bluuebunny/crossref_metadata_2025_split huggingface dataset:
Retrospective analysis of 105 cases of uterine sarcoma
Authors: Yoney A. , Eskici S. , Eren B. , Salman A. , Unsal M. 
Published: March 2020

16079 Background: Currently there is no randomized study based or widely accepted therapeutic modality in uterine sarcomas which are rare tumors forming a heterogeneous group in respect to their pathologic classification. Methods: In our trial, 105 pts. with uterine sarcoma who were referred to our clinic between years 1995–2003 have been retrospectively researched to evaluate the results in this tumor group. 43.8% had Leiomyosarcoma (LMS), 28.6% had Endometrial Stromal Sarcoma (ESS) and 27.6% had a Malign Mullarian Mixed Tumor (MMMT) while the distribution according to the histological subgroups were found to be 58.8% and 41.2% in low + middle grade tumors combined and in high grade tumors respectively. 76.2% had a Total Abdominal Hysterectomy + Bilateral Salphingooverectomy (TAH+BSO), 18.1% had a Total Abdominal Hysterectomy + Bilateral Salphingooverectomy + Lymphadenectomy (TAH+BSO+LND) and 5.7% had a suboptimal surgery as a surgical procedure. 38.1% of the pts. had Radiotherapy (RT), 18.1% had Chemotherapy (CT) and 12.4% had Chemo-radiotherapy (CT+RT) in addition to surgery. Results: The median age of the whole group is 51 (24–87). 55% of our pts. are under 50 years old and 68.5% had an “organ limited disease” ( stages I-II combined). The distant metastases rate is 30% and the local recurrence is 16.2%. All the local recurrences and 90% of the distant metastases have occurred within the first two years. The disease free survival rates at 3 and 5 years are 54.46% and 49.88% ; while the overall survival rates at 3 and 5 years are 54.63% and 51.09% all respectively. The stage is the most important factor effecting on the O.S and 5- year O.S rate is 68.43% in Stage I disease. Conclusions: The aggressive tumor progression pattern and the poor prognosis of uterine sarcomas require adjuvant therapies. The merit of current therapeutic options are still on debate since none of them has proved any specific effects. Planning further multi-center retrospective studies with high number of pts., a more clear description of the prognostic factors and thus the determination of the most appropriate therapeutic option is definitely needed. No significant financial relationships to disclose.
Radical surgery is not necessary following neoadjuvant chemotherapy in stage III-IV resectable, non-laryngeal head and neck cancer (NLHNC)
Authors: Shultz J. A. , Pameijer C. R. , Ellenhorn J. , Shibata S. , Vora N. , Maghami E. , Paz I. B. 
Published: March 2020

16501 Background: Traditionally, following neoadjuvant chemotherapy (NC), head and neck surgeons have insisted in performing radical surgery regardless of the response to NC. This prospective study evaluates the results of conservative surgery following NC in resectable stage III-IV non-laryngeal head and neck cancer (NLHNC). Methods: Between 1993 and 2003, 70 patients with NLHNC were treated with one of the following NC: Cisplatin and 5FU (17.1%); Cisplatin, 5FU, Leucovorin, and Taxotere (58.6%); Cisplatin, 5FU, and Taxol (24.3%). After three courses of NC, patients were reevaluated to determine the need for local therapy. Local excision or biopsy was performed for patients with near-complete pathological response (n-CPR) or patients with a complete pathological response (CPR). Radical surgery was reserved for patients with partial response (PPR). All patients received radiation to the primary and neck. Results: The median follow up was 35 months, median disease-free survival was 33.4 months and 3-year overall survival was 71.4% for the entire group. Thirty-five patients (50.0%) had a complete pathological response (CPR), 11 (15.7%) had a complete clinical response (CCR) and no pathological staging, 5 patients (7.1%) had a n-CPR, and 19 patients (27.1%) had a partial pathological response (PPR). Primary surgery is shown in the following table : At the time of the last follow up, 1/35 (2.9%) patients with CPR had a local recurrence (LR) at the primary and 5/11 (45.5%) patients with CCR and no pathological staging had a LR; in 3/6 (50%) patients with LR the primary was controlled with salvage surgery. Seven of eleven (63.6%) patients with PPR had a LR, only one achieved local control with salvage surgery. Conclusions: Complete pathological response at the primary site is a good predictor of long term local control in NLHNC. Radical surgery, is not necessary in non-laryngeal head and neck cancers following a complete pathological response at the primary site. [Table: see text] No significant financial relationships to disclose.
Management of synchronous lung nodules in patients with potentially curable head and neck cancer
Authors: Dowell J. , Ha H. 
Published: March 2020

16503 The presence of a solitary pulmonary nodule in patients with otherwise curable head and neck cancer is a complex clinical scenario. We retrospectively reviewed the management of such patients at the Dallas VA Medical Center to determine if our process for selecting patients to treat with curative intent was in fact identifying patients with meaningful survivals. All patients presented at the institutional multimodality head and neck tumor board from 1998 - 2004 were reviewed. This insured more than 24 months follow up for each patient. Included patients had head and neck cancer that was felt to be potentially curable with either surgery and/or radiation or a combination of chemotherapy and radiation. In addition, all had a solitary lung nodule that was biopsy proven and potentially resectable lung cancer. Pretreatment imaging included CT scans of the head and neck and chest. Patients all had adequate renal, pulmonary, and performance status to tolerate planned treatment for their head and neck cancer and thoracotomy for their lung cancer. In all cases, the head and neck cancer was addressed first followed by treatment of the lung cancer. Twelve patients were identified with potentially curable head and neck cancer and a synchronous solitary pulmonary nodule that was biopsy proven lung cancer. Six of these patients were determined to be candidates for aggressive treatment of both cancers. The pathologic stage, survival, and management for the 6 patients were as follows: The synchronous occurrence of potentially curable head and neck and lung cancers was uncommon in our population. Using stringent criteria for selection of patients who might benefit from an aggressive approach to both cancers, we achieved reasonable outcomes with a median survival for the group of 29 months and with 4/6 patients (67%) surviving more than 2 years. Curative intent therapy should be offered to appropriately selected patients. [Table: see text] No significant financial relationships to disclose.
First-line docetaxel (Dx) and capecitabine (Cap) in advanced head and neck cancer
Authors: Gil-Negrete A. , Mañe J. M. , Ruiz de Lobera A. , Martinez-Bueno A. , Rubio I. , Fuente N. , Lopez-Vivanco G. , Ancizar N. , Fernandez R. , Sancho A. 
Published: March 2020

16505 Background: Dx and Cap are useful drugs in head and neck cancer. Our purpose was to establish the efficacy and safety of this combination in non selected patients (pts) with advanced or metastatic (M1) head and neck cancer. Methods: : Between Apr 2005 and Nov 2006, 33 pts with squamous cell locally advanced or M1 head and neck cancer received the following chemotherapy (Ct) schedule: Dx 75 mg/m2 day 1 and Cap 950 mg/m2/12h days 2–14, every 3 weeks.30 pts (90.9%) had received previous local radiotherapy, 11 of them with concomitant Ct. Results: Mean age was 60 years old (range 46–75). M/F: 32/1. PS 0/1/2: 1/29/3. Location of disease: only local 49%; local and M1 36%; only M1 15% (Main M1 site: lung 76.5%, nodes 11.8%, bone 5.9%, soft tissue 5.9%). Mean number of Ct cycles: 4 (range 1–7). Worst hematologic toxicities per patient G3/G4 (%): neutropenia 6/39; febrile neutropenia 36/0; anemia 3/0; trombopenia 3/3. Non-hematologic toxicities G2/G3 (%): vomiting 3/3; neuropathy 6/0; asthenia 33/6; diarrhea 21/3; mucositis 33/18; nail changes 12/0; hand foot syndrome 3/12. Other events to remark: 4 pts had neumonia (2 toxic deaths), 1 pts had angor and required a different Ct schedule, 2 pts had massive hemorrage (1 exitus). There were 7 pts not evaluable for response (4 not yet evaluated, 1 early death due to massive hemorrage, 1 toxic death due to neumonia, 1 early disphagia). Among the evaluated pts, responses were: 2 CR (7.7%), 10 PR (38.5%), 9 SD (34.6%) and 5 PD (19.2%). Median TTP was 21 weeks (95%CI 17.5 - 24.2). Median OS was 39.8 weeks (95%CI 32.4 - 47.4) by Kaplan-Meier method. Conclusions: This combination appears to be active in pts with advanced or M1 head and neck cancer. Main toxicities were neutropenia, febrile neutropenia, mucositis and asthenia. Global toxicity was important with two toxic deaths documented No significant financial relationships to disclose.
A phase II study of ARQ 501 in patients with advanced squamous cell carcinoma of the head and neck
Authors: Kawecki A. , Adkins D. R. , Cunningham C. C. , Vokes E. , Yagovane D. M. , Dombal G. , Koralewski P. , Hotko Y. , Vladimirov V. 
Published: March 2020

16509 Background: ARQ 501 is a DNA damage checkpoint pathway activator whose effect is to induce selective cell death in cancer cells, independent of the tumor cell's p53 status. Current evidence implicates a rapid and sustained increase of the pro-apoptotic protein E2F-1 by ARQ 501 as the mechanism of action. Cancer cells are selectively affected due to their pre-existing DNA damage. In initial clinical trials, there was evidence of activity in some patients with head and neck cancer and pre-clinical investigations also supported this application. Therefore, a phase 2 trial is warranted in this patient population. Methods: A phase 2 study in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck who had received up to 3 prior systemic therapies was initiated to assess overall response rate, progression free survival at six months, and to further characterize safety. Cycles consist of four weekly administrations of ARQ 501 at a dose of 450 mg/m2. Dose escalation is allowed if a patient successfully completed a full cycle of therapy and had no related grade 2 adverse events. Results: 59 patients have been enrolled to date and 47 have received at least one infusion of ARQ 501. Data is available for 34 patients (27M / 7F, median age, 57 years). Of the 47 patients treated, 11 patients did not reach a post baseline assessment (2 deaths, 8 PD prior to week 8 and 1 withdrew consent). Although at the current date, most patients have not reached their first tumor evaluation, 5 have been assessed for response per RECIST at eight weeks and one patient is demonstrating stable disease. The drug has been well tolerated with the most common adverse event being anemia (11% ) with corresponding edema, fatigue (both 5%), dyspnea (4%), and hyperbilirubinemia (2%). Conclusions: ARQ 501 is well tolerated in patients with advanced, recurrent or persistent squamous cell carcinoma of the head and neck. Enrollment is ongoing and further results will be presented. No significant financial relationships to disclose.
A phase I study of intra-arterial (IA) cisplatin (C) and accelerated fractionation (AF) radiotherapy (RT) for locally advanced head and neck squamous cell carcinoma (HNSCC)
Authors: Yu K. , Yu S. C. , Vlantis A. C. , Kam M. K. , Hui E. P. , King A. , Tsang R. K. , Tse G. M. , Mo F. , Chan A. T. 
Published: March 2020

16512 Background: Concurrent IAC and conventional fractionation (CF) RT is an effective treatment for locally advanced HNSCC. AF RT with 2 late concurrent IAC doses may be equally effective since AF RT produces better local tumor control compared with CF RT and late chemotherapy boost may counteract accelerated repopulation of tumor cells. The maximum-tolerated dose (MTD) of IAC given concurrently with AF RT is not known. Methods: A phase I study was conducted in patients with locally advanced stage III/IV HNSCC to determine the MTD of C that was given as 2 selective IA infusions 1 week apart during the last 2 weeks of AF RT (70 Gy/35 fractions/6 weeks) using 6 fractions/week. IV sodium thiosulfate was used to neutralize the systemic toxicity of C. Starting at 100 mg/m2, cohorts of 3 to 6 patients were treated with escalating doses of IAC, in 25 mg/m2 increments, up to the highest level of 200 mg/m2 per infusion. Dose-limiting toxicity (DLT) was defined as the occurrence in 2 patients at a dose level of grade 3 acute mucositis or skin reactions lasting more than 8 weeks after completion of treatment; grade 4 hematologic, infective, metabolic or hearing toxicity; or grade 3 renal, hepatic or neurological toxicity. The MTD was defined as the dose level immediately lower than that resulting in DLT. Results: Ten patients were recruited with a mean age of 56 years. Two patients had stage III; 1, stage IVa; and 7, stage IVb disease. The T-stages were T1 (n = 2), T2 (n = 1), T3 (n = 2), and T4 (n = 5). The N-stages were N0 (n = 2), N1 (n = 1), N2 (n = 4), and N3 (n = 3). Three patients received IAC at a dose level of 100 mg/m2, 3 at 125 mg/m2, and 4 at 150 mg/m2. All patients had the 2 planned doses except one in the lowest dose level who developed grade 3 hyponatremia after the first dose. There was no treatment-related mortality. DLT occurred in 2 patients at the 150 mg/m2 dose level. One of them had grade 4 leukopenia, and the other had grade 3 acute skin reactions lasting 9 weeks after RT. Thus, MTD was 125 mg/m2. At a median follow-up of 24 months, 6 patients remained alive and disease-free. Conclusions: In patients with locally advanced HNSCC, AF RT with 2 doses of late IAC boost was feasible. The MTD of IAC was 125 mg/m2. No significant financial relationships to disclose.
Gabapentin for the treatment of pain related to radiation-induced mucositis in patients with head and neck cancers treated with intensity modulated radiation therapy (IMRT)
Authors: Bar Ad V. , Both S. , Dutta P. , Quon H. 
Published: March 2020

16513 Background: Gabapentin has been reported to effectively treat multiple neuropathic pain syndromes. This retrospective study evaluates the efficacy of gabapentin for the treatment of pain related to radiation induced mucositis, in patients with head and neck cancers, treated with radiation therapy (RT). Methods: This retrospective study includes 30 pts with head and neck cancers, treated with RT, without concomitant or induction chemotherapy. IMRT planning was performed using a concomitant boost technique with a median dose of 54 Gy, 63 Gy, and 66 Gy delivered to the low risk clinical tumor volume (CTV), high risk CTV and boost target volume, respectively, using 30- 34 fractions. The dose of gabapentin was gradually increased starting on the second week of RT from 600 mg/day to the dose of 2700 mg/d over the course of one week. Narcotic pain medication (Roxicodone) was prescribed as needed. Results: 26 (86%) pts required no pain medication during the first two weeks of RT, despite the presence of grade 1 and/or 2 mucositis in 24 of them. During the third and fourth weeks of RT, 28 (93%) pts were treated with a median dose of 2700 mg/day of gabapentin, with only 3 (10%) pts requiring low dose narcotic pain medication, 15–30 mg/day of Roxicodone, added to gabapentin for adequate pain control, despite grade 2 or higher mucositis in 22 pts. During weeks 5 and 6, 28 (93%) pts continued to be treated with a median dose of 2700 mg/day of gabapentin with only 10 (35%) pts requiring 15–40 mg/day of Roxicodone, in addition to gabapentin for pain control, despite the presence of grade 2 or higher mucositis in 23 pts. Only 3% of the pts in this group had delay in RT delivery. Gabapentin was well tolerated with only 13% of pts experiencing mild side effects (somnolence, nausea, or vomiting), which were managed with reducing the dose or changing the dosing schedule. Conclusions: Gabapentin is effective and well-tolerated for the treatment of mucositis-induced pain related to radiation treatment in patients with head and neck cancers, treated with IMRT. We further demonstrate that the use of gabapentin at doses of 2700 mg per day can reduce or eliminate the need for narcotic pain medication. No significant financial relationships to disclose.
Phase I trial of pemetrexed (P) in combination with cetuximab (C) and concurrent radiotherapy (RT) in patients (pts) with head and neck cancer (HNC)
Authors: Smith R. , Karamouzis M. V. , Heron D. E. , Ferris R. L. , Lai S. Y. , Kim S. , Boyer T. , Grandis J. R. , Johnson J. T. , Argiris A. 
Published: March 2020

16516 Background: P is a multitargeted antifolate that has demonstrated activity in HNC and radiosensitizing properties in animal models. C is a chimeric IgG1 monoclonal antibody directed against the epidermal growth factor receptor that has increased the survival of pts with stage III/IV HNC when added to RT. We conducted a phase I study to evaluate the dose-limiting toxicities (DLT) and maximum tolerated dose of P when combined with standard RT and C. Methods: Pts with high-risk HNC were enrolled and evaluated separately in 2 cohorts: pts with no prior head and neck RT (cohort A) and previously irradiated pts (cohort B). A loading dose of C 400 mg/m2 was given intravenously 7 days prior to starting RT followed by 250 mg/m2 weekly throughout RT. RT was given 2 Gy/day to a total dose of 70 Gy (cohort A) or 60–66 Gy (cohort B). P was administered intravenously on days 1 and 22 (and day 43 if >60 Gy was delivered) according to the following design: Starting dose level (0)-350 mg/m2, dose level (-1)-200 mg/m2, dose level (+1)-500 mg/m2. Additional pts could be treated at a lower dose level while other pts were being evaluated at a higher dose level. Results: 18 pts have been enrolled (A: 14; B:4). 2 pts in cohort A were not evaluable and replaced (1 pt was noncompliant due to transportation issues and 1 pt had sudden death attributable to aspiration). Histological types: squamous cell (13), undifferentiated (1), medullary thyroid (1), adenoid cystic (1), and adenosquamous carcinomas (2). In cohort A, 2 DLT (both neutropenic fever with ANC <500) occurred: 1/6 at dose level 0 and 1/6 at dose level -1. In cohort B, no DLT has occurred: 0/3 pts at dose level 0 and 0/1 pts at dose level +1. There were no grade (G) 4 non- hematologic toxicities. Other serious toxicities included: neutropenic fever (NF) with ANC <1000 (n=1), G 3/4 neutropenia (n=3/n=4), G 3 dysphagia (n=5), G 3 dermatitis (n=3), G 3 mucositis (n=4), G 3 fatigue (n=1), and G 3 anemia (n=1). Due to the development of 3 cases of NF in cohort A the protocol was amended and prophylactic antibiotics were added. Conclusions: The addition of P to RT and C was feasible in pts with or without a history prior RT. Neutropenia and in-field toxicities were predominant but manageable. Pts are currently being treated at dose level +1 (P 500 mg/m2). No significant financial relationships to disclose.
Retrospective analysis of surgical resection after induction chemotherapy for patients with T4b squamous cell head and neck cancer
Authors: Rivera F. , Vega-Villegas M. E. , López C. , López-Brea M. F. , Rodriguez-Iglesias J. , Rubio A. , del Valle A. , García- Reija M. F. , García-Montesinos B. , Sanz-Ortiz J. 
Published: March 2020

16517 Background: Although standard treatment of patients with T4b Squamous Cell Head and Neck Cancer (T4b-SCHNC) for the last decade has been concomitant Chemo-Radiotherapy (CT-RT), recent Phase III trials with new Induction Chemotherapy (IC) regimens suggest that IC could also play a role in this setting. The value of adding surgery of the residual mass after IC and before RT if the resection is technically feasible is not clear in this context. Methods: We present the results of a retrospective analysis focused on this topic. Results: Between 1984 and 2001, 113 patients (pts) with T4b-SCHNC were treated at our institution with platin-based IC. Four pts dead during IC and 57 pts achieved a complete or a >90% partial response at primary and proceeded to definitive RT (or concomitant CT/RT). In the other 52 pts, surgical resection was reconsidered after IC and before RT and in 13 of them this surgery was performed: in 7 pts (6 had PR and 1 minor response after IC) the resection was R1, all these patients had loco-regional progression (2 of them also developed systemic metastases) and median OS after surgery was 21 months with no patient alive at 48 months; In the other 6 pts (3 had a PR and 3 had minor response after IC) an R0 resection was performed: 3 of these pts had loco-regional relapses (1 of them also developed systemic metastases) and the other 3 pts remain alive and disease free 56, 62 and 72 months after surgery. OS of the 52 pts that achieved less than a 90% partial response at primary with IC, was equivalent for those no resected after IC pts and for R1 resected pts (actuarial 5 year OS 8% vs 0%, lrk, p=0,74) but a statistically significant improvement in OS was observed when an R0 resection was obtained after IC (actuarial 5 years OS 50%, lrk, p=0,02).Conclusions: R0 resections after IC and before RT could improve OS in pts with T4b-SCHNC that obtain less than a 90%PR at primary after IC. R1 resection appears to have no value in this setting. This approach should be studied in properly designed prospective clinical trials. No significant financial relationships to disclose.
Malignant salivary gland tumors: A large single-institutional series evaluating long-term outcome
Authors: Limaye S. , Dulala R. , Roy R. , Thomas A. , Janson D. , Fantasia J. , Mehrotra B. 
Published: March 2020

16523 Background: Malignant salivary gland tumors comprise 3 to 6% of Head and Neck cancers. Long term survival data for salivary gland tumors are lacking. We undertook an analysis of all such patients treated at our institution over a 15 yr period. Methods: IRB approval was obtained for this retrospective analysis. Tumor registry data were reviewed for all adult patients diagnosed with salivary gland malignancies for the years 1990 - 2005. Age, Gender, Stage, histology, treatment modalities and survival data were recorded. Results: 200 patients were identified. Median age was 64 yrs (59–69). M:F ratio was 1:1.1 (M: 96; F: 104). Histology and stages: ( Table 1 )Mucoepidermoid Carcinoma (n=50), Adenoid Cystic Carcinoma (n=21), Acinar Cell Carcinoma (n=19), Adenocarcinoma (n=22; Stages: I= 7, II= 4, III= 3, IV= 8), Squamous (n= 12; Stages: I= 1, II= 3, III= 3, IV=5), Poorly Differentiated Carcinoma(n=10), Epithelial Myoepithelial Carcinoma (n=7), Malignant Mixed Carcinoma (n=4), Malignant Myoepithelioma (n=2), Carcinoma in Pleomorphic Adenoma (n=2) and Others (n=15). Hodgkin's and NHL (n=36).Treatment modalities: Surgery (S): n=88 (44%), Radiotherapy (RT): n=6 (3%); Chemotherapy (CT): n=6 (3%); S+RT: n =76(38%); S+CT: n=8 (4%); RT+CT: n =2(1%); S+RT+CT: n =4 (2%). Observation only : n=10(5%). Survival data (Med. survival and 5 yr OS respectively) for all histologies excluding lymphomas are: Stage I - 84 mos,93%; II - 93 mos,85%; III - 39 mos,60 %; IV - 24 mos, 40%. Survival data (Med survival and 5 yr OS) for lymphomas: Stage I - 55 mos,85%; II - 20 mos, 0%; III - 100 mos, 100%; IV- 48 mos, 25%. Median survival of all histology types excluding lymphoma by treatment: S=55 mos, S+RT= 60 mos, S+ CT= 56 mos, RT= 53 mos, RT+CT=15 mos, CT= 24 mos. Conclusions: This large series provides long term outcome data for a relatively rare group of HNCs. Long term survival is noted in several histological sub-types even in the setting of advanced disease. These data should help further define the natural history and biological behaviors of these tumors. [Table: see text] No significant financial relationships to disclose.