Conventional fractionation versus quad shot in advanced head-and-neck cancers: A randomized controlled trial

Choudhary, Akansha; Gupta, Ajay

doi:10.4103/ijpc.ijpc_209_18

Cited by 8 publications

(9 citation statements)

References 28 publications

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“…A total of 225 published trials, representing 24 281 patients, and 67 trial registrations met the general eligibility criteria (eAppendix 2 in the Supplement ). Among the published trials, 116 trials 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 ,…”

Section: Resultsmentioning

confidence: 99%

“…Among the published trials, 116 trials 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 ,…”

Section: Resultsunclassified

“…A total of 225 published trials, representing 24 281 patients, and 67 trial registrations met the general eligibility criteria (eAppendix 2 in the Supplement). Among the published trials, 116 trials (52%) used PROs. PROs were primary end points in 45 trials (20% of all published trials; 31% of 145 trials clearly stating their primary end point; 39% of 116 trials including a PRO) and secondary end points in 71 trials (31% of all published trials; 61% of trials including a PRO).…”

Section: Resultsmentioning

confidence: 99%

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Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

et al. 2022

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ImportanceApproximately 50% of all patients with cancer have an indication for radiotherapy, and approximately 50% of radiotherapy is delivered with palliative intent, with the aim of alleviating symptoms. Symptoms are best assessed by patient-reported outcomes (PROs), yet their reliable interpretation requires adequate reporting in publications.ObjectiveTo investigate the use and reporting of PROs in clinical trials of palliative radiotherapy.Evidence ReviewThis preregistered systematic review searched PubMed/Medline, EMBASE, and the Cochrane Center Register of Controlled Trials for clinical trials of palliative radiotherapy published from 1990 to 2020. Key eligibility criteria were palliative setting, palliative radiotherapy as treatment modality, and clinical trial design (per National Institutes of Health definition). Two authors independently assessed eligibility. Trial characteristics were extracted and standard of PRO reporting was assessed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. The association of the year of publication with the use of PROs was assessed by logistic regression. Factors associated with higher CONSORT-PRO adherence were analyzed by multiple regression. This study is reported following the PRISMA guidelines.FindingsAmong 7377 records screened, 225 published clinical trials representing 24 281 patients were eligible. Of these, 45 trials (20%) used a PRO as a primary end point and 71 trials (31%) used a PRO as a secondary end point. The most prevalent PRO measures were the Numeric Rating Scale/Visual Analogue Scale (38 trials), European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (32 trials), and trial-specific unvalidated measures (25 trials). A more recent year of publication was significantly associated with a higher chance of PROs as a secondary end point (odds ratio [OR], 1.04 [95% CI, 1.00-1.07]; P = .03) but not as primary end point. Adherence to CONSORT-PRO was poor or moderate for most items. Mean (SD) adherence to the extension adherence score was 46.2% (19.6%) for trials with PROs as primary end point and 31.8% (19.8%) for trials with PROs as a secondary end point. PROs as a primary end point (regression coefficient, 9.755 [95% CI, 2.270-17.240]; P = .01), brachytherapy as radiotherapy modality (regression coefficient, 16.795 [95% CI, 5.840-27.751]; P = .003), and larger sample size (regression coefficient, 0.028 [95% CI, 0.006-0.049]; P = .01) were significantly associated with better PRO reporting per extension adherence score.Conclusions and RelevanceIn this systematic review of palliative radiotherapy trials, the use and reporting of PROs had room for improvement for future trials, preferably with PROs as a primary end point.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsunclassified

“…A total of 225 published trials, representing 24 281 patients, and 67 trial registrations met the general eligibility criteria (eAppendix 2 in the Supplement). Among the published trials, 116 trials (52%) used PROs. PROs were primary end points in 45 trials (20% of all published trials; 31% of 145 trials clearly stating their primary end point; 39% of 116 trials including a PRO) and secondary end points in 71 trials (31% of all published trials; 61% of trials including a PRO).…”

Section: Resultsmentioning

confidence: 99%

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Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

et al. 2022

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“…Hypofractionated radiation has been found to be effective in combination with anti-PD-1 therapy in the treatment of head and neck carcinoma (28)(29)(30)(31). Neoadjuvant QUAD shot radiation has also been observed to downstage cancer of the oral cavity prior to definitive surgery in case series (32).…”

Section: Discussionmentioning

confidence: 99%

Case report: The power of immunotherapy in advanced cutaneous squamous cell carcinoma

et al. 2023

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We describe the case of a neglected cutaneous squamous cell carcinoma with extensive facial involvement. The patient is a male in his late 70s who presented to dermatology with a large destructive facial mass that had increased in size gradually over 3 years and then rapidly proliferated, consuming a large portion of his left maxillofacial region. While the immediate reaction was referral to hospice care, medical oncology recommended treatment with cemiplimab, an immune checkpoint inhibitor. Collaboration with multiple providers facilitated the delivery of a multidisciplinary approach utilizing immunotherapy with QUAD shot radiotherapy. The immunotherapy treatment resulted in a dramatic disease regression, but the large facial anatomical defect caused by the carcinoma remained. The patient is undergoing reconstructive surgeries. This case illustrates the potential for significant response with immune checkpoint inhibitors delivered in combination with cyclical hypofractionated radiation therapy for patients with cutaneous squamous cell carcinoma, even in very advanced disease.

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“…Studies show that with even one cycle of Quad-Shot, patients may achieve approximately 55% palliation, with almost 90% reduction in symptoms with 3 cycles [ 9 , 20 , 21 ]. Additionally, the tumor response rates and decreased toxicity with Quad-Shot are comparable to conventional hypofractionated palliative RT (30 Gy/10 fractions/2 weeks) [ 22 ].…”

Section: Discussionmentioning

confidence: 99%

Pathologic complete response following low-dose radiation for advanced oral cavity cancer in a patient with human immunodeficiency virus

Leming

Johnston

Krempl

et al. 2022

Journal of Otolaryngology - Head & Neck Surgery

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Background Advanced squamous cell carcinoma (SCCa) of the oral cavity is often not amenable to curative-intent therapy due to tumor location, tumor size, or comorbidities. Case presentation A 51-year-old male patient with human immunodeficiency virus and on highly active antiretroviral therapy (HAART) presented with a cT4aN2c SCCa of the tongue. He received a preoperative single course of Quad-Shot radiation therapy to 14 Gy in 4 fractions followed by surgical resection. Patient had no residual carcinoma on surgical pathology and no evidence of disease on subsequent clinical and radiological exams. Conclusions To our knowledge, this is the first case of pathologic complete response for a patient on HAART following a single cycle of the Quad-Shot regimen for advanced oral cavity SCCa. Protease inhibitors in HAART can induce spontaneous tumor regression via inhibition of proteasome function and activation of apoptosis, and thus act as a cancer therapeutic. Graphical Abstract

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Conventional fractionation versus quad shot in advanced head-and-neck cancers: A randomized controlled trial

Cited by 8 publications

References 28 publications

Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

Use and Reporting of Patient-Reported Outcomes in Trials of Palliative Radiotherapy

Case report: The power of immunotherapy in advanced cutaneous squamous cell carcinoma

Pathologic complete response following low-dose radiation for advanced oral cavity cancer in a patient with human immunodeficiency virus

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