title: Radiation therapy for hypersalivation: a prospective study in 50 amyotrophic lateral sclerosis patients.
abstract: OBJECTIVE
  This study aimed to evaluate the efficiency and the tolerance of radiation therapy (RT) on salivary glands in a large series of amyotrophic lateral sclerosis (ALS) patients with hypersalivation.
  
  
  METHODS
  Fifty ALS patients that had medically failure pretreatment were included in this prospective study. RT was delivered through a conventional linear accelerator with 6-MV photons and 2 opposed beams fields including both submandibular glands and two-thirds of both parotid glands. Total RT dose was 10 Gy in 2 fractions (n=30) or 20 Gy in 4 fractions (n=20). RT efficacy was assessed with the 9-grade Sialorrhea Scoring Scale (SSS), recently prospectively validated as the most effective and sensitive tool to measure sialorrhea in ALS patients.
  
  
  RESULTS
  At the end of RT, all patients had improved: 46 had a complete response (92% CR, SSS 1-3) and 4 had a partial response (8% PR, SSS 4-5). A significant lasting salivary reduction was observed 6 months after RT completion: there was 71% CR and 26% PR, and there was a significant SSS reduction versus baseline (P<10(-6)). There was no grade 3 to 4 toxicity, and most side effects (34%) occurred during RT. Nine patients (18%) underwent a second salivary gland RT course, with a 3-months mean delay from the first RT, resulting in a SSS decrease (-77%). Both RT dose regimens induced a significant SSS decrease with no significant toxicity. There were, however, more patients with CR/PR in the 20-Gy protocol (P=.02), and 8 of 9 patients (89%) receiving a second RT course had previously been treated within the 10-Gy protocol.
  
  
  CONCLUSIONS
  Radiation therapy of 20 Gy in 4 fractions is an efficient and safe treatment for ALS patients with sialorrhea. A shorter RT course (10 Gy in 2 fractions) may be proposed in patients in poor medical condition.
authors.affiliation: Department of Radiation Oncology, Centre Clinique de la Porte de Saint Cloud, Boulogne-Billancourt, France; Department of Radiation Oncology, Groupe Hospitalier Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris (APHP), Paris, France. Electronic address: avi.assouline@ccpsc.fr.
authors.forename: Avi
authors.initials: A
authors.lastname: Assouline
authors.affiliation: Department of Radiation Oncology, Gustave Roussy, Université Paris-Sud XI, Villejuif, France.
authors.forename: Antonin
authors.initials: A
authors.lastname: Levy
authors.affiliation: Service Evaluation Pharmaceutique et Bon Usage (SEPBU), Unité Evaluation Scientifique, Bon Usage et Information (ESBUI), APHP AGEPS/pôle Pharmacie Hospitalière, Hôpitaux de Paris (PHHP), Paris, France.
authors.forename: Maya
authors.initials: M
authors.lastname: Abdelnour-Mallet
authors.affiliation: Departement of Pneumology and Intensive Care, Groupe Hospitalier Pitié-Salpêtrière, APHP, Paris, France.
authors.forename: Jesus
authors.initials: J
authors.lastname: Gonzalez-Bermejo
authors.affiliation: Departement of Nervous System Diseases, Paris ALS center, Groupe Hospitalier Pitié-Salpêtrière, APHP, Paris, France.
authors.forename: Timothée
authors.initials: T
authors.lastname: Lenglet
authors.affiliation: Departement of Nervous System Diseases, Paris ALS center, Groupe Hospitalier Pitié-Salpêtrière, APHP, Paris, France; Département de Recherche ES3, Emmanuel Hirsch, EA 1610 Études sur les Sciences et les Techniques, Université Paris-Sud XI, Paris, France.
authors.forename: Nadine
authors.initials: N
authors.lastname: Le Forestier
authors.affiliation: Departement of Nervous System Diseases, Paris ALS center, Groupe Hospitalier Pitié-Salpêtrière, APHP, Paris, France.
authors.forename: François
authors.initials: F
authors.lastname: Salachas
authors.affiliation: Departement of Nervous System Diseases, Paris ALS center, Groupe Hospitalier Pitié-Salpêtrière, APHP, Paris, France.
authors.forename: Gaelle
authors.initials: G
authors.lastname: Bruneteau
authors.affiliation: Departement of Nervous System Diseases, Paris ALS center, Groupe Hospitalier Pitié-Salpêtrière, APHP, Paris, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Meininger
authors.affiliation: Department of Radiation Oncology, Centre Clinique de la Porte de Saint Cloud, Boulogne-Billancourt, France; Department of Radiation Oncology, Hôpital Saint Louis, APHP, Paris, France.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Delanian
authors.affiliation: Departement of Nervous System Diseases, Paris ALS center, Groupe Hospitalier Pitié-Salpêtrière, APHP, Paris, France; UMR-678, INSERM-UPMC, Groupe Hospitalier Pitié-Salpêtrière, Paris, France.
authors.forename: Pierre-François
authors.initials: PF
authors.lastname: Pradat
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000690:Amyotrophic Lateral Sclerosis / Q000150:complications*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010306:Parotid Gland / Q000528:radiation effects; D017785:Photons / Q000627:therapeutic use; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D012074:Remission Induction / Q000379:methods; D012798:Sialorrhea / Q000209:etiology / Q000532:radiotherapy*; D018709:Statistics, Nonparametric; D013363:Submandibular Gland