scholarly journals Institutional Clinical Trial Accrual Volume and Survival of Patients With Head and Neck Cancer

2015 ◽  
Vol 33 (2) ◽  
pp. 156-164 ◽  
Author(s):  
Evan J. Wuthrick ◽  
Qiang Zhang ◽  
Mitchell Machtay ◽  
David I. Rosenthal ◽  
Phuc Felix Nguyen-Tan ◽  
...  

Purpose National Comprehensive Cancer Network guidelines recommend patients with head and neck cancer (HNC) receive treatment at centers with expertise, but whether provider experience affects survival is unknown. Patients and Methods The effect of institutional experience on overall survival (OS) in patients with stage III or IV HNC was investigated within a randomized trial of the Radiation Therapy Oncology Group (RTOG 0129), which compared cisplatin concurrent with standard versus accelerated fractionation radiotherapy. As a surrogate for experience, institutions were classified as historically low- (HLACs) or high-accruing centers (HHACs) based on accrual to 21 RTOG HNC trials (1997 to 2002). The effect of accrual volume on OS was estimated by Cox proportional hazards models. Results Median RTOG accrual (1997 to 2002) at HLACs was four versus 65 patients at HHACs. Analysis included 471 patients in RTOG 0129 (2002 to 2005) with known human papillomavirus and smoking status. Patients at HLACs versus HHACs had better performance status (0: 62% v 52%; P = .04) and lower T stage (T4: 26.5% v 35.3%; P = .002) but were otherwise similar. Radiotherapy protocol deviations were higher at HLACs versus HHACs (18% v 6%; P < .001). When compared with HHACs, patients at HLACs had worse OS (5 years: 51.0% v 69.1%; P = .002). Treatment at HLACs was associated with increased death risk of 91% (hazard ratio [HR], 1.91; 95% CI, 1.37 to 2.65) after adjustment for prognostic factors and 72% (HR, 1.72; 95% CI, 1.23 to 2.40) after radiotherapy compliance adjustment. Conclusion OS is worse for patients with HNC treated at HLACs versus HHACs to cooperative group trials after accounting for radiotherapy protocol deviations. Institutional experience substantially influences survival in locally advanced HNC.

2017 ◽  
Vol 35 (5_suppl) ◽  
pp. 137-137
Author(s):  
Daisuke Kawakita ◽  
Sarah Abdelaziz ◽  
Yuji Chen ◽  
Kerry G. Rowe ◽  
Yuan Wan ◽  
...  

137 Background: Sites of head and neck are associated with chewing, swallowing and speaking. As for treatment of head and neck cancer (HNC), we have to consider organ preservation as well as clinical outcomes. Although non-surgical treatments have been preferred in recent years, complications after treatment have been a concern. The aim of this study was to evaluate the late effects in a cohort of HNC survivors in Utah compared to a matched cohort of cancer free individuals. Methods: Up to 5 cancer free individuals were matched to each HNC survivor on birth year, sex, birth state, and follow up time. Electronic medical records and statewide ambulatory and inpatient surgery data were used to identify late effects over two time periods: 1-5 and 5-10 years after cancer diagnosis. Cox proportional hazards models were used to estimate the risks of late effects. We adjusted for matching factors, race and number of hospital visit. Results: In this study, 2,432 HNC survivors and 12,149 matched controls were enrolled. More than 80% cases had loco-regional disease and a histological type of squamous cell carcinoma. Hazard ratio (HR) for second primary HNC was notably increased among HNC survivors for both 1-5 years (HR: 1498.46; 95% confidence interval (CI), 158.58-14159.69) and 5-10 years (HR: 1509.62; 95% CI, 147.94-15404.15) post cancer diagnosis. And, HRs for respiratory disease, including respiratory system, lung cancer and pneumoniae, were also increased among HNC survivors for both 1-5 years and 5-10 years post cancer diagnosis. As for hearing loss, HNC survivors had a increased HR for 1-5 years post cancer diagnosis (HR: 5.90; 95% CI, 2.67-13.01) and this association was consistent for 5-10 years post cancer diagnosis (HR: 5.01; 95% CI, 2.06-12.18). Conclusions: In this study, we found HNC survivors have notable associations with second primary HNC, smoking related respiratory disease, and hearing loss which might be associated with chemotherapy when compared to cancer free subjects.


1989 ◽  
Vol 7 (7) ◽  
pp. 838-845 ◽  
Author(s):  
E E Vokes ◽  
W J Moran ◽  
R Mick ◽  
R R Weichselbaum ◽  
W R Panje

To increase the complete response (CR) rate of patients with locally advanced head and neck cancer after three cycles of neoadjuvant chemotherapy, we added sequential methotrexate to the combination of cisplatin and continuous infusion fluorouracil (5-FU). We also evaluated the feasibility of administering three additional cycles of the same regimen as adjuvant chemotherapy. Thirty-eight patients were treated; the median age was 53 years and 36 patients had stage IV disease. Chemotherapy consisted of methotrexate 120 mg/m2 followed 24 hours later by cisplatin 100 mg/m2 and a five-day continuous infusion of 5-FU at 1,000 mg/m2/d. Of 34 patients evaluable for response to neoadjuvant chemotherapy, nine had a CR, 21 a partial response (PR), two a minimal response (MR), and one patient each stable disease (SD) and no response (NR). Of 31 patients who received local therapy, 15 were treated with surgery and radiotherapy and 16 with radiotherapy alone. Of 25 patients eligible to receive adjuvant chemotherapy only ten received all three intended cycles, while 15 received less or no adjuvant chemotherapy because of patient refusal, cumulative toxicity, or early disease progression. With a median follow-up time of 39 months, the median survival is estimated to be 20 months. Of eight patients with nasopharyngeal or paranasal sinus cancer, none has had disease recurrence. Patients with good initial performance status and low N-stage also had a significant survival advantage. Chemotherapy-related toxicities consisted mainly of mucositis, requiring 5-FU dose reduction in the majority of patients; similar toxicities were exacerbated in the adjuvant setting. The addition of methotrexate did not increase the CR rate over what has been reported for the combination of cisplatin and 5-FU alone. Certain subsets of patients appear to have a good prognosis when treated in this fashion. The administration of adequate adjuvant chemotherapy in patients with head and neck cancer remains difficult due to toxicity and poor patient compliance.


1994 ◽  
Vol 12 (2) ◽  
pp. 385-395 ◽  
Author(s):  
S G Taylor ◽  
A K Murthy ◽  
J M Vannetzel ◽  
P Colin ◽  
M Dray ◽  
...  

PURPOSE To compare two published schedules of cisplatin plus fluorouracil (5-FU) infusion and radiation as either sequential or concomitant treatment for toxicity and efficacy in patients with unresectable head and neck cancer. PATIENTS AND METHODS This was a randomized trial between cisplatin 100 mg/m2 over 15 minutes on day 1 plus 5-FU 1.0 g/m2 by continuous infusion on days 1 to 5, repeated every 3 weeks for three cycles, followed by 70 Gy of radiation in 7 to 8 weeks, versus cisplatin 60 mg/m2 over 15 minutes on day 1 plus 5-FU 800 mg/m2 by continuous infusion on days 1 to 5 plus radiation 2 Gy on days 1 to 5, repeated every other week for seven cycles. Unresectable head and neck squamous cancer patients not previously treated with radiation or chemotherapy and with a performance status of 0 to 2 were stratified by tumor (T) and node (N) groupings and performance status and randomized. RESULTS Two hundred fifteen patients were entered and 214 analyzed, 107 on each arm. After all treatment, overall response rates were different (P = .003), with similar complete response rates, but more partial responses and fewer patients with no change or progression with concomitant treatment. Cox regression analysis for progression-free survival identified concomitant treatment (P = .003), Radiation Therapy Oncology Group (RTOG) stage III grouping (P < .0001), performance status (P = .0002), concomitant treatment (P = .003), and treating institution (P = .006) as significant. The sequential and concomitant treatments showed similar distant failure patterns (10% and 7%, respectively), but divergent regional failure rates (55% and 39%). Severe and worse toxic events were similar between the treatment programs, but radiation-induced mucositis combined with cisplatin-induced water-losing nephropathy, in the concomitant arm only, demanded more supportive care. Survival duration was similar between the treatment arms, but significantly more patients in the sequential arm died of their cancer (P = .011). CONCLUSION Concomitant treatment offered improved disease control, predominantly of regional disease, but benefit was dependent on the experience of the treating institution. Translation of this benefit into improved survival is not yet evident, with an excess of deaths from other causes in the concomitant arm.


2021 ◽  
Author(s):  
Hao Song ◽  
Ranran Yang ◽  
Kailiu Wu ◽  
Chao Lou ◽  
Meng Xiao ◽  
...  

Abstract Background:The clinical characteristics of second primary tumors in oral cavity after radiation was a special subtype of oral cancer and remained poorly studied. The purpose of the present study was to investigate the clinicopathological characteristics and prognostic factors of second primary oral squamous cell carcinoma (OSCC) after radiotherapy for head and neck cancer.Methods:The clinicopathological characteristics of 48 OSCC patients underwent radiotherapy for head and neck cancer were retrospectively analyzed by Kaplan-Meier survival analysis and Cox proportional hazards model, including gender, age, alcohol consumption, smoking, clinical stage, margin status, regional lymph node status, tumor differentiation and treatment mode.Results:The second primary OSCC mostly occurred on the tongue (18/48), bucca (12/48) and gingiva (10/48), and the 3- and 5-year overall survival (OS) was 60.3% and 39.4%, respectively. Margin status (p=0.001, log-rank=10.777) and extranodal extension (p=0.045, log-rank=4.017) were significantly associated with OS, while only margin status was found to be an independent prognostic factor of OS in the Cox proportional hazards model (p=0.003, HR=3.976).Conclusions: OSCC patients underwent radiotherapy for head and neck cancer show poor survival outcomes. Margin status is an independent prognostic factor of second primary OSCC, and the prognostic of second primary OSCC was not in accordance with sporadic OSCC.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5501-5501 ◽  
Author(s):  
J. Bourhis ◽  
A. Le Maı̂tre ◽  
J. Pignon ◽  
K. Ang ◽  
J. Bernier ◽  
...  

5501 Background: The Meta-Analysis of Radiotherapy in Carcinomas of Head & Neck (MARCH; Bourhis J, ASTRO 2002) showed that altered fractionation radiotherapy (Alt-RT) could improve survival as compared to standard RT in patients with locally advanced HNC (pooled hazard ratio - HR -: 0.92, 95% confidence interval: 0.86–0.97). The Meta-Analysis of Chemotherapy in Head and Neck Cancer (MACH-NC; Bourhis J, ASCO 2004) demonstrated that concomitant chemotherapy (CT), added to RT, improved survival (HR: 0.82, 95% CI: 0.78–0.86). This study considers age as a potential modifier of the treatment effect. Methods: 15 randomized trials with 6,515 patients were included in MARCH (median follow up: 6.0 years), and 50 with 9,471 patients in concomitant part of MACH-NC (median follow up: 5.6 years). The interaction between age and treatment effect, using HR of death, was tested with heterogeneity test. Effect of prognostic factors on the interaction was analysed using Cox model. Results: The effect of Alt-RT in MARCH and of concomitant CT in MACH-NC on overall survival decreased with increased age ( table ). Patients aged 71+ had a lower performance status, less advanced stage, and more often laryngeal cancer than the younger patients; there were more women in the oldest patients group. However, adjusting on covariates did not modify the results. Causes of death was available in MARCH and in recent (1994–2000) trials of MACH-NC. The proportion of deaths not due to HNC increased with age, from 18% at age 50 to 41% at age 71+ in MARCH, and from 15% to 39% in MACH-NC. Conclusions: Treatment benefit decreases with increasing age. Patients aged 71+ did not benefit from Alt- RT nor from concomitant CT. The increasing risk of death from other causes with age may explain part of these observations. Supported by PHRC, ARC, LNCC [Table: see text] No significant financial relationships to disclose.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6086-6086
Author(s):  
F. C. Holsinger ◽  
W. Dong ◽  
N. Bekele ◽  
R. S. Weber ◽  
M. S. Kies ◽  
...  

6086 Background: Despite advances in achieving improved locoregional control for patients with head and neck cancer (HNC), overall survival has not improved in the last 30 years. Several studies have implicated distant metastasis as a potential cause, hindering progress in the treatment of HNC. However, little is known about which patients fail systemically. We therefore sought to identify clinico-pathological factors that are associated with distant metastasis as the only cite of failure. Methods: We retrospectively studied 389 patients with head neck squamous cell carcinomas with distant metastases as the primary site of failure excluding all patients with locoregional recurrence and those receiving chemotherapy at primary presentation. The median follow up period was 5.3 years. An estimate of the risk of DM and DM free survival by prognostic factors was calculated using multivariate analysis and Cox proportional modeling. Results: Overall, 11% (43/389) of the patients developed DM. With univariate analysis, site of the tumor arising within the laryngopharynx, T stage (T3–4), N stage>2, and metastasis to level IV were significantly associated with DM. However, using Cox proportional hazards regression modeling, two clinicopathologic variables, N classification >N2b and diminishing degree of histologic differenention, were found to be most significantly associated with the development of systemic, distant metastasis. For patients staged as N2b or N2c, there was a relative risk (RR) of 6.13 (95% CI: 2.61 - 14.38; p < 0.0001) for developing DM. For patients staged as N3, the RR was 8.23 (95% CI: 2.39 - 28.38; p < 0.001). For patients with poorly differently HNSCC, RR was 11.01 (95% CI: 1.42 - 85.15; p = 0.022) Conclusions: Recognizing patients at primary presentation with tumors with the highest risk for the development of DM might le us to selectively treat them aggressively with systemic therapy to eradicate the tumor, thus improving overall survival rates. No significant financial relationships to disclose.


1995 ◽  
Vol 81 (5) ◽  
pp. 354-358 ◽  
Author(s):  
◽  
George Fountzilas ◽  
Dimosthenis Skarlos ◽  
Angelos Nikolaou ◽  
Anna Kalogera-Fountzila ◽  
...  

Aims and Background To improve local control in patients with locally advanced inoperable head and neck cancer we administered carboplatin concurrently with radiation. Methods Thirty-nine patients entered the study. There were 35 men and 4 women with a median age of 58 years (range, 24-74) and a median performance status of 90 (range, 60-100) of the Karnofsky scale. The primary site included nasopharynx (5 patients), oropharynx (n=10), hypopharynx (n=5), larynx (n=12), oral cavity (n=2), paranasal sinuses (n=3), salivary glands (n=1) and unknown (n=1). Histology was squamous cell carcinoma in all cases. All patients were irradiated with a 60Co unit. According to the protocol, they should receive 66-70 Gy to the tumor area and 45 Gy to the tumor-free area of the neck. Carboplatin was administered at a dose of 400 mg/m2 on days 2, 22 and 42. Results Totally, 112 cycles of carboplatin were administered, of which 106 (95%) were at full dose. Median dose intensity of carboplatin actually delivered was 170 mg/m2/week (range, 57-200). All patients were irradiated, although only 30 (77%) received >66 Gy. After the completion of combined treatment, 23 (59%, 95% C.I. 42-74%) achieved a CR and 10 (26%, 95% C.I. 13-42%) a PR. Grade 3-4 myelotoxicity was noticed in 60% of the patients. Other grade 3-4 toxicities included stomatitis (13%), dysphagia (5%) and weight loss (3%). Median time to progression was 18 months (range, 2-25). Conclusions Radiation and concurrent administration of carboplatin determined a high CR rate in patients with HNC, although the superiority of this combined modality approach over radiation alone has to be proven in phase III trials.


2009 ◽  
Vol 18 (4) ◽  
pp. 433-437 ◽  
Author(s):  
Giorgio Capuano ◽  
Pier Carlo Gentile ◽  
Federico Bianciardi ◽  
Michela Tosti ◽  
Anna Palladino ◽  
...  

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