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1.  Potential risk factors for jaw osteoradionecrosis after radiotherapy for head and neck cancer 
To identify potential risk factors for the development of jaw osteoradionecrosis (ORN) after 3D-conformal radiotherapy (3D-CRT) and intensity-modulated radiotherapy (IMRT) among patients with newly diagnosed head and neck cancer.
Material and methods
This study included 776 patients who underwent 3D-CRT or IMRT for head and neck cancer at the Department of Radiotherapy at the University Hospital Halle-Wittenberg between 2003 and 2013. Sex, dental status prior to radiotherapy, tumor site, bone surgery during tumor resection, concomitant chemotherapy, and the development of advanced ORN were documented for each patient. ORN was classified as grade 3, 4, or 5 according to the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer classification or grade 3 or 4 according to the late effects in normal tissues/subjective, objective, management, and analytic scale. The cumulative incidence of ORN was estimated. Cox regression analysis was used to identify prognostic risk factors for the development of ORN.
Fifty-one patients developed advanced ORN (relative frequency 6.6 %, cumulative incidence 12.4 %). The highest risk was found in patients who had undergone primary bone surgery during tumor resection (hazard ratio [HR] = 5.87; 95 % confidence interval [CI]: 3.09–11.19) and in patients with tumors located in the oral cavity (HR = 4.69; 95 % CI: 1.33–16.52). Sex, dentition (dentulous vs. edentulous), and chemotherapy had no clinically relevant influence.
Discussion and conclusion
In contrast to most previous studies, we noted a low cumulative incidence of advanced ORN. Patients with tumors located in the oral cavity and those who undergo bone surgery during tumor resection prior to RT may be considered a high-risk group for the development of ORN.
PMCID: PMC4967325  PMID: 27473433
Osteoradionecrosis; Radiotherapy; Head and neck cancer; Dental status; Bone surgery; Tumor site
2.  Radiation myelitis after hypofractionated radiotherapy with concomitant gefitinib 
We describe the case of a 71-year-old Caucasian female with primary disseminated non-small cell cancer of the lung, presented for palliative radiotherapy of metastatic spread to the 9th and 11th thoracic vertebrae without intramedullary growth. Palliative radiotherapy with daily fractions of 3 Gy and a cumulative dose of 36 Gy to thoracic vertebrae 8-12 was performed. The patient received concomitantly 250 mg gefitinib daily. After a latent period of 16 months, the patient developed symptoms of myelitis. Magnetic resonance imaging (MRI) did not reveal any bony or intraspinal tumor progression, but spinal cord signal alteration. No response to steroids was achieved. The neurological symptoms were progressive in August 2013 with the right leg being completely plegic. The left leg was incompletely paralyzed. Deep and superficial sensitivity was also diminished bilaterally. The patient was completely urinary and anally incontinent. Contrary to the clinical findings, a follow-up MRI (July 2013) showed amelioration of the former signal alterations in the spinal cord. The diagnosis of paraneoplastic myelopathy was refuted by a negative test for autologous antibodies. At the last clinical visit in May 2014, the neurological symptoms were stable. The last tumor-specific treatment the patient is receiving is erlotinib 125 mg/d.
We reviewed the literature and found no reported cases of radiation myelopathy after the treatment in such a setting. The calculated probability of such complication after radiotherapy alone is statistically measurable at the level of 0.02%. We suppose that gefitinib could also play a role in the development of this rare complication.
PMCID: PMC4313465  PMID: 25631068
Radiation myelitis; Concomitant radiotherapy; Gefitinib
3.  Subjective voice quality, communicative ability and swallowing after definitive radio(chemo)therapy, laryngectomy plus radio(chemo)therapy, or organ conservation surgery plus radio(chemo)therapy for laryngeal and hypopharyngeal cancer 
Journal of Radiation Research  2014;56(1):159-168.
This retrospective analysis focusses on the impact of therapy on perceived long-term post-cancer treatment function. A validated questionnaire including items and components for the assessment of communicative ability, quality of voice and swallowing was sent to 129 patients. All patients were treated between 1998 and 2007. A total of 76 patients (58.9%) with carcinoma of the larynx or hypopharynx replied to the questionnaire. Data was evaluated retrospectively. Therapy delivered was definitive radio(chemo)therapy (defchRT/RT) (21/76, 28%), laryngectomy + radio(chemo)therapy (LE + chRT/RT) (28/76, 37%), or larynx conservation surgery + radio(chemo)therapy (LCS + chRT/RT) (27/76, 36%). Radiotherapy was administered using 2D- or 3D-conformal planning. The most common concomitant chemotherapy delivered was cisplatin + 5FU. For statistical analyses of the components, averages were calculated and tested using the Kruskal–Wallis test and the U-test of Mann and Whitney. Differences were assessed by the Monte Carlo method or Fisher's exact test. The single item rates were compared with Fisher's exact test. Mean follow-up was 56.7 months (range, 8–130 months). After defchRT/RT, patients trended towards more substantial–strong hoarseness compared with LCS + chRT/RT (P = 0.2). After LE, patients were dissatisfied with their artificial larynx/electrolarynx and the tone of their voice (P = 0.3, P = 0.07) and communicative ability (P = 0.005, P = 0.008) compared with those treated with defchRT/RT and LCS + chRT/RT, respectively. Dysphagia and additional percutaneous endoscopic gastrostomy (PEG) feeding were more frequent after defchRT/RT in comparison with the other two groups (P < 0.05). Voice quality and communicative ability were slightly worse after defchRT/RT and LE + chRT/RT, but satisfying with all treatment modalities. Further development of the therapy approach is necessary to reduce long-term side effects, with measures of post-treatment function as important endpoints.
PMCID: PMC4572584  PMID: 25348250
radiation; surgery; quality of voice; dysphagia
4.  Phase I trial of split-dose induction docetaxel, cisplatin, and 5-fluorouracil (TPF) chemotherapy followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1) 
BMC Cancer  2012;12:483.
Induction chemotherapy (ICT) with docetaxel, cisplatin and fluorouracil (TPF) followed by radiotherapy is an effective treatment option for unresectable locally advanced head and neck cancer. This phase I study was designed to investigate the safety and tolerability of a split-dose TPF ICT regimen prior to surgery for locally advanced resectable oral and oropharyngeal cancer.
Patients received TPF split on two dosages on day 1 and 8 per cycle for one or three 3-week cycles prior to surgery and postoperative radiotherapy or radiochemotherapy. Docetaxel was escalated in two dose levels, 40 mg/m2 (DL 0) and 30 mg/m2 (DL −1), plus 40 mg/m2 cisplatin and 2000 mg/m2 fluorouracil per week using a 3 +3 dose escalation algorithm.
Eighteen patients were enrolled and were eligible for toxicity and response. A maximum tolerated dose of 30 mg/m2 docetaxel per week was reached. The most common grade 3+ adverse event was neutropenia during ICT in 10 patients. Surgery reached R0 resection in all cases. Nine patients (50%) showed complete pathologic regression.
A split-dose regime of TPF prior to surgery is feasible, tolerated and merits additional investigation in a phase II study with a dose of 30 mg/m docetaxel per week.
Trial registration number
NCT01108042 ( Identifier)
PMCID: PMC3485626  PMID: 23083061
Docetaxel; Cisplatin; 5-fluorouracil; Locally advanced oral cancer; Surgery; Radiotherapy
5.  Parotid gland-recovery after radiotherapy in the head and neck region - 36 months follow-up of a prospective clinical study 
The aim of the present study was to evaluate the recovery potential of the parotid glands after using either 3D-conformal-radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) by sparing one single parotid gland.
Between 06/2002 and 10/2008, 117 patients with head and neck cancer were included in this prospective, non-randomised clinical study. All patients were treated with curative intent. Salivary gland function was assessed by measuring stimulated salivary flow at the beginning, during and at the end of radiotherapy as well as 1, 6, 12, 24, and 36 months after treatment. Measurements were converted to flow rates and normalized relative to rates before treatment. Mean doses (Dmean) were calculated from dose-volume histograms based on computed tomographies of the parotid glands.
Patients were grouped according to the Dmean of the spared parotid gland having the lowest radiation exposure: Group I - Dmean < 26 Gy (n = 36), group II - Dmean 26-40 Gy (n = 45), and group III - Dmean > 40 Gy (n = 36). 15/117 (13%) patients received IMRT. By using IMRT as compared to 3D-CRT the Dmean of the spared parotid gland could be significantly reduced (Dmean IMRT vs. 3D-CRT: 21.7 vs. 34.4 Gy, p < 0.001). The relative salivary flow rates (RFSR) as a function of the mean parotid dose after 24 and 36 months was in group I 66% and 74%, in group II 56% and 49%, and in group III 31% and 24%, respectively. Multiple linear regression analyses revealed that the parotid gland dose and the tumor site were the independent determinants 12 and 36 months after the end of RT. Patients of group I and II parotid gland function did recover at 12, 24, and 36 months after the end of RT.
If a Dmean < 26 Gy for at least one parotid gland can be achieved then this is sufficient to reach complete recovery of pre-RT salivary flow rates. The radiation volume which depends on tumor site did significantly impact on the Dmean of the parotids, and thus on the saliva flow and recovery of parotid gland.
PMCID: PMC3201902  PMID: 21951317
head and neck cancer; irradiation; saliva; hyposalivation; parotid gland sparing; recovery
6.  Plasma osteopontin levels in patients with head and neck cancer and cervix cancer are critically dependent on the choice of ELISA system 
BMC Cancer  2006;6:207.
The tumor-associated glycoprotein osteopontin (OPN) is discussed as a plasma surrogate marker of tumor hypoxia and as an indicator of the presence of pleural mesothelioma in asbestos-exposed individuals. The clinical introduction of plasma OPN measurements requires the availability of a reliable enzyme-linked immunosorbence assay (ELISA).
We compared previously described and currently available ELISA systems on 88 archival plasma samples obtained from patients with head and neck or cervix cancer between 20 days before and 171 after the start of radiotherapy.
Median (range) plasma OPN levels were 667 (148.8–2095) ng/ml and 9.8 (3.5–189.5) ng/ml for a previously described and a newly marketed assay, respectively. Although results for different assays were significantly correlated (r = 0.38, p < 0.05, Spearman rank test), between-assay factors ranged from 2.0 to 217.9 (median 74.6) in individual patients. OPN levels in cervix cancer patients were comparable to those of head and neck cancer patients.
Commercially available OPN ELISA systems produce different absolute plasma OPN levels, compromising a comparison of individual patient data with published results. However, different assays appear to have a similar capacity to rank patients according to plasma OPN level. A review of literature data suggests that plasma OPN levels measured even with identical ELISA systems can only be compared with caution.
PMCID: PMC1564036  PMID: 16911785

Results 1-6 (6)