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Purpose: The aim of this randomized, placebo-controlled, two-stage, phase II/III trial was to determine the efficacy of an oral cannabis extract in adults with refractory nausea and/or vomiting during moderately or highly emetogenic, intravenous chemotherapy despite guideline-consistent antiemetic prophylaxis. Here, we report results of the prespecified combined analysis including the initial phase II and subsequent phase III components., Patients and Methods: Study treatment consisted of oral capsules containing either tetrahydrocannabinol 2.5 mg plus cannabidiol 2.5 mg capsules (THC:CBD) or matching placebo, taken three times a day from days -1 to 5, in addition to guideline-consistent antiemetics. The primary measure of effect was the difference in the proportions of participants with no vomiting or retching and no use of rescue medications (a complete response) during hours 0-120 after the first cycle of chemotherapy on study (cycle A)., Results: We recruited 147 evaluable of a planned 250 participants from 2016 to 2022. Background antiemetic prophylaxis included a corticosteroid and 5-hydroxytryptamine antagonist in 97%, a neurokinin-1 antagonist in 80%, and olanzapine in 10%. THC:CBD compared with placebo improved the complete response rate from 8% to 24% (absolute difference 16%, 95% CI, 4 to 28, P = .01), with similar effects for absence of significant nausea, use of rescue medications, daily vomits, and the nausea scale on the Functional Living Index-Emesis quality-of-life questionnaire. More frequent bothersome adverse events of special interest included sedation (18% v 7%), dizziness (10% v 0%), and transient anxiety (4% v 1%). There were no serious adverse events attributed to THC:CBD., Conclusion: THC:CBD is an effective adjunct for chemotherapy-induced nausea and vomiting despite standard antiemetic prophylaxis, but was associated with additional adverse events. Drug availability, cultural attitudes, legal status, and preferences may affect implementation. Future analyses will evaluate the cost-effectiveness of THC:CBD.

Purpose: Sleep quality commonly deteriorates in people receiving chemotherapy for breast cancer (BC). We aimed to determine feasibility and acceptability of telehealth-delivered cognitive behaviour therapy for insomnia (CBT-I) in people with early BC receiving (neo)adjuvant chemotherapy., Methods: Multi-centre, single arm, phase 2 feasibility trial. People with stage I-III BC received 4 sessions of telehealth CBT-I over 8 weeks, during chemotherapy. Participants completed Pittsburgh Sleep Quality Index (PSQI) and other Patient Reported Outcome Measures (PROMs) at baseline, post-program (week 9) and post-chemotherapy (week 24); and an Acceptability Questionnaire at week 9. Primary endpoint was proportion completing 4 sessions of telehealth CBT-I., Results: In total, 41 participants were recruited: mean age 51 years (range 31-73). All 4 CBT-I sessions were completed by 35 (85%) participants. Acceptability of the program was high and 71% reported 'the program was useful'. There was no significant difference in the number of poor sleepers (PSQI score ≥ 5) at baseline 29/40 (73%) and week 24 17/25 (68%); or in the mean PSQI score at baseline (7.43, SD 4.06) and week 24 (7.48, SD 4.41). From baseline to week 24, 7/25 (28%) participants had a ≥ 3 point improvement in sleep quality on PSQI, and 5/25 (20%) had a ≥ 3 point deterioration. There was no significant difference in mean PROM scores., Conclusion: It is feasible to deliver telehealth CBT-I to people with early BC receiving chemotherapy. Contrary to literature predictions, sleep quality did not deteriorate. Telehealth CBT-I has a potential role in preventing and managing sleep disturbance during chemotherapy. Australian New Zealand Clinical Trials Registry (ANZCTR) registration number: ACTRN12620001379909 and date 22/12/2020., (© 2024. The Author(s).)

Background: People living with a cancer diagnosis often experience cancer-related fatigue (CRF). Between 9% and 45% of people report CRF as moderate to severe, negatively impacting their quality-of-life (QOL). The evidence-base for managing CRF recommends exercise-related therapies over pharmaceutical interventions. One such exercise-like therapy is Baduanjin mind-body exercise (MBE), which has additional benefits. A remotely delivered program may further benefit people with CRF. The primary objective of this pilot will test study feasibility of a remotely delivered Baduanjin MBE exercise program for people living with CRF., Methods: This is a randomized wait-list controlled pilot study and will take place in Sydney, Australia. Subject to informed consent, 40 adults with moderate CRF levels and receiving or previously received adjuvant chemotherapy, will undertake a home-based 8-week Baduanjin MBE program supported by online resources and instructors. The primary feasibility outcomes are recruitment, enrollment, retention, and adherence rates; and safety as measured by tolerance and adverse-event frequency. Clinical outcomes (eg, changes in CRF, QOL, and participant perceptions) are assessed at pre-intervention, week 1, week 4, week 8, and post-intervention. Analyses follows the Intent-to-Treat (all participants as per randomization) and per-protocol (participants adhering to the protocol). Missing data will be imputed from previous data entries and regression models may be tested to predict missing outcomes., Discussion: To our knowledge, this is the first study evaluating the feasibility and effects of Baduanjin MBE on CRF using a remote delivery method. These feasibility data will inform a fully powered future trial investigating evidence of effect on CRF and QOL. Trial registration : Australian and New Zealand Clinical Trials Registry (ANZCTR 12623000177651). Ringgold ID : 651498 Chinese Medicine Centre., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: This multicentre, randomised, double-blinded, placebo-controlled, phase II/III trial aimed to evaluate an oral THC:CBD (tetrahydrocannabinol:cannabidiol) cannabis extract for prevention of refractory chemotherapy-induced nausea and vomiting (CINV). Here we report the phase II component results., Patients and Methods: Eligible patients experienced CINV during moderate-to-high emetogenic intravenous chemotherapy despite guideline-consistent antiemetic prophylaxis. Study treatment consisted of one cycle of 1-4 self-titrated capsules of oral THC 2.5 mg/CBD 2.5 mg (TN-TC11M) three times daily, from days -1 to 5, and 1 cycle of matching placebo in a crossover design, then blinded patient preference for a third cycle. The primary end point was the proportion of participants with complete response during 0-120 h from chemotherapy. A total of 80 participants provided 80% power to detect a 20% absolute improvement with a two-sided P value of 0.1., Results: A total of 81 participants were randomised; 72 completing two cycles were included in the efficacy analyses and 78 not withdrawing consent were included in safety analyses. Median age was 55 years (range 29-80 years); 78% were female. Complete response was improved with THC:CBD from 14% to 25% (relative risk 1.77, 90% confidence interval 1.12-2.79, P = 0.041), with similar effects on absence of emesis, use of rescue medications, absence of significant nausea, and summary scores for the Functional Living Index-Emesis (FLIE). Thirty-one percent experienced moderate or severe cannabinoid-related adverse events such as sedation, dizziness, or disorientation, but 83% of participants preferred cannabis to placebo. No serious adverse events were attributed to THC:CBD., Conclusion: The addition of oral THC:CBD to standard antiemetics was associated with less nausea and vomiting but additional side-effects. Most participants preferred THC:CBD to placebo. Based on these promising results, we plan to recruit an additional 170 participants to complete accrual for the definitive, phase III, parallel group analysis., Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616001036404; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370473&isReview=true., Competing Interests: Disclosure PG: Research funding to institution—ASLAN Pharmaceuticals (Inst), Boston Biomedical (Inst), Eisai (Inst), Eisai (Inst), Five Prime (Inst), Genentech (Inst), Gilead Sciences (Inst), Halozyme (Inst), Medimmune, MSD (Inst), Pfizer (Inst), Pfizer (Inst), Specialised Therapeutics, Tigermed (Inst), Tilray (Inst), Zucero. MS: Research funding to institution—Amgen (Inst), Astellas Pharma (Inst), AstraZeneca (Inst), Bayer (Inst), Bionomics (Inst), Bristol-Myers Squibb (Inst), Celgene (Inst), Medivation (Inst), Merck Sharp & Dohme (Inst), Pfizer (Inst), Roche (Inst), Sanofi (Inst), Tilray (Inst); Travel, Accommodations, Expenses—Medivation/Pfizer. NL: Consulting or Advisory Role—Camurus, Indivior, Mundipharma; Speakers' Bureau—PCM Healthcare Ltd; Research funding to institution—Camurus (Inst). AM: Travel, Accommodations, Expenses—Roche. AT: Travel, Accommodations, Expenses—Ipsen. JS: Research funding to institution—AbbVie (Inst), Amgen (Inst), Astellas Pharma (Inst), AstraZeneca (Inst), Bayer (Inst), Bristol-Myers Squibb (Inst), Merck Serono (Inst), Pfizer (Inst), Roche (Inst). RM: Research funding to institution—Edwards Life Sciences (Inst). IO: Consulting or Advisory Role—Aucentra, Con Ca Pty Ltd, VieCure; Speakers' Bureau—Pierre Fabre (Inst). IM: Honoraria—Janssen; Patents, Royalties, Other Intellectual Property—Kinoxis Therapeutics. CG: Honoraria—Novotech; Consulting or Advisory Role—AbbVie (Inst), Bristol-Myers Squibb (Inst), Ipsen (Inst), Merck Sharp & Dohme (Inst), Novotech, Pfizer (Inst); Research funding to institution—Amgen (Inst), Bristol-Myers Squibb (Inst), Merck Sharp & Dohme (Inst); Travel, Accommodations, Expenses—Astellas Pharma, Astellas Pharma, Merck Sharp & Dohme. SC: Employment—GenesisCare; Stock and Other Ownership Interests—GenesisCare; Honoraria—Tetra Health; Consulting or Advisory Role—All Vascular, AstraZeneca/MedImmune, Bayer, Ipsen, Merck; Speakers' Bureau—Merck, Novartis/Ipsen; Travel, Accommodations, Expenses—Bristol-Myers Squibb, MedLab. All remaining authors have declared no conflicts of interest., (Copyright © 2020 European Society for Medical Oncology. All rights reserved.)

Aim: Patients with cancer have varied preferences for involvement in decision-making. We sought older adults' preferred and perceived roles in decision-making about palliative chemotherapy; priorities; and information received and desired., Methods: Patients ≥65y who had made a decision about palliative chemotherapy with an oncologist completed a written questionnaire. Preferred and perceived decision-making roles were assessed by the Control Preferences Scale. Wilcoxon rank-sum tests evaluated associations with preferred role. Factors important in decision-making were rated and ranked, and receipt of, and desire for information was described., Results: Characteristics of the 179 respondents: median age 74y, male (64%), having chemotherapy (83%), vulnerable (Vulnerable Elders Survey-13 score ≥ 3) (52%). Preferred decision-making roles (n = 173) were active in 39%, collaborative in 27%, and passive in 35%. Perceived decision-making roles (n = 172) were active in 42%, collaborative in 22%, and passive in 36% and matched the preferred role for 63% of patients. Associated with preference for an active role: being single/widowed (p = .004, OR = 1.49), having declined chemotherapy (p = .02, OR = 2.00). Ranked most important (n = 159) were "doing everything possible" (30%), "my doctor's recommendation" (26%), "my quality of life" (20%), and "living longer" (15%). A minority expected chemotherapy to cure their cancer (14%). Most had discussed expectations of cure (70%), side effects (88%) and benefits (82%) of chemotherapy. Fewer had received quantitative prognostic information (49%) than desired this information (67%)., Conclusion: Older adults exhibited a range of preferences for involvement in decision-making about palliative chemotherapy. Oncologists should seek patients' decision-making preferences, priorities, and information needs when discussing palliative chemotherapy., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: Industry-supported decision impact studies demonstrate that Oncotype Dx (ODX) changes treatment recommendations (TR) in 24-40% of hormone receptor+/HER2- patients. ODX is not reimbursed by third-party payers in Australia, potentially resulting in more selective use. We sought to evaluate the impact of self-funded ODX on TRs., Methods: Data collected included demographics, tumor characteristics, indication for ODX and pre- and post-recurrence score (RS) TR. Primary endpoint was frequency of TR change and associations with TR change were sought., Results: Eighteen physicians contributed 382 patients (median age 54). A total of 232 (61%) of tumors were T1 and were grade 1, 2 and 3 in 49 (13%), 252 (66%) and 79 (21%). A total of 257 (67%) were node negative. Assay indications were: confirm need for chemotherapy (CT) (36%), confirm omission of CT (40%) and genuine equipoise (24%). RS was low (≤17) in 55%, intermediate (18-31) in 36% and high (≥32) in 9%. Thirty-eight percent of patients had TR change post-ODX. Sixty-five percent of patients recommended CT pre-ODX changed to hormone therapy alone (HT)-more likely if lower grade and if ER and/or PR > 10%. Fourteen percent of patients with pre-ODX TR for HT added CT-more likely if ER and/or PR ≤10% and if Ki67 > 15% Overall, TR for CT decreased from 47% to 24%., Conclusion: Patient-funded ODX changed TRs in 38% of patients, de-escalating 65% from CT to HT and adding CT to 14% of those recommended HT. These changes were greater than an industry-funded study suggesting that physicians can identify situations where the assay may influence decisions., (© 2018 John Wiley & Sons Australia, Ltd.)

Background: Octogenarians represent a growing population reviewed in medical oncology clinics, yet there is a paucity of data on how chemotherapy is tolerated in this age group., Aim: To describe the use of palliative first-line chemotherapy in patients 80 years and over and factors associated with its use., Methods: We identified all new patients aged 80 years or older diagnosed with incurable advanced solid organ cancer and seen in one of three Sydney medical oncology outpatient clinics between January 2009 and December 2013. Patient, disease and treatment details were summarised and factors associated with chemotherapy use explored., Results: Of 420 eligible patients, 100 (24%) started first-line chemotherapy. Younger age at diagnosis was the only factor associated with receiving chemotherapy (median 82.9 vs 84.1 years, P = 0.002). A total of 78% of patients had single-agent chemotherapy, and 41% received a full dose for the first cycle. During treatment, 54% experienced toxicity, necessitating dose reduction, delay or omission, and 32% were hospitalised. These events were associated with receipt of combination chemotherapy (OR 5.1; P = 0.04) and full-dose chemotherapy for cycle 1 (OR 3.5; P = 0.02). Radiological disease control was achieved in 60%. Chemotherapy was stopped because of progressive disease (48%), toxicity (37%) or completion of planned course (17%)., Conclusion: A quarter of patients 80 years and older received first-line palliative chemotherapy. Despite most receiving a modified dose, one third were hospitalised during treatment. These findings highlight the need for careful clinical assessment and selection of older cancer patients for chemotherapy., (© 2016 Royal Australasian College of Physicians.)

Background: Patient-reported outcome (PRO) measures have been used widely to screen for depression, anxiety, and symptoms in cancer patients. Computer-based applications that collect patients' responses and transfer them to the treating health professional in real time have the potential to improve patient well-being and cancer outcomes., Objective: This study will test the feasibility and acceptability of a newly developed eHealth system which facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research., Methods: The eHealth system is being developed in consultation with 3 overarching content-specific expert advisory groups convened for this project: the clinical advisory group, technical advisory group, and evaluation advisory group. The following work has already been completed during this phase of the study: the Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) eHealth system was developed, patient-reported outcomes were selected (distress, symptoms, unmet needs), algorithms to inform intervention thresholds for clinical and self-management were determined, clinician PRO feedback summary and longitudinal reports were designed, and patient self-management resources were collated. PROsaiq, a custom information technology system, will transfer PRO data in real time into the hospital-based oncology information system to support clinical decision making. The PROMPT-Care system feasibility and acceptability will be assessed through patients completing PROMPT-Care assessments, participating in face-to-face cognitive interviews, and completing evaluation surveys and telephone interviews and oncology staff participating in telephone interviews., Results: Over the course of 3 months, the system will be pilot-tested with up to 50 patients receiving treatment or follow-up care and 6 oncology staff at 2 hospitals in New South Wales, Australia. Data will be collected to determine the accuracy and completeness of data transfer procedures, extent of missing data from participants' assessments, acceptability of the eHealth system and usefulness of the self-management resources (via patient evaluation surveys and interviews), and acceptability and perceived usefulness of real-time PRO reporting (via oncology staff interviews) at the completion of the pilot phase., Conclusions: This research investigates implementation of evidence into real world clinical practice through development of an efficient and user-friendly eHealth system. This study of feasibility and acceptability of the newly developed eHealth system will inform the next stage of larger scale testing and future implementation of the system as part of routine care., Clinicaltrial: Australian New Zealand Clinical Trials Registry ACTRN1261500135294; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369299&isReview=true (Archived by WebCite at http://www.webcitation.org/6lzylG5A0)., Competing Interests: Conflicts of Interest: None declared., (©Afaf Girgis, Geoff P Delaney, Anthony Arnold, Alexis Andrew Miller, Janelle V Levesque, Nasreen Kaadan, Martin G Carolan, Nicole Cook, Kenneth Masters, Thomas T Tran, Tiffany Sandell, Ivana Durcinoska, Martha Gerges, Sandra Avery, Weng Ng, Stephen Della-Fiorentina, Haryana M Dhillon, Ashley Maher. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.11.2016.)

Background: Despite the effectiveness of adjuvant endocrine therapy in preventing breast cancer recurrence, breast cancer events continue at a high rate for at least 10 years after completion of therapy., Patients and Methods: This randomised open label phase III trial recruited postmenopausal women from 29 Australian and New Zealand sites, with hormone receptor-positive early breast cancer, who had completed ≥4 years of endocrine therapy [aromatase inhibitor (AI), tamoxifen, ovarian suppression, or sequential combination] ≥1 year prior, to oral letrozole 2.5 mg daily for 5 years, or observation. Treatment allocation was by central computerised randomisation, stratified by institution, axillary node status and prior endocrine therapy. The primary outcome was invasive breast cancer events (new invasive primary, local, regional or distant recurrence, or contralateral breast cancer), analysed by intention to treat. The secondary outcomes were disease-free survival (DFS), overall survival, and safety., Results: Between 16 May 2007 and 14 March 2012, 181 patients were randomised to letrozole and 179 to observation (median age 64.3 years). Endocrine therapy was completed at a median of 2.6 years before randomisation, and 47.5% had tumours of >2 cm and/or node positive. At 3.9 years median follow-up (interquartile range 3.1-4.8), 2 patients assigned letrozole (1.1%) and 17 patients assigned observation (9.5%) had experienced an invasive breast cancer event (difference 8.4%, 95% confidence interval 3.8% to 13.0%, log-rank test P = 0.0004). Twenty-four patients (13.4%) in the observation and 14 (7.7%) in the letrozole arm experienced a DFS event (log-rank P = 0.067). Adverse events linked to oestrogen depletion, but not serious adverse events, were more common with letrozole., Conclusion: These results should be considered exploratory, but lend weight to emerging data supporting longer duration endocrine therapy for hormone receptor-positive breast cancer, and offer insight into reintroduction of AI therapy., Clinical Trials Number: Australian New Zealand Clinical Trials Registry (www.anzctr.org.au), ACTRN12607000137493., (© The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Shared understanding of prognosis is vital for optimal, multidisciplinary, clinical decision making., Aims: This study aims to determine the frequency and nature of prognostic information in medical oncologists' letters to referring doctors for patients with metastatic cancer., Methods: We reviewed all consultation letters (to June 2014) for new patients with metastatic cancer presenting to medical oncologists at Concord and Macarthur Cancer Centres between June 2012 and June 2013. We recorded the presence and nature of prognostic information in the letters, patients' characteristics and survival. Characteristics associated with inclusion of prognostic information were explored., Results: We analysed 1344 letters pertaining to 272 patients with a median survival of 13 months. The median number of letters per patient was 4 (interquartile range 1-7), with 50% written by trainees. The terms 'metastatic' or 'stage IV cancer' were included in letters for 253 patients (93%), treatment was described as 'palliative' for 174 patients (64%) and the word 'incurable' was included for 93 (34%). Only 31 patients (11%) had a quantitative estimate of prognosis in any correspondence: median or average survival in 14, general time frame in 12 and, best case, typical and worst case scenarios in 5. Inclusion of quantitative prognostic information was not associated with patient age, cancer type, treatment plan, trainee authoring letter or shorter survival., Conclusion: Inclusion of quantitative prognostic information in written correspondence from medical oncologists regarding patients with metastatic cancer was infrequent. Encouraging oncologists to include quantitative prognostic information in their letters could improve communication between oncologists, referring doctors and patients., (© 2015 Royal Australasian College of Physicians.)

Aim: In early stage breast cancer chemotherapy relative dose intensity (RDI) of <85% leads to poorer outcomes. This study assesses what proportion of such patients at a south-west Sydney cancer clinic received optimal RDI and the reasons and risk factors contributing to RDI reduction, as well as comparing survival outcomes., Methods: A retrospective analysis of 308 patients treated with adjuvant chemotherapy for early stage breast cancer at the Macarthur Cancer Centre was undertaken, with an overall RDI calculated for each patient. The study analysed reasons for reductions in RDI as well as predictive factors for reduced RDI and overall and disease-free survival., Results: Mean RDI was 92%. Of the participants, 17% had an RDI less than 85%, 55% received 100% RDI. Hematological toxicity, infection and patient choice were the most common reasons for RDI reduction. Body surface area capping (BSA) was the most common cause of initial dose reduction. Obesity, increasing body mass index and age ≥65 years were risk factors for RDI reduction. Disease-free and overall survival were reduced with RDI < 50%; overall survival decreased when RDI < 65%., Conclusion: Most patients attained the RDI benchmark; however dose intensity reducing events occurred frequently. Despite contrary recommendations in the literature, BSA capping and dose reduction due to patient choice were common. Implementation of focused patient and physician education strategies may improve these results, as could measures directed as supporting those at risk (i.e. elderly or obese)., (© 2013 Wiley Publishing Asia Pty Ltd.)

Background: Delays in commencing adjuvant chemotherapy for early breast cancer beyond 12 weeks are associated with increased mortality. The aim of this study was to identify factors delaying chemotherapy in an inner metropolitan, outer metropolitan, small rural and large rural cancer centre in New South Wales, Australia., Methods: We retrospectively reviewed 400 consecutive patients that received adjuvant chemotherapy for stages I-III breast cancer. We evaluated factors affecting time from primary and definitive surgery until commencing chemotherapy., Results: The primary factor associated with chemotherapy delays was the geographic location of the cancer centre. The median time from primary surgery to chemotherapy was longer for the large rural centre (median 58 days), compared with the outer metropolitan (45 days), small rural (39 days) and inner metropolitan centre (33 days). Treatment delays in the large rural centre were associated with higher rates of multiple operations (43% versus 31% elsewhere), mainly because of more staged axillary dissections (34% versus 19%), and longer time from definitive surgery to oncology assessment., Conclusion: Patients in the large rural centre, who are served by fly-in medical oncology services, are more likely to experience delays in receiving adjuvant chemotherapy for early breast cancer. Strategies to reduce delays include use of intraoperative frozen section analysis, multidisciplinary meetings, improving efficiency in pathology reporting and employment of a breast cancer care coordinator and an on-site medical oncologist., (© 2012 The Authors. ANZ Journal of Surgery © 2012 Royal Australasian College of Surgeons.)

New glycolipids and a benzylammonium lipid were rationally designed by varying the chemical structure of a D-glucose-derived hit compound active as lipid A antagonist. We report the synthesis of these compounds, their in vitro activity as lipid A antagonists on HEK cells, and the capacity to inhibit LPS-induced septic shock in vivo. The lack of toxicity and the good in vivo activity suggest the use of some compounds of the panel as hits for antisepsis drug development.

Background: With poor cure rates in gastric cancer using surgery alone, the safety, efficacy and feasibility of preoperative and postoperative chemotherapy was investigated., Methods: Patients with advanced but operable gastric or cardio-oesophageal adenocarcinoma were staged using endoscopy, computed tomography scan and laparoscopy. If considered potentially resectable, they received chemotherapy (epirubicin, cisplatin and 5-fluorouracil) for 9 weeks before and after surgery., Results: Of 59 participants entered, two were found to have metastatic disease and were excluded from the analysis. Of the participants, 10 were women and 47 men; their median age was 58 years (range 27-83 years) and median performance status 0 (range 0-1). Two of the 57 participants commencing chemotherapy did not undergo surgery (one sudden death, one new liver metastases). Grade 3 and 4 preoperative and postoperative toxicity rates were, respectively, neutropenia 22 and 18%, emesis 12 and 14% and other non-haematological toxicity <10 and <10%. Of the 55 who underwent surgery, 40 had apparently curative resections (clear or positive microscopic margins), 2 died after surgery (anastomotic leak, sepsis) and 16 had postoperative complications. Of these, 27 participants commenced postoperative chemotherapy and 21 completed it. Median progression-free survival and overall survival were 19.6 and 22 months, respectively., Conclusion: Epirubicin, cisplatin and protracted venous infusion of 5-fluorouracil chemotherapy was well-tolerated in the preoperative setting and did not appear to increase complication rates of surgery for advanced and operable stomach cancer. These findings demonstrate the feasibility of this strategy in the Australasian clinical setting and are in keeping with the results of a recently reported randomized trial, which demonstrated a significant survival advantage using this chemotherapy regimen.

The purpose of the present paper was to review the outcomes of care of small cell lung cancer (SCLC) at one Sydney teaching hospital. A retrospective cohort study was carried out of patients with SCLC seen between January 1996 and July 2000. The main outcomes were relapse-free and overall survival. Secondary outcomes of interest were the uniformity of staging investigations, initial treatment, use of prophylactic cranial irradiation (PCI), patterns of relapse and treatment received following relapse. One hundred and three patients with SCLC were treated at the Liverpool Hospital Cancer Therapy Centre during this period. There were 58 men (56%) and 45 women (44%). Forty-two patients (41%) had limited stage disease (LD) and 61 (59%) had extensive stage disease (ED). There was considerable variation in staging investigations. There was little variation in systemic treatment of SCLC. Only 32 of 42 patients with limited stage SCLC were candidates for thoracic radiotherapy and only seven patients received PCI. Median relapse-free survival was 11.2 months (95% confidence interval (CI): 7.7-14.8) for patients with LD and 6 months (95%CI: 4.4-7.5) for ED. Median overall survival was 15.1 months (95%CI: 11-19.1) for patients with LD and 8.9 months (95%CI: 7.5-10.2) for ED. Some health outcomes similar to that reported in clinical trials can be achieved in clinical practice. Measuring health outcomes is an important process of maintaining quality of care.