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Helical intensity-modulated radiotherapy of the pelvic lymph nodes with a simultaneous integrated boost to the prostate--first results of the PLATIN 1 trial.

ABSTRACT: Definitive, percutaneous irradiation of the prostate and the pelvic lymph nodes in high-risk prostate cancer is the alternative to prostatectomy plus lymphadenectomy. To date, the role of whole pelvis radiotherapy (WPRT) has not been clarified especially taking into consideration the benefits of high conformal IMRT (intensity modulated radiotherapy) of complex-shaped target volumes.From 2009 to 2012, 40 patients of high-risk prostate cancer with an increased risk of microscopic lymph node involvement were enrolled into this prospective phase II trial. Patients received at least two months of antihormonal treatment (AT) before radiotherapy continuing for at least 2 years. Helical IMRT (tomotherapy) of the pelvic lymph nodes (51.0 Gy) with a simultaneous integrated, moderate hypofractionated boost (single dose of 2.25 Gy) to the prostate (76.5 Gy) was performed in 34 fractions. PSA levels, prostate-related symptoms and quality of life were assessed at regular intervals for 24 months.Of the 40 patients enrolled, 38 finished the treatment as planned. Overall acute toxicity rates were low and no acute grade 3 or 4 gastrointestinal (GI) and genitourinary (GU) toxicity occurred. 21.6% of patients experienced acute grade 2 but no late grade ? 2 GI toxicity. Regarding GU side effects, results showed 48.6% acute grade 2 and 6.4% late grade 2 toxicity. After a median observation time of 23.4 months the PLATIN 1 trial can be considered as sufficiently safe meeting the prospectively defined aims of the trial. With 34/37 patients free of a PSA recurrence it shows promising efficacy.Tomotherapy of the pelvic lymph nodes with a simultaneous integrated boost to the prostate can be performed safely and without excessive toxicity. The combined irradiation of both prostate and pelvic lymph nodes seems to be as well tolerated as the irradiation of the prostate alone.Trial Numbers: ARO 2009-05, ClinicalTrials.gov: NCT01903408.

SUBMITTER: Habl G

PROVIDER: S-EPMC4637144 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Helical intensity-modulated radiotherapy of the pelvic lymph nodes with a simultaneous integrated boost to the prostate--first results of the PLATIN 1 trial.

Habl Gregor G Katayama Sonja S Uhl Matthias M Kessel Kerstin A KA Edler Lutz L Debus Juergen J Herfarth Klaus K Sterzing Florian F

BMC cancer 20151107

<h4>Background</h4>Definitive, percutaneous irradiation of the prostate and the pelvic lymph nodes in high-risk prostate cancer is the alternative to prostatectomy plus lymphadenectomy. To date, the role of whole pelvis radiotherapy (WPRT) has not been clarified especially taking into consideration the benefits of high conformal IMRT (intensity modulated radiotherapy) of complex-shaped target volumes.<h4>Methods</h4>From 2009 to 2012, 40 patients of high-risk prostate cancer with an increased ri ...[more]

PMID: 26547188

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Project description:ObjectiveThis study aimed to evaluate the efficacy and safety of simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) versus standard-dose intensity-modulated radiotherapy (SD-IMRT) in the treatment of locally advanced esophageal squamous cell carcinoma.MethodsFrom July 2003 to March 2014, 1748 patients in a single center who received definitive chemoradiotherapy were included in the analysis. A total of 109 patients who underwent SIB-IMRT and fulfilled all inclusion and exclusion criteria were identified as the study group. A total of 266 patients who underwent SD-IMRT (60 Gy/30 fractions, 2 Gy/fraction, 1 time/day, 5 times/week) during the same period were selected as the control group. Propensity score matching (PSM) was used to balance the baseline characteristics. Survival status, treatment failure mode, and the occurrence of adverse events were compared between the two groups.ResultsThere were more women and more cervical and upper thoracic cancers (P = 0.038, < 0.001, respectively) in the SIB-IMRT group before case matching. The median progression-free survival (PFS) in the SD-IMRT and SIB-IMRT groups was 22 and 19 months, respectively, and the median overall survival duration was 24 and 22 months, respectively, with χ2 = 0.244 and P = 0.621. After PSM of 1:1, 138 patients entered the final analysis (69 cases from each group). The median PFS of the SD-IMRT group and the SIB-IMRT group was 13 and 18 months, respectively, with χ2 = 8.776 and P = 0.003. The 1‑, 3‑, and 5‑year overall survival rates were 66.7, 21.7, and 8.7% and 65.2, 36.2, and 27.3%, respectively, and the median overall survival duration was 16 and 22 months, respectively, with χ2 = 5.362 and P = 0.021. Treatment failure mode: 5‑year local regional recurrence rates of SD-IMRT and SIB-IMRT were 50.7 and 36.2%, respectively, with χ2 = 2.949 and P = 0.086. The 5‑year distant metastasis rates of the two groups were 36.2 and 24.6%, respectively, with χ2 = 2.190 and P = 0.139.Adverse events3 patients experienced grade 4-5 toxicity (2.2%), including one case of grade 4 radiation esophagitis and two cases of grade 5 radiation pneumonitis, all in the SD-IMRT group; 14 patients experienced grade 3 adverse events (10.1%), primarily including radiation esophagitis, radiation pneumonitis, and hematological toxicity.ConclusionThe technique of SIB-IMRT was safe and reliable compared with SD-IMRT. In addition, SIB-IMRT had locoregional control advantages and potential survival benefits.

Project description:ObjectiveThe objective of this study was to retrospectively explore the clinical implications of simultaneous intensity-modulated radiotherapy (IMRT) boost to the tumor bed in cervical cancer with full-thickness stromal invasion (FTSI).Patients and methodsPatients diagnosed with the International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB and IIA cervical cancer with confirmed FTSI were included. Patients received pelvic IMRT from a dose of 50.4 Gy in 28 fractions with (or without) a simultaneous integrated boost (SIB) to 58.8 Gy in 28 fractions for the tumor bed. The progression-free survival (PFS), overall survival (OS), and pelvic-PFS (p-PFS) were analyzed using the Kaplan-Meier method, and independent prognostic factors were explored by Cox regression analyses.ResultsPatients without a tumor bed boost had a poor prognosis. The 5-year OS was 81.3% versus 58.3% and the 5-year PFS rates were 75.0% versus 57.6% (boost vs non-boost). The FIGO stage, pathology, adjuvant chemotherapy, and tumor bed boost were independent factors affecting both the 5-year OS and PFS. Subgroup analysis showed that the SIB group had a higher 5-year OS, PFS, and p-PFS for different stages, lymph node status, and risk groups than the non-SIB group. Recurrence occurred in 268 of 910 (29.5%) patients without SIB and 49 of 293 (16.7%) with SIB. Among patients with recurrence, 113 of 282 (40.1%) in the non-boost group compared with 14 of 51 (23.0%) patients in the boost group had a pelvic recurrence. Tumor bed boost resulted in an increase in the mean radiation dose to the intestine, rectum, and bladder, although there were no differences in the rates of acute and late toxicities between the 2 groups.ConclusionTumor bed boost by external beam radiotherapy (EBRT) is an effective and safe method for patients with FTSI and risk factors. Compared with the standard prophylactic radiation, tumor bed boost by EBRT was not associated with increased acute and late toxicities.

Project description:PurposeWhile intensity modulated proton therapy can deliver simultaneous integrated boost (SIB) to the dominant intraprostatic lesion (DIL) with high precision, it is sensitive to anatomic changes. We investigated the dosimetric effects from these changes based on pretreatment cone-beam computed tomographic (CBCT) images and identified the most important factors using a multilayer perceptron neural network (MLPNN).Methods and materialsDILs were contoured based on coregistered multiparametric magnetic resonance images for 25 previously treated prostate cancer patients. SIB plans were created with (1) prostate clinical target volume - V70 Gy = 98%; (2) DIL - V98 Gy > 95%; and (3) all organs at risk (OARs)"?> within clinical constraints. SIB plans were applied to daily CBCT-based deformed planning computed tomography (CT)"?>. DIL - V98 Gy, bladder/rectum maximum dose (Dmax) and volume changes, femur shifts, and the distance from DIL to organs at riskOARs"?> in both planning computed tomogramsCT"?> and CBCT were calculated. Wilcoxon signed-ranks tests were used to compare the changes. MLPNNs were used to model the change in ΔDIL - V98 Gy > 10% and bladder/rectum Dmax > 80 Gy, and the relative importance factors for the model were provided. The performances of the models were evaluated with receiver operating characteristic curves.ResultsComparing initial plan to the average from evaluation plans, respectively, DIL - V98 Gy was 89.3% ± 19.9% versus 86.2% ± 21.3% (P = .151); bladder Dmax 71.9 ± 0.6 Gy versus 74.5 ± 2.9 Gy (P < .001); and rectum Dmax 70.1 ± 2.4 Gy versus 74.9 ± 9.1Gy (P = .007). Bladder and rectal volumes were 99.6% ± 39.5% and 112.8% ± 27.2%, respectively, of their initial volume. The femur shift was 3.16 ± 2.52 mm. In the modeling of ΔDIL V98 Gy > 10%, DIL to rectum distance changes, DIL to bladder distance changes, and rectum volume changes ratio are the 3 most important factors. The areas under the receiver operating characteristic curves were 0.89, 1.00, and 0.99 for the modeling of ΔDIL - V98 Gy > 10%, and bladder and rectum Dmax > 80 Gy, respectively.ConclusionsDosimetric changes in DIL SIB with intensity modulated proton therapy can be modeled and classified based on anatomic changes on pretreatment images by an MLPNN.

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Helical intensity-modulated radiotherapy of the pelvic lymph nodes with a simultaneous integrated boost to the prostate--first results of the PLATIN 1 trial.

Publications

Helical intensity-modulated radiotherapy of the pelvic lymph nodes with a simultaneous integrated boost to the prostate--first results of the PLATIN 1 trial.

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