Health-related quality of life in colorectal cancer patients

References

• World Health Organization. International Agency for Research on Cancer. World Cancer Report. Stewart BW, Kleihues P (Eds), International Agency for Research on Cancer, Lyon, France (2003).
   Google Scholar
• Colorectal Cancer Collaborative Group. Palliative chemotherapy for advanced colorectal cancer: systematic review and meta-analysis. BE Med 321(7260), 531–536 (2000).
   PubMedGoogle Scholar
• Kjeldsen BJ, Thorsen H, Whalley D, Kronborg 0. Influence of follow-up on health-related quality of life after radical surgery for colorectal cancer. Scant J. Castroenterol 34(5), 509–515 (1999).
   Google Scholar
• •Important randomized study evaluating the influence of follow-up visits on quality of life (QoL) and assessing the attitude of the patients to check-up. Validation of the Nottingham Health Profile in colorectal cancer (CRC) patients.
   Google Scholar
• Camilleri-Brennan J, Ruta DA, Steele RJ. Patient Generated Index: new instrument for measuring quality of life in patients with rectal cancer. World J. Sorg. 26(11), 1354–1359 (2002).
   Google Scholar
• Spitzer WO, Dobson AJ, Hall J etal. Measuring the quality of life of cancer patients. A concise QL-index for use by physicians. J. Chron. Dis. 34(12), 585–597 (1981).
   Google Scholar
• Sloan JA, Loprinzi CL, Kuross SA et al Randomized comparison of four tools measuring overall quality of life in patients with advanced cancer. j Clin. Oncol 16(11), 3662–3673 (1998).
   Google Scholar
• •Unique randomized study comparing four QoL instruments and supporting the hypothesis that QoL is prognostic for survival. Poor concordance between the physicians and the patients own assessment of their QoL.
   Google Scholar
• Zieren HU, Jacobi CA, Zieren J, Muller JM. Lebensqualitatserfassung nach resektion colorectaler carcinome. Chirurg 67(7), 703–709 (1996).
   Google Scholar
• Schipper H, Clinch J, McMurray A, Lewitt M. Measuring the quality of life of cancer patients: the Functional Living Index — Cancer: development and validation. J. Clin. Oncol 2(5), 472–483 (1984).
   Google Scholar
• Aaronson NK, Ahmedzai S, Bergman B etal The European Organization for Research and Treatment of Cancer QLQ-C30: a Quality-of-Life instrument for use in international clinical trials in oncology. .1. Natl Cancer Inst. 85(5), 365–376 (1993).
   Google Scholar
• ••The European Organization for theResearch and Treatment of Cancer (EORTC) QLQ-C30 core questionnaire contains 30 items addressing functional aspects of QoL and symptoms that commonly occur in patients with cancer. Excellent psychometric data support its credibility. Now the most widely used specific instrument.
   Google Scholar
• Garratt A, Schmidt L, Mackintosh A, Fitzpatrick R. Quality of life measurement: bibliographic study of patient-assessed health outcome measures. BE Med. J. 324(7351), 1417 (2002). iiApolone G, Filiberti A, Cifani R, Ruggiata R, Mosconi P. Evaluation of the EORTC QLQ-C30 questionnaire: a comparison with SF-36 Health Survey in a cohort of Italian long-survival cancer patients. Ann. Oncol 9(5), 549–557 (1998).
   Google Scholar
• •Comparison of the psychometric properties of the EORTC QLQ-C30 and of the SF-36 in a cohort of long-term survivors.
   Google Scholar
• Seymour MT, Tabah-Fisch I, Homerin M. Quality of Life (HRQoL) in advanced colorectal cancer (ACC): a comparison of HRQ0L, during bolus plus infusion 5FLYleucovorin (LV5FU2) with or without oxaliplatin. Proc. Am. Soc. Clin. Oncol 18, 234a (1999) (Abstract 901).
   Google Scholar
• Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. 1 Clin. 0=1 16(1), 139–144 (1998).
   Google Scholar
• ••Major study assessing the clinicalsignificance of scores from the EORTC QLQ-C30.
   Google Scholar
• Cella DF, Tu1sky DS, Gray G etal The Functional Assessment of Cancer Therapy Scale: development and validation of the general measure. J. Clin. Oncol 11(3), 570–579 (1993).
   Google Scholar
• ••The Functional Assessment of CancerTherapy — Coloiectal (FACT-C) consisted of 27 items addressing functional aspects of QoL and symptoms. Excellent psychometric data support its use in patients with cancer.
   Google Scholar
• Cella D, Hahn EA, Dineen K. Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qual Life Res. 11(3), 207–221 (2002).
   PubMed Web of Science ®Google Scholar
• De Haes JCJM, Van Knippenberg FCE, Neijt JR Measuring psychological and physical distress in cancer patients: structure and application of the Rotterdam Symptom Checklist. BT. J. Cancer 62(6), 1034–1038 (1990).
   Google Scholar
• Zigmond AS, Snaith RR The Hospital Anxiety and Depression Scale. Acta fiychiatr Land. 67(6), 361–370 (1983).
   Google Scholar
• Bosset JF, Schraub S, Pelissier E etal Proposition of a specific quality of life scale for patients treated by conservative surgery for rectal cancer. Lyon Chir. 89(1), 135 (1993) (Abstract).
   Google Scholar
• Padilla GV, Grant MM. Quality of life as a cancer nursing outcome variable. ANS AdV. NUTS. Li. 8(1), 45–60 (1985).
   Google Scholar
• Sprangers MAG, te Velde A, Aaronson NK. The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38). Eur. Cancer35(2), 238–247 (1999).
   Google Scholar
• •Report on the development and testing of the EORTC colorectal cancer module for assessing QoL.
   Google Scholar
• WS J, Sahmoud T, Sobrero A et al Evaluation of clinical efficacy of new medical treatments in advanced colorectal cancer. Results of a workshop organized by the EORTC GITCCG. Tumori84(3), 335–347 (1998).
   PubMedGoogle Scholar
• Kavadas V, Blazeby JM, Conroy T et al Development of an EORTC disease-specific quality of life questionnaire for use in patients with liver metastases from colorectal cancer. Eur j Cancer 39(6), 1259–1263 (2003).
   PubMedGoogle Scholar
• •Report on the development of a new instrument (QLQ-LMC21) to assess QoL of patients with hepatic metastases from colorectal cancer.
   Google Scholar
• Ward WL, Hahn EA, Mo F, Hernandez L, Tulsky DS, Cella D. Reliability and validity of the Functional Assessment of Cancer Therapy — Colorectal (FACT-C) quality of life instrument. Qua'. Life Res. 8(3), 181–195 (1999).
   PubMed Web of Science ®Google Scholar
• Revicki DA, Osoba D, Fairclough D etal. Recommendations on health-related quality of life research to support labeling and promotional claims in the United States. Qua'. Life Res. 9(8), 887–900 (2000).
   Google Scholar
• •Proposal of standards for design, analysis and report of QoL for use by pharmaceutical companies before promotional claims of a QoL benefit.
   Google Scholar
• Sprangers MA, Taal BG, Aaronson NK, te Velde A. Quality of life in colorectal cancer. Stoma vs. nonstoma patients. Dis. Colon Rectum 38 (4), 361–369 (1995) .
   Google Scholar
• •Review of QoL in stoma versus nonstoma surgery
   Google Scholar
• Sprangers MAG, te Velde A, Aaronson NK, Taal BG. Quality of Life following surgery for colorectal cancer: a literature review. Psychooncology 2(4), 247–259 (1993).
   Google Scholar
• •First review of QoL following surgery for CRC.
   Google Scholar
• Camilleri-Brennan J, Steele RJC. Quality of life after treatment for rectal cancer. BE j Surg. 85(8), 1036–1043 (1998).
   PubMedGoogle Scholar
• •Review of QoL following surgery for rectal cancer.
   Google Scholar
• Kuzu MA, Topcu 0, Ucar K et al Effect of sphincter-sacrificing surgery for rectal carcinoma on quality of life in Muslim patients. Dis. Colon Rectum 45 (10), 1359–1366 (2002)
   Google Scholar
• O'Leary DP, Fide CJ, Foy C, Lucarotti ME. Quality of life after low anterior resection with total mesorectal excision and temporary loop ileostomy for rectal carcinoma. BE j Surg. 88(9), 1216–1220 (2001).
   Google Scholar
• Grumann MM, Noack EM, Hoffmann IA, Schlag PM. Comparison of quality of life in patients undergoing abdominoperineal extirpation or anterior resection for rectal cancer. Ann. Surg. 233(2), 149–156 (2001).
   PubMedGoogle Scholar
• Allal AS, Bieri S, Pelloni A etal Sphincter- sparing surgery after preoperative radiotherapy for low rectal cancers: feasibility, oncologic results and quality of life outcomes. Br. Cancer82(6), 1131–1137 (2000).
   Google Scholar
• Pocard M, Zinzindohoue F, Haab F, Caplin S, Part R, Tiret E. A prospective study of sexual and urinary function before and after total mesorectal excision with autonomic nerve preservation for rectal cancer. Surgery 131 (4), 368–372 (2002) .
   PubMed Web of Science ®Google Scholar
• Mannaerts GH, Rutten HJT, Martjin H, Hanssens PEJ, Wiggers T Effects on functional outcome after TORT-containing multimodality treatment for locally advanced primary and locally recurrent rectal cancer. Int. J. Racliat. Oncol Biol. Phys. 54(4), 1082–1088 (2002).
   Google Scholar
• Shibata D, Guillem JG, Lanouette N etal Functional and quality-of-life outcomes in patients with rectal cancer after combined modality therapy, intraoperative radiation therapy and sphincter preservation. Dis. Colon Rectum 43 (6), 752–758 (2000) .
   PubMedGoogle Scholar
• Camilleri-Brennan J, Steele RJC. Prospective analysis of quality of life and survival following mesorectal excision for rectal cancer. Br. Surg. 88(12), 1617–1622 (2001).
   Google Scholar
• Guren MG, Wiig JN, Dueland S et al Quality of life in patients with urinary diversion after operation for locally advanced rectal cancer. Eur j Surg. Oncol 27(7), 645–651 (2001).
   Google Scholar
• Rockwood TH, Church JM, Fleshman JW etal Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis. Colon Rectum 43(1), 9–16 (2000).
   PubMed Web of Science ®Google Scholar
• Furst A, Burghofer K, Hutzel L, Jauch KW Neorectal reservoir is not the functional principle of the colonic J- pouch: the volume of a short colonic J-pouch does not differ from a straight coloanal anastomosis. Dis. Colon Rectum 45 (5), 660–667 (2002) .
   PubMedGoogle Scholar
• Hallbook 0, Hass U, Wanstrom A, Sjodahl R. Quality of life measurement after rectal excision for cancer. Comparison between straight and colonic J-pouch anastomosis. Scam/. j Castroenterol 32 (5), 490–493 (1997).
   Google Scholar
• Sailer M, Fuchs KH, Fein M, Thiede A. Randomized clinical trial comparing quality of life after straight and pouch coloanal reconstruction. BE J. Surg. 89(9), 1108–1117 (2002).
   Google Scholar
• Weeks JC, Nelson H, Gelber S, Sargent D, Schroeder G. Short-term quality-of-life outcomes following laparoscopic-assisted colectomy versus open colectomy for colon cancer: a randomized trial. JA/V/A 287(3), 321–328 (2002).
   Google Scholar
• Schwenk W, Bohm B, Muller JM. Postoperative pain and fatigue after laparoscopic or conventional colorectal resections. A prospective randomized trial. Surg. Enclosc. 12(9), 1131–1136 (1998).
   Google Scholar
• Guren MG, Dueland S, Skovlund E, Fossa SD, Poulsen JP, Tveit KM. Quality of life during radiotherapy for rectal cancer. Eur I Cancer 39 (5), 587–594 (2003) .
   PubMedGoogle Scholar
• •Prospective study demonstrating a moderate and transient decrease in QoL during (neo)adjuvant radiotherapy for rectal cancer.
   Google Scholar
• Norum J, Vonen B, Olsen JA, Revhaug A. Adjuvant chemotherapy (5-fluorouracil and levamisole) in Dukes' B and C colorectal carcinoma. A cost-effectiveness analysis. Ann. Oncol 8(1), 65–70 (1997).
   Google Scholar
• Zaniboni A, Labianca R, Marsoni S etal GIVIO-SITAC 01: a randomized trial of adjuvant 5-fluorouracil and folinic acid administered to patients with colon carcinoma: long-term results and evaluation of the indicators of health-related quality of life. Cancer82(11), 2135–2144 (1998).
   Google Scholar
• Bernhard J, Hurny C, Maibach R, Herrmann R, Laffer U. Quality of life as subjective experience: reframing of perception in patients with colon cancer undergoing radical resection with or without adjuvant chemotherapy. Ann. Oncol 10(7), 775–782 (1999).
   Google Scholar
• •Important methodological study demonstrating changes in the internal standards on which patients base their QoL estimation after surgery for colon cancer. Adjuvant chemotherapy had no impact on these changes.
   Google Scholar
• Gray R, Watson M, McConkey C etal Adjuvant chemotherapy for colorectal cancer has only minor impact on patient reported quality of life: a study of 785 patients randomized in the UKCCCR QUASAR trial. Proc. Am. Soc. Clin. Oncol 20\(Pt 1), 407a (2001) (Abstract 1623).
   Google Scholar
• Stiggelbout AM, De Haes JC, Vree R etal Follow-up of colorectal cancer patients: quality of life and attitudes towards follow-up. Br. Cancer75(6), 914–920 (1997).
   Google Scholar
• •Impressive study carefully asking preferences of patients and attitudes towards follow-up after resected CRC.
   Google Scholar
• Schag CAC, Ganz PA, Wing DS, Sim MS, Lee JJ. Quality of life in adult survivors of lung, colon and prostate cancer. (Aral Life Res. 3(2), 127–141 (1994).
   PubMed Web of Science ®Google Scholar
• •The first detailed QoL survey of long-term survivors of CRC.
   Google Scholar
• Ramsey SD, Andersen MR, Etzioni R etal. Quality of life in survivors of colorectal carcinoma. Cancer88(6), 1294–1303 (2000).
   PubMed Web of Science ®Google Scholar
• Ramsey SD, Berry K, Moinpour C, Giedzinska A, Andersen MR. Quality of life in long-term survivors of colorectal cancer. Am. .1. Castroenterol 97(5), 1228–1234 (2002).
   Google Scholar
• Mosconi P, Apolone G, Barni S, Secondino S, Sbanotto A, Filiberti A. Quality of life in breast and colon cancer long-term survivors: an assessment with the EORTC QLQ-C30 and SF-36 questionnaires. Tumor] 88(2), 110–116 (2002).
   Google Scholar
• Hamashima C. Long-term quality of life of postoperative rectal cancer patients. J: Castroenterol Hepatol 17(5), 571–576 (2002).
   PubMedGoogle Scholar
• American Society of Clinical Oncology. Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J: Clin. Oncol 14(3), 671–679 (1996).
   Google Scholar
• Sullivan BA, McKinnis R, Laufman L. Quality of life in patients with metastatic colorectal cancer receiving chemotherapy: a randomized, double-blind trial comparing 5-FU versus 5-FU with leucovorin. Pharmacotherapy15(5), 600–607 (1995).
   Google Scholar
• Earlam S, Glover C, Portly C, Burke D, Allen-Mersh TG. Relation between tumor size, quality of life and survival in patients with colorectal liver metastases. J. Clin. Oncol 14(1), 171–175 (1996).
   Google Scholar
• Hilgenfeld RU, Mansmann U, Guggenmoos-Holzmann I, Thiel E, Kreuser ED. Quality of life (QL) is a prognostic factor (PF) for survival in patients with advanced colorectal cancer (CRC) . Eur. Cancer 33 (Suppl. 8), S170 (1997) (Abstract 760).
   Google Scholar
• Mormont MC, Waterhouse J, Bleuzen P et al Marked 24-h rest/activity rhythms are associated with better quality of life, better response and longer survival in patients with metastatic colorectal cancer and good performance status. Clin. Cancer Res. 6(8), 3038–3045 (2000).
   Google Scholar
• Maughan TS, James RD, Kerr DJ etal. Comparison of survival, palliation and quality of life with three chemotherapy regimens in metastatic colorectal cancer: a multicentre randomised trial. Lancet 359(9317), 1555–1563 (2002).
   PubMed Web of Science ®Google Scholar
• ••Important randomized study thatdemonstrated that raltitrexed in metastatic CRC was associated with similar response rates and overall survival to continuous 5-fluorouracil (5-FU) infusion but resulted in inferior Q0L.
   Google Scholar
• Maisey NR, Norman A, Watson M, Allen MJ, Hill ME, Cunningham D. Baseline quality of life predicts survival in patients with advanced colorectal cancer. Eur.j Cancer38(10), 1351–1357 (2002).
   Google Scholar
• •Clear demonstration in 501 CRC patients that the majority of the Q01, domains has a strong independent prognostic value.
   Google Scholar
• Glimelius B, Graf W, Hoffman K, Pahlman L, Sjödén PO, Wennberg A. General condition of asymptomatic patients with advanced colorectal cancer receiving palliative chemotherapy. Acta Oncol 31(6), 645–651 (1992).
   PubMed Web of Science ®Google Scholar
• Glimelius B, Hoffman K, Graf W, Pahlman L, Sjöden PO for the Nordic Gastrointestinal Tumor Adjuvant Therapy Group. Quality of life during chemotherapy in patients with symptomatic advanced colorectal cancer. Cancer 73 (3), 556–562 (1994) .
   PubMedGoogle Scholar
• Cunningham D, Zalcberg JR, Rath U etal Final results of a randomised trial comparing Tomudex° (raltitrexed) with 5-fluorouracil plus leucovorin in advanced colorectal cancer. Ann. Oncol 7(9), 961–965 (1996).
   Google Scholar
• Camilleri-Brennan J, Steele RJC. The impact of recurrent rectal cancer on quality of life. Eur.j Sing. Oncol 27(4), 349–353 (2001).
   Google Scholar
• Esnaola NF, Cantor SB, Johnson ML etal Pain and quality of life after treatment in patients with locally recurrent rectal cancer. Clin. Oncol 20(21), 4361–4367 (2002).
   Google Scholar
• Scheithauer W, Rosen H, Komek G-V, Sebesta C, Depisch D. Randomized comparison of combination chemotherapy plus supportive care with supportive care alone in patients with metastatic colorectal cancer. BE Med. J 306(6880), 752–755 (1993).
   Google Scholar
• Allen-Mersh TG, Earlam S, Portly C, Abrams K, Houghton J. Quality of life and survival with continuous hepatic artery floxuridine infusion for colorectal liver metastases. Lancet 344 (8932), 1255–1260 (1994).
   PubMed Web of Science ®Google Scholar
• Gray B, Van Hazel G, Hope M etal. Randomised trial of SIR-Spheres ° plus chemotherapy vs. chemotherapy alone for treating patients with liver metastases from primary large bowel cancer. Ann. Oncol 12(12), 1711–1720 (2001).
   Google Scholar
• Allen-Mersh TG, Glover C, Portly C, Mathur P, Quinn H. Randomized trial of regional plus systemic fluorinated pyrimidine compared with systemic fluorinated pyrimidine in treatment of colorectal liver metastases. Eur. j Surg. Oncol 26(5), 468–473 (2000).
   Google Scholar
• Kerr DJ, McArdle CS, Ledermann J etal Intrahepatic arterial versus intravenous fluorouracil and folinic acid for colorectal cancer liver metastases: a multicentre randomised trial. Lancet 361(9355), 368–373 (2003).
   PubMed Web of Science ®Google Scholar
• •Large randomized study comparing intrahepatic arterial 5-FU to intravenous 5-FU: no differences in terms of progression-free or overall survival but a decrease in QoL in the intra-arterial group was observed.
   Google Scholar
• Hobday TJ, Kugler JW, Mahoney MR etal. Efficacy and quality-of-life data are related in a Phase II trial of oral chemotherapy in previously untreated patients with metastatic colorectal carcinoma. Clin. Oncol 20(23), 4574–4580 (2002).
   Google Scholar
• ••Very well documented Phase II study withdetailed QoL analysis showing large improvement in responders and no major changes in nonresponding patients with an oral chemotherapy regimen.
   Google Scholar
• Seymour MT, Slevin ML, Kerr DJ etal Randomized trial assessing the addition of interferon-a2a to fluorouracil and leucovorin in advanced colorectal cancer. Clin. Oncol 14(8), 2280-2288 (1996).
   Google Scholar
• Glimelius B, Hoffman K, Olafsdottir M, Pahlman L, Sjöden PO, Wennberg A. Quality of life during cytostatic therapy for advanced symptomatic colorectal carcinoma: a randomized comparison of two regimens. Eur j Cancer Clin. Oncol 25(5), 829–835 (1989).
   Google Scholar
• De Gramont A, Figer A, Seymour M etal. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J: Clin. Oncol 18(16), 2938–2947 (2000).
   Google Scholar
• Liu G, Franssen E, Fitch MI, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. Clin. Oncol 15(1), 110–115 (1997).
   Web of Science ®Google Scholar
• Douillard JY, Hoff PM, Skillings JR etal Multicenter Phase III study of uracil/tegafur and oral leucovorin versus fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer. Clin. Oncol 20(17), 3605–3616 (2002).
   Google Scholar
• Carmichael J, Popiela T, Radstone D etal. Randomized comparative study of tegafur/uracil and oral leucovorin versus parenteral fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer. J: Clin. Oncol 20(17), 3617–3627 (2002).
   Google Scholar
• ••
   Google Scholar
• Borras JM, Sanchez-Hernandez A, Navarro M etal Compliance, satisfaction and quality of life of patients with colorectal cancer receiving home chemotherapy or out-patient treatment: a randomised controlled trial. BE Merl J. 322(7290), 826 (2001).
   Google Scholar
• Schöffski P, Köhne CH, Schellenberger U etal. Does effective chemotherapy metastatic colorectal cancer (CC) improve quality of life (QL). Preliminary results of a randomized Phase II-study using the EORTC QLQ C30. Eur .1. Cancer 31A\(Suppl. 5), S62 (1995) (Abstract 284).
   Google Scholar
• Topham C, Moore J. Patient preferences for chemotherapy schedules used in the treatment of advanced colorectal cancer: a pilot study. Eur. .1. Cancer Cate 6 (4), 291–294 (1997).
   Google Scholar
• Ross P, Norman A, Cunningham D etal A prospective randomised trial of protracted venous infusion 5-fluorouracil with or without mitomycin C in advanced colorectal cancer. Ann. Oncol 8 (10), 995–1001 (1997).
   Google Scholar
• Douillard JY, Cunningham D, Roth AD etal Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicenter randomised trial. Lancet 355(9209), 1041–1047 (2000).
   PubMed Web of Science ®Google Scholar
• •Large randomized study in metastatic CRC demonstrating a survival advantage for patients treated with irinotecan combined with 5-FU as compared to 5-FU alone, with a later deterioration in Q0L.
   Google Scholar
• Saltz LB, Cox JV, Blanke C et al Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl. Med. 343(13), 905–914 (2000).
   Google Scholar
• •Three-arm study comparing irinotecan alone, 5-FU alone and irinotecan/5-FU in metastatic CRC: the combination significantly increases response rate, toxicity and survival without degradation of Q0L.
   Google Scholar
• Maughan TS, James RD, Kerr DJ etal Comparison of intermittent and continuous palliative chemotherapy for advanced colorectal cancer: a multicentre randomised trial. Lancet 361 (9356), 457–464 (2003).
   PubMedGoogle Scholar
• ••Unique randomized study comparing patients with advanced CRC Q0I, during continuous or intermittent chemotherapy.
   Google Scholar
• Loprinzi CL, Kuross SA, OTallon JR et al Randomized placebo-controlled evaluation of hydrazine sulfate in patients with advanced colorectal cancer. J. Clin. Oncol 12(6), 1121–1125 (1994).
   Google Scholar
• Cunningham D, Pyrhönen S, James RD etal Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet 352(9138), 1413–1418 (1998).
   PubMed Web of Science ®Google Scholar
• •Demonstration of a survival and a QoL advantage for patients with metastatic CRC randomly assigned to irinotecan as second-line treatment compared with patients given best supportive care.
   Google Scholar
• Michael M, Hedley D, Oza A etal The palliative benefit of irinotecan in 5-fluorouracil-refractory colorectal cancer: its prospective evaluation by a multicenter Canadian trial. Clin. Colorectal Cancer2 (2), 93–101 (2002).
   Google Scholar
• Rougier P, Van Cutsem E, Bajetta E etal Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet 352(9138), 1407–1412 (1998).
   PubMed Web of Science ®Google Scholar
• Henry B, Becouarn Y, Aussage P. Clinical benefits of stabilisation with second-line chemotherapy in patients with metastatic colorectal cancer. Grit. Rev Oncol Hernatol 32(2), 145–154 (1999).
   Google Scholar
• Fuchs CS, Moore MR, Harker G, Villa L, Rinaldi D, Hecht JR. Phase III comparison of two irinotecan dosing regimens in second-line therapy of metastatic colorectal cancer. 1 Clin. Oncol 21(5), 807–814 (2003).
   Google Scholar
• Bernhard J, Gelber RD. Workshop on missing data in quality of life research in cancer trials: practical and methodological issues. Stat. Med. 17(5-7), 511–796 (1998).
   Google Scholar
• •Numerous papers on worldwide experience of clinical research groups to improve compliance in Q0I., data.
   Google Scholar
• Cocconi G, Cunningham D, Van Cutsem E et al Open, randomised, multicenter trial of raltitrexed versus fluorouracil plus high-dose leucovorin in patients with advanced colorectal cancer. J. Clin. Oncol 16(9), 2943–2952 (1998).
   Google Scholar
• Lee CW, Chi KN. The standard of reporting of health-related quality of life in clinical cancer trials. J. Clin. Epidenriol 53(5), 451–458 (2000).
   Google Scholar
• Bottomley A, Vanvoorden V, Flechtner H, Therasse P. The challenges and achievements involved in implementing quality of life research in cancer clinical trials. Eur.j Cancer39(3), 275–285 (2003).
   Google Scholar
• McLachlan SA, Allenby A, Matthews J et al Randomized trial of co-ordinated psychosocial interventions based on self-assessments versus standard care to improve the psychosocial functioning of patients with cancer. J. Clin. Oncol 19 (21), 4117–4125 (2001).
   Google Scholar