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Objective This study aimed to determine the healthcare experiences, quality of life, and psychosocial needs of patients with cancer of unknown primary (CUP) early after diagnosis; comparing their experiences to patients with advanced cancer of a known primary (non-CUP control patients) and published general population reference data where available. Methods This study was a cross-sectional, multi-site study comparing CUP patients (n = 139) compared to non-CUP controls (n = 45). Demographic, clinical information and patient-reported outcome questionnaire data were collected at baseline. Results Differences in healthcare experienced were found between CUP and non-CUP controls with CUP patients reporting higher scores for unmet medical communication/information needs compared with non-CUP control patients (p = 0.013) as well as greater uncertainty in illness (p = 0.042). Whilst no differences were found between CUP and non-CUP controls on the EORTC and PROMIS measures, of those that ‘received written information about your cancer…’ and asked ‘…how useful was it?’ fewer CUP patients reported finding the information useful 40% vs 61%, and more were likely to not have received written information at all 59% vs 32%; (p = 0.002). Additionally, of those that found information about their cancer online, fewer patients with CUP reported finding it useful 32% vs 48% control patients (p = 0.005). Conclusions CUP patients have unmet medical communication/information needs and greater uncertainty in illness but do not differ in health-related quality of life domains compared to patients with advanced cancer of a known primary.

Background Diagnosis and management of cancers of unknown primary (CUP) remain challenging. This study examines the referral patterns, management and outcomes of patients referred to Australia’s first dedicated CUP clinic. Methods Retrospective medical record review was conducted for patients seen at the Peter MacCallum Cancer Centre CUP clinic between July 2014 and August 2020. Overall survival (OS) was analysed for patients with a CUP diagnosis where treatment information was available. Results Of 361 patients referred, fewer than half had completed diagnostic work-up at the time of referral. A diagnosis of CUP was established in 137 (38%), malignancy other than CUP in 177 (49%) and benign pathology in 36 (10%) patients. Genomic testing was successfully completed in 62% of patients with initial provisional CUP and impacted management in 32% by identifying a tissue of origin or actionable genomic alteration. The use of site-specific, targeted therapy or immunotherapy was independently associated with longer OS compared to empirical chemotherapy. Conclusion Our specialised CUP clinic facilitated diagnostic work-up among patients with suspected malignancy and provided access to genomic testing and clinical trials for patients with a CUP diagnosis, all of which are important to improve outcomes in this patient population.

Background Pamiparib, a PARP1/2 inhibitor, demonstrated antitumor activity in preclinical models. Methods This Phase 1A/1B dose-escalation/dose-expansion study enrolled adults (≥18 years) with advanced/metastatic cancer. The dose-escalation phase evaluated the recommended Phase 2 dose (RP2D), maximum tolerated dose (MTD), and pharmacokinetics; the dose-expansion phase evaluated the antitumor activity and food effects. Results Patients (N = 101) were enrolled in dose-escalation (n = 64) and dose-expansion (n = 37). During BID dose-escalation, dose-limiting toxicities were Grade 2 nausea (n = 1, 40 mg; n = 1, 80 mg); Grade 2 nausea and Grade 2 anorexia (n = 1, 120 mg), Grade 2 nausea, Grade 3 fatigue and Grade 3 paraesthesia (n = 1, 120 mg); MTD was 80 mg BID and RP2D was 60 mg BID. Common adverse events (AEs) were nausea (69.3%), fatigue (48.5%) and anaemia (35.6%); the most common Grade ≥3 AE was anaemia (24.8%). There was a dose-proportional increase in pamiparib exposure; no food effects on pharmacokinetics were observed. In the efficacy-evaluable population (n = 77), objective response rate (ORR) was 27.3% (95% CI, 17.7–38.6%). Median duration of response was 14.9 months (95% CI, 8.7–26.3). In the epithelial ovarian cancer (EOC)-evaluable population (n = 51), ORR was 41.2% (95% CI, 27.6–55.8%). Conclusions Pamiparib was tolerated with manageable AEs, and antitumor activity was observed in patients with EOC. ClinicalTrials.gov Identifier NCT02361723.

Immunotherapy (IT) and targeted therapy (TT) have improved survival for some patients with metastatic non-small cell lung cancer (NSCLC). Their lived experience is under-studied. We conducted a single centre, qualitative study to understand concerns and unmet needs amongst this novel survivor population. Eligible participants had metastatic NSCLC, aged >18, English-speaking and >6 months post initiation of IT/TT without progressive disease. Semi-structured interviews focused on physical, psychological, social and functional impacts of diagnosis, therapy and prognosis. Interviews were recorded and transcribed. Data were analysed via qualitative thematic analysis. Between May and December 2019, 20 participants were interviewed: median age 62 (range 34–83), 13 (65%) female; median time since diagnosis of metastatic NSCLC 27 months (range 10–108). Twelve out of 20 (60%) participants had a targetable mutation (EGFR/ALK/BRAF); 6 were receiving IT, 11 TT, 2 IT + chemotherapy and 1 IT + TT. Four main themes were identified: living long-term on IT and TT (chronic toxicities), psychological concerns (living with uncertainty, fear of cancer progression, scan-related anxiety), support with practical issues (finances, employment amidst prognostic uncertainty, challenges with trial participation) and wanting information pertinent to NSCLC subtype. Longer-term survivors of metastatic NSCLC experience significant physical, psychological and functional concerns and unmet needs. Results will inform a broader cross-sectional survey and resources to address the needs of this growing survivor group. A ‘one-size-fits-all’ approach to NSCLC survivorship is no longer appropriate. Survivors of metastatic NSCLC treated with novel therapies may benefit from specific information regarding long-term toxicities and psychological supports.

To report 5-year outcomes of a prospective registry study investigating posttherapy FDG PET/CT in women with locally advanced cervical cancer. A secondary analysis assessing the prognostic significance of HPV infection was performed. Patients underwent definitive chemoradiation followed by a single FDG PET/CT scan for response assessment. A complete metabolic response (CMR) was defined as no evidence of FDG-avid disease. Patients were dichotomized according to HPV infection status into a ‘higher-risk’ group and a ‘lower-risk’ group, with the higher-risk group comprising those with alpha-7 strain HPV (subtypes 18, 39 and 45) and those who were HPV-negative and the lower-risk group comprising those with alpha-9 strain HPV (subtypes 16, 31, 33, 52 and 58) and those with mixed strains. Survival outcomes, patterns of failure and salvage therapy outcomes were investigated for their association with metabolic response and HPV status. In 105 patients the median prospective follow-up was 5.2 years. The 5-year cancer-specific, overall and progression-free survival rates in patients with a CMR were 97 %, 93 % and 86 %, respectively. In patients without a CMR, the corresponding 5-year survival rates were 36 %, 22 % and 0 % respectively (p

Background: Cancer of unknown primary (CUP) is the fourth most common cause of cancer death. With advanced diagnostics and treatments, we investigated the proportion of cancers diagnosed as CUP, treatment outcomes and association with socioeconomic disparities. Methods: We analysed trends in CUP diagnosis and outcome within the Surveillance, Epidemiology, and End Results registry between 1973 and 2008. Results: The percentage of all cancers diagnosed as CUP has decreased over time comprising

The goal of the present study was to investigate recruitment issues relevant to psychotherapy trials for metastatic cancer patients. First, we undertook a literature review of the psychotherapy intervention research for metastatic cancer patients. Second, we piloted pragmatic recruitment methods for a couples' intervention for women with metastatic breast cancer and their partners.An extensive literature search was conducted to identify psychotherapy trials involving people with metastatic cancer published in peer-reviewed journals. Study characteristics and recruitment methodologies were examined. In the pilot study, we trialled the recruitment strategies of approaching participants at outpatients' appointments, via letter, referral from the treating team and through direct advertising using two community support services.The literature search identified 1,905 potentially relevant articles, which were narrowed to 18 studies specifically involving metastatic cancer patients involving a professionally trained facilitator and a specified theoretical orientation. Limited information was found on recruitment rates and the success of recruitment strategies. Barriers to recruitment identified in the literature included degree of patient illness, lack of interest/perceived benefit, insufficient time, socio-demographic factors and negative clinician attitudes. Our pilot study identified 72 eligible couples of which 66 were approached. Our recruitment strategies resulted in six couples consenting (9.1%) but only three couples completing the study (4.5%). The main reasons for study refusal were the intervention was not needed, lack of interest, insufficient time, patient illness and travel distance.Recruitment for couple-based psychotherapy interventions is challenging. More work is required on developing acceptable and feasible recruitment processes for metastatic cancer patients to be able to access support.

Treatment options for patients with myeloma who relapse after allogeneic stem cell transplantation are limited. Thalidomide, an antineoplastic agent, has been shown to be effective in multiple myeloma through proposed mechanisms that may include angiogenesis inhibition. Herein we report successful thalidomide treatment of four patients who relapsed following allogeneic transplantation, three of whom had predominantly extramedullary relapse. Thalidomide was well tolerated in all patients; in two patients interferon-alpha was subsequently added to thalidomide as maintenance therapy without worsening graft-versus-host disease. We suggest that extramedullary myeloma is particularly sensitive to thalidomide, speculating that growth biology may in part be dependent on angiogenesis.

The use of high-dose chemotherapy for metastatic breast cancer has been an area of recent interest and the role of such treatment in the management of metastatic breast cancer is still to be defined. Multiple studies have suggested that such treatment can be given with minimal morbidity and mortality. We describe two cases of life-threatening interstitial pneumonitis, following high-dose chemotherapy (HDT) with cyclophosphamide, thiotepa and docetaxel with stem cell rescue given for metastatic breast cancer. The available relevant literature is reviewed.

Assessing response rates in clinical trials of treatment for relapsed or refractory multiple myeloma: a study of bortezomib and thalidomide

To The Editor, Jefford et al discuss the results of a study designed to assess patients’ knowledge and satisfaction regarding the informed consent process in cancer clinical trials (CCT) [1]. This study, carried out across four Australian hospitals, enrolled 102 patients registered in 27 therapeutic CCT. The quality of informed consent and understanding of CCT were assessed using a patient-completed questionnaire developed by Joffe and colleagues [2]. In this population, the overall knowledge of CCT was found to be similar to previous published data [3]. While aspects of trial participation were poorly understood by objective assessment, satisfaction with the decision to participate (SWD) was very high. Objective knowledge was inversely correlated with the length of the patient information and consent form (PICF) [4]. Satisfaction was associated with greater subjective understanding of the trial and an improved quality of life. In the study, patients were also surveyed about their understanding of their specific clinical situation, and we present these results here. Questions assessed (1) knowledge of diagnosis, site and extent of disease, the aim of treatment, and potential for complete response, (2) general understanding of what their treatment entailed, (3) general comprehension of the purpose of their treatment, and (4) knowledge of at least two therapy related side-effects detailed in the PICF. Associations were sought between responses and the phase of CCT, and with aspects of the PICF including the Flesch–Kincaid readability score (FKR), reading grade level, number of pages, and compliance with the National Cancer Institute (NCI) template, for which a compliance index was constructed. A PICF with a higher FKR score and lower grade level is easier to read [5]. Data were available for all 102 patients. All were aware that they had cancer: 95.1% knew what type of cancer they had and 88.2% knew the sites (primary and/or metastatic) of their disease. Some 81.4% of patients correctly understood the main aim of their treatment, i.e., whether to cure, control, or prevent recurrence of their cancer. Eleven people (10.8%) incorrectly thought cure was the aim; eight patients in this group had metastatic disease. Correct understanding of the chance of cure was not related to any features of the PICF. A number of patients (70.6%) could describe what their trial treatment involved; 24.5% could not (4.9% did not answer this question). Better responses were seen with phase I trials, higher FKR scores and lower grade level (i.e., easier to read), and a shorter PICF. Some 66.7% of patients could name at least one of the drugs that they were being treated with. Almost a third (30.4%) were unable to name any of the drugs (2.9% did not answer this question). Better responses were seen in phase I and II trials and with shorter PICFs. Some patients (80.4%) accurately described at least two side effects of their treatment; however, 12.7% were not able to identify any side effects (6.9% did not answer this J. Yoong :M. Jefford : L. Mileshkin Peter MacCallum Cancer Centre, Locked Bag 1, A’Beckett St, Melbourne, VIC 8006, Australia