Nikhil G Rao1, Andy Trotti2, Jongphil Kim3, Michael J Schell3, Xiuhua Zhao3, Robert J Amdur4, David M Brizel5, Mark S Chambers6, Jimmy J Caudell2, Curtis Miyamoto7, David I Rosenthal8. 1. Department of Radiation Oncology, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Nikhil.Rao@moffitt.org. 2. Department of Radiation Oncology, Moffitt Cancer Center, Tampa, FL, USA. 3. Department of Biostatistics, Moffitt Cancer Center, Tampa, FL, USA. 4. Department of Radiation Oncology, University of Florida, Gainsville, FL, USA. 5. Department of Radiation Oncology, Duke University Cancer Center, Durham, NC, USA. 6. Department of Onc Dentistry Prosthodontics, MD Anderson Cancer Center, Houston, TX, USA. 7. Department of Radiation Oncology, Temple University Cancer Center, Philadelphia, PA, USA. 8. Department of Radiation Oncology, MD Anderson Cancer Center, Houston, TX, USA.
Abstract
PURPOSE: We conducted a phase II multicenter study evaluating Caphosol in patients receiving head and neck radiation (H/N RT) +/- chemotherapy or biologic sensitizer. MATERIALS/ METHODS: The primary endpoint of the study tested the rate of functional mucositis (WHO grade > or equal to 2) with the hypothesis that <75% of patients would develop > or equal to 2 mucositis with Caphosol compared with a historical rate of >90%. New methods were applied with higher than historic rigor. 5 Institutions were included in this study: Moffitt Cancer Center (MCC), MD Anderson Cancer Center (MDACC), Duke University Cancer Center (DUCC), University of Florida (UF) and Temple University Cancer Center (TUCC). Caphosol was taken by patients at least 4 times a day and up to 10 times per day commencing with day 1 of RT and for a total duration of 8 weeks after completion of RT. Detailed questionnaires were completed weekly by patients and a unique algorithm was used to generate the WHO grade of mucositis. RESULTS: 98 Patients were enrolled in the study. 59/98 (60%) patients were evaluable for the primary endpoint giving us 80% power. All evaluable patients experienced WHO grade > or equal to 2 mucositis and the trial failed to reject the null hypothesis. > or equal to 2 mucositis rates at weeks 2, 4, 6, 11 and 15 were as follows: 45%, 90%, 98%, 71%, 50%. CONCLUSION: We were unable to demonstrate that Caphosol significantly reduced WHO grade 2 or higher mucositis below a 90% historic rate. We are not surprised with this finding given our rigorous methodology in grading.
PURPOSE: We conducted a phase II multicenter study evaluating Caphosol in patients receiving head and neck radiation (H/N RT) +/- chemotherapy or biologic sensitizer. MATERIALS/ METHODS: The primary endpoint of the study tested the rate of functional mucositis (WHO grade > or equal to 2) with the hypothesis that <75% of patients would develop > or equal to 2 mucositis with Caphosol compared with a historical rate of >90%. New methods were applied with higher than historic rigor. 5 Institutions were included in this study: Moffitt Cancer Center (MCC), MD Anderson Cancer Center (MDACC), Duke University Cancer Center (DUCC), University of Florida (UF) and Temple University Cancer Center (TUCC). Caphosol was taken by patients at least 4 times a day and up to 10 times per day commencing with day 1 of RT and for a total duration of 8 weeks after completion of RT. Detailed questionnaires were completed weekly by patients and a unique algorithm was used to generate the WHO grade of mucositis. RESULTS: 98 Patients were enrolled in the study. 59/98 (60%) patients were evaluable for the primary endpoint giving us 80% power. All evaluable patients experienced WHO grade > or equal to 2 mucositis and the trial failed to reject the null hypothesis. > or equal to 2 mucositis rates at weeks 2, 4, 6, 11 and 15 were as follows: 45%, 90%, 98%, 71%, 50%. CONCLUSION: We were unable to demonstrate that Caphosol significantly reduced WHO grade 2 or higher mucositis below a 90% historic rate. We are not surprised with this finding given our rigorous methodology in grading.
Authors: Quynh-Thu Le; Harold E Kim; Charles J Schneider; Györgyi Muraközy; Krzysztof Skladowski; Sabine Reinisch; Yuhchyau Chen; Michael Hickey; May Mo; Mon-Gy Chen; Dietmar Berger; Richard Lizambri; Michael Henke Journal: J Clin Oncol Date: 2011-06-13 Impact factor: 44.544
Authors: A Waśko-Grabowska; P Rzepecki; S Oborska; J Barzał; K Gawroński; B Młot; C Szczylik Journal: Transplant Proc Date: 2011-10 Impact factor: 1.066
Authors: Stephen T Sonis; Linda S Elting; Dorothy Keefe; Douglas E Peterson; Mark Schubert; Martin Hauer-Jensen; B Nebiyou Bekele; Judith Raber-Durlacher; J Peter Donnelly; Edward B Rubenstein Journal: Cancer Date: 2004-05-01 Impact factor: 6.860
Authors: Andy Trotti; Lisa A Bellm; Joel B Epstein; Diana Frame; Henry J Fuchs; Clement K Gwede; Eugene Komaroff; Luba Nalysnyk; Marya D Zilberberg Journal: Radiother Oncol Date: 2003-03 Impact factor: 6.280
Authors: Neal J Meropol; Robert A Somer; John Gutheil; Robert J Pelley; Manuel R Modiano; Eric K Rowinsky; Mace L Rothenberg; Spencer W Redding; Cuneyt M Serdar; Bin Yao; Robert Heard; Lee S Rosen Journal: J Clin Oncol Date: 2003-04-15 Impact factor: 44.544
Authors: A S Papas; R E Clark; G Martuscelli; K T O'Loughlin; E Johansen; K B Miller Journal: Bone Marrow Transplant Date: 2003-04 Impact factor: 5.483
Authors: Kranti A Mapuskar; Carryn M Anderson; Douglas R Spitz; Ines Batinic-Haberle; Bryan G Allen; Rebecca E Oberley-Deegan Journal: Semin Radiat Oncol Date: 2019-01 Impact factor: 5.934
Authors: Carryn M Anderson; Stephen T Sonis; Christopher M Lee; Douglas Adkins; Bryan G Allen; Wenqing Sun; Sanjiv S Agarwala; Madhavi L Venigalla; Yuhchyau Chen; Weining Zhen; Diane R Mould; Jon T Holmlund; Jeffrey M Brill; John M Buatti Journal: Int J Radiat Oncol Biol Phys Date: 2017-10-16 Impact factor: 7.038
Authors: Kee H Wong; Aleksandra Kuciejewska; Mansour T A Sharabiani; Brian Ng-Cheng-Hin; Sonja Hoy; Tara Hurley; Joanna Rydon; Lorna Grove; Ana Santos; Motoko Ryugenji; Shreerang A Bhide; Chris M Nutting; Kevin J Harrington; Kate L Newbold Journal: Radiother Oncol Date: 2016-07-05 Impact factor: 6.280
Authors: Marika Cinausero; Giuseppe Aprile; Paola Ermacora; Debora Basile; Maria G Vitale; Valentina Fanotto; Giuseppe Parisi; Lorenzo Calvetti; Stephen T Sonis Journal: Front Pharmacol Date: 2017-06-08 Impact factor: 5.810
Authors: Carryn M Anderson; Christopher M Lee; Deborah P Saunders; Amarinthia Curtis; Neal Dunlap; Chaitali Nangia; Arielle S Lee; Sharon M Gordon; Philip Kovoor; Roberto Arevalo-Araujo; Voichita Bar-Ad; Abhinand Peddada; Kyle Colvett; Douglas Miller; Anshu K Jain; James Wheeler; Dukagjin Blakaj; Marcelo Bonomi; Sanjiv S Agarwala; Madhur Garg; Francis Worden; Jon Holmlund; Jeffrey M Brill; Matt Downs; Stephen T Sonis; Sanford Katz; John M Buatti Journal: J Clin Oncol Date: 2019-10-16 Impact factor: 44.544
Authors: Aida Kusiak; Barbara AlicjaJereczek-Fossa; Dominika Cichońska; Daniela Alterio Journal: Int J Environ Res Public Health Date: 2020-04-03 Impact factor: 3.390