Cetuximab-radiotherapy versus cetuximab-radiotherapy plus concurrent chemotherapy in patients with N0-N2a squamous cell carcinoma of the head and neck (SCCHN): Results of the GORTEC 2007-01 phase III randomized trial.

Bourhis, Jean; Sun, Xu; Siré, C.; Tao, Yungan; Martin, Laurent; Khoury, C.; Maingon, P.; Bardet, É.; Lapeyre, M.; Chatellier, Thierry; Ollivier, Nathalie; Cornely, A.; Aupérin, Anne

doi:10.1200/jco.2016.34.15_suppl.6003

Cited by 13 publications

(8 citation statements)

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“…In a preliminary report, the carboplatin/5-fluorouracil arm had significantly higher locoregional control and progression-free survival than the cetuximab-only arm. 27 Taken together, the results from those 2 trials suggest the nonequivalence of cetuximab-based and platinum-based therapy.…”

Section: Discussionmentioning

confidence: 98%

“…The reciprocal question of platinum added to a cetuximab backbone was investigated in the French Head and Neck Oncology and Radiotherapy Group (GORTEC) 2007‐01 trial, in which patients with stage III through IVB disease who had relatively low lymph node burden (N0‐N2a) and received RT plus cetuximab were randomized to groups that did or did not receive carboplatin/5‐fluorouracil. In a preliminary report, the carboplatin/5‐fluorouracil arm had significantly higher locoregional control and progression‐free survival than the cetuximab‐only arm . Taken together, the results from those 2 trials suggest the nonequivalence of cetuximab‐based and platinum‐based therapy.…”

Section: Discussionmentioning

confidence: 98%

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Survival of patients with head and neck cancer treated with definitive radiotherapy and concurrent cisplatin or concurrent cetuximab: A Surveillance, Epidemiology, and End Results‐Medicare analysis

Xiang

Holsinger

Colevas

et al. 2018

Cancer

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Background Cisplatin and cetuximab are both systemic therapies commonly used in combination with radiation (RT) for the definitive treatment of head and neck cancers, but their comparative efficacy is unclear. Methods Patients with locoregionally advanced (American Joint Committee on Cancer stage III‐IVB) squamous cell carcinomas of the oropharynx, larynx, or hypopharynx were identified in the Surveillance, Epidemiology, and End Results‐Medicare database. Patients received either cisplatin or cetuximab concurrent with RT, as determined by Medicare claims. The primary study outcome was head and neck cancer‐specific mortality (CSM) analyzed with competing risks. Filtering, propensity score matching, and multivariable Fine‐Gray regression were used to adjust for differences between the cisplatin and cetuximab cohorts, including age, comorbidity, and cycles of systemic therapy received. Results The total cohort consisted of 1395 patients, of whom 786 (56%) received cisplatin and 609 (44%) received cetuximab; the median follow‐up was 3.5 years in the patients who remained alive. In the cetuximab cohort, CSM was significantly higher than in the cisplatin cohort (39% vs 25% at 3 years; P < .0001). In the matched cohorts (n = 414), the adjusted hazard ratio of CSM for cetuximab was 1.65 (95% confidence interval, 1.30‐2.09; P < .0001) relative to cisplatin, corresponding to an absolute difference of approximately 10% in both CSM and overall survival at 3 years. Cetuximab was associated with less dysphagia, more dermatitis, and a similar incidence of mucositis. Conclusions In this sizeable, national patient population, treatment with cetuximab was associated with significantly higher CSM than cisplatin. These results suggest that cisplatin may be the preferred chemotherapeutic agent in this setting.

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Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 98%

Survival of patients with head and neck cancer treated with definitive radiotherapy and concurrent cisplatin or concurrent cetuximab: A Surveillance, Epidemiology, and End Results‐Medicare analysis

Xiang

Holsinger

Colevas

et al. 2018

Cancer

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“…In contrast, while the association of an EGFR-directed monoclonal antibody to CCRT does not improve the outcome and increases the toxicity, the addition of chemotherapy to radiotherapy plus cetuximab is associated with an improved PFS and LCR as demonstrated in the GORTEC 2007-01 trial (6) in which 406 patients with nonnasopharyngeal non-metastatic stage III/IV HNSCC with no or limited nodal spread (N0-N2a) were randomized 1:1 between radiotherapy (70 Gy, 2 Gy/day, 5 days/week) plus cetuximab (arm A) and radiotherapy plus cetuximab plus concurrent chemotherapy (three cycles of carboplatin 70 mg/m 2 /d + 5FU 600 mg/m 2 /d d1-4). After a median follow up of 4.4 years, 3-year PFS rate (primary endpoint) was 52.3% in arm B vs. 40.5% in arm A [hazard ratio (HR) =0.73; 95% CI, 0.57-0.94; P=0.015].…”

mentioning

confidence: 97%

“…The OS was not significantly different between both arms (HR =0.80; 95% CI, 0.61-1.05; P=0.11). Mucositis and leucopenia were significantly more frequent in arm B (6). In DAHANCA 19 (7), 619 patients were randomized to receive radiotherapy 68 Gy, 2 Gy/fraction, 6 fractions/week, and concomitant daily nimorazole, and in case of stage III or IV tumors, weekly cisplatin 40 mg/m 2 either with or without zalutumumab.…”

mentioning

confidence: 99%

CONCERT-1, an additional piece in the puzzle of (bio)-(chemo)-radiation

Specenier¹,

Vermorken²

2016

Ann. Transl. Med.

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CONCERT-1 (1) is an international, open-label, randomized, controlled, phase 2 trial, in which 150 patients with previously untreated stage III, IVa, or IVb, locally advanced (LA) non-nasopharyngeal squamous cell carcinoma of the head and neck (HNSCC) from 41 sites in 9 countries were randomly assigned 2:3 to open-label concurrent chemoradiotherapy (CCRT) (three cycles of cisplatin 100 mg/m 2) or panitumumab plus CCRT (three cycles of intravenous panitumumab 9.0 mg/kg every 3 weeks plus cisplatin 75 mg/m 2). All patients received 70 Gy to gross tumor and 50 Gy to areas at risk for subclinical disease with standard fractionation. The primary endpoint was local-regional control at 2 years, which was 68% (95% CI, 54-78%) in the CCRT group and 61% (95% CI, 50-71%) in the panitumumab plus CCRT group. The most frequent grade 3/4 adverse events were dysphagia (27% with CCRT vs. 40% with CCRT plus panitumumab), mucositis (24% vs. 55%) and radiodermatitis (13% vs. 31%). Serious adverse events were also more common in the CCRT plus panitumumab group (32% with CCRT vs. 43% in the CCRT plus panitumumab group). Median radiation therapy relative dose intensity in patients receiving CCRT was 69%, representing a median of 70 Gy (IQR 70-70) over a median of 51 days (IQR 49-53), and 66% [representing a median of 70 Gy (IQR 70-70) over a median of 52 days (IQR 50-57)] for patients receiving panitumumab plus CCRT. Major radiation therapy deviations occurred in 8% of the patients receiving CCRT and in 14% of the patients receiving CCRT plus panitumumab. Treatment interruptions greater than ten cumulative days occurred in 3% and 16% of the patients, respectively. Although this was a phase 2 trial with a sample

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“…The largest of these preliminary studies, the RTOG 0522, shows that cetuximab plus cisplatin, in comparison to cisplatin alone, yields increased acute toxicities, more frequent radiotherapy interruption, and no survival benefits [26]. Recently, the GORTEC 2007-01 phase III randomized trial showed that the addition of concomitant chemotherapy to cetuximab-based radiotherapy markedly improved progression-free survival and locoregional control, with a non-significant gain in survival [27]. This study targeted patients with limited locally advanced disease (N0-N2a), mainly HPV negative (65% of the patients had oropharyngeal cancer, but only 20% of them were p16 positive).…”

Section: Monoclonal Antibodiesmentioning

confidence: 99%

Radiotherapy plus EGFR inhibitors: synergistic modalities

Bossi

Platini

2017

Cancers Head Neck

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Locally advanced (stage III or IV) squamous cell carcinoma of the head and neck (SCCHN) often requires multimodal treatment, consisting of a combination of surgery, radiation, and/or systemic therapy, namely chemotherapy or targeted agents. The expression of the epidermal growth factor receptor (EGFR) has been detected in more than 90% of all cases of SCCHN and has been correlated with decreased survival rates, resistance to radiotherapy, loco-regional treatment failure, and increased rates of distant metastases. This paper discusses several strategies aimed at targeting EGFR in combination with radiation. Until now, cetuximab, an anti-EGFR monoclonal antibody, is the only targeted agent that has been shown to improve overall survival in combination with radiation therapy. However, considering that there are multiple mechanisms of primary and acquired resistance to EGFR inhibitors, we focused on dissecting molecular pathways of EGFR inhibition to find alternative or complementary strategies for increasing tumour responsiveness. We suggest that the combination of treatments targeting the EGFR pathway and drugs aimed at increasing immune responses represent a promising approach that deserves to be further explored.

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Cetuximab-radiotherapy versus cetuximab-radiotherapy plus concurrent chemotherapy in patients with N0-N2a squamous cell carcinoma of the head and neck (SCCHN): Results of the GORTEC 2007-01 phase III randomized trial.

Cited by 13 publications

References 0 publications

Survival of patients with head and neck cancer treated with definitive radiotherapy and concurrent cisplatin or concurrent cetuximab: A Surveillance, Epidemiology, and End Results‐Medicare analysis

Survival of patients with head and neck cancer treated with definitive radiotherapy and concurrent cisplatin or concurrent cetuximab: A Surveillance, Epidemiology, and End Results‐Medicare analysis

CONCERT-1, an additional piece in the puzzle of (bio)-(chemo)-radiation

Radiotherapy plus EGFR inhibitors: synergistic modalities

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