Cetuximab, a Monoclonal Antibody Targeting the Epidermal Growth Factor Receptor, in Combination With Gemcitabine for Advanced Pancreatic Cancer: A Multicenter Phase II Trial

Xiong, Henry Q.; Rosenberg, Arthur; LoBuglio, Albert F.; Schmidt, William; Wolff, Robert A.; Deutsch, John C.; Needle, Michael N.; Abbruzzese, James L.

doi:10.1200/jco.2004.12.040

Cited by 436 publications

(251 citation statements)

References 25 publications

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“…One patient with SD at the end of the second 4-week cycle had a partial tumour response after the third cycle. Encouraging findings have also been reported with the combination of gemcitabine and the anti-EGFR chimeric monoclonal antibody cetuximab in the first-line treatment of patients with advanced pancreatic cancer (Xiong et al, 2004). The study was similar to ours, except that the cetuximab study was a phase II design and the initial 7 weeks of gemcitabine were administered without rest.…”

Section: Ck-1 P27supporting

confidence: 67%

Phase I study of the humanised anti-EGFR monoclonal antibody matuzumab (EMD 72000) combined with gemcitabine in advanced pancreatic cancer

et al. 2006

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The humanised anti-epidermal growth factor receptor (EGFR) monoclonal antibody matuzumab (formerly EMD 72000) is active against pancreatic cancer in preclinical studies. This phase I study assessed the safety and potential benefit of combined treatment with matuzumab and standard-dose gemcitabine. Three groups of chemotherapy-naive advanced pancreatic adenocarcinoma patients (n ¼ 17) received escalating doses of matuzumab (400 mg weekly, 800 mg biweekly, or 800 mg weekly) and gemcitabine (1000 mg m -2 weekly in weeks 1 -3 of each 4-week cycle). Toxicity, antitumour activity, pharmacokinetic (PK) parameters, and pharmacodynamic (PD) markers in skin biopsies were evaluated. Severe treatment-related toxicities were limited to grade 3 neutropenia (n ¼ 3), leucopenia (n ¼ 1), and decreased white blood cell count (n ¼ 1). Common study drug-related adverse events were skin toxicities (grade 2 ¼ 6, grade 1 ¼ 7) and fever (grade 1 ¼ 4). Matuzumab inhibited phosphorylated EGFR and affected receptor-dependent signalling and transduction; effects were seen even in the lowest-dose group. Pharmacokinetic data were consistent with results of matuzumab monotherapy. Partial response (PR) or stable disease occurred in eight of 12 evaluated patients (66.7%), with three PRs among six evaluated patients in the group receiving 800 mg weekly. Matuzumab in biologically effective doses with standard gemcitabine therapy appears well tolerated. The combination is feasible and may have enhanced activity.

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Section: Ck-1 P27supporting

confidence: 67%

Phase I study of the humanised anti-EGFR monoclonal antibody matuzumab (EMD 72000) combined with gemcitabine in advanced pancreatic cancer

et al. 2006

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“…A correlation between grade of skin toxicity and outcome was reported. Better response rate, progression free survival and survival were achieved in the Cetuximab arm compared to classic schedule [30,31].…”

Section: Introductionmentioning

confidence: 96%

Assessment of Tumor Response and Resection Rates in Unresectable Colorectal Liver Metastases Following Neoadjuvant Chemotherapy with Cetuximab

Somashekhar

Ashwin

Zaveri

et al. 2015

Indian J Surg Oncol

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To investigate efficacy and safety of cetuximab combined with neo adjuvant chemotherapy regimen in patients with unresectable colorectal liver. This was a prospective trial with rate of Ro liver metastases resection as primary end point. Between January 2010 and December 2014, 46 patients with unresectable liver metastases from colon or rectum were enrolled. Patients received Cetuximab along with neoadjuvant chemotherapy where 34 (74 %) and 12 (26 %) patients received FOLFOX and FOLFIRI, respectively. They were assessed for response after 2-3 cycles by CT scan. Patients with resectable disease were offered liver surgery within 3-6 weeks of the last treatment cycle. The primary end point was resection rate of liver metastases, which was evaluated in all patients. Secondary end points were response rate according to Response evaluation criteria in solid tumors (RECIST) criteria, perioperative morbidity and mortality. An objective response was observed in 28 (60.9 %) patients. Seven (15.2 %) patients were reported radiologically to have a complete response (CR); 21 (45.7 %) patients had radiological partial response (PR). An additional 12 patients (26.1 %) demonstrated stable disease (SD) and only six patients (13.0 %) had disease progression (PD). Microscopically complete resections (R0 resection) was performed in all 28 patients (60.9 %). The most frequent toxicities were skin rash and diarrhoea. There was no operative mortality. Chemotherapy with cetuximab yields high response rates compared with historical controls, and leads to significantly increased resectability. Complete resection of previously unresectable colorectal liver metastases can be performed with minimal morbidity and mortality. This therapeutic strategy involves a multimodal approach.

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“…Furthermore, gefitinib monotherapy has not produced significant clinical activity in patients with advanced refractory gastric cancer (148). However, pharmacodynamic data Improved objective response rates in second-line (186) Progression-free survival and overall survival benefit vs placebo (79,187) Minimal clinical activity in heavily pretreated patients (188) Minimal clinical activity in first-line (189) No clear clinical activity in pretreated patients however, increased disease stabilization suggests benefit (190) No significant clinical activity (98) Clinical activity as second-line treatment (92) Suggested increased activity in combination with gemcitabine as first-line treatment (97) Clinical activity in combination with platinum as second-line treatment (93) Increase in response rate, suggested survival advantage with the addition of cetuximab to cisplatin as first-line treatment (194) Clinical activity as first-line treatment (130) Survival advantage vs chemotherapy alone (gemcitabine) in first-line treatment (120) Minimal clinical activity (142) Minimal clinical activity (147) Minimal clinical activity (141) Clinical activity reported (139) Suggested increased activity combined with chemotherapy (docetaxel) as first-line treatment (146) The Role of VEGF and EGFR Inhibition…”

Section: Egfr Inhibitionmentioning

confidence: 99%

The Role of VEGF and EGFR Inhibition: Implications for Combining Anti–VEGF and Anti–EGFR Agents

Tabernero

2007

Molecular Cancer Research

383

266

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Cetuximab, a Monoclonal Antibody Targeting the Epidermal Growth Factor Receptor, in Combination With Gemcitabine for Advanced Pancreatic Cancer: A Multicenter Phase II Trial

Abstract: Cetuximab in combination with gemcitabine showed promising activity against advanced pancreatic cancer. Further clinical investigation is warranted.

Cited by 436 publications

References 25 publications

Phase I study of the humanised anti-EGFR monoclonal antibody matuzumab (EMD 72000) combined with gemcitabine in advanced pancreatic cancer

Phase I study of the humanised anti-EGFR monoclonal antibody matuzumab (EMD 72000) combined with gemcitabine in advanced pancreatic cancer

Assessment of Tumor Response and Resection Rates in Unresectable Colorectal Liver Metastases Following Neoadjuvant Chemotherapy with Cetuximab

The Role of VEGF and EGFR Inhibition: Implications for Combining Anti–VEGF and Anti–EGFR Agents

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