Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy—results of a multicentric randomized German trial in advanced head-and-neck cancer

Staar, Susanne; Rudat, Volker; Stuetzer, Hartmut; Dietz, Andreas; Volling, P.; Schroêder, M.; Flentje, Michael; Eckel, Hans Edmund; Mueller, Rolf‐Peter

doi:10.1016/s0360-3016(01)01544-9

Cited by 347 publications

(217 citation statements)

References 33 publications

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“…The reduction in incidence of ORN occurred despite increasing intensity of therapy in recent years, such as concurrent chemo-RT and altered fractionated RT, which are characterized by increased acute side effects of therapy and occasionally by increased rates of late sequellae 19,20 . The reduction in recent years of ORN risk is reflected in our series, in which no case was observed among 176 patients, with a 95% confidence interval of 0; 2% (meaning that we cannot exclude a rate of ORN of up to 2% in patient populations similar to the sample we have studied).…”

Section: Discussionmentioning

confidence: 99%

Lack of Osteoradionecrosis of the Mandible After Intensity-Modulated Radiotherapy for Head and Neck Cancer: Likely Contributions of Both Dental Care and Improved Dose Distributions

Ben‐David

Diamante

Radawski

et al. 2007

International Journal of Radiation Oncology*Biology*Physics

269

223

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Purpose-To assess the prevalence and the dosimetric and clinical predictors of mandibular osteoradionecrosis (ORN) in patients with head and neck (HN) cancer who underwent pre-therapy dental evaluation and prophylactic treatment according to a uniform policy and were treated with intensity modulated radiation therapy (IMRT). [1996][1997][1998][1999][2000][2001][2002][2003][2004][2005] all patients with HN cancer treated with parotid gland sparing IMRT in prospective studies underwent dental examination and prophylactic treatment according to a uniform policy including extractions of high-risk, periodontally involved and nonrestorable teeth in parts of the mandible expected to receive high doses, fluoride supplements, and guards aiming to reduce electron backscatter off metal teeth restorations. The IMRT plans included dose constraints for the maximal mandibular doses and reduced mean parotid gland and non-involved oral cavity doses. Retrospective analysis of grade ≥2 (clinical) ORN was performed. Methods and Materials-BetweenResults-176 patients had minimal follow-up 6 months. Thirty-one (17%) had teeth extractions prior to radiation and 13 (7%) post-radiation. 75% and 50% of the patients received at least 65Gy and 70Gy to ≥ 1% of the mandibular volumes, respectively. Fall-off across the mandible characterized the dose distributions: the average gradient (in the axial plane containing the maximal mandibular dose) was 11 Gy (range 1-27Gy, median 8Gy). At median 34 months follow-up there were no cases of ORN (95% CI, 0; 2%).Conclusions-The use of a strict prophylactic dental care policy and IMRT resulted in no case of clinical ORN. In addition to the dosimetric advantages offered by IMRT, meticulous dental prophylactic care is likely an essential factor in reducing ORN risk.

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Section: Discussionmentioning

confidence: 99%

Lack of Osteoradionecrosis of the Mandible After Intensity-Modulated Radiotherapy for Head and Neck Cancer: Likely Contributions of Both Dental Care and Improved Dose Distributions

Ben‐David

Diamante

Radawski

et al. 2007

International Journal of Radiation Oncology*Biology*Physics

269

223

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“…At least seven prospective phase III trials comparing concurrent chemotherapy-radiation therapy vs radiation therapy have been reported (Table 4). [18][19][20][21][22][23][24] All were positive in favor of the combined-therapy arm. The majority of these randomized trials used hyperfractionated radiation therapy as the standard arm and in combination with chemotherapy, despite previous reports of no improvement in overall survival when daily irradiation was compared with twice-a-day radiation therapy.…”

Section: Locally Advanced Resectable Cancermentioning

confidence: 99%

Treatment of Locally Advanced Head and Neck Cancer: Historical and Critical Review

Al‐Sarraf

2002

Cancer Control

104

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Background Advanced squamous cell cancers of the head and neck have traditionally been associated with high rates of morbidity and mortality. Advances in management have improved outcomes for most of these patients. Methods The author reviews the historical progress in management of these difficult tumors and adds his own wide experience to describe and evaluate newer approaches to management. Results Over the last 10 years, overall survival rates for patients with head and neck cancers have improved as has quality of life. New standards of care have been defined for patients with nasopharyngeal cancer and for those with advanced unresectable disease. Organ preservation is more commonly achieved. Conclusions Newer targeted therapies are likely to add to the progress that has already been achieved in the multimodality management of patients with head and neck cancers.

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“…Numerous systemic agents have been employed for concurrent regimens, including 5-fluorouracil (5-FU), cisplatin, hydoxyurea, and bleomycin. [7][8][9][10][11][12][13] Recently, there has been significant interest in the use of the taxanes (docetaxel and paclitaxel) in concurrent, combinedmodality treatment programs for treating patients with solid malignancies, including SCCHN. 14 -24 The rationale for integrating the taxanes into combined treatment regimens has been based on 1) the proven efficacy of the taxanes both as single agents and as components of multiagent chemotherapy programs in the treatment patients with of SCCHN and 2) the in vitro data demonstrating the beneficial, interactive effect of concurrent taxane and radiation.…”

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confidence: 99%

A Phase I/II trial of concurrent docetaxel and radiation after induction chemotherapy in patients with poor prognosis squamous cell carcinoma of the head and neck

Tishler

Norris

Colevas

et al. 2002

Cancer

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BACKGROUNDThe authors conducted a Phase I/II study in patients with a poor prognosis who had locally advanced squamous cell carcinoma of the head and neck (SCCHN) and who were treated initially with induction chemotherapy. Patients were treated with weekly docetaxel and concurrent daily fractionated radiation therapy to determine the maximum tolerated dose (MTD) of docetaxel and the efficacy of the regimen.METHODSTwenty‐two patients were enrolled, and 21 patients were treated. Eight patients had Stage III SCCHN, and 13 patients had Stage IV SCCHN without distant metastases and were treated first with 2‐3 cycles of induction chemotherapy, which consisted of cisplatin plus 5‐fluorouracil with or without leucovorin. Patients with a poor prognosis were identified as those who achieved a partial response to induction treatment, achieved a complete response with a positive biopsy, or were at high risk for developing recurrent disease. Patients were treated subsequently with concurrent, escalating doses of docetaxel (given weekly × 6) and once daily 200‐centigray radiation fractions.RESULTSThree patients were treated with a weekly docetaxel dose of 20 mg/m2 without dose‐limiting toxicity (DLT). Both patients who were treated at the next dose level of 30 mg/m2 experienced DLT. A dose of 25 mg/m2 was studied without DLT in the 16 patients who were treated, establishing this as the MTD. Sixty‐seven percent of the patients are alive without disease at a median follow‐up of 35 months (range, 12–59 months) after the initiation of chemoradiotherapy.CONCLUSIONSThe MTD of weekly docetaxel with concurrent daily radiation therapy in the postinduction setting was 25 mg/m2. Disease free survival data from this study were good and indicated that this regimen was effective in the treatment of patients with SCCHN who had a poor prognosis. Cancer 2002;95:1472–81. © 2002 American Cancer Society.DOI 10.1002/cncr.10873

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Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy—results of a multicentric randomized German trial in advanced head-and-neck cancer

Cited by 347 publications

References 33 publications

Lack of Osteoradionecrosis of the Mandible After Intensity-Modulated Radiotherapy for Head and Neck Cancer: Likely Contributions of Both Dental Care and Improved Dose Distributions

Lack of Osteoradionecrosis of the Mandible After Intensity-Modulated Radiotherapy for Head and Neck Cancer: Likely Contributions of Both Dental Care and Improved Dose Distributions

Treatment of Locally Advanced Head and Neck Cancer: Historical and Critical Review

A Phase I/II trial of concurrent docetaxel and radiation after induction chemotherapy in patients with poor prognosis squamous cell carcinoma of the head and neck

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