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Title: Clinical outcomes of a phase I/II study of 48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer using a stereotactic body frame

Abstract

Purpose: To evaluate the clinical outcomes of 48 Gy of three-dimensional stereotactic radiotherapy in four fractions for treating Stage I lung cancer using a stereotactic body frame. Methods and Materials: Forty-five patients who were treated between September 1998 and February 2004 were included in this study. Thirty-two patients had Stage IA lung cancer, and the other 13 had Stage IB lung cancer where tumor size was less than 4 cm in diameter. Three-dimensional treatment planning using 6-10 noncoplanar beams was performed to maintain the target dose homogeneity and to decrease the irradiated lung volume >20 Gy. All patients were irradiated using a stereotactic body frame and received four single 12 Gy high doses of radiation at the isocenter over 5-13 (median = 12) days. Results: Seven tumors (16%) completely disappeared after treatment (CR) and 38 tumors (84%) decreased in size by 30% or more (PR). Therefore, all tumors showed local response. During the follow-up of 6-71 (median = 30) months, no pulmonary complications greater than an National Cancer Institute-Common Toxicity Criteria of Grade 3 were noted. No other vascular, cardiac, esophageal, or neurologic toxicities were encountered. Forty-four (98%) of 45 tumors were locally controlled during the follow-up period. However, regionalmore » recurrences and distant metastases occurred in 3 and 5 of T1 patients and zero and 4 of T2 patients, respectively. For Stage IA lung cancer, the disease-free survival and overall survival rates after 1 and 3 years were 80% and 72%, and 92% and 83%, respectively, whereas for Stage IB lung cancer, the disease-free survival and overall survival rates were 92% and 71%, and 82% and 72%, respectively. Conclusion: Forty-eight Gy of 3D stereotactic radiotherapy in 4 fractions using a stereotactic body frame is useful for the treatment of Stage I lung tumors.« less

Authors:
 [1];  [2];  [2];  [2];  [2];  [2];  [2];  [2];  [2];  [2];  [2];  [2]
  1. Department of Therapeutic Radiology and Oncology, Kyoto University, Graduate School of Medicine, Sakyo, Kyoto (Japan). E-mail: nag@kuhp.kyoto-u.ac.jp
  2. Department of Therapeutic Radiology and Oncology, Kyoto University, Graduate School of Medicine, Sakyo, Kyoto (Japan)
Publication Date:
OSTI Identifier:
20788235
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 63; Journal Issue: 5; Other Information: DOI: 10.1016/j.ijrobp.2005.05.034; PII: S0360-3016(05)00944-2; Copyright (c) 2005 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CARCINOMAS; IRRADIATION; LUNGS; METASTASES; PATIENTS; PLANNING; RADIATION DOSES; RADIOTHERAPY; TOXICITY

Citation Formats

Nagata, Yasushi, Takayama, Kenji, Matsuo, Yukinori, Norihisa, Yoshiki, Mizowaki, Takashi, Sakamoto, Takashi, Sakamoto, Masato, Mitsumori, Michihide, Shibuya, Keiko, Araki, Norio, Yano, Shinsuke, and Hiraoka, Masahiro. Clinical outcomes of a phase I/II study of 48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer using a stereotactic body frame. United States: N. p., 2005. Web. doi:10.1016/J.IJROBP.2005.0.
Nagata, Yasushi, Takayama, Kenji, Matsuo, Yukinori, Norihisa, Yoshiki, Mizowaki, Takashi, Sakamoto, Takashi, Sakamoto, Masato, Mitsumori, Michihide, Shibuya, Keiko, Araki, Norio, Yano, Shinsuke, & Hiraoka, Masahiro. Clinical outcomes of a phase I/II study of 48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer using a stereotactic body frame. United States. doi:10.1016/J.IJROBP.2005.0.
Nagata, Yasushi, Takayama, Kenji, Matsuo, Yukinori, Norihisa, Yoshiki, Mizowaki, Takashi, Sakamoto, Takashi, Sakamoto, Masato, Mitsumori, Michihide, Shibuya, Keiko, Araki, Norio, Yano, Shinsuke, and Hiraoka, Masahiro. Thu . "Clinical outcomes of a phase I/II study of 48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer using a stereotactic body frame". United States. doi:10.1016/J.IJROBP.2005.0.
@article{osti_20788235,
title = {Clinical outcomes of a phase I/II study of 48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer using a stereotactic body frame},
author = {Nagata, Yasushi and Takayama, Kenji and Matsuo, Yukinori and Norihisa, Yoshiki and Mizowaki, Takashi and Sakamoto, Takashi and Sakamoto, Masato and Mitsumori, Michihide and Shibuya, Keiko and Araki, Norio and Yano, Shinsuke and Hiraoka, Masahiro},
abstractNote = {Purpose: To evaluate the clinical outcomes of 48 Gy of three-dimensional stereotactic radiotherapy in four fractions for treating Stage I lung cancer using a stereotactic body frame. Methods and Materials: Forty-five patients who were treated between September 1998 and February 2004 were included in this study. Thirty-two patients had Stage IA lung cancer, and the other 13 had Stage IB lung cancer where tumor size was less than 4 cm in diameter. Three-dimensional treatment planning using 6-10 noncoplanar beams was performed to maintain the target dose homogeneity and to decrease the irradiated lung volume >20 Gy. All patients were irradiated using a stereotactic body frame and received four single 12 Gy high doses of radiation at the isocenter over 5-13 (median = 12) days. Results: Seven tumors (16%) completely disappeared after treatment (CR) and 38 tumors (84%) decreased in size by 30% or more (PR). Therefore, all tumors showed local response. During the follow-up of 6-71 (median = 30) months, no pulmonary complications greater than an National Cancer Institute-Common Toxicity Criteria of Grade 3 were noted. No other vascular, cardiac, esophageal, or neurologic toxicities were encountered. Forty-four (98%) of 45 tumors were locally controlled during the follow-up period. However, regional recurrences and distant metastases occurred in 3 and 5 of T1 patients and zero and 4 of T2 patients, respectively. For Stage IA lung cancer, the disease-free survival and overall survival rates after 1 and 3 years were 80% and 72%, and 92% and 83%, respectively, whereas for Stage IB lung cancer, the disease-free survival and overall survival rates were 92% and 71%, and 82% and 72%, respectively. Conclusion: Forty-eight Gy of 3D stereotactic radiotherapy in 4 fractions using a stereotactic body frame is useful for the treatment of Stage I lung tumors.},
doi = {10.1016/J.IJROBP.2005.0},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 5,
volume = 63,
place = {United States},
year = {Thu Dec 01 00:00:00 EST 2005},
month = {Thu Dec 01 00:00:00 EST 2005}
}
  • Purpose: To retrospectively analyze the clinical outcomes of stereotactic body radiotherapy (SBRT) for patients with Stages 1A and 1B non-small-cell lung cancer. Methods and Materials: We reviewed the records of patients with non-small-cell lung cancer treated with curative intent between Dec 2001 and May 2007. All patients had histopathologically or cytologically confirmed disease, increased levels of tumor markers, and/or positive findings on fluorodeoxyglucose positron emission tomography. Staging studies identified their disease as Stage 1A or 1B. Performance status was 2 or less according to World Health Organization guidelines in all cases. The prescribed dose of 50 Gy total in fivemore » fractions, calculated by using a superposition algorithm, was defined for the periphery of the planning target volume. Results: One hundred twenty-one patients underwent SBRT during the study period, and 63 were eligible for this analysis. Thirty-eight patients had Stage 1A (T1N0M0) and 25 had Stage 1B (T2N0M0). Forty-nine patients were not appropriate candidates for surgery because of chronic pulmonary disease. Median follow-up of these 49 patients was 31 months (range, 10-72 months). The 3-year local control, disease-free, and overall survival rates in patients with Stages 1A and 1B were 93% and 96% (p = 0.86), 76% and 77% (p = 0.83), and 90% and 63% (p = 0.09), respectively. No acute toxicity was observed. Grade 2 or higher radiation pneumonitis was experienced by 3 patients, and 1 of them had fatal bacterial pneumonia. Conclusions: The SBRT at 50 Gy total in five fractions to the periphery of the planning target volume calculated by using a superposition algorithm is feasible. High local control rates were achieved for both T2 and T1 tumors.« less
  • Purpose: Image-guided biopsy occasionally fails to diagnose small lung lesions, which are highly suggestive of primary lung cancer. The aim of the present study was to evaluate the outcome of stereotactic body radiotherapy (SBRT) for small lung lesions that were clinically diagnosed as primary lung cancer without pathologic confirmation. Methods and Materials: A total of 115 patients were treated with SBRT in 12 institutions. Tumor size ranged from 5 to 45 mm in diameter, with a median of 20 mm. Results: The 3-year and 5-year overall survival rates for patients with a tumor size <=20 mm in diameter (n =more » 58) were both 89.8%, compared with 60.7% and 53.1% for patients with tumors >20 mm (n = 57) (p <0.0005), respectively. Local progression occurred in 2 patients (3.4%) with a tumor size <=20 mm and in 3 patients (5.3%) with tumors >20 mm. Among the patients with a tumor size <=20 mm, Grade 2 pulmonary complications were observed in 2 (3.4%), but no Grade 3 to 5 toxicity was observed. In patients with a tumor size >20 mm, Grades 2, 3, and 5 toxicity were observed in 5 patients (8.8%), 3 patients (5.3%), and 1 patient (1.8%), respectively. Conclusion: In patients with a tumor <=20 mm in diameter, SBRT was reasonably safe in this retrospective study. The clinical implications of the high local control rate depend on the accuracy of clinical/radiologic diagnosis for small lung lesions and are to be carefully evaluated in a prospective study.« less
  • Purpose: To evaluate the efficacy and toxicity of hypofractionated stereotactic body radiotherapy in patients with Stage I/II non-small-cell lung cancer. Methods and Materials: Forty-three patients with inoperable Stage I/II non-small-cell lung cancer underwent treatment prospectively using the stereotactic gamma-ray whole-body therapeutic system (body gamma-knife radiosurgery) with 30 rotary conical-surface Co{sup 6} sources focused on the target volume. Low-speed computed tomography simulation was conducted, which was followed by three-dimensional conformal radiotherapy planning. A total dose of 50 Gy was delivered at 5 Gy/fraction to the 50% isodose line covering the planning target volume, whereas a total dose of 70 Gy wasmore » delivered at 7 Gy/fraction to the gross target volume. The median follow-up duration was 27 months. Results: Three to 6 months after treatment, the complete response rate for body-gamma knife radiosurgery was 63%, and the overall response rate was 95%. The 1-year, 2-year, and 3-year local control rates were all 95% in all patients. The 1-year, 2-year, and 3-year overall survival rates were 100%, 91%, and 91%, respectively, in patients with Stage I disease and 73%, 64%, and 64%, respectively, in those with Stage II disease. Only 2.3% (1/43) of the patients had Grade 3 pneumonitis. Conclusion: Our highly focused stereotactic body radiotherapy method resulted in promising local control and survival with minimal toxicity.« less
  • Purpose: The radiobiology of prostate cancer favors a hypofractionated dose regimen. We report results of a prospective Phase II clinical trial of stereotactic body radiotherapy (SBRT) for localized prostate cancer. Methods and Materials: Forty-one low-risk prostate cancer patients with 6 months' minimum follow-up received 36.25 Gy in five fractions of 7.25 Gy with image-guided SBRT alone using the CyberKnife. The early (<3 months) and late (>6 months) urinary and rectal toxicities were assessed using validated quality of life questionnaires (International Prostate Symptom Score, Expanded Prostate Cancer Index Composite) and the Radiation Therapy Oncology Group (RTOG) toxicity criteria. Patterns of prostate-specificmore » antigen (PSA) response are analyzed. Results: The median follow-up was 33 months. There were no RTOG Grade 4 acute or late rectal/urinary complications. There were 2 patients with RTOG Grade 3 late urinary toxicity and none with RTOG Grade 3 rectal complications. A reduced rate of severe rectal toxicities was observed with every-other-day vs. 5 consecutive days treatment regimen (0% vs. 38%, p = 0.0035). A benign PSA bounce (median, 0.4 ng/mL) was observed in 12 patients (29%) occurring at 18 months (median) after treatment. At last follow-up, no patient has had a PSA failure regardless of biochemical failure definition. Of 32 patients with 12 months minimum follow-up, 25 patients (78%) achieved a PSA nadir {<=}0.4 ng/mL. A PSA decline to progressively lower nadirs up to 3 years after treatment was observed. Conclusions: The early and late toxicity profile and PSA response for prostate SBRT are highly encouraging. Continued accrual and follow-up will be necessary to confirm durable biochemical control rates and low toxicity profiles.« less
  • Purpose: Using a retrospective analysis of treatment plans submitted from multiple institutions accruing patients to the Radiation Therapy Oncology Group (RTOG) 0236 non-small-cell stereotactic body radiotherapy protocol, the present study determined the dose prescription and critical structure constraints for future stereotactic body radiotherapy lung protocols that mandate density-corrected dose calculations. Method and Materials: A subset of 20 patients from four institutions participating in the RTOG 0236 protocol and using superposition/convolution algorithms were compared. The RTOG 0236 protocol required a prescription dose of 60 Gy delivered in three fractions to cover 95% of the planning target volume. Additional requirements were specifiedmore » for target dose heterogeneity and the dose to normal tissue/structures. The protocol required each site to plan the patient's treatment using unit density, and another plan with the same monitor units and applying density corrections was also submitted. These plans were compared to determine the dose differences. Two-sided, paired Student's t tests were used to evaluate these differences. Results: With heterogeneity corrections applied, the planning target volume receiving {>=}60 Gy decreased, on average, 10.1% (standard error, 2.7%) from 95% (p = .001). The maximal dose to any point {>=}2 cm away from the planning target volume increased from 35.2 Gy (standard error, 1.7) to 38.5 Gy (standard error, 2.2). Conclusion: Statistically significant dose differences were found with the heterogeneity corrections. The information provided in the present study is being used to design future heterogeneity-corrected RTOG stereotactic body radiotherapy lung protocols to match the true dose delivered for RTOG 0236.« less