Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study

The Lancet Oncology - Tập 16 - Trang 187-199 - 2015
Jeffrey D Bradley1, Rebecca Paulus2, Ritsuko Komaki3, Gregory Masters4, George Blumenschein3, Steven Schild5, Jeffrey Bogart6, Chen Hu2, Kenneth Forster7, Anthony Magliocco8, Vivek Kavadi9, Yolanda I Garces10, Samir Narayan11, Puneeth Iyengar12, Cliff Robinson1, Raymond B Wynn13, Christopher Koprowski14, Joanne Meng15, Jonathan Beitler, Rakesh Gaur16
1Washington University, St. Louis, MO, USA
2Radiation Therapy Oncology Group-Statistical Center, Philadelphia, PA, USA
3The University of Texas MD Anderson Cancer Center, Houston, TX, USA
4Christiana Care/Helen Graham Medical Center, Newark, DE, USA
5Mayo Clinic, Scottsdale, AZ, USA
6SUNY Upstate Medical University, Syracuse NY, USA
7H. Lee Moffitt Cancer Center, Tampa, FL, USA
8H Lee Moffitt Cancer Center, Tampa, FL, USA
9USON- Texas Oncology-Sugarland, Sugarland, TX, USA
10Mayo Clinic, Rochester, MN, USA
11Michigan Cancer Research Consortium CCOP, Ypsilanti, MI, USA
12University of Texas Southwestern, Dallas, TX, USA
13UPMC-Shadyside Hospital, Pittsburgh, PA, USA
14Christiana Care Health CCOP, Newark, DE, USA
15The Ottawa Hospital Cancer Centre, Ottawa, Canada
16Kansas City CCOP, Kansas City, MO, USA

Tài liệu tham khảo

Perez, 1980, A prospective randomized study of various irradiation doses and fractionation schedules in the treatment of inoperable non-oat-cell carcinoma of the lung. Preliminary report by the Radiation Therapy Oncology Group, Cancer, 45, 2744, 10.1002/1097-0142(19800601)45:11<2744::AID-CNCR2820451108>3.0.CO;2-U

Bradley, 2010, A phase I/II radiation dose escalation study with concurrent chemotherapy for patients with inoperable stages I to III non-small-cell lung cancer: phase I results of RTOG 0117, Int J Radiat Oncol Biol Phys, 77, 367, 10.1016/j.ijrobp.2009.04.029

Bradley, 2010, Primary analysis of the phase II component of a phase I/II dose intensification study using three-dimensional conformal radiation therapy and concurrent chemotherapy for patients with inoperable non-small-cell lung cancer: RTOG 0117, J Clin Oncol, 28, 2475, 10.1200/JCO.2009.27.1205

Schild, 2006, Results of a Phase I trial of concurrent chemotherapy and escalating doses of radiation for unresectable non-small-cell lung cancer, Int J Radiat Oncol Biol Phys, 65, 1106, 10.1016/j.ijrobp.2006.02.046

Socinski, 2008, Randomized phase II trial of induction chemotherapy followed by concurrent chemotherapy and dose-escalated thoracic conformal radiotherapy (74 Gy) in stage III non-small-cell lung cancer: CALGB 30105, J Clin Oncol, 26, 2457, 10.1200/JCO.2007.14.7371

Stinchcombe, 2008, Long-term follow-up of a phase I/II trial of dose escalating three-dimensional conformal thoracic radiation therapy with induction and concurrent carboplatin and paclitaxel in unresectable stage IIIA/B non-small cell lung cancer, J Thorac Oncol, 3, 1279, 10.1097/JTO.0b013e31818b1971

Machtay, 2012, Higher biologically effective dose of radiotherapy is associated with improved outcomes for locally advanced non-small cell lung carcinoma treated with chemoradiation: an analysis of the Radiation Therapy Oncology Group, Int J Radiat Oncol Biol Phys, 82, 425, 10.1016/j.ijrobp.2010.09.004

Curran, 2011, Sequential vs. concurrent chemoradiation for stage III non-small cell lung cancer: randomized phase III trial RTOG 9410, J Natl Cancer Inst, 103, 1452, 10.1093/jnci/djr325

Li, 2005, Structural basis for inhibition of the epidermal growth factor receptor by cetuximab, Cancer Cell, 7, 301, 10.1016/j.ccr.2005.03.003

Blumenschein, 2011, Phase II study of cetuximab in combination with chemoradiation in patients with stage IIIA/B non-small-cell lung cancer: RTOG 0324, J Clin Oncol, 29, 2312, 10.1200/JCO.2010.31.7875

Zelen, 1974, The randomization and stratification of patients to clinical trials, J Chronic Dis, 27, 365, 10.1016/0021-9681(74)90015-0

Therasse, 2000, New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada, J Natl Cancer Inst, 92, 205, 10.1093/jnci/92.3.205

Pirker, 2012, EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study, Lancet Oncol, 13, 33, 10.1016/S1470-2045(11)70318-7

Haybittle, 1971, Repeated assessment of results in clinical trials of cancer treatment, Br J Radiol, 44, 793, 10.1259/0007-1285-44-526-793

Peto, 1976, Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design, Br J Cancer, 34, 585, 10.1038/bjc.1976.220

Freidlin, 2002, A comment on futility monitoring, Control Clin Trials, 23, 355, 10.1016/S0197-2456(02)00218-0

Kaplan, 1958, Nonparameteric estimation from incomplete observations, J Am Stat Assoc, 53, 457, 10.1080/01621459.1958.10501452

Mantel, 1966, Evaluation of survival data and two new rank order statistics arising in its consideration, Cancer Chemother Rep, 50, 163

Cox, 1972, Regression models and life tables, J R Stat Soc Series B Stat Methodol, 34, 187

Kalbfleisch, 1980

Gray, 1988, A class of K-sample tests for comparing the cumulative incidence of a competing risk, Ann Stat, 16, 1141, 10.1214/aos/1176350951

Fine, 1999, A proportional hazards model for the subdistribution of a competing risk, J Am Stat Assoc, 94, 496, 10.1080/01621459.1999.10474144

Bonner, 2006, Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck, N Engl J Med, 354, 567, 10.1056/NEJMoa053422

Thông tin
Thông tin xuất bản

The Lancet Oncology

Tập 16

187-199

Thông tin tác giả