The Laryngoscope Lippincott Williams zyxwvutsrqpon & Wilkins, Philadelphia zyxwvutsrqp 0 1998 The American Laryngological, Rhinological and Otological Society, Inc. Palliative Laser Therapy for Recurrent Head and Neck Cancer: zyx A Phase I1 Clinical Study Marcos B. Paiva, MD, PhD; Keith E. Blackwell, MD; Romaine E. Saxton, PhD; Thomas C. Calcaterra, MD; Paul H. Ward, MD; Jac Soudant, MD; Dan J. Castro, MD zyxwvu Objectives: Laser therapy is becoming a more pre- cise, minimally invasive alternative for tumor abla- tion. Recent reports confirm successful palliation of pain and functional disabilities in patients with ad- vanced deep carcinoma of the head and neck using in- terstitial laser phototherapy (ILT). Study Design, zyxwvu Pu- tients, and Methods: The current study describes an ongoing Phase I1 trial of neodymidyttrium-alu- minum-garnet (NdYAG)laser therapy for palliation of advanced head and neck cancer. A total of 40 ad- vanced cancer patients have been entered into this protocol (26 men and 16 women). Results: Nineteen of these patients had no evidence of recurrence after ILT with an average follow-up of 11 months (range, 2 to 24 mo). Currently, 19 of these patients are alive, 14 with tumor remission and six with persistent disease. A to- tal of 79 tumor sites received ILT with 43 (64.6%) com- pletely ablated. Stratified by tumor site, ILT led to a complete response in 21 of 24 in the oral cavity, eight of 28 neck tumors, four of 10 in skin, and 10 of 17 in other sites. The procedure was well tolerated in most cases and was repeated at intervals in patients with residual disease or recurrences for a total of 118 laser treatments (average, 2.96 treatments per patient). Conclusions: The results suggest that ILT can be per- formed safely and repeated as needed, and may be less costly than conventional surgery for head and neck cancer. However, additional follow-up is needed to obtain convincing evidence of long-term therapeu- tic benefits. Luryngoecope, 108:1277-1283,1998 Presented at the Meeting of the Western Section of the American Laryngological, Rhinological and Otological Society, Inc., San Diego, Cali- fornia, January 11,1998. From the Division of Head and Neck Surgery (M.B.P., K.E.B., T.c.c., P.H.W., D.J.c.), Division of Surgical Oncology (R.E.s.), University of Califor- nia, Los Angeles, School of Medicine, Los Angeles, California; and the De- partment of Head and Neck Surgery zyxwvutsr (J.s.), Groupe Hospitalier Pitie- Salpetriere, Paris, France. This study was supported by the Division of Head and Neck Surgery and the Jonsson Comprehensive Cancer Center, University of California, Los Angeles, School of Medicine; NIH grant no. CA65053-01R E-Z-EM, Inc.; Laserscope; GE Medical Systems; and the Association de Recherche 8ur le Cancer (A.R.C., BP 3-94801Villejuif Cedex, France). Send Correspondence to Marcos B. Paiva, MD, PhD, UCLA School of Medicine, 31-24 Rehab Building, 1000 Veteran Avenue, Los Angeles, CA 90095-1794, U.S.A. INTRODUCTION Squamous cell carcinoma of the head and neck occurs frequently worldwide with more than 500,000 new cases projected annually.' Once recurrent after primary treat- ment, survival rates for head and neck cancers are very po0r.2~3 Management of recurrent head and neck cancer is a seldom reported but common clinical dilemma.4The fail- ure rate in the treatment of advanced head and neck car- cinoma remains unacceptably high despite surgery, radia- tion therapy, and/or chemotherapy. Experience is accumulating with the neodymiudyt- trium-aluminum-garnet (Nd:YAG) laser for treatment of recurrent, unresectable head and neck cancers leading to favorable results and apparent long-term efficacy in some cases. Imaging-guided interstitial laser therapy (ILT) is a new and promising clinical alternative that has recently become a useful procedure for tumor palliation.5-7 During the last 6 years at the University of California, Los Ange- les (UCLA), ultrasound (UTZ) imaging-guided palliative laser therapy of head and neck tumors has evolved in a stepwise fashion.7.8 This report reviews our experience us- ing the Nd:YAG laser in a Phase I1 study to treat 40 pa- tients with advanced head and neck cancer in whom sur- gical resection was not an option. Most patients had successful palliation by ILT with a prolonged median sur- vival rate of 14 months. PATIENTS AND lMETHODS From July 1994 to July 1997, a total of 53 patients with head and neck cancer were treated in a Phase I1 clinical study. Patients were excluded if the Karnofsky performance status was less than 70% or in cases with tumor immediately adjacent to the carotid artery, esophagus, or trachea. Tumor volume was mea- sured with a Vernier caliper using the formula ( L x W x H)/2, where L is the greatest diameter, W is the greatest perpendicular width, and H is the greatest depth or height. Tumor volume ranged from 0.1 to 50 cm3. Complete medical records with fol- low-up of 40 patients were available to accurately assess treat- ment area, tumor size, and outcome. All patients presented with recurrent or metastatic unre- sectable tumors (or both) unresponsive to previous conventional therapy using surgery (average, 2.2 surgeriedpatient), radiation therapy (0.97/patient), or chemotherapy (0.33/patient). The age distribution of the reviewed cases ranged from 33 to 84 years (av- erage, 64 y) with a peak incidence in the fifth and sixth decades. Laryngoscope 108: September 1998 Paiva et al.: Laser Therapy 1277