title: Hypofractionated Helical Tomotherapy for Older Aged Patients With Prostate Cancer: Preliminary Results of a Phase I-II Trial.
abstract: In our center, the feasibility and related acute toxicities of hypofractionated helical tomotherapy have been evaluated in older aged patients with prostate cancer . Between February 2009 and February 2014, 67 patients (older than 65 years) were enrolled in a prospective phase I-II study (registered number, ChiCTR-ONC-13004037). Patients in cohort 1 (n = 33) and cohort 2 (n = 34) received 76 Gy in 34 fractions (2.25 Gy/F) and 71.6 Gy in 28 fractions (2.65 Gy/F), respectively, to the prostate and seminal vesicles, while 25 patients in cohort 2 also received integrated elective lymph node irradiation (50.4 Gy). All patients were treated with helical tomotherapy, and daily image guidance was performed before each treatment. Acute toxicities were assessed with Radiation Therapy Oncology Group (RTOG)/European Organization for Research on Treatment of Cancer (EORTC) criteria. No significant difference was detected between the 2 cohorts in the incidence of acute toxicities. In cohort 1, the incidences of grade 1 and 2 genitourinary and gastrointestinal toxicities were 45.5% and 45.4%, respectively, and without grade 3 and 4 toxicities. In cohort 2, the incidences of acute grade 1 and 2 genitourinary and gastrointestinal toxicities were 47.1% and 55.9%, respectively, and grade 3 genitourinary toxicity (hematuria) was noted only in 1 patient. No significant difference was detected in the incidence of acute toxicities between the patients receiving integrated elective lymph node irradiation and those receiving irradiation to prostate and seminal vesicle in cohort 2. Univariate and multivariate analyses were performed with clinical parameters. Only the baseline weight was found negatively correlated with genitourinary toxicities at a weak level (relative risk = 0.946, 95% confidence interval 0.896-0.998], P = .043). This study shows that 2 hypofractionation regimens (76 Gy/34F and 71.6 Gy/28F) delivered with HT are well tolerated in older aged patients having prostate cancer without significant difference for acute toxicities between the 2 cohorts. Late toxicities and treatment outcomes for these patients are under investigation.
authors.affiliation: Department of Radiation Oncology, Chinese PLA General Hospital, Beijing, China.
authors.forename: Hai-Xia
authors.initials: HX
authors.lastname: Liu
authors.affiliation: Department of Radiation Oncology, Chinese PLA General Hospital, Beijing, China Department of Radiation Oncology, Hainan Branch of Chinese PLA General Hospital, Sanya, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Du
authors.affiliation: Department of Radiation Oncology, Chinese PLA General Hospital, Beijing, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Yu
authors.affiliation: Department of Radiation Oncology, Chinese PLA General Hospital, Beijing, China.
authors.forename: Bo-Ning
authors.initials: BN
authors.lastname: Cai
authors.affiliation: Department of Radiation Oncology, Chinese PLA General Hospital, Beijing, China.
authors.forename: Shou-Ping
authors.initials: SP
authors.lastname: Xu
authors.affiliation: Department of Radiation Oncology, Chinese PLA General Hospital, Beijing, China.
authors.forename: Chuan-Bin
authors.initials: CB
authors.lastname: Xie
authors.affiliation: Department of Radiation Oncology, Chinese PLA General Hospital, Beijing, China Department of Radiation Oncology, Hainan Branch of Chinese PLA General Hospital, Sanya, China malinpharm@sina.com.
authors.forename: Lin
authors.initials: L
authors.lastname: Ma
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor; D019583:Dose Fractionation, Radiation; D006801:Humans; D008297:Male; D064847:Multimodal Imaging; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D011379:Prognosis; D011471:Prostatic Neoplasms / Q000175:diagnosis / Q000401:mortality / Q000532:radiotherapy*; D011879:Radiotherapy Dosage; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects / Q000379:methods; D016896:Treatment Outcome
chemical_list: D014408:Biomarkers, Tumor
keywords: helical tomotherapy; hypofractionation; older aged patients; phase I-II trial; prostate cancer