title: High-dose concurrent chemo-proton therapy for Stage III NSCLC: preliminary results of a Phase II study.
abstract: The aim of this report is to present the preliminary results of a Phase II study of high-dose (74 Gy RBE) proton beam therapy (PBT) with concurrent chemotherapy for unresectable locally advanced non-small-cell lung cancer (NSCLC). Patients were treated with PBT and chemotherapy with monthly cisplatin (on Day 1) and vinorelbine (on Days 1 and 8). The treatment doses were 74 Gy RBE for the primary site and 66 Gy RBE for the lymph nodes without elective lymph nodes. Adapted planning was made during the treatment. A total of 15 patients with Stage III NSCLC (IIIA: 4, IIIB: 11) were evaluated in this study. The median follow-up period was 21.7 months. None of the patients experienced Grade 4 or 5 non-hematologic toxicities. Acute pneumonitis was observed in three patients (Grade 1 in one, and Grade 3 in two), but Grade 3 pneumonitis was considered to be non-proton-related. Grade 3 acute esophagitis and dermatitis were observed in one and two patients, respectively. Severe ( ≥ Grade 3) leukocytopenia, neutropenia and thrombocytopenia were observed in 10 patients, seven patients and one patient, respectively. Late radiation Grades 2 and 3 pneumonitis was observed in one patient each. Six patients (40%) experienced local recurrence at the primary site and were treated with 74 Gy RBE. Disease progression was observed in 11 patients. The mean survival time was 26.7 months. We concluded that high-dose PBT with concurrent chemotherapy is safe to use in the treatment of unresectable Stage III NSCLC.
authors.affiliation: Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki, Japan.
authors.forename: Yoshiko
authors.initials: Y
authors.lastname: Oshiro
authors.affiliation: Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki, Japan.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Okumura
authors.affiliation: Department of Respiratory Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Kurishima
authors.affiliation: Department of Respiratory Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Homma
authors.affiliation: Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki, Japan.
authors.forename: Masashi
authors.initials: M
authors.lastname: Mizumoto
authors.affiliation: Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Ishikawa
authors.affiliation: Department of Respiratory Surgery, University of Tsukuba, Tsukuba, Ibaraki, Japan.
authors.forename: Masataka
authors.initials: M
authors.lastname: Onizuka
authors.affiliation: Department of Respiratory Surgery, University of Tsukuba, Tsukuba, Ibaraki, Japan.
authors.forename: Mitsuaki
authors.initials: M
authors.lastname: Sakai
authors.affiliation: Department of Respiratory Surgery, University of Tsukuba, Tsukuba, Ibaraki, Japan.
authors.forename: Yukinobu
authors.initials: Y
authors.lastname: Goto
authors.affiliation: Department of Respiratory Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Hizawa
authors.affiliation: Department of Respiratory Surgery, University of Tsukuba, Tsukuba, Ibaraki, Japan.
authors.forename: Yukio
authors.initials: Y
authors.lastname: Sato
authors.affiliation: Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki, Japan hsakurai@pmrc.tsukuba.ac.jp.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Sakurai
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000473:pathology* / Q000628:therapy*; D059248:Chemoradiotherapy / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000473:pathology / Q000628:therapy*; D008297:Male; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D010865:Pilot Projects; D061766:Proton Therapy; D011832:Radiation Injuries / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D011879:Radiotherapy Dosage; D011882:Radiotherapy, High-Energy / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine
keywords: Phase II study; chemo–proton therapy; lung cancer; proton therapy; radiotherapy