Lenvatinib plus pembrolizumab for patients with previously treated advanced ovarian cancer: Results from the phase 2 multicohort LEAP-005 study.

OBJECTIVES: The phase 2, multicohort, open-label LEAP-005 study evaluated lenvatinib plus pembrolizumab in patients with previously treated advanced solid tumors. We report outcomes from the ovarian cancer cohort. METHODS: Eligible patients had metastatic/unresectable ovarian cancer and had received 3 previous lines of therapy. Patients received lenvatinib 20 mg/day plus pembrolizumab 200 mg every 3 weeks. Treatment continued until progression, unacceptable toxicity, or (for pembrolizumab) completion of 35 cycles. Primary endpoints were objective response rate (ORR) per RECIST version 1.1 and safety. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and overall survival (OS). RESULTS: Thirty-one patients were enrolled. 39% had high grade serous ovarian cancer, 23% were platinum-sensitive, 55% were platinum-resistant, 23% were platinum-refractory, and 84% had tumors that had a PD-L1 combined positive (CPS) score ≥1. ORR (95% CI) was 26% (12%-45%) by investigator assessment and 35% (19%-55%) by blinded independent central review (BICR). Per BICR, median DOR was 9.2 (1.5+ to 37.8+) months. ORRs (95% CI) by BICR were 35% (9/26 patients; 17%-56%) for PD-L1 CPS ≥ 1 disease and 50% (2/4 patients; 7%-93%) for PD-L1 CPS < 1 disease. Median (95% CI) PFS by BICR and OS were 6.2 (4.0-8.5) months and 21.3 (11.7-32.3) months, respectively. Treatment-related AEs occurred in 94% of patients (grade 3-4, 77%). One patient died from treatment-related hypovolemic shock. CONCLUSIONS: Lenvatinib plus pembrolizumab demonstrated antitumor activity as fourth line therapy in patients with advanced ovarian cancer, and no unanticipated safety signals were identified. Responses were observed regardless of PD-L1 status.

Clinical Trials in the Brain Tumour Population: Challenges and Strategies for the Future.

PURPOSE OF REVIEW: This review identifies challenges and barriers to successful development of drugs in neuro-oncology trials at the preclinical, clinical and translational stages that we believe has contributed to poor outcomes for patients over the last 30 years. RECENT FINDINGS: Several key strategies have been proposed by leading groups to address these and improve patient outcomes. Better preclinical testing using more sophisticated and clinically relevant models is needed. A greater focus on assessing blood-brain barrier penetrance and targeting key biological processes such as tumour heterogeneity and immune response is vital. Adopting innovative trial designs permitting faster results and addressing key issues (including molecular heterogeneity and combinatorial approaches) is highly desirable. A stronger translational focus is also clearly needed. Implementation of these strategies is already starting to occur. Maintaining and increasing these novel approaches will require coordinated efforts between clinicians, scientists, industry and funding/regulator bodies.

Beyond standard data collection - the promise and potential of BRAIN (Brain tumour Registry Australia INnovation and translation registry).

BACKGROUND: Real-world data (RWD) is increasingly being embraced as an invaluable source of information to address clinical and policy-relevant questions that are unlikely to ever be answered by clinical trials. However, the largely unrealised potential of RWD is the value to be gained by supporting prospective studies and translational research. Here we describe the design and implementation of an Australian brain cancer registry, BRAIN, which is pursuing these opportunities. METHODS: BRAIN was designed by a panel of clinicians in conjunction with BIOGRID to capture comprehensive clinical data on patients diagnosed with brain tumours from diagnosis through treatment to recurrence or death. Extensive internal and external testing was undertaken, followed by implementation at multiple sites across Victoria and Tasmania. RESULTS: Between February 2021 and December 2021, a total of 350 new patients from 10 sites, including one private and two regional, were entered into BRAIN. Additionally, BRAIN supports the world's first registry trial in neuro-oncology, EX-TEM, addressing the optimal duration of post-radiation temozolomide; and BioBRAIN, a dedicated brain tumour translational program providing a pipeline for biospecimen collection matched with linked clinical data. CONCLUSIONS: Here we report on the first data collection effort in brain tumours for Australia, which we believe to be unique worldwide given the number of sites and patients involved and the extent to which the registry resource is being leveraged to support clinical and translational research. Further directions such as passive data flow and data linkages, use of artificial intelligence and inclusion of patient-entered data are being explored.

Experiencing the SARS-CoV-2 Pandemic Whilst Living With Cancer.

The SARS-CoV-2 pandemic has resulted in considerable consequences for many cancer patients, exacerbating pre-existing systemic health system limitations as well as creating new challenges. From socially distanced clinics and the widespread introduction of telehealth, to the halting of clinical trials and the reassessment of what constitutes "essential" treatment, care in oncology has abruptly changed. There is currently limited analysis of cancer patients' experiences of the pandemic and its impacts on illness, wellness, and everyday life. Through semi-structured interviews with 54 people living with cancer during the 2020 phase of the SARS-CoV-2 pandemic in Australia, we explore how patients experience illness and care in reflecting upon a range of pandemic challenges, including delay, distance, and vulnerability. We find that in some cases, these pandemic conditions redefined the meaning of essential cancer care, reconfigured expectations around clinical trials, constructed new affective distances, and amplified dread and fear for people living with cancer.

A sociology of precision-in-practice: The affective and temporal complexities of everyday clinical care.

The idea of 'precision medicine', which has gained increasing traction since the early 2000s, is now ubiquitous in health and medicine. Though varied in its implementation across fields, precision medicine has raised hopes of revolutionary treatments and has spurred the proliferation of novel therapeutics, the alteration of professional trajectories and various reconfigurations of health/care. Nowhere is the promise of precision medicine more apparent, nor further institutionalised, than in the field of oncology. While the transformative potential of precision medicine is widely taken for granted, there remains scant attention to how it is being experienced at the coalface of care. Here, drawing on the perspectives of 54 cancer care professionals gleaned through eight focus group discussions in two hospitals in Australia, we explore clinicians' experiences of the day-to-day dynamics of precision-in-practice. We illustrate some of the affective and temporal complexities, analysed here under the rubrics of enchantment, acceleration and distraction that are emerging alongside the uptake of precision medicine in the field of oncology. We argue that these complexities, and their dis/continuities with earlier iterations of cancer care, demonstrate the need for sociological analyses of precision medicine as it is being implemented in practice and its varied effects on 'routine' care.

Responses to a cancer diagnosis: a qualitative patient-centred interview study.

PURPOSE: A cancer diagnosis is an emotive and challenging time for patients. This study aimed to systematically explore patients' accounts of experiencing their cancer diagnosis. The purpose of this article is to offer a typology of patient responses to receiving a cancer diagnosis as a means through which to affirm the range of patients' experiences and to guide clinicians' practice. METHODS: Qualitative semi-structured interviews were conducted between 2015 and 2017 with 80 patients living with cancer: 34 females and 46 males, aged between 31 and 85, diagnosed with a range of cancer types, stages and treatment trajectories, from two metropolitan hospitals on the east coast of Australia. Interview data were analysed thematically, using the framework approach. RESULTS: A typology of responses to the cancer diagnosis was derived from the analysis and included (1) the incongruent diagnosis, unexpected because it did not 'fit' with the patient's 'healthy' identity; (2) the incidental diagnosis, arising from seemingly unrelated or minor medical investigations; (3) the validating diagnosis, as explanation and confirmation of previously unexplained symptoms, pain or feelings; (4) the life context diagnosis, where the cancer diagnosis was positioned relative to other challenging life events, or as relatively inconsequential compared with the hardship of others. CONCLUSIONS: A diagnosis of cancer is not always (or only) experienced by patients with shock and despair. Diagnosis is perceived and experienced in diverse ways, shaped by broader social or life contexts, and with important implications for the clinical encounter and communication from an oncology perspective.

Weighted activity unit effect: evaluating the cost of diagnosis-related group coding.

BACKGROUND: Activity-based funding (ABF) is a means of healthcare reimbursement, where hospitals are allocated funding based on the number and mix of clinical activity. The ABF model is based solely on Australian refined diagnosis-related group (AR-DRG) classifications of hospital encounters. Each AR-DRG is allocated a weighted activity unit (WAU) translating to cost value to determine ongoing funding allocations for each hospital annually. AIM: We explored cost consequences of AR-DRG coding variances within our Medical Oncology department over a 6-month period. METHODS: All inpatient encounters for medical oncology from 1 January to 30 June 2014 were identified and paired with actual AR-DRG coding sheets submitted by the hospital coders. Inpatient charts were manually reviewed by a Medical Oncology Registrar to capture any changes or additional AR-DRGs, which were subsequently evaluated for total WAU value variance. Applying 1 WAU = $4676 as per the 2014 Queensland model, cost consequences were calculated. RESULTS: A total of 116 encounters was identified for 72 patients. Of 116 patients, 95 (81%) had additional diagnoses captured, leading to an AR-DRG and WAU change in 26 encounters. The total reimbursement variance for this period was $143 404.07. Cost consequences resulted from: (i) use of abbreviations in clinical notes unable to be coded; and (ii) diagnoses not documented despite treatment delivered as per medication charts. CONCLUSION: Clinical note documentation ultimately determines the future funding of our healthcare system. Appropriate communication and education of medical staff and hospital coders are vital to ensure precise documentation and accurate AR-DRG coding for optimal and appropriate reimbursement in this funding model.

Reciprocity, Autonomy, and Vulnerability in Men's Experiences of Informal Cancer Care.

Men are increasingly participating, and acknowledging their roles, as informal carers. Yet, there has been comparatively little exploration of their experiences therein, especially within the context of cancer care. Here, drawing on semi-structured qualitative interviews with 16 Australian male carers for a relative with cancer, and using constructivist grounded theory, we explore their experiences of informal caring. Our analysis highlights a series of tensions, including the following: the meanings and practicalities of care provision including notions of reciprocity, duty, autonomy, and interdependence; the discomforts of dependency and vulnerability; and the complicated moralities that inflect "caring well." Given the shifting dynamics around informal care, we argue for increased attention to the affective tensions that arise at the nexus of moralities and masculinities in informal caring relations, especially as they are articulated in the context of illness, affliction, and dependency.

The (Co)Production of Difference in the Care of Patients With Cancer From Migrant Backgrounds.

An extensive body of scholarship focuses on cultural diversity in health care, and this has resulted in a plethora of strategies to "manage" cultural difference. This work has often been patient-oriented (i.e., focused on the differences of the person being cared for), rather than relational in character. In this study, we aimed to explore how the difference was relational and coproduced in the accounts of cancer care professionals and patients with cancer who were from migrant backgrounds. Drawing on eight focus groups with 57 cancer care professionals and one-on-one interviews with 43 cancer patients from migrant backgrounds, we explore social relations, including intrusion and feelings of discomfort, moral logics of rights and obligation, and the practice of defaulting to difference. We argue, on the basis of these accounts, for the importance of approaching difference as relational and that this could lead to a more reflexive means for overcoming "differences" in therapeutic settings.

The dystroglycan receptor maintains glioma stem cells in the vascular niche.

Glioblastomas (GBMs) are malignant central nervous system (CNS) neoplasms with a very poor prognosis. They display cellular hierarchies containing self-renewing tumourigenic glioma stem cells (GSCs) in a complex heterogeneous microenvironment. One proposed GSC niche is the extracellular matrix (ECM)-rich perivascular bed of the tumour. Here, we report that the ECM binding dystroglycan (DG) receptor is expressed and functionally glycosylated on GSCs residing in the perivascular niche. Glycosylated αDG is highly expressed and functional on the most aggressive mesenchymal-like (MES-like) GBM tumour compartment. Furthermore, we found that DG acts to maintain an MES-like state via tight control of MAPK activation. Antibody-based blockade of αDG induces robust ERK-mediated differentiation leading to reduced GSC potential. DG was shown to be required for tumour initiation in MES-like GBM, with constitutive loss significantly delaying or preventing tumourigenic potential in-vivo. These findings reveal a central role of the DG receptor, not only as a structural element, but also as a critical factor promoting MES-like GBM and the maintenance of GSCs residing in the perivascular niche.

Why is optimisation of antimicrobial use difficult at the end of life?

The antibiotic optimisation imperative is now ubiquitous, with national policy frameworks in Organisation for Economic Co-operation and Development (OECD) countries incorporating the requirement for antimicrobial stewardship within healthcare services. Yet in practice, the optimisation agenda often raises complex ethical- and practice-based dilemmas. Antibiotic use at the end of life is multidimensional. It includes balancing complex issues, such as accuracy of prognostic estimates, benevolence to the individual versus the broader public health, personalised value judgement of time and quality of life and the right to treatment versus the right to die. It also occurs in an emotional context where the clinician and patient (and their family) collectively confront mortality. This provides a scenario where amplification of the already strong social and behavioural forces that drive overuse of antibiotics in many other clinical settings may occur. It therefore offers an important case for illustrating how antibiotic optimisation may be limited by social, value-based and ethical dilemmas.

The collective/affective practice of cancer survivorship.

Whether within an atmosphere of hope, or amidst relations of fear, the emotions of cancer are unavoidably collectively produced. Yet persistent individualistic paradigms continue to obscure how the emotions of cancer operate relationally - between bodies, subjects, discourses, and practices - and are intertwined with circulating beliefs, cultural desires, and various forms of normativity. Drawing on interviews with 80 people living with cancer in Australia, this paper illustrates why recognition of the collective enterprise of survivorship - and the collective production of emotion, more generally - is important in light of persistent, culturally dominant conceptions of the individual patient as the primary 'afflicted', 'feeling', and 'treated' subject. Building on previous work on affective relations and moral framings, we posit that the collective affects of survivorship inflect what people living with cancer can, and should, feel. We highlight how such things as hope, resignation, optimism, and dread are 'products' of the collective affects of cancer, with implications for how survivorship is lived, felt, and done.

Outcomes after second surgery for recurrent glioblastoma: a retrospective case-control study.

Studies looking at the benefit of surgery at first relapse (second surgery) for recurrent glioblastoma were confounded by including patients with varying grades of glioma, performance status and extent of resection. This case-controlled study aims to remove these confounders to assess the survival impact of second surgery in recurrent glioblastoma. Retrospective data on patients with glioblastoma recurrence at two tertiary Australian hospitals from July 2009 to April 2015 was reviewed. Patients who had surgery at recurrence were matched with those who did not undergo surgery at recurrence, based on the extent of their initial resection and age. Overall survival (OS1 assessed from initial diagnosis and OS2 from the date of recurrence) as well as functional outcomes after resection were analysed. There were 120 patients (60 in each institution); median age at diagnosis was 56 years. Median OS1 was 14 months (95% CI 11.5-15.7) versus 22 months (95% CI 18-25) in patients who did not undergo second surgery and those with surgery at recurrence. OS2 was improved by second surgery (4.7 vs 9.6, HR 0.52, 95% CI 0.38-0.72, P < 0.001), and by chemotherapy, given at recurrence, (HR 0.47, 95% CI 0.24-0.92, P = 0.03). After second surgery, 80% did not require rehabilitation and 61% were independently mobile. Second surgery for recurrent glioblastoma was associated with a survival advantage. Chemotherapy independent of surgery, also improved survival. Functional outcomes were encouraging. More research is required in the era of improved surgical techniques and new antineoplastic therapies.

"It doesn't exist ": negotiating palliative care from a culturally and linguistically diverse patient and caregiver perspective.

BACKGROUND: The end of life represents a therapeutic context that acutely raises cultural and linguistic specificities, yet there is very little evidence illustrating the importance of such dynamics in shaping choices, trajectories and care practices. Culture and language interplay to offer considerable potential challenges to both patient and provider, with further work needed to explore patient and caregiver perspectives across cultures and linguistic groups, and provider perspectives. The objective of this study was to develop a critical, evidence-based understanding of the experiences of people from Culturally and Linguistically Diverse (CALD) backgrounds, and their caregivers, in a palliative care setting. METHODS: A qualitative study, using semi-structured interviews to explore key experiences and perspectives of CALD patients and caregivers currently undergoing treatment under oncology or palliative care specialists in two Australian hospitals. Interviews were digitally audio recorded and transcribed in full. A thematic analysis was conducted utilising the framework approach. RESULTS: Sixteen patients and fourteen caregivers from a range of CALD backgrounds participated in semi-structured interviews. The research identified four prevalent themes among participants: (1) Terminology in the transition to palliative care; (2) Communication, culture and pain management; (3) (Not) Talking about death and dying; and, (4) Religious faith as a coping strategy: challenging the terminal diagnosis. CONCLUSIONS: CALD patients and caregivers' experiences are multifaceted, particularly in negotiating linguistic difficulties, beliefs about treatment, and issues related to death and dying. Greater attention is needed to develop effective communication skills, recognise CALD patients' particular cultural, linguistic and spiritual values and needs, and acknowledge the unique nature of each doctor-patient interaction.

Neutrophil-lymphocyte ratio dynamics during concurrent chemo-radiotherapy for glioblastoma is an independent predictor for overall survival.

Elevated neutrophil-lymphocyte ratio (NLR) may predict worse outcomes in cancer, including glioblastoma (GBM). This study assessed whether change in NLR during focal radiotherapy and concomitant temozolomide (RT-TMZ) provides further prognostic information. This was a retrospective review of patients treated with RT-TMZ for histologically confirmed GBM from January 2004 to September 2010. Variables assessed included age, ECOG performance status (PS), dexamethasone use and extent of surgery. Hematological results were collected at baseline, during and 4 weeks post RT-TMZ. Kaplan-Meier method was used to calculate overall survival (OS). Multivariable analysis (MVA) assessed for joint effect of covariates on OS and Pearson Correlation Coefficients assessed for association between dexamethasone dose and NLR change. With a median age of 55 (range 18-70), 369 patients were included. Median follow up was 15.1 month (range 1.6-134.6). The OS was 66.1% (95% CI 61.2-70.6) and 31.4 (95% CI 26.8-36.1) at 1 and 2 years, respectively. On univariate analysis, both decrease in NLR post RT-TMZ (HR 0.641, p < 0.0001) and baseline NLR < 7.5 (HR 0.628, p < 0.0001) were associated with longer OS. On MVA decrease in NLR (HR 0.727, 95% CI 0.578-0.915), age (HR 1.025, 95% CI 1.012-1.038), baseline neutrophil (<8) (HR 0.689, 95% CI 0.532-0.891), total TMZ cycles (HR 0.89, 95% CI 0.867-0.913) and PS (HR 0.476, 95% CI 0.332-0.683) were independent predictors of OS. These findings suggest that a decrease in NLR during RT-TMZ, accounting for known prognostic factors, is an independent prognostic factor for survival in GBM.

The Social Reception of Women With Cancer.

Experiences of cancer are enmeshed with cultural understandings and social discourses around responsibility and causation. A cancer diagnosis can raise questions about its causation-including the role of the individual-whereas the disease and its treatment provide various social markers of illness. We present a sociological study of 81 women's accounts of living with cancer, with a focus on how women interpret their illness, in light of their interpersonal interactions and accounts of social relations. Our analysis reveals women's experiences of cancer diagnosis and treatment, the varied sociocultural meanings of cancer and the responses it elicits, the presence of moral assessments within everyday interactions, and the implications for the support and care they receive. We argue that the experience of cancer should be seen as intimately interwoven with its social reception and cultural sense-making practices, including normative constructs which promote ideas about (in)justice, responsibilization, and shame.

Factors impacting survival following second surgery in patients with glioblastoma in the temozolomide treatment era, incorporating neutrophil/lymphocyte ratio and time to first progression.

Patients with progressive glioblastoma (GBM) have a poor prognosis. Neutrophil/lymphocyte ratio (NLR), a host inflammatory marker, is prognostic in several solid tumors. The prognostic impact of either NLR, or time from first surgery for GBM to first progression (TTP), in patients undergoing second surgery, has not been assessed. Patients undergoing second surgery for GBM were retrospectively reviewed. Primary outcome was overall survival (OS) and Cox proportional hazard models were used to assess the prognostic value of baseline characteristics including TTP and NLR. Univariable and multivariable analysis (MVA) of OS from second surgery were performed using accelerated failure time Weibull model. Of 584 patients with GBM, 107 (18 %) underwent second surgery between 01/04 and 12/11. Patients who underwent second surgery had longer OS versus those having primary surgery alone; 20.9 versus 9.9 months (P < 0.001). Median OS from second surgery in patients with NLR ≤ 4 versus NLR > 4 was 9.7 versus 5.9 months (log rank P = 0.02). The NLR retained its prognostic significance for survival on MVA (time ratio [TR] 1.65, 95 % confidence interval [CI] 1.15-2.35, P < 0.01). No chemotherapy post second surgery (TR 0.23, 95 % CI 0.16-0.33, P < 0.001) portended worse survival. In patients undergoing second surgery, when TTP was ≤ 12 months, 12-24 months, or >24 months, median OS from second surgery was 7.2, 7.0 and 6.3 months, respectively (P = 0.6). A NLR > 4 prior to second surgery is a poor prognostic factor in GBM and later progression is associated with longer survival in patients but not in longer survival after second surgery.

Conditional probability of survival and post-progression survival in patients with glioblastoma in the temozolomide treatment era.

With standard treatment for glioblastoma (GBM) consisting of surgery followed by radiotherapy (RT) with concurrent and adjuvant temozolomide (TMZ), median survival is ~14.6 months. This is not as informative to patients who have survived for some time. Conditional probability of survival may offer more relevant survival estimates. Outcomes/conditional probability of survival and post-progression survival (PPS) estimates were retrospectively reviewed in the TMZ treatment era of 882 consecutive patients with a diagnosis of GBM from January 2004 to August 2010. Median age of entire cohort was 62 years including 62 % males. Baseline performance status (PS) was 0-1 in 67, 23 % had frontal lobe tumors, 58 % received concurrent RT/TMZ ± adjuvant TMZ. Survival (OS) was similar for those with frontal lobe tumors versus other locations (P = 0.25). OS for patients receiving standard RT/TMZ ± TMZ was 14.2 months. Age, PS, extent of surgery, therapy post-surgery had significant effects on OS. OS for entire cohort at 1, 2, 3, 4, 5 years was 43.4, 17.9, 10.4, 8.4, 7.2 % respectively. Conditional probability of survival of an additional year given survival to 1, 2, 3, 4, 5 years was 41.4, 58, 80.7, 85.7, 81.5 % respectively. Conditional probability of survival for those patients receiving concurrent RT/TMZ ± adjuvant TMZ was similar. Patients who progress >18 months after their initial treatment for GBM had significantly greater 2 and 5 year PPS as well as OS. Conditional probabilities of survival may provide more meaningful life expectancy predictions for survivors of GBM than conventional survival outcomes.

Glioblastoma treatment in the elderly in the temozolomide therapy era.

BACKGROUND: optimal treatment of glioblastoma (gBM) in the elderly remains unclear. the impact of age on treatment planning, toxicity, and efficacy at a Canadian Cancer Centre was retrospectively reviewed. METHODS: glioblastoma patients treated consecutively between 2004 and 2008 were reviewed. utilizing 70 years as the threshold for definition of an elderly patient, treatments and outcome were compared in younger and elderly populations. RESULTS: four hundred and twenty one patients were included in this analysis and median overall survival (oS) for the entire cohort was 9.8 months. 290 patients were aged <70 (median age 57, range 17- 69) and 131 were aged ≥ 70 (median age 76, range 70-93). patients ≥ 70 were more likely to receive best supportive care (BSC) and all patients >70 who were treated with radiotherapy received <60 gy (P<0.001), except one. patients aged >70 demonstrated inferior survival (one year oS 16% versus 54% for those <70, hr 3.46, P<0.001). in patients treated with BSC only, age had no impact on survival (median survival two months in both groups, hr 0.89, P=0.75). for those treated with higher doses of radiotherapy (>30 gy to <60 gy), one year survival was 19% versus 24% in patients aged >70 versus <70 (hr 1.47, P=0.02) respectively. CONCLUSION: in this retrospective single institution series, elderly patients were more likely to be treated with BSC or palliative doses of radiotherapy. randomized phase iii study results are required for guidance in treatment of this population of patients.

Involvement of low- and middle-income countries in randomized controlled trial publications in oncology.

BACKGROUND: We describe trends in participation by investigators from low- and middle-income countries (LMCs) in publications describing oncology randomized control trials (RCTs) over a decade. METHODS: We used Medline to identify RCTs published in English from 1998 to 2008 evaluating treatment in lung, breast, colorectal, stomach and liver cancers. Data on author affiliations, authorship roles, trial characteristics, funding and interventions were extracted from each article. Countries were stratified as low-, middle- or high-income using World Bank data. Interventions were categorized as requiring basic, limited, enhanced or maximal resources as per the Breast Health Global Initiative classification. Logistic regression was used to identify factors associated with authorship by investigators from LMCs. RESULTS: 454 publications were identified. Proportion of articles with at least one LMC author increased over time from 20% in 1998 to 29% in 2008 (p = 0.01), but almost all LMC authors were from middle-income countries. Proportion of articles with at least one LMC author was higher among articles that explicitly reported recruitment in at least one LMC vs those that did not (76% vs 13%). Among 87 articles (19%) that involved authors from LMCs, 17% had LMC authors as first or corresponding authors, and 67% evaluated interventions requiring enhanced or maximal resources. Factors associated with LMC authorship included industry funding (OR = 3.54, p = 0.0001), placebo comparator arm (OR = 2.57, p = 0.02) and palliative intent treatment (OR = 4.00, p = 0.0003). CONCLUSION: An increasing number of publications describing oncology RCTs involve authors from LMC countries but primarily in non-leadership roles in industry-funded trials.