Phase II trial of combination treatment with paclitaxel, carboplatin and cetuximab (PCE) as first-line treatment in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (CSPOR-HN02).

Tahara, Makoto; Kiyota, Naomi; Yokota, Tomoya; Hasegawa, Yasuhisa; Muro, Kei; Takahashi, Shunji; Onoe, Takuma; Homma, Akihiro; Taguchi, Jun; Suzuki, Masami; Minato, Koichi; Yane, Katsunari; Ueda, Shinya; Saijo, Ken; Yamanaka, T.

doi:10.1200/jco.2016.34.15_suppl.6026

Cited by 21 publications

(31 citation statements)

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“…De Mello et al also conducted a retrospective study of 121 patients receiving the EXTREME regimen as first-line treatment in the R/M SCCHN setting (58). Median PFS and OS were 8 and 11 months, respectively, which are also in line with findings for cetuximab plus platinum-based CT in clinical trials (9, 11, 56). Similarly, in a retrospective study of 31 patients with R/M SCCHN, cetuximab plus CT followed by maintenance with biweekly cetuximab led to a stable disease rate of 52%, partial response rate of 39%, and complete response rate of 9% (59).…”

Section: First-line Treatment Options In R/m Scchnsupporting

confidence: 85%

“…Siano et al have also shown benefits of such regimens in a retrospective analysis of 117 patients treated with cetuximab plus platinum-based CT with or without 5-FU in first-line R/M SCCHN (57). The median OS of 12.4 months was in line with OS findings for cetuximab plus platinum-based CT in clinical trials (9, 11, 56). Median PFS and OS during follow-up second-line treatment with methotrexate, paclitaxel, or other agents were between 2.6 and 6.1 months, showing the need for stronger options in later-line treatments of R/M SCCHN.…”

Section: First-line Treatment Options In R/m Scchnsupporting

confidence: 82%

“…In the DIRECT study, prospective data were collected for 154 patients with untreated SCCHN in the R/M setting receiving cetuximab according to the EXTREME regimen guidelines (53). The EXTREME regimen was shown to be feasible in everyday clinical practice and yielded a median time to progression of 6 months, which is in line with PFS findings in the EXTREME study (9, 11, 56). Siano et al have also shown benefits of such regimens in a retrospective analysis of 117 patients treated with cetuximab plus platinum-based CT with or without 5-FU in first-line R/M SCCHN (57).…”

Section: First-line Treatment Options In R/m Scchnsupporting

confidence: 79%

“…Over the past decade, retrospective and observational studies have consistently confirmed the benefits of the EXTREME regimen in patients with first-line R/M SCCHN (9, 11, 56). In the DIRECT study, prospective data were collected for 154 patients with untreated SCCHN in the R/M setting receiving cetuximab according to the EXTREME regimen guidelines (53).…”

Section: First-line Treatment Options In R/m Scchnmentioning

confidence: 93%

“…In the first-line treatment of R/M SCCHN, combination therapy with cetuximab plus cisplatin/carboplatin plus 5-fluorouracil (5-FU) followed by maintenance cetuximab (the “EXTREME” regimen) has shown the best results so far in terms of overall response rate (ORR), progression-free survival (PFS), and OS (8, 9). A variation on this regimen allows for the substitution of 5-FU for a taxane (e.g., docetaxel or paclitaxel) (10, 11). In clinical practice, other combinations, such as a taxane or cisplatin plus cetuximab, are also sometimes used as first-line treatment for R/M SCCHN when patients are not fit enough for the EXTREME regimen, even though these are not evidence-based approaches.…”

Section: Introductionmentioning

confidence: 99%

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Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

et al. 2017

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The major development of the past decade in the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) was the introduction of cetuximab in combination with platinum plus 5-fluorouracil chemotherapy (CT), followed by maintenance cetuximab (the “EXTREME” regimen). This regimen is supported by a phase 3 randomized trial and subsequent observational studies, and it confers well-documented survival benefits, with median survival ranging between approximately 10 and 14 months, overall response rates between 36 and 44%, and disease control rates of over 80%. Furthermore, as indicated by patient-reported outcome measures, the addition of cetuximab to platinum-based CT leads to a significant reduction in pain and problems with social eating and speech. Conversely, until very recently, there has been a lack of evidence-based second-line treatment options, and the therapies that have been available have shown low response rates and poor survival outcomes. Presently, a promising new treatment option in R/M SCCHN has emerged: immune checkpoint inhibitors (ICIs), which have demonstrated favorable results in second-line clinical trials. Nivolumab and pembrolizumab are the first two ICIs that were approved by the US Food and Drug Administration. We note that the trials that showed benefit with ICIs included not only patients who previously received ≥1 platinum-based regimens for R/M SCCHN but also patients who experienced recurrence within 6 months after combined modality therapy with a platinum agent for locally advanced disease. In this review, we outline the available clinical and observational evidence for the EXTREME regimen and the initial results from clinical trials for ICIs in patients with R/M SCCHN. We propose that these treatment options can be integrated into a new continuum of care paradigm, with first-line EXTREME regimen followed by second-line ICIs. A number of ongoing clinical trials are comparing regimens with ICIs, alone and in combination with other ICIs or CT, with the EXTREME regimen for first-line treatment of R/M SCCHN. As we eagerly await the results of these trials, the EXTREME regimen remains the standard of care for the first-line treatment of R/M SCCHN.

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Section: First-line Treatment Options In R/m Scchnsupporting

confidence: 85%

Section: First-line Treatment Options In R/m Scchnsupporting

confidence: 82%

Section: First-line Treatment Options In R/m Scchnsupporting

confidence: 79%

Section: First-line Treatment Options In R/m Scchnmentioning

confidence: 93%

Section: Introductionmentioning

confidence: 99%

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Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

et al. 2017

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Efficacy and toxicity of weekly paclitaxel, carboplatin, and cetuximab as induction chemotherapy or in cases of metastases or relapse for head and neck cancer with a focus on elderly or frail patients

et al. 2022

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Background: Paclitaxel, carboplatin, and cetuximab (PCC) has shown promise as induction chemotherapy and in patients with metastatic/recurrent head and neck cancer (HNC). Given its tolerability, the regimen is used in frail and elderly patients.Methods: Software generated the cohort of adult patients with HNC treated with PCC in 2014-2019. Modified RECIST response rate (RR), progression-free survival (PFS), and overall survival (OS) were calculated for the metastatic/ recurrent group, and successful induction rate and RR for the induction group. These were also calculated in the elderly/frail subset (EF): age ≥75, performance status ≥2, albumin <3.5. Results: Fifty-two percent of patients experienced ≥grade 3 toxicities. For metastatic/recurrent disease (N = 58), RR was 22%, mean PFS was 7.1 months.Mean OS was 15.2 months. In the induction cohort (N = 22), 86% reached their endpoint. The RR was 64%. There were no significant differences for EF.Conclusions: PCC is well-tolerated with good induction success rate and reasonable PFS/OS in metastatic/recurrent disease.head and neck cancer, geriatric oncology, induction chemotherapy, metastatic/recurrent head and neck cancer, chemotoxicity

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Therapy of head and neck cancer in China: Introduction to the special issue

Guo

2022

Head & Neck

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Phase II trial of combination treatment with paclitaxel, carboplatin and cetuximab (PCE) as first-line treatment in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (CSPOR-HN02).

Cited by 21 publications

References 0 publications

Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Evidence-Based Treatment Options in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Efficacy and toxicity of weekly paclitaxel, carboplatin, and cetuximab as induction chemotherapy or in cases of metastases or relapse for head and neck cancer with a focus on elderly or frail patients

Therapy of head and neck cancer in China: Introduction to the special issue

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