Survival Outcomes in Patients Undergoing Pelvic Exenteration for Pelvic Mucosal Melanomas: Retrospective Single Institution Australian Study.
Abstract Background: Pelvic mucosal melanomas, including anorectal and urogenital melanomas, are rare and aggressive, with a median overall survival of up to 20 months. Pelvic mucosal melanomas behave differently from their cutaneous counterparts and present late with locoregional disease, making pelvic exenteration its only curative surgical option. Objective: This study aimed to evaluate the survival outcomes after pelvic exenteration in pelvic mucosal melanomas at Royal Prince Alfred Hospital. Design: Retrospective case series from a prospectively collected pelvic exenteration database from October 1994 to November 2023. Setting: Royal Prince Alfred Hospital (quaternary institution), Camperdown, New South Wales, Australia. Patients: Seven patients undergoing pelvic exenteration for [...]
Tissue-Based Profiling Techniques to Achieve Precision Medicine in Cancer: Opportunities and Challenges in Melanoma.
Abstract Immunotherapies targeting the programmed cell death 1 (PD-1) and cytotoxic T-lymphocyte antigen 4 (CTLA-4) checkpoint receptors have revolutionized the treatment of metastatic melanoma. However, half of the treated patients do not respond to or eventually progress on standard therapies and many experience adverse events as a result of drug toxicity. The identification of accurate biomarkers of clinical outcomes are required in order to move away from the one-size-fits-all treatment approach of standard clinical practice and toward a more personalized approach to enable the administration of the optimal therapy for any given patient and further improve patient outcomes. Recent [...]
Adjuvant systemic therapy in melanoma: Relative versus absolute benefit; the number needed to treat (NNT) versus the number needed to harm (NNH)?
Abstract Adjuvant (ADJ) systemic therapy has transformed melanoma treatment during the past decade. There are, however, still important unanswered questions that lead to debates on the utility and place of ADJ therapy for melanoma. When ADJ trials are reported, they present a hazard ratio with a significant P-value. This illustrates the relative benefit of the ADJ therapy, but do not give insight into the absolute benefit for an individual patient. Number needed to treat (NNT) expresses the number of patients required to receive an intervention in order to prevent one event of interest. It is measured by taking the reciprocal of [...]
Short-Term Effectiveness of a Stepped-Care Model to Address Fear of Cancer Recurrence in Patients With Early-Stage Melanoma.
Abstract Objective: To investigate the effectiveness of the Melanoma Care Programme when implemented into routine clinical practice coupled with fear of cancer recurrence (FCR) screening and a stepped-care model of intervention delivery. Methods: Using a Type-I hybrid effectiveness-implementation design, individuals with stage 0-II melanoma and a Fear of Cancer Recurrence Inventory FCR severity score of ≥ 13 were offered the Melanoma Care Programme. The programme included a psychoeducational booklet and 3 to 5 psychotherapeutic telehealth sessions with a clinical psychologist, timed around routine dermatological appointments. Multivariable linear mixed modelling was used to analyse the effect of the intervention at 1-week post-intervention [...]
Editorial Expression of Concern: Temozolomide induces senescence but not apoptosis in human melanoma cells.
No abstract available. Read Full Paper
Ipilimumab plus nivolumab versus nivolumab alone in patients with melanoma brain metastases (ABC): 7-year follow-up of a multicentre, open-label, randomised, phase 2 study.
Abstract Background: Patients with melanoma brain metastases respond well to immunotherapy, but long-term comparative survival data are scarce. We aimed to assess the efficacy of ipilimumab plus nivolumab versus nivolumab alone in patients with melanoma brain metastases at 7 years. Methods: This open-label, randomised, phase 2 study was conducted at four sites (two research institute cancer centres and two university teaching hospitals) in Australia. Patients aged 18 years or older with active, immunotherapy-naive melanoma brain metastases and Eastern Cooperative Oncology Group performance status of 0-2 were eligible. Asymptomatic patients with no previous brain-directed therapy were randomly assigned (5:4) using the biased-coin [...]
Patient and Staff Experiences of Embedding Electronic Patient Reported Outcome Measures for Distress Screening and Quality of Life Assessment, Into Routine Melanoma Care: A Mixed-Methods Study
Abstract Objective: Patient reported outcome measures (PROMs) are commonly collected in melanoma research. However, they are not used to guide immediate clinical care in Australia. This study explored the views and experiences of patients with Stage III melanoma and clinic staff during implementation of an electronic Patient-Reported Outcome Measures in melanoma (ePROMs-MEL) pilot to assess distress and quality of life. Methods: A prospective mixed-methods study in specialist melanoma clinics in Sydney, Australia between May 2021 and February 2023. Forty-two post-ePROMs implementation surveys and 17 semi-structured interviews were undertaken among patients and staff (including oncologists, melanoma nurses and clinic managers). Survey responses [...]
Patient and Staff Experiences of Embedding Electronic Patient Reported Outcome Measures for Distress Screening and Quality of Life Assessment, Into Routine Melanoma Care: A Mixed-Methods Study.
Abstract Objective: Patient reported outcome measures (PROMs) are commonly collected in melanoma research. However, they are not used to guide immediate clinical care in Australia. This study explored the views and experiences of patients with Stage III melanoma and clinic staff during implementation of an electronic Patient-Reported Outcome Measures in melanoma (ePROMs-MEL) pilot to assess distress and quality of life. Methods: A prospective mixed-methods study in specialist melanoma clinics in Sydney, Australia between May 2021 and February 2023. Forty-two post-ePROMs implementation surveys and 17 semi-structured interviews were undertaken among patients and staff (including oncologists, melanoma nurses and clinic managers). Survey responses [...]
Nivolumab (NIVO) plus relatlimab (RELA) vs. NIVO in previously untreated, metastatic, or unresectable melanoma (RELATIVITY-047): 3- year overall survival (OS) and melanoma-specific survival (MSS) results.
Abstract Introduction: The fixed-dose combination (FDC) of NIVO + RELA demonstrated a statistically significant progression-free survival (PFS) benefit compared to NIVO monotherapy in the RELATIVITY-047 study ( NCT03470922 ), a non-statistically significant increase in OS, and a numerically higher objective response rate (ORR), leading to regulatory approval of the FDC of NIVO + RELA. Here, we present updated descriptive analyses after 3 years of follow-up. Materials and Methods: Patients (pts) were randomized 1:1 to receive NIVO 480 mg + RELA 160 mg FDC or NIVO 480 mg monotherapy every 4 weeks. PFS per RECIST v1.1 was assessed by blinded independent central review (BICR); secondary endpoints included OS and ORR per BICR. [...]
121MO Anti-IL-8 (BMS-986253) in combination with nivolumab (NIVO) plus ipilimumab (IPI) in patients (pts) with advanced melanoma: Final analysis from the randomized part 2 of the phase I/II CA027-002 study.
Abstract Background: Elevated serum IL-8 is associated with increased tumour burden, immunotherapy resistance, and poor outcomes in many solid tumour types. Low IL-8 correlates with improved response to checkpoint inhibitors. Anti–IL-8 (BMS-986253) is a fully human IgG1κ mAb. Anti–IL-8 +/– NIVO demonstrated tolerability in pts with selected advanced cancers. Here, we report the final analysis from part 2 of CA027-002, a randomized phase 2 study of anti–IL-8 + NIVO + IPI vs placebo (PBO) + NIVO + IPI in pts with advanced melanoma resistant to PD-(L)1 blockade. Methods: Pts with unresectable, stage III/IV melanoma who had progressed on/after anti–PD-(L)1 [...]