Stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a non-randomised phase 2 trial.

BACKGROUND: Stereotactic ablative body radiotherapy (SABR) is a novel non-invasive alternative for patients with primary renal cell cancer who do not undergo surgical resection. The FASTRACK II clinical trial investigated the efficacy of SABR for primary renal cell cancer in a phase 2 trial. METHODS: This international, non-randomised, phase 2 study was conducted in seven centres in Australia and one centre in the Netherlands. Eligible patients aged 18 years or older had biopsy-confirmed diagnosis of primary renal cell cancer, with only a single lesion; were medically inoperable, were at high risk of complications from surgery, or declined surgery; and had an Eastern Cooperative Oncology Group performance status of 0-2. A multidisciplinary decision that active treatment was warranted was required. Key exclusion criteria were a pre-treatment estimated glomerular filtration rate of less than 30 mL/min per 1·73 m2, previous systemic therapies for renal cell cancer, previous high-dose radiotherapy to an overlapping region, tumours larger than 10 cm, and direct contact of the renal cell cancer with the bowel. Patients received either a single fraction SABR of 26 Gy for tumours 4 cm or less in maximum diameter, or 42 Gy in three fractions for tumours more than 4 cm to 10 cm in maximum diameter. The primary endpoint was local control, defined as no progression of the primary renal cell cancer, as evaluated by the investigator per Response Evaluation Criteria in Solid Tumours (version 1.1). Assuming a 1-year local control of 90%, the null hypothesis of 80% or less was considered not to be worthy of proceeding to a future randomised controlled trial. All patients who commenced trial treatment were included in the primary outcome analysis. This trial is registered with ClinicalTrials.gov, NCT02613819, and has completed accrual. FINDINGS: Between July 28, 2016, and Feb 27, 2020, 70 patients were enrolled and initiated treatment. Median age was 77 years (IQR 70-82). Before enrolment, 49 (70%) of 70 patients had documented serial growth on initial surveillance imaging. 49 (70%) of 70 patients were male and 21 (30%) were female. Median tumour size was 4·6 cm (IQR 3·7-5·5). All patients enrolled had T1-T2a and N0-N1 disease. 23 patients received single-fraction SABR of 26 Gy and 47 received 42 Gy in three fractions. Median follow-up was 43 months (IQR 38-60). Local control at 12 months from treatment commencement was 100% (p<0·0001). Seven (10%) patients had grade 3 treatment-related adverse events, with no grade 4 adverse events observed. Grade 3 treatment-related adverse events were nausea and vomiting (three [4%] patients), abdominal, flank, or tumour pain (four [6%]), colonic obstruction (two [3%]), and diarrhoea (one [1%]). No treatment-related or cancer-related deaths occurred. INTERPRETATION: To our knowledge, this is the first multicentre prospective clinical trial of non-surgical definitive therapy in patients with primary renal cell cancer. In a cohort with predominantly T1b or larger disease, SABR was an effective treatment strategy with no observed local failures or cancer-related deaths. We observed an acceptable side-effect profile and renal function after SABR. These outcomes support the design of a future randomised trial of SABR versus surgery for primary renal cell cancer. FUNDING: Cancer Australia Priority-driven Collaborative Cancer Research Scheme.

Patient-reported functional outcome measures and treatment choice for prostate cancer.

BACKGROUND: The aim of this study was to describe changes in patient-reported functional outcome measures (PROMs) comparing pre-treatment and 12 months after radical prostatectomy (RP), external beam radiation therapy (EBRT), brachytherapy and active surveillance (AS). METHODS: Men enrolled from 2010 to 2019 in the South Australian Prostate Cancer Clinical Outcomes Collaborative registry a prospective clinical registry were studied. Urinary, bowel, and sexual functions were measured using Expanded Prostate Cancer Index Composite (EPIC-26) at baseline and 12 months post-treatment. Higher scores on the EPIC-26 indicate better function. Multivariable regression models were applied to compare differences in function and extent of bother by treatment. RESULTS: Of the 4926 eligible men, 57.0% underwent RP, 20.5% EBRT, 7.0% brachytherapy and 15.5% AS. While baseline urinary and bowel function varied little across treatment groups, sexual function differed greatly (adjusted mean scores: RP = 56.3, EBRT = 45.8, brachytherapy = 61.4, AS = 52.8; p < 0.001). Post-treatment urinary continence and sexual function declined in all treatment groups, with the greatest decline for sexual function after RP (adjusted mean score change - 28.9). After adjustment for baseline differences, post-treatment sexual function scores after EBRT (6.4; 95%CI, 0.9-12.0) and brachytherapy (17.4; 95%CI, 9.4-25.5) were higher than after RP. Likewise, urinary continence after EBRT (13.6; 95%CI, 9.0-18.2), brachytherapy (10.6; 95%CI, 3.9-17.3) and AS (10.6; 95%CI, 5.9-15.3) were higher than after RP. Conversely, EBRT was associated with lower bowel function (- 7.9; 95%CI, - 12.4 to - 3.5) than RP. EBRT and AS were associated with lower odds of sexual bother (OR 0.51; 95%CI, 0.29-0.89 and OR 0.60; 95%CI, 0.38-0.96, respectively), and EBRT with higher odds of bowel bother (OR 2.01; 95%CI, 1.23-3.29) compared with RP. CONCLUSION: The four common treatment approaches for prostate cancer were associated with different patterns of patient-reported functional outcomes, both pre- and 12 months post-treatment. However, after adjustment, RP was associated with a greater decline in urinary continence and sexual function than other treatments. This study underscores the importance of collecting baseline PROMs to interpret post-treatment functional outcomes.

TROG 15.03 phase II clinical trial of Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney - FASTRACK II.

BACKGROUND: Stereotactic ablative body radiotherapy (SABR) is a non-invasive alternative to surgery to control primary renal cell cancer (RCC) in patients that are medically inoperable or at high-risk of post-surgical dialysis. The objective of the FASTRACK II clinical trial is to investigate the efficacy of SABR for primary RCC. METHODS: FASTRACK II is a single arm, multi-institutional phase II study. Seventy patients will be recruited over 3 years and followed for a total of 5 years. Eligible patients must have a biopsy confirmed diagnosis of primary RCC with a single lesion within a kidney, have ECOG performance ≤2 and be medically inoperable, high risk or decline surgery. Radiotherapy treatment planning is undertaken using four dimensional CT scanning to incorporate the impact of respiratory motion. Treatment must be delivered using a conformal or intensity modulated technique including IMRT, VMAT, Cyberknife or Tomotherapy. The trial includes two alternate fractionation schedules based on tumour size: for tumours ≤4 cm in maximum diameter a single fraction of 26Gy is delivered; and for tumours > 4 cm in maximum diameter 42Gy in three fractions is delivered. The primary outcome of the study is to estimate the efficacy of SABR for primary RCC. Secondary objectives include estimating tolerability, characterising overall survival and cancer specific survival, estimating the distant failure rate, describing toxicity and renal function changes after SABR, and assessment of cost-effectiveness of SABR compared with current therapies. DISCUSSION: The present study design allows for multicentre prospective validation of the efficacy of SABR for primary RCC that has been observed from prior single institutional and retrospective series. The study also allows assessment of treatment related toxicity, overall survival, cancer specific survival, freedom from distant failure and renal function post therapy. TRIAL REGISTRATION: Clinicaltrials.gov NCT02613819 , registered Nov 25th 2015.

Dose-Effect Relationship of Kidney Function After SABR for Primary Renal Cell Carcinoma: TROG 15.03 FASTRACK II.

PURPOSE: Stereotactic ablative body radiotherapy (SABR) is a novel option to treat primary renal cell carcinoma. However, a high radiation dose may be received by the treated kidney, which may affect its function posttreatment. This study investigates the dose-effect relationship of kidney SABR with posttreatment renal function. METHODS AND MATERIALS: This was a prespecified secondary endpoint of the multicenter FASTRACK II (Focal Ablative STereotactic RAdiotherapy for Cancers of the Kidney phase II) clinical trial (National Clinical Trial 02613819). Patients received either 26 Gy in a single fraction (SF) for tumors with a maximal diameter of 4 cm or less or 42 Gy in 3 fractions (multifraction [MF]) for larger tumors. To determine renal function change, 99mTc-dimercaptosuccinic acid (DMSA) single-photon emission computed tomography/computed tomography (SPECT/CT) scans were acquired, and the glomerular filtration rate was estimated at baseline, 12, and 24 months posttreatment. Imaging data sets were rigidly registered to the planning CT where kidneys were segmented to calculate dose-response curves. RESULTS: From 71 enrolled patients, 36 (51%) and 26 (37%) patients were included in this study based on availability of posttreatment data at 12 and 24 months, respectively. The ipsilateral kidney glomerular filtration rate decreased from baseline by 42% and 39% in the SF cohort and by 45% and 62% in the MF cohort, at 12 and 24 months, respectively (P < .03). The loss in renal function was 3.6%/Gy ± 0.8%/Gy and 4.5%/Gy ± 1.0%/Gy in the SF cohort and 1.7%/Gy ± 0.1%/Gy and 1.7%/Gy ± 0.2%/Gy in the MF cohort at 12 and 24 months, respectively. The major loss in renal function occurred in high-dose regions, where dose-response curves converged to a plateau. CONCLUSIONS: For the first time in a multicenter study, the dose-effect relationship at 12 and 24 months post-SABR treatment for primary renal cell carcinoma was quantified. Kidney function reduces linearly with dose up to 100 Gy BED3.

Clinical and functional outcomes for risk-appropriate treatments for prostate cancer.

Objectives: To describe real-world clinical and functional outcomes in an Australian cohort of men with localised prostate cancer according to treatment type and risk category. Subjects and methods: Men diagnosed from 2008 to 2018 who were enrolled in South Australian Prostate Cancer Clinical Outcomes Collaborative registry-a multi-institutional prospective clinical registry-were studied. The main outcome measures were overall survival, cancer-specific survival, decline in functional outcomes, biochemical recurrence and transition to active treatment following active surveillance. Multivariable adjusted models were applied to estimate outcomes. Results: Of the 8513 eligible men, majority of men (46%) underwent radical prostatectomy (RP) followed by external beam radiation therapy with or without androgen deprivation therapy (EBRT +/- ADT) in 22% of the cohort. Five-year overall survival was above 91%, and 5-year prostate cancer-specific survival was above 97% in the low- and intermediate-risk categories across all treatments. Five-year prostate cancer-specific survival in the active surveillance group was 100%. About 37% of men with high-risk disease treated with RP and 17% of men treated with EBRT +/- ADT experienced biochemical recurrence within 5 years of treatment. Of men on active surveillance, 15% of those with low risk and 20% with intermediate risk converted to active treatment within 2 years. The decline in urinary continence and sexual function 12 months after treatment was greatest among men who underwent RP while the decline in bowel function was greatest for men who received EBRT +/- ADT. Conclusion: This contemporary real-world evidence on risk-appropriate treatment outcomes helps inform treatment decision-making for clinicians and patients.

Medication-based Comorbidity Measures and Prostate Cancer Treatment Selection.

INTRODUCTION: We aimed to assess the association between comorbidities and prostate cancer management. PATIENTS AND METHODS: We studied 12,603 South Australian men diagnosed with prostate cancer between 2003 and 2019. Comorbidity was measured one year prior to prostate cancer diagnosis using a medication-based comorbidity index (Rx-Risk). Binomial logistic regression analyses were used to assess the association between comorbidities and primary treatment selection (active surveillance, radical prostatectomy (RP), external beam radiotherapy (EBRT) with or without androgen deprivation therapy (ADT), brachytherapy, ADT alone, and watchful waiting (WW)). Certain common comorbidities within Rx-Risk (cardiac disorders, diabetes, chronic airway diseases, depression and anxiety, thrombosis, and chronic pain) were also assessed. All models were adjusted for sociodemographic and tumor characteristics. RESULTS: Likelihood of receiving RP was lower among men with Rx-Risk score ≥3 (odds ratio (OR) 0.62, 95%CI:0.56-0.69) and Rx-Risk 2 (OR 0.80, 95%CI:0.70-0.92) compared with no comorbidity (Rx-Risk ≤0). Men with high comorbidity (Rx-Risk ≥3) were more likely to have received ADT alone (OR 1.76, 95%CI:1.40-2.21), EBRT (OR 1.30, 95%CI:1.17-1.45) or WW (OR 1.49, 95%CI:1.19-1.88) compared with Rx-Risk ≤0. Pre-existing cardiac and respiratory disorders, thrombosis, diabetes, depression and anxiety, and chronic pain were associated with lower likelihood of selecting RP and higher likelihood of EBRT (except chronic airway disease) or WW (except diabetes and depression and anxiety). Cardiac disorders and thrombosis were associated with higher likelihood of selecting ADT alone. Furthermore, age had greater effect on treatment choice than the level of comorbidity. CONCLUSION: High comorbidity burden was associated with primary treatment choice, with significantly less RP and more EBRT, WW and ADT alone among men with higher levels of comorbidity. Each of the individual comorbid conditions also influenced treatment selection.

Risk of secondary malignancy following radiation therapy for prostate cancer.

We investigated whether prostate cancer patients treated with external beam radiation therapy (EBRT) have a higher cumulative incidence of secondary cancer compared with patients treated with radical prostatectomy (RP). We used state-wide linked data from South Australia to follow men with prostate cancer diagnosed from 2002 to 2019. The cumulative incidence of overall and site-specific secondary cancers between 5 and 15 years after treatment was estimated. Fine-Gray competing risk analyses were performed with additional sensitivity analyses to test different scenarios. A total of 7625 patients were included (54% underwent RP and 46% EBRT). Characteristics of the two groups differed significantly, with the EBRT group being older (71 vs. 64 years), having higher comorbidity burden and being more likely to die during follow-up than the RP group. Fifteen-year cumulative incidence for all secondary cancers was 27.4% and 22.3% in EBRT and RP groups, respectively. In the adjusted models, patients in the EBRT group had a significantly higher risk of genitourinary (adjusted subhazard ratio (aSHR), 2.29; 95%CI 1.16-4.51) and lung (aSHR, 1.93; 95%CI 1.05-3.56) cancers compared with patients in the RP group. However, there was no statistically significant difference between the two groups for risk of any secondary cancer, gastro-intestinal, skin or haematologic cancers. No statistically significant differences in overall risk of secondary cancer were observed in any of the sensitivity analyses and patterns for risk at specific cancer sites were relatively consistent across different age restriction and latency/time-lag scenarios. In conclusion, the increased risk of genitourinary and lung cancers among men undergoing EBRT may relate partly to treatment effects and partly to unmeasured residual confounding.

Patterns of practice regarding use of radiation therapy following radical prostatectomy: A survey of Radiation Oncologists and Urologists in Australia and New Zealand.

INTRODUCTION: This study aimed to investigate the patterns of practices of radiation oncologists (ROs) and urologists in Australia and New Zealand with respect to the utilisation of post-prostatectomy radiation therapy (RT) and help guide the development of an update to the existing Faculty of Radiation Oncology Genito-Urinary Group post-prostatectomy guidelines. METHODS: ROs and urologists with subspecialty practice in prostate cancer from Australia and New Zealand were invited to participate in an online survey comprised of clinical scenarios regarding post-prostatectomy RT. RESULTS: Sixty-five ROs and 28 urologists responded to the survey. In the setting of low-risk biochemical relapse, the threshold for initiating RT was lower for ROs than urologists. ROs were more likely than urologists to recommend adjuvant RT for node-positive disease. When salvage RT was advised for a pT3N0R1 recurrence, there was no consensus amongst ROs on whether to add either ADT or nodal treatment over prostate bed RT alone. For a solitary PSMA-avid pelvic lymph node recurrence, whole pelvis RT with androgen deprivation therapy was the preferred treatment option (72% ROs, 43% urologists). Most ROs (92%) recommended conventionally fractionated RT to 66-70 Gy, with a boost to any PSMA PET avid recurrent disease. CONCLUSION: This survey highlights the marked discordance in practice for the management of prostate cancer relapse post-prostatectomy. This is seen not only between specialties but also within the radiation oncology community. This emphasises the need for an updated evidence-based guideline to be produced.

Long-Term Outcomes of TROG 13.01 SAFRON II Randomized Trial of Single- Versus Multifraction Stereotactic Ablative Body Radiotherapy for Pulmonary Oligometastases.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.In a randomized phase II clinical trial, the Trans Tasman Radiation Oncology Group compared single- versus multifraction stereotactic ablative body radiotherapy (SABR) in 90 patients with 133 oligometastases to the lung. The study found no differences in safety, efficacy, systemic immunogenicity, or survival between arms, with single-fraction SABR picked as the winner on the basis of cost-effectiveness. In this article, we report the final updated survival outcome analysis. The protocol mandated no concurrent or post-therapy systemic therapy until progression. Modified disease-free survival (mDFS) was defined as any progression not addressable by local therapy, or death. At a median follow-up of 5.4 years, the 3- and 5-year estimates for overall survival (OS) were 70% (95% CI, 59 to 78) and 51% (95% CI, 39 to 61). There were no significant differences between the multi- and single-fraction arms for OS (hazard ratio [HR], 1.1 [95% CI, 0.6 to 2.0]; P = .81). The 3- and 5-year estimates for disease-free survival were 24% (95% CI, 16 to 33) and 20% (95% CI, 13 to 29), with no differences between arms (HR, 1.0 [95% CI, 0.6 to 1.6]; P = .92). The 3- and 5-year estimates for mDFS were 39% (95% CI, 29 to 49) and 34% (95% CI, 24 to 44), with no differences between arms (HR, 1.0 [95% CI, 0.6 to 1.8]; P = .90). In this patient population, where patients receive SABR in lieu of systemic therapy, one-in-three patients are alive without disease in the long term. There were no differences in outcomes by fractionation schedule.

Evaluation of Hypofractionated Radiation Therapy Use and Patient-Reported Outcomes in Men With Nonmetastatic Prostate Cancer in Australia and New Zealand.

Importance: Randomized clinical trials in prostate cancer have reported noninferior outcomes for hypofractionated radiation therapy (HRT) compared with conventional RT (CRT); however, uptake of HRT across jurisdictions is variable. Objective: To evaluate the use of HRT vs CRT in men with nonmetastatic prostate cancer and compare patient-reported outcomes (PROs) at a population level. Design, Setting, and Participants: Registry-based cohort study from the Australian and New Zealand Prostate Cancer Outcomes Registry (PCOR-ANZ). Participants were men with nonmetastatic prostate cancer treated with primary RT (excluding brachytherapy) from January 2016 to December 2019. Data were analyzed in March 2021. Exposures: HRT defined as 2.5 to 3.3 Gy and CRT defined as 1.7 to 2.3 Gy per fraction. Main Outcomes and Measures: Temporal trends and institutional, clinicopathological, and sociodemographic factors associated with use of HRT were analyzed. PROs were assessed 12 months following RT using the Expanded Prostate Cancer Index Composite (EPIC)-26 Short Form questionnaire. Differences in PROs were analyzed by adjusting for age and National Comprehensive Cancer Network risk category. Results: Of 8305 men identified as receiving primary RT, 6368 met the inclusion criteria for CRT (n = 4482) and HRT (n = 1886). The median age was 73.1 years (IQR, 68.2-77.3 years), 2.6% (168) had low risk, 45.7% (2911) had intermediate risk, 44.5% (2836) had high-/very high-risk, and 7.1% (453) had regional nodal disease. Use of HRT increased from 2.1% (9 of 435) in the first half of 2016 to 52.7% (539 of 1023) in the second half of 2019, with lower uptake in the high-/very high-risk (1.9% [4 of 215] to 42.4% [181 of 427]) compared with the intermediate-risk group (2.2% [4 of 185] to 67.6% [325 of 481]) (odds ratio, 0.26; 95% CI, 0.15-0.45). Substantial variability in the use of HRT for intermediate-risk disease remained at the institutional level (median 53.3%; range, 0%-100%) and clinician level (median 57.9%; range, 0%-100%) in the last 2 years of the study period. There were no clinically significant differences across EPIC-26 urinary and bowel functional domains or bother scores. Conclusions and Relevance: In this cohort study, use of HRT for prostate cancer increased substantially from 2016. This population-level data demonstrated clinically equivalent PROs and supports the continued implementation of HRT into routine practice. The wide variation in practice observed at the jurisdictional, institutional, and clinician level provides stakeholders with information that may be useful in targeting implementation strategies and benchmarking services.

Single-Fraction vs Multifraction Stereotactic Ablative Body Radiotherapy for Pulmonary Oligometastases (SAFRON II): The Trans Tasman Radiation Oncology Group 13.01 Phase 2 Randomized Clinical Trial.

IMPORTANCE: Evidence is lacking from randomized clinical trials to guide the optimal approach for stereotactic ablative body radiotherapy (SABR) in patients with pulmonary oligometastases. OBJECTIVE: To assess whether single-fraction or multifraction SABR is more effective for the treatment of patients with pulmonary oligometastases. DESIGN, SETTING, AND PARTICIPANTS: This multicenter, unblinded, phase 2 randomized clinical trial of 90 patients across 13 centers in Australia and New Zealand enrolled patients with 1 to 3 lung oligometastases less than or equal to 5 cm from any nonhematologic malignant tumors located away from the central airways, Eastern Cooperative Oncology Group performance status 0 or 1, and all primary and extrathoracic disease controlled with local therapy. Enrollment was from January 1, 2015, to December 31, 2018, with a minimum patient follow-up of 2 years. INTERVENTIONS: Single fraction of 28 Gy (single-fraction arm) or 4 fractions of 12 Gy (multifraction arm) to each oligometastasis. MAIN OUTCOMES AND MEASURES: The main outcome was grade 3 or higher treatment-related adverse events (AEs) occurring within 1 year of SABR. Secondary outcomes were freedom from local failure, overall survival, disease-free survival, and patient-reported outcomes (MD Anderson Symptom Inventory-Lung Cancer and EuroQol 5-dimension visual analog scale). RESULTS: Ninety participants were randomized, of whom 87 were treated for 133 pulmonary oligometastases. The mean (SD) age was 66.6 [11.6] years; 58 (64%) were male. Median follow-up was 36.5 months (interquartile range, 24.8-43.9 months). The numbers of grade 3 or higher AEs related to treatment at 1 year were 2 (5%; 80% CI, 1%-13%) in the single-fraction arm and 1 (3%; 80% CI, 0%-10%) in the multifraction arm, with no significant difference observed between arms. One grade 5 AE occurred in the multifraction arm. No significant differences were found between the multifraction arm and single-fraction arm for freedom from local failure (hazard ratio [HR], 0.5; 95% CI, 0.2-1.3; P = .13), overall survival (HR, 1.5; 95% CI, 0.6-3.7; P = .44), or disease-free survival (HR, 1.0; 95% CI, 0.6-1.6; P > .99). There were no significant differences observed in patient-reported outcomes. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, neither arm demonstrated evidence of superior safety, efficacy, or symptom burden; however, single-fraction SABR is more efficient to deliver. Therefore, single-fraction SABR, as assessed by the most acceptable outcome profile from all end points, could be chosen to escalate to future studies. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01965223.

Development of quality indicators to monitor radiotherapy care for men with prostate cancer: A modified Delphi method.

BACKGROUND AND PURPOSE: Quality indicators (QIs) have been developed for many aspects of prostate cancer care, but are under-developed with regard to radiotherapy treatment. We aimed to develop a valid, relevant and feasible set of core QIs to measure quality of radiotherapy care in men with prostate cancer. MATERIALS AND METHODS: We used a RAND-modified Delphi process to select QIs that were regarded as both important and feasible measures of quality radiotherapy care. This involved two phases: (1) a literature review to identify a list of proposed QIs; and (2) a QI selection process by an expert panel (n = 12) conducted in a series of three rounds: two online questionnaires' and one face-to-face meeting. The RAND criterion identified variation in ratings and determined the level of agreement after each round of voting. RESULTS: A total of 144 candidate QIs, which included measures from pre-treatment to post-treatment and survivorship care were identified. After three rounds of voting, the panel approved a comprehensive set of 17 QIs, with most assessing a process of care (n = 16, 94.1%) and the remaining assessing a health outcome. CONCLUSION: This study developed a core set of 17 QIs which will be used to report from the Prostate Cancer Outcomes Registry-Australia & New Zealand, to monitor the quality of radiotherapy care prostate cancer patients receive.

Comparison of effective I-131 half-life between thyroid hormone withdrawal and recombinant human thyroid-stimulating hormone for thyroid cancer: a retrospective study.

INTRODUCTION: Preparation for postoperative radioiodine ablation for differentiated thyroid carcinoma is performed by either thyroid hormone withdrawal or recombinant human thyroid-stimulating hormone (rhTSH) administration. There is little information on the impact of the method of preparation with respect to whole-body effective I-131 half-life and its potential clinical implications in the Australian setting. METHODS: A retrospective study was performed on patients admitted for adjuvant radioiodine ablation for non-metastatic differentiated thyroid carcinoma at the Royal Adelaide Hospital over a 4½-year period from 2009. Dose rate measurements were analysed for 19 rhTSH and 31 thyroid hormone withdrawal patients. RESULTS: The mean effective I-131 half-lives were 11.51 and 13.29 h for the rhTSH and thyroid hormone withdrawal groups, respectively, with no statistically significant difference between the two groups (P = 0.761). This result differs from previously published data where withdrawal periods were typically longer, resulting in slower renal clearance and longer half-lives for withdrawal patients. CONCLUSIONS: Our study did not demonstrate a significant difference in whole-body effective half-life of I-131 between the two methods of preparation for radioiodine ablation. This suggests that putative advantages of rhTSH over withdrawal in terms of whole-body radiation dose, duration of hospital admission and quality of life may be sensitive to duration of withdrawal.

Ophthalmic and adnexal complications of radiotherapy.

The role of radiotherapy in ophthalmic practice continues to grow. This growth has seen an expansion of indications for radiotherapy, a refinement of the modalities that can be used and a reduction in the ocular and adnexal complications that result from this form of therapy. The compendium of indications for radiotherapy in ophthalmology continues to grow and now includes many conditions such as the treatment of lid and adnexal disease, ocular surface disorders and both benign and malignant disease of the posterior segment and optic pathways. The radiotherapeutic modalities employed to manage these conditions are numerous and include both radioactive plaques (brachytherapy) and external beam radiation techniques. New techniques such as stereotactic radiosurgery are delivering benefits in the management of conditions such as optic nerve sheath meningioma, where the treatment of this blinding and occasionally life-threatening intracranial neoplasm now results in fewer adverse affects. The purpose of this review is to give a brief overview of the indications and treatment modalities, and a more in-depth discussion of the potential side-effects when radiotherapy is used for ocular and periorbital disease.