Concurrent Cetuximab, Cisplatin, and Concomitant Boost Radiotherapy for Locoregionally Advanced, Squamous Cell Head and Neck Cancer: A Pilot Phase II Study of a New Combined-Modality Paradigm

Pfister, David G.; Su, Yungpo Bernard; Kraus, Dennis H.; Wolden, Suzanne L.; Lis, Eric; Aliff, Timothy B.; Zahalsky, Andrew J.; Lake, Simone; Needle, Michael N.; Shaha, Ashok R.; Shah, Jatin P.; Zeléfsky, Michael J.

doi:10.1200/jco.2004.00.1792

Cited by 292 publications

(188 citation statements)

References 32 publications

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“…In contrast, the optimisation of the cisplatin -irinotecan -radiotherapy regimen could be potentially feasible. Epidermal growth factor receptor (EGFr) antibody or inhibitor could also increase the efficacy of the regimen: first by improving the therapeutic effect of irinotecan via EGFr antibodies as demonstrated in vitro (Prewett et al, 2002), second by the specific approach as demonstrated in head and neck cancer, by using radiation therapy and EGF receptor antibodies (Bonner et al, 2006;Pfister et al, 2006). The association cisplatinirinotecan -radiotherapy with EGFr antibody warrants further study.…”

Section: Discussionmentioning

confidence: 99%

Induction cisplatin–irinotecan followed by concurrent cisplatin–irinotecan and radiotherapy without surgery in oesophageal cancer: multicenter phase II FFCD trial

et al. 2006

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A recent phase I study showed that weekly cisplatin, irinotecan and concurrent radiotherapy can be administered with moderate toxicity in patients with oesophageal cancer. Patients with no prior treatment and oesophageal cancer stage I to III, performance status o3, caloric intake 41500 kcal day À1 were included. Chemotherapy, with cisplatin 30 mg m À2 and irinotecan 60 mg m À2 , was administered at days 1, 8, 22, 29, and concurrently with radiotherapy at days 43, 50, 64 and 71. Radiotherapy was delivered with 50 or 50.4 Gy in 25 fractions/5 weeks. Forty-three patients were included, 10 stage I, 19 stage II and 14 stage III. Mean age was 59.2 years (range 44 -79). A total of 30 out of 43 (69.8%) patients underwent all planned treatment. During induction chemotherapy, 14 severe toxicities of grade 3 or 4 in 10 patients (23.3%) were reported with 57.1% due to haematoxicity. During chemoradiotherapy, 31 severe toxicities of grade 3 or 4 with 64.5% due to haematotoxicity were reported in 18 patients. One toxic death occurred (diarrhoea grade 4). The complete clinical response rate was 58.1% (95% CI: 43.4 -72.8%). Overall survival rate at 1 and 2 years was 62.8%, (95% CI, 58.3 -77.3%) and 27.9% (95% CI, 13.4 -41.3%), respectively. In conclusion, cisplatin -irinotecan -radiotherapy is an active and well-tolerated regimen feasible in out-patients.

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Section: Discussionmentioning

confidence: 99%

Induction cisplatin–irinotecan followed by concurrent cisplatin–irinotecan and radiotherapy without surgery in oesophageal cancer: multicenter phase II FFCD trial

et al. 2006

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“…A pilot phase II study of concurrent cetuximab, cisplatin and concomitant boost radiotherapy for locoregionally advanced SCCHN patients (n ¼ 32) reported a 3-year OS of 75%, PFS of 56% and a locoregional control rate of 71%. However, the study was closed for significant AEs including two deaths (Pfister et al, 2006). A randomised phase III study compared radiation with or without cetuximab for patients with locally advanced inoperable SCCHN patients (Bonner et al, 2006).…”

Section: Anti-egfr Mabsmentioning

confidence: 99%

Targeting EGF-receptor-signalling in squamous cell carcinomas of the head and neck

2007

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Despite significant advances in the use of surgery, chemotherapy and radiotherapy to treat squamous cell carcinoma of the head and neck (SCCHN), prognosis has improved little over the past 30 years. There is a clear need for novel, more effective therapies to prevent relapse, control metastases and improve overall survival. Improved understanding of SCCHN disease biology has led to the introduction of molecularly targeted treatment strategies in these cancers. The epidermal growth factor receptor (EGFR) is expressed at much higher levels in SCCHN tumours than in normal epithelial tissue, and EGFR expression correlates with poor prognosis. Therefore, much effort is currently directed toward targeting aberrant EGFR activity (e.g. cell signalling) in SCCHN. This review discusses the efficacy of novel therapies targeting the EGFR (e.g. anti-EGFR antibodies and EGFR tyrosine kinase inhibitors) that are currently tested in SCCHN patients.

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“…Early phase studies of EGFRIs given concurrently with RT/platinum have demonstrated feasibility and an attendant increase in both expected and unexpected toxicities [45]. A single-arm phase II study of RT/cisplatin/ cetuximab, for example, demonstrated encouraging 3-year OS of 76% and 3-year PFS of 56%, but rates of adverse events (AEs) including myocardial infarction were unacceptably high [46]. When studied in a prospective comparative fashion, as occurred in the RTOG 0522 study, the addition of cetuximab to RT/cisplatin increased toxicity without improving PFS or OS [27].…”

Section: Definitive Therapy For Unresectable Diseasementioning

confidence: 99%

Balancing Safety and Efficacy of Epidermal Growth Factor Receptor Inhibitors in Patients With Squamous Cell Carcinoma of the Head and Neck

Iberri

Colevas

2015

The Oncologist

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The epidermal growth factor receptor (EGFR) is overexpressed in more than 80% of squamous cell cancers of the head and neck (SCCHN). An evolving understanding of the role of EGFR in tumorigenesis has made the receptor an important therapeutic target in SCCHN. Several EGFR inhibitors (EGFRIs) are active in SCCHN, and their use is associated with improvement in progression-free survival and overall survival in various treatment settings. Nevertheless, EGFR inhibition is associated with significant mucocutaneous toxicity that must be balanced against its anticipated efficacy. This review summarizes the relevant clinical trial experience with EGFRIs, with attention to efficacy, toxicity, and methods of selecting patients most likely to benefit from therapy.

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Concurrent Cetuximab, Cisplatin, and Concomitant Boost Radiotherapy for Locoregionally Advanced, Squamous Cell Head and Neck Cancer: A Pilot Phase II Study of a New Combined-Modality Paradigm

Abstract: This regimen is not currently recommended outside of the clinical trial setting. Further investigation of its safety profile is needed. However, preliminary efficacy is encouraging, and further development of this targeted combined-modality paradigm is warranted.

Cited by 292 publications

References 32 publications

Induction cisplatin–irinotecan followed by concurrent cisplatin–irinotecan and radiotherapy without surgery in oesophageal cancer: multicenter phase II FFCD trial

Induction cisplatin–irinotecan followed by concurrent cisplatin–irinotecan and radiotherapy without surgery in oesophageal cancer: multicenter phase II FFCD trial

Targeting EGF-receptor-signalling in squamous cell carcinomas of the head and neck

Balancing Safety and Efficacy of Epidermal Growth Factor Receptor Inhibitors in Patients With Squamous Cell Carcinoma of the Head and Neck

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