Evaluation of Clinical Efficacy of New Medical Treatments in Advanced Colorectal Cancer. Results of a Workshop Organized by the Eortc Gitccg

During the last few years several factors have contributed to an increasing change in the medical treatment of advanced colorectal cancer. Among them are the more general acceptance of the impact of chemotherapy on quality of life and survival in first as well as in second-line treatment, the introduction of new drugs and the definition of novel endpoints which can roughly be defined as “patient benefit”. For this reason the European Organization for Research and Treatment of Cancer (EORTC) Gastrointestinal Tract Cancer Cooperative Group (GITCCG) felt it was appropriate to organize a workshop with experts from different countries and national groups to discuss in depth several aspects concerning the treatment of patients with advanced colorectal cancer.

[1]  W. Scheithauer,et al.  Reinduction therapy with the same cytostatic regimen in patients with advanced colorectal cancer. , 1998, British Journal of Cancer.

[2]  M. Ducreux,et al.  5-Fluorouracil (5-FU) continuous intravenous infusion compared with bolus administration. Final results of a randomised trial in metastatic colorectal cancer. , 1997, European journal of cancer.

[3]  C. Köhne,et al.  The identification of high risk patients with metastatic colorectal cancer , 1997 .

[4]  A. Padhani,et al.  1097 – A prospective randomlsed trial of protracted venous infusion (PVI) 5-FU with or without mitomycin C (MMC) in advanced colorectal cancer , 1997 .

[5]  R. Goldberg,et al.  Phase II trial of irinotecan in patients with metastatic colorectal carcinoma. , 1997, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[6]  D. V. Von Hoff,et al.  Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. , 1997, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[7]  H. Bleiberg Colorectal cancer--is there an alternative to 5-FU? , 1997, European journal of cancer.

[8]  W. Scheithauer,et al.  Fluorouracil plus racemic leucovorin versus fluorouracil combined with the pure l-isomer of leucovorin for the treatment of advanced colorectal cancer: a randomized phase III study. , 1997, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[9]  S. Barni,et al.  High- versus low-dose levo-leucovorin as a modulator of 5-fluorouracil in advanced colorectal cancer: A ‘GISCAD’ phase III study , 1997 .

[10]  P. Rougier,et al.  Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study. , 1997, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[11]  C. Tournigand,et al.  Oxaliplatin with high-dose leucovorin and 5-fluorouracil 48-hour continuous infusion in pretreated metastatic colorectal cancer. , 1997, European journal of cancer.

[12]  S. Culine,et al.  Phase II study of irinotecan in the treatment of advanced colorectal cancer in chemotherapy-naive patients and patients pretreated with fluorouracil-based chemotherapy. , 1997, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[13]  J. Bertino,et al.  Fluorouracil in colorectal cancer--a tale of two drugs: implications for biochemical modulation. , 1997, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[14]  M Buyse,et al.  On the relationship between response to treatment and survival time. , 1996, Statistics in medicine.

[15]  D. Kerr,et al.  Final results of a randomised trial comparing 'Tomudex' (raltitrexed) with 5-fluorouracil plus leucovorin in advanced colorectal cancer. "Tomudex" Colorectal Cancer Study Group. , 1996, Annals of oncology : official journal of the European Society for Medical Oncology.

[16]  L. Fallowfield Quality of quality-of-life data , 1996, The Lancet.

[17]  L. Collette,et al.  Modulation of high-dose infusional fluorouracil by low-dose methotrexate in patients with advanced or metastatic colorectal cancer: final results of a randomized European Organization for Research and Treatment of Cancer Study. , 1996, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[18]  J. Michaelis,et al.  Weekly high-dose leucovorin versus low-dose leucovorin combined with fluorouracil in advanced colorectal cancer: results of a randomized multicenter trial. Study Group for Palliative Treatment of Metastatic Colorectal Cancer Study Protocol 1. , 1996, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[19]  D. V. Von Hoff,et al.  A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer. , 1996, Annals of oncology : official journal of the European Society for Medical Oncology.

[20]  I. Seymour,et al.  ZD1694: A novel thymidylate synthase inhibitor with substantial activity in the treatment of patients with advanced colorectal cancer. Tomudex Colorectal Study Group. , 1996, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[21]  Thomas J. Smith,et al.  Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. American Society of Clinical Oncology. , 1996, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[22]  E. Cutsem A Glimpse of the Future. New Directions in the Treatment of Colorectal Cancer , 1996 .

[23]  C. Stoffregen,et al.  Weekly High-Dose 5-Fluorouracil 24-Hour Infusion and Intermediate-Dose Folinic Acid Bolus in Metastatic Colorectal Cancer , 1996 .

[24]  M. Ychou,et al.  Two consecutive phase II studies of oxaliplatin (L-OHP) for treatment of patients with advanced colorectal carcinoma who were resistant to previous treatment with fluoropyrimidines. , 1996, Annals of oncology : official journal of the European Society for Medical Oncology.

[25]  D. Grignon,et al.  College of American Pathologists Conference XXVI on clinical relevance of prognostic markers in solid tumors. Summary. Members of the Cancer Committee. , 1995, Archives of pathology & laboratory medicine.

[26]  L. Fielding,et al.  College of American Pathologists Conference XXVI on clinical relevance of prognostic markers in solid tumors. Report of the Colorectal Cancer Working Group. , 1995, Archives of pathology & laboratory medicine.

[27]  S. Brienza,et al.  933 Oxaliplatin (L-OHP®): Global safety in 682 patients (PTS) , 1995 .

[28]  D. Kerr,et al.  'Tomudex' (ZD1694): results of a randomised trial in advanced colorectal cancer demonstrate efficacy and reduced mucositis and leucopenia. The 'Tomudex' Colorectal Cancer Study Group. , 1995, European journal of cancer.

[29]  D. Alderson,et al.  Two phase III trials of tauromustine (TCNU) in advanced colorectal cancer. , 1995, Annals of oncology : official journal of the European Society for Medical Oncology.

[30]  A. Norman,et al.  The prognostic value of CEA, βHCG, AFP, CA125, CA19-9 and C-erb B-2, (βHCG immunohistochemistry in advanced colorectal cancer , 1995 .

[31]  T. Fleming,et al.  Phase II study of fluorouracil and its modulation in advanced colorectal cancer: a Southwest Oncology Group study. , 1995, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[32]  D. Fairclough,et al.  Comparison of Time-tradeoff Utilities and Rating Scale Values of Cancer Patients and Their Relatives , 1995, Medical decision making : an international journal of the Society for Medical Decision Making.

[33]  W. Hiddemann,et al.  Failure of orally administered dipyridamole to enhance the antineoplastic activity of fluorouracil in combination with leucovorin in patients with advanced colorectal cancer: a prospective randomized trial. , 1995, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[34]  C. Marsault,et al.  A Randomized Study of Bolus Fluorouracil Plus Folinic Acid Versus 21‐Day Fluorouracil Infusion Alone or in Association with Cyclophosphamide and Mitomycin C in Advanced Colorectal Carcinoma , 1995, American journal of clinical oncology.

[35]  C. Tangen,et al.  Fluorouracil plus Levamisole as Effective Adjuvant Therapy after Resection of Stage III Colon Carcinoma: A Final Report , 1995, Annals of Internal Medicine.

[36]  A. Norman,et al.  The prognostic value of CEA, beta HCG, AFP, CA125, CA19-9 and C-erb B-2, beta HCG immunohistochemistry in advanced colorectal cancer. , 1995, Annals of oncology : official journal of the European Society for Medical Oncology.

[37]  N. Petrelli,et al.  Age and sex are independent predictors of 5‐fluorouracil toxicity. Analysis of a large scale phase III trial , 1995, Cancer.

[38]  K. Abrams,et al.  Quality of life and survival with continuous hepatic-artery floxuridine infusion for colorectal liver metastases , 1994, The Lancet.

[39]  F. Lévi,et al.  Chronomodulated versus fixed-infusion-rate delivery of ambulatory chemotherapy with oxaliplatin, fluorouracil, and folinic acid (leucovorin) in patients with colorectal cancer metastases: a randomized multi-institutional trial. , 1994, Journal of the National Cancer Institute.

[40]  J. Ajani,et al.  Phase II trial of uracil and tegafur plus oral leucovorin: an effective oral regimen in the treatment of metastatic colorectal carcinoma. , 1994, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[41]  L. Påhlman,et al.  The relationship between an objective response to chemotherapy and survival in advanced colorectal cancer. , 1994, British Journal of Cancer.

[42]  W. Scheithauer,et al.  Randomized comparison of fluorouracil and leucovorin therapy versus fluorouracil, leucovorin, and cisplatin therapy in patients with advanced colorectal cancer , 1994, Cancer.

[43]  L. Påhlman,et al.  Quality of life during chemotherapy in patients with symptomatic advanced colorectal cancer , 1994, Cancer.

[44]  A. Oxman,et al.  Chemotherapy for advanced non-small-cell lung cancer: how much benefit is enough? , 1993, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[45]  W. Scheithauer,et al.  Randomised comparison of combination chemotherapy plus supportive care with supportive care alone in patients with metastatic colorectal cancer. , 1993, BMJ.

[46]  D. Osoba,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. , 1993, Journal of the National Cancer Institute.

[47]  D. Tulsky,et al.  The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. , 1993, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[48]  B. Meyerowitz Quality of life in breast cancer patients: the contribution of data to the care of patients. , 1993, European journal of cancer.

[49]  H. Schmoll,et al.  Chemotherapeutic strategies in metastatic colorectal cancer: an overview of current clinical trials. , 1992, Seminars in oncology.

[50]  J. Wils High-dose fluorouracil: a new perspective in the treatment of colorectal cancer? , 1992, Seminars in oncology.

[51]  P. Piedbois Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. Advanced Colorectal Cancer Meta-Analysis Project. , 1992, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[52]  S. Barni,et al.  Folinic acid + 5-fluorouracil (5-FU) versus equidose 5-FU in advanced colorectal cancer. Phase III study of 'GISCAD' (Italian Group for the Study of Digestive Tract Cancer). , 1991, Annals of oncology : official journal of the European Society for Medical Oncology.

[53]  K. Westbrook,et al.  Prognostic significance of carcinoembryonic antigen in colorectal carcinoma. Serum levels before and after resection and before recurrence. , 1991, Archives of surgery.

[54]  J. de Haes,et al.  Measuring psychological and physical distress in cancer patients: structure and application of the Rotterdam Symptom Checklist. , 1990, British Journal of Cancer.

[55]  D. Tulsky,et al.  Measuring quality of life today: methodological aspects. , 1990, Oncology.

[56]  L. Påhlman,et al.  Quality of life during cytostatic therapy for advanced symptomatic colorectal carcinoma: a randomized comparison of two regimens. , 1989, European journal of cancer & clinical oncology.

[57]  J G Fryer,et al.  A prospective randomized comparison of continuous infusion fluorouracil with a conventional bolus schedule in metastatic colorectal carcinoma: a Mid-Atlantic Oncology Program Study. , 1989, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[58]  A. Howell,et al.  The definition of the 'no change' category in patients treated with endocrine therapy and chemotherapy for advanced carcinoma of the breast. , 1988, European journal of cancer & clinical oncology.

[59]  G. Torrance Measurement of health state utilities for economic appraisal. , 1986, Journal of health economics.

[60]  R. Temple,et al.  Food and Drug Administration requirements for approval of new anticancer drugs. , 1985, Cancer treatment reports.

[61]  A McMurray,et al.  Measuring the quality of life of cancer patients: the Functional Living Index-Cancer: development and validation. , 1984, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[62]  K C Cain,et al.  Analysis of survival by tumor response. , 1983, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.