Defining and analysing symptom palliation in cancer clinical trials: A deceptively difficult exercise

British Journal of Cancer

Volumn 79, Issue 3-4, 1999, Pages 538-544

  Stephens, R J ^a   Hopwood, P ^b   Girling, D J ^a  

^a MEDICAL RESEARCH COUNCIL   (United Kingdom)

^b CHRISTIE HOSPITAL   (United Kingdom)

Author keywords

Clinical trials; Symptom palliation

Indexed keywords

ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER PALLIATIVE THERAPY; CLINICAL TRIAL; COUGHING; LUNG NON SMALL CELL CANCER; PREVENTIVE MEDICINE; PRIORITY JOURNAL; QUESTIONNAIRE; SELF EVALUATION; SYMPTOMATOLOGY;

CARCINOMA, SMALL CELL; CLINICAL TRIALS; COUGH; FALSE POSITIVE REACTIONS; HUMANS; LUNG NEOPLASMS; PALLIATIVE CARE; QUALITY OF LIFE; QUESTIONNAIRES; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; SENSITIVITY AND SPECIFICITY;

EID: 0032928624     PISSN: 00070920     EISSN: None     Source Type: Journal    
DOI: 10.1038/sj.bjc.6690085     Document Type: Article

References (34)

1. Ahlgren JD, Ellison NM, Gottlieb RJ, Laluna F. Lokich JJ, Sinclair PR, Veno W, Wampler GL, Yeung K-Y, Alt D and Fryer JG (1993) Hormonal palliation of chemoresistant ovarian cancer: three consecutive phase II trials of the Mid-Atlantic Oncology Program. J Clin Oncol 11: 1957-1968
2. Ball D, Smith J, Bishop J. Olver I, Davis S, O'Brien P, Bernshaw D, Ryan G and Millward M (1997) A phase III study of radiotherapy with and without continuous-infusion fluorouracil as palliation for non-small cell lung cancer. Br J Cancer 75: 690-697
3. Barr H, Krasner N, Raouf A and Walker RJ (1990) Prospective randomised trial of laser therapy only and laser therapy followed by endoscopic intubation for the palliation of malignant dysphagia. Gut 31: 252-258
4. Brewster AE, Davidson SE, Makin WP, Stout R and Burt PA (1995) Intraluminal brachytherapy using the high dose rate microselectron in the palliation of carcinoma of the oesophagus. Clin Oncol 7: 102-105
5. Buroker TR, O'Connell MJ, Weiand HS, Krook JE, Gerstner JB, Mailliard JA, Schaefer PL, Levitt R, Kardinal CG and Gesme Jr DH (1994) Randomized comparison of two schedules of fluorouracil and leucovorin in the treatment of advanced colorectal cancer. J Clin Oncol 12: 14-20
6. Burris H and Storniolo AM (1997) Assessing clinical benefit in the treatment of pancreas cancer: gemcitabine compared to 5-fluorouracil. Eur J Cancer 33 (suppl. I): S18-S22
7. De Haes JCJM, van Knippenberg FCE and Neijt JP (1990) Measuring psychological and physical distress in cancer patients: structure and application of the Rotterdam Symptom Checklist. Br J Cancer 61: 1034-1038
8. Glimelius B, Hoffman K, Sjoden PO, Jacobsson G, Sellström H, Enander L-K, Linné T and Svensson C (1996) Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol 7: 593-600
9. Haie-Meder C, Pellae-Cosset B, Laplanche A, Lagrange JL, Tuchais C, Nogues C and Arriagada R (1993) Results of a randomized clinical trial comparing two radiation schedules in the palliative treatment of brain metastases. Radial Oncol 26: 111-116
10. Hopwood P, Stephens RJ and Machin D for the MRC Lung Cancer Working Party (1994) Approaches to the analysis of quality of life data: experiences gained from a Medical Research Council Lung Cancer Working Party palliative chemotherapy trial. Quality Life Res 3: 339-352
11. James LE, Gower NH, Rudd RM, Spiro SG, Harper PG, Trask CW, Partridge M, Souhami RL and Ruiz de Elvira M-C (1996) A randomised trial of low-dose/ high-frequency chemotherapy as palliative treatment of poor-prognosis small cell lung cancer: a Cancer Research Campaign trial. Br J Cancer 73: 1563-1568
12. Kurtz JM, Gelber R, Brady LW, Carella RJ and Cooper JS (1981 ) The palliation of brain metastases in a favorable patient population: a randomized clinical trial by the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys 7: 891-895
13. Leibel SA, Pajak TF, Massullo V, Order SE, Komaki RU, Chang CH, Wasserman TH, Phillips TL, Lipshutz J and Durbin LM (1987) A comparison of misonidazole sensitized radiation therapy to radiation therapy alone for the palliation of hepatic metastases: results of a Radiation Therapy Oncology Group randomized prospective trial. Int J Radiat Oncol Biol Phys 13: 1057-1064
14. Lewington VJ, McEwan AJ, Ackery DM, Bayly RJ, Keeling DH, Macleod PM, Porter AT and Zivanovic MA (1991 ) A prospective randomised double-blind crossover study to examine the efficacy of strontium-89 in pain palliation in patients with advanced cancer metastatic to bone. Eur J Cancer 27: 954-958
15. Maher EJ, Hopwood P, Girling DJ, Macbeth FR and Mansi JL (1994) Measurement of outcome in palliative oncology. J Cancer Care 3: 94-102
16. Marty M, on behalf of the Granisetron Study Group (1992) A comparison of granisetron as a single agent with conventional combination antiemetic therapies in the treatment of cytostatic-induced emesis. Eur J Cancer 28A (suppl. 1): S12-S16
17. Medical Research Council Lung Cancer Working Party (1989a) Survival, adverse reactions and quality of life during combination chemotherapy compared with selective palliative treatment for small cell lung cancer. Respir Med 83: 51-58
18. Medical Research Council Lung Cancer Working Party (1989b) Controlled trial of twelve versus six courses of chemotherapy in the treatment of small cell lung cancer. Br J Cancer 59: 584-590
19. Medical Research Council Lung Cancer Working Party (1991) Inoperable non-small cell lung cancer (NSCLC): a Medical Research Council randomised trial of palliative radiotherapy with two fractions or ten fractions. Br J Cancer 63: 265-270
20. Medical Research Council Lung Cancer Working Party (1992) A Medical Research Council (MRC) randomised trial of palliative radiotherapy with two fractions or a single fraction in patients with inoperable non-small cell lung cancer (NSCLC) and poor performance status. Br J Cancer 65 934-941
21. Medical Research Council Lung Cancer Working Party (1993) A randomised trial of three or six courses of etoposide cyclophosphamide methotrexate and vincristine or six courses of etoposide and ifosfamide in small cell lung cancer (SCLC). II. Quality of life. Br J Cancer 68: 1157-1166
22. Medical Research Council Lung Cancer Working Party (1996a) Randomized trial of palliative two-fraction versus more intensive 13-fraclion radiotherapy for patients with inoperable non-small cell lung cancer and good performance status. Clin Oncol 8: 167-175
23. Medical Research Council Lung Cancer Working Party (1996b) Randomized trial of four-drug versus less intensive two-drug chemotherapy in the palliative treatment of patients with small cell king cancer (SCLC) and poor prognosis. Br J Cancer 73: 406-413
24. Medical Research Council Lung Cancer Working Party (1996c) Comparison of oral etoposide and standard intravenous multidrug chemotherapy for small cell lung cancer: a stopped multicentre randomised trial. Lancet 348: 563-566
25. Mohiuddin M, Chen E and Ahmad N (1996) Combined liver radiation and chemotherapy for palliation of hepatic metastases from colorectal cancer. J Clin Oncol 14: 722-728
26. Muers MF and Round CE (1993) Palliation of symptoms in non-small cell lung cancer: a study by the Yorkshire Regional Cancer Organisation thoracic group. Thorax 48: 339-343
27. Richards MA, Hopwood P, Ramirez AJ, Twelves CJ, Ferguson J, Gregory WM, Swindell R, Scrivener W, Miller J, Howell A and Rubens RD (1992) Doxorubicin and advanced breast cancer: influence of schedule on response, survival and quality of life. Eur J Cancer 28A: 1023-1028
28. Stephens RJ, Girling DJ and Machin D (1994) Treatment-related deaths in small cell lung cancer: can patients at risk be identified? Lung Cancer 11: 259-274
29. Sur RK, Kochhar R and Singh DP (1994) Oral sucralfate in acute radiation oesophagitis. Acta Oncol 33: 61-63
30. Tannock IF, Osoba D, Stockler MR, Ernst DS, Neville AJ, Moore MJ, Armitage GR, Wilson JJ, Venner PM. Coppin CML and Murphy KC (1996) Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomised trial with palliative endpoints. J Clin Oncol 14: 1756-1764
31. Tong D, Gillick L and Hendrickson FR (1982) The palliation of symptomatic osseous metastases. Final results of the study by the Radiation Therapy Oncology Group. Cancer 50: 893-899
32. Twelves CJ, Dobbs NA, Lawrence MA, Ramirez AJ, Summerhayes M, Richards MA, Towlson KE and Rubens RD (1994) Iododoxorubicin in advanced breast cancer: a phase II evaluation of clinical activity, pharmacology and quality of life. Br J Cancer 69:726-731
33. Van Holten-Verzantvoort ATM, Kroon HM, Bijvoet OLM, Cleton FJ, Beex LVAM, Blijham G, Hermans J, Neijt JP, Papapoulos SE, Sleeboom HP, Vermey P and Zwinderman AH (1993) Palliative pamidronate treatment in patients with bone metastases from breast cancer. J Clin Oncol 11: 491-498
34. World Health Organization (1979) WHO Handbook for Reporting Results of Cancer Treatment. WHO Offset publication no. 48. WHO: Geneva