OC-0331: Cetuximab versus Platinum-based Chemoradiation in Locally Advanced p16 Positive Oropharyngeal Cancer

Barney, C.; Walston, Steve; Zamora, Pablo Conesa; Nolan, Nicholas G.; Diavolitsis, V.M.; Blakaj, D.; Wobb, Jessica; Mitchell, D.; Grecula, J.C.; Savvides, P.; Bhatt, Aditi

doi:10.1016/s0167-8140(17)30773-9

Cited by 4 publications

(3 citation statements)

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“…Because of retrospective studies from comparable patient groups and settings indicating inferior disease control of RT plus cetuximab compared with RT plus cisplatin, 9 an unplanned interim analysis was performed by the study's independent safety data monitoring committee. Following their recommendation, patient inclusion was prematurely closed in March 2018.…”

Section: Introductionmentioning

confidence: 99%

ARTSCAN III: A Randomized Phase III Study Comparing Chemoradiotherapy With Cisplatin Versus Cetuximab in Patients With Locoregionally Advanced Head and Neck Squamous Cell Cancer

Gebre‐Medhin

Brun

Engström

et al. 2021

JCO

116

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PURPOSE We performed an open-label randomized controlled phase III study comparing treatment outcome and toxicity between radiotherapy (RT) with concomitant cisplatin versus concomitant cetuximab in patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC; stage III-IV according to the Union for International Cancer Control TNM classification, 7th edition). MATERIALS AND METHODS Eligible patients were randomly assigned 1:1 to receive either intravenous cetuximab 400 mg/m2 1 week before start of RT followed by 250 mg/m2/wk, or weekly intravenous cisplatin 40 mg/m2, during RT. RT was conventionally fractionated. Patients with T3-T4 tumors underwent a second random assignment 1:1 between standard RT dose 68.0 Gy to the primary tumor or dose escalation to 73.1 Gy. Primary end point was overall survival (OS) evaluated using adjusted Cox regression analysis. Secondary end points were locoregional control, local control with dose-escalated RT, pattern of failure, and adverse effects. RESULTS Study inclusion was prematurely closed after an unplanned interim analysis when 298 patients had been randomly assigned. At 3 years, OS was 88% (95% CI, 83% to 94%) and 78% (95% CI, 71% to 85%) in the cisplatin and cetuximab groups, respectively (adjusted hazard ratio, 1.63; 95% CI, 0.93 to 2.86; P = .086). The cumulative incidence of locoregional failures at 3 years was 23% (95% CI, 16% to 31%) compared with 9% (95% CI, 4% to 14%) in the cetuximab versus the cisplatin group (Gray’s test P = .0036). The cumulative incidence of distant failures did not differ between the treatment groups. Dose escalation in T3-T4 tumors did not increase local control. CONCLUSION Cetuximab is inferior to cisplatin regarding locoregional control for concomitant treatment with RT in patients with locoregionally advanced HNSCC. Additional studies are needed to identify possible subgroups that still may benefit from concomitant cetuximab treatment.

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Section: Introductionmentioning

confidence: 99%

ARTSCAN III: A Randomized Phase III Study Comparing Chemoradiotherapy With Cisplatin Versus Cetuximab in Patients With Locoregionally Advanced Head and Neck Squamous Cell Cancer

Gebre‐Medhin

Brun

Engström

et al. 2021

JCO

116

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“…One such phase III study was ARTSCAN III [9] , comparing Cetuximab-RT with CCRT with weekly cisplatin (40 mg/m 2 ). Even before the planned analysis, the study was prematurely closed as results of contemporary retrospective study [29] was published that showed inferiority of Cetuximab-RT regimen. The comparative arm in this study used 40 mg/m 2 dose of weekly Cisplatin with standard Dose RT.…”

Section: Evolution Of the Clinical Use Of Brtmentioning

confidence: 99%

The dogma of Cetuximab and Radiotherapy in head and neck cancer – A dawn to dusk journey

Krishnamurthy¹,

Ahmed²,

Bhise³

et al. 2022

Clinical and Translational Radiation Oncology

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“…For example, the H1 for the recently published ARTSCAN III trial [11] posited a 10% higher 5-year OS for cetuximab versus cisplatin which was based on one trial of cetuximab compared to radiotherapy-alone [12] without considering the effect from concurrent chemotherapy (CCRT) [13]. However, after the trial initiation, the authors responded to emerging evidence showing inferior outcome of cetuximab-radiation versus chemoradiation [14], prompting an unplanned interim analysis that resulted in early trial termination due to inferior outcomes in the intervention (cetuximab-radiotherapy) arm.…”

Section: Superior Non-inferiority and Equivalence Trialsmentioning

confidence: 99%

Statistical fundamentals on cancer research for clinicians: Working with your statisticians

Huang

et al. 2021

Clinical and Translational Radiation Oncology

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To facilitate understanding statistical principles and methods for clinicians involved in cancer research. Methods: An overview of study design is provided on cancer research for both observational and clinical trials addressing study objectives and endpoints, superiority tests, non-inferiority and equivalence design, and sample size calculation. The principles of statistical models and tests including contemporary standard methods of analysis and evaluation are discussed. Finally, some statistical pitfalls frequently evident in clinical and translational studies in cancer are discussed. Results: We emphasize the practical aspects of study design (superiority vs non-inferiority vs equivalence study) and assumptions underpinning power calculations and sample size estimation. The differences between relative risk, odds ratio, and hazard ratio, understanding outcome endpoints, purposes of interim analysis, and statistical modeling to minimize confounding effects and bias are also discussed. Conclusion: Proper design and correctly constructed statistical models are critical for the success of cancer research studies. Most statistical inaccuracies can be minimized by following essential statistical principles and guidelines to improve quality in research studies.

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OC-0331: Cetuximab versus Platinum-based Chemoradiation in Locally Advanced p16 Positive Oropharyngeal Cancer

Cited by 4 publications

References 0 publications

ARTSCAN III: A Randomized Phase III Study Comparing Chemoradiotherapy With Cisplatin Versus Cetuximab in Patients With Locoregionally Advanced Head and Neck Squamous Cell Cancer

ARTSCAN III: A Randomized Phase III Study Comparing Chemoradiotherapy With Cisplatin Versus Cetuximab in Patients With Locoregionally Advanced Head and Neck Squamous Cell Cancer

The dogma of Cetuximab and Radiotherapy in head and neck cancer – A dawn to dusk journey

Statistical fundamentals on cancer research for clinicians: Working with your statisticians

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