Perioperative chemotherapy with or without epidermal growth factor receptor blockade in unselected patients with locally advanced oesophagogastric adenocarcinoma: Randomized phase II study with advanced biomarker program of the German Cancer Society (AIO/CAO STO-0801)

2018 ◽  
Vol 93 ◽  
pp. 119-126 ◽  
Author(s):  
Michael Stahl ◽  
Annett Maderer ◽  
Florian Lordick ◽  
Andre L. Mihaljevic ◽  
Stefan Kanzler ◽  
...  
Keyword(s):  
Epidermal Growth Factor Receptor ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Growth Factor Receptor ◽  
Receptor Blockade ◽  
Perioperative Chemotherapy ◽  
German Cancer Society ◽  
Cancer Society ◽  
Randomized Phase Ii ◽  
Epidermal Growth

scholarly journals Randomized Phase II Study of the Anti–Epidermal Growth Factor Receptor Monoclonal Antibody Cetuximab With Cisplatin Versus Cisplatin Alone in Patients With Metastatic Triple-Negative Breast Cancer

2013 ◽  
Vol 31 (20) ◽  
pp. 2586-2592 ◽  
Author(s):  
José Baselga ◽  
Patricia Gómez ◽  
Richard Greil ◽  
Sofia Braga ◽  
Miguel A. Climent ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Epidermal Growth Factor Receptor ◽  
Growth Factor ◽  
Epidermal Growth Factor ◽  
Phase Ii ◽  
Triple Negative ◽  
Phase Ii Study ◽  
Growth Factor Receptor ◽  
Randomized Phase Ii ◽  
Epidermal Growth

Purpose Epidermal growth factor receptor is overexpressed in metastatic triple-negative breast cancers (mTNBCs), an aggressive subtype of breast cancer. Our randomized phase II study investigated cisplatin with or without cetuximab in this setting. Patients and Methods Patients who had received no more than one previous chemotherapy regimen were randomly assigned on a 2:1 schedule to receive no more than six cycles of cisplatin plus cetuximab or cisplatin alone. Patients receiving cisplatin alone could switch to cisplatin plus cetuximab or cetuximab alone on disease progression. The primary end point was overall response rate (ORR). Secondary end points studied included progression-free survival (PFS), overall survival (OS), and safety profiles. Analyses included a significance level of α = .10 with no adjustments for multiplicity. Results The full analysis set comprised 115 patients receiving cisplatin plus cetuximab and 58 receiving cisplatin alone; 31 patients whose disease progressed on cisplatin alone switched to cetuximab-containing therapy. The ORR was 20% (95% CI, 13 to 29) with cisplatin plus cetuximab and 10% (95% CI, 4 to 21) with cisplatin alone (odds ratio, 2.13; 95% CI, 0.81 to 5.59; P = .11). Cisplatin plus cetuximab resulted in longer PFS compared with cisplatin alone (median, 3.7 v 1.5 months; hazard ratio [HR], 0.67; 95% CI, 0.47 to 0.97; P = .032). Corresponding median OS was 12.9 versus 9.4 months (HR, 0.82; 95% CI, 0.56 to 1.20; P = .31). Common grade 3/4 adverse events included acne-like rash, neutropenia, and fatigue. Conclusion While the primary study end point was not met, adding cetuximab to cisplatin doubled the ORR and appeared to prolong PFS and OS, warranting further investigation in mTNBC.

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