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Background: Pembrolizumab monotherapy, whilst not standard of care, has demonstrated efficacy in clear cell renal cell carcinoma (ccRCC). The first-line KEYNOTE-427 study ...demonstrated an overall response rate (ORR) of 34%, and a median progression-free survival (PFS) of 7.1 mo (McDermott D et al. J Clin Oncol 2020; 38:S15; 5069-5069). Stereotactic ablative body radiotherapy (SABR) is an option for oligometastatic ccRCC, but patients often develop distant progression or relapse within irradiated sites. The RAPPORT study (NCT02855203) was a multi-institutional single arm, phase I/II study evaluating safety and efficacy of SABR and pembrolizumab. Methods: Patients with up to 2 lines of prior systemic therapy with 1-5 oligometastases from ccRCC were eligible. A single fraction of 20Gy SABR to all metastatic sites was given (or 10 fractions of 3 Gy of conventional radiotherapy CRT if SABR was not feasible), followed by pembrolizumab 200mg administered Q3W for 8 cycles. The primary objective was safety (CTCAEv4.03), with secondary key objectives of efficacy (RECIST1.1) by disease control rate (DCR), defined as complete response (CR), partial response (PR) or stable disease for at least 6 months, ORR, PFS and overall survival (OS). Results: Thirty patients were enrolled and received protocol treatment. The median follow-up was was 2.3 years. The median age was 62 (range 47-80) years, 23 patients (77%) were male. Twenty-three patients (77%) were treatment naïve, 1 patient (3%) had a prior interleukin-2 therapy and 6 patients (20%) had a prior tyrosine kinase inhibitor. Nine patients (30%) had prior metastasectomy. Eighty-three oligometastases were treated (median of 3 per patient), of which 64 (77%) received SABR, and 19 (23%) received CRT. There were 8 adrenal, 11 bone, 43 lung, 12 lymph node and 9 soft tissue metastases irradiated. Four patients (13% 95%CI: 4-31%) had one or more grade 3 treatment-related AE: Pneumonitis (n=2), dyspnoea (n=1) and elevated ALP/ALT (n=1). There were no grade 4 or 5 AEs. All eight cycles of pembrolizumab were completed by 24 (80%) patients. DCR was 83% (95%CI: 65-94%). ORRs are tabulated below. Median PFS was 15.6 mo. Estimated 1 and 2-year OS was 90% (95%CI: 72-97%) and 74% (95%CI: 53-87%), respectively, while PFS was 60% (95%CI: 40-75%) and 45% (95%CI: 27-62%), respectively. Freedom from local progression at 2-years was 92% (95%CI: 80-97%). Conclusions: The combination of SABR and pembrolizumab in oligometastatic renal cell carcinoma is well tolerated with excellent local control. Durable responses and encouraging PFS were observed with this approach, which warrants further investigation. Clinical trial information: NCT02855203 . Table: see text
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.
The safe introduction of transanal total mesorectal excision (taTME) has been documented by the Australasian group previously. The most important prognostic indicator for rectal cancer is the ability ...to achieve a clear resection margin. By utilizing false planes for taTME surgery, the endopelvic fascia and or presacral fascia can be resected en bloc.
This case highlights the utilization of a taTME platform to perform a distal taTME with presacral fascial stripping and a lateral pelvic sidewall transanal-assisted dissection in a 53-year-old otherwise healthy woman with a mid-rectal tumor. Radiologically the tumor was staged as a T3c/T4 rectal cancer with an N1c deposit extending beyond mesorectal fascia abutting the left piriformis muscle. An extramural venous invasion positive tumor was evident with a positive circumferential resection margin at 4 o' clock. In addition, the taTME platform was used to allow transanal intraoperative radiotherapy (IORT) delivery to the sacrum. An R0 resection was achieved and the patient recovered well without incident.
Total operative time was 250 minutes with the patient being discharged on day 7 postoperatively without complication. Macroscopic evaluation revealed a grade III mesorectal excision with en bloc removal of presacral fascia. On microscopic evaluation, revealed a T3N1b tumor with 2 of 14 positive lymph nodes (0/5 pelvic sidewall nodes).
The case highlights a novel application of taTME and is to the authors' best knowledge the first described use of a transanal platform to deliver intraoperative radiation therapy in the literature.
Background
Several unanswered questions surround the management of retroperitoneal sarcoma (RPS). Guidelines recommend treatment by a multidisciplinary team at a specialized referral centre. The ...objective of this study was to describe the management of RPS at an Australian specialist sarcoma centre, comparing outcomes to international standards and analysing for predictors of local failure.
Methods
A retrospective review of a prospectively maintained database was performed on patients with RPS treated between 2008 and 2016. A 5‐year outcome analyses focussed on patients undergoing curative‐intent surgery for primary, non‐metastatic RPS.
Results
Eighty‐eight patients underwent surgery for primary RPS. Five‐year overall survival was 66%, 5‐year freedom from local recurrence was 65% and 5‐year freedom from distant metastasis was 71%. Overall survival was associated with tumour grade (hazard ratio (HR) 6.1, P < 0.001) and histologic organ invasion (HR 5.7, P < 0.001). Variables associated with improved freedom from local recurrence were macroscopically complete resection (HR 0.14, P < 0.001) and neoadjuvant radiotherapy (HR 0.33, P = 0.014). Treatment at a specialist sarcoma centre was associated with a higher rate of preoperative biopsy and neoadjuvant radiotherapy (both with P < 0.001). There was a trend towards improved local control for patients undergoing surgery at a specialist centre (P = 0.055).
Conclusion
This is the largest Australian series of RPS and outcomes are comparable to major international sarcoma centres. Patients treated at a specialist centre had higher rates of preoperative diagnosis and tailored therapy which was associated with improved outcomes. Patients with suspected RPS should be referred to a specialist centre for optimal preoperative evaluation and multidisciplinary management.
This study analyses seminal vesicle displacement relative to the prostate and in relation to treatment time.
A group of eleven patients undergoing prostate cancer radiotherapy were imaged with a ...continuous 3 T cine-MRI in the standard treatment setup position. Four images were recorded every 4 seconds for 15 minutes in the sagittal plane and every 6.5 seconds for 12 minutes in the coronal plane. The prostate gland and seminal vesicles were contoured on each MRI image. The coordinates of the centroid of the prostate and seminal vesicles on each image was analysed for displacement against time. Displacements between the 2.5 percentile and 97.5 percentile (i.e. the 2.5% trimmed range) for prostate and seminal vesicle centroid displacements were measured for 3, 5, 10 and 15 minutes time intervals in the anterior-posterior (AP), left-right (LR) and superior-inferior (SI) directions. Real time prostate and seminal vesicle displacement was compared for individual patients.
The 2.5% trimmed range for 3, 5, 10 and 15 minutes for the seminal vesicle centroids in the SI direction measured 4.7 mm; 5.8 mm; 6.5 mm and 7.2 mm respectively. In the AP direction, it was 4.0 mm, 4.5 mm, 6.5 mm, and 7.0 mm. In the LR direction for 3, 5 and 10 minutes; for the left seminal vesicle, it was 2.7 mm, 2.8 mm, 3.4 mm and for the right seminal vesicle, it was 3.4 mm, 3.3 mm, and 3.4 mm. The correlation between the real-time prostate and seminal vesicle displacement varied substantially between patients indicating that the relationship between prostate displacement and seminal vesicles displacement is patient specific with the majority of the patients not having a strong relationship.
Our study shows that seminal vesicle motion increases with treatment time, and that the prostate and seminal vesicle centroids do not move in unison in real time, and that an additional margin is required for independent seminal vesicle motion if treatment localisation is to the prostate.
Purpose
Mitomycin C (MMC) plus standard 5‐fluorouracil (FU) infusion in weeks 1 and 5 often contributes to radiotherapy interruptions and possibly less‐than‐ideal outcomes in anal cancer. This study ...was to evaluate alternative strategies for chemotherapy delivery that might be less toxic or more efficacious, and outcomes of patient‐initiated treatment interruption for severe acute toxicity.
Materials and methods
This was a prospective, nonrandomized study for patients with T1‐4N0‐3M0 anal squamous carcinoma. Radiotherapy of 54 Gy in 30 fractions over 6 weeks was given with infusion FU 300 mg/m2/day for 96 hours/week for 6 weeks plus bolus MMC at 10 mg/m2 on D1.
Results
Fifty patients were recruited (72% female). Median age was 60.5 years (35–84). Forty‐seven patients (94%) received 54 Gy. Median duration of chemoradiation was 39 days (37–105). Grade 3 and 4 acute toxicity were observed in 66%. Thirty‐one percent with severe acute toxicity developed severe late toxicity. Of those who experienced severe late skin toxicity, 29% did not have severe acute toxicity.
Disease‐free survival at 5 years was 74% (95% confidence interval CI, 60–84), and at 9 years 61% (95% CI, 46–74). Overall survival at 5 years was 84% (95% CI, 71–92), and at 9 years 67% (95% CI, 50–81). Colostomy‐free survival at 5 years was 70% (95% CI, 56–81), and at 9 years 57% (95% CI, 40–72).
Conclusion
It is feasible to deliver chemoradiation with bolus MMC and protracted infusion FU for anal cancer. Efficacy and toxicity of this regimen seem similar to conventional chemoradiation with FU/MMC. Acute skin toxicity is not a reliable predictor of severe late skin toxicity.
Abstract Purpose Preoperative radiotherapy provides advantages in the management of retroperitoneal sarcoma (RPS). We describe our experience treating a cohort who underwent pre- and ...post-radiotherapy functional imaging with FDG-PET scan. Methods and materials Consecutive patients presenting between January 1999 and December 2009 with a diagnosis of either primary or recurrent RPS were identified from the hospital patient record database using ICD codes, and cross-referenced with the completed radiotherapy course database. Those patients suitable for preoperative radiotherapy and surgery who underwent both pre- and post-radiotherapy FDG-PET were included. Exclusions included presence of metastatic disease, age under 18 years and/or paediatric histology, and treatment with palliative intent. Results Eleven patients were included, of whom six were male. Median age was 63 years (range, 38–78 years). The majority of patients had Stage T2b, high-grade disease. Ten patients were treated at initial presentation and one at first local recurrence. A malignant diagnosis was confirmed in all patients who underwent CT-guided core biopsy; a diagnosis of sarcoma was reached in 91%. Sensitivity of FDG-PET imaging was 100%. Metabolic partial or complete response did not correlate with change in tumour size, nor pathological response assessment. Pulmonary and hepatic metastatic disease was detected in one patient on post-treatment imaging. All patients in the cohort completed preoperative radiotherapy. There was no grade 3 or 4 toxicity. Sixty-four percent proceeded to radical resection. Complete macroscopic excision was achieved in all cases. There was no perioperative mortality. Conclusion Combined therapy with preoperative radiotherapy and surgery has acceptable levels of toxicity. CT-guided core biopsy is an accurate means of confirming a diagnosis of RPS prior to definitive treatment. Utility of PET scan in the management of RPS is evolving and further investigation is warranted.
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