Actikerall (fluorouracil salicylic acid) / Almirall - LARVOL DELTA

Successful topical 5-aminolevulinic acid photodynamic therapy in the treatment of resistant, multiple palmar warts - two clinical cases with general evidence analysis (EADV-Sp 2024) - "Materials & 28-year old man with multiple (>20) verrucae on eight fingers in the periungual area and a 51-year old woman with >25 lesions present on the both hands were referred to the dermatology clinic after unsuccessful, multiple treatments by curettage, cryotherapy with liquid nitrogen, topical salicylic acid and 5-fluorouracil with no clinical improvement observed... In cases of multiple, resistant palmar warts, 5-ALA PDT may be an effective and safe treatment method, exhibiting few side effects."

Clinical • Dermatology • Oncology • Pain

Systematic review of randomized controlled trials of topicals for actinic keratosis field therapy. (PubMed, Arch Dermatol Res) - "We identified 20 original randomized controlled trials for topical cutaneous field therapy. 0.5% 5-Fluorouracil/salicylic acid and 0.5% 5-fluorouracil received a clinical recommendation grade of A, while diclofenac sodium received a clinical recommendation grade of B. Calcipotriol/5-fluorouracil, Imiquimod, sunscreen combination therapies, and tirbanibulin received a recommendation grade of C. This review provides a framework for clinicians when considering topical treatments for patients with field cancerization."

Journal • Review • Actinic Keratosis • Dermatology • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

New topical agents for actinic keratoses: clinical and OCT evaluation (WCD 2023) - "OBSERVATION: Among available treatments, it is possible to distinguish lesion-directed therapies (cryotherapy, laser therapy, conventional photodynamic theapy and surgery when a progression to iSCC is suspected) and field-directed therapies (5-fluorouracil, diclofenac,piroxicam, imiquimod and daylight photodynamic therapy)associated to daily appropriate photoprotection...We evaluated efficacy, safety and adherence to therapy of topical ointments indicated for the treatment of the different clinico-pathologic variants of AK (focusing on tirbanibulin and 5-Fluorouracil 0.5%, Salicylic Acid 10%), providing a clinical, dermoscopic and OCT longitudinal evaluation...Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis...2021;384(6):512-520. doi:10.1056/NEJMoa2024040"

Clinical • Actinic Keratosis • Allergy • Bowens Disease • Dermatology • Immunology • Oncology • Squamous Cell Carcinoma

Remission of a large plantar verruca vulgaris in an immunocompromised patient postincisional punch biopsy (BAD 2023) - "His immunosuppressive treatment consists of tacrolimus, mycophenolate mofetil and prednisolone 5 mg once daily...This had been recalcitrant to extensive treatment, including topical salicylic acid, 5-fluorouracil, cantharidin and numerous courses of cryotherapy and paring over the previous 6 years...Renal transplant patients represent a unique cohort in relation to verruca vulgaris, whereby impaired cell-mediated immunity can increase their susceptibility to HPV, thereby reducing effective treatment options and meaning definitive clearance may never be achieved. Our case highlights that incisional punch biopsy may represent an accessible and cost-effective approach to the treatment of verruca vulgaris in immunosuppressed patients, where alternative treatment options would necessitate numerous hospital visits."

Biopsy • Clinical • Anesthesia • Dermatology • Human Papillomavirus Infection • Infectious Disease • Oncology • Pain • Transplantation

Poor Adherence to Self-Applied Topical Drug Treatment Is a Common Source of Low Lesion Clearance in Patients with Actinic Keratosis-A Cross-Sectional Study. (PubMed, J Clin Med) - "A thorough pre-treatment consultation can help to increase treatment adherence and ensure lesion clearance."

Adherence • Journal • Observational data • Actinic Keratosis • Dermatology

On the possibility of using the Ti@Si superatom as a novel drug delivery carrier for different drugs: A DFT study. (PubMed, J Mol Graph Model) - "The potential application of an experimentally synthesized superatom Ti@Si as a novel drug carrier for cisplatin (DDP), isoniazid (INH), acetylsalicylic acid (ASA), 5-fluorouracil (5-Fu), and favipiravir (FPV) has been explored by density functional theory. More importantly, the release of DDP drug from the Ti@Si surface can be effectively controlled by exerting small orientation external electric fields on the DDP@[Ti@Si] complex. Therefore, this study demonstrates that Ti@Si can serve as a promising drug carrier for DDP, and thus will further expand its practical applications in the biomedical field."

Journal

Assessing Similarity of Studies for Network Meta-Analysis: The Use of Feasibility Assessment and Sensitivity Analyses to Estimate the Efficacy of Tirbanibulin, a New Drug for Actinic Keratosis (ISPOR-EU 2022) - "OBJECTIVES: We conducted a systematic literature review and network meta-analysis (NMA) to assess complete clearance of actinic keratosis by a new drug, tirbanibulin 1% ointment, compared with existing treatments in Europe...In the primary analysis, all odds ratios credible intervals overlapped, suggesting similar efficacy across treatments (tirbanibulin, imiquimod 5%, imiquimod 3.75%, fluorouracil 0.5% + salicylic acid, diclofenac sodium 3%, fluorouracil 5%, fluorouracil 4%, ingenol mebutate 0.015%, cryosurgery, photodynamic therapy with aminolevulinic acid and with methyl aminolevulinate)... Results of the primary analysis suggested that tirbanibulin can achieve similar complete clearance to other treatments for AK. The treatment-effect modifiers were found to have little impact on the results, increasing confidence in their generalizability within the population of interest. Identifying potential treatment-effect modifiers and quantitatively assessing their impact on..."

Retrospective data • Actinic Keratosis • Dermatology

Challenges of Network Meta-Analysis for Safety Outcomes: The Analysis of Tirbanibulin Against Common Treatments in Europe for Actinic Keratosis (ISPOR-EU 2022) - "OBJECTIVES: We conducted a systematic literature review and network meta-analysis (NMA) to assess the safety of a new drug, tirbanibulin 1% ointment, compared with common treatments for actinic keratosis (AK) in Europe...While eligible interventions generally reported low rates of ≤2%, including tirbanibulin with 0% and placebo between 0 and 0.6%, two of the interventions, fluorouracil 0.5%+salicylic acid and diclofenac sodium 3%, reported rates between 6 and 9%... Although severe LSRs and resulting discontinuations were key outcomes of interest, a lack of reporting and methodological challenges hindered any in-depth comparison of these safety data. FA is a useful tool to identify issues with data quality, which informs whether to compare data quantitively or only summarize qualitatively."

Retrospective data • Actinic Keratosis • Dermatology

Comprehensive Treatment of Basal Cell Carcinoma in Nevoid Basal Cell Carcinoma Syndrome with 5-fluorouracil and Salicylic Acid. (PubMed, Dermatol Ther) - No abstract available

Journal • Basal Cell Carcinoma • Oncology • Rare Diseases

Combination of topical fluorouracil and salicylic acid as a therapeutic option for recalcitrant warts of the nail unit. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Dermatology

Early clinical response to 5-fluorouracil 0.5% and salicylic acid 10% topical solution in the treatment of actinic keratoses of the head: a prospective observational study (EADO 2022) - No abstract available

Clinical • Observational data

Early clinical response to 5-fluorouracil 0.5% and salicylic acid 10% topical solution in the treatment of actinic keratoses of the head: an observational study. (PubMed, J Dermatolog Treat) - "5-fluorouracil and salicylic acid topical solution is effective in the treatment of mild to moderate actinic keratoses. In the future, further studies are needed to evaluate the chance of adjusting drug dosage according to patients' and actinic keratoses features."

Journal • Observational data • Actinic Keratosis • Dermatology • Oncology

Cutaneous Manifestations of a Rare RASopathy: Costello Syndrome (AAD 2022) - "Other previously-reported treatments also include topical fluorouracil, salicylic acid, and tretinoin.DiscussionGiven its rarity and the complexity of associated co-morbidities, the differential diagnosis of CS should include Noonan and cardio-facio-cutaneous syndromes. Of note, the papillomata of CS are quite characteristic for this syndrome. Suspicion of CS should prompt initial evaluation with molecular genetics, followed by an early comprehensive, multidisciplinary work-up for anatomic and physiologic abnormalities, given the likely multisystem involvement."

Cardiomyopathy • Cardiovascular • Hypertrophic Cardiomyopathy • Oncology • HRAS

Comparative Efficacy and Safety of Tirbanibulin for Actinic Keratosis of the Face and Scalp in Europe: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. (PubMed, J Clin Med) - "We conducted a systematic review of efficacy and safety for key treatments for AK of the face and scalp, including the novel 5-day tirbanibulin 1% ointment...The network meta-analysis revealed the following odds ratios and 95% credible intervals: cryosurgery 13.4 (6.2-30.3); diclofenac 3% 2.9 (1.9-4.3); fluorouracil 0.5% + salicylic acid 7.6 (4.6-13.5); fluorouracil 4% 30.3 (9.1-144.7); fluorouracil 5% 35.0 (10.2-164.4); imiquimod 3.75% 8.5 (3.5-22.4); imiquimod 5% 17.9 (9.1-36.6); ingenol mebutate 0.015% 12.5 (8.1-19.9); photodynamic therapy with aminolevulinic acid 24.1 (10.9-52.8); photodynamic therapy with methyl aminolevulinate 11.7 (6.0-21.9); tirbanibulin 1% 11.1 (6.2-20.9)...Safety outcomes were assessed qualitatively. These results suggest that tirbanibulin 1% offers a novel treatment for AK, with a single short treatment period, favourable safety profile and efficacy, in line with existing topical treatments available in Europe."

Journal • Retrospective data • Review • Actinic Keratosis • Dermatology • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

5-Fluorouracil 0.5%/Salicylic Acid 10% Solution in the Treatment of Ano-Genital Warts. (PubMed, Dermatol Ther) - "The clearance rate that we found for 5-FU/SAsol after 3 months of treatment is comparable with that of the other commonly used therapeutic modalities (liquid nitrogen cryotherapy, imiquimod 5% cream). In conclusion, although nowadays in Italy 5-FU/SAsol is marketed only for the treatment of actinic keratosis, our study described its effectiveness and tolerability also in the treatment of AGWs. Our data suggest that 5-FU/SAsol should be considered not only in case of resistant/recurrent AGWs but also as the first therapeutic option, especially when the number of lesions is small."

Journal • Actinic Keratosis • Dermatology • Pain

Tirbanibulin 1% ointment (Klisyri) for actinic keratosis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Actinic Keratosis • Dermatology

Effectiveness of New 5-Fluorouracil/Salicylic Acid Application Method for Periungual Warts: A Descriptive Study. (PubMed, Ann Dermatol) - No abstract available

Journal • Dermatology

Actively Recruiting Clinical Trials on Colorectal Cancer (THE ASCO POST) - "This Clinical Trials Resource Guide lists actively recruiting trials on colorectal cancer, focusing on novel treatments, combinations of treatments, and testing options to determine which patients may be most likely to benefit from further treatment....Principal Investigator: Frank A. Sinicrope, MD."

Effectiveness and Tolerability of Treatment for Isolated Actinic Keratoses: A Retrospective Comparison Between Cryotherapy, CO2 laser and 5-Fluorouracil 0.5% /Salicylic Acid 10. (PubMed, Dermatol Ther) - "Cryotherapy, CO2 laser and 5-FU 5%/SA 10% were all effective, with no significant efficacy differences among them. Additionally, 5-FU 5%/SA 10% was proved to have the best aesthetic result and to cause the least pain, while necessitating long-term administration. This should be taken into account for patients with low pain tolerance and low treatment adherence. Cryotherapy and CO laser have the advantage of requiring a single session, which might be more suitable for uncooperative patients."

Journal • Retrospective data • Actinic Keratosis • Dermatology • Oncology • Pain • Squamous Cell Carcinoma

Onvansertib Triplet Shows Promise in KRAS-Mutant Metastatic Colorectal Cancer (Targeted Oncology) - "The preliminary results from the study are interesting because this is a phase Ib dose-escalation trial looking at the standard chemotherapy regimen FOLFIRI plus bevacizumab in combination with onvansertib. What we noticed is that when we looked at some of the correlative work, including capturing circulating tumor DNA (ctDNA), which demonstrated a decrease in percentage ofKRAS-mutated circulating tumor DNA. These were the patients that were treated with the investigational agents in combination with chemotherapy and bevacizumab. Not only did we see evidence of radiographic response, but we also saw evidence of a decrease in theirKRAS-mutated ctDNA."

Interview

Actikerall: an alternative to curettage for some seborrhoeic keratoses? (PubMed, Clin Exp Dermatol) - No abstract available.

Journal • Biosimilar • Ophthalmology

R/R metastatic CRC: Correct, IMblaze370, and ReDOS trials (OncLive) - "Insights From: Marwan Fakih, MD...Axel Grothey, MD...Scott Kopetz, MD, PhD...Axel Grothey, MD: The data that we have for efficacy of treatment in third-line therapy are based on large randomized trials that showed survival benefit for drugs like regorafenib and TAS-102 [trifluridine, tipiracil]....Regorafenib came out as the de facto winner of this study, not in terms of statistically significant prolonged overall survival. But survival was, again, better than expected in the range of about 8.5 months, 8.6 months in overall survival. It clearly established itself again as a standard of care in this setting."

Video

Cetuximab harmful for operable CRC liver metastases - More than 2-year drop in survival when added to chemotherapy (MedPageToday) - "Writing in an accompanying editorial...and Axel Grothey...commented that since the start of the trial, 'new insights into prognostic and predictive molecular signatures of metastatic colorectal cancer have emerged,' as well as the fact that first-line treatment with cetuximab was shown to be worse compared to bevacizumab (Avastin) when it came to OS for patients with right-sided CRCs....'Although historically good responses have been achieved with more aggressive therapies in the advanced setting, cetuximab and cytotoxic therapy (oxaliplatin plus fluorouracil) in resectable stage IV and III colorectal cancers apparently might have a detrimental effect on survival,'...and Grothey concluded."

Clinical • Media quote

ASCO GI 2020: Abstract recommendations in colorectal cancer from Dr. Axel Grothey (PracticeUpdate) - "Dr. Axel Grothey...recommends the following abstracts in colorectal cancer being presented at the ASCO Gastrointestinal Cancers Symposium...Pembrolizumab for advanced anal squamous cell carcinoma (ASCC): Results from the multicohort, phase II KEYNOTE-158 study....Encorafenib plus cetuximab with or without binimetinib for BRAF V600E-mutant metastatic colorectal cancer: Quality-of-life results from a randomized, three-arm, phase III study versus the choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC)."

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