A randomized trial comparing radiotherapy alone versus radiotherapy with Geftinib in locally advance oral cavity cancer

Singh, Pramod Kumar; Dixit, Ashwini Kumar; Prashad, SN; Saxena, Tripti; Shahoo, DP; Sharma, Deepti

doi:10.4103/2278-0513.110768

Cited by 5 publications

(20 citation statements)

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“…Results of the overall “Risk of Bias” assessment are displayed in Figure 2(a) and a summary of the risk of bias for each included trial was displayed in Figure 2(b). All included studies stated that they were “randomized.” Three trials [12, 13, 15] described an adequate random sequence generation process only, and one trial [16] performed imbalanced randomization. Allocation was adequately concealed in two studies [12, 16], and the remaining five studies did not report the method of allocation concealment.…”

Section: Resultsmentioning

confidence: 99%

“…All included studies stated that they were “randomized.” Three trials [12, 13, 15] described an adequate random sequence generation process only, and one trial [16] performed imbalanced randomization. Allocation was adequately concealed in two studies [12, 16], and the remaining five studies did not report the method of allocation concealment. Three trials [12, 15, 16] were double blind, while one trial [13] allocation was open-label; the other trials were unclear.…”

Section: Resultsmentioning

confidence: 99%

“…Allocation was adequately concealed in two studies [12, 16], and the remaining five studies did not report the method of allocation concealment. Three trials [12, 15, 16] were double blind, while one trial [13] allocation was open-label; the other trials were unclear. Four articles [12, 13, 16, 17] have reported complete outcome data, and the other three articles [14, 15, 18] explicitly provided the number and reasons for withdrawal or loss to follow-up.…”

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Efficacy and Safety of Gefitinib in Patients with Advanced Head and Neck Squamous Cell Carcinoma: A Meta-Analysis of Randomized Controlled Trials

Tang

et al. 2019

Journal of Oncology

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Background. Trials on assessing the benefits of EGFR inhibitors in head and neck squamous cell carcinoma (HNSCC) patients have gradually been published. Nevertheless, the benefits of gefitinib in advanced HNSCC are still unknown. Methods. The Cochrane library, PubMed, and EMBASE databases were systematically searched from the inception dates to 17 July 2017, 18 July 2017, and 19 July 2017, respectively. The keywords “head and neck” and gefitinib were used to retrieve in articles and abstracts. An additional search for recently published randomized trials was performed from July 17, 2017, to April 18, 2018. Then we assessed the risk of bias of the included studies based on the Cochrane “Risk of Bias” tool. Quantitative analysis was carried out to evaluate the overall survival (OS), progression free survival (PFS), overall response rate (ORR), and grade 3-4 adverse effects by Review Manager 5.0.2 and the quality-of-life was analyzed in the included studies. Results. Seven randomized controlled trials and a total number of 1287 patients were involved. There were no significant differences in OS, PFS, or ORR between gefitinib and no gefitinib group (HR 1.07, 95% CI 0.93 to 1.22, and P=0.35; HR 0.84, 95% CI 0.69 to 1.04, and P=0.11; RR 1.04, 95% CI 0.90 to 1.20, and P =0.60, respectively). However, gefitinib alone was equivalent to chemotherapeutics (i.e., methotrexate; methotrexate + fluorouracil) in ORR in patients with recurrent HNSCC, and a trend of improvement in QOL in gefitinib group was showed. Toxicities revealed no differences except for diarrhea and skin toxicity (p=0.0003; p=0.03, respectively). Conclusion. For patients with advanced HNSCC, gefitinib cannot prolong the OS and PFS or improve ORR, and odds of skin toxicity and diarrhea increased. However, gefitinib alone is equivalent to methotrexate or methotrexate + fluorouracil and tends to improve QOL for recurrent patients.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Efficacy and Safety of Gefitinib in Patients with Advanced Head and Neck Squamous Cell Carcinoma: A Meta-Analysis of Randomized Controlled Trials

Tang

et al. 2019

Journal of Oncology

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“…We were able to identify some research gaps on this topic such as targeted therapy, since just only one RCT44 addressing this topic was included in one SR 18. Moreover, despite a sharp increase in research into molecularly targeted therapies and a rapid expansion in the number of trials assessing new targeted therapies, their value for treating oral cancers remains unclear.…”

Section: Discussionmentioning

confidence: 99%

Evidence mapping and quality assessment of systematic reviews on therapeutic interventions for oral cancer

Anaya¹,

Franco²,

Ballesteros³

et al. 2018

CMAR

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Purpose: This evidence mapping aims to describe and assess the quality of available evidence in systematic reviews (SRs) on treatments for oral cancer. Materials and methods: We followed the methodology of Global Evidence Mapping. Searches in MEDLINE, EMBASE, Epistemonikos and The Cochrane Library were conducted to identify SRs on treatments for oral cancer. The methodological quality of SRs was assessed using the Assessing the Methodological Quality of Systematic Reviews-2 tool. We organized the results according to identified Population-Intervention-Comparison-Outcome (PICO) questions and presented the evidence mapping in tables and a bubble plot. Results: Fifteen SRs met the eligibility criteria, including 118 individual reports, of which 55.1% were randomized controlled clinical trials. Ten SRs scored "Critically low" methodological quality. We extracted 30 PICOs focusing on interventions such as surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy; 18 PICOs were for resectable oral cancer, of which 8 were reported as beneficial. There were 12 PICOs for unresectable oral cancer, of which only 2 interventions were reported as beneficial. Conclusion: There is limited available evidence on treatments for oral cancer. The methodological quality of most included SRs scored "Critically low". The main beneficial treatment reported by authors for patients with resectable oral cancer is surgery alone or in combination with radiotherapy or chemotherapy. Evidence about the benefits of the treatments for unresectable oral cancer is lacking. These findings highlight the need to address future research focused on new treatments and knowledge gaps in this field, and increased efforts are required to improve the methodology quality and reporting process of SRs on treatments for oral cancer.

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“…Eleven of the RCTs identified had been included in the MACH-NC meta-analysis; including one published report of a previously unpublished RCT [28] and seven updated reports of six previously published RCTs [11, 29–34]. Four RCTs [35–38] identified were also included in the review of larynx preservation reported by Denaro et al [39] The results of the remaining 30 unique RCTs that were not included in the MACH-NC meta-analysis were reviewed: four tested concurrent CRT [40–43], nine tested taxane-based triplet induction chemotherapy [37, 44–51], 14 investigated anti-EGFR targeted drugs [42, 52–64], two investigated radiosensitizers [65, 66], and one studied organ preservation [67]. …”

Section: Resultsmentioning

confidence: 99%

Systemic therapy in the curative treatment of head and neck squamous cell cancer: A systematic review

Winquist

Agbassi

Meyers

et al. 2017

Journal of Otolaryngology - Head & Neck Surgery

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ObjectiveTo review the available evidence and make recommendations regarding use of systemically administered drugs in combination or in sequence with radiation (RT) and/or surgery for cure and/or organ preservation in patients with locally advanced nonmetastatic (Stage III to IVB) squamous cell carcinoma of the head and neck (LASCCHN).MethodRecognizing the Meta-analysis of Chemotherapy in Head and Neck Cancer (MACH-NC) group reports have de facto guided practice since 2000, we searched for systematic reviews in the MEDLINE, EMBASE and Cochrane Database of Systematic Reviews published from January 2000 to February 2015 in reference to 4 research questions. A search was also conducted for randomized trials (RCTs) up to February 2015 not included in the meta-analyses.ResultThe MACH-NC reports, 5 additional meta-analyses, and 30 RCTs not included by MACH-NC were identified. For chemotherapy, MACH-NC findings showing improved overall survival with concomitant chemoRT did not require modification. High-dose cisplatin was most commonly studied. We confirmed this benefit with cisplatin monotherapy in patients treated with with postoperative concurrent chemoRT. Other than cetuximab, no targeted agents and radiosensitizers studied in RCTs were shown effective. TPF induction chemotherapy was superior to PF for tumor response and larynx preservation but not survival. Larynx preservation was reported with both CRT and induction chemotherapy approaches.ConclusionChemoRT with cisplatin at least 40 mg/m2 per week given as radical or postoperative adjuvant remains a standard treatment approach for LASCCHN that improves overall survival but increases toxicity. 5-FU plus platinum is supported by less data but may be a reasonable alternative for patients unsuitable for cisplatin. Of note, stratification of outcomes by HPV-status was not available but outcomes for oropharynx cancer appeared similar to other subsites in chemoRT RCTs. No RCTs have yet demonstrated superiority or non-inferiority of cetuximab-RT to CRT. In view of this, cetuximab-RT is suggested only for patients not candidates for CRT. Taxane-based triplet induction chemotherapy is superior to doublets for rapid tumour downsizing and for larynx preservation, but does not improve overall survival and should be used with primary G-CSF prophylaxis. Further investigation of induction approaches for larynx preservation may be warranted.

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A randomized trial comparing radiotherapy alone versus radiotherapy with Geftinib in locally advance oral cavity cancer

Cited by 5 publications

References 1 publication

Efficacy and Safety of Gefitinib in Patients with Advanced Head and Neck Squamous Cell Carcinoma: A Meta-Analysis of Randomized Controlled Trials

Efficacy and Safety of Gefitinib in Patients with Advanced Head and Neck Squamous Cell Carcinoma: A Meta-Analysis of Randomized Controlled Trials

Evidence mapping and quality assessment of systematic reviews on therapeutic interventions for oral cancer

Systemic therapy in the curative treatment of head and neck squamous cell cancer: A systematic review

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