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Aim: Peritoneal dissemination of infiltrative appendiceal tumors is a rare and poorly understood phenomenon. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a well‐recognized treatment option for selected patients. Neoadjuvant systemic chemotherapy (NAC) has been shown to be associated with improved overall survival (OS) in colorectal peritoneal metastases but little is known of the impact of this from an appendiceal adenocarcinoma perspective. Method: A prospective database of 294 patients with advanced appendiceal primary tumors undergoing CRS ± HIPEC between June 2009 and December 2020 was reviewed. Baseline characteristics and long‐term outcomes were compared between patients with adenocarcinoma who received neoadjuvant chemotherapy or upfront surgery. Results: Eighty‐six (29%) patients were histologically diagnosed with an appendiceal cancer. These included intestinal‐type adenocarcinoma (11.6%), mucinous adenocarcinoma (43%), and goblet cell adenocarcinoma (GCA) or signet ring cell adenocarcinoma (SRCA) (45.4%). Twenty‐five (29%) of these underwent NAC, of which eight (32%) exhibited some degree of radiological response. There was no statistical difference in OS at 3 years between the NAC and upfront surgery groups (47.3% vs. 75.8%, p = 0.372). Appendiceal histology subtypes, particularly GCA and SRCA (p = 0.039) and peritoneal carcinomatosis index >10 (p = 0.009), were factors independently associated with worse OS. Conclusion: Administration of NAC did not appear to prolong OS in the operative management of disseminated appendiceal adenocarcinomas. GCA and SRCA subtypes display a more aggressive biological phenotype. [ABSTRACT FROM AUTHOR]

Aim: Carcinoid heart disease (CHD) is a well‐documented complication of neuroendocrine tumors (NETs) due to secreted hormones causing fibrosis. Somatostatin analogues (SSAs) can decrease hormonal secretion and inhibit tumor growth. The reported incidence of CHD has decreased as SSA use has increased. We describe a series of patients who have developed CHD even though they were treated with SSA therapy. Methods: Nine patients were seen in four centers in Australia and New Zealand. The average duration of follow‐up from diagnosis was 39 months. Results: Three patients had Grade 1 and six Grade 2 disease by World Health Organization 2010 criteria. All patients had no CHD symptoms at baseline and started SSA therapy soon after diagnosis, yet developed significant, symptomatic cardiac dysfunction in their disease course. The median time from NET diagnosis to SSA initiation was 1 month, and median time from NET diagnosis to CHD diagnosis was 23 months (range 4–52). All patients who were tested had persistently increased hormonal levels (chromogranin A, urinary 5‐hydroxyindolacetic acid). Conclusions: The good symptomatic control afforded by SSAs should not lead to reduced vigilance in screening for CHD, especially in patients with persistently elevated hormonal assays. Clinicians should consider regular echocardiographic screening in patients with a secretory syndrome. [ABSTRACT FROM AUTHOR]

NeuroEndocrine Cancer Australia (NECA) plays an essential role in advocacy for patients with NETs by linking patients to specialist NET centers, providing NET information to patients, running general practitioner education services, developing national NET guidelines, and overseeing the innovative development of the PLANET registry. We note that withdrawal due to side effects in the trials was relatively low (PROMID 5/43 patients and CLARINET 3/101 patients) and that adverse events were not severe.11,12 There are three types of patients who may derive less benefit from an SSA if there is a delay in treatment initiation. Patient diaries are useful in the first few months of treatment as they provide an objective measure of treatment effects, and the clinician can demonstrate to the patient the impact of the treatment on their NET. However, not all patients are suitable for this "watch and wait" strategy, especially patients with poor hepatic reserve, grade 2 or higher disease, poor performance status, and patients with pancreatic NETs who have a poorer prognosis. [Extracted from the article]

Aims: This multicenter phase II trial evaluates the efficacy of everolimus in poor prognosis grade 2 (G2) pancreatic neuroendocrine tumors (PNETs), defined by 2‐[fluorine‐18]fluoro‐2‐deoxy‐d‐glucose (FDG) positron‐emission tomography (PET) avidity. FDG–PET avidity in NETs is associated with a significantly higher risk of death, outperforming Ki‐67 index or liver metastases as a poor prognostic factor. We hypothesized that everolimus has efficacy in patients with FDG–PET‐avid G2 PNETs and prospectively evaluated progression‐free survival (PFS) and response in the first‐line setting. Methods: Patients with FDG–PET‐avid G2 advanced PNET received everolimus 10 mg daily until disease progression. Patients were staged every 12 weeks with CT/MRI and FDG–PET and every 24 weeks with Gallium 68 (68Ga) 1,4,7,10‐tetraazacyclododecane‐1,4,7,10‐tetraacetic acid (DOTA)–octreotate (DOTATATE, GaTate) PET. The primary endpoint was PFS at 6 months. Overall survival rate, PET/structural imaging response and toxicity were also measured. Results: Nine patients were accrued from December 2012 to February 2015. Median treatment duration was 13.8 months. The estimated PFS rate at 6 months was 78%. The best response on CT/MRI was stable disease in nine patients (100%) and partial response on FDG–PET in five patients (55.5%). Treatment‐related adverse effects were consistent with previous studies of everolimus. Conclusion: Everolimus is active with prolonged disease control in poor prognosis FDG‐avid G2 PNETs. Treatment individualization based on functional imaging warrants further evaluation. [ABSTRACT FROM AUTHOR]

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 FROM AUTHOR]

Abstract: Aim: Complementary medicine (CAM) use in the cancer population is higher than the general population: some studies estimate up to 70%. Our Medicines Information Centre, in a tertiary cancer institution, receives many enquiries regarding use and safety of CAM with conventional cancer therapies (chemotherapy, radiotherapy and surgery). This project aims to review the CAM most commonly enquired about with an emphasis on potential interactions with conventional cancer therapies. Methods: An audit and review of CAM enquiries from patients or medical professionals at our center, over a 2‐year period (July 2011–June 2013), was conducted. The most commonly enquired about CAM, excluding vitamins and minerals, were identified, reviewed and potential interactions described. Results: Enquiries were received from 462 patients involving 330 different CAMs. The 10 CAMs most commonly enquired about were fish oil (3.54%), turmeric (3.24%), coenzyme Q10 (2.63%), milk thistle (2.44%), green tea (2.38%), ginger (2.14%), lactobacillus (2.08%), licorice (1.83%), astragalus (1.77%) and reishi mushroom (1.59%). All were found to have predicted or potential drug interactions or therapeutic issues when combined with conventional therapies. Human studies are lacking and potential drug interactions are often predicted using in vitro or in vivo animal data. Conclusions: While many CAMs may be safe when taken by themselves, there is theoretically a potential for interactions and/or increased risk of serious adverse effects when taken concurrently with conventional anticancer therapies. The paucity of human data implies that their clinical significance is difficult to quantify and hence caution is required. [ABSTRACT FROM AUTHOR]

Aim: Despite the considerable impact of neuroendocrine tumors (NETs) on patients' lives, the patient journey is not well documented. The aim of this survey was to identify the impact and burden of NETs from the patient perspective. Methods: This was a self-reported global survey regarding NET knowledge/awareness, disease impact/management, interaction with medical teams, and desired improvements. One hundred thirty-eight patients (7% of the global study) in the Oceania region answered closed-ended questions using graded descriptors on their experience of living with NETs. Results: The personal lives of patients were negatively impacted by NETs, including overall energy levels (72%, 99/138), emotional health (66%, 91/138), and finances (56%, 77/138). Eighty-one percent (22/27) of patients not currently working stated that their NET was the reason they were not employed. Of those still working, taking days off work (64%, 39/61), working reduced hours (44%, 27/61) and stopping work for a period of time (31%, 19/61) were the most frequently reported outcomes of having a NET. Although most patients felt supported by their medical team (53% [73/138] reported being extremely or very supported by healthcare professionals in general), patients also identified areas for improvement in patient care. Better access to NET-specific treatments (58%, 80/138), more awareness about NETs (58%, 80/138) and materials to help patients better explain their condition (52%, 72/138) were indicated by patients as ways to help them live better with their disease. Conclusion: The survey demonstrated a considerable burden of NETs on patients' lives and identified areas for improvements in long-term management. [ABSTRACT FROM AUTHOR]

Aim The potential beneficial interaction between erlotinib and chemotherapy may require sequencing or pharmacodynamic separation. The aim of this study was to evaluate the efficacy and tolerance of sequential erlotinib and gemcitabine versus gemcitabine monotherapy as first-line therapy in elderly or ECOG PS-2 patients with advanced non-small cell lung carcinoma. Methods The primary objective of this multicenter randomized Phase II study was progression-free survival ( PFS). Secondary objectives were overall response rate ( ORR), disease control rate, response duration, overall survival and safety. Patients were randomized to either gemcitabine (1250 mg/m2 Day 1, 8 q28 days) followed by erlotinib (150 mg/day on day 15 through day 28), ( EG-arm), or gemcitabine monotherapy (1000 mg/m2 Days 1, 8, 15 q28 days), ( G-arm) for up to six cycles. Results Fifty-four patients were recruited, 28 G-arm and 26 EG-arm. Overall, efficacy results were not significantly different between study arms. Median PFS and ORR for the G- versus EG-arms were 8.0 versus 10.3 weeks (hazard ratio 1.3; 95% confidence interval [0.63;2.68]; P = 0.48) and 7.1 versus 3.8 percent respectively (difference −3.30; 95% confidence interval [−17.5;10.9]). The majority of adverse events ( AEs) in both arms were Grade 1-2. The commonest AEs recorded in the EG- and G-arms were rash-like events (65 percent) and nausea (42 percent) respectively. Four patients (17 percent) in EG-arm and five (16 percent) in G-arm experienced at least one treatment-related serious AE. Conclusions In this study, patients with non-small cell lung carcinoma at ECOG PS-2 or aged ≥70 years derived no efficacy advantage from sequential erlotinib in combination with gemcitabine relative to gemcitabine alone. No unexpected safety findings were noted. [ABSTRACT FROM AUTHOR]

The issue of medication safety is highly significant when anti-cancer therapy is used as a treatment modality due to the high potential for harm from these agents and the disease context in which they are being used. These guidelines provide recommendations on the safe prescribing, dispensing and administration of chemotherapy and related agents used in the treatment of cancer. The guidelines represent a multidisciplinary collaboration to standardise the complex process of providing chemotherapy for cancer and to enhance patient safety. These are consensus guidelines based on the best available evidence and expert opinion of professionals working in cancer care. The aim of these guidelines is to assist in the prevention of medication errors and to improve patient safety with respect to the treatment of cancer. This guidance is intended for a multi-disciplinary audience and will have most relevance for medical, nursing and pharmacy staff involved in the complex processes of delivering chemotherapy and associated treatment. The scope of the guidelines includes; all patients and age groups receiving chemotherapy and targeted therapy for the treatment of cancer and cancer therapy administered by any route in both the hospital and home setting. These guidelines should be seen as point of reference for practitioners providing cancer chemotherapy services. [ABSTRACT FROM AUTHOR]

Aim: Peritoneal dissemination of infiltrative appendiceal tumors is a rare and poorly understood phenomenon. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a well-recognized treatment option for selected patients. Neoadjuvant systemic chemotherapy (NAC) has been shown to be associated with improved overall survival (OS) in colorectal peritoneal metastases but little is known of the impact of this from an appendiceal adenocarcinoma perspective., Method: A prospective database of 294 patients with advanced appendiceal primary tumors undergoing CRS ± HIPEC between June 2009 and December 2020 was reviewed. Baseline characteristics and long-term outcomes were compared between patients with adenocarcinoma who received neoadjuvant chemotherapy or upfront surgery., Results: Eighty-six (29%) patients were histologically diagnosed with an appendiceal cancer. These included intestinal-type adenocarcinoma (11.6%), mucinous adenocarcinoma (43%), and goblet cell adenocarcinoma (GCA) or signet ring cell adenocarcinoma (SRCA) (45.4%). Twenty-five (29%) of these underwent NAC, of which eight (32%) exhibited some degree of radiological response. There was no statistical difference in OS at 3 years between the NAC and upfront surgery groups (47.3% vs. 75.8%, p = 0.372). Appendiceal histology subtypes, particularly GCA and SRCA (p = 0.039) and peritoneal carcinomatosis index >10 (p = 0.009), were factors independently associated with worse OS., Conclusion: Administration of NAC did not appear to prolong OS in the operative management of disseminated appendiceal adenocarcinomas. GCA and SRCA subtypes display a more aggressive biological phenotype., (© 2023 The Authors. Asia‐Pacific Journal of Clinical Oncology published by John Wiley & Sons Australia, Ltd.)

Aim: Carcinoid heart disease (CHD) is a well-documented complication of neuroendocrine tumors (NETs) due to secreted hormones causing fibrosis. Somatostatin analogues (SSAs) can decrease hormonal secretion and inhibit tumor growth. The reported incidence of CHD has decreased as SSA use has increased. We describe a series of patients who have developed CHD even though they were treated with SSA therapy., Methods: Nine patients were seen in four centers in Australia and New Zealand. The average duration of follow-up from diagnosis was 39 months., Results: Three patients had Grade 1 and six Grade 2 disease by World Health Organization 2010 criteria. All patients had no CHD symptoms at baseline and started SSA therapy soon after diagnosis, yet developed significant, symptomatic cardiac dysfunction in their disease course. The median time from NET diagnosis to SSA initiation was 1 month, and median time from NET diagnosis to CHD diagnosis was 23 months (range 4-52). All patients who were tested had persistently increased hormonal levels (chromogranin A, urinary 5-hydroxyindolacetic acid)., Conclusions: The good symptomatic control afforded by SSAs should not lead to reduced vigilance in screening for CHD, especially in patients with persistently elevated hormonal assays. Clinicians should consider regular echocardiographic screening in patients with a secretory syndrome., (© 2021 John Wiley & Sons Australia, Ltd.)

Aims: This multicenter phase II trial evaluates the efficacy of everolimus in poor prognosis grade 2 (G2) pancreatic neuroendocrine tumors (PNETs), defined by 2-[fluorine-18]fluoro-2-deoxy-d-glucose (FDG) positron-emission tomography (PET) avidity. FDG-PET avidity in NETs is associated with a significantly higher risk of death, outperforming Ki-67 index or liver metastases as a poor prognostic factor. We hypothesized that everolimus has efficacy in patients with FDG-PET-avid G2 PNETs and prospectively evaluated progression-free survival (PFS) and response in the first-line setting., Methods: Patients with FDG-PET-avid G2 advanced PNET received everolimus 10 mg daily until disease progression. Patients were staged every 12 weeks with CT/MRI and FDG-PET and every 24 weeks with Gallium 68 (68Ga) 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA)-octreotate (DOTATATE, GaTate) PET. The primary endpoint was PFS at 6 months. Overall survival rate, PET/structural imaging response and toxicity were also measured., Results: Nine patients were accrued from December 2012 to February 2015. Median treatment duration was 13.8 months. The estimated PFS rate at 6 months was 78%. The best response on CT/MRI was stable disease in nine patients (100%) and partial response on FDG-PET in five patients (55.5%). Treatment-related adverse effects were consistent with previous studies of everolimus., Conclusion: Everolimus is active with prolonged disease control in poor prognosis FDG-avid G2 PNETs. Treatment individualization based on functional imaging warrants further evaluation., (© 2020 John Wiley & Sons Australia, Ltd.)

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/m 2 /day for 96 hours/week for 6 weeks plus bolus MMC at 10 mg/m 2 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., (© 2018 John Wiley & Sons Australia, Ltd.)

Aim: Complementary medicine (CAM) use in the cancer population is higher than the general population: some studies estimate up to 70%. Our Medicines Information Centre, in a tertiary cancer institution, receives many enquiries regarding use and safety of CAM with conventional cancer therapies (chemotherapy, radiotherapy and surgery). This project aims to review the CAM most commonly enquired about with an emphasis on potential interactions with conventional cancer therapies., Methods: An audit and review of CAM enquiries from patients or medical professionals at our center, over a 2-year period (July 2011-June 2013), was conducted. The most commonly enquired about CAM, excluding vitamins and minerals, were identified, reviewed and potential interactions described., Results: Enquiries were received from 462 patients involving 330 different CAMs. The 10 CAMs most commonly enquired about were fish oil (3.54%), turmeric (3.24%), coenzyme Q10 (2.63%), milk thistle (2.44%), green tea (2.38%), ginger (2.14%), lactobacillus (2.08%), licorice (1.83%), astragalus (1.77%) and reishi mushroom (1.59%). All were found to have predicted or potential drug interactions or therapeutic issues when combined with conventional therapies. Human studies are lacking and potential drug interactions are often predicted using in vitro or in vivo animal data., Conclusions: While many CAMs may be safe when taken by themselves, there is theoretically a potential for interactions and/or increased risk of serious adverse effects when taken concurrently with conventional anticancer therapies. The paucity of human data implies that their clinical significance is difficult to quantify and hence caution is required., (© 2018 John Wiley & Sons Australia, Ltd.)

Aim: Despite the considerable impact of neuroendocrine tumors (NETs) on patients' lives, the patient journey is not well documented. The aim of this survey was to identify the impact and burden of NETs from the patient perspective., Methods: This was a self-reported global survey regarding NET knowledge/awareness, disease impact/management, interaction with medical teams, and desired improvements. One hundred thirty-eight patients (7% of the global study) in the Oceania region answered closed-ended questions using graded descriptors on their experience of living with NETs., Results: The personal lives of patients were negatively impacted by NETs, including overall energy levels (72%, 99/138), emotional health (66%, 91/138), and finances (56%, 77/138). Eighty-one percent (22/27) of patients not currently working stated that their NET was the reason they were not employed. Of those still working, taking days off work (64%, 39/61), working reduced hours (44%, 27/61) and stopping work for a period of time (31%, 19/61) were the most frequently reported outcomes of having a NET. Although most patients felt supported by their medical team (53% [73/138] reported being extremely or very supported by healthcare professionals in general), patients also identified areas for improvement in patient care. Better access to NET-specific treatments (58%, 80/138), more awareness about NETs (58%, 80/138) and materials to help patients better explain their condition (52%, 72/138) were indicated by patients as ways to help them live better with their disease., Conclusion: The survey demonstrated a considerable burden of NETs on patients' lives and identified areas for improvements in long-term management., (© 2017 John Wiley & Sons Australia, Ltd.)

The issue of medication safety is highly significant when anti-cancer therapy is used as a treatment modality due to the high potential for harm from these agents and the disease context in which they are being used. These guidelines provide recommendations on the safe prescribing, dispensing and administration of chemotherapy and related agents used in the treatment of cancer. The guidelines represent a multidisciplinary collaboration to standardise the complex process of providing chemotherapy for cancer and to enhance patient safety. These are consensus guidelines based on the best available evidence and expert opinion of professionals working in cancer care. The aim of these guidelines is to assist in the prevention of medication errors and to improve patient safety with respect to the treatment of cancer. This guidance is intended for a multi-disciplinary audience and will have most relevance for medical, nursing and pharmacy staff involved in the complex processes of delivering chemotherapy and associated treatment. The scope of the guidelines includes; all patients and age groups receiving chemotherapy and targeted therapy for the treatment of cancer and cancer therapy administered by any route in both the hospital and home setting. These guidelines should be seen as point of reference for practitioners providing cancer chemotherapy services.