting by clinicians. Qual Life Res 2012; 21: 1159-64
29. Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med 2010; 362: 865-9
30. Basch E, Reeve BB, Mitchell SA, et al. Development of The National Cancer Institute?s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst 2014; 106: pii: dju244
31. Dueck AC, Mendoza TR, Mitchell SA, et al. Validity and reliability of the US National Cancer Institute?s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol 2015; 1: 1051-9
32. McCarberg BH, Barkin RL. Long-Acting opioids for chronic pain: pharmacotherapeutic opportunities to enhance compliance, quality of life, and analgesia. Am J Ther 2001; 8: 181-6