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Journal ArticleDOI

Phase III Randomized Trial of Amifostine as a Radioprotector in Head and Neck Cancer

TLDR
With and without amifostine, 2-year local-regional control, disease-free survival, and overall survival were 58% versus 63, 53% versus 57%, and 71% versus 66%, respectively, while Antitumor treatment efficacy was preserved.
Abstract
PURPOSE: Radiotherapy for head and neck cancer causes acute and chronic xerostomia and acute mucositis. Amifositine and its active metabolite, WR-1065, accumulate with high concentrations in the salivary glands. This randomized trial evaluated whether amifostine could ameliorate these side effects without compromising the effectiveness of radiotherapy in these patients. PATIENTS AND METHODS: Patients with previously untreated head and neck squamous cell carcinoma were eligible. Primary end points included the incidence of grade ≥ 2 acute xerostomia, grade ≥ 3 acute mucositis, and grade ≥ 2 late xerostomia and were based on the worst toxicity reported. Amifostine was administered (200 mg/m2 intravenous) daily 15 to 30 minutes before irradiation. Radiotherapy was given once daily (1.8 to 2.0 Gy) to doses of 50 to 70 Gy. Whole saliva production was quantitated preradiotherapy and regularly during follow-up. Patients evaluated their symptoms through a questionnaire during and after treatment. Local-regional c...

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Journal ArticleDOI

Head and neck cancer.

TL;DR: There have been important advances in understanding of the molecular pathogenesis and progression of head and neck cancer and also in approaches to therapy, which include innovations in surgery, radiation therapy, and cytotoxic-drug therapy.
Journal ArticleDOI

Preventing or reducing late side effects of radiation therapy: radiobiology meets molecular pathology.

TL;DR: Progress in molecular pathology and normal-tissue radiobiology has improved the mechanistic understanding of late normal-Tissue effects and shifted the focus from initial-damage induction to damage recognition and tissue remodelling, which stimulates research into new pharmacological strategies for preventing or reducing the side effects of radiation therapy.
Journal ArticleDOI

Effects of radiation on normal tissue: consequences and mechanisms.

TL;DR: Treatments that reduce the risk or severity of damage to normal tissue or that facilitate the healing of radiation injury are being developed, which could greatly improve the quality of life of patients treated for cancer.
Journal ArticleDOI

Xerostomia and its predictors following parotid-sparing irradiation of head-and-neck cancer

TL;DR: An improvement over time in xerostomia, occurring in tandem with rising salivary production from the spared major Salivary glands, suggests a long-term clinical benefit from their sparing.
References
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Book ChapterDOI

Nonparametric Estimation from Incomplete Observations

TL;DR: In this article, the product-limit (PL) estimator was proposed to estimate the proportion of items in the population whose lifetimes would exceed t (in the absence of such losses), without making any assumption about the form of the function P(t).
Journal ArticleDOI

Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial.

Stuart J. Pocock, +1 more
- 01 Mar 1975 - 
TL;DR: A new general procedure for treatment assignment is described which concentrates on minimizing imbalance in the distributions of treatment numbers within the levels of each individual prognostic factor.
Journal ArticleDOI

Hyperfractionated Irradiation with or without Concurrent Chemotherapy for Locally Advanced Head and Neck Cancer

TL;DR: Combined treatment for advanced head and neck cancer is more efficacious and not more toxic than hyperfractionated irradiation alone.
Journal ArticleDOI

Minimization: A new method of assigning patients to treatment and control groups

TL;DR: A new method of assigning patients to treatment and control groups to minimize differences between the groups, not only in the number of patients but in patient characteristics is described, demonstrating a four‐ to fivefold reduction of the probability of severe imbalance, relative to randomization.
Journal ArticleDOI

Hyperfractionation versus conventional fractionation in oropharyngeal carcinoma: final analysis of a randomized trial of the EORTC cooperative group of radiotherapy.

TL;DR: EORTC protocol 22791 compared once daily fractionation (CF) to pure hyperfractionation (HF) of 80.5 Gy in 70 fractions in 7 weeks using 2 fractions of 1.15 Gy per day in T2-T3 oropharyngeal carcinoma (excluding base of tongue), N0,N1 of less than 3 cm.
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