Biweekly cetuximab and irinotecan as second-line therapy in patients with gastro-esophageal cancer previously treated with platinum

Schoennemann, Katrine Rahbek; Bjerregaard, Jon Kroll; Hansen, Tine Plato; Stricker, Karin de; Gjerstorff, Morten F.; Jensen, Hanne Irene; Vestermark, Lene Weber; Pfeiffer, Per

doi:10.1007/s10120-011-0031-7

Cited by 19 publications

(10 citation statements)

References 37 publications

(41 reference statements)

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“…13,21,22 However, the efficacy and tolerability of cetuximab at 500 mg/m 2 q2w in this study for patients with advanced HNSCC, and the pharmacokinetic/pharmacodynamic similarities of q2w and conventional dosing described by others, 12,14 suggest that it should be feasible to study this q2w cetuximab regimen in combination with cytotoxic chemotherapy in patients with head and neck cancer. Off-protocol, cetuximab monotherapy at 500 mg/m 2 q2w is an appropriate palliative option for some patients with advanced HNSCC (eg, in those for whom exposure to the EXTREME regimen is not believed to be clinically indicated).…”

Section: Discussionmentioning

confidence: 74%

A Randomized Phase II Study of Cetuximab Every 2 Weeks at Either 500 or 750 mg/m²for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer

Fury¹,

Sherman²,

Lisa³

et al. 2012

J Natl Compr Canc Netw

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Cetuximab is typically administered on a weekly schedule for patients with recurrent or metastatic head and neck squamous cell cancer (HNSCC). This study explores cetuximab administered every 2 weeks (q2w). In this multicenter randomized prospective phase II study, eligible patients (≤2 prior cytotoxic chemotherapy regimens for recurrent or metastatic disease; ECOG performance status ≤2) were randomized to receive cetuximab q2w at 500 mg/m2 (Group A) or 750 mg/m2 (Group B). The primary end point was response rate (RECIST 1.0). Sixty-one patients were enrolled: 35 in Group A and 26 in Group B, which was closed early for lack of efficacy. Confirmed partial response rates were 11% for Group A (4/35) and 8% for Group B (2/26) according to intention to treat analysis. Partial responses occurred only among patients whose primary tumors were in the oral cavity or larynx. Median progression-free survival (PFS) and median overall survival (OS) were similar for both groups (PFS, 2.2 and 2.0 months; OS, 7.0 and 9.4 months; Groups A and B, respectively). The most common cetuximab-related adverse events (all grades) among treated subjects included rash, fatigue, and hypomagnesemia. Cetuximab, 500 mg/m2, q2w achieves similar efficacy as conventional dosing for patients with recurrent or metastatic HNSCC. Escalating the dose to 750 mg/m2 q2w offers no obvious therapeutic advantage.

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Section: Discussionmentioning

confidence: 74%

A Randomized Phase II Study of Cetuximab Every 2 Weeks at Either 500 or 750 mg/m²for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer

Fury¹,

Sherman²,

Lisa³

et al. 2012

J Natl Compr Canc Netw

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“…In NSCLC, the median PFS is 4.2-13.1 months23-33 and 1.7-4.6 months34-43 for first- and second line-treatment; respectively. In gastro-esophageal cancer, the median PFS is 3.9-7.0 months44-49 and 1.8-4.1 months50-52 for first- and second-line therapy; respectively. The least favorable results are in patients with advanced pancreatic cancer, where the median PFS is 3.3-6.4 months53,54 and 1.4-4.1 months55-59 for first- and second-line treatment; respectively (Table II).…”

Section: Discussionmentioning

confidence: 99%

Progression-free Survival Decreases with Each Subsequent Therapy in Patients Presenting for Phase I Clinical Trials

Bailey¹,

Jameson²,

Sima³

et al. 2012

J. Cancer

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Background: There is often a finite progression-free interval of time between one systemic therapy and the next when treating patients with advanced cancer. While it appears that progression-free survival (PFS) between systemic therapies tends to get shorter for a number of factors, there has not been a formal evaluation of diverse tumor types in an advanced cancer population treated with commercially-available systemic therapies.Methods: In an attempt to clarify the relationship between PFS between subsequent systemic therapies, we analyzed the records of 165 advanced cancer patients coming to our clinic for consideration for participation in six different phase I clinical trials requiring detailed and extensive past medical treatment history documentation.Results: There were 77 men and 65 women meeting inclusion criteria with a median age at diagnosis of 55.3 years (range 9.4-81.6). The most common cancer types were colorectal (13.9%), other gastrointestinal (11.8%), prostate (11.8%). A median of 3 (range 1-11) systemic therapies were received prior to phase I evaluation. There was a significant decrease in PFS in systemic therapy for advanced disease from treatment 1 to treatment 2 to treatment 3 (p = 0.002), as well as, from treatment 1 through treatment 5 (p < 0.001).Conclusions: In an advanced cancer population of diverse tumor types, we observe a statistically significant decrease in PFS with each successive standard therapy. Identification of new therapies that reverse this trend of decreasing PFS may lead to improved clinical outcomes.

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“…Monotherapy with cetuximab for treatment of advanced GC showed minimal activity [38]. Trials investigating cetuximab treatment after first-line chemotherapies were reported with moderate activities [39,40]. In first-line settings (Table 2), in several phase II trials, cetuximab has shown some encouraging results when combined with various chemotherapeutic agents.…”

Section: Introductionmentioning

confidence: 99%

Novel targeted agents for gastric cancer

Liu

2012

J Hematol Oncol

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Contemporary advancements have had little impact on the treatment of gastric cancer (GC), the world’s second highest cause of cancer death. Agents targeting human epidermal growth factor receptor mediated pathways have been a common topic of contemporary cancer research, including monoclonal antibodies (mAbs) and receptor tyrosine kinase inhibitors (TKIs). Trastuzumab is the first target agent evidencing improvements in overall survival in HER2-positive (human epidermal growth factor receptor 2) gastric cancer patients. Agents targeting vascular epithelial growth factor (VEGF), mammalian target of rapamycin (mTOR), and other biological pathways are also undergoing clinical trials, with some marginally positive results. Effective targeted therapy requires patient selection based on predictive molecular biomarkers. Most phase III clinical trials are carried out without patient selection; therefore, it is hard to achieve personalized treatment and to monitor patient outcome individually. The trend for future clinical trials requires patient selection methods based on current understanding of GC biology with the application of biomarkers.

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Biweekly cetuximab and irinotecan as second-line therapy in patients with gastro-esophageal cancer previously treated with platinum

Cited by 19 publications

References 37 publications

A Randomized Phase II Study of Cetuximab Every 2 Weeks at Either 500 or 750 mg/m²for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer

A Randomized Phase II Study of Cetuximab Every 2 Weeks at Either 500 or 750 mg/m²for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer

Progression-free Survival Decreases with Each Subsequent Therapy in Patients Presenting for Phase I Clinical Trials

Novel targeted agents for gastric cancer

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Biweekly cetuximab and irinotecan as second-line therapy in patients with gastro-esophageal cancer previously treated with platinum

Cited by 19 publications

References 37 publications

A Randomized Phase II Study of Cetuximab Every 2 Weeks at Either 500 or 750 mg/m2for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer

A Randomized Phase II Study of Cetuximab Every 2 Weeks at Either 500 or 750 mg/m2for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer

Progression-free Survival Decreases with Each Subsequent Therapy in Patients Presenting for Phase I Clinical Trials

Novel targeted agents for gastric cancer

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Product

Resources

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A Randomized Phase II Study of Cetuximab Every 2 Weeks at Either 500 or 750 mg/m²for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer

A Randomized Phase II Study of Cetuximab Every 2 Weeks at Either 500 or 750 mg/m²for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer