Australian Cancer Centre Research Articles

Safety of Rituximab biosimilar (Riximyo®) following a single switch from the reference product in patients with Non-Hodgkin’s lymphoma: a retrospective study

Unlike small molecule drugs and generic products, the active component of biologics and biosimilars are not identical chemical entities. Despite bioequivalence, there is limited evidence in clinical practice (i.e. Phase IV post-marketing surveillance) regarding the safety of biosimilar rituximab and even less so for “switching therapy” with respect to safety. Drug substitution by switching aims to realise cost savings by changing therapy involving a reference (biologic) product to a biosimilar. A retrospective analysis of safety outcomes including treatment-emergent adverse effects (TEAEs), rates of death and discontinuation of therapy, for all patients that received switching therapy (from reference to biosimilar rituximab, n = 33) was compared to patients who did not did not switch therapy (received biosimilar rituximab only, n = 18) at an Australian metropolitan cancer centre, over a six-month period. There was no statistical significant differences for any safety outcomes examined. Switching therapy for patients receiving rituximab does not lead to poorer safety outcomes.

Real-World Implementation of Simulation-Free Radiation Therapy (SFRT-1000): A Propensity Score-Matched Analysis of 1000 Consecutive Palliative Courses Delivered in Routine Care.

The feasibility of simulation-free radiation therapy (SFRT) has been demonstrated but information regarding its routine care impact and scalability is lacking. In this single-institution, retrospective cohort study, all patients receiving palliative radiation therapy at an Australian tertiary cancer center were eligible for consideration of SFRT unless mask immobilization, a stereotactic technique, or a definitive dose was indicated. Coprimary endpoints were SFRT utilization, impact on consultation-to-RT time, and on-couch treatment duration. Timing metrics were compared with a contemporary local cohort that received simulation-based palliative radiation therapy using unadjusted Wilcoxon rank-sum tests and a propensity score-matched regression. Electronic patient-reported outcomes captured 2-week toxicity and pain response. Between April 2018 and February 2024, 2849 palliative radiation courses were delivered, of which 1904 were eligible. Of the 1904 courses, 1000 (52.5% SFRT utilization) received SFRT, including 668 using intensity-modulated radiation therapy/volumetric-modulated arc therapy. A total of 788 individual patients received SFRT and the median age was 71 years (IQR, 61-80) with 59% being male and 42% being Eastern Collaborative Oncology Group 2-4. SFRT utilization increased from 41% to 54% between years 2018-2019 and 2022-2024. SFRT reduced median consultation-to-RT time from 7.0 to 5.1 days (P < .0001) corresponding to an adjusted average treatment effect in the treated of -2.1 days (95% CI, -2.8 to -1.3). SFRT increased median on-couch treatment duration from 17.8 to 20.5 minutes (P < .0001; adjusted average treatment effect in the treated 2.6 minutes, 95% CI, 1.3-3.9). Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events grade 3 acute toxicity was 9% and at 4 weeks after RT, patients with moderate/severe pain at baseline (≥5/10) had a mean pain reduction of 3.5 points (7.1-3.6; P < .0001). Using widely available technologies, the SFRT-1000 cohort demonstrates routine care scalability with patient-centered and workflow benefits. SFRT is an attractive new paradigm implementable in most settings following adaptation to local requirements. Thus, SFRT opens new avenues to potentially improve access to palliative RT, which remains a global area of need.

Utility of 30-Day Mortality Following Systemic Anti-Cancer Treatment as a Quality Indicator in Advanced Lung Cancer

Background30-day mortality after systemic anti-cancer therapy (SACT) has been suggested as a quality indicator primarily for measuring use of chemotherapy towards the end of life. Utility across different cancer types is unclear, especially when using immunotherapy and targeted therapies. MethodsThis retrospective study included patients with a diagnosis of lung cancer who received palliative-intent SACT at an Australian metropolitan cancer center between 2015 and 2022. Using a prospectively maintained lung cancer database, patient, disease, and treatment characteristics were evaluated against annual 30-day mortality rates following SACT. Results1072 patients were identified. Annual 30-day mortality rate after palliative-intent SACT for lung cancer ranged between 9% and 15%, with significant variance between treatment types. Calculated rates of 30-day mortality are higher if longer reporting time periods are used. Patients who died within 30 days of SACT were more likely to have received targeted therapies or immunotherapy as their final line of treatment, have a poorer performance status at diagnosis, and have received multiple lines of treatment. ConclusionsOur data support differential interpretation of 30-day mortality for quality assurance, especially with regard to lung cancer. Consistency in population and reporting time periods, and accounting for treatment type is crucial if 30-day mortality is to be utilized as cancer care performance quality indicator. Relevance to quality care is questionable in the lung cancer setting.

Long-term outcomes of definitive radiation with volumetric modulated arc therapy and concurrent chemotherapy for squamous cell carcinoma of the anus in a regional Australian cancer centre.

Concurrent chemoradiotherapy is the standard of care in the curative intent treatment of squamous cell carcinoma (SCC) of the anus. Volumetric arc therapy (VMAT) is a highly conformal radiation therapy technique that has been implemented to reduce toxicity for these patients. However, there are few reports evaluating the long-term outcomes of VMAT. Thus, we evaluated the survival and toxicity outcomes of anal cancer patients treated in our regional cancer centre undergoing curative intent chemoradiotherapy using VMAT and following the Australian EviQ guidelines. All consecutive patients treated with the VMAT technique for curative-intent definitive chemoradiotherapy for anal SCC at our institution from 2013 until 2022 were retrospectively reviewed for survival and toxicity outcomes. Kaplan-Meier estimates of locoregional control, distant metastasis-free survival, disease-free survival, anal cancer-specific survival and overall survival were obtained. In total, 44 patients were analysed. The median follow-up was 48.9 months (Range 7.8-107). 97.7% of patients completed the prescribed radiation therapy and 88.6% chemotherapy. Five patients (11.4%) recurred. Four (9.1%) had isolated local failures, and one (2.3%) had an isolated distant failure. There were no regional nodal failures. The Kaplan-Meier estimates for locoregional control, distant metastasis-free survival, disease-free survival, anal cancer-specific survival and overall survival were 90.3%, 97.7%, 88.1%, 97.1% and 87% at 3 years, and 90.3%, 97.7%, 88.1%, 93.0% and 72.3% at 5 years, respectively. Acute grade 3 genitourinary (GU), gastrointestinal (GI) and skin toxicities occurred in 2.2%, 6.8% and 13.6% of patients, respectively. There were no acute grade 4 toxicities. Late grade 2 GU and GI toxicities occurred in 6.8% and 11.3% of patients, respectively. There were no late grade 3 or 4 toxicities or treatment-related deaths. The 5 -year colostomy-free survival rate was 86.4%. Outcomes for anal SCC after definitive chemoradiotherapy using VMAT in our regional cancer centre results in low rates of grade 3/4 toxicity, high rates of organ preservation and excellent survival outcomes.

A minority of women of childbearing potential are tested for pregnancy before chemoimmunotherapy: an Australian cancer centre experience.

Chemotherapy is potentially harmful to a developing foetus, and there are limited data on the foetal impact of chemoimmunotherapy (CIT). Therefore, determining pregnancy status prior to initiation of CIT should be standard of care. To determine how many women of childbearing age are tested for pregnancy prior to immunochemotherapy administration. A retrospective chart review at a large Australian metropolitan cancer referral centre, including 304 women aged 18-51 years with a diagnosis of cancer receiving outpatient-based CIT between 1 May 2015 and 12 June 2020. We assessed the uptake of pregnancy screening and contraception counselling prior to and during first-line CIT. Only 17.3% of CIT cycles (n = 416) screened patients for pregnancy no more than 90 days prior to administration, and the median time between pregnancy screening and treatment was approximately 3 weeks. One patient with early breast cancer had a spontaneous miscarriage estimated at 3-4 weeks' gestation, and neither the patient nor the treating oncologist was aware of this event. This was also the only patient who had a pregnancy test beyond the first cycle of CIT during their treatment. Our results highlight a concerningly low rate of pregnancy screening in women of childbearing age receiving CIT. The implication of missing a positive pregnancy test in this group of women could result in foetal complications, accidental miscarriage, potential bleeding risks and avoidable psychosocial stress. This highlights the urgent need for guidelines to mandate pregnancy testing in women of childbearing age receiving CIT and evidence-based implementation tools.

Experience and acceptability of a carer-focussed intervention in acute oncology settings: A qualitative study of people with advanced cancer and their carers.

Providing optimal support for carers of people with advanced cancer is critical to facilitating discharge home from hospital. Carer Support Needs Assessment Tool-Intervention (CSNAT-I) has shown promise in supporting carers' needs in this context. This study aimed to explore patient and carers experiences with and views on the acceptability of the CSNAT-I delivered by occupational therapists in an acute oncology setting. People with advanced cancer and their carers who had previously received the CSNAT-I as part of usual care while admitted to an Australian specialist cancer centre or acute hospital were invited to participate in interviews exploring their perceptions of the intervention. Data were analysed thematically. Two patients and 10 carers participated in semi-structured interviews. Three themes were constructed from the data: Carers viewed the CSNAT-I as comprehensive process that (1) 'covered everything' related to discharge planning; (2) generated an 'increased awareness of needs' for themselves, patients, and clinicians; and (3) triggered an emotional response of feeling 'wrapped up in care' that was maintained as they moved from hospital to home. This study has demonstrated that the CSNAT-I was highly acceptable to carers as part of existing discharge processes supporting them through the transition from hospital to home and can be delivered by occupational therapists and other clinicians with a natural synergy to discharge planning. These findings will inform further development and testing of the delivery model of the CSNAT-I in future trials.

Risk of immune-related adverse events (irAE) with immune checkpoint inhibitors (ICI) in patients (pts) with family history (FH) of autoimmune disease (AID).

2648 Background: Pts with personal history (PH) of AID are at increased risk of irAE following ICI. Risk of irAE in pts with FH of AID is unknown. Methods: In this retrospective cohort study, consecutive pts were recruited from 2 Australian melanoma cancer centers. Pts who received anti-PD-1 (PD1) based ICI with FH of AID were eligible. Pts with PH of AID were excluded. Toxicity data (CTCAE v5.0) was obtained and stratified by FH of AID (first/second/third degree relative). Descriptive statistics and Fisher’s Exact test were used for analysis. Results: 396 melanoma cases were screened, of which 44 (11.1%) were eligible for inclusion. Baseline characteristics are summarized. 57 irAE occurred in 44 pts. The most common irAE were dermatological (n=11; 19.3%), colitis (n=8; 14.0%), endocrinopathies (n=8; 14.0%), hepatitis (n=7; 12.3%) and arthritis (n=7; 12.3%). Among 57 irAE, frequency of Grade 1,2,3 and 4 irAE was 16 (28.1%), 26 (45.6%), 12 (21.0%) and 3 (5.3%) respectively. Corticosteroids were used for 31 (54.4%) irAE. Hospital admission for management of irAE occurred in 11 pts (25.0%). ICI was discontinued in 20 pts (45.5%) due to irAE. In pts with irAE, FH of that irAE/AID was present in 6 pts (13.6%) (n= 2 x arthritis, n= 2 x psoriasis, n= 1 x Crohn’s disease, n= 1 x Grave’s disease), and 4 of these patients had a first-degree relative with an AID. 3/6 pts had ICI ceased due to an irAE (peak toxicity Grade was 3) and 4/6 pts had RECIST response. There was no association in development of irAE between patients with FH of AID in a first-degree relative and those with FH of AID in second or third degree relative (p=0.17). Rate of irAE in pts with FH of AID was not statistically higher to that reported in registration trials of similar regimens (p=0.40). Conclusions: FH of AID is common in melanoma pts and was not associated with higher rate or morbidity of irAE. FH AID should be routinely collected, and larger scale studies need to be performed. [Table: see text]

Treatment approaches and outcomes of a head and neck lymphedema service at an Australian comprehensive cancer center

Patients treated for head and neck cancer are at high risk of developing head and neck lymphedema (HNL). We describe outcomes of HNL management at an Australian institution from 2018 to 2020. Electronic records from Chris O'Brien Lifehouse were retrospectively reviewed from January 1, 2018 to December 31, 2020. Objective changes in HNL were assessed using The M. D. Anderson Cancer Center (MDACC) HNL rating scale and Assessment of Lymphedema of the Head and Neck (ALOHA). Among the 100 patients referred for management of HNL, surgery was the most frequent treatment modality (80%; 70% with neck dissection) and 69% underwent radiotherapy. Manual lymphatic drainage (MLD) was most often prescribed (96%), followed by self-MLD (93%). Small but significant improvements in ALOHA measurements were observed for 50 patients (50%). Only 5/29 (17%) patients had post-treatment improvements on the MDACC scale. Standardized, prospective measurement of treatment approaches and outcomes is needed to further evaluate the service.

Outcomes of immediate dental implants in vascularised bone flaps for mandibular reconstruction.

The aim of this study is to assess the outcomes of immediate implant placement for dental rehabilitation following mandibular reconstruction with vascularised bone flaps in a single Australian tertiary cancer centre. A retrospective analysis of patients who underwent immediate dental implant or delayed placement in vascularised bone flaps was performed. Primary outcome measures assessed included the number of implants placed, operative time, complication rates, time to radiotherapy initiation, dental rehabilitation rates and time to dental rehabilitation. In total, 187 dental implants were placed in 52 patients, of which 34 patients underwent immediate implant placement and 18 had delayed implant placement. There were no significant differences in the postoperative complication rate (32% immediate vs. 33% delayed, P=0.89) or time to postoperative radiotherapy (median 42 days immediate vs. 47 days delayed, P=0.24). Dental rehabilitation was achieved in 62% of the immediate cohort versus 78% of the delayed cohort. The time to be fitted with a dental prosthesis was significantly shorter in the immediate cohort (median 150 days immediate vs. 843 days delayed, P=0.002). The placement of immediate dental implants at the time of primary reconstruction of the mandible is a safe procedure and facilitates timely dental rehabilitation.

212P Impact of COVID-19 on the timeliness to care in a rapid access lung lesions clinic in a large Australian cancer centre

212P Impact of COVID-19 on the timeliness to care in a rapid access lung lesions clinic in a large Australian cancer centre

Perceptions of telehealth in real-world oncological care: An exploration of matched patient- and clinician-reported acceptability data from an Australian cancer centre.

BackgroundPrior to 2020, the use of telehealth in cancer care was limited, but COVID‐19 necessitated its rapid and widespread adoption into routine care delivery. This study aimed to evaluate perceptions of telehealth through a dyadic exploration of matched cancer patient‐ and clinician‐reported acceptability data and to explore factors that may predict greater suitability for telehealth.MethodsA prospective, cross‐sectional, exploratory survey study assessed (matched) patient‐ and clinician‐reported perceptions of telehealth consultations occurring at a metropolitan, tertiary‐based cancer centre in Victoria, Australia.ResultsOne‐hundred and fifty‐five matched patient‐ and clinician‐reported data were included. High rates of acceptability with telehealth were reported by patients (93%) and clinicians (91%), who mostly shared concordant views (86%). Factors significantly associated with increased acceptability for telehealth, included, for clinicians, greater familiarity with the patient (OR 8.20, 95% CI: 1.50–45.06, p = 0.02), and younger patient age (OR 1.06, 95% CI: 0.99–1.13, p = 0.05), and for patients was earlier stage disease (≤stage III) (OR 5.29, 95% CI: 1.08–25.82, p = 0.04). Lower acceptability for telehealth according to clinicians was associated with poorer patient performance status (OR 0.04, 95% CI 1.00–1.08, p = 0.04) and for patients with the need for an interpreter (0R 0.06, 95% CI: 0.008–0.51, p = 0.009).ConclusionWhile overall telehealth is acceptable in cancer care, our findings raise important implications for future service development, notably that it may be less optimal for patients with higher complexity of need—including those with more advanced disease, poorer performance status, those less well known to treating clinicians and those identified to have additional language barriers.

A racial bias test with tertiary cancer centre employees: why anti-racist measures are required for First Nations Australians cancer care equity.

Objective To examine implicit bias in employees at a cancer centre using an Australian race (Aboriginal-white) Implicit Association Test (IAT), in an attempt to understand a potential factor for inequitable outcomes of First Nations Australians cancer patients. Methods All employees at an Australian cancer centre were invited to take part in a web-based, cross-sectional study using an Australian race IAT. The results were analysed using Welch t-tests, linear regression and ANOVA. Results Overall, 538/2871 participants (19%) completed the IAT between January and June 2020. The mean IAT was 0.147 (s.d. 0.43, P < 0.001, 95% CI 0.11-0.18), and 60% had a preference for white over First Nations Australians. There was no significant mean difference in IAT scores between sub-groups of gender, age or clinical/non-clinical employees. 21% of employees (95% CI 17.65-24.53) had moderate to strong preference for white over First Nations Australians, compared to 7.1% with moderate to strong preference for First Nations over white Australians (95% CI 5.01-9.09). Conclusions Inequitable cancer survival for First Nations patients has been well established and cancer is now the leading cause of mortality. This paper documents the presence of racial bias in employees at one cancer centre. We argue that this cannot be understood outside the history of colonialism and its effects on First Nations Australians, healthcare workers and our society. Further research is required to evaluate measures of racism, its effect on health care, and how to eliminate it.

A Descriptive Cohort Study of Adolescent and Young Adult Decedents Known to an Australian Comprehensive Cancer Center.

In Australia, cancer is the second leading cause of death in adolescents and young adults (AYA). In an audit of 76 AYA decedents known to a comprehensive cancer center, most were male (63%), and most had a parent as primary carer (78%). Median age at diagnosis was 21 years (range: 15-27). Median time from diagnosis to first palliative care consultation was 9 months, and from first palliative care review to death, 4 months. Location of death was hospital (41%), home (24%), and palliative care unit (16%). Eleven (65%) of 17 patients who wished to die at home achieved this.

A Minority of Women of Child Bearing Potential Are Tested for Pregnancy before Chemoimmunotherapy: An Australian Cancer Centre Experience

Background: Chemotherapy is potentially harmful to the developing foetus and there is limited data on the foetal impact of immunotherapy except for rituximab. Therefore determining pregnancy status prior to initiation of chemo- and or immuno-therapy (CIT) should be standard of care. Repeat screening or testing during and after chemotherapy should be considered as women often cannot tell that they are pregnant due to overlapping symptoms of pregnancy, malignancy and treatment. This is of particular importance in women who are not on effective forms of contraception for personal choice or clinical reasons. Clinicians cannot presume that a patient's pregnancy status has been checked, or rely on any assumptions of abstinence, contraception or infertility based on secondary amenorrhoea. While CIT teratogenicity should be part of the informed consent discussion and it is recommended that pregnancy screening occur prior to CIT, there are no specific guidelines on this or on testing during CIT. It is our institutional standard to document consent using a standard tick box form to confirm a discussion of common and uncommon side effects of treatment, long term and life threating complications and impacts on fertility. Teratogenicity, pregnancy implications or contraception are not specified. We performed a retrospective review to evaluate the uptake of pregnancy screening prior to and during first-line CIT as well as an audit of documentation of contraception counselling in haematological and solid-organ malignancies at a large Australian tertiary cancer centre.Methods: We searched our electronic outpatient medical record database for Women of Child Bearing Potential (WoCBP) who were diagnosed with a malignancy and received outpatient based CIT between May 1 2015 and June 12 2020. WoCBP was defined as women 18-55 years of age with no record of menopause or definitive infertility. We captured patient demographics, disease details and CIT regimen. We collected result of any serum or urine b-HCG pregnancy tests done within 90 days prior to or during CIT administration and if positive, the pregnancy outcome. We captured any documentation regarding contraception prior to or during treatment.Results: A total of 415 WoCBP with a median age of 42 years (range 19-51) were included. The majority of women (79.3%) were treated for solid organ malignancies compared to haematological malignancies (20.7%) (Table 1). Only 17.1% were screened for pregnancy prior to its initiation. The average time between screening and CIT initiation was 19.5 days (range 0-90 days). Given the broad range of regimens and taking into consideration teratogenicity potential, CIT was categorised as immunotherapy alone (32.5%), chemotherapy containing an alkylating agent (25.8%) or an antimetabolite (3.9%), combination chemoimmunotherapy (15.2%) and other (22.7%). Rates of pregnancy screening within these categories is represented in Figure 1.One patient with early breast cancer had a positive pregnancy test during her 4 th cycle of adjuvant chemotherapy with paclitaxel, in the emergency department for a presentation of nausea, anorexia, abdominal pain and diarrhoea. The outcome in this case was an early spontaneous miscarriage estimated at 3-4 weeks gestation. This is the only patient who had a pregnancy test beyond the first cycle of CIT. Only 14.8% of patients had documentation of past or present contraception methods. None of the patients had documentation regarding counselling on recommended forms of contraception.Conclusion: A minority of WoCBP received a pregnancy test prior to commencing CIT for haematological or solid organ malignancy, and none intentionally received a test prior to subsequent chemotherapy cycles through the oncology/haematology service. Also none of the women had documented counselling on contraception. These results are concerning because missing a positive pregnancy test puts women at risk of foetal complications, accidental miscarriage, potential bleeding risks and avoidable psychosocial stress. Our results are consistent with the 2 other reports on this topic and are likely generalizable to other cancer centres. This highlights the urgent need for guidelines to increase the rate of pregnancy testing in WoCBP receiving CIT and contraception counselling prior to CIT. [Display omitted] DisclosuresHamad: Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

Management of Early Breast Cancer at an Australian Cancer Centre During the Early Phase of COVID-19 Pandemic

Background: This study aimed to prospectively record changes to treatment for early breast cancer patients during the first wave of the COVID-19 pandemic in Australia. The purpose was to assess the impact on breast cancer outcomes and to determine the need for any mitigative actions. Methods: The study was conducted in the breast cancer unit of a tertiary referral hospital. Patients with early (non-metastatic) breast malignancy discussed in multidisciplinary team meetings between March and June 2020 were included. Patients were newly diagnosed, post-operative or post-neoadjuvant chemotherapy. Standard treatment was defined by Westmead Breast Cancer Institute protocols and any variations related to the pandemic were recorded. Results: In the study, 145 patients were included (median age 59 years). Pandemic-related changes to management were noted in 13 of 145 (9.0%) patients. Four patients experienced a delay to cancer treatments, four were not offered reconstructive/ symmetrisation surgical procedures, three had altered radiotherapy protocols and two patients were not offered enrolment to a clinical trial. These impacts affected the groups presenting with new cancers (n=7/86, 8.1%), post-operative cases (n=4/25, 16.0%) and post-neoadjuvant chemotherapy cases presenting for surgical planning (n=2/34, 5.9%). Conclusion: Most patients (91.0%) received standard treatment during the first wave of the pandemic. The minor variations from institutional protocols observed in this study are unlikely to affect local control or survival in this patient cohort, but close follow-up is required. Quality of life may have been affected for four patients who had downgraded or delayed reconstructive procedures.

Feasibility of implementing a pharmacist-led DPYD gene testing service for patients commencing 5-fluorouracil (5FU) or capecitabine.

e18644 Background: Polymorphisms in the DPYD gene, which encodes for dihydropyrimidine dehydrogenase (DPD), may impair DPD metabolism of fluoropyrimidines (FP) and cause life-threatening toxicities. The European Medicines Agency (EMA) recommend testing for DPD activity before FP therapy, but the Australian Therapeutic Goods Administration and the US Food and Drug Administration do not currently recommend this. At our hospital, pre-emptive DPYD gene screening was established in response to 7 cases of severe FP-toxicity and significant challenges for timely access to the life-saving antidote, uridine triacetate (UT), in the preceding 3 years. This study assessed the feasibility of a pharmacist-led DPYD gene testing service in an Australian cancer centre. Methods: Patients planned for FP therapy, without previous FP exposure, were referred to the Clinical Pharmacogenetics (CPGx) pharmacist for consenting, before a blood or buccal swab sample was taken. An external genomics company screened for the five Clinical Pharmacogenetics Implementation Consortium (CPIC) recommended gene variants (c.1905+1G &gt; A, c.1679T &gt; G, c.2846A &gt; T, c.1236G &gt; A and c.557A &gt; G). Dose recommendations based on CPIC guidelines and phenotype were made to the treating clinician. Patients were followed-up for toxicity (graded according to CTCAE v5.0) at 3-5 days post first FP exposure and pre-cycle 2. Results: Between 16 December 2019 and 11 December 2020, 311 patients were planned for FP therapy. Genetic testing did not occur for 13 patients, in the first two months of program implementation mostly due to unfamiliarity with procedures. Of the 298 genotyped patients (median age 59.5 years, 52.7% female, 67.8% Upper and Lower Gastrointestinal, 18.1% Breast), 274 (91.9%) were seen by the CPGx pharmacist within 1 day of referral. Median time from samples being taken to result availability was 6 days. 286 patient (96.0%) results were reported and acted upon prior to the planned cycle 1 FP commencement date. Overall, 1 patient (0.3%, 95%CI 0.1-1.9) was identified as a poor metaboliser and avoided FP therapy. Ten patients (3.4%, 95%CI 1.8-6.0) were identified as intermediate metabolisers, of which 2 patients did not receive chemotherapy due to changes in goals of care, 1 patient received only one cycle at 100% of the full dose but passed away due to disease progression, 1 patient required UT administration after cycle 2 despite 50% dose reductions for both cycles and 6 patients received an initial 50% dose reduction, where for subsequent cycles, 3 continued at this dose level, 2 had dose increases and 1 had a further dose reduction. 17 patients experienced at least one grade 3/4 toxicity pre-cycle 2; all had normal metaboliser phenotypes. Conclusions: A pharmacist-led DPYD gene testing service is feasible, with acceptable test result turnaround times and phenotype identification rates similar to that reported by the EMA.

177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) in patients with somatostatin-expressing neuroendocrine tumors: A real-world retrospective review of efficacy and safety from an Australian tertiary cancer Center.

e16198 Background: There is relatively limited data guiding optimal treatment algorithms for inoperable or metastatic neuroendocrine tumours (NETs). The randomised NETTER 1 study established PRRT as a standard of care in midgut NET. The aim of this study was to retrospectively review the efficacy and safety of patients treated with 177Lu-DOTATATE at Royal Brisbane and Women’s Hospital. Methods: Consecutive patients with unresectable or metastatic NET who received their first 177Lu-DOTATATE therapy between 2010 and 2017 were identified. Paragangliomas were excluded. Response rates, progression free survival (PFS) and overall survival (OS) were assessed via a combination of chart review, post-therapeutic 68Ga DOTATATE PET/CT and multi-disciplinary meeting decisions. Gr3/4 haematological and renal safety data was analysed via chart review. Progression free survival (PFS) and overall survival (OS) were assessed via the Kaplan-Meier method. Results: 123 consecutive patients were included in the analysis (57% male, median age 61). Primary site: 41% gastroenteric, 34% pancreatic, 10% lung, 6% colon/rectum, 9% other. Grade 1 (42%), Grade 2 (31%) Grade 3 (6%), unknown (21%). 76% of patients had previously received somatostatin analogues. 80% received four cycles (with persistent myelosuppression the most common cause of ceasing therapy early). 20% of patients received concurrent chemotherapy (10% capecitabine, 10% capecitabine and temozolomide). For the entire cohort, median follow up was 51 months. Median PFS, 34.2 months (95% CI, 30.3 – 38.17) and median OS, 61 months (95% CI, 54.2– 67.8). There was no significant difference in PFS or OS between small bowel and pancreatic patients. Response rates to PRRT included complete response (n = 4, 3%), stable or responding disease (n = 96, 78%), progressive disease (n = 22, 18%), not assessable (1, 1%). Grade 3 or 4 thrombocytopenia, neutropenia or anaemia occurred in less than 1% of patients. Confirmed acute leukaemia occurred in three patients. One patient had grade 3 renal toxicity secondary to treatment. 26 patients received retreatment with 177Lu-DOTATATE at progression with median time to re-treatment of 35 months. Conclusions: This single centre, retrospective audit confirms the efficacy of 177Lu-DOTATATE in the treatment of unresectable and metastatic NETs. Treatment was associated with low rates of severe haematological or renal adverse events. Our results are comparable to similar published reviews.

Patient-reported outcome measures and supportive care need assessment in patients attending an Australian comprehensive care centre: a multi-method study.

Patient-reported outcome measures (PROMs) are useful clinical tools to recognise symptoms, patient needs and their severity. Whilst PROMs are routinely utilised in integrative oncology (IO) and supportive care (SC) services to improve patient care, they are not as common in general oncology. We explored our patients' symptom burden, the approach taken by clinicians to identify and manage patient needs, and barriers and facilitators to using PROMs in an Australian tertiary comprehensive cancer centre to inform wider implementation of PROMs. From 2017 to 2018, PROM data collected for patients accessing IO and SC was retrospectively analysed. Semi-structured interviews with oncology doctors and nurses explored their approach to patient needs assessment and their use of PROMs. A total of 404 patients completed the Edmonton Symptom Assessment Scale (ESAS). The most frequently identified symptoms were sleep disturbance, fatigue and lack of wellbeing. Symptom clusters included drowsiness, fatigue and shortness of breath; anxiety and depression; sleep and pain; appetite and nausea. In total, 9 nurse consultants, 5 surgeons, 7 medical and 5 radiation oncologists were interviewed. Most participants took an intuitive approach to identifying and managing patient needs and did not routinely use PROMs. Perceived risks, barriers and facilitators to using PROMS are presented. High and complex symptom burden was found in our IO and SC patient population, reinforcing the need for screening. Whilst wider clinical use of PROMs within the hospital may improve clinical outcomes, the barriers and facilitators identified by Health Care Professionals (HCPs) need to be addressed before implementing PROMs more broadly.

Prognostic value of the 8th edition American Joint Commission Cancer nodal staging system for patients with head and neck cutaneous squamous cell carcinoma: A multi-institutional study.

The 8th edition American Joint Committee on Cancer staging manual (AJCC8) introduced a separate staging system for head and neck cutaneous squamous cell carcinoma (HNcSCC) which parallels mucosal SCC and incorporates extranodal extension (ENE). This study aims to evaluate its prognostic utility. Univariate analysis of 1146 patients with metastatic HNcSCC from four Australian cancer centers was performed according to both AJCC 7th (AJCC7) and the 8th editions. AJCC8 increased classification of 924 (80.6%) patients to either pN2a or pN3b and 341 patients (29.8%) from stage III to IV compared to AJCC7. The disease-specific survival (DSS) was not significantly different between pN1, pN2 or pN3a categories per AJCC8. Estimates of model performance for the AJCC8 pN staging revealed modest predictive capacity (Harrell's C of 0.62 for DSS). The risk stratification according to pN classification of AJCC8 staging system performed poorly as a prognostic indicator.

Routine Blood Tests in Asymptomatic Patients With Indolent Lymphoma Have Limited Ability to Detect Clinically Significant Disease Progression.

Patients with indolent non-Hodgkin lymphoma (iNHL) undergo regular active surveillance in between treatment periods to detect disease relapse or progression. As part of surveillance, international guidelines recommend regular routine blood testing, which is based on consensus rather than evidence of utility. We conducted a retrospective analysis of all patients older than age 16 years diagnosed with grade 1-3A follicular or marginal zone lymphoma between 2008 and 2017 from 2 Australian cancer centers to assess the utility of full blood examination, lactate dehydrogenase, and β2-microglobulin in detecting progression events, defined as either disease relapse or progression of disease. One hundred eighty patients attended 1,757 outpatient appointments (median follow-up, 36 months). Routine blood tests (RBTs) were performed before 83% of appointments. Seventy-four progression events occurred in 62 patients. Only 2 events (3%) were detected by RBTs alone, both of which occurred in treatment-naïve patients who subsequently developed symptoms within 3 weeks. The remainder of progression events were suspected clinically (88%) or detected by imaging (9%). RBT results were frequently abnormal in asymptomatic patients (19%), with abnormal results leading to either additional investigations or an increased surveillance frequency in 8% of cases. The overall sensitivity and positive predictive value of abnormal RBT results in detecting progression events were 39% and 9%, respectively. RBTs have poor performance characteristics and rarely detect clinically significant disease progression or relapse in asymptomatic patients with iNHL.