Analysis of tumor burden versus progression-free survival for Phase II decision making

Contemporary Clinical Trials

Volumn 32, Issue 3, 2011, Pages 446-452

  Fridlyand, Jane ^a   Kaiser, Lee D ^a   Fyfe, Gwen ^a  

^a GENENTECH INC   (United States)

Author keywords

Oncology; Phase II decision making; Re sampling; Tumor burden

Indexed keywords

ANTHRACYCLINE; BEVACIZUMAB; CAPECITABINE; CYCLOPHOSPHAMIDE; DOCETAXEL; ERLOTINIB; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; PACLITAXEL; TRASTUZUMAB;

ARTICLE; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER STAGING; CANCER SURVIVAL; COLORECTAL CANCER; COMPUTER ASSISTED TOMOGRAPHY; DECISION MAKING; HUMAN; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MULTIPLE CYCLE TREATMENT; ONCOLOGY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; POSITRON EMISSION TOMOGRAPHY; PREDICTION; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; REGRESSION ANALYSIS; STATISTICAL MODEL; STATISTICAL SIGNIFICANCE; TREATMENT INDICATION; TREATMENT OUTCOME; TUMOR VOLUME;

ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; COLORECTAL NEOPLASMS; DECISION MAKING; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; FEMALE; FLUOROURACIL; HUMANS; LUNG NEOPLASMS; NEOPLASM METASTASIS; PROTEIN KINASE INHIBITORS; QUINAZOLINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGRESSION ANALYSIS; SURVIVAL RATE; TUMOR BURDEN;

EID: 79953050574     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2011.01.010     Document Type: Article

References (16)

1. DiMasi J.A., Grabowski H.G. Economics of new oncology drug development. J Clin Oncol 2007, 25:209-216.
2. Ratain M.J., Eisen T., Stadler W.M., Flaherty K.T., Kaye S.B., Rosner G.L., et al. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol 2006, 24:2505-2512.
3. Karrison T.G., Maitland M.L., Stadler W.M., Ratain M.J. Design of phase II cancer trials using a continuous endpoint of change of tumor size: application to a study of sorafenib and erlotinib in non small-cell lung cancer. J Natl Cancer Inst 2007, 99:1455-1461.
4. Wang Y., Sung C., Dartois C., Ramchandani R., Booth B.P., Rock E., et al. Elucidation of relationship between tumor size and survival in non-small-cell lung cancer patients can aid early decision making in clinical drug development. Clin Pharmacol Ther 2009, 86:167-174.
5. Claret L., Girard P., Hoff P.M., Van Cutsem E., Zuideveld K.P., Jorga K., et al. Model-based prediction of phase III overall survival in colorectal cancer on the basis of phase II tumor dynamics. J Clin Oncol 2009, 27:4103-4108.
6. Bruno R., Claret L. On the use of change in tumor size to predict survival in clinical oncology studies: towards a new paradigm to design and evaluate phase II studies. Clin Pharmacol Ther 2009, 86:136-138.
7. Hurwitz H., Fehrenbacher L., Novotny W., Cartwright T., Hainsworth J., Heim W., et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004, 350:2335-2342.
8. Miller K.D., Chap L.I., Holmes F.A., Cobleigh M.A., Marcom P.K., Fehrenbacher L., et al. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol 2005, 23:792-799.
9. Kabbinavar F.F., Schulz J., McCleod M., Patel T., Hamm J.T., Hecht J.R., et al. Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: results of a randomized phase II trial. J Clin Oncol 2005, 23:3697-3705.
10. O'Shaughnessy J., Miles D., Vukelja S., Moiseyenko V., Ayoub J.-P., Cervantes G., et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 2002, 20:2812-2823.
11. Shepherd F.A., Pereira J.R., Ciuleanu T., Tan E.H., Hirsh V., Thongprasert S., et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005, 353:123-132.
12. Slamon D.J., Leyland-Jones B., Shak S., Fuchs H., Paton V., Bajamonde A., et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001, 344:783-792.
13. Kaiser L. Adjusting for baseline: change or percentage change?. Stat Med 1989, 8:1183-1190.
14. Cleveland W.S., Devlin S.J., Grosse E. Regression by local fitting. J Econom 1988, 37:87-114.
15. Cox D.R., Oakes D. Analysis of survival data 1984, Chapman and Hall, New York.
16. Nagelkerke N. A note on a general definition of the coefficient of determination. Biometrika 1991, 78:691-692.