Abstract 31: The INSPIRE trial: A randomized trial of neoadjuvant and adjuvant therapy with the IRX-2 regimen in patients with newly diagnosed stage II, III, or IVa squamous cell carcinoma of the oral cavity

e18556 Background: Two trials followed by a combined analysis of the trials in head and neck squamous cell carcinoma (SCC) established that the benefit of adjuvant chemotherapy concurrent with radiation (CRT) was only noted in patients with extracapsular extension of nodal disease (ECE) and positive resection margins (PM). Despite this recommendation, other high-risk pathological features including pT3 or pT4 disease, positive lymph nodes, perineural involvement, vascular tumor embolism and level IV or V lymph node involvement have been noted to increase the risk of recurrence and adjuvant chemotherapy has been utilized for these patients. We report an observational study to evaluate the factors impacting use of CRT in patients with oral cavity and lip SCC. Methods: We conducted a retrospective study of patients with oral cavity and lip SCC who underwent resection of primary tumor with or without neck dissection in the reporting hospital in the NCDB database. We compared demographic, clinical and pathological characteristics of patients who received adjuvant CRT versus radiation alone. Multivariate analysis was performed using logistic regression model. Results: Out of the 58,481 patients reported to have surgery in NCDB from 2004 to 2016, 11,413 patients received adjuvant therapy. In univariate analysis, patients who received CRT were most likely less than 65 years of age, males, patients with no insurance or private insurance, lower Charlson Deyo score, Stage IVA, pT4, grade 2 or higher, tumor size > 4cm, positive lymph nodes, involvement of level IV and V nodes, lymphovascular invasion, ECE and PM. In multivariate analysis, factors which influenced receiving CRT were age between 40 and 65 years, males, Stage IVA (compared to Stage I to III), positive nodes, ECE and PM. A total of 984 patients received CRT without having ECE or PM. Conclusions: In addition to ECE and PM, positive lymph nodes was the major pathological factor in patients receiving CRT compared to RT alone.

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High dose methotrexate adjuvant therapy and resection to cure squamous cell carcinoma of the oral cavity: Results

Journal of Oral and Maxillofacial Surgery ◽

10.1016/0278-2391(88)90491-0 ◽

1988 ◽

Vol 46 (12) ◽

pp. M9

Keyword(s):

Squamous Cell Carcinoma ◽

Adjuvant Therapy ◽

Oral Cavity ◽

Cell Carcinoma ◽

Squamous Cell ◽

High Dose ◽

High Dose Methotrexate ◽

Dose Methotrexate

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A randomized trial of postoperative adjuvant chemotherapy with cisplatin and 5-fluorouracil versus neoadjuvant chemotherapy for clinical stage II/III squamous cell carcinoma of the thoracic esophagus (JCOG 9907)

Journal of Clinical Oncology ◽

10.1200/jco.2008.26.15_suppl.4510 ◽

2008 ◽

Vol 26 (15_suppl) ◽

pp. 4510-4510 ◽

Cited By ~ 41

Author(s):

H. Igaki ◽

H. Kato ◽

N. Ando ◽

M. Shinoda ◽

H. Shimizu ◽

...

Keyword(s):

Squamous Cell Carcinoma ◽

Adjuvant Chemotherapy ◽

Neoadjuvant Chemotherapy ◽

Randomized Trial ◽

Cell Carcinoma ◽

Squamous Cell ◽

Clinical Stage ◽

Stage Ii ◽

Thoracic Esophagus ◽

Postoperative Adjuvant Chemotherapy

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Clinical impact of PET/CT imaging after adjuvant therapy in patients with oral cavity squamous cell carcinoma

European Journal of Nuclear Medicine and Molecular Imaging ◽

10.1007/s00259-017-3713-5 ◽

2017 ◽

Vol 44 (10) ◽

pp. 1702-1711 ◽

Cited By ~ 2

Author(s):

Huan-Chun Lin ◽

Chung-Jan Kang ◽

Shiang-Fu Huang ◽

Hung-Ming Wang ◽

Chien-Yu Lin ◽

...

Keyword(s):

Squamous Cell Carcinoma ◽

Adjuvant Therapy ◽

Oral Cavity ◽

Cell Carcinoma ◽

Squamous Cell ◽

Ct Imaging ◽

Clinical Impact ◽

Pet Ct

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KEYNOTE-689: Phase 3 study of adjuvant and neoadjuvant pembrolizumab combined with standard of care (SOC) in patients with resectable, locally advanced head and neck squamous cell carcinoma.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.tps6090 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. TPS6090-TPS6090 ◽

Cited By ~ 1

Author(s):

Ravindra Uppaluri ◽

Nancy Y. Lee ◽

William Westra ◽

Ezra E.W. Cohen ◽

Robert I. Haddad ◽

...

Keyword(s):

Squamous Cell Carcinoma ◽

Oral Cavity ◽

Cell Carcinoma ◽

Head And Neck ◽

Squamous Cell ◽

Primary Tumor ◽

Locally Advanced ◽

Pathological Response ◽

Newly Diagnosed ◽

Phase 3

TPS6090 Background: Evidence of efficacy and pathological response at the time of surgery was reported in two phase 2 studies (NCT02296684 and NCT02641093) of preoperative pembrolizumab in patients with high-risk, resectable, locally advanced (LA) head and neck squamous cell carcinoma (HNSCC). The randomized, open-label, phase 3 KEYNOTE-689 trial ( NCT03765918) will evaluate efficacy and safety of pembrolizumab as neoadjuvant and adjuvant therapy in combination with SOC (radiotherapy ± cisplatin) in patients with previously untreated, resectable LA HNSCC. Methods: Patients with newly diagnosed LA HNSCC will be randomly assigned 1:1 to two treatment arms. Patients in arm A will receive neoadjuvant pembrolizumab (200 mg Q3W for two cycles) followed by surgical resection then SOC plus adjuvant pembrolizumab (15 cycles). Patients in arm B will undergo only surgical resection followed by adjuvant SOC. Eligibility criteria will include age ≥18 years; newly diagnosed, resectable, stage III/IVA HNSCC (AJCC Cancer Staging Manual, 8th edition); and ECOG performance status 0-1. Randomization will be stratified by primary tumor site (oropharynx/oral cavity vs larynx vs hypopharynx), tumor stage (III vs IVA), and HPV p16 status (oropharynx p16 positive vs oropharynx p16 negative or larynx/hypopharynx/oral cavity). Treatment will continue until disease progression, unacceptable toxicity, or decision to withdraw. Patients in arm A will undergo the first radiologic imaging assessment after two cycles of neoadjuvant pembrolizumab and before surgery. In both arms, postoperative imaging will be performed 12 weeks after SOC, then every 3 months until the end of year 3, and then every 6 months until the end of year 5. Dual primary end points are major pathological response, defined as ≤10% invasive squamous cell carcinoma within resected primary tumor and sampled regional lymph nodes per blinded central pathology, and event-free survival. Secondary end points include overall survival, pathological complete response, and safety and tolerability. Recruitment is ongoing and will continue until ~600 patients are enrolled. Clinical trial information: NCT03765918.

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Clinical outcomes, prognosis, and predictors of salvage surgery in oral cavity squamous cell carcinoma.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e18040 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e18040-e18040

Author(s):

Wen-San Lan ◽

Hsueh-Ju Lu ◽

Yu-Wei Chiu ◽

Chih-Yu Peng ◽

Hsien-Chun Tseng ◽

...

Keyword(s):

Squamous Cell Carcinoma ◽

Oral Cavity ◽

Cell Carcinoma ◽

Negative Predictive Value ◽

Clinical Outcomes ◽

Squamous Cell ◽

Predictive Value ◽

Scoring System ◽

Salvage Surgery ◽

Newly Diagnosed

e18040 Background: Salvage surgery (SS) is one of the curative options for oral cavity squamous cell carcinoma (OCSCC) patients with locoregional recurrence (LRR) or secondary primary, but the role of SS should be reevaluated between life expectancy, morbidity, and quality of life. Selecting suitable OCSCC patients receiving SS is important. Methods: From 2010 to 2018, newly diagnosed OCSCC patients who progressed to LRR or secondary primary were recorded. Clinical outcomes, prognostic factors, and predictors were analyzed for the patients receiving SS. Cox regression analyses were performed for PSS, defined from the date of SS to the date of death or last follow-up. Survival was estimated using the Kaplan–Meier method and log-rank tests. Results: A total of 263 newly diagnosed OCSCC patients progressing to LRR or secondary primary were recorded. Half (55.1%, 145/263) of them received SS, and one-third (29.7%, 43/145) of the SS group received twice and more times SS. Median survivals after disease progression were 65.6 and 10.6 months for patients with or without SS, respectively (P < 0.001). A total of 214 SS events were enrolled for analysis. Nearly twenty percentage (20.1%, 39/194) of SS events would progress to death within 1 year after surgery (PSS < 1 year). PSSs of the first, secondary, third, and fourth or more times SS were 64.2, 47.6, 40.9, and 18.9 months, respectively (P = 0.217). Surgical features of the last surgery (perineural invasion and depth of invasion), the interval between the last and current surgery, and clinical N staging of the current surgery were the four independent factors for PSS. To predict the patients with PSS < 1 year, a scoring system was established that each of the independent factors was scored one point. The area under the curve of the scoring system was 0.755, and sensitivity, specificity, positive predictive value, and negative predictive value were 66.7%, 76.0%, 39.0%, and 90.8%, respectively (Table). Conclusions: A scoring system with a high negative predictive value was established to predict PSS < 1 year.[Table: see text]

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