O-103 A comparison of the antitumour efficacy of ZD6474 and gefitinib(Iressa™) in patients with NSCLC: Results of a randomized, double-blind Phase II study

Natale, R.; Bodkin, David; Govindan, Ramaswamy; Sleckman, Bethany G.; Rizvi, Naiyer A.; Capó, Adolfo; Germonpré, Paul; Dimery, Isaiah W.; Webster, Alan; Ranson, Malcolm R

doi:10.1016/s0169-5002(05)80237-5

Cited by 33 publications

(12 citation statements)

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“…Preclinical data indicate that vandetanib has activity against NSCLC cell lines and against xenograft models resistant to treatment with gefitinib [39]. Furthermore, in phase II trials, it has been demonstrated to have second-line activity against NSCLC, both as a monotherapy and in combination with docetaxel [16,83].…”

Section: Discussionmentioning

confidence: 99%

Bevacizumab and Erlotinib: A Promising New Approach to the Treatment of Advanced NSCLC

Herbst

Sandler

2008

The Oncologist

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Biologic agents that target molecules involved in tumor growth, progression, and pathological angiogenesis—such as the human epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF)—have demonstrated efficacy in patients with non‐small cell lung cancer (NSCLC). Erlotinib (Tarceva®; OSI Pharmaceuticals, Inc., Melville, NY, Genentech, Inc., South San Francisco, CA, and F. Hoffmann‐La Roche Ltd, Basel, Switzerland), a highly selective tyrosine kinase inhibitor that inhibits EGFR, and bevacizumab (Avastin®; Genentech, Inc., South San Francisco, CA, and F. Hoffmann‐La Roche Ltd, Basel, Switzerland), a VEGF‐targeted recombinant humanized monoclonal antibody, have displayed very encouraging activity in a randomized phase II trial in patients with previously treated NSCLC. Because erlotinib and bevacizumab act on two different pathways critical to tumor growth and dissemination, administering these drugs concomitantly may confer additional clinical benefits to cancer patients with advanced disease, by virtue of their complementary (or additive) antitumor activity. The combination of bevacizumab plus erlotinib may prove to be a viable second‐line alternative to chemotherapy or erlotinib monotherapy in patients with NSCLC. The benefits of the combination may be further enhanced by selecting for patients who are likely to respond to this therapy. While a number of potential predictive markers have been identified for erlotinib, their value remains to be confirmed in prospective trials. In addition, the application of such personalized therapy will also depend on the availability of validated screening methods.

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Section: Discussionmentioning

confidence: 99%

Bevacizumab and Erlotinib: A Promising New Approach to the Treatment of Advanced NSCLC

Herbst

Sandler

2008

The Oncologist

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“…Mutations were detected in one of the three patients with a partial response and in one of the three patients with stable disease. It is interesting that one of the patients with stable disease and no mutations [wild-type (WT), exons [19][20][21] was a female nonsmoker with bronchioloalveolar carcinoma, a demographic subset that has been associated with response to EGFR tyrosine kinase inhibitors. Although it is possible that patients reported as WT could have mutations in unexamined exons, these results suggest the possibility that the combination of erlotinib with bevacizumab may provide benefit to patients with WT EGFR and is justification for further study of this combination.…”

Section: Erlotinib In Combination With Bevacizumab: Advanced Nsclcmentioning

confidence: 99%

Combining Targeted Agents: Blocking the Epidermal Growth Factor and Vascular Endothelial Growth Factor Pathways

Sandler

Herbst

2006

Clinical Cancer Research

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Bevacizumab is a recombinant, humanized monoclonal antibody against vascular endothelial growth factor. Erlotinib HCl is a reversible, highly selective epidermal growth factor receptor tyrosine kinase inhibitor. Additionally, both agents have shown benefit in patients with previously treated non^small cell lung cancer (NSCLC). Preclinical data in xenograft models produced greater growth inhibition with the combination than with either agent alone. A phase I/II study in two centers examined combined erlotinib and bevacizumab treatment in patients with nonsquamous stage IIIB/IV NSCLC with one or more prior chemotherapy. In phase I, 150 mg/d erlotinib orally plus 15 mg/kg bevacizumab i.v. every 21days was established as the phase II dose. A total of 40 patients were enrolled and treated in this study (34 patients at phase II dose): 21 were female, 30 had adenocarcinoma histology, 9 were never smokers, and 22 had two or more prior regimens. The most common adverse events were mild to moderate rash, diarrhea, and proteinuria. Preliminary data showed no pharmacokinetic interaction between erlotinib and bevacizumab. Eight patients (20.0%) had partial responses and 26 (65.0%) had stable disease as their best response. The median overall survival for the 34 patients treated at the phase II dose was 12.6 months, with progression-free survival of 6.2 months. Encouraging antitumor activity and safety of erlotinib plus bevacizumab support further development of this combination for patients with advanced NSCLC. A randomized phase II trial has been completed, and a phase III trial is ongoing.

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“…Over 40% of patients in the Western study had disease stabilization of at least 8 weeks, and in the Japanese study four of nine patients with refractory NSCLC had partial responses. A very recent phase II randomized trial used on about 160 pretreated advanced NSCLC patients ZD6474 or the EGFR-TKI gefitinib [68]. Patients received daily oral dose of ZD6474 (300 mg) or gefitinib (250 mg), and treatment continued until disease progression or evidence of toxicity.…”

Section: Vegf-receptor Tyrosine Kinase Inhibitorsmentioning

confidence: 99%

New antiangiogenetic agents and non-small cell lung cancer

Gridelli

Rossi

Maione

2006

Critical Reviews in Oncology/Hematology

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O-103 A comparison of the antitumour efficacy of ZD6474 and gefitinib(Iressa™) in patients with NSCLC: Results of a randomized, double-blind Phase II study

Cited by 33 publications

References 0 publications

Bevacizumab and Erlotinib: A Promising New Approach to the Treatment of Advanced NSCLC

Bevacizumab and Erlotinib: A Promising New Approach to the Treatment of Advanced NSCLC

Combining Targeted Agents: Blocking the Epidermal Growth Factor and Vascular Endothelial Growth Factor Pathways

New antiangiogenetic agents and non-small cell lung cancer

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