Cetuximab and Radiotherapy Versus Cisplatin and Radiotherapy for Locally Advanced Head and Neck Cancer: A Randomized Phase II Trial

Magrini, Stefano Maria; Buglione, Michela; Corvò, Renzo; Pirtoli, Luigi; Paiar, Fabiola; Ponticelli, Pietro; Petrucci, Alessandra; Bacigalupo, Almalina; Crociani, Monica; Lastrucci, Luciana; Vecchio, Stefania; Bonomo, Pierluigi; Pasinetti, Nadia; Triggiani, Luca; Cavagnini, R.; Costa, Loredana; Tonoli, Sandro; Maddalo, Marta; Grisanti, Salvatore

doi:10.1200/jco.2015.63.1671

Cited by 200 publications

(158 citation statements)

References 30 publications

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“…Pryor et al24 reported higher rate of mucosal toxicity in LAHNC patients treated with concurrent cetuximab compared to Bonner trial, and Walsh et al25 reported significantly higher toxicity including OM in concurrent cetuximab arm compared to concurrent cisplatin arm. A recent randomized phase II trial26 also has shown different toxicity profiles between concurrent cisplatin arm vs. concurrent cetuximab arm – hematologic, renal and GI toxicities were more frequent in the cisplatin arm while cutaneous toxicity and need for nutritional support were more frequent in the cetuximab arm – without significant difference in the rate of OM. The results of the large Radiation Therapy Oncology Group 1016 trial with prospective quality of life data collection will hopefully resolve this controversy.…”

Section: Discussionmentioning

confidence: 99%

Feasibility of optimizing intensity‐modulated radiation therapy plans based on measured mucosal dose adjacent to dental fillings and toxicity outcomes

Seol

Aggarwal

Eyben

et al. 2018

J Applied Clin Med Phys

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We prospectively investigated the feasibility of IMRT treatment plan optimization based on dosimeter measurements of lateral tongue mucosal dose adjacent to the dental fillings and evaluated dose‐toxicity relationship and factors affecting oral mucositis (OM) in head and neck cancer patients. Twenty‐nine head and neck cancer patients with metallic dental fillings who were scheduled to undergo fractionated external beam radiation therapy (RT) ± chemotherapy were enrolled. The lateral tongue dose was measured and if the calculated dose for the entire treatment was ≥35 Gy, a re‐plan was generated to reduce the lateral tongue mucosal dose. OM was graded weekly according to Common Terminology Criteria for Adverse Events version 4.0 and the patients completed the Oral Mucositis Weekly Questionnaire‐Head and Neck Cancer. The result showed that it was not feasible to optimize the IMRT plan based on measured tongue dose in most of the patients who needed re‐plan as re‐planning compromised the target coverage in 60% of these patients. The duration of grade (Gr) 2 OM was correlated with measured lateral tongue dose (P = 0.050). Concurrent cetuximab was significantly associated with faster onset of Gr2 OM than concurrent cisplatin (P = 0.006) and with longer duration of OM (P = 0.041) compared to concurrent cisplatin or IMRT‐alone. The pattern of reported pain over time was significantly different for each treatment type (RT and cetuximab, RT and cisplatin and RT‐alone) and depending on the dose level (P = 0.006). In conclusion, optimizing the IMRT plan based on measured lateral tongue dose was not feasible. Measured lateral tongue dose was significantly correlated with longer duration of OM ≥Gr2, and concurrent cetuximab was associated with earlier onset and longer duration of OM ≥Gr2.

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Section: Discussionmentioning

confidence: 99%

Feasibility of optimizing intensity‐modulated radiation therapy plans based on measured mucosal dose adjacent to dental fillings and toxicity outcomes

Seol

Aggarwal

Eyben

et al. 2018

J Applied Clin Med Phys

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“…Badania kliniczne III fazy wskazują na możliwość zastosowania w niedrobnokomórkowym raku płuca także innych przeciwciał blokujących receptor EGF -matuzumab, panitumumab oraz necitumumab [4,46]. Dowiedziono także skuteczności stosowania cetuksymabu w skojarzeniu z radioterapią w nowotworach głowy i szyi (badania II fazy) [50] oraz z terapią neoadjuwantową i radioterapią raka krtani [51]. Panitumumab jest ludzkim, ukierunkowanym wprost przeciwko EGFR, monoklonalnym przeciwciałem klasy IgG 2 , które wykazuje swoje działanie poprzez niekowalencyjne wiązanie z podjednostką wiążącą ligand białka EGFR.…”

Section: Przeciwciała Stosowane W Innych Typach Nowotworów Złośliwychunclassified

Monoclonal antibodies in regulation of signal transduction of Epidermal Growth Factor Receptor (EGFR) pathway in cancer cells

Kampa¹,

Bednarek²,

Sypniewski³

2018

Ann. Acad. Med. Siles.

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ST R ES ZCZ E NI EReceptor naskórkowego czynnika wzrostu EGFR (Epidermal Growth Factor Receptor), ze względu na jego ważny udział w patogenezie nowotworów złośliwych, jest obiektem intensywnych badań naukowych ostatnich lat. W wielu typach nowotworów wewnątrzkomórkowe szlaki sygnalizacyjne pobudzane przez EGFR mają wręcz kluczowe znaczenie w ich rozwoju. Z drugiej strony wykazano, iż EGFR może stanowić bardzo obiecujący punkt uchwytu dla czynników terapeutycznych. Podjęto próby modyfikacji transdukcji sygnału przekazywanego przez aktywny EGFR wewnątrz komórek poprzez blokowanie aktywności elementów tego szlaku bądź samego receptora. Wykazano też, że blokowanie receptora EGFR przez przeciwciała monoklonalne podwyższa efektywność stosowanych w terapii konwencjonalnych czynników przeciwnowotworowych, np. cisplatyny. Dodatkowo opracowano wiele terapii przeciwnowotworowych opierając się na zastosowaniu inhibitorów wybranych, kluczowych składowych szlaku sygnalizacyjnego EGFR, z których wiele bazuje na zastosowaniu przeciwciał monoklonalnych.kancerogeneza, terapia przeciwnowotworowa, transdukcja sygnału, EGFR, przeciwciała monoklonalne

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“…The risk of disease progression was also reduced by 30% (hr: 0.70; 95% ci: 0.54 to 0.90; p = 0.006), and the median duration of locoregional control was significantly longer in the cetuximab group (hr: 0.68; 95% ci: 0.52 to 0.89; p = 0.005) with no difference between the groups in the incidence of grades 3 and 4 toxic effects or quality-of-life scores 18,19 . Those significant survival benefits were not observed in another study that compared the addition of cetuximab or of platin-based chemotherapy to concurrent hyperfractionated radiation therapy 20 .…”

Section: Key Evidence and Qualifying Statementsmentioning

confidence: 99%

“…It is also unclear whether cetuximab is noninferior to ccrt. Cetuximab avoided chemotherapy toxicities but was associated with a high rate of severe mucositis 19 . Compared with standard therapy, other epidermal growth factor receptor inhibitors have not demonstrated a better treatment effect.…”

Section: Key Evidence and Qualifying Statementsmentioning

confidence: 99%

Systemic Therapy in the Curative Treatment of Head-and-Neck Squamous Cell Cancer: Cancer Care Ontario Clinical Practice Guideline

et al. 2017

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Objective The aim of the present work was to make recommendations about the use of systemically administered drugs in combination or in sequence with radiation (rt) or surgery, or both, for cure or organ preservation, or both, in patients with locally advanced nonmetastatic (stages iii-ivb) squamous cell carcinoma of the head and neck (lascchn). MethodsThe Meta-analysis of Chemotherapy in Head and Neck Cancer (mach-nc) reports have, de facto, guided practice since 2000, and so we searched the literature for systematic reviews published from January 2000 to February 2015 in reference to five research questions. A search was also conducted up to February 2015 for randomized trials (rcts) not included in the meta-analyses. Recommendations were constructed using the Cancer Care Ontario Program in Evidence-Based Care practice guidelines development cycle. ResultsIn addition to updated mach-nc reports, five additional meta-analyses and thirty rcts were identified.Five recommendations for lascchn treatment were generated based on those data. Concurrent chemoradiation (ccrt) is recommended to maximize the chance of cure in patients less than 71 years of age when rt is used as definitive treatment. The same recommendation also applies to patients with resected lascchn considered to be at high risk for locoregional recurrence. For lascchn patients who are candidates for organ preservation strategies and would otherwise require total laryngectomy, either ccrt or induction chemotherapy, followed by rt or surgery based on tumour response is recommended. The addition of cetuximab to intensified rt (concomitant boost or hyperfractionated schedule) is an alternative to ccrt. Routine use of induction chemotherapy to improve overall survival is not recommended. ConclusionsWe were able to use high-level evidence from patients receiving rt as definitive or postoperative treatment to generate recommendations for the use of systemic therapy in the treatment of lascchn. A limitation is a lack of stratification for human papillomavirus-related cancers of the oropharynx. One rct provided evidence for the use of cetuximab as an alternative to chemotherapy in the definitive rt setting. Concurrent chemoradiation provides one strategy for larynx preservation, but the best strategy is unclear. Use of induction chemotherapy does not improve overall survival, and its use should be limited to patients requiring immediate tumour downsizing before local therapy.

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Cetuximab and Radiotherapy Versus Cisplatin and Radiotherapy for Locally Advanced Head and Neck Cancer: A Randomized Phase II Trial

Abstract: CTX concomitant to RT lowered compliance and increased acute toxicity rates. Efficacy outcomes were similar in both arms. These results raise the issue of appropriately selecting patients with head and neck cancer who can benefit from CTX in combination with RT.

Cited by 200 publications

References 30 publications

Feasibility of optimizing intensity‐modulated radiation therapy plans based on measured mucosal dose adjacent to dental fillings and toxicity outcomes

Feasibility of optimizing intensity‐modulated radiation therapy plans based on measured mucosal dose adjacent to dental fillings and toxicity outcomes

Monoclonal antibodies in regulation of signal transduction of Epidermal Growth Factor Receptor (EGFR) pathway in cancer cells

Systemic Therapy in the Curative Treatment of Head-and-Neck Squamous Cell Cancer: Cancer Care Ontario Clinical Practice Guideline

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