Preoperative chemotherapy in advanced resectable OCSCC: long-term results of a randomized phase III trial

Bossi, Paolo; Vullo, Salvatore Lo; Guzzo, Marco; Mariani, Luigi; Granata, Roberta; Orlandi, Ester; Locati, Laura D.; Scaramellini, G.; Fallai, C.; Licitra, Lisa

doi:10.1093/annonc/mdt555

Cited by 104 publications

(94 citation statements)

References 23 publications

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“…Nos dois grupos, os pacientes com características tumorais de alto risco para recidiva (margens cirúrgicas positivas e/ou extravasamento extracapsular e/ou mais de três linfonodos cervicais metastáticos e/ou invasão de partes moles da face) foram submetidos à radioterapia adjuvante (101,107) . No segundo estudo, 256 pacientes foram alocados aleatoriamente para receber quimioterapia de indução com três drogas (docetaxel, cisplatina e 5-fluorouracil) seguida por cirurgia radical ou cirurgia radical.…”

Section: Discussionunclassified

“…Os gráficos de comparação da metanálise entre os dois grupos não apresentaram diferença na recorrência locorregional, na sobrevida livre de doença e na sobrevida global em dois anos de seguimento. Além disso, após 5 e 10 anos de seguimento, Bossi et al (107) demonstraram resultados semelhantes no que se refere a esses desfechos clínicos. Nenhuma análise estatística foi realizada no que diz respeito à toxicidade nessa metanálise pela falta de homogeneidade das informações apresentadas nos estudos incluídos.…”

Section: Discussionunclassified

“…Considerou-se e discutiu-se os resultados dessas análises em comparação com os resultados globais. (107) , Licitra et al 2003 (101) e Zhong et al 2013 (103) ].…”

Section: Análise De Sensibilidadeunclassified

“…e Bossi et al (107) mostraram 37% de toxicidade grave (grau 3 ou 4) e três mortes relacionadas com a quimioterapia de indução.…”

Section: Sítio Tumoral N -(%)unclassified

“…O Quadro 2 apresenta as toxicidades observadas durante a quimioterapia de indução. (105) , ambos os estudos (101,107) foram classificados como tendo baixo risco de viés. …”

Section: Sítio Tumoral N -(%)unclassified

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Quimioterapia de indução seguida de cirurgia com ou sem radioterapia adjuvante para pacientes com diagnóstico de câncer de cavidade oral: revisão sistemática e metanálise

Marta¹

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Section: Discussionunclassified

“…Considerou-se e discutiu-se os resultados dessas análises em comparação com os resultados globais. (107) , Licitra et al 2003 (101) e Zhong et al 2013 (103) ].…”

Section: Análise De Sensibilidadeunclassified

“…e Bossi et al (107) mostraram 37% de toxicidade grave (grau 3 ou 4) e três mortes relacionadas com a quimioterapia de indução.…”

Section: Sítio Tumoral N -(%)unclassified

“…O Quadro 2 apresenta as toxicidades observadas durante a quimioterapia de indução. (105) , ambos os estudos (101,107) foram classificados como tendo baixo risco de viés. …”

Section: Sítio Tumoral N -(%)unclassified

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Quimioterapia de indução seguida de cirurgia com ou sem radioterapia adjuvante para pacientes com diagnóstico de câncer de cavidade oral: revisão sistemática e metanálise

Marta¹

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Neoadjuvant PD-1/PD-L1 Inhibitors for Resectable Head and Neck Cancer

Masarwy

Kampel

Horowitz

et al. 2021

JAMA Otolaryngol Head Neck Surg

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The emerging approach of neoadjuvant immunotherapy for solid cancers has set the ground for the integration of programmed cell death 1 (PD-1)/PD-1 ligand 1 (PD-L1) inhibitors into the neoadjuvant setting of head and neck squamous cell carcinoma (HNSCC) treatment.OBJECTIVE To assess the reported efficacy and safety of neoadjuvant immunotherapy for resectable HNSCC.DATA SOURCES AND STUDY SELECTION Electronic databases, including PubMed (MEDLINE), Embase, the Cochrane Library, and ClinicalTrials.gov were systematically searched for published and ongoing cohort studies and randomized clinical trials that evaluate neoadjuvant immunotherapy for resectable HNSCC. The search results generated studies from 2015 to July 2021.DATA EXTRACTION AND SYNTHESIS Two investigators (R.M. and L.K.) independently identified and extracted articles for potential inclusion. Random and fixed models were used to achieve pooled odds ratios. All results are presented with 95% CIs. Data quality was assessed by means of the Cochrane Collaboration's risk of bias tool. MAIN OUTCOMES AND MEASURESThe primary outcomes were reported efficacy, evaluated by major pathological response and pathological complete response in the primary tumors and lymph nodes separately, and safety, assessed by preoperative grade 3 to 4 treatment-related adverse events and surgical delay rate.RESULTS A total of 344 patients from 10 studies were included. In 8 studies, neoadjuvant immunotherapy only was administered, and the other 2 studies combined immunotherapy with neoadjuvant chemotherapy and/or radiotherapy. The overall major pathological response rate in the primary tumor sites from studies reporting on neoadjuvant immunotherapy only was 9.7% (95% CI, 3.1%-18.9%) and the pathological complete response rate was 2.9% (95% CI, 0%-9.5%). Preoperative grade 3 to 4 treatment-related adverse events were reported at a rate of 8.4% (95% CI, 0.2%-23.2%) and surgical delay at a rate of 0% (95% CI, 0%-0.9%). There was a favorable association of neoadjuvant immunotherapy with all outcome measures. The subgroup analyses did not find one specific anti-PD-1/PD-L1 agent to be superior to another, and the favorable association was demonstrated by either immunotherapy alone or in combination with anti-CTLA-4. CONCLUSIONS AND RELEVANCEIn this systematic review and meta-analysis, neoadjuvant anti-PD-1/PD-L1 immunotherapy for resectable HNSCC was well tolerated and may confer therapeutic advantages implied by histopathological response. Long-term outcomes are awaited.

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Phase III trial of docetaxel cisplatin 5‐fluorouracil induction chemotherapy for resectable oral cancer suggests favorable pathological response as a surrogate endpoint for good therapeutic outcome

Liu

Wang

et al. 2021

Cancer Communications

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Induction chemotherapy has been utilized for decades in locally advanced head and neck squamous cell carcinoma (HNSCC). The docetaxel, cisplatin, 5-fluorouracil (TPF) regimen is the most recommended induction chemotherapy regimen for HNSCC and oral squamous cell carcinoma (OSCC) [1]. However, our initial phase III trial failed to demonstrate a significant survival benefit of TPF induction chemotherapy in patients with locally advanced OSCC [2]. Although the efficacy of TPF induction chemotherapy on the overall prognosis on locally advanced OSCC patients is unclear, it is highly possible that a subset of patients could still obtain better outcomes when treated with TPF induction chemotherapy. As favorable pathological response (FPR) has been considered the most reliable prognostic predictor of induction chemotherapy since the last decade [3], it could be crucial to further confirm whether FPR after induction chemotherapy could predict the survival benefit of OSCC patients. We herein report the final results of our TPF induction chemotherapy trial and evaluate its predictive value in OSCC patients. As previously described [2], 256 locally advanced (T1-2N1-2M0 or T3-4N0-2M0 according to the Union for International Cancer Control [2002]) OSCC patients were enrolled in this prospective, open-labeled, randomized

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Preoperative chemotherapy in advanced resectable OCSCC: long-term results of a randomized phase III trial

Cited by 104 publications

References 23 publications

Quimioterapia de indução seguida de cirurgia com ou sem radioterapia adjuvante para pacientes com diagnóstico de câncer de cavidade oral: revisão sistemática e metanálise

Quimioterapia de indução seguida de cirurgia com ou sem radioterapia adjuvante para pacientes com diagnóstico de câncer de cavidade oral: revisão sistemática e metanálise

Neoadjuvant PD-1/PD-L1 Inhibitors for Resectable Head and Neck Cancer

Phase III trial of docetaxel cisplatin 5‐fluorouracil induction chemotherapy for resectable oral cancer suggests favorable pathological response as a surrogate endpoint for good therapeutic outcome

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