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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.)

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.)