8514 SPECTRUM, a phase III trial for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) receiving chemotherapy with or without panitumumab: interim pooled safety analysis

2009 ◽  
Vol 7 (2) ◽  
pp. 474-475
Author(s):  
J. Stöhlmacher ◽  
I. Davidenko ◽  
E. Winquist ◽  
L. Licitra ◽  
K. Skladowski ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Safety Analysis ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Metastatic Squamous Cell Carcinoma

Phase III Randomized Trial of Cisplatin Plus Placebo Compared With Cisplatin Plus Cetuximab in Metastatic/Recurrent Head and Neck Cancer: An Eastern Cooperative Oncology Group Study

2005 ◽  
Vol 23 (34) ◽  
pp. 8646-8654 ◽  
Author(s):  
Barbara Burtness ◽  
Meredith A. Goldwasser ◽  
William Flood ◽  
Bassam Mattar ◽  
Arlene A. Forastiere
Keyword(s):  
Overall Survival ◽  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Response Rate ◽  
Hazard Ratio ◽  
Phase Iii ◽  
End Points ◽  
Metastatic Squamous Cell Carcinoma

Purpose Therapy of recurrent/metastatic squamous cell carcinoma of the head and neck results in median progression-free survival (PFS) of 2 months. These cancers are rich in epidermal growth factor receptor (EGFR). We wished to determine whether the addition of cetuximab, which inhibits activation of EGFR, would improve PFS. Patients and Methods Patients with recurrent/metastatic squamous cell carcinoma of the head and neck were randomly assigned to receive cisplatin every 4 weeks, with weekly cetuximab (arm A) or placebo (arm B). Tumor tissue was assayed for EGFR expression by immunohistochemistry. The primary end point was PFS. Secondary end points of interest were response rate, toxicity, overall survival, and correlation of EGFR with clinical end points. Results There were 117 analyzable patients enrolled. Median PFS was 2.7 months for arm B and 4.2 months for arm A. The hazard ratio for progression of arm A to arm B was 0.78 (95% CI, 0.54 to 1.12). Median overall survival was 8.0 months for arm B and 9.2 months for arm A (P = .21). The hazard ratio for survival by skin toxicity in cetuximab-treated patients was 0.42 (95% CI, 0.21 to 0.86). Objective response rate was 26% for arm A and 10% for arm B (P = .03). Enhancement of response was greater for patients with EGFR staining present in less than 80% of cells. Conclusion Addition of cetuximab to cisplatin significantly improves response rate. There was a survival advantage for the development of rash. Progression-free and overall survival were not significantly improved by the addition of cetuximab in this study.

Tirapazamine, Cisplatin, and Radiation Versus Cisplatin and Radiation for Advanced Squamous Cell Carcinoma of the Head and Neck (TROG 02.02, HeadSTART): A Phase III Trial of the Trans-Tasman Radiation Oncology Group

2010 ◽  
Vol 28 (18) ◽  
pp. 2989-2995 ◽  
Author(s):  
Danny Rischin ◽  
Lester J. Peters ◽  
Brian O'Sullivan ◽  
Jordi Giralt ◽  
Richard Fisher ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Survival Rates ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Locoregional Failure ◽  
Radiation Oncology Group ◽  
Intent To Treat

Purpose Promising results in a randomized phase II trial with the hypoxic cytotoxin tirapazamine (TPZ) combined with cisplatin (CIS) and radiation led to this phase III trial. Patients and Methods Patients with previously untreated stage III or IV (excluding T1-2N1 and M1) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx were randomly assigned to receive definitive radiotherapy (70 Gy in 7 weeks) concurrently with either CIS (100 mg/m2) on day 1 of weeks 1, 4, and 7 or CIS (75 mg/m2) plus TPZ (290 mg/m2/d) on day 1 of weeks 1, 4, and 7 and TPZ alone (160 mg/m2/d) on days 1, 3, and 5 of weeks 2 and 3 (TPZ/CIS). The primary end point was overall survival (OS). The planned sample size was 850, estimated to result in 334 deaths, which would provide 90% power to detect a difference in 2-year survival rates of 60% v 70% for CIS versus TPZ/CIS, respectively (hazard ratio = 0.69). Results Eight hundred sixty-one patients were accrued from 89 sites in 16 countries. In an intent-to-treat analysis, the 2-year OS rates were 65.7% for CIS and 66.2% for TPZ/CIS (TPZ/CIS – CIS: 95% CI, −5.9% to 6.9%). There were no significant differences in failure-free survival, time to locoregional failure, or quality of life as measured by Functional Assessment of Cancer Therapy–Head and Neck. Conclusions We found no evidence that the addition of TPZ to chemoradiotherapy, in patients with advanced head and neck cancer not selected for the presence of hypoxia, improves OS.

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