bluuebunny/crossref_metadata_2025_split huggingface dataset:
First results of induction chemotherapy with cisplatin, docetaxel, and capecitabine for the treatment of nasopharyngeal carcinoma
Authors: Beldjilali Y. , Benhadji K. A. , Boukerche A. , Khellafi H. , Abdelaoui A. , Betkaoui F. , Tourabi Z. K. , Kaïd M. Y. , Djellali L. , Yamouni M. 
Published: August 2020

6045 Background: The purpose of this phase II study is to assess a new induction chemotherapy regimen combining cisplatin (P), docetaxel (T), and capecitabine (X) in advanced nasopharyngeal carcinoma. Methods: Previously untreated patients (pts) with histological diagnosed locally advanced nasopharyngeal carcinoma (stages III, IVA, and IVB UICC 2002) received induction chemotherapy associating P 75 mg/m2, T 75 mg/m2, both on day 1 and X 1,000 mg/m2/d days 1–14. Cycles were repeated every 3 weeks. A total of 4 cycles was planned for each patient. Induction chemotherapy was followed by concurrent chemo-radiotherapy: P 75 mg/m2 days 1, 22, 42 and radiotherapy (65–70 Gy) 4 to 6 weeks after the fourth cycle of induction treatment. Primary end point was tumor response of the induction regimen. Pts were evaluated according to RECIST criteria by clinical examination and CT scan of the nasopharynx. Results: 40 pts (26 male and 14 female) were enrolled. Median age was 40 years (range 18–56), ECOG performance status was 0–1 in all pts. 30 pts (75%) had an undifferentiated carcinoma of nasopharyngeal type (UCNT) and 10 pts (25%) a poorly differentiated nasopharyngeal carcinoma. 5 pts had stage III disease, 20 pts stage IVA disease and 15 pts stage IVB. Toxicity and tumor response were assessable in 40 pts. After 160 cycles, grade 3–4 toxicities (NCI-CTC 3.0) were: neutropenia (11 %), anemia (10.5%), nausea and vomiting (28%), diarrhea (8%), mucositis (3%), reversible alopecia (100%), and fatigue (10%). No febrile neutropenia was noted. 2 pts had grade 3 renal toxicity and only one patient had hand-foot syndrome (grade 3). Response rates for the 40 pts were: complete response 48%, partial response 40%, stable disease 4%, and progressive disease 8%. Conclusions: PTX induction chemotherapy resulted on a high response rate with manageable toxicity. Outcome of patients after chemoradiotherapy is awaited to evaluate the effectiveness of this new treatment modality. No significant financial relationships to disclose.
Phase II study of capecitabine as palliative treatment for patients (p) with squamous head and neck cancer (HNC) with locoregional and/or metastatic relapse after previous platinum-based treatment (PBT): Final results of Spanish Head and Neck Cancer Group (TTCC)
Authors: Martinez-Trufero J. , Isla D. , Adansa J. C. , Irigoyen A. , Hitt R. , Lambea J. , Cruz J. J. 
Published: August 2020

6047 Background: PBT is widely used as first line treatment in relapsed and/or metastatic HNC. Therefore, new non-platinum drugs need to be asses as second line treatment options. We proposed this study to evaluate activity and tolerability of capecitabine (X) when used as palliative monotherapy for relapsed HNC p previously treated with PBT. Methods: Forty patients (p) aged 18–75 years, ECOG PS 0–2, with advanced squamous HNC with locoregional and/or metastatic relapse previously treated with PBT and adequate bone marrow, renal and hepatic functions were included. X (1,250 mg/m2 BID) during 14 days was administered every 21 days, for at least 2 cycles. RECIST objective response rate (ORR) was assessed and toxicity following NCI-CTC v2 criteria. Results: Forty patients with median age 58 years old, all of them male, ECOG 0–2 (0:25%/1:70%/2:5%) and with squamous HNC, were analyzed. 34 p had local disease, 9 p regional disease and 19 p distant metastases(12 p lung). Median time since HNC diagnosis was 17.7 months and since disease extension diagnosis, 1.1 months. All p received a total of 169 cycles of X (median 4, range 1–9) and the median relative dose intensity was 91%. 7 p were not evaluable for response, since they do not receive at least 3 cycles ( 3 died, 2p due to toxicity, 2p due to decrease in ECOG PS ). ORR was 22.5 %.The median follow-up time was 5.2 months (alive p: 8.8 months), median TTP was 4.6 months and median OS was 6.2 months. Hematological toxicity G3/4 was reported in 6 p. 2p reported as grade 4 non-hematological toxicity: dysphagia and palmar-plantar erythrodysesthesia; grade III toxicities were: asthenia (4 p), anorexia (1 p), dehydratation (1 p), diarrhea (3 p), dysphagia (3 p) mucositis (4 p), weight loss (1 p), and palmar-plantar erythrodysesthesia (3 p). The most common grade II toxicity was asthenia (8 p). Conclusions: Capecitabine seems to be an active, feasible and well tolerated palliative treatment for advanced HNC patients that have previously received platinum-based schedules. No significant financial relationships to disclose.
Cetuximab (C) and bevacizumab (B) in patients with recurrent or metastatic head and neck squamous cell carcinoma: An updated report
Authors: Gibson M. K. , Kies M. , Kim S. , Savvides P. , Kotsakis A. , Blumenschein G. , Worden F. , Chen H. , Grandis J. , Argiris A. 
Published: August 2020

6049 Background: Epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) represent important therapeutic targets in SCCHN. Cetuximab (C), an IgG1 monoclonal antibody against EGFR, has single agent activity in SCCHN. Upregulation of VEGF has been associated with C resistance, thus, combined targeting may enhance anti-tumor activity. We designed a phase II trial of bevacizumab (B), an anti-VEGF humanized monoclonal antibody, with C to evaluate this hypothesis. Methods: Eligible patients have recurrent or metastatic SCCHN, measurable disease (RESIST), ECOG performance status (PS) 0–2, and no history of bleeding or thrombosis. Up to 1 regimen (without an EGFR inhibitor) for recurrent or metastatic disease and prior chemoradiotherapy with curative intent are allowed. Treatment consists of weekly cetuximab, 250 mg/m2 (after a loading dose 400 mg/m2) and bevacizumab, 15 mg/kg given intravenously every 21 days, until disease progression. The primary endpoint is the objective response rate. Sample size is 45 eligible patients. Specific biomarkers relating to EGFR and VEGFR signaling will be evaluated in tumor tissues and blood samples. Results: 28 patients enrolled (27 eligible). Median age 60 years (range 33–92); male 19; PS 0 (7 pts), PS 1 (18), PS 2 (2). All had prior RT, and 26 had chemotherapy. A median of 4 cycles were given (range, 1–12). Best response in 25 evaluable patients: 5 (20%) PR (1 was uncomfirmed), 14 (56%) SD, and 6 (24%) PD. Progression-free survival was 2.8 months and median overall survival was 8.1 months. Grade (G) 3 adverse events included: hemorrhage (from a benign neck ulcer), 1; hypertension, 2; infection, 2; rash, 2; dysphagia, 4; hypophosphatemia, 1; and fatigue, 1. G 4 AEs: proteinuria, 1. One pt died of aspiration pneumonia, with possible cardiac ischemia of uncertain relationship to study drugs. Conclusions: Preliminary results show that cetuximab and bevacizumab is an active regimen in SCCHN with rare serious toxicities. In particular, our results establish the safety of this bevacizumab-based regimen in regards to bleeding complications in SCCHN. Study accrual continues and biomarker analysis is planned. (Supported by U01 CA099168–01 and P50 CA097190) No significant financial relationships to disclose.
Phase II study of pemetrexed (P) and gemcitabine (G) in patients with advanced head and neck cancer (SCCHN)
Authors: Mehra R. , Sherman E. , Ruth K. , Litwin S. , Sylvester J. , Tuttle H. , Burtness B. , Cohen R. B. , Langer C. 
Published: August 2020

6052 Background: Unresectable/metastatic squamous cell cancer of the head and neck (SCCHN) has a poor prognosis despite standard therapy with cisplatin. Given the substantial toxicities of cisplatin and its widespread use in combination with RT in LA- SCCHN, we investigated an alternative regimen of gemcitabine (G) and pemetrexed (P). A phase II study of pemetrexed in SCCHN had a response rate (RR) of 26.5%. A phase I study of the P and G combination showed the doses and schedule below to be feasible. Methods: Eligibility stipulated measurable, incurable, unresectable recurrent/metastatic SCCHN; Karnofsky PS of > 60%, and adequate bone marrow, renal and hepatic function. One prior therapy for recurrent disease was allowed. Patients were treated with P 500 mg/m2 and G 1,500 mg/m2 every 2 weeks. Each cycle was 28 days. Primary endpoint was RR. Secondary endpoints included overall survival and toxicity. Patients were re-imaged every 2 cycles. In a 2-step design, 16 patients were to be accrued during stage 1, and 16 were projected for stage 2. If 1 or fewer responses were observed during the first stage, then the trial was to be stopped and the regimen deemed insufficiently active. Results: 17 patients were enrolled in stage 1. Median age was 64 years (range, 49–82); 10 males; 13 smokers (including 4 current smokers). 15 patients previously received definitive therapy with surgery and/or chemo-RT, and 9 had prior systemic therapy for recurrent/metastatic disease. Median number of cycles administered was 2 (range, <1 to 10). Reasons for treatment discontinuation included progressive disease in 15 patients and decreased PS in 1. Grade 3 toxicities included neutropenia (1), anemia (3), thrombocytopenia (1), dysphagia (11), fatigue (4), hypertension (4), and hyperglycemia (4). 1 pt had grade 4 anemia. Best response: 1 confirmed PR, 1 unconfirmed PR, 3 SD, 10 PD, 2 not evaluable. 7 patients received subsequent treatment. Estimated median overall survival is 5.5 months. Conclusions: The combination of P and G for advanced HNSCC was well tolerated, but its clinical efficacy was marginal in an unselected population. Due to early stopping rules, the study was closed to accrual after stage 1 for lack of efficacy. Further study of this regimen should be considered in patients enriched for TS and RRM1 status. [Table: see text]
A phase II study examining the feasibility of long-term and low-dose oral capecitabine in newly diagnosed head and neck squamous cell carcinoma after surgery, radiation, and/or chemotherapy
Authors: Sukari A. , Mulrenan H. , Almhanna K. , Kafri Z. , Kim H. , Ensley J. , Kucuk O. , Yoo G. 
Published: August 2020

6053 Background: In advanced head and neck squamous cell carcinoma (HNSCC), the five-year survival rate is less than 40%. Although the efficacy and tolerability of continuous IV 5-Fluorouracil (5FU) therapy has been established in HNSCC, the feasibility and tolerability of long-term therapy of oral capecitabine has not been established in HNSCC. Our primary objective is to assess the feasibility of treating patients with squamous cell carcinoma of the head and neck (HNSCC) with adjuvant Capecitabine after undergone definitive treatment. The secondary objectives are to estimate time to recurrence, local-regional control and survival rates along with incidence of second primary tumors. Methods: Eligible patients with newly diagnosed locally advanced HNSCC received capecitabine 1,000 mg orally once daily for one year, after undergone definitive treatment. Patients’ compliance with oral capecitabine as will as the side effects profile was evaluated on monthly basis over the first 12 months. Feasibility, survival, progression and progression free survival were measured over 36 months. Results: Thirty five patients were enrolled in the study. 17 patients had stage IV b, 7 had stage III, and 5 had unknown primary HNSCC. All but one took at least 60% of dispensed tablets. Twenty six patients completed at least 7 months of capecitabine. Sixteen patients completed at least 10 month of capecitabine. Two years overall survival rate was 97%. Three years progression free survival was 86%. Conclusions: Adjuvant capecitabine in locally advanced HNSCC is a feasible approach with minimum side effects. A favorable 3-year progression-free survival was found as compare to historical results. We recommend a randomized phase III trail to examine the effect of one year of adjuvant capecitabine versus placebo in locally advanced HNSCC after definitive treatment. No significant financial relationships to disclose.
UAB 0210: A phase I/II trial of induction chemotherapy followed by concomitant docetaxel/radiotherapy with subcutaneous amifostine for advanced squamous cell carcinoma of the head and neck (SCCHN)
Authors: Nabell L. M. , Peters G. , Meredith R. , Carroll W. , Bonner J. , Ove R. , Spencer S. 
Published: August 2020

6061 Background: Attempts to improve the outcome of locally advanced SCCHN have generally added chemotherapy to radiation, though the optimal manner of integration has been controversial. To impact distant and local control, we utilized neoadjuvant chemotherapy followed by concomitant boost radiation (CBR) with docetaxel as a radiosensitizer. To improve cytoprotection, subcutaneous amifostine was added during radiotherapy. Methods: From April 2003-March 2007 46 patients with stage III or IV newly diagnosed SCCHN were enrolled (30 Caucasian, 16 African-American). Treatment consisted of 3 cycles of neoadjuvant chemotherapy with cisplatin 75 mg/m2 and docetaxel 75 mg/m2 intravenously at 21 day intervals followed by CBR and concurrent dose-escalated weekly docetaxel starting at 20 mg/m2. Standard 2D radiotherapy was used in the majority of patients. Subcutaneous amifostine was administered at 500 mg during each day of radiation. Results: 39 patients were evaluable. The neoadjuvant chemotherapy was well tolerated by the majority of patients and appeared effective; no patient had progressive disease while on therapy. Three patients required a change to carboplatin due to toxicity. Weekly docetaxel during all weeks of CBR was not tolerable due to severe mucositis and the phase I component defined the MTD of concurrent docetaxel as 20 mg/m2 for 4 cycles during CBR. 4 patients (10%) had persistent disease at completion of treatment. Amifostine administration was well tolerated though 4 patients required discontinuation of the drug. The majority of recurrences have been localized at the primary site (6 patients). 3 patients developed isolated pulmonary metastasis. Only 2 patients remain PEG dependent with median follow-up of 24 months. Conclusions: Induction chemotherapy using cisplatin and docetaxel is feasible and easy to administer in the outpatient setting; those patients who had a major radiographic and clinical response did particularly well in follow-up. Weekly docetaxel can be safely and effectively administered during CBR with good local control. Amifostine can be safely administered via the subcutaneous route; the benefit in locally advanced patients is difficult to assess. No significant financial relationships to disclose.
Prophylactic fluconazole treatment of mucositis in radiotherapy of head and neck cancer patients
Authors: Demiroz C. , Ozkan L. , Karadag O. 
Published: August 2020

6062 Background: The aim of the study is to evaluate the preventive role of antifungal fluconazole prophylaxis on mucositis in head and neck cancer patients treated with radiotherapy. Methods: We evaluated 43 head and neck cancer patients treated with radiotherapy with/without chemotherapy. The patients were randomized to two groups: twenty patients (group A) received fluconazole when micotic infections appeared; 23 patients (group B) received fluconazole 200 mg once a week starting from the sixth irradiation session throughout the treatment.The two groups were similar in terms of patients and radiotherapy characteristics. Oral mucositis was recorded according to EORTC/RTOG criteria. Results: The usage of fluconazole 200 mg once a week was well tolerated and no early and late toxicity was observed. Mucositis was appeared in both groups on the third week of radiotherapy. Grade 3 mucositis developed at eight of the patients in group A (40%), three of the patients in group B (13%) and the result was statistically significant (p = 0.044). While grade 3 mucositis was observed the second/third week in group A, it was also observed in group B on third/fourth week in group B (p = 0.043). Conclusions: Weekly fluconazole prophylaxis showed a significant effect on the grade 3 mucositis and improved radiotherapy results. No significant financial relationships to disclose.
Oral cavity squamous cell carcinoma in patients aged 80 or older: Risk factors, treatment, and outcome
Authors: Ortholan C. , Bensadoun R. , Italiano A. , Teman S. , Dassonville O. , Benezery K. , Lusinchi A. , Thariat J. , Auperin A. , Bourhis J. 
Published: August 2020

6064 Background: We have recently reported a large series of patients aged ≥ 80 years showing that in this population about half of head and neck squamous cell carcinomas (SCC) are located in the oral cavity. There are no specific data on this cancer location outcome in elderly patients. Therefore, we report here the experience of two French cancer centers in the treatment of oral cavity SCC in patients aged ≥ 80 years. Methods: Two hundred sixty patients aged ≥ 80 years with a primary oral cavity SCC were included in this retrospective analysis. Results: Sex ratio was near to 1. The risk factor distribution was significantly different between men and women: tobacco/alcohol consumption (66.3% vs 15.8%, p < 0.001), history of leukoplakia/lichen planus/oral traumatism (10.8% vs 55.3%, p = 0.002). Two hundred patients received a loco regional (LR) treatment with a curative intent (surgery and/or radiotherapy), 29 with a palliative intent and 31 did not receive a LR treatment. Curative treatments were delivered according to the institution policy in 56 patients (28%).The median disease specific survival (DSS) was 16.9 months. In multivariate analysis, independent prognostic factors were stage (HR = 0.45 [0.29–0.69], p < 0.001), and curative intent of treatment (HR = 0.28 [0.17–0.45], p < 0.001). Median overall survival (OS) was 13.9 months. In multivariate analysis, the independent prognostic factors for OS were age (HR = 0.63 [0.33–0.76], p < 0.001), stage (HR = 0.61 [0.40–0.91], p = 0,016), and curative intent of treatment (HR = 0.41 [0.23–0.71], p < 0.001. In patients treated with a curative intent, the standard treatment was not associated with improved overall survival or disease specific survival as compared with those treated with an adapted treatment. However, prophylactic lymph node treatment in early stage cancer decreased the rate of nodal recurrence from 38% to 6% (p = 0.01). Conclusions: This study emphasizes the need for prospective evaluation of standard and adapted schedules in elderly patients with oral cavity cancer. No significant financial relationships to disclose.
Neurocognitive outcomes of head and neck chemoradiotherapy: A pilot study
Authors: Gan H. K. , Bernstein L. J. , Brown J. , Ringash J. , Vakilha M. , Wang L. , O'Sullivan B. , Waldron J. , Chen E. X. , Siu L. L. 
Published: August 2020

6068 Background: Evidence suggests cancer-related treatments affect cognition. To our knowledge, no studies have systematically investigated cognitive impairment in head and neck cancer (HNC) patients (pts). We assessed ten relapse-free HNC pts after curative-intent radiotherapy (RT), half of whom received cisplatin (Cp). Methods: Pts completed a 2-hr battery of tests/questionnaires assessing objective cognitive function (CF), subjective CF, quality of life and affect. Objective measures of CF were transformed to Z-scores (mean=0, standard deviation=1) using age normative data. A negative value for the Difference Score (DS=Z-score minus IQ score) in each tested domain indicates cognitive deterioration as IQ is a pre-morbid estimate of pts’ CF. A Global Deficit Score (GDS) was obtained by averaging the DS of all tested CF domains. Results: Pt demographics were: M:F=8:2; mean age=58 yrs(range 47–66); mean smoking pack yrs=15(0–45); mean drinks/week=7(0–25); mean IQ Z-score=+1.2(-1.0 to +2.0), mean school yrs=15 (6–18) and mean time post treatment=20 mo(9–41). All pts completed the battery within 2 hr. Nine participants appeared to have impaired CF based on negative DS and GDS scores ( Table 1 ). Exploratory univariate analyses showed trends that higher RT dose and Cp use were associated with increased impairment but cytokines, anemia, hormonal status and affective state were not. Conclusions: This feasibility study suggests cancer-related treatment affects cognition in HNC survivors. A longitudinal study is underway. [Table: see text] No significant financial relationships to disclose.
Correlation of body mass index with toxicity and survival in locoregionally advanced head and neck cancer patients treated with induction chemotherapy and concurrent chemoradiotherapy
Authors: Jain A. K. , Salama J. K. , Stenson K. M. , Blair E. , Cohen E. E. , Witt M. , Haraf D. J. , Vokes E. E. 
Published: August 2020

6074 Background: Concurrent chemoradiotherapy (CRT) offers high functional organ preservation rates for locoregionally advanced head and neck cancer (LRAHNC) patients, but is associated with significant acute and chronic speech and swallowing toxicity. Recently, body mass index (BMI) has been suggested as a predictor of head and neck cancer patient outcome. In this analysis we sought to determine the impact of BMI on survival and toxicity outcomes in LRAHNC patients treated with CRT. Methods: 220 LRAHNC patients were treated on a multiinstitutional protocol consisting of induction carboplatin and paclitaxel followed by CRT. CRT was delivered for 4–5 cycles; each 14-day cycle consisted of 5 days concurrent paclitaxel, continuous infusion 5-FU, hydroxyurea, and 1.5 Gy twice daily radiation followed by 9 days without any treatment. Each patient's pre-treatment BMI was classified as overweight (BMI >= 25) or non-overweight (BMI < 25). As an independent variable, BMI was analyzed as a predictor of IndCT or CRT toxicity, locoregional control, and overall survival. BMI was analyzed as categorical variable, and also a continuous variable in a multivariate proportional hazards model. Results: There was no association between BMI and IndCT toxicity. During CRT overweight patients had significantly lower rates (24/103 vs 42/112) of grade 3 or higher neutropenia (p = 0.027), mucositis (p = 0.05), dermatitis (p = 0.028) and higher rates of anorexia (p = 0.05). Overweight patients had 12% long term PEG tube rate, compared to 34% of non-overweight patients (p < 0.001). On pooled survival analysis, patients with BMI > 25 had significantly better overall survival outcomes (mean 81.2 months, 95% CI 75.1–87.3 months) than patients with BMI < 25 (median 58.2 months; mean 56.5 months, 95% CI 49.6–63.3 months) (log-rank p < 0.001). Conclusions: Our data suggest patients with pre-treatment BMI > 25 experience lower rates of toxicity commonly associated with chemoradiation, and have a significantly better prognosis than patients with BMI < 25. Although the mechanism of BMI as an independent predictor of outcomes is unclear, we are continuing to explore mechanisms underlying this association. No significant financial relationships to disclose.