Best supportive care in clinical trials: Review of the inconsistency in control arm design

British Journal of Cancer

Volumn 113, Issue 1, 2015, Pages 6-11

  Nipp, R D ^a   Currow, D C ^b   Cherny, N I ^c   Strasser, F ^d   Abernethy, A P ^e   Zafar, S Y ^e  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b FLINDERS UNIVERSITY   (Australia)

^c Department of Oncology Cancer Pain and Palliative Medicine Unit   (Israel)

^d Kantonsspital St Gallen Division of Oncology Haematology   (Switzerland)

^e DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

health services research; palliative care; randomized controlled trial; Research design; symptom assessment

Indexed keywords

BEST SUPPORTIVE CARE; CLINICAL TRIAL (TOPIC); CONSENSUS; CONTROL GROUP; DELPHI STUDY; EVIDENCE BASED PRACTICE; HEALTH CARE DELIVERY; HUMAN; MEDICAL DOCUMENTATION; MEDICAL SPECIALIST; PALLIATIVE THERAPY; PATIENT CARE; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; STANDARD; SYMPTOM ASSESSMENT; NEOPLASMS; STANDARDS;

CLINICAL TRIALS AS TOPIC; DELPHI TECHNIQUE; HUMANS; NEOPLASMS; PALLIATIVE CARE;

EID: 84934435139     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2015.192     Document Type: Review

References (33)

1. Ahmed N, Ahmedzai S, Vora V, Hillam S, Paz S (2004) Supportive care for patients with gastrointestinal cancer. Cochrane Database Syst Rev CD003445.
2. Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA (2009) Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA 302: 741-749.
3. Bellmunt J, Theodore C, Demkov T, Komyakov B, Sengelov L, Daugaard G, Caty A, Carles J, Jagiello-Gruszfeld A, Karyakin O, Delgado FM, Hurteloup P, Winquist E, Morsli N, Salhi Y, Culine S, Von der Maase H (2009) Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J Clin Oncol 27: 4454-4461.
4. Brodowicz T, Krzakowski M, Zwitter M, Tzekova V, Ramlau R, Ghilezan N, Ciuleanu T, Cucevic B, Gyurkovits K, Ulsperger E, Jassem J, Grgic M, Saip P, Szilasi M, Wiltschke C, Wagnerova M, Oskina N, Soldatenkova V, Zielinski C, Wenczl M. Central European Cooperative oncology group CECOG (2006) Cisplatin and gemcitabine first-line chemotherapy followed by maintenance gemcitabine or best supportive care in advanced non-small cell lung cancer: a phase III trial. Lung Cancer 52(2): 155-163.
5. Buikhuisen WA, Burgers JA, Vincent AD, Korse CM, van Klaveren RJ, Schramel FM, Pavlakis N, Nowak AK, Custers FL, Schouwink JH, Gans SJ, Groen HJ, Strankinga WF, Baas P (2013) Thalidomide versus active supportive care for maintenance in patients with malignant mesothelioma after first-line chemotherapy (NVALT 5): an open-label, multicentre, randomised phase 3 study. Lancet Oncol 14(6): 543-551.
6. Cherny NI, Abernethy AP, Strasser F, Sapir R, Currow D, Zafar SY (2009) Improving the methodologic and ethical validity of best supportive care studies in oncology: lessons from a systematic review. J Clin Oncol 27: 5476-5486.
7. Cherny NI, Catane R, Kosmidis P. ESMO Taskforce on Supportive & Palliative Care (2003) ESMO takes a stand on supportive and palliative care. Ann Oncol 14: 1335-1337.
8. Ciuleanu TE, Pavlovsky AV, Bodoky G, Garin AM, Langmuir VK, Kroll S, Tidmarsh GT (2009) A randomised Phase III trial of glufosfamide compared with best supportive care in metastatic pancreatic adenocarcinoma previously treated with gemcitabine. Eur J Cancer 45(9): 1589-1596.
9. Cullen M (2001) 'Best supportive care' has had its day. Lancet Oncol 2: 173-175.
10. El-Jawahri A, Greer JA, Temel JS (2011) Does palliative care improve outcomes for patients with incurable illness? A review of the evidence. J Support Oncol 9: 87-94.
11. Ferris FD, Bruera E, Cherny N, Cummings C, Currow D, Dudgeon D, Janjan N, Strasser F, Von Gunten CF, Von Roenn JH (2009) Palliative cancer care a decade later: accomplishments, the need, next steps-from the American Society of Clinical Oncology. J Clin Oncol 27: 3052-3058.
12. Harousseau JL, Martinelli G, Jedrzejczak WW, Brandwein JM, Bordessoule D, Masszi T, Ossenkoppele GJ, Alexeeva JA, Beutel G, Maertens J, Vidriales MB, Dombret H, Thomas X, Burnett AK, Robak T, Khuageva NK, Golenkov AK, Tothova E, Mollgard L, Park YC, Bessems A, De Porre P, Howes AJ. FIGHT-AML-301 Investigators (2009) A randomized phase 3 study of tipifarnib compared with best supportive care, including hydroxyurea, in the treatment of newly diagnosed acute myeloid leukemia in patients 70 years or older. Blood 114: 1166-1173.
13. Jassem J, Ramlau R, Santoro A, Schuette W, Chemaissani A, Hong S, Blatter J, Adachi S, Hanauske A, Manegold C (2008) Phase III trial of pemetrexed plus best supportive care compared with best supportive care in previously treated patients with advanced malignant pleural mesothelioma. J Clin Oncol 26: 1698-1704.
14. Jonker DJ, O'Callaghan CJ, Karapetis CS, Zalcberg JR, Tu D, Au HJ, Berry SR, Krahn M, Price T, Simes RJ, Tebbutt NC, van Hazel G, Wierzbicki R, Langer C, Moore MJ (2007) Cetuximab for the treatment of colorectal cancer. N Engl J Med 357(20): 2040-2048.
15. Kang JH, Lee SI, Lim Do H, Park KW, Oh SY, Kwon HC, Hwang IG, Lee SC, Nam E, Shin DB, Lee J, Park JO, Park YS, Lim HY, Kang WK, Park SH (2012) Salvage chemotherapy for pretreated gastric cancer: a randomized phase III trial comparing chemotherapy plus best supportive care with best supportive care alone. J Clin Oncol 30: 1513-1518.
16. Macdonald N (1998) Best supportive care. Cancer Prev Control 2: 191-192.
17. Machiels JP, Subramanian S, Ruzsa A, Repassy G, Lifirenko I, Flygare A, Sørensen P, Nielsen T, Lisby S, Clement PM (2011) Zalutumumab plus best supportive care versus best supportive care alone in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after failure of platinum-based chemotherapy: an open-label, randomised phase 3 trial. Lancet Oncol 12(4): 333-343.
18. Mubarak N, Gaafar R, Shehata S, Hashem T, Abigeres D, Azim HA, El-Husseiny G, Al-Husaini H, Liu Z (2012) A randomized, phase 2 study comparing pemetrexed plus best supportive care versus best supportive care as maintenance therapy after first-line treatment with pemetrexed and cisplatin for advanced, non-squamous, non-small cell lung cancer. BMC Cancer 12: 423.
19. MuersMF, Stephens RJ, Fisher P, Darlison L, Higgs CM, Lowry E, Nicholson AG, O'brien M, Peake M, Rudd R, Snee M, Steele J, Girling DJ, Nankivell M, Pugh C, Parmar MK. MS01 Trail Management Group (2008) Active symptom control with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma (MS01): a multicentre randomised trial. Lancet 371: 1685-1694.
20. O'Brien ME, Ciuleanu TE, Tsekov H, Shparyk Y, Cucevia B, Juhasz G, Thatcher N, Ross GA, Dane GC, Crofts T (2006) Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer. J Clin Oncol 24: 5441-5447.
21. Pelzer U, Schwaner I, Stieler J, Adler M, Seraphin J, Dörken B, Riess H, Oettle H (2011) Best supportive care (BSC) versus oxaliplatin, folinic acid and 5-fluorouracil (OFF) plus BSC in patients for second-line advanced pancreatic cancer: a phase III-study from the German CONKO-study group. Eur J Cancer 47(11): 1676-1681.
22. Reichardt P, Blay JY, Gelderblom H, Schlemmer M, Demetri GD, Bui-Nguyen B, Mcarthur GA, Yazji S, Hsu Y, Galetic I, Rutkowski P (2012) Phase III study of nilotinib versus best supportive care with or without a TKI in patients with gastrointestinal stromal tumors resistant to or intolerant of imatinib and sunitinib. Ann Oncol 23: 1680-1687.
23. Rodrigues G, Arra I, Velker V, Rotenberg B, Sexton T (2011) Two decades of oncology randomized controlled trials: factors associated with CONSORT clinical trial reporting checklist compliance. J Clin Oncol 29(Suppl): abstr 6126.
24. Schulz KF, Altman DG, Moher D. GROUP, C. (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 152: 726-732.
25. Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP (2010) Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol 28: 4581-4586.
26. Smith TJ, Temin S, Alesi ER, Abernethy AP, Balboni TA, Basch EM, Ferrell BR, Loscalzo M, Meier DE, Paice JA, Peppercorn JM, Somerfield M, Stovall E, Von Roenn JH (2012) American Society of Clinical Oncology provisional clinical opinion: the integration of palliative care into standard oncology care. J Clin Oncol 30: 880-887.
27. Spiro SG, Rudd RM, Souhami RL, Brown J, Fairlamb DJ, Gower NH, Maslove L, Milroy R, Napp V, Parmar MK, Peake MD, Stephens RJ, Thorpe H, Waller DA, West P. Big Lung Trial participants (2004) Chemotherapy versus supportive care in advanced non-small cell lung cancer: improved survival without detriment to quality of life. Thorax 59(10): 828-836.
28. Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ (2010) Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med 363: 733-742.
29. Thuss-Patience PC, Kretzschmar A, Bichev D, Deist T, Hinke A, Breithaupt K, Dogan Y, Gebauer B, Schumacher G, Reichardt P (2011) Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer-a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer 47(15): 2306-2314.
30. Van Cutsem E, Peeters M, Siena S, Humblet Y, Hendlisz A, Neyns B, Canon JL, Van Laethem JL, Maurel J, Richardson G, Wolf M, Amado RG (2007) Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 25: 1658-1664.
31. Zafar SY, Currow D, Abernethy AP (2008) Defining best supportive care. J Clin Oncol 26: 5139-5140.
32. Zafar SY, Currow DC, Cherny N, Strasser F, Fowler R, Abernethy AP (2012) Consensus-based standards for best supportive care in clinical trials in advanced cancer. Lancet Oncol 13: e77-e82.
33. Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, Moore M, Rydall A, Rodin G, Tannock I, Donner A, Lo C (2014) Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet 383: 1721-1730.