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Nivolumab + Rintatolimab Therapy for Melanoma
Melanoma, Skin Cancer

UVA-1 Therapy Shows No Rise in Skin Cancer Risk

KEY TAKEAWAYS The study aimed to investigate the carcinogenic risk of medium-dose UVA-1 phototherapy in patients with MM. Researchers noticed that medium-dose UVA-1 phototherapy does not increase skin tumor risk or worsen facial photoaging; further investigation is...

May 30, 2024

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UVA-1 Therapy Shows No Rise in Skin Cancer Risk

KEY TAKEAWAYS

  • The study aimed to investigate the carcinogenic risk of medium-dose UVA-1 phototherapy in patients with MM.
  • Researchers noticed that medium-dose UVA-1 phototherapy does not increase skin tumor risk or worsen facial photoaging; further investigation is ongoing.

UVA-1 phototherapy was first used to treat atopic dermatitis and afterwards to several other skin diseases. The contribution of UVA-1 in human photocarcinogenesis, skin photoaging, immune suppression, and hyperpigmentation is now well established. The actual contribution of UVA-1 radiation to the development of malignant melanoma (MM) in humans cannot be excluded.

Davide Cosetti and the team aimed to evaluate the risk of developing skin cancers (non-melanoma skin cancers (NMSCs) and MM) in patients treated with UVA-1 phototherapy with a 5-year dermatological follow-up.

They performed an inclusive analysis in a retrospective cohort study with 31 patients diagnosed with morphea and atopic dermatitis, all of whom were treated with medium-dose UVA-1 phototherapy (34 J/cm2). The study involved annual oncologic prevention visits over a 5-year follow-up period, during which a comprehensive clinical evaluation of the entire skin surface was conducted for each patient.

About 5-year follow-up, a case of basal cell carcinoma (BCC) in the cervical region and 1 case of MM on the back (pT1a) were recorded. In both instances, the patients were female and diagnosed with morphea. The Glogau 3 group was prevalent (42%), consistent with moderate to severe aging, indicating compatibility with the age.

The study concluded that medium-dose UVA-1 phototherapy does not elevate the risk of skin tumors and does not exacerbate facial photoaging. However, the small sample size was the main limitation, precluding statistically significant findings. Individual analysis of daily sun exposure and its correlation with tumor development was also unfeasible.

Further research with larger sample sizes is necessary to validate these findings. Nonetheless, the study underscores the importance of annual dermatological examinations in monitoring patients undergoing this therapy.

No funding information was given.

Source: https://pubmed.ncbi.nlm.nih.gov/38787937/

Cosetti D, Cioppa V, Rubegni P, et qal. (2024). “Carcinogenic risk in patients treated with UVA-1 phototherapy: A 5-year retrospective study.” Photodermatol Photoimmunol Photomed. 2024 May;40(3):e12975. doi: 10.1111/phpp.12975. PMID: 38787937.

Impact of E-mailing Photos on Time to Melanoma Consultation

KEY TAKEAWAYS

  • The study aimed to investigate the impact of e-mailing suspected melanoma photos from GPs to dermatologists on consultation time.
  • Researchers noticed that e-mailing photos from GPs to dermatologists did not improve the management of suspicious skin lesions; further research is ongoing.

Difficulty obtaining a dermatological consultation is an obstacle to the early diagnosis of melanoma. On the one hand, patient survival depends on the lesion thickness at the time of diagnosis. On the other hand, dermatologists treat many patients with benign lesions. Optimizing patient care pathways is a major concern.

Céline Bouton and the team aimed to assess whether the e-mail transmission of photographs of suspected melanoma lesions between general practitioners (GPs) and dermatologists reduces the time to dermatological consultation for patients whose suspicious skin lesions ultimately require resection.

They performed an inclusive analysis in a cluster-randomized controlled study involving 51 French GPs from April 2017 to August 2019. A total of 250 patients referred to a dermatologist for suspected melanoma lesions were included. GPs were randomized to either the smartphone arm or the usual care arm.

In the smartphone arm, GPs referred patients by sending 2 photographs of the suspicious lesion using their smartphone, while in the usual care arm, GPs referred patients according to their typical practice. The primary outcome measured was the time to dermatological consultation for patients whose lesions ultimately required resection.

About 57 GPs volunteered were randomized (27 to the smartphone arm and 30 to the usual care arm). A total of 125 patients were included in each arm (mean age: 49.8 years; 53% women) and followed for 8 months.

About 23 dermatologists participated in the study. The time to dermatological consultation for patients whose suspicious skin lesion required resection was 56.5 days in the smartphone arm and 63.7 days in the usual care arm (mean adjusted time reduction: -18.5 days, 95% CI [-74.1;23.5], P = .53).

The study concluded that the e-mail transmission of photographs from GPs to dermatologists did not enhance the dermatological management of patients with suspicious skin lesions necessitating resection. Further research is imperative to validate quality criteria for tele-expertise in dermatology.

The study was sponsored by the Nantes University Hospital and the French National Ministry of Health.

Source: https://pubmed.ncbi.nlm.nih.gov/38783296/

Clinical Trial: https://clinicaltrials.gov/study/NCT03137511

Bouton C, Schmeltz H, Lévèque C, et al. (2024). “Early diagnosis of melanoma: a randomized trial assessing the impact of the transmission of photographs taken with a smartphone from the general practitioner to the dermatologist on the time to dermatological consultation.” BMC Health Serv Res. 2024 May 24;24(1):660. doi: 10.1186/s12913-024-11106-9. PMID: 38783296; PMCID: PMC11118897.

Optimizing ICI Treatment: Shorter Nivolumab Duration

KEY TAKEAWAYS

  • The study aimed to evaluate if stopping ICIs early is safe for individuals with unresectable stage III or metastatic melanoma on combination therapy.
  • The primary endpoint was the rate of ongoing response.
  • The results concluded that shorter nivolumab treatment was preferred for patients with favorable tumor responses.

Patients with unresectable stage III or metastatic melanoma, often with poor prognostic factors, commonly receive a combination of immune checkpoint inhibitors (ICIs), specifically ipilimumab and nivolumab. This treatment approach is associated with severe immune-related adverse events (irAEs) in approximately 60% of individuals.

Typically, patients undergo ICI therapy for up to 2 years or until disease progression or unacceptable adverse events occur. The incidence of irAEs tends to rise with prolonged treatment duration. Despite observing enduring tumor responses following early treatment discontinuation, consensus on the optimal treatment duration remains elusive.

J C Janssen and the team aimed to assess the safety of early discontinuation of ICIs in individuals with unresectable stage III or metastatic melanoma receiving combination therapy.

The Safe Stop IPI-NIVO trial is a nationwide, multicenter, prospective, single-arm, interventional study conducted in the Netherlands. It aims to include 80 patients with unresectable stage III or metastatic melanoma who are undergoing combination therapy with ipilimumab-nivolumab and have achieved a complete or partial response (CR/PR) according to RECIST v1.1. These patients will be enrolled to undergo early discontinuation of maintenance therapy with anti-PD-1.

The primary endpoint was the rate of ongoing response at 12 months after the initiation of ICI treatment. Secondary endpoints were ongoing response at 24 months, disease control at various time points, melanoma-specific and overall survival, the incidence of immune-related adverse events (irAEs), and health-related quality of life.

From medical, healthcare, and economic viewpoints, avoiding overtreatment is paramount, favoring shorter ICI durations if safe, especially for individuals with favorable tumor responses.

The trial was sponsored by the Erasmus Medical Center.

Source: https://pubmed.ncbi.nlm.nih.gov/38783238/

Clinical Trial: https://clinicaltrials.gov/study/NCT05652673

Janssen JC, van Dijk B, de Joode K, et al. (2024). “Safe Stop IPI-NIVO trial: early discontinuation of nivolumab upon achieving a complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab – study protocol.” BMC Cancer. 2024 May 23;24(1):632. doi: 10.1186/s12885-024-12336-0. PMID: 38783238.

PCD-Related Genes as Prognostic Biomarkers in SKCM

PCD-Related Genes as Prognostic Biomarkers in SKCM

KEY TAKEAWAYS

  • The study aimed to investigate the prognostic significance of PCD pathways in SKCM for personalized treatment strategies.
  • The analysis showed CDI’s prognostic value in SKCM, indicating potential for personalized treatment and improved outcomes.

Programmed cell death (PCD) pathways are crucial in skin cutaneous melanoma (SKCM) pathogenesis. Understanding their prognostic significance and clinical implications is essential for developing personalized treatment strategies.

Xiaoxia Wu and the team aimed to investigate the prognostic significance of PCD pathways in people with SKCM to inform personalized treatment strategies.

Using data from The Cancer Genome Atlas (TCGA)-SKCM cohort (n=353), about 1,466 PCD-related genes were analyzed. Researchers established and validated the prognostic cell death index (CDI) through survival analysis and predictive modeling. They conducted functional enrichment, protein-protein interaction (PPI) analysis, consensus clustering, tumor microenvironment assessment, and drug sensitivity analysis to elucidate the biological and clinical relevance of CDI.

The results revealed that CDI effectively stratified individuals with SKCM into high and low-risk groups, demonstrating significant differences in survival outcomes. CDI showed predictive value for survival at 1, 3, and 5 years. The concordance index (C-index) was 0.794 in the training set and 0.792 and 0.821 in the internal and external validation sets, respectively. The area under the curve (AUC) was above 0.75 in all data sets.

Functional enrichment analysis revealed significant associations with immune response and inflammatory processes. Protein-protein interaction (PPI) analysis identified key molecular modules linked to apoptosis and chemokine signaling. Consensus clustering unveiled three distinct subtypes with notable survival disparities based on CDI expression profiles. Tumor microenvironment assessment highlighted correlations with immune cell infiltration, including M1 macrophages and T cells. Drug sensitivity analysis indicated strong correlations between CDI levels and response to immunotherapy.

The study concluded that the analysis establishes the prognostic significance of PCD-related genes in SKCM. CDI emerges as a promising prognostic biomarker, providing insights into tumor biology and potential implications for personalized treatment strategies. Further validation and clinical integration of CDI are warranted to enhance SKCM management and improve outcomes for individuals with the condition.

No funding-related information was available.

Source: https://pubmed.ncbi.nlm.nih.gov/38766879/

Wu X, Chen S, Ji Q, et al. (2024). “Characteristics and significance of programmed cell death-related gene expression signature in skin cutaneous melanoma.” Skin Res Technol. 2024 May;30(5):e13739. doi: 10.1111/srt.13739. PMID: 38766879; PMCID: PMC11103559.

Ferroptosis Model Reveals New Insights for Melanoma Therapy

KEY TAKEAWAYS

  • The study aimed to develop a novel prognostic model assessing FRGs’ role in personalized melanoma treatment.
  • The results suggested a strong ferroptosis-related prognostic model, providing new insights into targeted and immunotherapy for melanoma.

Melanoma is highly malignant and heterogeneous, making it essential to develop a specific prognostic model to improve survival and treatment strategies for individuals with the disease. Recent studies have shown that ferroptosis, an iron-dependent form of programmed cell death, results from the overproduction of lipid peroxidation. Despite this, the clinical significance of ferroptosis-related genes (FRGs) in malignant melanoma remains unknown.

Meng Wu and the team aimed to evaluate the involvement of FRGs in melanoma, aiming to create an innovative prognostic model.

Researchers systematically characterized the genetic alterations and mRNA expression of 73 FRGs in The Cancer Genome Atlas (TCGA)-skin cutaneous melanoma (SKCM) dataset. The results were validated using real-time RT-PCR and Western blotting. Subsequently, a multi-gene feature model was constructed using the TCGA-SKCM cohort.

Based on the feature model, individuals with melanoma were classified into high-risk and low-risk groups. Finally, correlations between ferroptosis-related signatures and immune features, immunotherapy efficacy, and drug response were analyzed.

A prognostic model associated with FRGs, developed using the LASSO Cox regression method, identified 13 FRGs correlated with overall survival prognosis in individuals and was validated with external datasets. Subsequently, functional enrichment and immune response analysis indicated notable differences in immune cell infiltration, mutation burden, and hypoxia status between the high-risk and low-risk groups. Additionally, the model proved effective in predicting responses to immunotherapy and drug sensitivity.

The study concluded that a robust ferroptosis-related prognostic signature model was developed, offering potential new insights into targeted therapy and immunotherapy for patients with melanoma.

No funding-related information was available.

Source: https://pubmed.ncbi.nlm.nih.gov/38755712/

Wu M, Li K, Liao Y, et al. (2024). “Multi-omics analysis for ferroptosis-related genes as prognostic factors in cutaneous melanoma.” Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2024 Feb 28;49(2):159-174. doi: 10.11817/j.issn.1672-7347.2024.230401. PMID: 38755712; PMCID: PMC11103070.

Predicting LACSC Recurrence with SCC

KEY TAKEAWAYS

  • The study aimed to investigate the clinical significance of serum SCC antigen levels in patients with LACSC.
  • Researchers noticed a strong correlation between serum SCC antigen levels and recurrence sites in patients with LACSC.

Although serum squamous cell carcinoma (SCC) antigen values are known to be useful in predicting the prognosis of cervical SCC, they have only been examined in a cursory manner.

Yusuke Yamaoka and the team aimed to meticulously investigate the clinical significance of serum SCC antigen levels in patients with locally advanced cervical squamous cell carcinoma (LACSC).

They performed an inclusive analysis involving patients diagnosed with the local stage (T-stage) 1b3/2/3 LACSC who underwent initial treatment at the institute between January 2006 and December 2016 (T-1b3: n=30; T-2: n=75; T-3: n=34). Patients were categorized into three groups based on pre-treatment SCC values, and differences in clinical background, laboratory and pathology findings, and prognosis were examined.

About the SCC distribution, no significant difference was observed among the T-1b3/2/3 cases with elevated SCC levels. In stages T-1b3, T-2, and T-3, most recurrences in the SCC-High group were distant (T-1b3: 3 out of 5 recurrences; T-2: 6 out of 7 recurrences; T-3: 4 out of 8 recurrences), while most recurrences in the SCC-Low group were pelvic (T-1b3: 2 out of 3 recurrences; T-2: 8 out of 8 recurrences; T-3: 3 out of 3 recurrences).

The study concluded that in LACSC, serum SCC antigen levels before treatment strongly correlate with the recurrence site. Patients with low levels should be closely monitored for local recurrence, while those with high levels warrant vigilance for distant recurrence.

No funding information was given.

Source: https://pubmed.ncbi.nlm.nih.gov/38677756/

Yamaoka Y, Tamura S, Yamanoi K, et al. (2024). “Clinical Significance of Serum SCC Levels Before Treatment for Locally Advanced Cervical Squamous Cell Carcinoma.” Anticancer Res. 2024 May;44(5):2009-2019. doi: 10.21873/anticanres.17004. PMID: 38677756.

Nivo-Ipi vs. Nivo Alone in Advanced Cancers: Meta-Analysis

KEY TAKEAWAYS

  • The study aimed to investigate the efficacy and safety of Nivo-Ipi combination therapy compared to Nivo alone in advanced cancer types (excluding melanoma).
  • The primary endpoints were to determine OS, PFS, and AE’s.
  • Researchers found no significant OS benefit with Nivo-Ipi over Nivo alone in advanced cancers (excluding melanoma); further investigation is ongoing.

Nivolumab (Nivo) and ipilimumab (Ipi) have emerged as potent agents in cancer treatment, targeting distinct immune pathways. While their combination has shown efficacy in melanoma, its benefits in other cancers remain unclear.

Hussain Sohail Rangwala and the team aimed to evaluate the efficacy and safety of Nivo-Ipi versus Nivo alone in advanced cancer types, excluding melanoma.

They performed an inclusive meta-analysis following PRISMA guidelines up to September 30, 2023. Databases were systematically searched for randomized controlled trials (RCTs) focusing on advanced solid malignancies (excluding melanoma), with specific dosing of Nivo and Ipi. Primary outcomes encompassed overall survival (OS), progression-free survival (PFS), grades 3-4 adverse events (AEs), and treatment-related discontinuations. Secondary outcomes included specific AEs. Statistical analysis in Review Manager incorporated hazard ratio (HR) and risk ratio (RR), evaluating heterogeneity (Higgins I2).

About 9 RCTs, encompassing 2152 patients with various malignancies, were analyzed. The Nivo plus Ipi group demonstrated a median OS of 12.3 months and a median PFS of 3.73 months, while monotherapy exhibited 11.67 months and 3.98 months, respectively. No significant difference was observed in OS between the Nivo-Ipi combination and Nivo alone (HR = 0.97, 95% CI: 0.88 to 1.08, P = 0.61). However, a slight improvement in PFS was noted with combination therapy (HR = 0.91, 95% CI: 0.82 to 1.00, P = 0.04).

Treatment-related cumulative grades 3-4 AE’s were higher with Nivo and Ipi (RR = 1.52, 95% CI: 1.30 to 1.78, P < 0.00001), as were treatment-related discontinuations (RR = 1.99, 95% CI: 1.46 to 2.70, P < 0.0001). Additionally, hepatotoxicity (RR = 2.42, 95% CI: 1.39 to 4.24, P = 0.002), GI toxicity (RR = 2.84, 95% CI: 1.44 to 5.59, P = 0.002), pneumonitis (RR = 2.29, 95% CI: 1.24 to 2.23, P = 0.008), dermatitis (RR = 2.96, 95% CI: 1.08 to 8.14, P = 0.04), and endocrine dysfunction (RR = 6.22, 95% CI: 2.31 to 16.71, P = 0.0003) were more frequent with Nivo and Ipi.

The study concluded that combining Nivo and Ipi did not significantly improve OS compared to Nivo alone in advanced cancers (excluding melanoma). However, it did demonstrate slightly better PFS at the expense of increased toxicity, notably grades 3-4 AEs. Specific AEs were more prevalent in the combination group. Further trials are warranted to comprehensively evaluate the efficacy and safety of this combination in treating advanced cancers.

The study received no funds.

Source: https://pubmed.ncbi.nlm.nih.gov/38705953/

Rangwala HS, Fatima H, Ali M, et al. (2024). “Evaluating the efficacy and safety of nivolumab and ipilimumab combination therapy compared to nivolumab monotherapy in advanced cancers (excluding melanoma): a systemic review and meta-analysis.” J Egypt Natl Canc Inst. 2024 May 6;36(1):14. doi: 10.1186/s43046-024-00218-2. PMID: 38705953.

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